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MS2_1shot200
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: The purpose of this study was to compare circadian blood pressure and heart rate patterns and other cardiovascular effects of nicotine delivered rapidly ( via nasal spray , NNS ) , slowly ( transdermal nicotine , TDN ) , by cigarette smoking ( rapid delivery of nicotine plus other smoke toxins ) , and placebo NNS . Twelve healthy cigarette smokers were studied on a research ward when they smoked cigarettes ( 16 per day ) or used TDN ( 15 mg/16 h ) , NNS ( 24 1-mg doses per day ) , or placebo NNS , each for 5 days . There were no significant differences in systolic blood pressure , but diastolic blood pressure was slightly increased during cigarette smoking . Plasma epinephrine , & bgr;-thromboglobulin , and fibrinogen levels were higher during cigarette smoking than with TDN . For most measurements , NNS values were intermediate between and not significantly different from those of cigarette smoking and TDN . We conclude that , at recommended doses , TDN and NNS have fewer effects on biomarkers of cardiovascular risk than does cigarette smoking INTRODUCTION Tobacco smoking leads to changes in hemodynamic parameters such as heart rate and systolic or diastolic blood pressure . It has a direct influence on the elasticity of blood vessels and increases arterial stiffness , which can result in development of atherosclerosis . Data show that the nicotine in tobacco smoke probably is responsible for these changes . Electronic cigarettes ( e-cigarettes ) were supposedly a healthier alternative to combustible cigarettes because they imitate a process of cigarettes smoking but generate nicotine aerosol without the toxic substances from tobacco combustion . However , the use of e-cigarettes is still controversial because their toxicity , safety and long term use health impact have not been sufficiently studied . AIM The aim of this study was to evaluate changes in arterial stiffness parameters after smoking a cigarette or e-cigarette use . METHODS Fifteen healthy women , aged 19 - 25 years old , smoking ≥5 cigarettes per day for at least two years participated in the study . A non-invasive measurement of arterial stiffness parameters - Stiffness Index ( SI ) and Reflection Index ( RI ) - was conducted and systolic and diastolic blood pressure and heart rate were measured before and after smoking a conventional cigarette as well as use of an e-cigarette . RESULTS Statistically significant changes in the SI and RI were observed before and after smoking of a conventional cigarette [ SI : 6.75 m/s ( 6.66 - 6.85 , 95 % CI ) vs 6.56 m/s ( 6.46 - 6.65 . 95 % CI ) , p=0.0056 ; RI : 54.0 % ( 51.5 - 56.7 , 95 % CI ) vs 49.6 % ( 47.5 - 51.8 , 95 % CI ) , p=0.010 ] . The use of e-cigarettes result ed in no statistically significant changes in the SI and RI . After both product use systolic and diastolic blood pressure and heart rate increased but the changes were not statistically significant . CONCLUSIONS In contrast to conventional cigarette use , the use of electronic cigarettes causes no changes in arterial stiffness . This may indicate lower bioavailability of nicotine from the e-cigarette or an additional effect of other substances present in cigarette smoke but absent in an e-cigarette aerosol Background Electronic cigarettes ( e-cigarettes ) are becoming increasingly popular with smokers worldwide . Users report buying them to help quit smoking , to reduce cigarette consumption , to relieve tobacco withdrawal symptoms , and to continue having a ‘ smoking ’ experience , but with reduced health risks . Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators , healthcare providers and consumers are based on science . Methods ECLAT is a prospect i ve 12-month r and omized , controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model ( ‘ Categoria ’ ; Arbi Group Srl , Italy ) compared to its non-nicotine choice . GroupA ( n = 100 ) received 7.2 mg nicotine cartridges for 12 weeks ; GroupB ( n = 100 ) , a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges ; GroupC ( n = 100 ) received no-nicotine cartridges for 12 weeks . The study consisted of nine visits during which cig/day use and exhaled carbon monoxide ( eCO ) levels were measured . Smoking reduction and abstinence rates were calculated . Adverse events and product preferences were also review ed . Results Declines in cig/day use and eCO levels were observed at each study visits in all three study groups ( p<0.001 vs baseline ) , with no consistent differences among study groups . Smoking reduction was documented in 22.3 % and 10.3 % at week-12 and week-52 respectively . Complete abstinence from tobacco smoking was documented in 10.7 % and 8.7 % at week-12 and week-52 respectively . A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study . Participants ’ perception and acceptance of the product under investigation was satisfactory . Conclusion In smokers not intending to quit , the use of e-cigarettes , with or without nicotine , decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects . Trial Registration Clinical Trials.gov NCT01164072 Objective . To examine the effects of maternal prenatal smokeless tobacco use on infant birth size . Design . A retrospective medical record review of 502 r and omly selected deliveries . Population and Setting . Singleton deliveries to Alaska Native women residing in a defined geographical region in western Alaska , 1997–2005 . Methods . A regional medical center 's electronic records were used to identify singleton deliveries . Data on maternal tobacco exposure and pregnancy outcomes were abstract ed from medical records . Logistic models were used to estimate adjusted mean birthweight , length and head circumference for deliveries to women who used no tobacco ( n=121 ) , used smokeless tobacco ( n=237 ) or smoked cigarettes ( n=59 ) . Differences in mean birthweight , length and head circumference , 95 % confidence intervals and p‐values were calculated using non‐users as the reference group . Main Outcome Measures . Infant birthweight , crown – heel length and head circumference . Results . After adjustment for gestational age and other potential confounders , the mean birthweight of infants of smokeless tobacco users was reduced by 78 g compared with that of infants of non‐users ( p=0.18 ) and by 331 g in infants of smokers ( p<0.01 ) . No association was found between maternal smokeless tobacco use and infant length or infant head circumference . Conclusions . We found a modest but non‐significant reduction in the birthweight of infants of smokeless tobacco users compared with infants of tobacco non‐users . Because smokeless tobacco contains many toxic compounds that could affect other pregnancy outcomes , results of this study should not be construed to mean that smokeless tobacco use is safe during pregnancy Objective To evaluate the safety and efficacy as a tool of smoking cessation of electronic cigarettes ( e-cigarettes ) , directly comparing users of e-cigarettes only , smokers of tobacco cigarettes only , and smokers of both . Design Prospect i ve cohort study . Final results are expected in 2019 , but given the urgency of data to support policies on electronic smoking , we report the results of the 12-month follow-up . Data Sources Direct contact and structured question naires by phone or via internet . Methods Adults ( 30–75 years ) were included if they were smokers of ≥1 tobacco cigarette/day ( tobacco smokers ) , users of any type of e-cigarettes , inhaling ≥50 puffs weekly ( e-smokers ) , or smokers of both tobacco and e-cigarettes ( dual smokers ) . Carbon monoxide levels were tested in a sample of those declaring tobacco smoking abstinence . Main Outcome Measures Sustained smoking abstinence from tobacco smoking at 12 months , reduction in the number of tobacco cigarettes smoked daily . Data Synthesis We used linear and logistic regression , with region as cluster unit . Results Follow-up data were available for 236 e-smokers , 491 tobacco smokers , and 232 dual smokers ( overall response rate 70.8 % ) . All e-smokers were tobacco ex-smokers . At 12 months , 61.9 % of the e-smokers were still abstinent from tobacco smoking ; 20.6 % of the tobacco smokers and 22.0 % of the dual smokers achieved tobacco abstinence . Adjusting for potential confounders , tobacco smoking abstinence or cessation remained significantly more likely among e-smokers ( adjusted OR 5.19 ; 95 % CI : 3.35–8.02 ) , whereas adding e-cigarettes to tobacco smoking did not enhance the likelihood of quitting tobacco and did not reduce tobacco cigarette consumption . E-smokers showed a minimal but significantly higher increase in self-rated health than other smokers . Non significant differences were found in self-reported serious adverse events ( eleven overall ) . Conclusions Adding e-cigarettes to tobacco smoking did not facilitate smoking cessation or reduction . If e-cigarette safety will be confirmed , however , the use of e-cigarettes alone may facilitate quitters remaining so . Registration Number NCT01785537 We conducted a case-control study to test the hypothesis that women smokers who use oral contraceptives have an increased risk of developing venous thrombosis . Patients and controls were drawn from two sets of hospital patients already included in the Boston Collaborative Drug Surveillance Programme . Sixty patients with uncomplicated thromboembolism were matched with 180 controls with other diagnoses ; all were premenopausal women taking oral contraceptives . Patients with conditions that might predispose to thromboembolism or be related to smoking were excluded . We found no association between smoking habits and thromboembolism . Similarly , we found no association between thromboembolism , smoking , and duration of oral contraceptive use . Thus we conclude that differences in fibrinolytic activity between smokers and non-smokers are not major factors in the aetiology of uncomplicated thromboembolism in women using oral contraceptives Background Electronic cigarettes have been developed and marketed in recent years as smoking substitutes . However , no studies have evaluated their effects on the cardiovascular system . The purpose of this study was to examine the immediate effects of electronic cigarette use on left ventricular ( LV ) function , compared to the well-documented acute adverse effects of smoking . Methods Echocardiographic examinations were performed in 36 healthy heavy smokers ( SM , age 36 ± 5 years ) before and after smoking 1 cigarette and in 40 electronic cigarette users ( ECIG , age 35 ± 5 years ) before and after using the device with “ medium-strength ” nicotine concentration ( 11 mg/ml ) for 7 minutes . Mitral flow diastolic velocities ( E , A ) , their ratio ( E/A ) , deceleration time ( DT ) , isovolumetric relaxation time ( IVRT ) and corrected-to-heart rate IVRT ( IVRTc ) were measured . Mitral annulus systolic ( Sm ) , and diastolic ( Em , Am ) velocities were estimated . Myocardial performance index was calculated from Doppler flow ( MPI ) and tissue Doppler ( MPIt ) . Longitudinal deformation measurements of global strain ( GS ) , systolic ( SRs ) and diastolic ( SRe , SRa ) strain rate were also performed . Results Baseline measurements were similar in both groups . In SM , IVRT and IVRTc were prolonged , Em and SRe were decreased , and both MPI and MPIt were elevated after smoking . In ECIG , no differences were observed after device use . Comparing after-use measurements , ECIG had higher Em ( P = 0.032 ) and SRe ( P = 0.022 ) , and lower IVRTc ( P = 0.011 ) , MPI ( P = 0.001 ) and MPIt ( P = 0.019 ) . The observed differences were significant even after adjusting for changes in heart rate and blood pressure . Conclusions Although acute smoking causes a delay in myocardial relaxation , electronic cigarette use has no immediate effects . Electronic cigarettes ’ role in tobacco harm reduction should be studied intensively in order to determine whether switching to electronic cigarette use may have long-term beneficial effects on smokers ’ health . Trial registration Current Controlled Trials IS RCT OBJECTIVE We examined screening practice s and attitudes of obstetricians-gynecologists toward the use of noncombustible tobacco products ( chewing tobacco , snuff/snus , electronic cigarettes , and dissolvables ) during pregnancy . STUDY DESIGN The authors mailed a survey in 2 Output:
We identified no evidence on CV outcomes among e-cigarette users using HC . Limited data reporting mostly acute outcomes suggested that CV events are rare among e-cigarette users in the general population and that e-cigarettes may affect heart rate and blood pressure less than conventional cigarettes .
MS2_1shot201
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Objective - To compare the effectiveness of two different stop smoking interventions . Design - A r and omised , controlled trial . Results based on intention to treat . Setting - Three towns in the south-eastern part of Norway . Interventions - Visits to GP for " practice as usual " ( GP group ) or participation in the behavioural programme SmokEnders ( SE group ) with follow-up 2 weeks , 2 months and 1 year after an agreed stopping date . Subjects - 139 smokers recruited through open invitation . Main outcome measure - Self-reported smoking stop rate 2 weeks , 2 months and 1 year after an agreed stopping date , completed with biochemical indicators by the 1-year registration . Results ? Two weeks after the agreed cessation date , 10/70 ( 14 % ) of the GP group and 46/69 ( 67 % ) of the SE group had stopped smoking . After 2 months , 9/70 ( 13 % ) in the GP group and 37/69 ( 54 % ) in the SE group were non-smokers . One year after cessation 5/70 ( 7 % ) in the GP group and 21/69 ( 30 % ) in the SE group were non-smokers . Conclusions ? Both interventions were effective as measured by the smoking cessation rate . However , the intervention in the SE group was considerably more effective than in the GP group , which suffered from a sizeable number of drop-outs OBJECTIVES To compare the effects of a worksite intervention by the occupational physician offering simple advice of smoking cessation with a more active strategy of advice including a “ quit date ” and extra support . POPULATION Employees of an electrical and gas company seen at the annual visit by their occupational physicians . CRITERIA END POINTS Smoking point prevalence defined as the percentage of smokers who were non-smokers at one year . Secondary criteria were the percentage of smokers who stopped smoking for more than six months and the difference in prevalence of smoking in both groups . METHODS R and omised controlled trial . The unit of r and omisation was the work site physician and a r and om sample of the employees of whom he or she was in charge . The length of the follow up was one year . Each of 30 work site physicians included in the study 100 to 150 employees . RESULTS Among 504 subjects classified as smokers at baseline receiving simple advice ( group A ) and 591 the more active programme ( group B ) , 68 ( 13.5 % ) in group A and 109 ( 18.4 % ) were non-smokers one year later ( p=0.03 ; p=0.01 taking the occupational physician as the statistical unit and using a non-parametric test ) . Twenty three subjects ( 4.6 % ) in group A and 36 ( 6.1 % ) in group B ( p=0.26 ) declared abstinence of six months or more . Among non-smokers at baseline , 3.4 % in both groups were smokers after one year follow up . The prevalence of smokers did not differ significantly at baseline ( 32.9 % and 32.4 % , p=0.75 ) . After the intervention the prevalence of smoking was 30.8 % in group A and 28.7 % in group B ( p=0.19 ) . An increase of the mean symptoms score for depression in those who quit was observed during this period . CONCLUSIONS A simple cessation intervention strategy during a m and atory annual examination , targeting a population of smokers independently of their motivation to stop smoking or their health status , showed a 36 % relative increase of the proportion of smokers who quit smoking as compared with what can be achieved through simple advice The purpose of this study was to examine the effectiveness of different practice -based approaches to assist patients of primary care physicians to quit smoking and sustain cessation . Forty-four nonsmoking general practitioners volunteered for the study . After a period of training , they r and omized 923 smoking clients , unselected for motivation toward quitting , to four different intervention groups : ( i ) minimal intervention , consisting of one single counselling session and a brief h and out on quitting techniques ; ( ii ) repeated counselling including reinforcing sessions at Months 1 , 3 , 6 , and 9 ; ( iii ) repeated counselling and use of nicotine gum ; and ( iv ) repeated counselling and spirometry . Biochemically vali date d smoking status was assessed at six and 12 months after recruitment . The proportion of verified quitters at 12 months was 4.8 percent among subjects r and omized to the minimal intervention group , compared to 5.5 percent , 7.5 percent , and 6.5 percent among those r and omized to the three repeated-counselling groups . In no treatment group was the outcome significantly different from that for one-time counselling at the ( P<0.05 ) level . Lack of power , contamination , and low attendance at reinforcing sessions should be taken into account in interpreting the results This study was design ed to see whether the offer and prescription of nicotine chewing gum would enhance the efficacy of general practitioners ' advice to stop smoking . A sample of 1938 cigarette smokers who attended the surgeries of 34 general practitioners in six group practice s were assigned by week of attendance ( in a balanced design ) to one of three groups : ( a ) non-intervention controls , ( b ) advice plus booklet , and ( c ) advice plus booklet plus the offer of nicotine gum . Follow up was done after four months and one year . The results show a clear advantage for those offered the nicotine gum ( p less than 0.001 ) . After correction for those who refused or failed chemical validation and those who switched from cigarettes to a pipe or cigars , the proportions who were abstinent at four months and still abstinent at one year were 3.9 % , 4.1 % , and 8.8 % in the three groups , respectively . These percentages are based on all cigarette smokers who attended the surgeries including those who did not wish to stop and those in the gum group who did not try the gum ( 47 % ) . The effect of the offer and prescription of gum was to motivate more smokers to try to stop , to increase the success rate among those who tried , and to reduce the relapse rate of those who stopped . The self selected subgroup of 8 % who used more than one box of 105 pieces of gum achieved a success rate of 24 % . It would be feasible and effective for general practitioners to include the offer of nicotine gum and brief instructions on its use as part of a minimal intervention routine with all cigarette smokers . A general practitioner who adopts such a routine with similar success could expect to achieve about 35 - 40 long term ex-smokers a year and so save the lives of about 10 of them . If replicated by all general practitioners throughout the country the yield of ex-smokers would be about one million a year The effect of different follow-up programs reinforced or not reinforced with the nicotine chewing gum Nicorette was tested by 13 physicians working in the open health care system . A total of 151 patients were advised to stop smoking , and were asked to participate in the program if judged sufficiently motivated by the physicians . After inclusion they were r and omized into short or long follow-up , and nicotine gum vs no gum . The physicians conducted the follow-up therapy in their own personal way . Short follow-up was comprised of one appointment 14 days after cessation , while long follow-up consisted of a telephone call ( 1 week ) , an appointment ( 2 weeks ) , a second appointment ( 1 month ) , and a letter ( 3 months ) . The results at 12 months were that long follow-up showed a trend ( P less than 0.12 toward being better than short follow-up , while nicotine gum was significantly better than no gum ( P less than 0.05 ) in maintaining abstinence . The group with the best outcome was the one receiving long follow-up and nicotine gum , which yielded an expired air carbon monoxide-controlled , 12-month abstinence rate of 27 % . The abstinence outcomes at 12 months for the other groups were short follow-up and nicotine gum , 22 % ; long follow-up and no gum , 15 % ; and short follow-up and no gum , 3 % . The physicians ' reactions to the smoking cessation treatment were largely positive . The nicotine gum seems to be a relatively simple , cost-effective , and practical tool for physicians to enhance and reinforce their antismoking advice . With a longer active follow-up period than was used here ( 1 month ) , even better results may be possible A 2 × 2 r and omized , factorial pretest/posttest group design was used to evaluate the effectiveness of self-help smoking cessation methods at the worksite . The study investigated the effect of a multicomponent health education and skill intervention versus the effect of a monetary incentive to the employee for quitting . All employees received , in addition , a st and ardized self-help smoking cessation manual and maintenance manual . Following agreement to participate and a baseline smoking history , all participants were followed for 6 weeks , 6 months , and 12 months . Saliva was obtained for thiocyanate ( SCN ) analysis of smoking status . Of the estimated 2000 smokers at the site , 387 smokers were recruited . Employees were r and omly assigned to one of four groups . Results of this r and om trial indicate that those employees receiving a multicomponent program were most successful in quitting and remaining abstinent . The monetary incentive appears to have no effect on quit rate Physician-delivered , stop-smoking interventions significantly improve quit rates among smoking patients [ 1 - 6 ] . Unfortunately , only about one half of physicians in non research setting s consistently counsel smokers [ 7 - 11 ] , and fewer than one half of all smokers report that a physician has ever advised them to quit [ 12 - 14 ] . Given the pressures of routine medical practice , it is not surprising that physicians do not take 3 to 5 minutes to counsel every smoking patient they see . Tobacco counseling competes with other pressing clinical tasks ; physicians are often too busy to routinely and repeatedly counsel all patients who smoke [ 11 , 15 - 17 ] . Physicians will deliver a cessation protocol as part of a study [ 5 , 6 , 18 ] , but barriers such as a lack of time , training , and confidence make counseling in non research setting s less likely [ 1 , 4 , 19 , 20 ] . New approaches [ 21 - 23 ] , such as involving other office staff in counseling [ 17 , 24 , 25 ] , are needed if tobacco counseling is to become a consistent and sustainable part of medical care delivery [ 26 ] . Because physicians see roughly 70 % , or 38 million , of the 53 million smokers in the United States each year [ 15 ] , even a modestly effective physician-driven intervention would have considerable impact on the nation 's health . This study tested the feasibility and effectiveness of a team counseling approach design ed to minimize the burden on physicians by using non-physician clinic staff to provide the more time-consuming parts of cessation counseling . Key features of the team approach were a brief ( 30-second ) physician-delivered cessation message , referral to an on-site nurse or other staff for additional cessation support , and the use of videos to deliver much of the intervention in an efficient and st and ardized manner . A previous report of process and short-term outcome measures showed that this organized team approach proved practical and sustainable [ 27 ] . The participating physicians and other providers delivered brief advice to 86 % of identified smokers during the 1-year intake period , and most patients ( 87 % ) saw the counselor for material s and additional counseling . Nurse-Assisted counseling led to significantly improved quit rates at 3 months compared with brief physician advice alone . We present the effects of the intervention on long-term abstinence at 1 year . Methods Setting We conducted our study in two large primary care facilities of Kaiser Permanente Northwest Region , a group- practice health maintenance organization ( HMO ) in Portl and , Oregon . Receptionists asked patients between 18 and 70 years of age to complete a health habit survey while waiting for their visit . The patients were seeing 1 of 60 primary care physicians ( n = 42 ) , physician assistants ( n = 7 ) , or nurse practitioners ( n = 11 ) in outpatient internal medicine and family practice offices . Intervention Regular clinic nurses and clinical assistants collected the surveys as patients were taken to examination rooms and attached a notice to the medical charts of smokers ( n = 3161 ) to alert providers to deliver a brief stop-smoking advice message . Providers were oriented to their role in a 1-hour training session . They were encouraged to use their own words but to not go beyond the following basic 30-second message : The best thing you can do for your health is to stop smoking and I want to advise you to stop as soon as possible . I know it can be hard and many try several times before they finally make it . You may or may not want to stop now , but I want you to talk briefly with our health counselor , who has some tips to make stopping easier when you decide the time is right . The 2707 ( 86 % ) smokers who received the provider advice message were considered participants in the study , regardless of whether they were willing to see the counselor or had any interest in quitting smoking . By the end of follow-up , 16 patients died , leaving a total sample of 2691 . At the conclusion of the physician consultation , patients were seen by an on-site project nurse or health counselor who described what would be offered and obtained verbal consent to proceed . Patients who would not see the health counselor were mailed material s appropriate to their treatment assignment . Two r and om digits contained in Output:
The study confirmed that non-pharmacological smoking cessation methods available in Pol and , i.e. the physician 's advice and individual and group counseling , increase the probability of smoking abstinence , and determined the 12-month effects of these interventions
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Objective To examine the prevalence rate , impairment , comorbidity , course of illness and determinants of eight specific phobia variants : animals ( animal subtype ) ; heights , water , storms ( natural environment subtype ) ; flying , enclosed spaces , being alone ( situational subtype ) ; and blood/injury ( blood/injury subtype ) . Method Data were obtained from the Netherl and s Mental Health Survey and Incidence Study , a prospect i ve study in the Dutch general population aged 18–65 ( N = 7,076 ) . Results The most prevalent condition was specific phobia with a fear of heights ( 4.9 % ) . On all parameters except duration , specific phobia with a fear of being alone emerged as the most severe condition . Phobias with fear of enclosed spaces and phobias with fear of blood showed a slightly greater likelihood of impairment , comorbidity and personality problems than phobias with fear of animals , heights , water or storms . Conclusion The situational and blood/injury phobia subtypes appear to be a more significant index for impairments and for comorbid psychiatric disorders than the animal and natural environment phobia subtypes Experimental tests of the preparedness theory of phobias have found that skin conductance responses ( SCRs ) conditioned to fear-relevant stimuli ( e.g. pictures of snakes and spiders ) exhibit more resistance to extinction than those conditioned to fear-irrelevant stimuli ( e.g. pictures of flowers and geometric figures ) . However , there are no published replications of this phenomenon outside the laboratories of Ohman and his associates . The experiment reported here failed to replicate previous findings insofar as SCRs established to fear-relevant stimuli were no more resistant to extinction than those established to fear-irrelevant stimuli . Indeed , ‘ preparedness ’ effects were absent even in Ss who reported prior fear of snakes and spiders . Correlational analyses indicated that the strength of conditioning was the only predictor of resistance to extinction to fear-relevant stimuli — a finding consistent with general process-learning theories The effects of conditioned stimulus ( CS ) pre-exposure and fear- relevance of the CS on human Pavlovian electrodermal conditioning were investigated . A differential delayed conditioning paradigm was used with a CS-unconditioned stimulus ( US ; shock ) interval of 8 s. In Experiment 1 , 64 subjects were r and omized into four groups , two of which received fear-relevant stimuli and the other two fear-irrelevant stimuli . Half of the subjects were pre-exposed to the to-be-CSs and the other half to two not-to-be-CSs , with 15 exposure of each stimulus . During acquisition , subjects received 8 reinforced and 8 nonreinforced CS+ and CS- trials , and during the extinction phase 15 nonreinforced trials of each CS . Pre-exposure to the to-be-CSs retarded conditioning for the first and second interval anticipatory responses ( FIRs and SIRs ) ; that is , a latent inhibition effect was demonstrated , although the results for the FIR were inconclusive . The expected effects of fear- relevance were not revealed . Experiment 2 addressed the question whether the long pre-exposure period interfered with the frequently observed " preparedness effect " of higher resistance to extinction to fear-relevant stimuli . The design was similar to that of Experiment 1 , but for half of the subjects the acquisition phase was initiated immediately after a short rest period , and for the other half acquisition started after an extended rest period , equal to the duration of the pre-exposure phase in Experiment 1 . Twenty extinction trials of each CS were presented . A reliable difference in arousal in terms of spontaneous fluctuations was produced by the rest periods , but although differential conditioning was observed , no effect of fear- relevance was seen during extinction Output:
Thus , the body of evidence suggests that preparedness theory does not explain the origin of specific phobias
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background The emergence of resistance against artemisinin combination treatment is a major concern for malaria control . ACTs are recommended as the rescue treatment , however , there is limited evidence as to whether treatment and re-treatment with ACTs select for drug-resistant P. falciparum parasites . Thus , the purpose of the present study is to investigate the impact of (re-)treatment using artesunate-amodiaquine ( ASAQ ) and artemether-lumefantrine ( AL ) on the selection of P. falciparum multidrug resistance-1 ( Pfmdr1 ) alleles in clinical setting s. Methods P. falciparum positive sample s were collected from children aged 12–59 months in a clinical trial in DR Congo and Ug and a. Pfmdr1 single nucleotide polymorphisms ( SNPs ) analysis at codons N86Y , Y184F , and D1246Y were performed at baseline and post-treatment with either AL or ASAQ as a rescue treatment using nested PCR followed by restriction fragment length polymorphism ( RFLP ) assays . Results The pre-treatment prevalence of Pfmdr1 N86 and D1246Y varied significantly between the sites , ( p>0.001 ) and ( p = 0.013 ) , respectively . There was borderline significant directional selection for Pfmdr1 184F in recurrent malaria infections after treatment with AL in Ug and a site ( p = 0.05 ) . Pfmdr1 NFD haplotype did not significantly change in post-treatment infections after re-treatment with either AL or ASAQ . Comparison between pre-treatment and post-treatment recurrences did not indicate directional selection of Pfmdr1 N86 , D1246 alleles in the pre- RCT , RCT and post- RCT phases in both AL and ASAQ treatment arms . Pfmdr1 86Y was significantly associated with reduced risk of AL treatment failure ( RR = 0.34 , 95 % CI:0.11–1.05 , p = 0.04 ) while no evidence for D1246 allele ( RR = 1.02 ; 95 % CI : 0.42–2.47 , p = 1.0 ) . Survival estimates showed that the Pfmdr1 alleles had comparable mean-time to PCR-corrected recrudescence and new infections in both AL and ASAQ treatment arms . Conclusion We found limited impact of (re-)treatment with AL or ASAQ on selection for Pfmdr1 variants and haplotypes associated with resistance to partner drugs . These findings further supplement the evidence use of same or alternative ACTs as a rescue therapy for recurrent P.falciparum infections . Continued monitoring of genetic signatures of resistance is warranted to timely inform malaria (re-)treatment policies and guidelines Background The emergence of artemisinin-resistant P. falciparum malaria in South-East Asia highlights the need for continued global surveillance of the efficacy of artemisinin-based combination therapies . Methods On the Kenyan coast we studied the treatment responses in 474 children 6–59 months old with uncomplicated P. falciparum malaria in a r and omized controlled trial of dihydroartemisinin-piperaquine vs. artemether-lumefantrine from 2005 to 2008 . ( IS RCT N88705995 ) Results The proportion of patients with residual parasitemia on day 1 rose from 55 % in 2005–2006 to 87 % in 2007–2008 ( odds ratio , 5.4 , 95%CI , 2.7–11.1 ; P<0.001 ) and from 81 % to 95 % ( OR , 4.1 , 95%CI , 1.7–9.9 ; P = 0.002 ) in the DHA-PPQ and AM-LM groups , respectively . In parallel , Kaplan-Meier estimated risks of apparent recrudescent infection by day 84 increased from 7 % to 14 % ( P = 0.1 ) and from 6 % to 15 % ( P = 0.05 ) with DHA-PPQ and AM-LM , respectively . Coinciding with decreasing transmission in the study area , clinical tolerance to parasitemia ( defined as absence of fever ) declined between 2005–2006 and 2007–2008 ( OR body temperature > 37.5 ° C , 2.8 , 1.9–4.1 ; P<0.001 ) . Neither in vitro sensitivity of parasites to DHA nor levels of antibodies against parasite extract accounted for parasite clearance rates or changes thereof . Conclusions The significant , albeit small , decline through time of parasitological response rates to treatment with ACTs may be due to the emergence of parasites with reduced drug sensitivity , to the coincident reduction in population -level clinical immunity , or both . Maintaining the efficacy of artemisinin-based therapy in Africa would benefit from a better underst and ing of the mechanisms underlying reduced parasite clearance rates . Trial Registration Controlled-Trials.com IS RCT Summary Background Artemisinin-based combination therapies ( ACTs ) are the most effective treatment for uncomplicated Plasmodium falciparum malaria infection . A commonly used indicator for monitoring and assessing progress in coverage of malaria treatment is the proportion of children younger than 5 years with reported fever in the previous 14 days who have received an ACT . We propose an improved indicator that incorporates parasite infection status ( as assessed by a rapid diagnostic test [ RDT ] ) , which is available in recent household surveys . In this study we estimated the annual proportion of children younger than 5 years with fever and a positive RDT in Africa who received an ACT in 2003–15 . Methods Our modelling study used cross-sectional data on treatment for fever and RDT status for children younger than 5 years compiled from all nationally available representative household surveys ( the Malaria Indicator Surveys , Demographic and Health Surveys , and Multiple Indicator Cluster Surveys ) across sub-Saharan Africa between 2003 and 2015 . Estimates for the proportion of children younger than 5 years with a fever within the previous 14 days and P falciparum infection assessed by RDT who received an ACT were incorporated in a generalised additive mixed model , including data on ACT distributions , to estimate coverage across all countries and time periods . We did r and om effects meta-analyses to examine individual , household , and community effects associated with ACT coverage . Findings We obtained data on 201 704 children younger than 5 years from 103 surveys ( 22 MIS , 61 DHS , and 20 MICS ) across 33 countries . RDT results were available for 40 of these surveys including 40 261 ( 20 % ) children , and we predicted RDT status for the remaining 161 443 ( 80 % ) children . Our results showed that ACT coverage in children younger than 5 years with a fever and P falciparum infection increased across sub-Saharan Africa in 2003–15 , but even in 2015 , only 19.7 % ( 95 % CI 15.6–24.8 ) of children younger than 5 years with a fever and P falciparum infection received an ACT . In meta-analyses , children younger than 5 years were more likely to receive an ACT for fever and P falciparum infection if they lived in an urban area ( vs rural area ; odds ratio [ OR ] 1.18 , 95 % CI 1.06–1.31 ) , had household wealth above the national median ( vs wealth below the median ; OR 1.26 , 1.16–1.39 ) , had a caregiver with any education ( vs no education ; OR 1.31 , 1.22–1.41 ) , had a household insecticide-treated net ( ITN ; vs no ITN ; OR 1.21 , 1.13–1.29 ) , were older than 2 years ( vs ≤2 years ; OR 1.09 , 1.01–1.17 ) , or lived in an area with a higher mean P falciparum prevalence in children aged 2–10 years ( OR 1.12 , 1.02–1.23 ) . In the subgroup of children for whom treatment was sought , those who sought treatment in the public sector were more likely to receive an ACT ( vs the private sector ; OR 3.18 , 2.67–3.78 ) . Interpretation Despite progress during the 2003–15 malaria programme , ACT treatment for children with malaria remains unacceptably low . More work is needed at the country level to underst and how health-care access , service delivery , and ACT supply might be improved to ensure appropriate treatment for all children with malaria . Funding US President 's Malaria Initiative and Medicines for Malaria Venture Background Molecular tools for detection of low-density asymptomatic Plasmodium infections are needed in malaria elimination efforts . This study reports results from the hitherto largest implementation of loop-mediated isothermal amplification ( LAMP ) for central ized mass screening of asymptomatic malaria in Zanzibar . Methods Healthy individuals present and willing to participate in r and omly selected households in 60 villages throughout Zanzibar were screened for malaria by rapid diagnostic tests ( RDT ) . In 50 % of the study households , participants were asked to provide 60 μL of finger-prick blood for additional LAMP screening . LAMP was conducted in two central ized laboratories in Zanzibar , by trained technicians with limited or no previous experience of molecular methods . The LAMP assay was performed with LoopampTM MALARIA Pan/Pf Detection Kit ( Eiken Chemical Company , Japan ) . Sample s positive for Plasmodium genus (Pan)-LAMP were re-tested using Plasmodium falciparum-specific LAMP kits . Results Paired RDT and LAMP sample s were available from 3983 individuals . The prevalence of asymptomatic malaria was 0.5 % ( CI 95 % 0.1 - 0.8 ) and 1.6 % ( CI 95 % 1.1 - 2.2 ) by RDT and Pan-LAMP , respectively . LAMP detected 3.4 ( CI 95 % 2.2 - 5.2 ) times more Plasmodium positive sample s than RDT . DNA contamination was experienced , but solved by repetitive decontamination of all equipment and reagents . Conclusions LAMP is a simple and sensitive molecular tool , and has potential in active surveillance and mass-screening programmes for detection of low-density asymptomatic malaria in pre-elimination setting s. However , in order to deploy LAMP more effectively in field setting s , protocol s may need to be adapted for processing larger numbers of sample s. A higher throughput , affordable closed system would be ideal to avoid contamination Background Plasmodium falciparum uncomplicated malaria can successfully be treated with an artemisinin-based combination therapy ( ACT ) . However resistance is spreading to the different ACT compounds ; the artemisinin derivative and the partner drug . Studies of P. falciparum polymorphisms associated with drug resistance can provide a useful tool to track resistance and guide treatment policy as well as an in-depth underst and ing of the development and spread of resistance . Methods The role of P. falciparum molecular markers in selection of reinfections was assessed in an efficacy trial comparing artesunate – amodiaquine fixed-dose combination with artemether – lumefantrine to treat malaria in Nimba County , Liberia 2008–2009 . P. falciparum polymorphisms in pfcrt 76 , pfmdr1 86 , 184 and 1246 , and pfmrp1 876 and 1466 were analysed by PCR-RFLP and pyrosequencing . Results High baseline prevalence of pfmdr1 1246Y was found in Nimba county ( 38 % ) . Pfmdr1 1246Y and pfmdr1 86 + 184 + 1246 haplotypes NYY and YYY were selected in reinfections in the artesunate – amodiaquine arm and pfcrt K76 , pfmdr1 N86 and pfmdr1 haplotype NFD were selected in artemether – lumefantrine reinfections . Parasites harbouring pfmdr1 1246Y could reinfect earlier after treatment with artesunate – amodiaquine and parasites carrying pfmdr1 N86 could reinfect at higher lumefantrine concentrations in patients treated with artemether – lumefantrine . Conclusions Although treatment is highly efficacious , selection of molecular markers in reinfections could indicate a decreased sensitivity or tolerance of parasites to the current treatments and the baseline prevalence of molecular markers should be closely monitored . Since individual drug levels and the day of reinfection were demonstrated to be key determinants for selection of reinfections , this data needs to be collected and taken into account for accurate evaluation of molecular markers for anti-malarial treatments . The protocol s for the clinical trial was registered with Current Controlled Trials , under the Identifier Number IS RCT N51688713 on 9 October Artemisinin derivative-based combination therapy is expected to suppress the development of Plasmodium falciparum drug resistance in Africa . We have performed an artemether-lumefantrine ( Coartem ; Novartis ) follow-up clinical trial in Zanzibar , in which pfcrt K76 T and pfmdr1 N86Y frequencies were determined before drug administration and in all recurrent parasites during a follow-up period of 42 days . A significant increase in pfmdr1 86 Output:
However , these trends could also be explained by a difference in initial SNP frequencies at the time of ACT introduction . There were non-significant trends for faster selection of N86 and D1246 in areas with higher AL consumption and no trend with transmission intensity . Recorded consumption of AS-AQ was low in the locations and times Pfmdr1 data were collected . SNP trends in countries with AL policies suggest a broad increase in sensitivity of parasites to AS-AQ , by 7 - 10 years after AL introduction .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Overdispersion is a common feature of models of biological data , but research ers often fail to model the excess variation driving the overdispersion , result ing in biased parameter estimates and st and ard errors . Quantifying and modeling overdispersion when it is present is therefore critical for robust biological inference . One means to account for overdispersion is to add an observation-level r and om effect ( OLRE ) to a model , where each data point receives a unique level of a r and om effect that can absorb the extra-parametric variation in the data . Although some studies have investigated the utility of OLRE to model overdispersion in Poisson count data , studies doing so for Binomial proportion data are scarce . Here I use a simulation approach to investigate the ability of both OLRE models and Beta-Binomial models to recover unbiased parameter estimates in mixed effects models of Binomial data under various degrees of overdispersion . In addition , as ecologists often fit r and om intercept terms to models when the r and om effect sample size is low ( < 5 levels ) , I investigate the performance of both model types under a range of r and om effect sample sizes when overdispersion is present . Simulation results revealed that the efficacy of OLRE depends on the process that generated the overdispersion ; OLRE failed to cope with overdispersion generated from a Beta-Binomial mixture model , leading to biased slope and intercept estimates , but performed well for overdispersion generated by adding r and om noise to the linear predictor . Comparison of parameter estimates from an OLRE model with those from its corresponding Beta-Binomial model readily identified when OLRE were performing poorly due to disagreement between effect sizes , and this strategy should be employed whenever OLRE are used for Binomial data to assess their reliability . Beta-Binomial models performed well across all context s , but showed a tendency to underestimate effect sizes when modelling non-Beta-Binomial data . Finally , both OLRE and Beta-Binomial models performed poorly when models contained < 5 levels of the r and om intercept term , especially for estimating variance components , and this effect appeared independent of total sample size . These results suggest that OLRE are a useful tool for modelling overdispersion in Binomial data , but that they do not perform well in all circumstances and research ers should take care to verify the robustness of parameter estimates of OLRE models ABSTRACT The serogroup A meningococcal conjugate vaccine MenAfriVac has the potential to confer herd immunity by reducing carriage prevalence of epidemic strains . To better underst and this phenomenon , we initiated a meningococcal carriage study to determine the baseline carriage rate and serogroup distribution before vaccine introduction in the 1- to 29-year old population in Burkina Faso , the group chosen for the first introduction of the vaccine . A multiple cross-sectional carriage study was conducted in one urban and two rural districts in Burkina Faso in 2009 . Every 3 months , oropharyngeal sample s were collected from > 5,000 r and omly selected individuals within a 4-week period . Isolation and identification of the meningococci from 20,326 sample s were performed by national laboratories in Burkina Faso . Confirmation and further strain characterization , including genogrouping , multilocus sequence typing , and porA-fetA sequencing , were performed in Norway . The overall carriage prevalence for meningococci was 3.98 % ; the highest prevalence was among the 15- to 19-year-olds for males and among the 10- to 14-year-olds for females . Serogroup Y dominated ( 2.28 % ) , followed by serogroups X ( 0.44 % ) , A ( 0.39 % ) , and W135 ( 0.34 % ) . Carriage prevalence was the highest in the rural districts and in the dry season , but serogroup distribution also varied by district . A total of 29 sequence types ( STs ) and 51 porA-fetA combinations were identified . The dominant clone was serogroup Y , ST-4375 , P1.5 - 1,2 - 2/F5 - 8 , belonging to the ST-23 complex ( 47 % ) . All serogroup A isolates were ST-2859 of the ST-5 complex with P1.20,9/F3 - 1 . This study forms a solid basis for evaluating the impact of MenAfriVac introduction on serogroup A carriage A prospect i ve carriage and serological study was conducted in Burkina Faso during the 2003 meningitis season , which was characterized by hyperendemic Neisseria meningitidis serogroup W135 ( NmW135 ) and serogroup A ( NmA ) disease . Participants were evaluated five times at monthly intervals . In the presence of moderate NmW135 carriage , we found a low prevalence of putatively protective levels of specific immunoglobulin G ( IgG ) and serum bactericidal antibody ( SBA ) against NmW135 . Specific IgG concentrations and SBA titers against NmA were relatively high in this recently vaccinated population , while no NmA carriage was detected . NmW135 carriage infrequently induced protective immunity against reference or homologous strains , while natural immunity against NmW135 was frequently lost . A vaccine that is effective against W135 will be beneficial for sub-Saharan Africa Summary In a study of carriage of Neisseria meningitidis in family contacts of patients with group A meningococcal meningitis in the African meningitis belt an overall carrier rate of 17 per cent was observed . The rate was higher in the younger age groups ( 5–19 years ) . No overall sex difference was observed . The carrier rate was significantly higher in the contacts who had been sleeping in the same room as the patient . Rifampicin reduced the carrier rate from 20 per cent to five per cent within two weeks of treatment and a further drop of 2·5 per cent was observed four weeks later . The corresponding results for sulphadimidine were 14 , 14 and 10 per cent . More than 90 per cent of the strains isolated were resistant to 50 μg/ml of sulphadiazine in vitro . All of the strains initially isolated were sensitive to rifampicin , but of the 11 strains isolated after treatment with this drug four were partially resistant A combined group A and group C meningococcal polysaccharide vaccine was given to 438 Nigerian schoolboys shortly before an outbreak of group A meningococcal disease occurred in their school . Four months after vaccination the carriage rate of group A meningococci among vaccinated subjects ( 11 % ) was no different from that found among the controls ( 12 % ) , although a good antibody response to both components of the vaccine was observed . One case of group A meningococcal disease was recorded amongst 438 vaccinated subjects while five cases occurred among 874 controls Output:
This is consistent with contact studies in Africa , which show that children 10–14 years have the highest frequency of contacts . Targeting older children in Africa for conjugate vaccination may be effective in reducing meningococcal transmission
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background Cancer patients receiving chemotherapy are at increased risk of thrombosis . Nadroparin has been demonstrated to reduce the incidence of venous and arterial thrombotic events ( TEs ) by about 50 % in cancer out patients receiving chemotherapy . The aims of this retrospective analysis were to evaluate the thromboembolic risk and the benefit of thromboprophylaxis according to type of chemotherapy . Methods Cancer out patients were r and omly assigned to receive subcutaneous injections of nadroparin or placebo . The incidence of symptomatic TEs was assessed according to the type of chemotherapy . Results were reported as risk ratios with associated 95 % CI and two-tailed probability values . Results 769 and 381 patients have been evaluated in the nadroparin and placebo group , respectively . In the absence of thromboprophylaxis , the highest rate of TEs was found in patients receiving gemcitabine- ( 8.1 % ) or cisplatin-based chemotherapy ( 7.0 % ) . The combination of gemcitabine and cisplatin or carboplatin increased the risk to 10.2 % . Thromboprophylaxis reduced TE risk by 68 % in patients receiving gemcitabine ; with a further decrease to 78 % in those receiving a combination of gemcitabine and platinum . Conclusions This retrospective analysis confirms that patients undergoing chemotherapy including gemcitabine , platinum analogues or their combination are at higher risk of TEs . Our results also suggest that out patients receiving chemotherapy regimens including these agents might achieve an increased benefit from thromboprophylaxis with nadroparin . Clinical Trial registration number : NCT Lenalidomide plus dexamethasone is effective in the treatment of multiple myeloma ( MM ) but is associated with an increased risk of venous thromboembolism ( VTE ) . This prospect i ve , open-label , r and omized sub study of a phase 3 trial compared the efficacy and safety of thromboprophylaxis with low-dose aspirin ( ASA ) or low-molecular-weight heparin ( LMWH ) in patients with newly diagnosed MM , treated with lenalidomide and low-dose dexamethasone induction and melphalan-prednisone-lenalidomide consolidation . Overall , 342 patients who did not have clinical indications or contraindications to antiplatelet or anticoagulant therapy were r and omly assigned to receive ASA 100 mg/d ( n = 176 ) or LMWH enoxaparin 40 mg/d ( n = 166 ) . The incidence of VTE was 2.27 % in the ASA group and 1.20 % in the LMWH group . Compared with LMWH , the absolute difference in the proportion of VTE was 1.07 % ( 95 % confidence interval , -1.69 - 3.83 ; P = .452 ) in the ASA group . Pulmonary embolism was observed in 1.70 % of patients in the ASA group and none in the LMWH group . No arterial thrombosis , acute cardiovascular events , or sudden deaths were reported . No major hemorrhagic complications were reported . In previously untreated patients with MM receiving lenalidomide with a low thromboembolic risk , ASA could be an effective and less-expensive alternative to LMWH thromboprophylaxis PURPOSE Studies by the Veterans Administration Cooperative Studies Program and Cancer and Leukemia Group B ( CALGB ) suggested that the addition of warfarin to chemotherapy might enhance response and /or survival in small-cell lung cancer ( SCLC ) . This r and omized study evaluated the effect of warfarin with chemotherapy and radiation therapy in limited-stage SCLC . PATIENTS AND METHODS Patients were r and omized to receive warfarin or no warfarin . All patients received three cycles of doxorubicin , cyclophosphamide , and etoposide ( ACE ) . Cycles 4 and 5 ( cisplatin , cyclophosphamide , and etoposide [ PCE ] ) were given concurrently with radiation therapy . Three cycles of ACE were given after chemoradiation therapy , but were discontinued due to a high rate of pulmonary toxicity . RESULTS There were no significant differences in response rates , survival , failure-free survival , disease-free survival , or patterns of relapse between the warfarin-treated and control groups . In patients treated according to the initial design , an increase in failure-free survival seen with warfarin treatment approached significance ( P = .07 ) . Preamendment results , while not significant , did not have superimposable treatment survival curves . A l and mark analysis at 8 months showed a median survival time after the l and mark for complete responders of 33 months with warfarin treatment compared with < or = 13.75 months for complete or partial responders not treated with warfarin ( P = .05 ) . Differences between the complete responders in this preamendment population were not significant ( P = .103 ) . CONCLUSION Warfarin does not appear to improve outcome significantly in limited-stage SCLC . However , the differences in some variables between population s before the protocol amendment correspond to the favorable effects of anticoagulants observed in previous studies PURPOSE Initial heparinization followed by vitamin K antagonists is the treatment of choice for patients with venous thromboembolism . There is controversy whether known malignancy is a risk factor for recurrences and bleeding complications during this treatment . Furthermore , the incidence of such events in these patients is dependent on the achieved International Normalized Ratio ( INR ) . The aim of this study was to assess the incidence of venous thromboembolic recurrence and major bleeding among patients with venous thromboembolism in relation to both malignancy and the achieved INR . PATIENTS AND METHODS In a retrospective analysis , the INR-specific incidence of venous thromboembolic and major bleeding events during oral anticoagulant therapy was calculated separately for patients with and without malignancy . Eligible patients participated in two multicenter , r and omized clinical trials on the initial treatment of venous thromboembolism . Patients were initially treated with heparin ( st and ard or low-molecular weight ) . Treatment with vitamin K antagonists was started within 1 day and continued for 3 months , with a target INR of 2.0 to 3.0 . RESULTS In 1,303 eligible patients ( 264 with malignancy ) , 35 recurrences and 12 bleeds occurred . Patients with malignancy , compared with nonmalignant patients , had a clinical ly and statistically significantly increased overall incidence of recurrence ( 27.1 v 9.0 , respectively , per 100 patient-years ) as well as bleeding ( 13.3 v 2.1 , respectively , per 100 patient-years ) . In both groups of patients , the incidence of recurrence was lower when the INR was above 2.0 compared with below 2.0 . CONCLUSION Although adequately dosed vitamin K antagonists are effective in patients with malignant disease , the incidence of thrombotic and bleeding complications remains higher than in patients without malignancy Background Advanced pancreatic cancer , in addition to its high mortality , is characterized by one of the highest rates of venous thromboembolic events ( VTE ) as compared to other types of cancer . Enoxaparin , a low molecular weight heparin ( LMWH ) , has proven to be effective for the prevention and treatment of VTE in surgical and general medical patients . Results of some small studies suggest that this benefit might extend to patients with cancer , however , enoxaparin is not currently indicated for this use . This phase IIb study was design ed to analyze the efficacy of enoxaparin in patients with locally advanced or metastatic pancreatic cancer undergoing systemic chemotherapy . Methods The aim of this prospect i ve multicenter trial is to compare concomitant treatment with enoxaparin to no anticoagulation in 540 patients . Primary endpoint is the incidence of clinical ly relevant VTE ( symptomatic deep venous thrombosis ( DVT ) of the leg and /or pelvic and /or pulmonary embolism ( PE ) ) within the first 3 months . Secondary endpoints include the incidence of symptomatic and asymptomatic VTE after 6 , 9 and 12 months as well as remission at 3 , 6 , 9 and 12 months , overall survival and bleeding . Trial registration : is rct n.org identifier CCT-NAPN-16752 , controlled-trials.com identifier : IS RCT N02140505 . Results An interim analysis for safety performed after inclusion of 152 patients revealed no increased risk of bleeding ( 5 pts vs. 6 pts , Chi2 : 0.763 ) . Conclusion PROSPECT is a pivotal study in elucidating the role of low molecular weight heparins in advanced pancreatic cancer . Its results will lead to a new underst and ing of the role of heparins in the prevention of venous thromboembolism and of their effect on survival , remission rates and toxicity of chemotherapeutic regimens Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose OBJECTIVE To study the efficacy of daily low-dose aspirin ( 81 mg orally ) in decreasing the incidence of venous thromboembolic events ( VTEs ) in patients with multiple myeloma receiving pegylated doxorubicin , vincristine , and decreased-frequency dexamethasone , plus thalidomide ( DVd-T ) . PATIENTS AND METHODS In this phase 2 clinical trial of DVd-T , conducted by the Clevel and Clinic Foundation from August 2001 to October 2003 , 105 patients were enrolled . The first 35 patients experienced increased numbers of VTEs . von Willebr and levels and platelet aggregation to ristocetin before and after treatment with DVd-T increased significantly , suggesting a pathophysiology involving platelet-endothelial interaction . Aspirin was added to the regimen , thus generating 3 patient groups : group 1 received aspirin from the start of DVd-T treatment before the study began ( 58 patients ) , group 2 received aspirin after the start of DVd-T treatment and after the study began ( 26 patients ) , and group 3 did not receive daily low-dose aspirin during the study ( 19 patients ) . Two patients being treated with warfarin for other indications were excluded from the study . The primary end point for this study was the incidence of VTE in the form of either deep venous thrombosis or pulmonary embolism . Secondary end points were the time to the first VTE , time to the composite end point of death or first VTE , and incidence of bleeding complications . RESULTS After a median follow-up of 24 months , on an intent-to-treat basis , 26 posttreatment VTEs occurred after a median of 90 days , with 19 % occurring in group 1 , 15 % in group 2 , and 58 % in group 3 . Following multivariate time-to-event analysis , aspirin use continued to be associated with lower relative risk of VTE ( hazard ratio , 0.22 ; confidence interval , 0.10 - 0.47 ; P<.001 ) and of the composite end point ( hazard ratio , 0.28 ; confidence interval , 0.15 - 0.51 ; P<.001 ) . CONCLUSION Daily low-dose aspirin ( 81 mg orally ) given to patients with newly diagnosed and relapsed/refractory multiple myeloma who were receiving DVd-T reduced the incidence of VTEs without an increase in bleeding complications BACKGROUND Children with acute lymphoblastic leukemia ( ALL ) have a substantial risk for thromboembolism ( TE ) that is related to L-asparaginase-induced antithrombin ( AT ) deficiency and placement of central venous lines . Recent in vitro studies showed that the anticoagulant effects of low-molecular-weight heparin were profoundly affected Output:
Antithrombin , evaluated in one study involving paediatric patients , had no significant effect on VTE or on major bleeding when compared with no antithrombin . AUTHORS ' CONCLUSIONS In this second up date , we confirmed that primary thromboprophylaxis with LMWH significantly reduced the incidence of symptomatic VTE in ambulatory cancer patients treated with chemotherapy . In addition , the uLMWH semuloparin , which is not commercially available , significantly reduced the incidence of symptomatic VTE .
MS2_1shot206
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Dementia with Lewy Bodies ( DLB ) was initially identified and confirmed primarily by pathology , but is soon to be incorporated into the Diagnostic and Statistical Manual criteria as a clinical disease entity . Despite these advances over more than 20 years , current data suggest that the sensitivity of accurate clinical diagnosis of DLB is still very low , although there is mounting evidence that supportive features may increase diagnostic accuracy . Although DLB remains easy to identify pathologically with different cellular pathologies differentiating it from other dementia syndromes , pathological identification using only Lewy body pathology has been shown to be inaccurate due to overlap with patients without dementia symptoms . A number of studies now suggest that a combination of cellular pathologies , which include α-synuclein and β-amyloid deposition as well as dopamine denervation , assist with differentiating this dementia syndrome from others . The clinical and pathological overlap with the tauopathy of Alzheimer ’s disease still remains to be clarified . To determine more robust and independent clinicopathological correlates from Alzheimer ’s disease , longitudinal prospect i ve studies , using specific clinical batteries on dementia patients reaching the proposed criteria for DLB , with post-mortem assessment of the multiple pathologies associated with dementia , are required . Identifying genetic causes for DLB is another approach to investigate the pathogenesis of DLB . However this approach has been hindered to date by difficulties with identifying DLB clinical ly . The use of novel techniques is likely to advance knowledge on the pathogenesis of DLB and assist with redefining clinical and pathologic diagnostic criteria . To achieve the goal of more accurate clinical diagnosis of DLB , breakthroughs are necessary on the pathogenesis of DLB We have review ed the clinical and pathological diagnoses of 143 cases of parkinsonism seen by neurologists associated with the movement disorders service at The National Hospital for Neurology and Neurosurgery in London who came to neuropathological examination at the United Kingdom Parkinson 's Disease Society Brain Research Centre , over a 10-year period between 1990 and the end of 1999 . Seventy-three ( 47 male , 26 female ) cases were diagnosed as having idiopathic Parkinson 's disease ( IPD ) and 70 ( 42 male , 28 female ) as having another parkinsonian syndrome . The positive predictive value of the clinical diagnosis for the whole group was 85.3 % , with 122 cases correctly clinical ly diagnosed . The positive predictive value of the clinical diagnosis of IPD was extremely high , at 98.6 % ( 72 out of 73 ) , while for the other parkinsonian syndromes it was 71.4 % ( 50 out of 70 ) . The positive predictive values of a clinical diagnosis of multiple system atrophy ( MSA ) and progressive supranuclear palsy ( PSP ) were 85.7 ( 30 out of 35 ) and 80 % ( 16 out of 20 ) , respectively . The sensitivity for IPD was 91.1 % , due to seven false-negative cases , with 72 of the 79 pathologically established cases being diagnosed in life . For MSA , the sensitivity was 88.2 % ( 30 out of 34 ) , and for PSP it was 84.2 % ( 16 out of 19 ) . The diagnostic accuracy for IPD , MSA and PSP was higher than most previous prospect i ve clinicopathological series and studies using the retrospective application of clinical diagnostic criteria . The seven false-negative cases of IPD suggest a broader clinical picture of disease than previously thought acceptable . This study implies that neurologists with particular expertise in the field of movement disorders may be using a method of pattern recognition for diagnosis which goes beyond that inherent in any formal set of diagnostic criteria Background : The long-term effectiveness of three different initial drug regimes in patients with early , mild PD was evaluated by the PD Research Group of the United Kingdom ( PDRGUK ) . In 1995 , the selegiline arm of the trial was terminated following an interim analysis . Method : This was an open , r and omized trial . Between 1985 and 1990 , 782 patients with de-novo PD were recruited and r and omized to one of three treatment arms : levodopa plus dopa decarboxylase inhibitor ; levodopa plus decarboxylase inhibitor and selegiline ; or bromocriptine . The main endpoints were mortality , disability , and adverse events . Intention-to-treat analysis was used . Results : There was no significant difference in mortality between the bromocriptine and the levodopa arms ( hazard ratio 1.15 [ 95 % CI 0.90 , 1.47 ] ) . Patients initially r and omized to bromocriptine had slightly worse disability scores throughout follow-up . This difference was significant during the first years . Patients in the bromocriptine arm returned to pretreatment disability levels one year earlier than those in the levodopa arm . Patients r and omized to bromocriptine had a significantly lower incidence of dyskinesias than those r and omized to levodopa ( rate ratio 0.73 [ 95 % CI 0.57 , 0.93 ] ) . However , this difference was not significant when only moderate to severe dyskinesias were considered . Patients in the bromocriptine arm had slightly lower rates of dystonias and on-off fluctuations , but moderate and severe forms were equally frequent in both arms . Conclusion : Starting treatment with the dopamine agonist bromocriptine does not reduce mortality in PD . A slightly lower incidence of motor complications is achieved at the expense of significantly worse disability scores throughout the first years of therapy Few detailed clinico-pathological correlations of Parkinson 's disease have been published . The pathological findings in 100 patients diagnosed prospect ively by a group of consultant neurologists as having idiopathic Parkinson 's disease are reported . Seventy six had nigral Lewy bodies , and in all of these Lewy bodies were also found in the cerebral cortex . In 24 cases without Lewy bodies , diagnoses included progressive supranuclear palsy , multiple system atrophy , Alzheimer 's disease , Alzheimer-type pathology , and basal ganglia vascular disease . The retrospective application of recommended diagnostic criteria improved the diagnostic accuracy to 82 % . These observations call into question current concepts of Parkinson 's disease as a single distinct morbid entity Overdiagnosis of Parkinson 's disease ( PD ) is suggested by specialist review of community diagnosis , and in postmortem studies . In specialist centers 4 to 15 % of patients entered into clinical trials as early PD do not have functional imaging support for a PD diagnosis . In a European multicenter , prospect i ve , longitudinal study , we compared clinical diagnosis with functional SPECT imaging using [123I]FP-CIT ( DaTSCAN , GE Healthcare ) . Repeat observations were performed over 3 years in patients with tremor and /or parkinsonism in whom there was initial diagnostic uncertainty between degenerative parkinsonism and nondegenerative tremor disorders . Video-recording of clinical features was scored independently of functional imaging results by two blinded clinicians at 36 months (= gold st and ard clinical diagnosis ) . Three readers , unaware of the clinical diagnosis , classified the images as normal or abnormal by visual inspection . The main endpoint was the sensitivity and specificity of SPECT imaging at baseline compared with the gold st and ard . In 99 patients completing the three serial assessment s , on-site clinical diagnosis overdiagnosed degenerative parkinsonism at baseline in diagnostically uncertain cases compared with the gold st and ard clinical diagnosis ( at 36 months ) , the latter giving a sensitivity of 93 % and specificity of 46 % . The corresponding baseline [123I]FP-CIT SPECT results showed a mean sensitivity of 78 % and a specificity of 97 % . Inter-reader agreement for rating scans as normal or abnormal was high ( Cohen 's kappa = 0.94 - 0.97 ) Background This study examines the clinical accuracy of movement disorder specialists in distinguishing tremor dominant Parkinson 's disease ( TDPD ) from other tremulous movement disorders by the use of st and ardised patient videos . Patients and methods Two movement disorder specialists were asked to distinguish TDPD from patients with atypical tremor and dystonic tremor , who had no evidence of presynaptic dopaminergic deficit ( subjects without evidence of dopaminergic deficit ( SWEDDs ) ) according to 123I-N-ω-fluoro-propyl- 2β-carbomethoxy-3β-(4-iodophenyl ) nortropane ( [ 123I ] FP-CIT ) single photon emission computed tomography ( SPECT ) , by ‘ blinded ’ video analysis in 38 patients . A diagnosis of parkinsonism was made if the step 1 criteria of the Queen Square Brain Bank criteria for Parkinson 's disease were fulfilled . The review er diagnosis was compared with the working clinical diagnosis drawn from the medical history , SPECT scan result , long term follow-up and in some cases the known response to dopaminergic medications . This comparison allowed a calculation for false positive and false negative rate of diagnosis of PD . Results High false positive ( 17.4 - 26.1 % ) and negative ( 6.7 - 20 % ) rates were found for the diagnosis of PD . The diagnostic distinction of TDPD from dystonic tremor was reduced by the presence of dystonic features in treated and untreated PD patients . Conclusion Clinical distinction of TDPD from atypical tremor , monosymptomatic rest tremor and dystonic tremor can be difficult due to the presence of parkinsonian features in tremulous SWEDD patients . The diagnosis of bradykinesia was particularly challenging . This study highlights the difficulty of differentiation of some cases of SWEDD from PD BACKGROUND Parkinson 's disease is a common disorder among older people . Accurate epidemiological information is essential to identify possible aetiological factors , plan health services and set priorities for medical research . OBJECTIVE to determine the incidence of idiopathic Parkinson 's disease in a defined geographical area in the North-East of Engl and . METHODS using a prospect i ve , longitudinal design , we sought to identify every new case of Parkinson 's disease arising in the Newcastle and Gateshead area in the North-East of Engl and . The base population comprised 488 576 individuals and multiple sources of case ascertainment were employed . All the patients with newly diagnosed idiopathic Parkinson 's disease or parkinsonism between 1 June 2009 and 31 May 2011 were invited to participate . Patients were examined by a specialist and followed longitudinally to permit diagnostic review . RESULTS we identified 257 potential cases , of whom 181 had suspected idiopathic Parkinson 's disease . After a follow-up period of 18 months , 155 patients retained a clinical diagnosis of probable Parkinson 's disease . The mean age at diagnosis was 72.4 ± 10 years . The crude incidence of PD in Newcastle and Gateshead was 15.9 per 100 000 persons per year ( 95 % CI : 13.4 - 18.4 ) . Age-st and ardised to the European population the incidence of Parkinson 's disease was 12.0 per 100 000 ( 95 % CI : 10.1 - 14.0 ) . We found a higher crude incidence among men 17.7 per 100 000 ( 95 % CI : 14.0 - 21.4 ) than women 14.0 per 100 000 ( 95 % CI : 10.7 - 17.4 ) . CONCLUSION in this prospect i ve longitudinal study , the incidence rate of Parkinson 's disease in North-East Engl and is similar to that of other modern European and American studies CONTEXT Since there is no diagnostic biological marker for Parkinson disease ( PD ) , the diagnosis is based on the results of clinical assessment . The accuracy of diagnosis improves with time and repeated assessment s. Studies that require only inclusion of early cases of PD present a diagnostic challenge . Previous studies concluded that initial diagnoses of PD made by general neurologists were incorrect in 24 % to 35 % of the cases when patients were examined at autopsy . Experts in movement disorders are expected to have greater accuracy of initial diagnosis of PD . OBJECTIVE To determine the evolution of clinical diagnosis in patients with early PD made initially by experts in PD . DESIGN Eight hundred patients with mild parkinsonian symptoms ( Hoehn and Yahr stage 1 or 2 ) who received a diagnosis of PD less than 5 years before the beginning of the study were included in the original Deprenyl and Tocopherol Antioxidative Therapy for Parkinson 's Disease study . These patients were followed up prospect ively with repeated clinical assessment s. The following clinical criteria were used to reassess the initial diagnosis : investigator 's confidence in the diagnosis of PD , presence of atypical clinical features , findings of imaging studies , response to levodopa , and results of autopsy examinations . RESULTS The mean + /- SD duration of illness in the 800 cases at enrollment was 2.2+/-1.3 years , and the mean + /- SD Hoehn and Yahr stage was 1.6+/-0.5 . The mean + /- SD follow-up was 6.0+/-1.4 years ( range , 0.2 - 7.6 years ) . In 5 cases , PD was not confirmed at autopsy , and in 15 patients , the results of imaging studies indicated the presence of other path Output:
Conclusion : The overall validity of clinical diagnosis of PD is not satisfying . The accuracy did not significantly improve in the last 25 years , particularly in the early stages of disease , where response to dopaminergic treatment is less defined and hallmarks of alternative diagnoses such as atypical parkinsonism may not have emerged .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVE : To compare the neurodevelopmental outcome of premature infants treated with recombinant human erythropoietin with that of control infants . STUDY DESIGN : A total of 20 treated infants and 20 control infants who had completed r and omized , double-blind , placebo-controlled studies of recombinant human erythropoietin as treatment for anemia of prematurity were followed for growth and developmental outcome in an intensive care nursery follow-up program . Infants were assessed by st and ard developmental tests . RESULTS : No differences were found between groups for neurologic outcome , cognitive outcome , or growth patterns . All infants treated with recombinant human erythropoietin were neurologically normal . The rate of cognitive deficits was similar in the two groups . CONCLUSION : In this small sample we did not see differences in neurodevelopmental outcome between infants treated with recombinant human erythropoietin and control infants OBJECTIVE . Erythropoietin therapy is effective in decreasing transfusions to varying degrees in preterm infants . Recent animal studies using erythropoietin doses to achieve serum concentrations > 1000 mU/mL report neuroprotective effects . We evaluated the relationship between erythropoietin concentrations and neurodevelopmental outcome in extremely low birth weight infants . METHODS . Preterm infants who weighed ≤1000 g at birth were r and omly assigned to erythropoietin ( 400 U/kg 3 times per week ) or placebo/control . Therapy was initiated by 4 days after birth and continued through the 35th postmenstrual week . All infants received supplemental parenteral and enteral iron . Peak serum erythropoietin concentrations were obtained every 2 weeks . Follow-up evaluation included anthropometric measurements , Bayley scales of mental and psychomotor development , neurologic examination , and determination of overall neurodevelopmental impairment . Data were collected at 18 to 22 months ' corrected age by certified examiners who were masked to the treatment group . Analyses were performed to identify correlations between erythropoietin concentrations and outcomes . RESULTS . Sixteen extremely low birth weight infants were enrolled ; 1 infant died at 2 weeks ( placebo/control ) , and 15 had erythropoietin concentrations measured ( 7 erythropoietin , 8 placebo/control ) . Peak erythropoietin concentrations were significantly different between groups during the study ( erythropoietin : 2027 ± 1464 mU/mL ; placebo/control : 26 ± 11 mU/mL ) . Before follow-up , 3 infants died ( 1 erythropoietin , 2 placebo/control ) , and 12 were available for follow-up ( 6 erythropoietin , 6 placebo/control ) . At 18 to 22 months ' follow-up , none of the erythropoietin recipients and 2 of the placebo/control infants had Mental Development Index scores < 70 . Erythropoietin recipients had Mental Development Index scores of 96 ± 11 , and placebo/control infants had Mental Development Index scores of 78 ± 7 . Psychomotor Development Index scores were similar between groups ( 87 ± 13 vs 80 ± 7 ) . There were no differences between groups with respect to anthropometric measurements . Two of 6 infants in the erythropoietin group and 4 of 6 infants in the placebo/control group had some form of neurodevelopmental impairment . Posthoc analysis showed that infants with erythropoietin concentrations ≥500 mU/mL had higher Mental Development Index scores than infants with erythropoietin concentrations < 500 mU/mL. CONCLUSIONS . Erythropoietin concentrations did not correlate with Psychomotor Development Index or overall incidence of neurodevelopmental impairment ; however , infants with elevated erythropoietin concentrations had higher Mental Development Index scores than those with lower erythropoietin concentrations . Close follow-up of infants who are enrolled in large , multicenter , high-dose erythropoietin studies is required to determine whether a correlation exists between elevated erythropoietin concentrations and improved neurodevelopmental outcome Erythropoietin has been reported to possess neuroprotective properties in animal studies . No previous studies have investigated the neurodevelopmental outcome of extremely low birth weight ( ELBW ) infants treated with recombinant human erythropoietin ( rEpo ) and evaluated it at school age Background . Clinical trials evaluating the use of erythropoietin ( Epo ) have demonstrated a limited reduction in transfusions ; however , long-term developmental follow-up data are scarce . Objective . We compared anthropometric measurements , postdischarge events , need for transfusions , and developmental outcomes at 18 to 22 months ' corrected age in extremely low birth weight ( ELBW ) infants treated with early Epo and supplemental iron therapy with that of placebo/control infants treated with supplemental iron alone . Methods . The National Institute of Child Health and Human Development Neonatal Research Network completed a r and omized , controlled trial of early Epo and iron therapy in preterm infants ≤1250 g. A total of 172 ELBW ( ≤1000-g birth weight ) infants were enrolled ( 87 Epo and 85 placebo/control ) . Of the 72 Epo-treated and 70 placebo/control ELBW infants surviving to discharge , follow-up data ( growth , development , rehospitalization , transfusions ) at 18 to 22 months ' corrected age were collected on 51 of 72 Epo-treated infants ( 71 % ) and 51 of 70 placebo/controls ( 73 % ) by certified examiners masked to the treatment group . Statistical significance was determined using χ2 analysis . Results . There were no significant differences between treatment groups in weight or length or in the percentage of infants weighing < 10th percentile either at the time of discharge or at follow-up , and no difference was found in the mean head circumference between groups . A similar percentage of infants in each group was rehospitalized ( 38 % Epo and 35 % placebo/control ) for similar reasons . There were no differences between groups with respect to the percentage of infants with Bayley-II Mental Developmental Index < 70 ( 34 % Epo and 36 % placebo/control ) , blindness ( 0 % Epo and 2 % placebo/control ) , deafness or hearing loss requiring amplification ( 2 % Epo and 2 % placebo/control ) , moderate to severe cerebral palsy ( 16 % Epo and 18 % placebo/control ) or the percentage of infants with any of the above-described neurodevelopmental impairments ( 42 % Epo and 44 % placebo/control ) . Conclusions . Treatment of ELBW infants with early Epo and iron does not significantly influence anthropometric measurements , need for rehospitalization , transfusions after discharge , or developmental outcome at 18 to 22 months ' corrected age OBJECTIVE To evaluate the effect of the early use of recombinant human erythropoietin ( rhu-EPO ) on neurobehavioral development in preterm infants . METHODS Forty-four preterm infants ( 30 males and 14 females ) were r and omly divided into two groups : Rhu-EPO treatment and untreated control ( n=22 each ) . From postnatal day 7 , the Rhu-EPO treatment group received intravenous rhu-EPO ( 250 IU/kg3 times weekly ) for 4 weeks . A Neonatal Behavioral Neurological Assessment ( NBNA ) was performed at 40 weeks of corrected gestational age . A Gesell Development Schedule was used to evaluate neurological development 6 and 12 months after birth . RESULTS The NBNA score in the rhu-EPO treatment group ( 36.20+/-0.75 ) was significantly higher than that in the control group ( 34.40+/-1.05 ) at 40 weeks of corrected gestational age ( P<0.05 ) . The developmental quotient of fine motor in the rhu-EPO treatment group was significantly higher than that in the control group 6 months after birth ( P<0.05 ) . By 12 months after birth , the developmental quotient of gross motor , fine motor and language in the rhu-EPO treatment group was significantly higher than that in the control group ( P<0.05 ) . CONCLUSIONS Early use of Rhu-EPO can promote neurobehavioral development in preterm infants OBJECTIVE . Erythropoietin has been shown to be protective against hypoxic-ischemic and inflammatory injuries in cell culture , animal models of brain injury , and clinical trials of adult humans . The rationale for our study was that early administration of high-dose recombinant human erythropoietin may reduce perinatal brain injury ( intraventricular hemorrhage and periventricular leukomalacia ) in very preterm infants and improve neurodevelopmental outcome . We investigated whether administration of high-dose recombinant human erythropoietin to very preterm infants shortly after birth and subsequently during the first 2 days is safe in terms of short-term outcome . METHODS . This was a r and omized , double-masked , single-center trial with a 2:1 allocation in favor of recombinant human erythropoietin . Preterm infants ( gestational age : 24 to 31 weeks ) were given recombinant human erythropoietin or NaCl 0.9 % intravenously 3 , 12 to 18 , and 36 to 42 hours after birth . RESULTS . The percentage of infants who survived without brain injury or retinopathy was 53 % in the recombinant human erythropoietin group and 60 % in the placebo group . There were no relevant differences regarding short-term outcomes such as intraventricular hemorrhage , retinopathy , sepsis , necrotizing enterocolitis , and bronchopulmonary dysplasia . For 5 infants who were in the recombinant human erythropoietin group and had a gestational age of < 26 weeks , withdrawal of intensive care was decided ( 3 of 5 with severe bilateral intraventricular hemorrhage , 2 of 5 with pulmonary insufficiency ) ; no infant of the control group died . Recombinant human erythropoietin treatment did not result in significant differences in blood pressure , cerebral oxygenation , hemoglobin , leukocyte , and platelet count . CONCLUSIONS . No significant adverse effects of early high-dose recombinant human erythropoietin treatment in very preterm infants were identified . These results enable us to embark on a large multicenter trial with the aim of determining whether early high-dose administration of recombinant human erythropoietin to very preterm infants improves neurodevelopmental outcome at 24 months ' and 5 years ' corrected age OBJECTIVES . High-dose recombinant erythropoietin is neuroprotective in animal models of neonatal brain injury . Extremely low birth weight infants are at high risk for brain injury and neurodevelopmental problems and might benefit from recombinant erythropoietin . We design ed a phase I/II trial to test the safety and determine the pharmacokinetics of high-dose recombinant erythropoietin in extremely low birth weight infants . METHODS . In a prospect i ve , dose-escalation , open-label trial , we compared 30 infants who were treated with high-dose recombinant erythropoietin with 30 concurrent control subjects . Eligible infants were < 24 hours old , ≤1000 g birth weight , and ≤28 weeks of gestation and had an umbilical artery catheter in place . Each infant received 3 intravenous doses of 500 , 1000 , or 2500 U/kg at 24-hour intervals beginning on day 1 of age . Blood sample s were collected at scheduled intervals to determine recombinant erythropoietin pharmacokinetics . Safety parameters were also evaluated . In the concurrent control group , only clinical data were collected . RESULTS . Mean erythropoietin concentrations 30 minutes after recombinant erythropoietin infusion were 5973 ± 266 , 12291 ± 403 , and 34197 ± 1641 mU/mL after 500 , 1000 , or 2500 U/kg , respectively . High-dose recombinant erythropoietin followed nonlinear pharmacokinetics as a result of decreasing clearance from the lowest dosage ( 17.3 mL/hour per kg for 500 U/kg ) to the highest dosage ( 8.2 mL/hour per kg for 2500 U/kg ) . Steady state was achieved within 24 to 48 hours . Both 1000 and 2500 U/kg recombinant erythropoietin produced peak serum erythropoietin concentrations that were comparable to neuroprotective concentrations that previously were seen in experimental animals . No excess adverse events occurred in the recombinant erythropoietin – treated infants compared with control infants . CONCLUSIONS . Early high-dose recombinant erythropoietin is well tolerated by extremely low birth weight infants , causing no excess morbidity or mortality . Recombinant erythropoietin dosages of 1000 and 2500 U/kg achieved neuroprotective serum levels Output:
The rhEPO treatment has beneficial effect on the neurodevelopment outcomes without severe adverse side effect in preterm infants
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVE Constipation and encopresis are common problems in children . Still today , the role of fiber in the treatment of chronic constipation in childhood is controversial . The aim of our study was to evaluate whether fiber supplementation is beneficial in the treatment of children with functional constipation with or without encopresis . We used glucomannan as the fiber supplement . METHODS We evaluated the effect of fiber ( glucomannan , a fiber gel polysaccharide from the tubers of the Japanese Konjac plant ) and placebo in children with chronic functional constipation with and without encopresis in a double-blind , r and omized , crossover study . After the initial evaluation , the patients were disimpacted with 1 or 2 phosphate enemas if a rectal impaction was felt during rectal examination . Patients continued with their preevaluation laxative . No enemas were given during each treatment period . Fiber and placebo were given as 100 mg/kg body weight daily ( maximal 5 g/day ) with 50 mL fluid/500 mg for 4 weeks each . Parents were asked to have children sit on the toilet 4 times daily after meals and to keep a stool diary . Age , frequency of bowel movements into the toilet and into the undergarment , presence of abdominal pain , dietary fiber intake , medications , and the presence of an abdominal and /or a rectal fecal mass were recorded on a structured form at the time of recruitment and 4 weeks and 8 weeks later . Children were rated by the physician as successfully treated when they had > or =3 bowel movements/wk and < or = 1 soiling/3 weeks with no abdominal pain in the last 3 weeks of each 4-week treatment period . Parents made a global assessment s to whether they believed that the child was better during the first or second treatment period . RESULTS Forty-six chronically constipated children were recruited into the study , but only 31 children completed the study . These 31 children ( 16 boys and 15 girls ) were 4.5 to 11.7 years of age ( mean : 7 + /- 2 years ) . All children had functional constipation ; in addition , 18 had encopresis when recruited for the study . No significant side effects were reported during each 4-week treatment period . Significantly fewer children complained of abdominal pain and more children were successfully treated while on fiber ( 45 % ) as compared with placebo treatment ( 13 % ) . Parents rated significantly more children ( 68 % ) as being better on fiber versus 13 % as being better on placebo . The initial fiber intake was low in 22 ( 71 % ) children . There was no difference in the percentage of children with low fiber intake living in the United States ( 70 % ) and Italy ( 71 % ) . Successful treatment ( physician rating ) and improvement ( parent rating ) were independent of low or acceptable initial fiber intake . The duration of chronic constipation ranged from 0.6 to 10 years ( mean : 4.0 + /- 2.5 years ) . Duration of constipation did not predict response to fiber treatment . Children with constipation only were significantly more likely to be treated successfully with fiber ( 69 % ) than those with constipation and encopresis ( 28 % ) . CONCLUSION We found glucomannan to be beneficial in the treatment of constipation with and without encopresis in children . Symptomatic children who were already on laxatives still benefited from the addition of fiber . Therefore , we suggest that we continue with the recommendation to increase the fiber in the diet of constipated children with and without encopresis OBJECTIVE To determine if Lactobacillus GG ( LGG ) is an effective adjunct to lactulose for treating constipation in children . STUDY DESIGN Eighty-four children ( 2 - 16 years of age ) with constipation ( <3 spontaneous bowel movements [ BMs ] per week for at least 12 weeks ) were enrolled in a double-blind , r and omized placebo-controlled trial in which they received 1 mL/kg/day of 70 % lactulose plus 10 9 colony-forming units ( CFU ) of LGG ( experimental group , n = 43 ) or a placebo ( control group , n = 41 ) orally twice daily for 12 weeks . The primary outcome measure was treatment success , and analyses were performed on an intention-to-treat basis . RESULTS Treatment success , defined as > or=3 spontaneous BMs per week with no fecal soiling , was similar in the control and experimental groups at 12 weeks ( 28/41 [ 68 % ] vs 31/43 [ 72 % ] , respectively ; P = .7 ) and at 24 weeks ( 27/41 [ 65 % ] vs 27/42 [ 64 % ] , respectively ; P = 1.0 ] . Groups also did not differ in their mean number of spontaneous BMs per week or episodes of fecal soiling per week at 4 , 8 , and 12 weeks . Adverse events and overall tolerance did not differ between groups . CONCLUSION LGG , as dosed in this study , was not an effective adjunct to lactulose in treating constipation in children OBJECTIVE To develop an evidence -based guideline for the primary pediatric care of children ( birth to 18 years old ) with idiopathic constipation and soiling . DATA SOURCES References were identified through a MEDLINE search from January 1975 through January 1998 to address 3 focus questions : ( 1 ) the best path to early , accurate diagnosis ; ( 2 ) best methods for adequate clean-out ; and ( 3 ) best approaches to promote patient and family compliance with management . DATA SELECTION Twenty-five references were identified . DATA EXTRACTION References were review ed by a multidisciplinary team and grade d according to the following criteria : r and omized controlled trial ; controlled trial , no r and omization ; observational study ; and expert opinion . Evidence tables were developed for each focus question . DATA SYNTHESIS An algorithm and clinical care guideline were developed by consultation and consensus among team members . Emphasis was placed on methods to promote early identification of pediatric idiopathic constipation and soiling , to recognize points of referral , and to increase patient and family compliance with treatment through use of education , developmentally based interventions , and variables for tracking success of management . CONCLUSION An algorithm and guideline for pediatric idiopathic constipation and soiling are presented for use by primary care physicians Simple , incentive based behaviour modification , with or without a modest programme of psychotherapy involving outpatient visits every four to six weeks , seems to be associated with a useful cure rate in children with lower bowel function disorders . Appreciable social disadvantage seems to be the most important factor mitigating against a successful outcome , associated with non-compliance with treatment . Failure to respond to treatment was associated with important psychological problems . These were more common in the socially disadvantaged groups . Children from satisfactory social background s who have lower bowl disturbances can be effectively treated by fairly simple programmes . More elaborate and expensive strategies should be reserved for those whose psychosocial circumstances make it possible to predict a less satisfactory outcome Background Nutrilon Omneo ( new formula ; NF ) contains high concentration of sn-2 palmitic acid , a mixture of prebiotic oligosaccharides and partially hydrolyzed whey protein . It is hypothesized that NF positively affects stool characteristics in constipated infants . Methods Thirty-eight constipated infants , aged 3–20 weeks , were included and r and omized to NF ( n = 20 ) or a st and ard formula ( SF ; n = 18 ) in period 1 and crossed-over after 3 weeks to treatment period 2 . Constipation was defined by at least one of the following symptoms : 1 ) defecation frequency < 3/week ; 2 ) painful defecation ; 3 ) abdominal or rectal palpable mass . Results Period 1 was completed by 35 infants . A significant increase in defecation frequency ( NF : 3.5 pre versus 5.6/week post treatment ; SF 3.6 pre versus 4.9/week post treatment ) was found in both groups , but was not significantly different between the two formulas ( p = 0.36 ) . Improvement of hard stool consistency to soft stool consistency was found more often with NF than SF , but did not reach statistical significance ( 90 % versus 50 % ; RR , 1.8 ; 95 % CI , 0.9–3.5 ; p = 0.14 ) . No difference was found in painful defecation or the presence of an abdominal or rectal mass between the two groups . Twenty-four infants completed period 2 . Only stool consistency was significantly different between the two formulas ( 17 % had soft stools on NF and hard stools on SF ; no infants had soft stools on SF and hard stools on NF , McNemar test p = 0.046 ) . Conclusion The addition of a high concentration sn-2 palmitic acid , prebiotic oligosaccharides and partially hydrolyzed whey protein result ed in a strong tendency of softer stools in constipated infants , but not in a difference in defecation frequency . Formula transition to NF may be considered as treatment in constipated infants with hard stools BACKGROUND The purpose of the present paper was to evaluate the efficacy of probiotics ( Lactobacillus casei rhamnosus , Lcr35 ) for treating children with chronic constipation and to compare its effect with magnesium oxide ( MgO ) and placebo . METHODS This double-blind placebo-controlled , r and omized study enrolled 45 children under 10 years old with chronic constipation . They were r and omly assigned to receive Lcr35 ( 8 x 10(8 ) c.f.u./day ; n = 18 ) , MgO ( 50 mg/kg/day ; n = 18 ) , or placebo ( n = 9 ) orally twice daily for 4 weeks . Lactulose use ( 1 mL/kg per day ) was allowed when no stool passage for 3 days was noted . Glycerin enema was used only when no defecation was noted for > 5 days or abdominal pain was suffered due to stool impaction . Bacterial cultures of stool were performed before and after treatment to evaluate the change of intestinal flora . Comparisons of the frequency of defecation , consistency of stool and the use of lactulose or enema during the period of treatment were made among the three groups . RESULTS The patients who received MgO or probiotics had a higher defecation frequency ( P = 0.03 ) , higher percentage of treatment success ( P = 0.01 ) , less use of glycerin enema ( P = 0.04 ) and less hard stool ( P = 0.01 ) than the placebo group . There was no significant difference between MgO and probiotic groups in the aforementioned comparisons . The first effect of MgO ( second week ) on constipation was slightly earlier than that of probiotic ( second to third week ) . Abdominal pain occurred less frequently in the probiotic group than in both the MgO and the placebo groups ( P = 0.03 ) . There was no statistically significant difference among the three groups in the use of lactulose , episodes of fecal soiling , and change of appetite . No adverse effect was noted in probiotic and placebo groups . Only one patient in the MgO group suffered from mild diarrhea . CONCLUSION Lcr35 was effective in treating children with chronic constipation . There is no statistically significant difference in efficacy between MgO and Lcr35 , but less abdominal pain occurred when using Lcr35 . Study with larger case number and longer follow up is needed in the future OBJECTIVES : This study examines long-term prognoses for children with constipation in adulthood and identifies prognostic factors associated with clinical outcomes . METHODS : In a Dutch tertiary hospital , children ( 5–18 years of age ) who were diagnosed as having functional constipation were eligible for inclusion . After a 6-week treatment protocol , prospect i ve follow-up evaluations were conducted at 6 and 12 months and annually thereafter . Good clinical outcomes were defined as ≥3 bowel movements per week for ≥4 weeks , with ≤2 fecal incontinence episodes per month , irrespective of laxative use . RESULTS : A total of 401 children ( 260 boys ; median age : 8 years [ interquartile range : 6–9 years ] ) were included , with a median follow-up period of 11 years ( interquartile range : 9–13 years ) . The dropout rate during follow-up was 15 % . Good clinical outcomes were achieved by 80 % of patients at 16 years of age . Thereafter , this proportion remained constant at 75 % . Poor clinical outcomes at adult age were associated with : older age at onset ( odds ratio [ OR ] : 1.15 [ 95 % confidence interval [ CI ] : 1.02–1.30 ] ; P = .04 ) , longer delay between onset and first visit to our outpatient clinic ( OR : 1.24 [ 95 % CI : 1.10–1.40 ] ; P = .001 ) , and lower defecation frequency at study entry ( OR : 0.92 [ 95 % CI : 0.84–1.00 ] ; P = .03 ) . CONCLUSIONS : One-fourth of children with functional constipation continued to experience symptoms at adult age . Certain risk factors for poor clinical outcomes in adulthood were identified . Referral to a specialized clinic should be considered at an early stage for children who are unresponsive to first-line treatment Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain cons Output:
Some evidence shows that fiber may be more effective than placebo in improving both the frequency and consistency of stools and in reducing abdominal pain . Compared with normal fluid intake , we found no evidence that water intake increases or that hyperosmolar fluid treatment is more effective in increasing stool frequency or decreasing difficulty in passing stools . We found no evidence to recommend the use of prebiotics or probiotics . Behavioral therapy with laxatives is not more effective than laxatives alone . : There is some evidence that fiber supplements are more effective than placebo . No evidence for any effect was found for fluid supplements , prebiotics , probiotics , or behavioral intervention .
MS2_1shot209
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Although r and omised trials are important for evidence -based medicine , little is known about their overall characteristics . We assessed the epidemiology and reporting of method ological details for all 519 PubMed -indexed r and omised trials published in December , 2000 ( 383 [ 74 % ] parallel-group , 116 [ 22 % ] crossover ) . 482 ( 93 % ) were published in specialty journals . A median of 80 participants ( 10th-90th percentile 25 - 369 ) were recruited for parallel-group trials . 309 ( 60 % ) were blinded . Power calculation , primary outcomes , r and om sequence generation , allocation concealment , and h and ling of attrition were each adequately described in less than half of publications . The small sample sizes are worrying , and poor reporting of method ological characteristics will prevent reliable quality assessment of many published trials Abstract Objective : To determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age . Design : Practice based , double blind , r and omised , placebo controlled trial . Setting : 53 general practice s in the Netherl and s. Subjects : 240 children aged 6 months to 2 years with the diagnosis of acute otitis media . Intervention : Amoxicillin 40 mg/kg/day in three doses . Main outcome measures : Persistent symptoms at day four and duration of fever and pain or crying , or both . Otoscopy at days four and 11 , tympanometry at six weeks , and use of analgesic . Results : Persistent symptoms at day four were less common in the amoxicillin group ( risk difference 13 % ; 95 % confidence interval 1 % to 25 % ) . The median duration of fever was two days in the amoxicillin group versus three in the placebo group ( P=0.004 ) . No significant difference was observed in duration of pain or crying , but analgesic consumption was higher in the placebo group during the first 10 days ( 4.1 v 2.3 doses , P=0.004 ) . In addition , no otoscopic differences were observed at days four and 11 , and tympanometric findings at six weeks were similar in both groups . Conclusions : Seven to eight children aged 6 to 24 months with acute otitis media needed to be treated with antibiotics to improve symptomatic outcome at day four in one child . This modest effect does not justify prescription of antibiotics at the first visit , provided close surveillance can be guaranteed BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected , but direct evidence of such bias is currently limited to case reports . OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of r and omized trials . DESIGN Cohort study using protocol s and published reports of r and omized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg , Denmark , in 1994 - 1995 . The number and characteristics of reported and unreported trial outcomes were recorded from protocol s , journal articles , and a survey of trialists . An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta- analysis . Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias . Protocol s and published articles were also compared to identify discrepancies in primary outcomes . MAIN OUTCOME MEASURES Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes ; consistency between primary outcomes defined in the most recent protocol s and those defined in published articles . RESULTS One hundred two trials with 122 published journal articles and 3736 outcomes were identified . Overall , 50 % of efficacy and 65 % of harm outcomes per trial were incompletely reported . Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy ( pooled odds ratio , 2.4 ; 95 % confidence interval [ CI ] , 1.4 - 4.0 ) and harm ( pooled odds ratio , 4.7 ; 95 % CI , 1.8 - 12.0 ) data . In comparing published articles with protocol s , 62 % of trials had at least 1 primary outcome that was changed , introduced , or omitted . Eighty-six percent of survey responders ( 42/49 ) denied the existence of unreported outcomes despite clear evidence to the contrary . CONCLUSIONS The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocol s. Published articles , as well as review s that incorporate them , may therefore be unreliable and overestimate the benefits of an intervention . To ensure transparency , planned trials should be registered and protocol s should be made publicly available prior to trial completion OBJECTIVE --To examine the efficacy and safety of conservative management of mild otitis media ( " the acute red ear " ) in children . DESIGN --Double blind placebo controlled trial . SETTING --17 group general practice s ( 48 general practitioners ) in Southampton , Bristol , and Portsmouth . PATIENTS --232 children aged 3 - 10 years with acute earache and at least one abnormal eardrum ( 114 allocated to receive antibiotic , 118 placebo ) . INTERVENTIONS --Amoxycillin 125 mg three times a day for seven days or matching placebo ; 100 ml paracetamol 120 mg/5 ml . MAIN OUTCOME MEASURES --Diary records of pain and crying , use of analgesic , eardrum signs , failure of treatment , tympanometry at one and three months , recurrence rate , and ear , nose , and throat referral rate over one year . RESULTS --Treatment failure was eight times more likely in the placebo than the antibiotic group ( 14.4 % v 1.7 % , odds ratio 8.21 , 95 % confidence interval 1.94 to 34.7 ) . Children in the placebo group showed a significantly higher incidence of fever on the day after entry ( 20 % v 8 % , p less than 0.05 ) , mean analgesic consumption ( 0.36 ml/h v 0.21 ml/h , difference 0.14 , 95 % confidence interval 0.07 to 0.23 ; p = 0.0022 ) , mean duration of crying ( 1.44 days v 0.50 days , 0.94 ; 0.50 to 1.38 ; p less than 0.001 ) , and mean absence from school ( 1.96 days v 0.52 days , 1.45 ; 0.46 to 2.42 ; p = 0.0132 ) . Differences in recorded pain were not significant . The prevalence of middle ear effusion at one or three months , as defined by tympanometry , was not significantly different , nor was there any difference in recurrence rate or in ear , nose , and throat referral rate in the follow up year . No characteristics could be identified which predicted an adverse outcome . CONCLUSIONS --Use of antibiotic improves short term outcome substantially and therefore continues to be an appropriate management policy R and omised controlled trials ( RCTs ) must be internally valid ( i.e. , design and conduct must eliminate the possibility of bias ) , but to be clinical ly useful , the result must also be relevant to a definable group of patients in a particular clinical setting ( i.e. , they must be externally valid ) . Lack of external validity is the most frequent criticism by clinicians of RCTs , systematic review s , and guidelines , and is one explanation for the widespread underuse in routine practice of many treatments that have been shown to be beneficial in trials and are recommended in guidelines [ 1 ] . Yet medical journals , funding agencies , ethics committees , the pharmaceutical industry , and governmental regulators seem to give external validity a low priority . Admittedly , whereas the determinants of internal validity are intuitive and can generally be worked out from first principles , underst and ing of the determinants of the external validity of an RCT requires clinical rather than statistical expertise , and often depends on a detailed underst and ing of the particular clinical condition under study and its management in routine clinical practice . However , reliable judgments about the external validity of RCTs are essential if treatments are to be used correctly in as many patients as possible in routine clinical practice . The results of RCTs or systematic review s will never be relevant to all patients and all setting s , but they should be design ed and reported in a way that allows clinicians to judge to whom the results can reasonably be applied . Table 1 lists some of the important potential determinants of external validity , each of which is review ed briefly below . Many of the considerations will only be relevant in certain types of trials , for certain interventions , or in certain clinical setting s , but they can each sometimes undermine external validity . Moreover , the list is not exhaustive and requires more detailed annotation and explanation than is possible in this short review . Table 1 Main Issues That Can Affect External Validity and Should Be Addressed in Reports of the Results of R and omised Controlled Trials or Systematic Review s and Considered by Clinicians Some of the issues that determine external validity are relevant to the distinction between pragmatic trials and explanatory trials [ 2 ] , but it would be wrong to assume that pragmatic trials necessarily have greater external validity than explanatory trials . For example , broad eligibility criteria , limited collection of baseline data , and inclusion of centres with a range of expertise and differing patient population s have many advantages , but they can also make it very difficult to generalise the overall average effect of treatment to a particular clinical setting The results of a r and omized clinical trial can be reported using relative and /or absolute estimators of treatment effect . These various measures convey different information , and the choice can influence the physician 's appreciation of the size of treatment effect and , subsequently , treatment decisions . We compare the estimators with respect to the clinical ly relevant information conveyed to physicians , and identify which clinical questions can and can not be answered directly by each . We also identify opportunities for misinterpretation when one estimator is substituted for another , or when an estimator is mislabeled . Clinical ly important questions are addressed most directly by reporting both relative and absolute effects using relative risk and its complement , relative risk reduction , and risk difference and its reciprocal , number needed to treat . This is true of estimates of treatment effect derived from a single trial and also from meta- analysis of a group of trials . Because the control group 's risk affects the numerical value of the odds ratio , the odds ratio can not substitute for the risk ratio in conveying clinical ly important information to physicians . This is especially important when large treatment effects are shown in trials carried out in population s at high baseline risk Controlled clinical trials of the treatment of acute myocardial infa rct ion offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment . A group of 145 papers was divided into those in which the r and omization process was blinded ( 57 papers ) , those in which it may have been unblinded ( 45 papers ) , and those in which the controls were selected by a nonr and om process ( 43 papers ) . At least one prognostic variable was maldistributed ( P less than 0.05 ) in 14.0 per cent of the blinded-r and omization studies , in 26.7 per cent of the unblinded-r and omization studies , and in 58.1 per cent of the nonr and omized studies . Differences in case-fatality rates between treatment and control groups ( P less than 0.05 ) were found in 8.8 per cent of the blinded-r and omization studies , 24.4 per cent of the unblinded-r and omization studies , and 58.1 per cent of the nonr and omized studies . These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration BACKGROUND Conflicting reports exist in the medical literature regarding the association between industry funding and published research findings . In this study , we examine the association between industry funding and the statistical significance of results in recently published medical and surgical trials . METHODS We examined a consecutive series of 332 r and omized trials published between January 1999 and June 2001 in 8 leading surgical journals and 5 medical journals . Each eligible study was independently review ed for method ological quality using a Output:
Results The general verdict from the check list type evaluations in nine relevant systematic review s was that Burke et al. ( 1991 ) is a good quality trial . All relevant meta-analyses extensively used its data to formulate therapeutic evidence . My comprehensive evaluation , on the other h and , brought to the surface a series of serious problems in the design , conduct , analysis and report of this trial that were missed by the earlier evaluations . Conclusion A check-list or instrument based approach , if used as a short-cut , may at times rate deeply flawed trials as good quality trials .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: A r and omized crossover trial on the effect of salt restriction on blood pressure was carried out involving 124 adolescents ( mean age 16 years ) . Dietary sodium was reduced from approximately 110 to 45 mEq/24 h for a period of 24 days . Blood pressure was non-significantly lower at the end of the experimental diet for all participants . A slight ( 0.7 kg ) , yet statistically significant fall in weight was observed ( P less than 0.05 ) . Subgroup analysis demonstrated that participants whose body mass index was below the median had a statistically significant fall in systolic blood pressure ( P less than 0.05 ) ; fall in weight and increase in heart rate were also more pronounced in the less obese individuals . It would appear that moderate sodium reduction does not have an overall short-term effect on blood pressure in normotensive adolescents . However , body size as reflected in body mass index may influence blood pressure response to sodium reduction The aim of this study was to assess the relation between blood pressure ( BP ) and arterial compliance in a healthy sample of young adults . School children ( aged 10 to 14 years at entry ) were surveyed in 1977 to 1978 , and 1,207 were followed once to twice yearly until age 23 years . Arterial compliance was measured in 179 adults at the last follow-up visit . The sample included individuals in the upper tertile of systolic BP during the last three follow-up visits and race- and sex-matched individuals in the lower two tertiles . We obtained radial artery waveforms using a calibrated tonometer device and characterized waveform morphology to determine large artery ( C1 ) and oscillatory ( C2 ) compliance . Blood pressure was measured using r and om zero sphygmomanometers . The mean and st and ard deviation of C1 was 2.13 + /- 0.59 mL/mm Hg and of C2 was 0.083 + /- 0.02 mL/mm Hg . Systolic BP was inversely related to C1 ( P < .001 ) and C2 ( P < .01 ) after adjustment for gender , height , weight , insulin , and HDL and LDL cholesterol . After adjustment , a 1 SD change in systolic BP was associated with a -0.30 mL/mm Hg change in C1 and a -.008 mL/mm Hg change in C2 . Data from the Minnesota Children 's Blood Pressure Study indicate that systolic BP is inversely related to arterial compliance , particularly C1 ( the large artery , or capacitive compliance ) To examine the long-term effects of weight loss and dietary sodium reduction on the incidence of hypertension , we studied 181 men and women who participated in the Trials of Hypertension Prevention , phase 1 , in Baltimore , Md. At baseline ( 1987 to 1988 ) , subjects were 30 to 54 years old and had a diastolic blood pressure ( BP ) of 80 to 89 mm Hg and systolic BP < 160 mm Hg . They were r and omly assigned to one of two 18-month lifestyle modification interventions aim ed at either weight loss or dietary sodium reduction or to a usual care control group . At the posttrial follow-up ( 1994 to 1995 ) , BP was measured by blinded observers who used a r and om-zero sphygmomanometer . Incident hypertension was defined as systolic BP > or = 160 mm Hg and /or diastolic BP > or = 90 mm Hg and /or treatment with antihypertensive medication during follow-up . Body weight and urinary sodium were not significantly different among the groups at the posttrial follow-up . After 7 years of follow-up , the incidence of hypertension was 18.9 % in the weight loss group and 40.5 % in its control group and 22.4 % in the sodium reduction group and 32.9 % in its control group . In logistic regression analysis adjusted for baseline age , gender , race , physical activity , alcohol consumption , education , body weight , systolic BP , and urinary sodium excretion , the odds of hypertension was reduced by 77 % ( odds ratio 0.23 ; 95 % confidence interval 0.07 to 0.76 ; P=0.02 ) in the weight loss group and by 35 % ( odds ratio 0.65 ; 95 % confidence interval 0.25 to 1.69 ; P=0.37 ) in the sodium reduction group compared with their control groups . These results indicate that lifestyle modification such as weight loss may be effective in long-term primary prevention of hypertension The roots of essential hypertension extend back into the first two decades of life , suggesting that effective intervention during those years may lead to a reduction in the incidence of adult hypertension . Decreasing the dietary sodium/potassium ratio offers a potentially effective approach to blood pressure reduction . This study tested the feasibility of 3-year sodium reduction or potassium supplementation in adolescents and the effect of these interventions on the rate of rise of blood pressure during adolescence . After 19,452 5th to 8th grade students were screened , 210 from the upper 15 percentiles of blood pressure distribution ( 105 boys , 105 girls ) were r and omly assigned to one of three groups : low sodium diet ( 70 mmol sodium intake per day ) , potassium chloride supplementation ( normal diet plus 1 mmol/kg potassium chloride per day ) , or placebo ( normal diet plus placebo capsule ) . Capsules for the potassium chloride and placebo groups were administered in a double blind protocol . Blood pressure was measured every 3 months for 3 years . The effect of the intervention was determined by comparing the rate of rise ( slope ) of blood pressure among the groups using a r and om-coefficient growth curve model . The boys groups and the girls placebo group had similar positive blood pressure slopes that were significantly different from zero . The girls low sodium group had a slightly negative slope ( significantly lower than the slope of the girls placebo group ) , and the girls potassium group had a slightly positive slope . Both of these slopes were not significantly different from zero and were significantly lower than the slopes of the respective boys groups . ( ABSTRACT TRUNCATED AT 250 WORDS In 1980 , a r and omized trial was conducted among 476 Dutch newborn infants to study the effect of a low or normal sodium diet on blood pressure during the first 6 months of life . At the end of the trial , systolic blood pressure in the low sodium group ( n = 231 ) was 2.1 mm Hg lower than in the control group ( n = 245 ) . To investigate whether contrasting levels of sodium intake in infancy are associated with blood pressure differences in adolescence , we measured blood pressure in 167 children from the original cohort ( 35 % ) after 15 years of follow-up . We assessed the differences in systolic and diastolic blood pressure levels between the diet groups using a multivariate regression model with adjustment for potential confounders . The adjusted systolic blood pressure at follow-up was 3.6 mm Hg lower ( 95 % confidence interval , -6.6 to -0.5 ) and the diastolic pressure was 2.2 mm Hg lower ( 95 % confidence interval , -4.5 to 0.2 ) in children who had been assigned to the low sodium group ( n = 71 ) compared with the control group ( n = 96 ) . These findings suggest that sodium intake in infancy may be important in relation to blood pressure later in life The position of both the body and the arm during indirect blood pressure ( BP ) measurement is often neglected . The aim of the present study was to test the influence of the position of the patient on BP readings : ( 1 ) sitting with the arms supported precisely at the right atrium level and ( 2 ) supine : ( a ) with the arms precisely at the right atrium level and ( b ) with the arms on the examination bed . In a first group of 57 hypertensive patients , two sessions of BP and heart rate ( HR ) measurements were performed in two positions : sitting and supine with the arms supported precisely at right atrium level in both positions . BP was measured simultaneously at both arms , with a Hawksley R and om Zero sphygmomanometer at the right arm , and with an automated oscillometric device ( Bosomat ) at the left arm . BP and HR readings obtained in the two positions were then compared . In a second group of 25 normo- and hypertensive persons , two sessions of BP and HR readings were performed in supine with the arms in two different arm positions : ( a ) the arm placed precisely at right atrium level and ( b ) the other arm on the examination bed . The measurements were performed at both arms with two automated devices ( Bosomat ) . The readings taken in the two positions were compared . Both systolic BP ( SBP ; by 9.5±9.0 ( st and ard deviation , s.d . ) ; right arm ) and diastolic BP ( DBP ; by 4.8±6.0 mmHg ; right arm ) were significantly higher in the supine than in the sitting position . When the two different arm positions ( body continously supine ) were compared in the second part of the study , significantly higher SBP ( by 4.6±6.1 mmHg ) and DBP ( by 3.9±2.8 mmHg ) were obtained when the arm of the patient was placed on the bed ( below the right atrium level ) , than when the arm was placed at the level of the right atrium . BP readings in sitting and supine positions are not the same . When according to guidelines the arm of the patient is meticulously placed at the right atrium level in both positions , the difference is even greater than when the arm rests on the desk or on the arm support of the chair . Moreover , in the supine position small but significant differences in BP are measured between arm on a 5 cm-high pillow and arm on the bed . In every study reporting BP values , the position of both the body and especially the arm should be precisely mentioned The relationship between sodium intake and blood pressure in adolescents was examined in a dietary intervention study . One hundred schoolchildren aged 11 - 14 years and representing the top , middle and bottom deciles of the blood pressure range completed a crossover protocol requiring them to raise and lower their sodium intake for alternate periods of 4 weeks . Blood pressure and urinary sodium excretion were assessed weekly and diet diaries were recorded at the end of each 4-week diet period . Diet-diary analysis confirmed that sodium intake was selectively affected by the intervention . Estimates of average urinary sodium excretion at the end of each diet period differed by more than 80 mmol/day . However , there was no significant change of either systolic or diastolic blood pressure , measured supine in the whole study group , in either sex or in any of the sub-groups , even in those children representing the highest blood pressure decile . Furthermore , the blood pressure changes seen in individuals during the crossover did not correlate with their changes in sodium excretion . This lack of effect of sodium on blood pressure is consistent with other dietary intervention studies in children and supports the hypothesis that the sodium sensitivity of blood pressure is age-related . We conclude that dietary sodium restriction alone has little potential for lowering blood pressure at an early age , even in children with higher than average blood pressure OBJECTIVE This study examined the impact of the Transcendental Meditation ( TM ) program on cardiovascular ( CV ) reactivity in adolescents with high normal BP . METHOD Thirty-five adolescents [ 34 African Americans ( AAs ) , 1 Caucasian American ( CA ) ; ages 15 - 18 years ] with resting systolic blood pressure ( SBP ) between the 85th and 95th percentile for their age and gender on three consecutive occasions , were r and omly assigned to either TM ( n=17 ) or health education control ( CTL , n=18 ) groups . The TM group engaged in 15-min meditation twice each day for 2 months including sessions during school lunch break . Primary CV outcome measures were changes in blood pressure ( BP ) , heart rate ( HR ) , and cardiac output ( CO ) at rest and in response to two laboratory stressors , a simulated car driving stressor and an interpersonal social stressor interview . RESULTS The TM group exhibited greater decreases in resting SBP ( P<.03 ) from pre- to postintervention , compared to the CTL group . The TM group exhibited greater decreases from pre- to postintervention in SBP , HR , and CO reactivity ( P's<.03 ) to the simulated car driving stressor , and in SBP reactivity ( P<.03 ) to the social stressor interview . CONCLUSION The TM program appears to have a beneficial impact upon CV functioning at rest and during acute laboratory stress in adolescents at-risk for hypertension Delineating the role that diet plays in blood pressure levels in children is important for guiding dietary recommendations for the prevention of hypertension . The purpose of this study was to investigate relationships between dietary nutrients and blood pressure in children . Data were analyzed from 662 participants in the Dietary Intervention Study in Children who had elevated low-density lipoprotein cholesterol and were aged 8 to 11 years at baseline . Three 24-hour dietary recalls , systolic pressure , diastolic pressure , height , and weight were obtained at baseline , 1 year , and 3 years . Nutrients analyzed were the micronutrients calcium , magnesium , and potassium ; the macronutrients protein , carbohydrates , total fat , saturated fat , polyunsaturated fat , and monounsaturated fat ; dietary cholesterol ; and total dietary fiber . Baseline and 3-year longitudinal relationships were examined through multivariate models on diastolic and systolic pressures separately , controlling for height , weight , Output:
It is important to emphasize that the decision to exclude overweight and obese children from the determination of reference points has led to BP cutoffs that were lower than those in the tables we had been using so far .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: BACKGROUND Collaboration between physicians and pharmacists is one approach to address drug-related morbidity and achieve therapeutic goals . A collaborative practice of pharmaceutical care has been used in the Fairview Clinics System of Minneapolis-St Paul since 1999 . METHODS The quality of therapeutic determinations made by pharmacists within this collaborative practice of pharmaceutical care was studied by a 12-member panel of physicians and pharmacists who used r and omly selected patient records . This was a quality improvement and care process validation component of a study evaluating the effects of drug therapy management in patients receiving prepaid medical assistance . An implicit review process was used to evaluate the clinical credibility of therapeutic determinations made by pharmaceutical care practitioners . RESULTS A total of 5780 drug therapy problems were resolved for 2524 patients receiving pharmaceutical care . The rate of therapeutic goals achieved increased from 74 % at the time of patients ' initial pharmaceutical care encounters to 89 % at patients ' latest encounters . In this quality assessment analysis panel members performed a total of 4779 evaluations of clinical decisions . Panelists indicated agreement with the evaluations in 94.2 % of cases , expressed a neutral opinion in 3.6 % of cases , and disagreed in 2.2 % of cases . Intraclass correlation coefficients ranged from 0.73 to 0.85 . CONCLUSIONS The decisions made by pharmaceutical care practitioners working in collaboration with physicians to provide drug therapy management services are clinical ly credible based on the evaluations and comments of a peer review panel . This study provides information on the quality of care provided by pharmacists when collaborating with physicians to provide drug therapy management services OBJECTIVES To evaluate the effect of pharmaceutical care provided in addition to acute Geriatric Evaluation and Management ( GEM ) care on the appropriateness of prescribing . DESIGN R and omized , controlled trial , with the patient as unit of r and omization . SETTING Acute GEM unit . PARTICIPANTS Two hundred three patients aged 70 and older . INTERVENTION Pharmaceutical care provided from admission to discharge by a specialist clinical pharmacist who had direct contacts with the GEM team and patients . MEASUREMENTS Appropriateness of prescribing on admission , at discharge , and 3 months after discharge , using the Medication Appropriateness Index ( MAI ) , Beers criteria , and Assessing Care of Vulnerable Elders ( ACOVE ) underuse criteria and mortality , readmission , and emergency visits up to 12 months after discharge . RESULTS Intervention patients were significantly more likely than control patients to have an improvement in the MAI and in the ACOVE underuse criteria from admission to discharge ( odds ratio (OR)=9.1 , 95 % confidence interval (CI)=4.2 - 21.6 and OR=6.1 , 95 % CI=2.2 - 17.0 , respectively ) . The control and intervention groups had comparable improvements in the Beers criteria . CONCLUSION Pharmaceutical care provided in the context of acute GEM care improved the appropriate use of medicines during the hospital stay and after discharge . This is an important finding , because only limited data exist on the effect of various strategies to improve medication use in elderly in patients . The present approach has the potential to minimize risk and improve patient outcomes OBJECTIVES To determine whether a medication review by a specialized team would promote regimen changes in elders taking multiple medications and to measure the effect of regimen changes on monthly cost and functioning . DESIGN A r and omized-controlled trial . SETTING Health center ambulatory clinic . PARTICIPANTS Community-dwelling older adults taking five or more medications were assessed at baseline and 6 weeks . A medication-change intervention group of 57 elders was compared with a control group of 76 elder adults . INTERVENTION The primary intervention was a comprehensive review and recommended modification of a patient 's medication regimen . Changes were endorsed by each patient 's primary physician and discussed with each patient . MEASUREMENTS Measures were the Timed Manual Performance Test , Physical Performance Test , Functional Reach Assessment , subtests from the Wechsler Adult Intelligence Scale , a modified R and t Memory Test , the Center for Epidemiological Studies -Depression Scale , the Self-Rating Anxiety Scale , and the R and 36-item Health Survey 1.0 . Comorbidity was determined using the International Classification of Diseases , Ninth Revision , Clinical Modification . Medication usage was determined using brown bag review . RESULTS Intervention subjects decreased their medications by an average of 1.5 drugs . No differences in functioning were observed between groups . Intervention subjects saved an average $ 26.92 per month in wholesale medication costs ; control subjects saved $ 6.75 per month ( P<.006 ) . CONCLUSION Although the intervention significantly reduced the medications taken and monthly cost , most patients were resistant to reducing medications to the recommended level . Further study is needed to underst and patient resistance to reducing adverse polypharmacy and to devise better strategies for addressing this important problem in geriatric health . Greater focus on prescriber behavior is recommended Aim : To measure the outcomes of a harmonised , structured pharmaceutical care programme provided to elderly patients by community pharmacists . Method : A r and omised , controlled , longitudinal , clinical trial with repeated measures was performed over an 18‐month period , involving community pharmacies ( 5 intervention and 5 control ) in Northern Irel and . Elderly , ambulatory patients ( ≥ 65 years ) , taking 4 or more prescribed medications were eligible for participation . Patients attending an intervention pharmacy received education on medical conditions , implementation of compliance strategies , rationalising of drug regimens and appropriate monitoring ; patients attending control sites received normal services . A battery of clinical , humanistic and economic outcomes were assessed . Results : A significantly higher proportion of intervention patients were compliant at the end of the 18‐month study and experienced fewer problems with medication compared to control patients ( P < 0.05 ) . There was little impact on quality of life and health care utilisation . Conclusions : Pharmaceutical care provision to community‐dwelling patients result ed in an improvement in medication compliance and evidence of cost‐savings . Future pharmaceutical care studies may benefit from a more focussed selective approach to data collection and outcomes measurement OBJECTIVE To compare patients ' adherence to therapy , expectations , satisfaction with pharmacy services , and health-related quality of life ( HRQOL ) after the provision of pharmaceutical care with those of patients who received traditional pharmacy care . DESIGN R and omized controlled cluster design . SETTING Sixteen community pharmacies in Alberta , Canada . PATIENTS AND OTHER PARTICIPANTS Ambulatory elderly ( > or = 65 years of age ) patients covered under Alberta Health & Wellness 's senior drug benefit plan and who were concurrently using three or more medications according to pharmacy profiles . INTERVENTION Pharmacies were r and omly assigned to either treatment ( intervention ) or control ( traditional pharmacy care ) groups . Patients at treatment pharmacies were recruited into the study , and pharmacists provided comprehensive pharmaceutical care services . Pharmacists at control pharmacies continued to provide traditional pharmacy care . MAIN OUTCOME MEASURES Study participants ' opinions , adherence to therapy , and scores on the Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) . RESULTS Compared with those of patients receiving traditional care , treatment patients ' expectations that their pharmacist would perform activities congruent with pharmaceutical care changed over the study period . Treatment patients ' satisfaction with the constructs " trust , " " evaluation and goal setting , " and " communicates with doctor " were also positively affected . HRQOL and patient adherence were not significantly affected by pharmaceutical care interventions . CONCLUSION Successful implementation of a pharmaceutical care practice model has the potential to increase patients ' satisfaction with their pharmacists ' activities and may increase patients ' expectations that pharmacists will work on their behalf to assist them with their health care needs . If pharmaceutical care affects patients ' HRQOL , instruments more specific than the SF-36 may be needed to detect the differences Abstract Objective : To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice . Design : R and omised controlled trial of clinical medication review by a pharmacist against normal general practice review . Setting : Four general practice s. Participants : 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community . Intervention : Patients were invited to a consultation at which the pharmacist review ed their medical conditions and current treatment . Main outcome measures : Number of changes to repeat prescriptions over one year , drug costs , and use of healthcare services . Results : 590 ( 97 % ) patients in the intervention group were review ed compared with 233 ( 44 % ) in the control group . Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions ( mean number of changes per patient 2.2 v 1.9 ; difference=0.31 , 95 % confidence interval 0.06 to 0.57 ; P=0.02 ) . Monthly drug costs rose in both groups over the year , but the rise was less in the intervention group ( mean difference £ 4.72 per 28 days , −£7.04 to -£2.41 ) ; equivalent to £ 61 per patient a year . Intervention patients had a smaller rise in the number of drugs prescribed ( 0.2 v 0.4 ; mean difference −0.2 , −0.4 to −0.1 ) . There was no evidence that review of treatment by the pharmacist affected practice consultation rates , outpatient consultations , hospital admissions , or death rate . Conclusions : A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs . Such review results in significant changes in patients ' drugs and saves more than the cost of the intervention without affecting the workload of general practitioners . What is already known on this topic Review of patients on long term drug treatment is important but is done inadequately Evidence from the United States shows that pharmacists can improve patient care by review ing drug treatment What this study adds Consultations with a clinical pharmacist are an effective method of review ing the drug treatment of older patients Review by a pharmacist results in more drug changes and lower prescribing costs than normal care plus a much higher review rate Use of healthcare services by patients is not OBJECTIVES To describe the processes of care used by community pharmacists participating in the Pharmaceutical Care Research and Education Project ( PREP ) in terms of drug-related problems ( DRPs ) , pharmacists ' recommendations , and status of DRPs at follow-up , and to determine characteristics associated with DRPs . DESIGN Descriptive analysis of the treatment group from a larger r and omized , controlled cluster design . SETTING Five independent community pharmacies in Alberta . PARTICIPANTS One hundred fifty-nine patients who were covered under Alberta Health and Wellness 's senior drug benefit plan ( i.e. , 65 years or older ) , were taking three or more medications concurrently according to pharmacy records , were able to complete telephone interviews as determined by pharmacists , maintained residence in Alberta for 12 of the 15 study months , agreed to receive their prescription medications only from the study pharmacy during the study period , and provided informed consent . MAIN OUTCOME MEASURES Frequency of DRPs , recommendations , status of DRPs , and analysis of clinical results as determined during pharmacists ' follow-up care . RESULTS In telephone surveys , patients reported taking 4.7 prescription medications per day , but pharmacists documented 8.7 prescription medications per day in their records . Pharmacists documented 559 DRPs , a mean ( + /- SD ) of 3.9+/-3.2 problems per patient . Approximately 39 % of problems were actual DRPs , while 60 % were potential DRPs . Medical conditions associated most frequently with a DRP involved the respiratory , cardiovascular , and musculoskeletal systems . The most common DRP categories were " patient requires drug therapy " or " patient requires influenza or pneumococcal vaccination . " Pharmacists wrote 551 initial clinical notes using the subjective , objective , assessment , plan ( SOAP ) format , and they recorded 346 follow-up interventions , also using SOAP notes . Counseling , preventive consultations , and clinical monitoring represented 40 % of their recommendations . In 80 % of situations , the pharmacist made the recommendation directly to the patient . On follow-up , 40 % of the 559 DRPs identified were resolved , controlled , or improved . Patients accepted 76 % of pharmacists ' recommendations , and physicians accepted 72 % of pharmacists ' suggested resolutions of DRPs . Pharmacists were more likely to follow up about actual DRPs , as compared with potential ones ; overall , they followed up on 62 % of identified DRPs . CONCLUSION Pharmacists identified more DRPs for study patients than previous community-based , observational studies have reported . Undertreatment appears to be a prevalent DRP . Community pharmacists ' recommendations to prevent and resolve DRPs were made primarily to patients and were well accepted . More follow-up was needed for all DRPs . When follow-up occurred , the DRP results generally showed improvement BACKGROUND Patients 80 years or older are underrepresented in scientific studies . The objective of this study was to investigate the effectiveness of interventions performed by ward-based pharmacists in reducing morbidity and use of hospital care among older patients . METHODS A r and omized controlled study of patients 80 years or older was conducted at the University Hospital of Uppsala , Uppsala , Sweden . Four hundred patients were recruited consecutively between October 1 , Output:
Conclusion This systematic review shows a significant association between the number of key elements of the intervention reflecting collaborative aspects in medication review and the implementation rate of recommendations
MS2_1shot212
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVE To investigate how ethnically diverse women who are eligible for tamoxifen prophylaxis because of their breast cancer risk decide about tamoxifen use for risk reduction . DESIGN A qualitative intervention pilot study used focus groups to discuss the use of tamoxifen and to identify the concerns of ethnically diverse women about the preventive use of this drug . Focus group discussion involved exploration of the benefits and risks of tamoxifen prophylaxis , presentation of a st and ardized educational intervention , and focused discussion on attitudes about tamoxifen for prevention . Prominent themes emerged from iterative review of focus group transcripts . RESULTS Fear of breast cancer was not prominent , and participants were less inclined to take tamoxifen as preventive therapy after receiving information . Decisions were based on participants ' underst and ings of competing risks and benefits . Specifically , participants expressed limited willingness to take medication with potential serious side effects for risk reduction and were unwilling to discontinue hormone replacement therapy . Uneasiness about the reliability of scientific studies surfaced in the focus groups comprised of White and Latina women . African-American women described faith as important to prevention . CONCLUSIONS Women were wary of taking a drug for a disease they might not develop . Women felt they had options other than tamoxifen to reduce their risk of breast cancer , including early detection , diet , faith , and complementary and alternative therapies Women with germline BRCA1 or BRCA2 ( BRCA1/2 ) mutations are considered as an extreme risk population for developing breast cancer . Prophylactic mastectomy provides a valid option to reduce such risk , impacting however , the quality of life . Medical prevention by aromatase inhibitor that has also recently shown to have preventive effect may thus be considered as an alternative . LIBER is an ongoing double-blind , r and omized phase III trial to evaluate the efficacy of 5-year letrozole versus placebo to decrease breast cancer incidence in post-menopausal BRCA1/2 mutation carriers ( NCT00673335 ) . We present data on the uptake of this trial . We compared characteristics of women in the LIBER trial ( n = 113 ) to those of women enrolled in the prospect i ve ongoing national GENEPSO cohort ( n = 1,505 ) . Uptake was evaluated through a survey sent to all active centres , with responses obtained from 17 to the 20 ( 85 % ) centres . According to the characteristics of the women enrolled in the GENEPSO cohort and the survey , approximately one-third of BRCA1/2 mutation carriers were eligible for the trial . Five hundred and thirty-four women eligible from chart review have been informed by mail about the prevention trial and were invited to an oral information by participating centres . Forty-four percentage of them came to the dedicated medical visit . Uptake of drug prevention trial was 32 % among women informed orally and 15 % of all the eligible women . The main reasons of refusal were : potential side effects , probability to receive the placebo and lack of support from their physicians . Additionally , we noticed that prior prophylactic oophorectomy and previous unilateral breast cancer were more frequent in women enrolled in the LIBER trial than in the French cohort ( 93 % vs. 60 % and 50 % vs. 39 % , respectively ) . Based on an overall 15 % uptake among all eligible subjects , greater and wider information of the trial should be offered to women with BRCA1/2 mutation to improve recruitment . Women with previous unilateral breast cancer or prior prophylactic oophorectomy are more likely to enter a medical prevention trial Background Adherence to preventive medication is often poor , and current interventions have had limited success . Purpose This study was conducted to pilot a r and omised controlled trial aim ed at increasing adherence to preventive medication in stroke survivors using a brief , personalised intervention . Methods Sixty-two stroke survivors were r and omly allocated to either a two-session intervention aim ed at increasing adherence via ( a ) introducing a plan linked to environmental cues ( implementation intentions ) to help establish a better medication-taking routine ( habit ) and ( b ) eliciting and modifying any mistaken patient beliefs regarding medication/stroke or a control group . Primary outcome was adherence to antihypertensive medication measured objective ly over 3 months using an electronic pill bottle . Results Fifty-eight people used the pill bottle and were analysed as allocated ; 54 completed treatment . The intervention result ed in 10 % more doses taken on schedule ( intervention , 97 % ; control , 87 % ; 95 % CI for difference ( 0.2 , 16.2 ) ; p = 0.048 ) . Conclusions A simple , brief intervention increased medication adherence in stroke survivors , over and above any effect of increased patient contact or mere measurement . ( http://controlled-trials.com , number IS RCT N38274953 . Background Asthma is a common medical condition caused by chronic inflammation of the airways . Characteristic symptoms of the illness include attacks of shortness of breath , wheezing , tightness in the chest , and cough . Asthma is commonly treated by inhaled corticosteroids , which help to suppress inflammation of the airways and reduce the frequency of severe symptoms and attacks . This medication in the form of inhalers is known as preventer or controller medication and many patients also take short-acting bronchodilators to control acute symptoms ( reliever medication ) . In order to provide therapeutic benefit , preventer medication needs to be taken regularly on a daily basis . However , non-adherence to preventer medication is a common problem in patients diagnosed with asthma and these results in the overuse of reliever medication , increased asthma symptoms , more frequent asthma attacks , and hospital admissions ( Stern et al. , 2006 ) . Optimal adherence to inhaled corticosteroids requires patients to take their preventer medication on 80 % or more occasions , as this is associated with greatest asthma control ( Lasmar et al. , 2009 ) . Objective While effective preventative medication is readily available for asthma , adherence is a major problem due to patients ’ beliefs about their illness and medication . We investigated whether a text message programme targeted at changing patients ’ illness and medication beliefs would improve adherence in young adult asthma patients . Methods Two hundred and sixteen patients aged between 16 and 45 on asthma preventer medication were recruited from pamphlets dispensed with medication and e-mails sent to members of a targeted marketing website . Participants were r and omized to receive individually tailored text messages based on their illness and medication beliefs over 18 weeks or no text messages . Illness and medication beliefs were assessed at baseline and at 18 weeks . Adherence rates were assessed by phone calls to participants at 6 , 12 , and 18 weeks and at 6 and 9 months . Results At 18 weeks , the intervention group had increased their perceived necessity of preventer medication , increased their belief in the long-term nature of their asthma , and their perceived control over their asthma relative to control group ( all p<0.05 ) . The intervention group also significantly improved adherence over the follow-up period compared to the control group with a relative average increase in adherence over the follow-up period of 10 % ( p<0.001 ) . The percentage taking over 80 % of prescribed inhaler doses was 23.9 % in the control group compared to 37.7 % in the intervention group ( p<0.05 ) . Conclusion A targeted text message programme increases adherence to asthma preventer inhaler and may be useful for other illnesses where adherence is a major issue BACKGROUND Exemestane can prevent breast cancer in postmenopausal women . Because of potential widespread use , we examined the safety of exemestane on bone health . METHODS In this nested safety sub study of the MAP.3 trial ( a r and omised , placebo-controlled , double-blind trial of exemestane 25 mg a day for the primary prevention of breast cancer ) , we included postmenopausal women from five centres who were eligible to participate in MAP.3 , not osteoporotic , not receiving drugs for bone-related disorders , with baseline lumbar spine , total hip , and femoral neck T-scores above -2·0 . The primary endpoint was percent change from baseline to 2 years in total volumetric bone mineral density ( BMD ) at the distal radius by high-resolution peripheral quantitative CT . The primary analysis was per protocol using a non-inferiority margin . This analysis was done earlier than originally planned because of the impending announcement of MAP.3 results and subsequent unmasking of patients to treatment assignment . This study is registered with Clinical Trials.gov , number NCT01144468 , and has been extended to 5 years of unmasked follow-up . FINDINGS 351 women ( 176 given exemestane , 175 given placebo ; median age 61·3 years [ IQR 59·2 - 64·9 ] ) met our inclusion criteria and completed baseline assessment . At the time of clinical cutoff , 242 women had completed 2-year follow-up ( 124 given exemestane , 118 given placebo ) . From baseline to 2 years , the mean percent change in total volumetric BMD at the distal radius was -6·1 % ( 95 % CI -7·0 to -5·2 ) in the exemestane group and -1·8 % ( -2·4 to -1·2 ) in the placebo group ( difference -4·3 % , 95 % CI -5·3 to -3·2 ; p<0·0001 ) . The lower limit of the 95 % CI was lower than our non-inferiority margin of negative 4 % ( one-sided test for non-inferiority p=0·70 ) , meaning the hypothesis that exemestane was inferior could not be rejected . At the distal tibia , the mean percent change in total volumetric BMD from baseline to 2 years was -5·0 % ( 95 % CI -5·5 to -4·4 ) in the exemestane group and -1·3 % ( -1·7 to -1·0 ) in the placebo group ( difference -3·7 % , 95 % CI -4·3 to -3·0 ; p<0·0001 ) . The mean percent change in cortical thickness was -7·9 % ( SD 7·3 ) in the exemestane group and -1·1 % ( 5·7 ) in the placebo group at the distal radius ( difference -6·8 % , 95 % CI -8·5 to -5·0 ; p<0·0001 ) and -7·6 % ( SD 5·9 ) in the exemestane group and -0·7 % ( 4·9 ) in the placebo group at the distal tibia ( difference -6·9 % , -8·4 to -5·5 ; p<0·0001 ) . Decline in areal BMD , as measured by dual-energy x-ray absorptiometry , in the exemestane group compared with the placebo group occurred at the lumbar spine ( -2·4 % [ 95 % CI -3·1 to -1·7 ] exemestane vs -0·5 % [ -1·1 to 0·2 ] placebo ; difference -1·9 % , 95 % CI -2·9 to -1·0 ; p<0·0001 ) , total hip ( -1·8 % [ -2·3 to -1·2 ] exemestane vs -0·6 % [ -1·1 to -0·1 ] placebo ; difference -1·2 % , -1·9 to -0·4 ; p=0·004 ) , and femoral neck ( -2·4 % [ -3·2 to -1·7 ] exemestane vs -0·8 % [ -1·5 to 0·1 ] placebo ; difference -1·6 % , -2·7 to -0·6 ; p=0·002 ) . INTERPRETATION 2 years of treatment with exemestane worsens age-related bone loss in postmenopausal women despite calcium and vitamin D supplementation . Women considering exemestane for the primary prevention of breast cancer should weigh their individual risks and benefits . For women taking exemestane , regular bone monitoring plus adequate calcium and vitamin D supplementation are important . To assess the effect of our findings on fracture risk , long-term follow-up is needed . FUNDING Canadian Breast Cancer Research Alliance ( Canadian Institutes of Health Research /Canadian Cancer Society ) Abstract Objective To investigate the effects of compliance and periodic telephone counselling by a pharmacist on mortality in patients receiving polypharmacy . Design Two year r and omised controlled trial . Setting Hospital medical clinic . Participants 502 of 1011 patients receiving five or more drugs for chronic disease found to be non-compliant at the screening visit were invited for r and omisation to either the telephone counselling group ( n = 219 ) or control group ( n = 223 ) at enrolment 12 - 16 weeks later . Main outcome measures Primary outcome was all cause mortality in r and omised patients . Associations between compliance and mortality in the entire cohort of 1011 patients were also examined . Patients were defined as compliant with a drug if they took 80 - 120 % of the prescribed daily dose . To calculate a compliance score for the whole treatment regimen , the number of drugs that the patient was fully compliant with was divided by the total number of prescribed drugs and expressed as a percentage . Only patients who complied with all recommended drugs were considered compliant ( 100 % score ) . Results 60 of the 502 eligible patients defaulted and only 442 patients were r and omised . After two years , 31 ( 52 % ) of the defaulters had died , 38 ( 17 % ) of the control group had died , and 25 ( 11 % ) of the intervention Output:
Uptake of therapeutic agents for the prevention of breast cancer is low , and long-term persistence is often insufficient for women to experience the full preventive effect .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Genome-wide DNA hypomethylation plays has an important role in genomic instability and colorectal carcinogenesis . However , the relationship between cellular DNA methylation level and patient outcome remains uncertain . Using 643 colon cancers in two independent prospect i ve cohorts , we quantified DNA methylation in repetitive long interspersed nucleotide element-1 ( LINE-1 ) elements using pyrosequencing , which is a good indicator of global DNA methylation level . We used Cox proportional hazard models to calculate hazard ratios ( HRs ) of colon cancer-specific and overall mortality , adjusting for patient and tumoral features , including CpG isl and methylator phenotype ( CIMP ) . Statistical tests were two-sided . LINE-1 hypomethylation was linearly associated with a statistically significant increase in colon cancer-specific mortality ( for a 30 % decrease in LINE-1 methylation : multivariable HR = 2.37 , 95 % confidence interval [ CI ] = 1.42 to 3.94 ; P(trend ) < .001 ) and overall mortality ( multivariable HR = 1.85 , 95 % CI = 1.25 to 2.75 ; P(trend ) = .002 ) . The association was consistent across the two independent cohorts and strata of clinical and molecular characteristics , including sex , age , tumor location , stage , and CIMP , microsatellite instability , KRAS , BRAF , p53 , and chromosomal instability status . In conclusion , tumoral LINE-1 hypomethylation is independently associated with shorter survival among colon cancer patients Responses of patients with gliomas to temozolomide are determined by O6-methylguanine-DNA methyltransferase ( MGMT ) and mismatch repair ( MMR ) pathways . This phase II study ( NCT00423150 ) investigated whether MGMT promoter methylation predicts response in patients with advanced aerodigestive tract and colorectal cancers ( CRC ) . Tumor and serum sample s were screened for MGMT promoter methylation . In methylation-positive patients , 150 mg/m2 temozolomide was administered daily on a seven-day-on , seven-day-off schedule for each 28-day cycle . The primary efficacy endpoint was response rate ( RR ) . MMR status was determined by a microsatellite instability assay . Among 740 patients screened , 86 were positive for MGMT promoter methylation and enrolled . Nineteen percent of the screened population ( 137/740 ) had confirmed tissue and /or serum MGMT promoter methylation , including 25 % ( 57 of 229 ) for CRC , 36 % ( 55 of 154 ) for esophageal cancer , 11 % ( 12 of 113 ) for head and neck cancer , and 5 % ( 13 of 242 ) for non – small cell lung carcinoma . Among patients with valid methylation results in both tissue and serum sample s , concordance was 81 % ( 339 of 419 ) . The majority of enrolled patients ( 69 of 86 ; 80 % ) had microsatellite stable cancer . Overall RR was 6 % ( 5 of 86 partial responses ) ; all responders had microsatellite stable cancer . Temozolomide result ed in low RRs in patients enriched for MGMT methylation . MGMT methylation status varied considerably in the patient population . Although serum methylation assay is an option for promoter methylation detection , tissue assay remains the st and ard for methylation detection . The low RR of this cohort of patients indicates that MGMT methylation as a biomarker is not applicable to heterogeneous tumor types , and tumor-specific factors may override vali date d biomarkers . Mol Cancer Ther ; 12(5 ) ; 809–18 . © 2013 AACR Purpose : Radiotherapy followed by total mesorectal excision surgery has been shown to significantly reduce local recurrence rates in rectal cancer patients . Radiotherapy , however , is associated with considerable morbidity . The present study evaluated the use of biochemical detection of enzymatic caspase-3 activity as preoperative marker for apoptosis to preselect patients that are unlikely to develop a local recurrence to spare these patients from overtreatment and the negative side effects of radiotherapy . Experimental Design : Nonirradiated freshly frozen tissue sample s from 117 stage III rectal cancer patients were collected from a r and omized clinical trial that evaluated preoperative radiotherapy in total mesorectal excision surgery . Additional frozen archival tissues from 47 preoperative biopsies and corresponding resected colorectal tumors were collected . Level of apoptosis was determined by measuring the enzymatic activity of caspase-3 in a biochemical assay . Results : In tumor tissue , caspase-3 activity lower than the median was predictive of 5-year local recurrence ( hazard ratio , 7.4 ; 95 % confidence interval , 1.7 - 32.8 ; P = 0.008 ) , which was unaffected by adjustment for type of resection , tumor location , and T status ( adjusted hazard ratio , 7.5 ; 95 % confidence interval , 1.7 - 34.1 ; P = 0.009 ) . Caspase-3 activity in preoperative biopsies was significantly correlated with caspase-3 activity in corresponding resected tumors ( r = 0.56 ; P < 0.0001 ) . Conclusion : Detection of tumor apoptosis levels by measuring caspase-3 activity , for which a preoperative biopsy can be used , accurately predicted local recurrence in rectal cancer patients . These findings indicate that caspase-3 activity is an important denominator of local recurrence and should be evaluated prospect ively to be added to the criteria to select rectal cancer patients in which radiotherapy is redundant BACKGROUND & AIMS Despite poor performance , guaiac-based fecal occult blood tests ( G-FOBT ) are most frequently implemented for colorectal cancer screening . Immunochemical fecal occult blood tests ( I-FOBT ) are cl aim ed to perform better , without r and omized comparison in screening population s. Our aim was to r and omly compare G-FOBT with I-FOBT in a screening population . METHODS We conducted a population -based study on a r and om sample of 20,623 individuals 50 - 75 years of age , r and omized to either G-FOBT ( Hemoccult-II ) or I-FOBT ( OC-Sensor ) . Tests and invitations were sent together . For I-FOBT , the st and ard cutoff of 100 ng/ml was used . Positive FOBTs were verified with colonoscopy . Advanced adenomas were defined as > or=10 mm , high- grade dysplasia , or > or=20 % villous component . RESULTS There were 10,993 tests returned : 4836 ( 46.9 % ) G-FOBTs and 6157 ( 59.6 % ) I-FOBTs . The participation rate difference was 12.7 % ( P < .01 ) . Of G-FOBTs , 117 ( 2.4 % ) were positive versus 339 ( 5.5 % ) of I-FOBTs . The positivity rate difference was 3.1 % ( P < .01 ) . Cancer and advanced adenomas were found , respectively , in 11 and 48 of G-FOBTs and in 24 and 121 of I-FOBTs . Differences in positive predictive value for cancer and advanced adenomas and cancer were , respectively , 2.1 % ( P = .4 ) and -3.6 % ( P = .5 ) . Differences in specificities favor G-FOBT and were , respectively , 2.3 % ( P < .01 ) and -1.3 % ( P < .01 ) . Differences in intention-to-screen detection rates favor I-FOBT and were , respectively , 0.1 % ( P < .05 ) and 0.9 % ( P < .01 ) . CONCLUSIONS The number-to-scope to find 1 cancer was comparable between the tests . However , participation and detection rates for advanced adenomas and cancer were significantly higher for I-FOBT . G-FOBT significantly underestimates the prevalence of advanced adenomas and cancer in the screening population compared with I-FOBT Output:
For diagnostic purpose s , the most independently vali date d genes to study further are VIM , SEPT9 , ITGA4 , OSM4 , GATA4 and NDRG4 . In terms of prognostic markers , myopodin , KISS1 , TMEFF2 , HLTF , hMLH1 , APAF1 , BCL2 and p53 are independently vali date d. Most prognostic markers published lack both a multivariate analysis in comparison to clinical risk factors and the appropriate patient group who will benefit by adjuvant chemotherapy . Methylation of IGFBP3 , mir148a and PTEN are found to be predictive markers for 5-FU and EGFR therapy respectively .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: ABSTRACT This study was design ed to assess the efficacy and tolerability of MAS065D ( Xclair ™ ) compared to a vehicle control in the management of radiation dermatitis in patients receiving radiotherapy for breast cancer . Twenty patients were r and omized blindly to use the two study substances , three times daily , on separate sections of irradiated skin throughout the duration of radiotherapy and for two weeks afterwards . Patients were monitored before therapy , weekly during therapy , and for 2 weeks after radiotherapy was completed . Skin appearance according to National Cancer Institute ( NCI ) toxicity criteria , erythema rating , transepidermal water loss ( TEWL ) , skin hydration , patients ' view of itch , pain , acceptance , and view of each cream and adverse events , were monitored ; at the final visit patients and investigators expressed their preference for one of the creams . MAS065D showed statistically significant superiority in the outcomes of NCI grading for radiation dermatitis and erythema . Patients ' and investigators ' preferences for one of the study substances were statistically in favor of MAS065D . Very few patients recorded nonzero itch and pain scales , so no significant differences emerged between the two groups . It was concluded that MAS065D can provide an effective option for managing radiation dermatitis although further studies are needed to assess its effect on pain and itch Objective : To determine if a hyaluronic acid/carboxymethylcellulose ( HA/CMC ) sinus dressing reduces the rate of postoperative scarring . Methods : In a r and omized , matched-controlled , single-blinded study , following the completion of surgery , an HA/CMC dressing was r and omly assigned to one side with the opposite unpacked side serving as a control . Results : Fifty-three patients underwent surgery for chronic rhinosinusitis ( CRS ; 39 patients ) or CRS with nasal polyposis ( 14 patients ) . At the 8-week follow-up , there was no difference in synechiae on the HA/CMC side compared to the control ( p = 0.09 ) . HA/CMC-treated sinuses , however , demonstrated fewer synechiae in the first 2 weeks postoperatively compared to the control ( p = 0.01 ) , and were associated with significantly less nasal congestion at the 4-week ( p = 0.02 ) and 8-week follow-up visits ( 0.03 ) . Conclusion : There was no long-term difference in the rate of synechiae in the HA/CMC-treated sinus compared to the control . However , less severe nasal congestion and synechiae in the initial postoperative period may reduce the need for aggressive sinus debridement The purpose of this study was to evaluate outcomes of persons with neuropathic diabetic foot wounds treated with a hyaluronan-containing dressing . Data were abstract ed for 36 patients with diabetes , 72.2 % male , aged 60.0+/-10.7 years and a mean glycated hemoglobin ( HbA(1c ) ) of 9.5+/-2.5 % presenting for care at two large , multidisciplinary wound care centers . All patients received surgical debridement for their diabetic foot wounds and were placed on therapy consisting of hyaluronan dressing ( Hyalofill , Convatec , USA ) with dressing changes taking place every other day . Outcomes evaluated included time to complete wound closure and proportion of patients achieving wound closure in 20 weeks . Hyalofill therapy was used until the wound bed achieved 100 % granulation tissue . Therapy was then followed by a moisture-retentive dressing until complete epithelialization . In total , 75.0 % of wounds measuring a mean 2.2+/-2.2 cm(2 ) healed in the 20-week evaluation period . Of those that healed in this period , healing took place in a mean 10.0+/-4.8 weeks . The average duration of Hyalofill therapy in all patients was 8.6+/-4.2 weeks . Deeper ( UT Grade 2A ) wounds were over 15 times less likely to heal than superficial ( 1A ) wounds ( 94.7 vs. 52.9 % , Odds Ratio=15.9 , 95 % Confidence Interval=1.7 - 142.8 , P=0.006 ) . We conclude that a regimen consisting of moist wound healing using hyaluronan-containing dressings may be a useful adjunct to appropriate diabetic foot ulcer care . We await the completion of a multicenter r and omized controlled trial in this area to either support or refute this initial assessment Neuropathic leg ulcers ( NLUs ) affect more than 10 % of diabetic patients with peripheral neuropathy and represent the most common cause of ulceration of the leg in these patients . Though their pathogenesis is well known , related to the chronic neuropathic edema , the management of NLUs , mainly based on elastocompression , is still controversial , with lower healing rates than nondiabetic venous leg ulcers . The authors tested if a novel gel formulation , containing amino acids and hyaluronic acid ( Vulnamin ® gel ; Errekappa , Milan , Italy ) , will improve the outcomes of NLUs when used together with elastocompression . Thirty patients affected by NLU were r and omized into 2 groups , both treated with 4-layer elastocompressive b and aging : patients in group A were topically treated with the application of Vulnamin ® gel , whereas patients in group B received only the inert gel vehicle . The healing rate at 3 months was evaluated as the primary endpoint , whereas the secondary endpoints were healing time , reduction in ulcer area and ulceration score in 4 weeks , number of infective complications , and overall satisfaction of patients . Healing rate was significantly ( P < .05 ) higher in patients in group A when compared with those in group B ; healing time , patients ’ satisfaction , and reduction in ulcer area and ulceration score in 4 weeks were also higher in patients in group A. However , no significant differences were found in the prevalence of infections and other adverse events . The use of Vulnamin ® gel with elastocompression is safe and effective in the management of NLUs of diabetic patients BACKGROUND The aim of this study was to evaluate the efficacy of a topical hyaluronic acid ( HA ) gel preparation ( 0.2 % ) in the management of oral lichen planus ( OLP ) . METHODS A total of 124 patients with erosive OLP participated in a r and omized , placebo-controlled , double-blind trial to evaluate the efficacy of a topical HA preparation . Outcome measures included soreness relief following immediate application , oral function and size of erosive/ulcerative area . Patients were medicated for 28 days and completed a log diary recording oral function and soreness scores . RESULTS Application of topical HA produced a significant reduction ( P < 0.05 ) in soreness scores when compared with placebo for up to 4 h post-application . There was no difference between treatment groups ( P > 0.05 ) with respect to oral function . Patients treated with 0.2 % HA showed a significant reduction ( P < 0.05 ) in the size of the erosive/ulcerated area after 28 days of treatment when compared with baseline . There was no significant difference in changes in ulcerative areas between treatment groups . CONCLUSIONS Topical HA ( 0.2 % ) does appear to be of some benefit in the management of erosive lichen planus providing efficacy for up to 4 h after administration . Very frequent applications should be considered to obtain a more significant clinical benefit . Topical HA gel may be a useful addition to the treatment option for OLP Prior studies have suggested that hyaluronic acid ( HA ) , a naturally occurring glycosaminoglycan , may accelerate the healing of superficial burn wounds . To objective ly assess whether exogenous HA could accelerate the rate of healing and limit scar formation in superficial wounds , 11 patients with burn injuries who were undergoing skin grafting were given two separate skin graft donor sites of similar size and depth ( 1 " x 1 " x 0.016 " ) . In a r and omized , double-blind fashion , one of these partial-thickness wounds had repeated application with 1.5 % HA ; 100 % glycerin , which served as a control of similar viscosity , was applied to the other wound . On alternating days , photographs were taken and then analyzed with computerized digital planimetry to objective ly quantitate the rate of reepithelialization . In contrary to our hypothesis , HA significantly delayed wound healing compared to the glycerin control ( time to > 95 % reepithelialization : 10.3 + /- 2 days HA vs. 9.1 + /- 1.6 days control ; mean + /- SD ) . Furthermore , no difference in the result ant scar at 6 weeks and at 3 months after wounding was evident . These results demonstrate that HA retards healing of partial thickness wounds in adults OBJECTIVE To evaluate the clinical efficacy and safety of HYAFF 11-based autologous dermal and epidermal grafts in the management of diabetic foot ulcers . RESEARCH DESIGN AND METHODS A total of 79 patients with diabetic dorsal ( n = 37 ) or plantar ( n = 42 ) ulcers were r and omized to either the control group with nonadherent paraffin gauze ( n = 36 ) or the treatment group with autologous tissue-engineered grafts ( n = 43 ) . Weekly assessment , aggressive debridement , wound infection control , and adequate pressure relief ( fiberglass off-loading cast for plantar ulcers ) were provided in both groups . Complete wound healing was assessed within 11 weeks . Safety was monitored by adverse events . RESULTS Complete ulcer healing was achieved in 65.3 % of the treatment group and 49.6 % of the control group ( P = 0.191 ) . The Kaplan-Meier mean time to closure was 57 and 77 days , respectively , for the treatment versus control groups . Plantar foot ulcer healing was 55 % and 50 % in the treatment and control groups , respectively . Dorsal foot ulcer healing was significantly different , with 67 % in the treatment group and 31 % in the control group ( P = 0.049 ) . The mean healing time in the dorsal treatment group was 63 days , and the odds ratio for dorsal ulcer healing compared with the control group was 4.44 ( P = 0.037 ) . Adverse events were equally distributed between the two groups , and none were related to the treatments . CONCLUSIONS The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current st and ard dressing . For plantar ulcers , the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment . This treatment , however , may be useful in patients for whom the total off-loading cast is not recommended and only a less effective off-loading device can be applied Intra-articular injections of hyaluronic acid products may eliminate pain , improve mobility and quality of life , and delay osteoarthritis progression . In this study , we evaluated the safety and efficacy of sodium hyaluronate injections given after knee arthroscopy . Forty-six patients with early osteoarthritis and a symptomatic meniscus tear were prospect ively r and omized into study ( injection ) and control groups and underwent knee arthroscopy . Study patients received 3 sodium hyaluronate injections after surgery . Study and control outcomes were compared 3 and 6 months after surgery . The injection patients had significantly less pain ( visual analog scale ) at 3-month follow-up and more flexion at 6-month follow-up . Tenderness , pain on motion , and crepitus were significantly more likely to be absent from injection patients at the 3- and 6-month follow-ups . Patients with osteoarthritis and a symptomatic meniscus tear may experience more pain relief and functional mobility after arthroscopic surgery plus hyaluronic acid injections than after arthroscopy alone This study evaluated the efficacy and tolerability of an autologous tissue-engineered graft — a 2-step HYAFF autograft — in the treatment of diabetic foot ulcers compared with st and ard care . In all , 180 patients with dorsal or plantar diabetic foot ulcers ( unhealed for ≥1 month ) were r and omized to receive Hyalograft-3D autograft first and then Laserskin autograft after 2 weeks ( n = 90 ; treatment group ) or nonadherent paraffin gauze ( n = 90 ; control group ) . Efficacy and adverse events were assessed weekly for 12 weeks , at 20 weeks , and at 18 months . The primary efficacy outcome was complete ulcer healing at 12 weeks . Wound debridement , adequate pressure relief , and infection control were provided to both groups . At 12 weeks , complete ulcer healing was similar in both groups ( 24 % of treated vs 21 % controls ) . A 50 % reduction in ulcer area was achieved significantly faster in the treatment group ( mean 40 vs 50 days ; P = .018 ) . Weekly percentage ulcer reduction was consistently higher in the treatment group . At 20 weeks , ulcer healing was achieved in 50 % of the treated group as compared with 43 % of controls . Dorsal ulcers had a 2.17-fold better chance of wound healing per unit time following autograft treatment ( P = .047 ) . In a subgroup with hard-to-heal ulcers , there was a 3.65-fold better chance of wound healing following autograft treatment of dorsal ulcers ( P = .035 ) . Adverse events were similar in both groups . The Output:
Further , it was found in a meta- analysis in subsets of patients with diabetic foot ulcers ( neuropathic ) that HA derivatives healed these types of wounds significantly faster than st and ard of care . These studies in aggregate show that HA derivatives accelerate the healing process in burns , epithelial surgical wounds , and chronic wounds
MS2_1shot215
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: The object of this study was to compare the protective action of a new barrier cream ( Excipial Protect ® , Spirig Pharma AG , Egerkingen , Switzerl and ) to its vehicle in the context of h and irritation of apprentice hairdressers caused by repeated shampooing and exposure to hair‐care products . This was a double‐blind cross‐over comparing Excipial Protect ® ( containing aluminium chlorohydrate 5 % as active ingredient ) against its vehicle alone . The efficacy of the creams was evaluated taking into account : ( 1 ) clinical scores by research ers , ( 2 ) biometric measurements , ( 3 ) subjective opinions of the subjects . An analysis of variance was performed considering order of application , degree of atopy , and reported number of shampoos . We observed very little difference in efficacy between the protective cream and its vehicle . The presence , however , of aluminium chlorhydrate in the protective cream was shown to have a positive effect against work‐related irritation . The cosmetic qualities of the creams seemed , to the participants , to be as important as their real protective and hydrating properties , an important factor in compliance issues The purpose of this study was to develop a new model for the induction of chronic irritant contact dermatitis , which would reflect well the conditions of daily practice . Various weak irritant agents were tested for irritating potency on the skin and the sensitivity of transepidermal water loss ( TEWL ) measurements in the detection of early skin changes was also studied . 10 widely used surfactants and 1 solubilizer were applied to the skin of the forearms of healthy volunteers in aqueous solutions of 12.5 millimoles/1 for 45 min twice daily for 3 weeks . The effect on the skin was evaluated daily by means of TEWL measurements and by a visual scoring system . Each solution caused an increase in TEWL value over time due to the cumulative irritating action on the epidermal barrier . This increase in TEWL was different for the various solutions , result ing in different mean TEWL values on the last day of the experiment . Thus , it was possible to rank the agents according to irritating potency . This ranking order was the same in almost every individual and remained constant during the 3 weeks . In comparison with the visual scoring system , the TEWL measurements were more sensitive in the detection of early changes in the skin BACKGROUND Limited information documents the prevention and treatment benefits of a h and care regimen using moisturizer in a controlled manner for employees in typical manufacturing situations . OBJECTIVE The objective was to assess the effectiveness of a comprehensive skin care program including skin conditioning lotion in multiple manufacturing environments where employees are at high risk for skin disease . METHODS A r and omized trial test design with multiple measures , including skin bioengineering measurement techniques , visual grading , and self- assessment question naires , was used to broadly characterize skin condition . RESULTS Comparison of the change in the skin condition of workers using the full h and care regimen with moisturizer versus a control group using a regimen without moisturizer demonstrated significant ( p < .05 ) improvements in multiple measures after 1 to 2 weeks . Corneometer readings consistently showed significant improvement for employees using moisturizer , regardless of their work location . CONCLUSION Improved skin condition result ed from the regular use of an effective skin conditioning h and moisturizer as part of a skin care regimen in work environments in which workers were prone to experiencing occupational irritant contact dermatitis An in vivo method was developed to measure the effectiveness of skin protective creams against 2 dye indicator solutions : methylene blue in water and oil red O in ethanol , representative of model hydrophilic and lipophilic compounds , 3 representative barrier creams commercialized as effective against lipophilic , hydrophilic , or lipophilic and hydrophilic substances were assayed by measurements of the dye in cyanoacrylate strips of protected skin sample s after various application limes . The flexural surfaces of the forearms of 6 normal volunteers ( 3 female and 3 male , mean age 26.8±4.1 years ) were treated . The method was as follows : solutions of 5 % methylene blue in water and 5 % oil red O in ethanol were prepared , and applied to untreated skin and protective‐cream‐pretreated skin with the aid of aluminum occlusive chambers , for 0 h and 4 h , respectively . At the end of the application time , the creams were removed . Consecutive skin surface biopsies ( SSB ) from 1 to 4 strips were taken . The amount of stain in each strip was determined by colorimetry , and the cumulative amount of stain from 1 to 4 strips in each measurement was calculated . The cumulative amount represents the amount of permeation of each solution at each time point , and the efficacy of skin barrier cream . The results showed one formulation at both 0 h and 4 h reduced the amount of permeation of melhylene blue ( p<0.0l ) and oil red O ( p<0.01 ) compared with the control group . Another formulation was protective against the permeation of oil red O ( p < 0.0l ) . but not against methylene blue at 0 h and 4 h ; it was not significantly different at 0 h versus 4 h. The 3rd formulation produced increased cumulative amounts to oil red O at both 0 h and 4 h ( p<0.05 ) ; it also increased permeation amounts to methylene blue ( p<0.05 ) after 4 h. This model appears a facile , rapid and objective early screen to evaluate the efficacy of skin barrier creams in vivo , as well as their individual ingredients A total of 942 workers of 13 dyeing and printing factories in the area of Como ( N. Italy ) were examined in order to detect skin complaints on the h and s and forearms . Of these , 868 were eligible for and consented to participate in a controlled and r and omized experiment aim ed at assessing the efficacy of using barrier creams in practical circumstances . 657 workers underwent all three control examinations arranged over about one year . In the r and omized group for treatment with barrier creams the cumulative incidence of objective skin lesions was significantly lower than in the group in which no particular recommendation of use was made ( 44.5 % versus 54.4 % positive for objective examination in at least one of the three control examinations after recruitment : 95 % confidence limits of the difference between 2%-17 % percentages ; 39.9 % versus 47.0 % in subjects who were negative at the recruitment examination , 59.0 % versus 76.8 % in subjects who were positive at the recruitment examination ) . The use of a hydrocarbon cream was significantly more effective than using a silicone cream ( 95 % confidence limits of the differences of cumulative incidences : -10.9 % + 20.7 % comparing silicone creams with non-treatment ; 2.8%-20.2 % comparing hydrocarbon creams with non-treatment ) The effect on the skin of housewives of using a washing product in the home for all cleaning purpose s under conditions of maximal exposure has been studied . Tests conducted on over 4,000 housewives showed that detergents containing proteolytic enzymes had no greater effect on the skin than conventional detergents , even when the h and skin condition was initially poor . The same was true in a further test on 130 housewives with “ dishpan ” h and s. No adverse reactions attributable specifically to the enzyme products were seen . No eruptions from contact with clothes washed in enzyme products were reported from any of the families involved in these tests Objective . The objective of this controlled intervention study was to quantify the efficacy of skin protection ( SP ) measures and ultraviolet B ( UVB ) hardening in the prevention of h and dermatitis in bakers ' apprentices . Method . SP measures were compared against UVB hardening in a controlled clinical trial of 94 apprentices . The apprentices were assigned to the intervention arms class-wise . Bakers ' apprentices involved in a previous follow-up study served as additional controls representing no intervention . The apprentices were interviewed and examined in a st and ardised way at the beginning of the training and at 4 monthly follow-ups . Transepidermal water loss ( TEWL ) was measured at the back of the h and s. Results . Demographic profile and atopy criteria were equally distributed in the two intervention arms and the control group . Point prevalence of h and dermatitis after 6 months was highest in the controls ( 29.1 % ) followed by the UVB ( 19.4 % ) and the SP group ( 13.3 % ) . UVB hardening and SP measures reduced h and dermatitis prevalence by 9.7 % ( 95%CI : –8.5 to 28.1 ) and 15.7 % ( 95%CI : –2.4 to 33.9 ) , respectively . Application of SP measures reduced the odds ratios ( ORs ) for h and dermatitis 0.8-fold ( 95%CI : 0.17–3.70 ) and 0.33-fold ( 95%CI : 0.09–1.23 ) compared with the UVB group and the controls , respectively . These clinical trends were confirmed by statistically significant differences in TEWL values . TEWL values were consistently higher in the UVB group than in the SP group ( P=0.002 ) . Conclusions . This study provided evidence , based on significant differences in TEWL levels , that general SP measures may be more effective than UV light hardening of the skin , which in turn was more effective than no intervention . This trend was supported by the frequency of development of clinical h and dermatitis , although differences did not reach statistical significance . A multi-centre trial is recommended to confirm the efficacy of SP measures in a larger r and omised study Aims : To evaluate the effect of implementation of an evidence based skin care programme for wet work employees as part of an occupational health and safety management system . Methods : 375 wet work employees were included in a prospect i ve r and omised controlled trial , allocated to either intervention ( n = 207 ) or control ( n = 168 ) . The intervention group was exposed to a skin care programme during the five month study period . The intervention included an educational programme for a group of frontline employees , who underwent formalised training , and subsequently introduced the information to their colleagues . As part of the intervention a skin care policy including written instructions was established at each workplace . Both groups answered a test quiz , completed question naires on behaviour and symptoms , and underwent clinical examination of their h and s before and after the five month period . Results : No difference between the intervention and the control group was found at baseline with respect to clinical symptoms or behaviour . Evaluation after the five months of intervention revealed a significantly higher information level on skin care in the intervention group compared to the control group , a significant change in behaviour in the intervention group but not in the control group , and significantly less skin symptoms as evaluated clinical ly in the intervention group but not in the control group . No significant difference was found for self reported skin problems . Conclusions : The intervention was successful with respect to information level ( knowledge ) , behaviour , and clinical symptoms . Implementation of a skin care programme as part of an occupational health and safety management system is recommended as a prophylactic measure for employees in wet occupations Objectives : The objective of the present implementation study is to document how an intervention to reduce work-related skin problems by means of implementing an evidence -based skin protection programme in six gut-cleaning departments in swine slaughterhouses was understood , accepted and carried out . The association between the degree of implementation and the reduction of work-related skin problems in each department is examined . The intervention included a top-down strategy with establishment of a management system focusing on skin risks and a bottom-up strategy with participation of a selected group of shop floor workers and the safety representative , as change agents , as well as an empowerment-based educational programme , where the middle management and representatives from the top management also participated . Methods : The study design was a r and omized controlled intervention study with a 1-year study period . The outcome of the intervention was evaluated by telephone interviews . Data on the implementation process consisted of self-administered question naires , focus interviews and compiled written material s. Four indexes referring to the management system and the change agents ’ intervention activities were constructed . Finally , the Pearson correlation coefficient was used to test the correlation between the degree of implementation and the eczema frequency at 1-year follow-up . Results : There was a statistically significant association ( p < 0.05 ) between both the index for the combined implementation method and the eczema frequency after 1 year of intervention , and between the activities of the change agents and the eczema frequency . In contrast to this there was only a weak association between the establishment of a formal management system alone and the outcome . Conclusion : The study evidence s that a combination of a top-down and a bottom-up implementation method is effective to reduce work-related skin problems , and that the process of implementation is a significant determinant of the overall results The effect of three industrial h and cleansers on transepidermal water loss ( TWL ) was evaluated in groups of healthy volunteers . After 2 weeks , subjects using Baracaide averaged 47 % less TWL than those using Swarfega und 35 % less than with Go‐Jo . In a second study in printers , the use of Baracaide decreased TWL by 20 % after 2 weeks . Because it contains no volatile solvents , Baracaide may be less injurious to the barrier layer OBJECTIVE To examine the impact of introduction of an alcohol-based h and rub on h and hygiene knowledge and compliance and h and colonization of healthcare workers ( HCWs ) in a long-term-care facility ( LTCF ) . METHODS Two floors of an LTCF participated . Ward A used the h and rub as an adjunct to soap and water ; ward B was the control . HCWs ' h and s were cultured using the bag-broth technique for Staphylococcus aureus , gram-negative bacilli ( GNB ) , C and ida , and vancomycin-resistant enterococci ( VRE ) . HCWs completed a question naire at baseline and after an educational intervention and introduction of rub . RESULTS H and Output:
However , this risk reduction may not be clinical ly important . The investigated interventions to prevent OIHD probably cause few or no serious adverse effects . AUTHORS ' CONCLUSIONS Moisturisers used alone or in combination with barrier creams may result in a clinical ly important protective effect , either in the long- or short-term , for the primary prevention of OIHD . Barrier creams alone may have slight protective effect , but this does not appear to be clinical ly important . For skin protection education , the results varied substantially across the trials , the effect was imprecise , and the pooled risk reduction was not large enough to be clinical ly important . The very low quality of the evidence means that we are unsure as to whether skin protection education reduces the risk of developing OIHD . The interventions probably cause few or no serious adverse effects . We conclude that at present there is insufficient evidence to confidently assess the effectiveness of interventions used in the primary prevention of OIHD . This does not necessarily mean that current measures are ineffective .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: ABSTRACT Despite increased interest among the public in breast cancer genetic risk and genetic testing , there are limited services to help women make informed decisions about genetic testing . This study , conducted with female callers ( N = 279 ) to the National Cancer Institute 's ( NCI 's ) Atlantic Region Cancer Information Service ( CIS ) , developed and evaluated a theory-based , educational intervention design ed to increase callers ' underst and ing of the following : ( a ) the kinds of information required to determine inherited risk ; ( b ) their own personal family history of cancer ; and ( c ) the benefits and limitations of genetic testing . Callers requesting information about breast/ovarian cancer risk , risk assessment services , and genetic testing were r and omized to either : ( 1 ) st and ard care or ( 2 ) an educational intervention . Results show that the educational intervention reduced intention to obtain genetic testing among women at average risk and increased intention among high-risk women at 6 months . In addition , high monitors , who typically attend to and seek information , demonstrated greater increases in knowledge and perceived risk over the 6-month interval than low monitors , who typically are distracted from information . These findings suggest that theoretically design ed interventions can be effective in helping women underst and their cancer risk and appropriate risk assessment options and can be implemented successfully within a service program like the CIS Abstract Objective : To investigate the feasibility of improving screening for carriers of haemoglobin disorders in general practice by using a nurse facilitator to work with primary care teams and the relevant haematology laboratories ; to identify problems in communication between all those involved in delivering the service , and to implement solutions . Design : Two year , practice based r and omised controlled trial . Setting : North London area where 29 % of residents and 43 % of births are in ethnic groups at risk for haemoglobin disorders . Subjects : 26 of the 93 practice s using the services of the area 's haematology laboratory agreed to take part and were r and omly divided into control and intervention practice s. Main outcome measure : Change in number of requests for screening tests for haemoglobin disorders made by control and intervention practice s in baseline and intervention years . Results : The number of screening tests requested varied from 0 - 150 in the 93 practice s in the baseline year . Study practice s tended to have made a moderate number of requests ( 10 - 50 ) during this period . During the intervention year intervention practice s made 292 more requests ( 99 % increase ) and control practice s made 74 fewer requests ( 23 % decrease ; P=0.001 for difference in median change ) . Four practice s , three of which were singleh and ed , accounted for 75 % of the increase . The number of requests from intervention practice s , adjusted for baseline requests , was 3.2 times higher than control practice s ( P<0.0001 ) . Conclusion : General practitioners and practice nurses are willing to undertake a new genetic screening service ( or exp and an existing one ) if they are persuaded that it benefits the health of a significant proportion of their practice population . They need appropriate tools ( for example , information material s for carriers and groups at risk ) , and the laboratory must be sensitive to their needs . Preconceptional carrier screening and counselling need to be coupled with antenatal screening OBJECTIVE Genetic testing is increasingly part of routine clinical care for women with a family history of breast cancer . Given their substantially elevated risk for breast cancer , BRCA1/BRCA2 mutation carriers must make the difficult decision whether or not to opt for risk reducing mastectomy . To help BRCA1/2 carriers make this decision , the authors developed a computer-based interactive decision aid that was tested against usual care in a r and omized controlled trial . DESIGN After the completion of genetic counseling , 214 female ( aged 21 - 75 ) BRCA1/BRCA2 mutation carriers were r and omized to Usual Care ( UC ; N = 114 ) or Usual Care plus Decision Aid ( DA ; N = 100 ) arms . UC participants received no additional intervention . DA participants were sent the CD-ROM DA to view at home . MAIN OUTCOME MEASURES The authors measured final management decision , decisional conflict , decisional satisfaction , and receipt of risk reducing mastectomy at 1- , 6- , and 12-months postr and omization . RESULTS Longitudinal analyses revealed that the DA was effective among carriers who were initially undecided about how to manage their breast cancer risk . Within this group , the DA led to an increased likelihood of reaching a management decision ( OR = 3.09 , 95 % CI = 1.62 , 5.90 ; p < .001 ) , decreased decisional conflict ( B = -.46 , z = -3.1 , p < 002 ) , and increased satisfaction ( B = .27 , z = 3.1 , p = .002 ) compared to UC . Among carriers who had already made a management decision by the time of r and omization , the DA had no benefit relative to UC . CONCLUSION These results demonstrate that BRCA1/BRCA2 mutation carriers who are having difficulty making a breast cancer risk management decision can benefit from adjunct decision support PURPOSE To evaluate the predictors of and time taken for the translation of highly promising basic research into clinical experimentation and use . METHODS We identified 101 articles , published between 1979 and 1983 in six major basic science journals , which clearly stated that the technology studied had novel therapeutic or preventive promises . Each case was evaluated for whether the promising finding result ed in relevant r and omized controlled trials and clinical use . Main outcomes included the time to published trials , time to published trials with favorable results ( " positive " trials ) , and licensed clinical use . RESULTS By October 2002 , 27 of the promising technologies had result ed in at least one published r and omized trial , 19 of which had led to the publication of at least one positive r and omized trial . Five basic science findings are currently licensed for clinical use , but only has been used extensively for the licensed indications . Promising technologies that did not lead to a published human study within 10 to 12 years were unlikely to be tested in humans subsequently . Some form of industry involvement in the basic science publication was the strongest predictor of clinical experimentation , accelerating the process by about eightfold ( 95 % confidence interval : 3 to 19 ) when an author had industry affiliations . CONCLUSION Even the most promising findings of basic research take a long time to translate into clinical experimentation , and adoption in clinical practice is rare PURPOSE Markers of genetic susceptibility to tobacco-related cancers could personalize harms of smoking and motivate cessation . Our objective was to assess whether a multicomponent intervention that included feedback about genetic susceptibility to lung cancer increased risk perceptions and rates of smoking cessation compared with a st and ard cessation intervention . EXPERIMENTAL DESIGN Our design was a two-arm trial with eligible smokers r and omized in a 1:2 ratio to Enhanced Usual Care or Biomarker Feedback ( BF ) . Surveys were conducted at baseline , 6 , and 12 months later . The setting was an inner city community health clinic . African-American patients who were current smokers ( n = 557 ) were identified by chart abstract ion and provider referral . All smokers received a self-help manual and , if appropriate , nicotine patches . Smokers in the BF arm also were offered a blood test for genotyping the GST(3 ) gene ( GSTM1 ) , sent a test result booklet , and called up to four times by a health educator . Prevalent abstinence was assessed by self-report of having smoked no cigarettes in the prior 7 days at the 6- and 12-month follow-ups and sustained abstinence , i.e. , not smoking at either follow-up or in-between . RESULTS Smoking cessation was greater for the BF arm than the Enhanced Usual Care arm ( 19 % versus 10 % , respectively ; P < 0.006 ) at 6 months but not at 12 months . CONCLUSIONS Smokers agreed to genetic feedback as part of a multicomponent cessation program . Although the program increased short-term cessation rates compared with st and ard intervention , genetic feedback of susceptibility may not benefit smokers with high baseline risk perceptions Prenatal diagnosis ( PND ) is offered routinely as part of pregnancy care to a large number of women at increased risk of fetal anomalies . Despite an extraordinary growth in the use of PND and significant re source allocation , few studies have examined outcomes of PND counseling , and virtually no research has evaluated the relative efficacy of various approaches to genetic counseling . This study was a r and omized trial that compared which counseling methods – individual , group , and use of a decision aid – are effective in PND counseling for women of advanced maternal age ( ≥35 years ) and their partners . Three hundred and fifty‐two women and 225 partners completed pre‐ and post‐intervention question naires assessing changes in knowledge , decisional conflict , state anxiety , satisfaction , use of PND , and pregnancy outcomes . All participants showed a significant increase in knowledge and a decrease in decisional conflict post intervention . Those in the group intervention showed a significantly greater increase in knowledge than those in the individual counseling intervention . While high levels of satisfaction were reported by all , those in individual counseling were significantly more satisfied than those receiving group counseling or the decision aid . This study has shown unique benefits with each type of intervention such that women and their partners preferred individual genetic counseling , while they learned best in group‐counseling sessions , and experienced the least decisional conflict regarding genetic testing with a decision aid OBJECTIVES (1)To compare an interactive multimedia decision aid ( IMDA ) with a leaflet and a video to give information about prenatal screening for Down syndrome and ( 2 ) to determine the women 's acceptance of IMDA . METHODS Two hundred and one women were recruited from the prenatal clinic of a university teaching hospital and r and omised into the intervention group ( IMDA , video , and information leaflet ) or the control group ( video and information leaflet ) . RESULTS There were no significant differences in the initial decision for and the final uptake of the prenatal screening test between the control and intervention groups . The proportion of women who were undecided was less than 10 % in both groups . Of the women in the intervention group , 86.6 % and 78.9 % agreed that IMDA was user-friendly and acceptable , respectively . Significantly more women aged < 35 ( 88.1 % ) accepted IMDA than women aged > or = 35 ( 68.3 % ) ( P = 0.030 ) , but the logistic regression analysis did not confirm this finding after adjusting for other factors ( computer knowledge and usage of computer ) . CONCLUSION The use of IMDA did not affect the women 's overall uptake rate of the prenatal screening test for Down syndrome . More women less than 35 years accepted IMDA probably because they used computer more frequently and had more computer knowledge BACKGROUND In response to the isolation of the BRCA1 gene , a breast-ovarian cancer-susceptibility gene , biotechnology companies are already marketing genetic tests to health care providers and to the public . Initial studies indicate interest in BRCA1 testing in the general public and in population s at high risk . However , the optimal strategies for educating and counseling individuals have yet to be determined . PURPOSE Our goal was to evaluate the impact of alternate strategies for pretest education and counseling on decision-making regarding BRCA1 testing among women at low to moderate risk who have a family history of breast and /or ovarian cancer . METHODS A r and omized trial design was used to evaluate the effects of education only ( educational approach ) and education plus counseling ( counseling approach ) , as compared with a waiting-list ( control ) condition ( n = 400 for all groups combined ) . The educational approach review ed information about personal risk factors , inheritance of cancer susceptibility , the benefits , limitations , and risks of BRCA1 testing , and cancer screening and prevention options . The counseling approach included this information , as well as a personalized discussion of experiences with cancer in the family and the potential psychological and social impact of testing . Data on knowledge of inherited cancer and BRCA1 test characteristics , perceived risk , perceived benefits , limitations and risks of BRCA1 testing , and testing intentions were collected by use of structured telephone interviews at baseline and at 1-month follow-up . Provision of a blood sample for future testing served as a proxy measure of intention to be tested ( in the education and counseling arms of the study ) . The effects of intervention group on study outcomes were evaluated by use of hierarchical linear regression modeling and logistic regression modeling ( for the blood sample outcome ) . All P values are for two-sided tests . RESULTS The educational and counseling approaches both led to significant increases in knowledge , relative to the control condition ( P < .001 for both ) . The counseling approach , but not the educational approach , was superior to the control condition in producing significant increases in perceived limitations and risks of BRCA1 testing ( P < .01 ) and decreases in perceived benefits ( P < .05 ) . However , neither approach produced changes in intentions to have BRCA1 testing . Prior to and following both education only and education plus counseling , approximately one half of the participants stated that they intended to be tested ; after the session , 52 % provided a blood sample . CONCLUSIONS St and ard educational approaches may be equally effective as exp and ed counseling approaches in enhancing knowledge . Since knowledge is a key aspect of medical decision-making , st and ard education may be adequate in situations where genetic testing must be streamlined . On the other h and , it has been argued that optimal decision-making requires not only knowledge , but also a reasoned evaluation of the positive and negative consequences of alternate decisions . Although the counseling approach is more likely to achieve this goal , it may not diminish interest in testing , even among women at low to moderate risk . Future research should focus on the merits of these alternate approaches for subgroups of individuals with different background s who are being counseled in the variety of setting s where BRCA1 testing is likely to be offered This trial tests the hypothesis that confirm Output:
CONCLUSIONS More research on the effectiveness of KT interventions regarding genetic testing in the clinical context may contribute to patients making informed value-based decisions and drawing the maximum benefit from clinical applications of genetic and genomic innovations
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background : Existing data suggest that physical activity reduces colon cancer risk , but the association is not consistently observed in women . One potential explanation for this inconsistency is that hormone therapy , which is associated with lower colon cancer risk , acts as a modifier of the physical activity/colon cancer relationship . Methods : Participants in the California Teachers Study ( N = 120,147 ) , a prospect i ve cohort of female teachers and administrators residing in California , ages 22 to 84 years at baseline and with no prior history of colon cancer were eligible for study . Between 1996 and 2002 , 395 patients were diagnosed with invasive colon cancer . The relative risks ( RR ) associated with lifetime ( high school through age 54 years or current age ) and recent ( past 3 years ) strenuous and moderate recreational physical activity were estimated using Cox proportional hazards regression models . Results : Combined lifetime moderate and strenuous recreational physical activity was only modestly associated with colon cancer risk in the cohort [ ≥4 versus ≤0.5 h/wk/y : RR , 0.75 ; 95 % confidence interval , 0.57 - 1.00 ; Ptrend = 0.23 ] . Lifetime physical activity reduced colon cancer risk among postmenopausal women who had never taken hormone therapy ( ≥4 versus ≤0.5 h/wk/y : RR , 0.51 ; 95 % confidence interval , 0.31 - 0.85 ; Ptrend = 0.02 ) . Postmenopausal women with histories of hormone therapy use had lower colon cancer risk , but their risk was not associated with physical activity . The likelihood ratio test for interaction between hormone use and lifetime moderate plus strenuous physical activity was of borderline statistical significance ( P = 0.05 ) . We observed no effect modification by age , body mass index , smoking status , menopausal status , or folate intake . Conclusions : Lifetime recreational physical activity may protect against colon cancer among postmenopausal women who have never used hormone therapy . Among hormone therapy users , who have lower risk of colon cancer , recreational physical activity does not seem to provide any additional benefit . With declining rates of hormone therapy use , physical activity offers one possible means for reducing women 's colon cancer risk . ( Cancer Epidemiol Biomarkers Prev 2007;16(3):517–25 Physical activity may reduce colon cancer risk , but the underlying mechanisms remain unclear . Relating physical activity to cancer risk in anatomic segments of the colon may advance our underst and ing of possible mechanisms . We conducted a prospect i ve study of 59,369 Norwegian men and women who were followed up for cancer incidence and mortality . Cox proportional hazards models were used to estimate multivariably adjusted hazard ratios ( HR ) and 95 % confidence intervals ( 95 % CI ) . All statistical tests were two sided . During 17 years of follow-up , 736 colon cancers and 294 rectal cancers were diagnosed . Overall , we found an inverse association between recreational physical activity and colon cancer risk , but subsite analyses showed that the association was confined to cancer in the transverse and sigmoid colon . The adjusted HR , comparing people who reported high versus no physical activity , was 0.44 ( 95 % CI , 0.25 - 0.78 ) for cancer in the transverse colon and 0.48 ( 95 % CI , 0.31 - 0.75 ) for cancer in the sigmoid colon . The corresponding HR for cancer mortality was 0.33 ( 95 % CI , 0.14 - 0.76 ) for the transverse colon and 0.29 ( 95 % CI , 0.15 - 0.56 ) for the sigmoid colon . For rectal cancer , there was no association with physical activity in these data . In conclusion , the inverse association of recreational physical activity with cancer risk and mortality in the transverse and sigmoid segments of the colon may point at increased colon motility and reduced fecal transit time as possible underlying mechanisms . ( Cancer Epidemiol Biomarkers Prev 2008;17(1):183–8 Studies of colon cancer risk in males have reported strong positive associations with obesity , particularly with central adiposity . The association has been weaker and less consistent for women . In a prospect i ve cohort study of women , body measurements were taken directly ; fat mass and fat‐free mass being estimated by bioelectrical impedance analysis and central adiposity by waist circumference and waist‐to‐hip ratio ( WHR ) . Among 24,072 women followed on average for 10.4 years , 212 colon cancers were ascertained via the population cancer registry . We review ed medical records of all cases and classified them according to anatomic site and stage . The central adiposity measures of WHR ( hazard ratio per 0.1 unit increase = 1.31 , 95 % confidence interval ( CI ) 1.08–1.58 ) and waist circumference ( hazard ratio per 10 cm increase = 1.14 , 95 % CI 1.02–1.28 ) were positively associated with colon cancer risk . There was little or no association between other anthropometric measures and risk of colon cancer . There was some evidence that the associations were stronger for proximal tumors , but no evidence that risk differed by stage for any of the anthropometric measures . Central adiposity appears to be associated with colon cancer risk in women . © 2005 Wiley‐Liss , Physical activity is protective against colon cancer , whereas colonic bile acid exposure is a suspected risk factor . Although likely related , the association between physical activity and bile acid levels has not been well-studied . Furthermore , the effect of triglycerides , which are known to modify bile acid levels , on this relationship has not been investigated . We conducted a cross-sectional analysis of baseline fecal bile acid levels for 735 colorectal adenoma formers obtained from participants in a phase III ursodeoxycholic acid chemoprevention trial . Compared with the lowest quartile of recreational physical activity duration , the highest quartile was associated with a 17 % lower fecal bile acid concentration , adjusted for age , sex , dietary fiber intake , and body mass index ( P = 0.042 ) . Furthermore , consistent with a previously established relationship between serum triglyceride levels and bile acid metabolism , we stratified by triglyceride level and observed a 34 % lower fecal bile acid concentration ( highest versus lowest quartiles of physical activity ) in individuals with low triglycerides ( < 136 mg/dL ; P = 0.002 ) . In contrast , no association between physical activity and fecal bile acid concentration was observed for subjects with high triglycerides ( ≥136 mg/dL ) . Our results suggest that the biological mechanism responsible for the protective effect of physical activity on the incidence of colon cancer may be partially mediated by decreasing colonic bile acid exposure . However , this effect may be limited to individuals with lower triglyceride levels . ( Cancer Epidemiol Biomarkers Prev 2009;18(5):1591–8 BACKGROUND Several studies of male colon cancer have found positive associations with body size and composition . It is uncertain whether this relationship is due to non-adipose mass , adipose mass , distribution of adipose mass such as central adiposity , or all three . METHODS In a prospect i ve cohort study of men aged 27 - 75 at recruitment in 1990 - 1994 , body measurements were taken by interviewers . Fat mass and fat-free mass ( FFM ) were estimated from bioelectrical impedance analysis . Waist circumference and waist-to-hips ratio ( WHR ) estimated central adiposity . Incident colon cancers were ascertained via the population cancer registry . Altogether , 16,556 men contributed 145,433 person-years and 153 colon cancers . RESULTS Rate ratios ( RRs ) comparing men in the fourth quartile with those in the first quartile were as follows : FFM 2.3 [ 95 % confidence interval ( CI ) 1.4 - 3.7 ] ; height 1.9 ( 95 % CI 1.1 - 3.1 ) ; waist circumference 2.1 ( 95 % CI 1.3 - 3.5 ) ; WHR 2.1 ( 95 % CI 1.3 - 3.4 ) ; fat mass 1.8 ( 95 % CI 1.1 - 3.0 ) ; and body mass index 1.7 ( 95 % CI 1.1 - 2.8 ) . When continuous measures of FFM and WHR were modeled together , the RR for FFM per 10 kg was 1.37 ( 95 % CI 1.04 - 1.80 ) and the RR for WHR per 0.1 unit was 1.65 ( 95 % CI 1.28 - 2.13 ) . After adjustment for FFM and WHR , the RRs for fat mass and body mass index were no longer statistically significant . CONCLUSION Male colon cancer appears to be related to body size and composition by two different pathways , via central adiposity and via non-adipose mass Objective To prospect ively examine the association between physical activity and the risk of developing colorectal cancer in a large population -based cohort study of Japanese men and women , and to investigate whether the effects of physical activity on colorectal cancer risk differ by sex and subsite . Methods We analyzed data from a population -based cohort of 65,022 subjects . A total of 486 incident colorectal cancers ( 154 proximal colon , 166 distal colon and 149 rectal cancers ) was identified during 6 years of follow-up . Results We observed a significant inverse association between physical activity and the risk of developing colorectal cancer , particularly colon cancer , among men . Relative to men in the lowest level of metabolic equivalent ( MET ) hours per day , those in the highest level had a RR of 0.69 ( 95 % CI = 0.49–0.97 ) . A significant decrease in risk of colorectal cancer was associated with increasing MET hours per day among men . This inverse association was essentially limited to colon cancer . A significant decrease in risk with increasing MET-hour score was observed predominantly for proximal colon cancer among men . In contrast , no significant decrease was seen among women . Conclusion These findings suggest that physical activity may prevent colon cancer among Japanese men Abstract Objective : Epidemiologic data relating obesity to risk of colorectal cancer in women have been inconclusive . Two recent studies have suggested that the association may be modified by estrogen status ; BMI was positively associated with colorectal cancer risk among women with high estrogen exposures [ premenopausal women , and postmenopausal women who currently received postmenopausal hormone therapy ( PMH ) ] . We prospect ively investigated the role of BMI in colorectal cancer risk along with the modifying effects of estrogen in a large cohort from the Women 's Health Study . Methods : Among 39,876 apparently healthy women aged ≥45 years at baseline ( 54 % of them were postmenopausal ) , 37,671 were eligible for the present study . During an average of 8.7 years of follow-up , 202 women had a confirmed diagnosis of colorectal cancer . Baseline BMI was calculated by dividing self-reported weight in kilograms by height in meters squared . Results : The multivariate relative risks ( RRs ) and 95 % confidence interval ( CI ) of colorectal cancer were 1.72 ( 1.12–2.66 ) for 27–29.9 kg/m2 , and 1.67 ( 1.08–2.59 ) for ≥30 kg/m2 , as compared with BMI < 23 kg/m2(p for trend = 0.02 ) . This positive association was seen primarily in the proximal colon ( p for trend = 0.004 ) . When the association was further examined according to PMH use among postmenopausal women , we found that both current and never users with higher BMI were at a greater risk of colorectal cancer ( p for interaction between BMI and PMH use = 0.33 ) . As compared with BMI < 23 kg/m2 , the multivariate RRs and 95 % CI for 27–29.9 and ≥30 kg/m2 were 1.98 ( 0.98–3.99 ) and 1.41 ( 0.65–3.06 ) among current users , and 1.05 ( 0.42–2.65 ) and 2.91 ( 1.40–6.06 ) among never users . Conclusions : These data suggest that higher BMI was associated with an elevated risk of colorectal cancer , and the positive relationship was not altered by estrogen exposure among postmenopausal women Anthropometric factors have been associated with colorectal cancer and adenomas but with conflicting results in women or regarding adenoma characteristics . The authors aim ed to explore associations between anthropometric factors ( height , weight , body mass index , waist and hip circumferences , and weight changes ) and adenoma risk . They analyzed the 17,391 women of the French Etude épidémiologique des femmes de la Mutuelle Générale de l'Education Nationale (E3N)-European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) cohort who underwent a colonoscopy during follow-up ( 1993 - 2002 ) , including 1,408 who developed a first colorectal adenoma . In Cox multivariate proportional hazard regression models , obesity was associated with an increased colorectal adenoma risk ( hazard ratio = 1.53 , 95 % confidence interval : 1.21 , 1.94 ) . This association was restricted to left colon adenomas ( P( Output:
In conclusion , the results suggest minor differences in the associations of BMI and the risk of cancer between the colorectal subsites . For physical activity , the association does not seem to differ between the colonic subsites , but a difference was observed between the colon and the rectum , perhaps indicating that different mechanisms are operating in the development of colon and rectal cancer
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: CONTEXT The effect of antihypertensive drugs on cardiovascular events in patients with coronary artery disease ( CAD ) and normal blood pressure remains uncertain . OBJECTIVE To compare the effects of amlodipine or enalapril vs placebo on cardiovascular events in patients with CAD . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized , multicenter , 24-month trial ( enrollment April 1999-April 2002 ) comparing amlodipine or enalapril with placebo in 1991 patients with angiographically documented CAD ( > 20 % stenosis by coronary angiography ) and diastolic blood pressure < 100 mm Hg . A sub study of 274 patients measured atherosclerosis progression by intravascular ultrasound ( IVUS ) . INTERVENTIONS Patients were r and omized to receive amlodipine , 10 mg ; enalapril , 20 mg ; or placebo . IVUS was performed at baseline and study completion . MAIN OUTCOME MEASURES The primary efficacy parameter was incidence of cardiovascular events for amlodipine vs placebo . Other outcomes included comparisons of amlodipine vs enalapril and enalapril vs placebo . Events included cardiovascular death , nonfatal myocardial infa rct ion , resuscitated cardiac arrest , coronary revascularization , hospitalization for angina pectoris , hospitalization for congestive heart failure , fatal or nonfatal stroke or transient ischemic attack , and new diagnosis of peripheral vascular disease . The IVUS end point was change in percent atheroma volume . RESULTS Baseline blood pressure averaged 129/78 mm Hg for all patients ; it increased by 0.7/0.6 mm Hg in the placebo group and decreased by 4.8/2.5 mm Hg and 4.9/2.4 mm Hg in the amlodipine and enalapril groups , respectively ( P<.001 for both vs placebo ) . Cardiovascular events occurred in 151 ( 23.1 % ) placebo-treated patients , in 110 ( 16.6 % ) amlodipine-treated patients ( hazard ratio [ HR ] , 0.69 ; 95 % CI , 0.54 - 0.88 [ P = .003 ] ) , and in 136 ( 20.2 % ) enalapril-treated patients ( HR , 0.85 ; 95 % CI , 0.67 - 1.07 [ P = .16 ] . Primary end point comparison for enalapril vs amlodipine was not significant ( HR , 0.81 ; 95 % CI , 0.63 - 1.04 [ P = .10 ] ) . The IVUS sub study showed a trend toward less progression of atherosclerosis in the amlodipine group vs placebo ( P = .12 ) , with significantly less progression in the subgroup with systolic blood pressures greater than the mean ( P = .02 ) . Compared with baseline , IVUS showed progression in the placebo group ( P<.001 ) , a trend toward progression in the enalapril group ( P = .08 ) , and no progression in the amlodipine group ( P = .31 ) . For the amlodipine group , correlation between blood pressure reduction and progression was r = 0.19 , P = .07 . CONCLUSIONS Administration of amlodipine to patients with CAD and normal blood pressure result ed in reduced adverse cardiovascular events . Directionally similar , but smaller and nonsignificant , treatment effects were observed with enalapril . For amlodipine , IVUS showed evidence of slowing of atherosclerosis progression The West of Scotl and Coronary Prevention Study ( WOSCOPS ) showed that pravastatin reduced the risk of coronary heart disease ( CHD ) events in 6,595 middle-aged hypercholesterolaemic men aged 45 - 64 years without prior myocardial infa rct ion followed for an average of 4.9 years . We hypothesised prospect ively ( a ) that baseline levels of haemorheological variables were related to baseline and incident CHD and to mortality ; and ( b ) that reduction in lipoproteins by pravastatin would lower plasma and blood viscosity , a potential contributory mechanism to CHD events . We therefore studied plasma and blood viscosity , fibrinogen , haematocrit , and blood cell counts at baseline and 1 year . At baseline , plasma and blood viscosity were related to risk factors , CHD measures , and claudication . On univariate analysis , baseline levels of all rheological variables ( except platelet count ) were related to incident CHD ; CHD mortality ; and total mortality . On multivariate analysis including baseline CHD and risk factors , plasma and blood viscosity , haematocrit and white cell count each remained significantly associated with incident CHD ; while fibrinogen remained an independent predictor of mortality ( all p < 0.03 ) . After one year , lipoprotein reduction by pravastatin was associated with significant reductions ( about one quarter of a st and ard deviation ) in plasma viscosity ( mean difference 0.02 mPa.s , p < 0.001 ) and in blood viscosity ( mean difference 0.06 mPa.s , p<0.001 ) , but was not associated with significant changes in other rheological variables . We therefore suggest that pravastatin therapy , which reduces elevated lipoproteins in hypercholesterolaemic men , may lower risks of CHD and mortality partly by lowering plasma and blood viscosity . Further studies are required to test this hypothesis To determine the effect of atorvastatin on blood rheology in patients with familial hypercholesterolemia ( FH ) on regular LDL apheresis , we prospect ively studied the rheological variables fibrinogen , plasma viscosity , red cell aggregation , whole blood viscosity , hematocrit and platelet aggregation in 12 patients ( two homozygous , ten heterozygous ) before and during treatment with atorvastatin . Baseline values of red cell aggregation and whole blood viscosity were increased in FH patients on regular LDL apheresis compared with healthy controls ( P<0.05 ) , whereas fibrinogen , plasma viscosity and hematocrit were similar in the two groups . Treatment with atorvastatin reduced red cell aggregation ( P<0.01 ) , whole blood viscosity ( P<0.01 ) , plasma viscosity ( P<0.01 ) and platelet aggregation ( P<0.05 ) , but caused a slight increase in plasma fibrinogen ( by 5 % ; P<0.01 ) . Our findings suggest that atorvastatin improves blood rheology in patients with FH on regular LDL-apheresis . This improvement in blood flow properties may contribute to the well-known beneficial effects of atorvastatin on cardiovascular risk in patients with severe hyperlipidemia and atherosclerotic vascular disease Background —The Clopidogrel in Unstable angina to prevent Recurrent Events ( CURE ) trial demonstrated that clopidogrel , given early and continued long term , was superior to placebo in patients with non-ST – elevation acute coronary syndromes receiving aspirin . The purpose of the present analysis was to estimate the treatment effect Zof clopidogrel in patients who were stratified according to their risk of future cardiovascular events . Methods and Results — Patients ( n=12 562 ) who presented within 24 hours after the onset of symptoms were r and omized to receive clopidogrel ( 300 mg followed by 75 mg daily ) or placebo in addition to aspirin for 3 to 12 months . Treatment effect was analyzed in various risk groups according to the Thrombolysis in Myocardial Infa rct ion ( TIMI ) risk score . The TIMI risk model was vali date d in the CURE population ( C statistic , 0.634 ) . The primary composite outcome of cardiovascular death , myocardial infa rct ion , or stroke increased proportionally with increasing risk according to the TIMI risk score . The impact of clopidogrel versus placebo on the rate of the primary outcome was as follows : low-risk group ( TIMI score 0 to 2 ) , 4.1 % versus 5.7 % ( relative risk [ RR ] , 0.71 ; 95 % confidence interval [ CI ] , 0.52 to 0.97;P < 0.04 ) , intermediate-risk group ( TIMI score 3 to 4 ) , 9.8 % versus 11.4 % ( RR , 0.85 ; 95 % CI , 0.74 to 0.98;P < 0.03 ) , and high-risk group ( TIMI score 5 to 7 ) , 15.9 % versus 20.7 % ( RR , 0.73 ; 95 % CI , 0.60 to 0.90;P < 0.004 ) . There was no evidence of statistical heterogeneity among the groups . Conclusions —The benefit of clopidogrel demonstrated in the CURE trial is consistent in low- , intermediate- , and high-risk patients with acute coronary syndromes ( as stratified by TIMI risk score ) , thus supporting its use in all patients with documented non – ST elevation acute coronary syndromes OBJECTIVES The Circadian Anti-ischemia Program in Europe ( CAPE II ) compared the efficacy of amlodipine and diltiazem ( Adizem XL ) and the combination of amlodipine/atenolol and diltiazem ( Adizem XL)/isosorbide 5-mononitrate on exercise and ambulatory myocardial ischemia during regular therapy and after omission of medication . BACKGROUND The optimal medical therapy for ischemia suppression and the impact of irregular dosing using agents with different pharmacologic properties has not been established in patients with coronary disease . METHODS Patients with > or = 4 ischemic episodes or > or = 20 min of ST segment depression on 72-h electrocardiogram were r and omized to amlodipine 10 mg once daily or diltiazem ( Adizem XL ) 300 mg once daily in a 14-week double-blind r and omized multicountry study . In the second phase , atenolol 100 mg was added to amlodipine and isosorbide 5-mononitrate 100 mg to diltiazem ( Adizem XL ) . Ambulatory monitoring ( 72 h ) and exercise testing were repeated after both phases , on treatment and after a 24-h drug-free interval . RESULTS Both monotherapy with amlodipine and diltiazem ( Adizem XL ) were effective on symptoms and ambulatory and exercise ischemia . Combination therapy reduced ischemia further , with amlodipine/atenolol superior to diltiazem ( Adizem XL)/isosorbide 5-mononitrate . Amlodipine/atenolol was significantly superior during the drug-free interval with maintenance of ischemia reduction . CONCLUSIONS Amlodipine , with its intrinsically long half-life alone or together with beta-blocker , is likely to produce superior ischemia reduction in clinical practice when patients frequently forget to take medication or dose irregularly BACKGROUND Angiotensin-converting-enzyme inhibitors improve the outcome among patients with left ventricular dysfunction , whether or not they have heart failure . We assessed the role of an angiotensin-converting-enzyme inhibitor , ramipril , in patients who were at high risk for cardiovascular events but who did not have left ventricular dysfunction or heart failure . METHODS A total of 9297 high-risk patients ( 55 years of age or older ) who had evidence of vascular disease or diabetes plus one other cardiovascular risk factor and who were not known to have a low ejection fraction or heart failure were r and omly assigned to receive ramipril ( 10 mg once per day orally ) or matching placebo for a mean of five years . The primary outcome was a composite of myocardial infa rct ion , stroke , or death from cardiovascular causes . The trial was a two-by-two factorial study evaluating both ramipril and vitamin E. The effects of vitamin E are reported in a companion paper . RESULTS A total of 651 patients who were assigned to receive ramipril ( 14.0 percent ) reached the primary end point , as compared with 826 patients who were assigned to receive placebo ( 17.8 percent ) ( relative risk , 0.78 ; 95 percent confidence interval , 0.70 to 0.86 ; P<0.001 ) . Treatment with ramipril reduced the rates of death from cardiovascular causes ( 6.1 percent , as compared with 8.1 percent in the placebo group ; relative risk , 0.74 ; P<0.001 ) , myocardial infa rct ion ( 9.9 percent vs. 12.3 percent ; relative risk , 0.80 ; P<0.001 ) , stroke ( 3.4 percent vs. 4.9 percent ; relative risk , 0.68 ; P<0.001 ) , death from any cause ( 10.4 percent vs. 12.2 percent ; relative risk , 0.84 ; P=0.005 ) , revascularization procedures ( 16.3 percent vs. 18.8 percent ; relative risk , 0.85 ; P<0.001 ) , cardiac arrest ( 0.8 percent vs. 1.3 percent ; relative risk , 0.62 ; P=0.02 ) , [ corrected ] heart failure ( Output:
Regarding the repolarization changes on the ECG NSTEMI shows similarities with other clinical symptoms where increased intramyocardial microvascular resistance can be supposed without coronary artery disease : false positive exercise stress test , supraventricular tachycardia , left ventricular strain and conduction disturbances . CONCLUSION The acute treatment of NSTEMI should aim to improve the blood inflow to the stiff myocardium and /or impaired microvascular system and decrease the high microvascular resistance
MS2_1shot219
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review In ninety-four Dutch nulliparous women the effects of a low-Na diet in pregnancy on blood pressure , energy and nutrient intake , Ca metabolism , Zn and Mg status and body composition were studied longitudinally . The women were r and omly divided into an intervention group ( n 41 ) , which used a low-Na diet ( mean urinary Na excretion 61 mmol/24 h ) from week 14 of pregnancy until delivery and a control group ( n 53 ; mean urinary Na excretion 142 mmol/24 h ) . No effect of the diet on blood pressure was observed . The use of a low-Na diet result ed in significantly reduced intakes of energy , protein , carbohydrates , fat , Ca , Zn , Mg , Fe and cholesterol . However , the women on the low-Na diet appeared to be able to adapt quite well to the reduced intake since Ca , Zn and Mg homeostasis was maintained . In the case of Ca and Mg this was probably due to the observed reduced urinary excretions of these nutrients . Non-significant reductions in weight gain ( 1.5 kg ) and fat-mass gain ( 0.9 kg ) over pregnancy were found in the women on the low-Na diet . No significant effects of the diet on birth weight or placental weight were observed OBJECTIVE To investigate the relation between gestational weight gain in women of normal prepregnant weight and complications during pregnancy and delivery in a population with high gestational weight gain and birth weight . METHODS Healthy women ( n = 615 ) of normal weight before pregnancy ( body mass index 19.5–25.5 kg/m2 ) were r and omly selected . Maternity records gave information on age , height , prepregnant weight , gestational weight gain , parity , smoking , gestational hypertension and diabetes , preeclampsia , delivery complications , and infants ' birth size and health . RESULTS The mean weight gain in pregnancy was 16.8 ± 4.9 kg ( mean ± st and ard deviation ) . A total of 26.4 % of the women had complications , either in pregnancy ( 9.1 % ) or delivery ( 17.3 % ) . Women gaining weight according to the recommendation of the Institute of Medicine ( 11.5–16.0 kg ) had lower frequency of pregnancy‐delivery complications than women gaining more than 20.0 kg ( P = .017 ) , but did not differ significantly from those gaining 16–20 kg ( P > .05 ) . When dividing weight gain in pregnancy into quintiles , a relative risk of 2.69 ( 95 % confidence interval 1.01 , 7.18 , P = .048 ) was found for complications in pregnancy in the fourth quintile ( 17.9–20.8 kg ) , using the second quintile as reference ( 12.5–15.5 kg ) . The mean birth weight was 3778 ± 496 g. A low weight gain in pregnancy ( less than 11.5 kg ) was associated with an increased frequency of infants weighing less than 3500 g at birth ( P < .01 ) . CONCLUSION A gestational weight gain of 11.5–16.0 kg ( Institute of Medicine recommendation ) for women of normal prepregnant weight is related to the lowest risk for pregnancy‐delivery complications . In the population studied , the upper limit might be higher ( up to 18 kg ) , and low weight gain should be avoided to optimize birth outcome BACKGROUND : The Institute of Medicine ( IOM ) recommends that normal‐weight women ( BMI ( body mass index ) of 19.8–26.0 ) gain 25–35 lb ( 11.4–15.9 kg ) during pregnancy , and that overweight women ( BMI of 26.1–29.0 ) gain 15–25 lbs ( 6.8–11.4 kg ) . A significant number of normal‐weight women and an even greater proportion of overweight women exceed these guidelines , which increases postpartum weight retention and may contribute to the development of obesity . OBJECTIVE : To determine whether a stepped care , behavioral intervention will decrease the percentage of women who gain more than the IOM recommendation . DESIGN : R and omized controlled trial comparing a stepped-care behavioral intervention with usual care . Women ( n=120 ) who had a BMI > 19.8 , age>18 and < 20 weeks gestation were recruited from a hospital-based clinic serving low-income women and r and omized by race and BMI category to the intervention or control group . The intervention group received education about weight gain , healthy eating , and exercise and individual graphs of their weight gain . Those exceeding weight gain goals were given more intensive intervention . Women were followed through pregnancy to their first postpartum clinic visit . The main outcome measure was weight gain during pregnancy categorized as above the IOM recommendations vs below or within the IOM recommendations . RESULTS : The intervention significantly decreased the percentage of normal-weight women who exceeded the IOM recommendations ( 33 vs 58 % , P<0.05 ) . There was a non-significant ( P=0.09 ) effect in the opposite direction among overweight women ( 59 % of intervention and 32 % of control gained more than recommended ) . Postpartum weight retention was strongly related to weight gain during pregnancy ( r=0.89 ) . CONCLUSIONS : The intervention reduced excessive weight gain during pregnancy among normal weight women Summary : A r and omised controlled trial was design ed to determine the effect of moderate 30 % maternal dietary energy restriction on the requirement for maternal insulin therapy and the incidence of macrosomia in gestational diabetes . Although the control group restricted their intake to a level similar to that of the intervention group ( 6845 kiloJoules ( kJ ) versus 6579 kJ ) , the result ing cohort could not identify any adverse effect of energy restriction in pregnancy . Energy restriction did not alter the frequency of insulin therapy ( 17.5 % in the intervention group and 16.9 % in the control group ) . Mean birth weight ( 3461 g in the intervention group and 3267 g in the control group ) was not affected . There was a trend in the intervention group towards later gestational age at commencement of insulin therapy ( 33 weeks versus 31 weeks ) and lower maximum daily insulin dose ( 23 units versus 60 units ) which did not reach statistical significance . Energy restriction did not cause an increase in ketonemia BACKGROUND A high prevalence of gestational diabetes mellitus and type 2 diabetes has been observed among the Cree of James Bay , Quebec . To address this problem , a diet and activity intervention during pregnancy , which was based on social learning theory , was initiated in 4 Cree communities . METHODS A prospect i ve intervention compared dietary , weight and glycemic indicators for 107 control subjects and for 112 women who received the intervention during the course of their pregnancy . A control period in 4 communities ( July 1995-March 1996 ) was followed by an intervention period ( April 1996-January 1997 ) when subjects were offered regular , individual diet counselling , physical activity sessions and other activities related to nutrition . RESULTS The intervention and control groups did not differ at baseline regarding their mean age ( 24.3 years [ SD 6.29 ] v. 23.8 years [ SD 5.86 ] ) , mean prepregnancy weight ( 81.0 kg [ SD 19.46 ] v. 78.9 kg [ SD 17.54 ] ) and mean gestational age at recruitment ( 17.1 weeks [ SD 7.06 ] v. 18.5 weeks [ SD 6.92 ] ) . The intervention did not result in differences in diet measured at 24 - 30 weeks ' gestation , rate of weight gain over the second half of pregnancy ( 0.53 kg per week [ SD 0.32 ] v. 0.53 kg per week [ SD 0.27 ] ) or plasma glucose level ( 50 g oral glucose screen ) between 24 and 30 weeks ( 7.21 mmol/L [ SD 2.09 ] v. 7.43 mmol/L [ SD 2.10 ] ) . Mean birth weights were similar ( 3741 g [ SD 523 ] v. 3686 g [ SD 686 ] ) , as was maternal weight at 6 weeks post partum ( 88.1 kg [ SD 16.8 ] v. 86.4 kg [ SD 19.0 ] ) . The only changes in dietary intake were a reduction in caffeine ( pregnancy ) and an increase in folate ( post partum ) . INTERPRETATION This intervention had only a minor impact on diet ; finding ways of encouraging appropriate body weight and activity levels remains a challenge OBJECTIVE The research addresses two questions : Are potentially modifiable psychosocial and behavioral factors related to gestational weight gain ? Do the same factors relate to both excessive and insufficient weight gain ? DESIGN Prospect i ve cohort study that followed women from early pregnancy until two years postpartum . Data were collected through mailed question naires and an audit of the medical record . Subjects/ setting The sample included 622 healthy adult women who gave birth to live singleton infants . Subjects were recruited from all women who registered for prenatal care in a hospital and primary care clinic system serving a 10-county area of Upstate New York . Statistical analyses performed Multiple linear and logistic regression with adjustment for timing of measurements and length of gestation were performed . RESULTS Only 38 % of women gained an amount of weight in pregnancy that was within the range recommended by the Institute of Medicine . Valid and easily implemented measures of change in food intake and physical activity from prepregnancy and cigarette smoking during pregnancy were each significantly ( P<.05 ) and independently related to gestational weight gain . Along with other variables in a biopsychosocial regression model , these variables accounted for 27 % of the variance in gestational weight gain and were also significantly related to risk of inadequate and excessive gain . APPLICATIONS/ CONCLUSIONS The findings facilitate the design of more effective nutrition interventions to promote appropriate gestational weight gain and the long-term health of women and their infants Objective To determine whether the risk of maternal overweight associated with an excessive rate of gestational gain needs to be balanced against the risks of impaired fetal growth associated with a low rate of gain . Methods Rate of gestational weight gain was measured prospect ively in a sample of 274 young , low-income , and primarily minority women ( 12–29 years old ) with pregravid body mass indices ( BMI ) in the normal range ( 19.8–26.0 ) . We defined an excessive rate of gain between 20–36 weeks ' gestation as one greater than 0.68 kg/week , and a low rate of gain as one less than 0.34 kg/week . Women were followed-up at 4–6 weeks and 6 months postpartum . Results Rate of measured gestational gain between 20–36 weeks ' gestation was associated with total weight gain based on pregravid weight , with infant birth weight and gestation duration , and with maternal overweight ( BMI greater than 26 ) and weight retention postpartum . Infant birth weight and gestation duration were significantly reduced for women with low rates of gain , and there was no significant difference between women with excessive and moderate gains . Despite little difference in pregravid BMI , women with excessive rates of gain retained more weight overall , attained a greater postpartum BMI , and had higher levels of subcutaneous fat and overweight . Maternal anthropometric status showed little change between 4–6 weeks and 6 months postpartum . Conclusion Weight gained at an excessive rate by women with a pregravid BMI in the Output:
The results of published intervention trials are of insufficient quality to enable evidence -based recommendations to be developed for clinical practice in antenatal care
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVE To assess the efficacy of a clomiphene citrate ( CC ) and tamoxifen citrate ( CC/tamoxifen ) combination therapy in ovulation induction by comparing with a CC alone therapy . DESIGN A r and omized cross-over study with CC alone and CC/tamoxifen combination therapies for 20 normoprolactinemic anovulatory women . R and omly selected 10 of the 20 women ( group A ) underwent a CC alone therapy ( 100 mg CC during cycle days 5 to 9 ) for the initial three consecutive treatment cycles and a CC/tamoxifen combination therapy ( 50 mg CC and 20 mg tamoxifen during cycle days 5 to 9 ) for the subsequent three consecutive treatment cycles . The remaining 10 ( group B ) were treated similarly but with the inverse sequence . Ovulation was documented when a high BBT phase persisted for 11 days or more , when midluteal serum P levels exceeded 7 ng/mL ( 22.3 nmol/L ) , or when pregnancy ensued . RESULTS The rates of ovulatory/treated , pregnant/treated , and pregnant/ovulatory cycles were 42 of 56 ( 75.0 % ) , 3 of 47 ( 6.4 % ) , and 3 of 35 ( 8.6 % ) for CC/tamoxifen , respectively . Those were 25 of 57 ( 43.9 % ) , 1 of 48 ( 2.1 % ) , and 1 of 21 ( 4.8 % ) for CC , respectively . Clomiphene citrate/tamoxifen was more effective in ovulation induction than CC . All the pregnancies were normal and single . None of the treatments was accompanied by any remarkable side effects . CONCLUSION Clomiphene citrate/tamoxifen is a novel treatment modality of ovulation induction with high efficacy OBJECTIVE --To determine whether pituitary suppression before induction of ovulation reduces the rate of spontaneous abortion in women with polycystic ovarian disease and primary recurrent spontaneous abortions . DESIGN --Closed , r and omised , sequential trial . Pairs of women were allocated to each treatment by the toss of a coin . SETTING --Supraregional clinic for women who had had recurrent spontaneous abortions . SUBJECTS -- Forty two women with polycystic ovarian disease and primary recurrent spontaneous abortions . INTERVENTIONS --Ovulation was induced by clomiphene or pituitary suppression with buserelin followed by pure follicle stimulating hormone . MAIN OUTCOME MEASURES --Preference for a particular treatment was noted . A preference occurred when one woman in a pair had a successful pregnancy ( defined as one of over 12 weeks ' gestation ) and one had a spontaneous abortion ; the preference was for the treatment result ing in the successful pregnancy . RESULTS --Spontaneous abortions occurred in 11 of 20 women given clomiphene compared with two of 20 who had pituitary suppression . Eleven preferences were found for buserelin and two for clomiphene . In seven pairs both women had successful pregnancies . One pair was discarded because one of the women did not become pregnant . The ratio of luteinising hormone concentration to follicular diameter was found to be a possible diagnostic indicator of spontaneous abortion . CONCLUSION --Pituitary suppression before induction of ovulation significantly reduces the risk of spontaneous abortion in women with polycystic ovarian disease and primary recurrent spontaneous abortions Antiestrogens are widely used to treat eugonadal anovulation , luteal phase deficiency ( LPD ) and oligospermia . This paper review s the rationale s , endocrine effects , profertility effects and side effects of these treatments . Furthermore , we present our own experience of the use of antiestrogens in this field . We have compared the results of clomiphene citrate ( CC ) to those of tamoxifen ( TAM ) in a r and omized study including 66 infertile women presenting eugonadal anovulation ( n = 26 ) or LPD ( n = 40 ) . Both drugs obtained the same pregnancy rate of 80 % at 9 months in the anovulatory patients . Conversely , CC was superior to TAM in the LPD cases ( pregnancy rates at 6 months of respectively 40 and 11 % ) . The abortion rates were of 11 % on CC versus 36 % on TAM . Both drugs significantly increased the luteal phase length and plasma progesterone level to the same extent . The results of endometrial biopsies suggest that the difference in their effects on female fertility could result from a detrimental effect of TAM on endometrium . The rates of the side effects proved to be almost identical on both drugs . Thus the use of TAM is not justified as a first-step treatment in ovulation disturbances . TAM should be reserved for patients who experience severe visual side effects on CC . We have also tested TAM in 100 subfertile males . In the 92 oligospermic males , TAM significantly increased the mean sperm count only in the normogonadotropic patients , but as much whether oligospermia was idiopathic or not . Sperm improvement was not significantly related to any hormone criterion except basal serum FSH . The cumulative pregnancy rate was of 41.2 % at 1 year . Whether TAM actually improves male fertility , and is superior to CC in this indication , remains to be confirmed in controlled studies Abstract Purpose : To study the effect of CYP17a inhibitor , “ ketoconazole , ” on clomiphene responsiveness in PCOS patients . Methods : Prospect i ve analysis was employed with the setup at Alex and ria IVF/ICSI center . Ninety-seven insulin-resistant PCOS patients undergoing ovulation induction using clomiphene citrate were r and omly divided , by r and om number table , into two groups . The first group ( n = 49 ) received ketoconazole ( 400 mg daily ) till correction of metabolic syndrome followed by clomiphene ( 100 mg/day ) ; the second group ( n = 48 ) receiving clomiphene without ketoconazole pretreatment . Main outcome measures were incidence of clomiphene resistance , monofollicular response , fasting insulin/glucose ratio , serum testosterone , and pregnancy rates . Results : The ketoconazole group showed significantly ( p < 0.05 ) higher incidence of monofollicular response ( 38 % ) , higher pregnancy rates , and significantly less marked antiestrogenic manifestations than did the control group . They also had significantly lower incidence of clomiphene resistance ( 11.6 % ) , lower serum testosterone levels , less hyperinsulinaemia , than did the control group . Conclusion : Ketoconazole improved clomiphene responsivenss in PCOS patients and attenuated its untoward biological effects Objective To determine the efficacy of pulsatile GnRH alone and in combination with clomiphene citrate or gonadotropins in a stepwise approach for inducing ovulation in women with clomiphene-resistant polycystic ovary syndrome ( PCOS ) . Methods Eighty women with clomiphene-resistant anovulatory infertility and PCOS were given subcutaneous pulsatile GnRH ( 15 μg every 90 minutes ) using a portable infusion pump . If no follicular development was seen , clomiphene citrate ( 100 mg/day for 5 days ) was given concurrently with the hormone in the next cycle of treatment . Those who still failed to ovulate regularly were treated with combined pulsatile GnRH with intramuscular gonadotropins ( one ampule per day for 5–7 days ) . Results Sixty-six of 131 ( 50 % ) pulsatile GnRH cycles , 94 of 142 ( 66 % ) pulsatile GnRH with clomiphene cycles , and 48 of 69 ( 70 % ) pulsatile GnRH with gonadotropin cycles were ovulatory . Monofollicular response ( one follicle at least 14 mm on the day of ovulation ) occurred in 80.6 , 83.9 , and 53.6 % of cycles , and multifollicular response occurred in 4.8 , 3.1 , and 21.6 % of cycles in the three groups , respectively . Mild ovarian hyperstimulation occurred in one of the 342 cycles . The cumulative conception rate was 30 % after three cycles , 60 % after six cycles , and 73 % after nine cycles . The miscarriage rate was 22 % ( ten of 45 pregnancies ) , and 35 women ( 78 % ) had live births ( 33 singletons and two sets of twins ) . Conclusion The use of subcutaneous pulsatile GnRH alone and in combination with clomiphene citrate or gonadotropins for induction of ovulation in clomiphene-resistant PCOS in a stepwise approach produces a high cumulative conception rate associated with a low rate of multiple pregnancy and ovarian hyperstimulation syndrome OBJECTIVE To use aromatase inhibition for induction of ovulation in women in whom clomiphene citrate ( CC ) treatment was unsuccessful . DESIGN Prospect i ve trial in infertility patients treated with CC . SETTING Two tertiary-referral infertility clinics associated with the Division of Reproductive Sciences , University of Toronto . PATIENT(S ) Twelve patients with anovulatory polycystic ovary syndrome ( PCOS ) and 10 patients with ovulatory infertility , all of whom had previously received CC with an inadequate outcome ( no ovulation and /or endometrial thickness of < or = 0.5 cm ) . INTERVENTION(S ) The aromatase inhibitor letrozole was given orally in a dose of 2.5 mg on days 3 - 7 after menses . MAIN OUTCOME MEASURE(S ) Occurrence of ovulation , endometrial thickness , and pregnancy rates . RESULT ( S ) With CC treatment in patients with PCOS , ovulation occurred in 8 of 18 cycles ( 44.4 % ) , and all ovulatory cycles for the women included in this study had endometrial thickness of < or = 0.5 cm . In 10 ovulatory patients , 15 CC cycles result ed in a mean number of 2.5 mature follicles , but all cycles had endometrial thickness of < or = 0.5 cm on the day of hCG administration . With letrozole treatment in the same patients with PCOS , ovulation occurred in 9 of 12 cycles ( 75 % ) and pregnancy was achieved in 3 patients ( 25 % ) . In the 10 patients with ovulatory infertility , letrozole treatment result ed in a mean number of 2.3 mature follicles and mean endometrial thickness of 0.8 cm . Pregnancy was achieved in 1 patient ( 10 % ) . CONCLUSION ( S ) Oral administration of the aromatase inhibitor letrozole is effective for ovulation induction in anovulatory infertility and for increased follicle recruitment in ovulatory infertility . Letrozole appears to avoid the unfavorable effects on the endometrium frequently seen with antiestrogen use for ovulation induction Improved underst and ing of follicular dynamics has led to a reevaluation of suppression of adrenal and rogens in ovulation induction . To test whether adrenal suppression during clomiphene citrate ( CC ) therapy would improve ovulation/pregnancy rates , 64 anovulatory patients who had not previously received CC were r and omly assigned to receive either 50 mg CC on days 5 to 9 alone or with 0.5 mg dexamethasone ( CC + DEX ) . Patients were then screened for dehydroepi and rosterone sulfate ( DHEA-S ) ( normal range , 80 to 320 micrograms/dl ) , prolactin , testosterone , and semen analysis of the partner . Nine patients discontinued participation prior to completing the first treatment cycle , and ten patients were found to have either elevated prolactin ( 4 ) , severe male factors ( 3 ) , or tubal disease ( 3 ) and were discontinued . CC was increased 50 mg/day per cycle through 150 mg/day until ovulation occurred . Once the patient was ovulatory on therapy , a properly timed postcoital test and endometrial biopsy for luteal phase defect were performed . If anovulatory at 150 mg/day of CC or demonstrating abnormal postcoital test or endometrial biopsy at 150 mg/day of CC , patients were crossed to the other arm of the treatment protocol . The results revealed a significantly higher rate of ovulation ( P less than 0.01 ) and conception ( P less than 0.05 ) in the CC + DEX-treated group . When correlated with DHEA-S levels , this improvement occurred in patients with DHEA-S greater than 200 micrograms/dl ( P less than 0.05 ) OBJECTIVE To evaluate the role of ketoconazole in prevention of ovarian hyperstimulation syndrome ( OHSS ) in women with the polycystic ovary syndrome ( PCOS ) undergoing ovarian stimulation with gonadotropins . DESIGN Prospect i ve , r and omized , double-blind , placebo-controlled study . SETTING University hospitals . One hundred nine women with PCOS who were referred for treatment with gonadotropins . INTERVENTION(S ) Fifty patients were r and omly assigned to receive two ampoules of hMG beginning on day 2 or 3 of the cycle and ketoconazole ( 50 mg every 48 hours ) starting on the first day of hMG treatment . Fifty-one patients received the same amount of hMG plus one Output:
Miscarriage and multiple pregnancy rates were poorly reported . This review shows evidence supporting the effectiveness of the current first line treatment , clomiphene citrate . No evidence of a difference in effect was found between clomiphene and tamoxifen . The use of dexamethasone as an adjunct to clomiphene therapy appears promising as do combined oral contraceptives .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: A double-blind , placebo-controlled , cross-over clinical trial was performed to assess the effect of betahistine hydrochloride ( Serc ) in Ménière 's disease . The diagnosis was based on paroxysmal attacks of rotational vertigo , with tinnitus , and a fluctuating sensori-neural deafness , together with the results of auditory and vestigular tests . Twenty-eight patients were admitted to the trial over 3 years . Twenty-two patients completed the trial . In total , they received betahistine 32 mg daily , for a period of 16 weeks , and placebo also for the same length of time , preceded in every case by a 4-week pre-treatment period . Daily symptom score cards were kept . There was a statistically significant improvement in favour of the drug with regard to vertigo , tinnitus and deafness . Vertigo was the most responsive symptom . No adverse reactions were observed Abstract . The present study compares the efficacy and safety of betahistine dihydrochloride to that of a placebo in recurrent vertigo result ing from Meniere 's disease ( MD ) or in paroxysmal positional vertigo ( PPV ) of probable vascular origin . The design was double-blind , multicentre and parallel-group r and omised . Eleven Italian centres enrolled 144 patients : 75 of the patients were treated with betahistine ( 41 MD/34 PPV ) and 69 with placebos ( 40 MD/29 PPV ) . The betahistine dosage was 16 mg twice per day for 3 months . Compared to the placebo , betahistine had a significant effect on the frequency , intensity and duration of vertigo attacks . Associated symptoms and the quality of life also were significantly improved by betahistine . Both the physician 's judgement and the patient 's opinion on the efficacy and acceptability of the treatment were in agreement as to the superiority of betahistine . The effective and safe profile of betahistine in the treatment of vertigo due to peripheral vestibular disorders was confirmed A double-blind , cross-over , placebo-controlled study of betahistine dihydrochloride ( 12 mg , t.i.d . ) was carried out in patients with vertigo of peripheral vestibular origin . Twenty-four patients completed the study , which consisted of two six-week treatment periods . The patients were diagnosed as suffering from Menière 's disease ( 15 patients ) , vertigo due to other ( specified ) causes ( five patients ) , or vertigo of unknown origin ( four patients ) . Patients were examined by the investigator at the start of the study and were re-assessed at three-weekly intervals . In addition , they recorded the nature , frequency and severity of their symptoms on diary cards . Both the incidence and severity of dizziness ( the predominant presenting complaint ) were found to be significantly reduced during betahistine treatment ( p = 0.004 ) . The occurrence of nausea and vomiting was also significantly reduced during betahistine treatment ( p = 0.014 and 0.036 respectively ) . There were no statistically significant differences in the results of audiometric or vestibulometric tests , or in the severity of tinnitus or deafness , between the two treatment periods . The overall comparisons of the two periods made by both the patients and the investigator were significantly in favour of betahistine ( p less than 0.001 ) . All diagnostic groups responded favourably to betahistine , confirming the efficacy of betahistine in the symptomatic treatment of peripheral vestibular vertigo . No unwanted signs or symptoms were reported The effects of betahistine hydrochloride ( Serc ) on the clinical features of Ménière 's disease were assessed in two double-blind , placebo-controlled , cross-over clinical studies . The diagnosis was based on a peripheral , fluctuating , recruiting , cochlear ( sensorineural ) deafness in one or both ears , tinnitus ( usually of low tone ) and paroxysmal attacks of rotational vertigo . Appropriate auditory and vestibular analyses confirmed the diagnosis . Twenty-four patients were admitted to the studies after careful screening over two- and -a-half years . Twenty-two patients completed the studies , ten of whom received betahistine and placebo for eight weeks each whereas the remaining twelve were given betahistine and placebo for twelve weeks each . the dose of betahistine was the same ( 16 mg . t.i.d . ) in both studies . Daily symptom score cards kept by all patients throughout the studies showed a statistically significant preference for betahistine over placebo with regard to vertigo ( p = 0 - 025 ) , tinnitus ( p = 0 - 010 ) and fullness of the ear ( p = 0 - 036 ) . Symptom scores of deafness and vomiting indicated trends in favour of betahistine but these did not attain statistical significance . Objective measurements of deafness ( mean db . loss ) , however , showed a highly significant improvement in favour of betahistine , when compared with placebo ( p less than 0 - 001 ) . Vestibular testing revealed no important difference between betahistine and placebo . No unwanted effects or adverse reactions attributable to betahistine were observed during the studies WHEN VERTIGO , associated with Meniere 's syndrome , becomes intractable and incapacitating , the patient becomes a c and i date for surgery . This is not a pleasant outlook for the patient , nor for the treating physician . As a consequence , there has been an incessant but yet unrewarding search for a satisfactory medical treatment . Williams 1 recently reported : Neither the definition , the diagnosis nor the dysfunction of Meniere 's disease is much clearer now than when Meniere first described the condition in 1861 .... On the basis of recently acquired information , we may define Meniere 's disease as a disorder of a predisposed stria vascularis , possibly in response to a hypothalamic stimulus , with the local synthesis of toxic amounts of histamine and possibly of norepinephrine , producing in the stria vascularis the picture of the slow stage of shock , increased hydrodynamic pressure in the endolymphatic system , loss of hearing , and , secondarily , attacks of vertigo , nausea and vomiting . In a Output:
None of the trials showed any effect of betahistine on hearing loss . No adverse effects were found with betahistine . REVIEW ER 'S CONCLUSIONS There is insufficient evidence to say whether betahistine has any effect on Menière 's disease
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Objective : To determine whether a cognitive test package can predict the onset of dementia up to 11 years later , and the extent to which this prediction is independent of that provided by APOE genotype . Methods : Prospect i ve cohort study based on 54 general practice s in the UK ; 657 survivors of the 1088 participants in the MRC treatment trial of hypertension in older adults were followed for up to 11 years ; 370 participants ( 57 % of survivors ) were traced , screened for dementia , and genotyped for APOE in 1994 . Baseline assessment s included trail making test A , paired associated learning test , Raven ’s progressive matrices , and national adult reading test . At follow up , both mini-mental state examination and CAMCOG were used . Outcome measures were DSM-IIIR dementia and NINCDS-ADRDA possible and probable Alzheimer ’s disease . Results : All the cognitive tests completed in 1983 predicted onset of dementia and Alzheimer ’s disease up to 11 years later , as did APOE genotype . Cognitive test performance was not associated with APOE genotype . Addition of cognitive tests increased the area under the ROC curve for the prediction of Alzheimer ’s disease provided by age , family history , and APOE genotype ( 0.81 v 0.69 , p = 0.048 ) ; addition of APOE genotype did not increase the area under the ROC curve for the prediction provided by age , family history , and cognitive tests ( 0.81 v 0.77 , p = 0.28 ) . Conclusions : Simple tests of cognitive ability provide useful predictive information up to a decade before the onset of dementia . The predictive information provided is independent of , but not enhanced by , the addition of APOE genotype We developed a modified trail-making test using a PC and touch panel and compared it with the mini mental state examination ( MMSE ) . The test consisted of a series of numbers from 1 to 36 , r and omly arranged across the display . The object of the test was for the subject to touch the numbers in order , beginning with 1 and ending with 36 , in as little time as possible . The system consisted of a PC and a liquid crystal display ( LCD ) touch-panel screen . One hundred and thirty-four patients with dementia performed the test . Sixty of the 134 patients ( 15 male , 45 female ; average age , 81.1plusmn7 years ) were diagnosed as having Alzheimer 's disease and the others had cerebrovascular dementia . Sixty-two of 134 patients ( 23 male , 39 female ; average age , 77.6plusmn8 years ; MMSE score , 21.5plusmn5.6 points ) completed the test . The correlation coefficient between test performance time and MMSE score was -0.534 . This test may also be a useful indicator of focal frontal lesions and can be used as an early screening test for Alzheimer 's In the community at large , many older adults with minimal cognitive and functional impairment remain stable or improve over time , unlike patients in clinical research setting s , who typically progress to dementia . Within a prospect i ve population -based study , we identified neuropsychological tests predicting improvement or worsening over 1 year in cognitively driven everyday functioning as measured by Clinical Dementia Rating ( CDR ) . Participants were 1682 adults aged 65 + and dementia-free at baseline . CDR change was modeled as a function of baseline test scores , adjusting for demographics . Among those with baseline CDR = 0.5 , 29.8 % improved to CDR = 0 ; they had significantly better baseline scores on most tests . In a stepwise multiple logistic regression model , tests which remained independently associated with subsequent CDR improvement were Category Fluency , a modified Token Test , and the sum of learning trials on Object Memory Evaluation . In contrast , only 7.1 % with baseline CDR = 0 worsened to CDR = 0.5 . They had significantly lower baseline scores on most tests . In multiple regression analyses , only the Mini-Mental State Examination , delayed memory for visual reproduction , and recall susceptible to proactive interference , were independently associated with CDR worsening . At the population level , changes in both directions are observable in functional status , with different neuropsychological measures predicting the direction of change The project Epidemiology Research on Dementia in Antwerp ( ERDA ) estimated the prevalence of dementia in a r and om , population -based sample , stratified for age and sex . The sample of 1,736 elderly was screened at home with the Mini-Mental State Examination . All elderly under the cutoff of 23 - 24/30 got a diagnostic examination with the Cambridge Mental Disorders of the Elderly Examination and the DSM-IIIR criteria . The prevalence of dementia in the population above 65 years was estimated at 9 % . The following age-specific prevalences of dementia ( included mild dementia ) were found in the age-groups 65 - 69 , 70 - 74 , 75 - 79 , 80 - 84 , 85 + : 0.6 , 5.1 , 7.6 , 16.2 and 33.6 % . The prevalence of at least moderate dementia was 0.3 , 3.9 , 4.0 , 11.2 and 25.0 % , respectively . The prevalence of dementia , vascular dementia and dementia of the Alzheimer type was markedly higher in women than in men Background : Dementia is poorly recognized even by physicians . This study compares three instruments used to assess dementia in a community setting in Sri Lanka . Method : Translated and culturally adapted versions of the Mini Mental State Examination ( MMSE ) , Informant Question naire on Cognitive Decline in the Elderly ( IQCODE ) and Clinical Dementia Rating ( CDR ) were administered to 363 individuals selected by stratified r and om sampling in a periurban community in Sri Lanka . The results on the three instruments were compared with the independent psychiatric evaluation done on a concentrated sample of 37 individuals from the study population . Results : Culturally adapted MMSE , IQCODE and CDR can be used to screen dementia in Sri Lanka . IQCODE is the best among the three instruments with a sensitivity of 71.4 % and a specificity of 82.6 % when 3.5 is the cut-off . In addition , IQCODE is culturally acceptable , easy to administer and can be used in those with a low level of literacy as well as in those with hearing or visual impairment . Conclusion : IQCODE was found to be more effective and culturally acceptable as a screening tool for dementia in Sri Lanka , compared with MMSE and CDR Objective . To design a brief cognitive screener with acceptable sensitivity and specificity for identifying subjects with cognitive impairment Design . Cohort one is assembled from a community-based survey coupled with a second-stage diagnostic evaluation using formal diagnostic criteria for dementia . Cohort two is assembled from referrals to a specialty clinic for dementing disorders that completed the same diagnostic evaluation . Setting . Urban neighborhoods in Indianapolis , Indiana and the Indiana Alzheimer Disease Center . Patients . Cohort one consists of 344 community-dwelling black persons identified from a r and om sample of 2212 black persons aged 65 and older residing in Indianapolis ; cohort two consists of 651 subject referrals to the Alzheimer Disease Center . Measurements . Formal diagnostic clinical assessment s for dementia including scores on the Mini-mental state examination ( MMSE ) , a six-item screener derived from the MMSE , the Blessed Dementia Rating Scale ( BDRS ) , and the Word List Recall . Based on clinical evaluations , subjects were categorized as no cognitive impairment , cognitive impairment-not demented , or demented . Results . The mean age of the community-based sample was 74.4 years , 59.4 % of the sample were women , and the mean years of education was 10.1 . The prevalence of dementia in this sample was 4.3 % and the prevalence of cognitive impairment was 24.6 % . Using a cut-off of three or more errors , the sensitivity and specificity of the six-item screener for a diagnosis of dementia was 88.7 and 88.0 , respectively . In the same sample , the corresponding sensitivity and specificity for the MMSE using a cut-off score of 23 was 95.2 and 86.7 . The performance of the two scales was comparable across the two population s studied and using either cognitive impairment or dementia as the gold st and ard . An increasing number of errors on the six-item screener is highly correlated with poorer scores on longer measures of cognitive impairment . Conclusions . The six-item screener is a brief and reliable instrument for identifying subjects with cognitive impairment and its diagnostic properties are comparable to the full MMSE . It can be administered by telephone or face-to-face interview and is easily scored by a simple summation of errors OBJECTIVE To determine the variability in annual Mini-Mental State Examination scores of patients with Alzheimer disease enrolled in the Consortium to Establish a Registry for Alzheimer 's Disease ( CERAD ) . PATIENTS A total of 372 patients with probable Alzheimer disease with 1 or more years of follow-up . SETTING Twenty-one CERAD clinical sites throughout the United States . RESULTS An average annual decline of 3.4 points in CERAD patients returning for longitudinal re assessment s was close to the SD of the measurement error of 2.8 points for the Mini-Mental State Examination . There was wide variability in individual rates of decline . Even with 4 years of follow-up , 15.8 % of the patients had no clinical ly meaningful decline in Mini-Mental State Examination score ( defined as a change in initial score > 3 , ie , 1 SD of measurement error ) . Validity of measurements of the rate of change in Mini-Mental State Examination scores improved with longer observation intervals and was reliable for most patients when observations were separated by 3 or more years . CONCLUSIONS Although the Mini-Mental State Examination is a useful screening instrument to assess level of cognitive function , it has limited value in measuring the progression of Alzheimer disease in individual patients for periods less than 3 years because of a large measurement error and substantial variation in change in annual score OBJECTIVES To determine whether the accuracy of the Mini-Mental State Examination ( MMSE ) in predicting future Alzheimer 's disease ( AD ) could be improved by the addition of patient and informant ratings of cognitive difficulties . DESIGN An inception cohort of nondemented patients followed longitudinally for 2 years . SETTING Patients referred to a university teaching hospital research investigation by their family physicians because of concerns about memory impairment . PARTICIPANTS One hundred sixty-five community-residing patients were included who did not have dementia or any identifiable cause for memory impairment . After 2 years , 29 met criteria for AD , and 95 were not demented . MEASUREMENTS Baseline assessment s included MMSE , an Informant Rating Scale , and a Patient Rating Scale of cognitive difficulties . After 2 years , patients were diagnosed following the reference st and ard for probable AD . Diagnosticians were blind to baseline scores . RESULTS Age and education were included in all analyses as covariates . The best logistic regression model included the Informant Rating Scale and the MMSE ( sensitivity = 83 % , specificity = 79 % ) . An empirically reduced six-item model that included two items each from the MMSE , the Patient Rating Scale , and the Informant Rating Scale produced a significantly better model than the one with the full test scores ( sensitivity = 90 % , specificity = 94 % ) . CONCLUSION Results indicate that inclusion of informant ratings with the MMSE significantly improved its accuracy in the prediction of probable AD . Replication in a new prospect i ve cohort of nondemented patients is necessary to confirm these findings Previous studies have suggested that education and race may affect performance on st and ardized mental status tests . In order to more clearly define these relationships , a prospect i ve longitudinal study was devised to answer two questions : ( 1 ) whether race or level of education affects scores on the Mini-Mental State ( MMS ) exam in non-demented people and ( 2 ) what numerical cutpoints maximize the sensitivity and specificity of utilizing the MMS to help diagnose dementia in blacks of varying educational attainment . A total of 100 white and 258 black individuals , recruited from two city hospital primary care geriatric clinics , were evaluated and subsequently followed longitudinally over a 2 1/2 year period in order to assess accurately the presence or absence of dementia . In the non-demented , total MMS scores and performance on each item of the MMS were analyzed , revealing that people with an 8th grade or less education consistently had significantly ( P less than .01 ) worse results than the better educated ( 9th grade or better ) on borough , attention items , recall of table and dog , copying , sentence writing , phrase repeating , and total score . Furthermore , a total of 25 % of the lower education group had an MMS score in the 18 - 23 range , traditionally thought to suggest dementia . There were no consistently significant differences between blacks and whites of equal education . In the better educated groups , using a score of 23 or less to define dementia maximizes the sensitivity and specificity of using the MMS in this diagnosis at 93 % and 100 % , respectively . In the lower education group , using 17 or less to define dementia maximizes sensitivity and specificity at 81 % and 100 % , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS Background and aims Output:
The MMSE contributes to a diagnosis of dementia in low prevalence setting s , but should not be used in isolation to confirm or exclude disease .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: We hypothesized that patients who fail weaning from mechanical ventilation recruit their inspiratory rib cage muscles sooner than they recruit their expiratory muscles , and that rib cage muscle recruitment is accompanied by recruitment of sternomastoid muscles . Accordingly , we measured sternomastoid electrical activity and changes in esophageal ( DeltaPes ) and gastric pressure ( DeltaPga ) in 11 weaning-failure and 8 weaning-success patients . At the start of trial , failure patients exhibited a higher DeltaPga-to-DeltaPes ratio than did success patients ( P = 0.05 ) , whereas expiratory rise in Pga was equivalent in the two groups . Between the start and end of the trial , failure patients developed additional increases in DeltaPga-to-DeltaPes ratio ( P < 0.0014 ) and the expiratory rise in Pga also increased ( P < 0.004 ) . At the start of trial , sternomastoid activity was present in 8 of 11 failure patients contrasted with 1 of 8 success patients . Over the course of the trial , sternomastoid activity increased by 53.0 + /- 9.3 % in the failure patients ( P = 0.0005 ) , whereas it did not change in the success patients . Failure patients recruited their respiratory muscles in a sequential manner . The sequence began with activity of diaphragm and greater-than-normal activity of inspiratory rib cage muscles ; recruitment of sternomastoids and rib cage muscles approached near maximum within 4 min of trial commencement ; expiratory muscles were recruited slowest of all . In conclusion , not only is activity of the inspiratory rib cage muscles increased during a failed weaning trial , but respiratory centers also recruit sternomastoid and expiratory muscles . Extradiaphragmatic muscle recruitment may be a mechanism for off setting the effects of increased load on a weak diaphragm Purpose : Respiratory muscle dysfunction is a key component of weaning failure . Balancing respiratory muscle loading and unloading by applying different ventilation modes along with spontaneous breathing episodes are established weaning strategies . However , the effects of body positioning on the respiratory muscles during weaning remains unclear . Material s and methods : This study aim ed at assessing respiratory drive by surface electromyography ( EMG ) of the diaphragm ( EMGdia ) and parasternal muscles ( EMGpara ) in tracheotomized patients during prolonged weaning in 3 r and omized body positions — supine , 30 ° semirecumbent , and 80 ° sitting — during mechanical ventilation and spontaneous breathing . Results : Nine patients were included for analysis . Cardiorespiratory parameters ( heart rate , blood pressure , arterial oxygen saturation , dyspnea ) did not change under each condition ( all P > .05 ) . EMGpara and EMGdia did not change under mechanical ventilation ( both P > .05 ) . EMGdia changed under spontaneous breathing from supine to sitting ( 0.45 ± 0.26 vs 0.32 ± 0.19 ; P = .012 ) and between semirecumbent to sitting ( 0.41 ± 0.23 vs 0.32 ± 0.19 ; P = .039 ) , whereas EMGpara did not change . Conclusions : This is the first study to show that body positioning influences respiratory drive to the diaphragm in tracheotomized patients with prolonged weaning from mechanical ventilation during unassisted breathing . Sitting position reduces respiratory drive compared with semirecumbent and supine positioning and might therefore be favored during spontaneous breathing trials . HighlightsThis work highlights the effects of simple physical strategies that impose effects on the respiratory drive in difficult to wean patients . Current treatment strategies often include placing a weaning patient in an upright position , to ease unassisted breathing ; however , scientific evidence for doing so was lacking so far . This study assessed the activation of the diaphragm and parasternal muscles in patients with prolonged weaning in 3 body positions — supine , semirecumbent , and sitting — during either mechanical ventilation or unassisted breathing . Interestingly , parasternal and diaphragmatic EMG did not change under mechanical ventilation , but the sitting position leads to a decrease of the neuromuscular drive to the diaphragm . Therefore , the sitting position might be favored during SBTs Context Pressure support ventilation ( PSV ) must be tailored to the load capacity balance of the respiratory system . While " over assistance " generated hyperinflation and ineffective efforts , " under assistance " increased respiratory drive and causes dyspnea . Surface electromyograms ( sEMGs ) of extradiaphragmatic inspiratory muscles were responsive to respiratory loading/unloading . Objectives To determine if sEMGs of extradiaphragmatic inspiratory muscles vary with PSV setting s and relate to the degree of discomfort and the intensity of dyspnea in acutely ill patients . Design Pathophysiological study , prospect i ve inclusion s of 12 intubated adult patients . Interventions Two PSV levels ( high and low ) and two expiratory trigger ( ET ) levels ( high and low ) . Measurements Surface electromyograms of the scalene , parasternal , and Alae Nasi muscles ( peak , EMGmax ; area under the curve , EMGAUC ) ; dyspnea visual analogue scale ( VAS ) ; prevalence of ineffective triggering efforts . Main results For the three recorded muscles , EMGmax and EMGAUC were significantly greater with low PS than high PS . The influence of ET was less important . A strong correlation was found between dyspnea and EMGmax . A significant inverse correlation was found between the prevalence of ineffective efforts and both dyspnea-VAS and EMGmin . Conclusions Surface electromyograms of extradiaphragmatic inspiratory muscles provides a simple , reliable and non-invasive indicator of respiratory muscle loading/unloading in mechanically ventilated patients . Because this EMG activity is strongly correlated to the intensity of dyspnea , it could be used as a surrogate of respiratory sensations in mechanically ventilated patients , and might , therefore , provide a monitoring tool in patients in whom detection and quantification of dyspnea is complex if not impossible Purpose To compare breathing pattern descriptors and diaphragm electromyographic activity (EAdi)-derived indices obtained from a neurally adjusted ventilatory assist catheter during a spontaneous breathing trial ( SBT ) in patients successfully and unsuccessfully separated from the ventilator and to assess their performance as a potential marker to discriminate these two categories of patients . Methods Fifty-seven ready-to-wean patients were included in a prospect i ve observational study . During a 30-min SBT ( pressure support 7 cmH2O , zero end expiratory pressure ) , tidal volume ( VT ) and respiratory rate ( RR ) were obtained from the flow signal at baseline and at 3 , 10 , 20 and 30 min during the SBT . EAdi-derived indices were simultaneously computed : maximum of the EAdi ( EAdimax ) , area under the inspiratory curve of EAdi ( EAdiAUC ) , the difference between EAdimax and EAdimin ( ∆EAdi ) , EAdimax/VT , EAdiAUC/VT and ∆EAdi/VT . Patients , successfully ( success group ; n = 35 ) and unsuccessfully ( failure group ; n = 22 ) separated from the ventilator were compared . Results At baseline , the breathing pattern was similar in the two groups , whereas EAdimax and EAdiAUC were significantly lower in the success group ( p < 0.05 ) . In the failure group , RR and RR/VT increased significantly during the trial , VT decreased , whereas EAdimax and EAdiAUC did not change . At 3 min , the areas under the receiver operating characteristic-curve of RR/VT and the EAdi-derived indices to predict weaning outcome were 0.83 for the rapid shallow breathing index ( RSBI ) , 0.84 for EAdimax/VT , 0.80 for EAdiAUC/VT ( 0.80 ) and 0.82 for ∆EAdi/VT . The coefficient of variation for VT decreased in the failure group while that for EAdimax remained unchanged . Conclusions EAdi-derived indices provide reliable and early predictors of weaning outcome . However , the performance of these indices is not better than the RR/VT Objective To compare the effects of adaptive support ventilation ( ASV ) and synchronized intermittent m and atory ventilation plus pressure support ( SIMV-PS ) on patient-ventilator interactions in patients undergoing partial ventilatory support . Design Prospect i ve , crossover interventional study . Setting Medical intensive care unit , university tertiary care center . Patients Ten patients , intubated and mechanically ventilated for acute respiratory failure of diverse causes , in the early weaning period , ventilated with SIMV-PS and clinical ly detectable sternocleidomastoid activity suggesting increased inspiratory load and patient-ventilator dyssynchrony . Interventions Measurement of respiratory mechanics , P0.1 , sternocleidomastoid electromyographic activity , arterial blood gases , and systemic hemodynamics in three conditions : 1 ) after 45 mins with SIMV-PS ( SIMV-PS 1 ) ; 2 ) after 45 mins with ASV , set to deliver the same minute-ventilation as during SIMV-PS ; 3 ) 45 mins after return to SIMV-PS ( SIMV-PS 2 ) , with setting s identical to those of the first SIMV-PS period . Main Results The same minute ventilation was observed during ASV ( 11.4 ± 3.1 l/min [ mean ± sd ] ) as during SIMV-PS 1 ( 11.6 ± 3.5 L/min ) and SIMV-PS 2 ( 10.8 ± 3.4 L/min ) . No parameter was significantly different between SIMV-PS 1 and 2 , hence subsequent results refer to ASV vs. SIMV-PS 1 . During ASV , tidal volume increased ( 538 ± 91 vs. 671 ± 100 mL , p < .05 ) and total respiratory rate decreased ( 22 ± 7 vs. 17 ± 3 breaths/min , p < .05 ) vs. SIMV-PS . However , spontaneous respiratory rate increased in six patients , decreased in four , and remained unchanged in one . P0.1 decreased during ASV in all patients except three in whom no change was noted ( 1.8 ± 0.9 vs. 1.1 ± 1 cm H2O , p < .05 ) . During ASV , sternocleidomastoid electromyogram activity was markedly reduced ( electromyogram index , where SIMV-PS 1 = 100 , ASV 34 ± 41 , SIMV-PS 2 89 ± 36 , p < .02 ) as was palpable muscle activity . No changes were noted in arterial blood gases , pH , or mean systemic pressure during the trial . Conclusion In patients undergoing partial ventilatory support , with clinical and electromyographic signs of increased respiratory muscle loading , ASV provided levels of minute ventilation comparable to those of SIMV-PS . However , with ASV , central respiratory drive and sternocleidomastoid activity were markedly reduced , suggesting decreased inspiratory load and improved patient-ventilator interactions . These preliminary results warrant further testing of ASV for partial ventilatory support [ Purpose ] This study aim ed to determine the effects of different intensities of inspiratory muscle training on the relative respiratory muscle activity in healthy adults . [ Subjects and Methods ] Thirteen healthy male volunteers were instructed to perform inspiratory muscle training ( 0 % , 40 % , 60 % , and 80 % maximal inspiratory pressure ) on the basis of their individual intensities . The inspiratory muscle training was performed in r and om order of intensities . Surface electromyography data were collected from the right-side diaphragm , external intercostal , and sternocleidomastoid , and pulmonary functions ( forced expiratory volume in 1 s , forced vital capacity , and their ratio ; peak expiratory flow ; and maximal inspiratory pressure ) were measured . [ Results ] Comparison of the relative activity of the diaphragm showed significant differences between the 60 % and 80 % maximal inspiratory pressure intensities and baseline during inspiratory muscle training . Furthermore , significant differences were found in sternocleidomastoid relative activity between the 60 % and 80 % maximal inspiratory pressure intensities and baseline during inspiratory muscle training . [ Conclusion ] During inspiratory muscle training in the clinic , the patients were assisted ( verbally or through feedback ) by therapists to avoid overactivation of their accessory muscles ( sternocleidomastoid ) . This study recommends that inspiratory muscle training be performed at an accurate and appropriate intensity through the practice of proper deep breathing CONTEXT Infection is a major cause of morbidity and mortality in intensive care units ( ICUs ) worldwide . However , relatively little information is available about the global epidemiology of such infections . OBJECTIVE To provide an up-to- date , international picture of the extent and patterns of infection in ICUs . DESIGN , SETTING , AND PATIENTS The Extended Prevalence of Infection in Intensive Care ( EPIC II ) study , a 1-day , prospect i ve , point prevalence study with follow-up conducted on May 8 , 2007 . Demographic , physiological , bacteriological , therapeutic , and outcome data were collected for 14,414 patients in 1265 participating ICUs from 75 countries on the study day . Analyses focused on the data from the 13,796 adult ( > 18 years ) patients . RESULTS Output:
Findings demonstrate that sEMG of extra-diaphragmatic muscle activity is a valid and applicable tool to evaluate mechanical loading/unloading of respiratory muscles and respiratory drive or sensation . Although it appears to be a valid and applicable tool , there is a scarcity of literature that directly demonstrates the diagnostic accuracy of sEMG of extra-diaphragmatic muscles in monitoring respiratory mechanics and respiratory drive or sensation during MV assistance across wide population s and conditions
MS2_1shot224
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVE The relationship between cognition and outcome in people with schizophrenia has been established in studies that , for the most part , examined chronic patients and were cross-sectional in design . The purpose of this study was to analyze the relationships between neurocognitive variables assessed at illness onset and functional outcome in a longitudinal design . An additional area of interest was whether the severity of negative symptoms would predict outcome independently from neurocognitive variables or whether there would be an overlap in their predictive power . METHOD The authors administered a comprehensive cognitive battery and clinical assessment s to 99 subjects who were in their first episode of illness and analyzed the relationship of cognition and symptom severity at intake with community outcome after an average follow-up period of 7 years . RESULTS Verbal memory , processing speed and attention , and the severity of negative symptoms at intake were related to subsequent outcome . Global psychosocial functioning was predicted by negative symptoms and attention . Verbal memory was the significant predictor of the degree of impairment in recreational activities . Impairment in relationships was predicted by negative symptoms and memory , whereas attention and negative symptoms were predictive of work performance . There was an overlap in the variance in outcome explained by cognitive variables and negative symptoms . CONCLUSIONS Verbal memory and processing speed and attention are potential targets for psychosocial interventions to improve outcome . Results from cross-sectional or chronic patient studies do not necessarily correspond to the findings of this prospect i ve first-episode study in which cognition appears to explain less of the variance in outcome CONTEXT Progressive loss of brain gray matter ( GM ) has been reported in childhood-onset schizophrenia ; however , it is uncertain whether these changes are shared by pediatric patients with different psychoses . OBJECTIVE To examine the progression of brain changes in first-episode early-onset psychosis and their relationship to diagnosis and prognosis at 2-year follow-up . DESIGN Prospect i ve , multicenter , naturalistic , 2-year follow-up study . SETTING Six child and adolescent psychiatric units in Spain . PARTICIPANTS A total of 110 patients and 98 healthy controls were recruited between March 1 , 2003 , and November 31 , 2005 . Magnetic resonance imaging of the brain was performed for 61 patients with schizophrenia ( n = 25 ) , bipolar disorder ( n = 16 ) , or other psychoses ( n = 20 ) and 70 controls ( both at baseline and after 2 years of follow-up ) . Mean age at baseline was 15.5 years ( patients ) and 15.3 years ( controls ) . MAIN OUTCOME MEASURES The GM and cerebrospinal fluid ( CSF ) volumes in the total brain and frontal , parietal , and temporal lobes . RESULTS Compared with controls , patients with schizophrenia showed greater GM volume loss in the frontal lobe during the 2-year follow-up ( left : -3.3 vs -0.6 cm(3 ) , P = .004 ; right : -3.7 vs -0.8 cm(3 ) , P = .005 ) and left frontal CSF volume increase ( left : 6.7 vs 2.4 cm(3 ) , P = .006 ) . In addition to frontal volume , changes for total GM ( -37.1 vs -14.5 cm(3 ) , P = .001 ) and left parietal GM ( -4.3 vs -2.2 cm(3 ) , P = .04 ) were significantly different in schizophrenic patients compared with controls . No significant differences emerged for patients with bipolar disease . Greater left frontal GM volume loss was related to more weeks of hospitalization , whereas severity of negative symptoms correlated with CSF increase in patients with schizophrenia . CONCLUSIONS Patients with schizophrenia or other psychoses showed greater loss of GM volume and increase of CSF in the frontal lobe relative to controls . Progressive changes were more evident in patients with schizophrenia than those with bipolar disorder . These changes in specific brain volumes after onset of psychotic symptoms may be related to markers of poorer prognosis Only few prospect i ve longitudinal studies have assessed the course of intelligence deficits in early onset schizophrenia ( EOS ) , and these have used different age appropriate versions of Wechsler Intelligence Scales and age appropriate norms . The post-psychotic development of intelligence in EOS has predominantly been characterized as relatively stable in these studies . However , comparisons of IQs from different test versions based on the different norms may not permit unequivocal interpretations . The objective of the current study was to compare the development of intelligence in EOS patients ( N = 10 ) from their first psychotic episode to 5 years of post onset with that of healthy controls ( N = 35 ) and patients who at baseline had been diagnosed with other non-affective psychoses ( N = 8) . The same version of a Wechsler Intelligence Scale was administered at both baseline and follow-up assessment s , and the same norms were used to derive IQs at baseline and follow-up . Significantly smaller change in mean full scale intelligence quotient ( FSIQ ) was found in diagnostically stable EOS patients compared with healthy controls during the follow-up period . However , no statistically significant difference in mean FSIQ change was observed between patients with EOS and patients with other non-affective psychoses , although this result must be interpreted with caution due to the small sample sizes . The results suggest abnormally slow acquisition of new intellectual information and skills in EOS patients during the first 5 years after full clinical presentation A total of 232 ( 84 % ) first episodes of schizophrenia from our epidemiologically defined ABC sample ( Age , Beginning and Course ) were retrospectively assessed with regard to the onset and early course of the disorder . In a follow-up study a representative subgroup ( n=133 ) was prospect ively examined in five cross sections over 3 years from first admission on . Population -based incidence rates for 5-year age groups comprising a range of < 10-<60 years were calculated on the basis of two definitions of onset : first sign of disorder and first psychotic symptom . In 40 % of adult patients who had been admitted with a first schizophrenic episode after age 20 years the prodromal phase , in 11 % the psychotic prephase , began before that age . This demonstrates that schizophrenia often begins in an age period in which the social and cognitive development and brain maturation are still unfinished . Early-onset schizophrenias ( < -20 years ) were compared with a medium-onset group ( 21<35 years ) and a late-onset group ( 35-<60 years ) with regard to age and type of onset , early symptom-related course , social development and social course . The number of schizophrenia-specific positive and negative syndromes in early-onset schizophrenia is comparable to that of higher age groups . However , neurotic syndromes , emotional disorders and conduct disorders are most frequent in younger patients , especially in young men . Paranoid syndromes seem to prevail in late-onset schizophrenia , whereas less differentiated positive syndromes , such as delusional mood , are more frequent in the youngest age group . An earlier onset of schizophrenia has more severe social consequences than onset in adults , because it interrupts the cognitive and social development at an earlier stage . The worse social course of schizophrenia in men compared with women can not be related to a more severe symtomatology , but to the earlier age at onset and the impairment or stagnation of social ascent at an earlier stage of social and cognitive development . Social disability in the sense of an adaptation to the expectations of the social environment , as well as symtomatology during the further course of schizophrenia , show no major differences between the genders nor between the age groups Premorbid adjustment is an important prognostic factor of schizophrenia . The relationships between sub-components of premorbid adjustment and outcomes on symptoms and cognition in first-episode schizophrenia were under-studied . In the current study , we prospect ively followed up 93 patients aged 18 - 55 years presenting with first-episode schizophrenia-spectrum disorder . Psychopathological and cognitive assessment s were conducted at baseline , clinical stabilization , 12 , 24 and 36 months . Premorbid adjustment was sub-divided into discrete functional domains , developmental stages and premorbid-course types based on ratings of the Premorbid Adjustment Scale ( PAS ) . The study focused on early developmental stages to minimize contamination by prodromal symptoms . Results indicated that gender differences in premorbid functioning were primarily related to early-adolescence adjustment and academic domain . Social domain was more strongly related to negative symptoms , while academic domain was more consistently linked to cognitive outcome ( Wisconsin Card Sorting test and verbal fluency ) . Patients with stable-poor premorbid course had more severe negative symptoms and cognitive impairment . In conclusion , in a Chinese cohort of first-episode schizophrenia-spectrum disorder , sub-components of early premorbid adjustment were shown to be differentially related to clinical and cognitive measures . The results highlighted the importance of applying a more refined delineation of premorbid functioning in study ing illness outcome Background There were few studies on the outcome of schizophrenia in developing countries . Whether the outcome is similar to or different from developed world is still a point for research . The main aim of the current study was to know if patients with early onset non affective psychosis can behave and function properly after few years from start of the illness or not . Other aims included investigation of possible predictors and associated factors with remission and outcome . Method The study prospect ively investigated a group of 56 patients with onset of psychosis during childhood or adolescence . Diagnosis made according to DSM-IV criteria and included ; schizophrenia , psychotic disorder not otherwise specified and acute psychosis . Severity of psychosis was measured by PANSS . Measures of the outcome included ; remission criteria of And reasen et al 2005 , the children 's global assessment scale and educational level . Results Analysis of data was done for only 37 patients . Thirty patients diagnosed as schizophrenia and 7 with Psychotic disorder not otherwise specified . Mean duration of follow up was 38.4 + /- 16.9 months . At the end of the study , 6 patients ( 16.2 % ) had one episode , 23(62.1 % ) had multiple episodes and 8 ( 21.6 % ) continuous course . Nineteen patients ( 51.4 % ) achieved full remission , and only 11(29.7 % ) achieved their average educational level for their age . Twenty seven percent of the sample had good outcome and 24.3 % had poor outcome . Factors associated with non remission and poor outcome included gradual onset , low IQ , poor premorbid adjustment , negative symptoms at onset of the illness and poor adherence to drugs . Moreover , there was tendency of negative symptoms at illness start to predict poor outcome . ConclusionS ome patients with early onset non affective psychosis can behave and function properly after few years from the start of the illness . Although remission is a difficult target in childhood psychosis , it is still achievable BACKGROUND The association between the duration of untreated psychosis ( DUP ) and outcome of schizophrenia may be confounded by other factors such as poor pre-morbid adjustment . The aim of the present study was to examine the independent contributions of DUP and of pre-morbid adjustment to the clinical and social outcomes of schizophrenia . METHOD A longitudinal , prospect i ve , 2-year follow-up study of 423 patients with first-episode schizophrenia-spectrum psychosis was conducted . Patients were comprehensively assessed at entry , 1-year and 2-year follow-up . At entry , DUP was measured by IRAOS ( an instrument for the assessment of onset and early course of schizophrenia ) and pre-morbid adjustment was measured by the Pre-morbid Adjustment Scale ( PAS ) as ' pre-morbid social adaptation ' and ' pre-morbid school adaptation ' . Outcome measures included the Scale for the Assessment of Positive Symptoms ( SAPS ) , the Scale for the Assessment of Negative Symptoms ( SANS ) , the Social Network Schedule and social information . Multiple linear regression models were used for data analysis . RESULTS The median DUP was 48 weeks , which is long compared to other studies . Longer DUP was independently associated with more psychotic symptoms at entry , 1-year and 2-year follow-up . Poorer pre-morbid social adaptation was independently associated with more negative symptoms and smaller social network at entry and 1-year follow-up . Poorer pre-morbid school adaptation was independently associated with poor vocational outcome at 1-year and 2-year follow-up . CONCLUSIONS Longer DUP is associated with poorer 2-year outcome of psychosis in schizophrenia-spectrum disorders , when pre-morbid functioning and other prognostic factors are controlled for . Impaired pre-morbid development is independently associated with more negative symptoms and poorer social outcome Adolescent-onset psychoses often raise diagnostic difficulties because of the mixture of schizophrenic and affective features . This study examined prospect ively which clinical dimensions contribute to difficulty in initial diagnosis and which clinical features have predictive value for outcomes of schizophrenia or affective disorders , and for eventual psychosocial functioning . Thirty-six adolescents consecutively admitted for a psychotic episode were followed up for 1 to 4 years . Symptoms were assessed at admission , at discharge , and once a year . DSM-III-R ( APA 1989 ) diagnoses were assessed at admission and once a year . Comparisons were performed across initial and followup diagnostic groups . Positive symptoms did not differentiate the initial clinical pictures , while negative symptoms , manic symptoms , and disorganization differentiated the manic and depressive episodes in the acute phase . When initial positive symptoms ( mainly delusions ) were severe , they predicted a final Output:
Using multivariate models , the most replicated predictors of worse clinical , functional , cognitive , and biological outcomes in EOP were premorbid difficulties and symptom severity ( especially of negative symptoms ) at baseline . Longer duration of untreated psychosis ( DUP ) predicted worse clinical , functional , and cognitive outcomes . Higher risk of attempting suicide was predicted by greater severity of psychotic illness and of depressive symptoms at the first episode of psychosis . Age at onset and sex were not found to be relevant predictors of outcome in most multivariate models , whereas studies using bivariate analyses yielded inconsistent results . Lower intelligence quotient at baseline predicted lower insight at follow-up , worse functional outcomes , and a diagnostic outcome of schizophrenia . Lower levels of antioxidants at baseline predicted greater brain volume changes and worse cognitive functioning at follow-up , whereas neuroimaging markers such as regional cortical thickness and gray matter volume at baseline predicted remission and better insight at follow-up , respectively . EOP patients with poorer premorbid adjustment and prominent negative symptoms at initial presentation are at risk of poor outcome . Early intervention strategies to reduce DUP may also improve outcome in EOP
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Abstract OBJECTIVE : Assess impact of a computer-based patient support system on quality of life in younger women with breast cancer , with particular emphasis on assisting the underserved . DESIGN : R and omized controlled trial conducted between 1995 and 1998 . SETTING : Five sites : two teaching hospitals ( Madison , Wis , and Chicago , Ill ) , two nonteaching hospitals ( Chicago , Ill ) , and a cancer re source center ( Indianapolis , Ind ) . The latter three sites treat many underserved patients . PARTICIPANTS : Newly diagnosed breast cancer patients ( N=246 ) under age 60 . INTERVENTIONS : Experimental group received Comprehensive Health Enhancement Support System ( CHESS ) , a home-based computer system providing information , decision-making , and emotional support . MEASUREMENTS AND MAIN RESULTS : Pretest and two posttest surveys ( at two- and five-month follow-up ) measured aspects of participation in care , social/information support , and quality of life . At two-month follow-up , the CHESS group was significantly more competent at seeking information , more comfortable participating in care , and had greater confidence in doctor(s ) . At five-month follow-up , the CHESS group had significantly better social support and also greater information competence . In addition , experimental assignment interacted with several indicators of medical underservice ( race , education , and lack of insurance ) , such that CHESS benefits were greater for the disadvantaged than the advantaged group . CONCLUSIONS : Computer-based patient support systems such as CHESS may benefit patients by providing information and social support , and increasing their participation in health care . These benefits may be largest for currently underserved population Background : Low-income African American women face numerous barriers to mammography screening . We tested the efficacy of a combined interactive computer program and lay health advisor intervention to increase mammography screening . Methods : In this r and omized , single blind study , participants were 181 African American female health center patients of ages 41 to 75 years , at ≤250 % of poverty level , with no breast cancer history , and with no screening mammogram in the past 15 months . They were assigned to either ( a ) a low-dose comparison group consisting of a culturally appropriate mammography screening pamphlet or ( b ) interactive , tailored computer instruction at baseline and four monthly lay health advisor counseling sessions . Self-reported screening data were collected at baseline and 6 months and verified by medical record . Results : For intent-to-treat analysis of primary outcome ( medical record – verified mammography screening , available on all but two participants ) , the intervention group had increased screening to 51 % ( 45 of 89 ) compared with 18 % ( 16 of 90 ) for the comparison group at 6 months . When adjusted for employment status , disability , first-degree relatives with breast cancer , health insurance , and previous breast biopsies , the intervention group was three times more likely ( adjusted relative risk , 2.7 ; 95 % confidence interval , 1.8 - 3.7 ; P < 0.0001 ) to get screened than the low-dose comparison group . Similar results were found for self-reported mammography stage of screening adoption . Conclusions : The combined intervention was efficacious in improving mammography screening in low-income African American women , with an unadjusted effect size ( relative risk , 2.84 ) significantly higher ( P < 0.05 ) than that in previous studies of each intervention alone . Cancer Epidemiol Biomarkers Prev ; 19(1 ) ; OBJECTIVES We conducted 1 of the first community-based trials to develop a multicomponent intervention that would increase colorectal cancer screening among an Asian American population . METHODS Filipino Americans ( n = 548 ) nonadherent to colorectal cancer ( CRC ) screening guidelines were r and omized into an intervention group that received an education session on CRC screening and free fecal occult blood test ( FOBT ) kits ; a second intervention group that received an education session but no free FOBT kits ; and a control group that received an education session on the health benefits of physical activity . RESULTS Self-reported CRC screening rates during the 6-month follow-up period were 30 % , 25 % , and 9 % for participants assigned to intervention with FOBT kit , intervention without the kit , and control group , respectively . Participants in either of the 2 intervention groups were significantly more likely to report screening at follow-up than were participants in the control group . CONCLUSIONS A multicomponent intervention that includes an educational group session in a community setting can significantly increase CRC screening among Filipino Americans , even when no free FOBT kits are distributed BACKGROUND North American Chinese women have lower levels of Papanicolaou ( Pap ) testing than other population subgroups . We conducted a r and omized controlled trial to evaluate the effectiveness of two alternative cervical cancer screening interventions for Chinese women living in North America . METHODS Four hundred and eighty-two Pap testing underutilizers were identified from community-based surveys of Chinese women conducted in Seattle , Washington , and Vancouver , British Columbia . These women were r and omly assigned to one of two experimental arms or control status . Several Chinese- language material s were used in both experimental arms : an education-entertainment video , a motivational pamphlet , an educational brochure , and a fact sheet . Women in the first experimental group ( outreach worker intervention ) received the material s , as well as tailored counseling and logistic assistance , during home visits by trilingual , bicultural outreach workers . Those in the second experimental group ( direct mail intervention ) received the material s by mail . The control group received usual care . Follow-up surveys were completed 6 months after r and omization to ascertain participants ' Pap testing behavior . All statistical tests were two-sided . RESULTS A total of 402 women responded to the follow-up survey ( 83 % response rate ) . Of these women , 50 ( 39 % ) of the 129 women in the outreach group , 35 ( 25 % ) of the 139 women in the direct mail group , and 20 ( 15 % ) of the 134 women in the control group reported Pap testing in the interval between r and omization and follow-up data collection ( P<.001 for outreach worker versus control , P = .03 for direct mail versus control , and P = .02 for outreach worker versus direct mail ) . Intervention effects were greater in Vancouver than in Seattle . CONCLUSION Culturally and linguistically appropriate interventions may improve Pap testing levels among Chinese women in North America ABSTRACT This article is the second of a two-part series reporting on a population -based study intended to use an eHealth system to examine the feasibility of reaching underserved women with breast cancer ( Gustafson , McTavish et al. , Reducing the digital divide for low-income women with breast cancer , 2004 ; Madison Center for Health Systems Research and Analysis , University of Wisconsin ; Comprehensive Health Enhancement Support System [ CHESS ] ) and determine how they use the system and what impact it had on them . Participants included women recently diagnosed with breast cancer whose income was at or below 250 % of poverty level and were living in rural Wisconsin ( n = 144 ; all Caucasian ) or Detroit ( n = 85 ; all African American ) . Because this was a population -based study all 229 participants received CHESS . A comparison group of patients ( n = 51 ) with similar demographics was drawn from a separate recently completed r and omized clinical trial . Use rates ( e.g. , frequency and length of use as well as type of use ) as well as impact on several dimensions of quality of life and participation in health care are reported . Low-income subjects in this study logged on and spent more time on CHESS than more affluent women in a previous study . Urban African Americans used information and analysis services more and communication services less than rural Caucasians . When all low-income women from this study are combined and compared with a low-income control group from another study , the CHESS group was superior to that control group in 4 of 8 outcome variables at both statistically and practically significant levels ( social support , negative emotions , participation in health care , and information competence ) . When African Americans and Caucasians are separated the control group 's sample size becomes 30 and 21 thus reducing power . Statistical significance is retained , however , in all four outcomes for Caucasians and in two of four for African Americans . Practical significance is retained for all four outcomes . We conclude that an eHealth system like CHESS will be used extensively and have a positive impact on low-income women with breast cancer Objective . Oncology patients often seek involvement in their medical consultations . Such involvement is endorsed by most health care providers and mirrored in practice guidelines . However , oncologists exhibit great variation in how they provide patients with disease-relevant information , and many remain reluctant to do so at all . The authors examined the impact of a patient-specific decision aid on women ’s decisions about adjuvant therapy for breast cancer . Method . 386 women with breast cancer were r and omized to receive either an informational pamphlet about adjuvant therapy ( usual care ) or a patient-specific , evidence -based decision aid about adjuvant therapy . The authors compared rates of adjuvant therapy between the groups controlling for age , education , marital status , race , tumor severity , and practice type of their physician ( university-based or community-based ) . Results . Among women with low tumor severity , only 58 % ( 35/60 ) of women in the decision aid group chose adjuvant therapy , compared to 87 % ( 33/38 ) of their counterparts in usual care ( P < 0.01 ) . Conclusions . This study illustrates the important impact of medical decision aids on treatment choices , particularly for patients for whom treatment has little benefit . In the case of adjuvant therapy for breast cancer , providing individualized , evidence -based risk information for shared decision making result ed in fewer women with low tumor severity choosing adjuvant treatment Background Minority racial/ethnic groups have low colorectal cancer ( CRC ) screening rates . Objective To evaluate a culturally tailored intervention to increase CRC screening , primarily using colonoscopy , among low income and non-English speaking patients . Design R and omized controlled trial conducted from January to October of 2007 . Setting Single , urban community health center serving a low-income , ethnically diverse population . Patients A total of 1,223 patients 52 - 79 years of age overdue for CRC screening , r and omized to intervention ( n = 409 ) vs. usual care control ( n = 814 ) groups . InterventionIntervention patients received an introductory letter with educational material followed by phone or in-person contact by a language -concordant “ navigator . ” Navigators ( n = 5 ) were community health workers trained to identify and address patient-reported barriers to CRC screening . Individually tailored interventions included patient education , procedure scheduling , translation and explanation of bowel preparation , and help with transportation and insurance coverage . Rates of colorectal cancer screening were assessed for intervention and usual care control patients . Results Over a 9-month period , intervention patients were more likely to undergo CRC screening than control patients ( 27 % vs. 12 % for any CRC screening , p < 0.001 ; 21 % vs. 10 % for colonoscopy completion , p < 0.001 ) . The higher screening rate result ed in the identification of 10.5 polyps per 100 patients in the intervention group vs. 6.8 in the control group ( p = 0.04 ) . Limitations Patients were from one health center . Some patients may have obtained CRC screening outside our system . Conclusions A culturally tailored , language -concordant navigator program design ed to identify and overcome barriers to colorectal cancer screening can significantly improve colonoscopy rates for low income , ethnically and linguistically diverse patients . Clinical Trials.gov registration number : BACKGROUND Latino immigrants face a higher burden of colorectal cancer ( CRC ) and screening rates are low . OBJECTIVE To assess the effectiveness of a multilevel intervention in increasing the rate of CRC screening among Latino immigrants . DESIGN A r and omized controlled trial , with r and omization at the physician level . PARTICIPANTS Pairs of 65 primary care physicians and 65 Latino immigrant patients participated , 31 in the intervention and 34 in the control group . INTERVENTIONCRC educational video in Spanish on a portable personal digital video display device accompanied by a brochure with key information for the patient , and a patient-delivered paper-based reminder for their physician . MEASUREMENTS Completed CRC screening , physician recommendation for CRC screening , and patient adherence to physician recommended CRC screening . RESULTS The overall rate of completed screening for CRC was 55 % for the intervention and 18 % for the control group ( p = 0.002 ) . Physicians recommended CRC screening for 61 % of patients in the intervention group versus 41 % in the control group ( p = 0.08 ) . Of those that received a recommendation , 90 % in the intervention group adhered to it versus 26 % in the control group ( p = 0.007 ) . CONCLUSIONS The intervention was successful in increasing rates of completed CRC screening primarily through increasing adherence after screening was recommended . Additional efforts should focus on developing new strategies to increase physician recommendation for CRC screening , while employing effective patient adherence interventions BACKGROUND We design ed this observational cohort study to assess the association between patient-centered communication in primary care visits and subsequent health and medical care utilization . METHODS We selected 39 family physicians at r and om , and 315 of their patients participated . Office visits were audiotaped and scored for patient-centered communication . In addition , patients were asked for their perceptions of the patient-centeredness of the visit . The outcomes were : ( 1 ) patients ' health , assessed by a visual analogue scale on symptom discomfort and concern ; ( 2 ) self-report of health , using Output:
The impact on patient participation was varied . The effect of a decision aid and patient navigator interventions on communication with health providers was positive . While the use of a decisions aid successfully facilitated shared decision-making and patients ' perception of treatment adherence , the use of patient navigators was ineffective . A computer support system was found to improve general patient participation ; however little clarification of what this involved was provided . This systematic review identified few rigorous evaluations of interventions to improve treatment participation for CALD people with cancer , highlighting the lack of a robust evidence base to improve this crucial aspect of care .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Abstract Objective : To investigate the performance of a novel assay for N-terminal pro-brain natriuretic peptide ( NT-proBNP ) in diagnosing heart failure in various r and omly selected general and high risk community population s. Design : Community cohort study ( sub study of the echocardiographic heart of Engl and screening study ) . Setting : Four r and omly selected general practice s in the West Midl and s of Engl and . Participants : 591 r and omly sample d patients over the age of 45 , stratified for age and socioeconomic status and falling into four cohorts ( general population , patients with an existing clinical label of heart failure , patients prescribed diuretics , and patients deemed at high risk of heart failure ) . Main outcome measure : Sensitivity , specificity , positive and negative predictive values , likelihood ratios , and area under receiver operating characteristic curve for NT-proBNP assay in the diagnosis of heart failure . Results : For NT-proBNP in the diagnosis of heart failure in the general population ( population screen ) , a level of > 36 pmol/l had a sensitivity of 100 % , a specificity of 70 % , a positive predictive value of 7 % , a negative predictive value of 100 % , and an area under the receiver operating characteristic curve of 0.92 ( 95 % confidence interval 0.82 to 1.0 ) . Similar negative predictive values were found for patients from the three other population s screened . Conclusions : This NT-proBNP assay seems to have value in the diagnosis of heart failure in the community . High negative predictive values indicate that the assay 's chief use would be to rule out heart failure in patients with suspected heart failure with normal concentrations of NT-proBNP . Positive results may identify patients who need cardiac imaging BACKGROUND Diagnostic echocardiography has poor access for patients with suspected heart failure . Pre-echocardiography screening with electrocardiograms ( ECGs ) is recommended as a means of targeting this scarce re source . There are data to support this policy when ECGs are interpreted by cardiologists but not by GPs . AIM To assess the value of GP-reported ECGs as a pre-echocardiography screening test for left ventricular systolic dysfunction ( LVSD ) . DESIGN OF STUDY Cross-sectional study of GPs ' ECG reporting skills . SETTING General practice , NHS in Scotl and . METHOD A r and omly selected , stratified sample of 123 Scottish GPs review ed 180 ECGs ( 100 abnormal , 50 normal and 30 duplicate ) from 150 patients with suspected heart failure . Forty-one patients had LVSD on echocardiography . GPs were required to categorise ECGs as normal or abnormal . RESULTS Mean sensitivity was 0.94 ( 95 % CI = 0.92 to 0.95 ) . Mean specificity 0.58 ( 95 % CI = 0.56 to 0.60 ) . Mean positive predictive value ( PPV ) was 0.47 ( 95 % CI = 0.46 to 0.48 ) . Mean negative predictive value ( NPV ) was 0.96 ( 95 % CI = 0.95 to 0.97 ) . Mean likelihood ratio was 2.39 ( 95 % CI = 2.28 to 2.50 ) . Seventy of 123 ( 57 % ) GPs achieved sensitivity of 0.9 and specificity of 0.5 for the detection of LVSD . CONCLUSION Most Scottish GPs have the skills to perform pre-echocardiography screening ECGs in patients with suspected LVSD . However , differences in ECG reporting performance between individual GPs will result in widely varying referral rates for echocardiography and differences in the detection rate of LVSD . The implication s of these findings need to be considered when heart failure diagnostic services are being developed BACKGROUND National guidelines suggest the use of natriuretic peptides in suspected heart failure but there have been no studies comparing assays in primary care . AIM To test and compare the diagnostic accuracy and utility of B-type natriuretic peptide ( BNP ) and N-terminal B-type natriuretic peptide ( NT proBNP ) in diagnosing heart failure due to left ventricular systolic dysfunction in patients with suspected heart failure referred by GPs to one-stop diagnostic clinics . DESIGN OF STUDY Community cohort , prospect i ve , diagnostic accuracy study . SETTING One-stop diagnostic clinics in Darlington Memorial and Bishop Auckl and General Hospitals and general practice s in South Durham . SUBJECTS Two hundred and ninety-seven consecutive patients with symptoms and signs suggestive of heart failure referred from general practice . METHOD The study measured sensitivity , specificity , positive and negative predictive values ( PPV , NPV ) , and area under receiver operating characteristic curve for BNP ( near patient assay ) and NT proBNP ( laboratory assay ) in diagnosis of heart failure due to left ventricular systolic dysfunction . The NPV of both assays was determined as a potential method of reducing the number of referrals for echocardiography . RESULTS One hundred and fourteen of the 297 patients had left ventricular systolic dysfunction ( 38 % ) . At the manufacturer 's recommended cut-off of 100 pg/ml BNP gave a NPV of 82 % . BNP performed better at a cut-off of 40 pg/ml with a NPV of 88 % . At a cut-off of 150 pg/ml , NT proBNP gave a NPV of 92 % . Using cut-offs of 40 pg/ml and 150 pg/ml for BNP and NT pro-BNP , respectively , could have prevented 24 % and 25 % of referrals to the clinic , respectively . CONCLUSIONS In this setting , NT pro-BNP performed marginally better than BNP , and would be easier to use practically in primary care . A satisfactory cut-off has been identified , which needs validating in general practice . NT pro-BNP could be used to select referrals to a heart failure clinic or for echocardiography . This process needs testing in real-life general practice BACKGROUND The early identification of patients at risk for the development of clinical heart failure ( HF ) is a new challenge in an effort to improve outcomes . METHODS We prospect ively evaluated whether the combination of brain natriuretic peptide ( BNP ) measurements ( Triage BNP test , Biosite Diagnostics ) and echocardiography would effectively stratify patients with new symptoms in a cost-effective HF program aim ed at early diagnosis of mild HF . A total of 252 patients were referred by 100 general practitioners . RESULTS Among the study population , the median BNP value was 78 ng/L ( range , 5 - 1491 ng/L ) . BNP concentrations were lower among patients without heart disease [ median 15 ng/L ( range , 5 - 167 ng/L ) ; n = 96 ] than among patients with confirmed HF [ median , 165 ng/L ( 22 - 1491 ng/L ) ; n = 157 ; Mann-Whitney U-test , 12.3 ; P < 0.001 ] . Patients were grouped into diastolic dysfunction [ BNP , 195 ( 223 ) ng/L ] , systolic dysfunction [ BNP , 290 ( 394 ) ng/L ] , and both systolic and diastolic dysfunction [ BNP , 776 ( 506 ) ng/L ] . In this model , a cutoff value of 50 ng/L BNP increases the diagnostic accuracy in predicting mild HF , avoiding 41 echocardiograms per 100 patients studied , with a net saving of 14 % of total costs . CONCLUSIONS Blood BNP concentrations , in a cost effective targeted screening , can play an important role in diagnosing mild HF and stratifying patients into risk groups of cardiac dysfunction BACKGROUND Diagnosing suspected left ventricular systolic dysfunction ( LVSD ) in the community is a challenge for GPs . We developed and vali date d a clinical prediction rule ( CPR ) for LVSD based on history , examination and electrocardiogram ( ECG ) . METHODS Prospect i ve cohort studies of 458 symptomatic patients ( derivation cohort ) and 535 patients ( validation cohort ) in 26 general practice s in Tayside and Fife , Scotl and . All patients underwent a structured clinical examination and ECG and the ' reference st and ard ' investigation of echocardiography to establish the presence of LVSD . RESULTS Four elements from the clinical history and examination were all independently associated with LVSD -- male sex [ adjusted odds ratio ( OR ) 2.5 ; 95 % CI 1.1 , 5.0 ] , presence of orthopnoea ( OR 5.4 ; 1.9 , 13.8 ) history of myocardial infa rct ion ( OR 5.6 ; 2.3 , 13.6 ) and elevated jugular venous pulsations ( OR 15.1 ; 4.6 , 49.3 ) . Addition of ECG ( OR 20.6 ; 2.7 , 158.6 ) provides important diagnostic information in terms of probability of LVSD . A CPR based on the presence or absence of these five elements will generate probabilities ranging from 1 % to 97 % for LVSD when applied to an individual patient . In the validation cohort , the model under-predicted the probability of LVSD , particularly at lower levels of expected risk , reflecting differences in the risk-factor profiles of the derivation and validation cohorts . CONCLUSIONS The derived CPR provides quantitative estimates of post-test probability for LVSD . This rule requires further validation in other population s and setting s because of the difficulties encountered in the validation cohort The objective was to prospect ively vali date a method of increasing the sensitivity , specificity and negative predictive value of a normal ECG in the exclusion of left ventricular systolic dysfunction by the addition of clinical history . We performed a prospect i ve three year study of all referrals to our direct access ECHO service for assessment of LV function . The ECG was reported blind of the result of the ECHO , history of MI or not was noted , and result of the ECHO predicted . Over three years 416 patients were assessed for the presence or absence of left ventricular systolic dysfunction and consequent changes in clinical management . A total of 320(77 % ) of patients referred with suspected left ventricular dysfunction were found to have normal left ventricular function . Of the 250(60 % ) patients treated prior to referral for assessment , 183(73 % ) were treated inappropriately . The combination of a normal ECG and a negative history of myocardial infa rct ion had a sensitivity of 98 % and a negative predictive value of 99 % in the assessment of LV function . This was an improvement over a normal ECG alone . Our study shows that diagnosis and treatment of heart failure in the community remains sub-optimal . The combination of a normal ECG and no previous history of myocardial infa rct ion is shown to be a sensitive and accurate predictor of normal left ventricular function . If adopted by general practitioners this would be a valuable method of optimising the use of ECHOCARDIOGRAPHIC in patients with suspected left ventricular dysfunction BACKGROUND The reliability of a clinical diagnosis of heart failure in primary care is poor . Concentrations of natriuretic peptides are high in heart failure . This population -based study examined the predictive value of natriuretic peptides in patients with a new primary -care diagnosis of heart failure . METHODS Concentrations of plasma atrial ( ANP and N-terminal ANP ) and B-type ( BNP ) natriuretic peptides were measured by radioimmunoassay in 122 consecutive patients referred to a rapid-access heart-failure clinic with a new primary -care diagnosis of heart failure . On the basis of clinical assessment , chest radiography , and transthoracic echocardiography , a panel of three cardiologists decided that 35 ( 29 % ) patients met the case definition for new heart failure . ANP and NT-ANP results were available for 117 patients ( 34 with heart failure ) and BNP results for 106 ( 29 with heart failure ) . FINDINGS Geometric mean concentrations of natriuretic peptides were much higher in patients with heart failure than in those with other diagnoses ( 29.2 vs 12.4 pmol/L for ANP ; 63.9 vs 13.9 pmol/L for BNP ; 1187 vs 410.6 pmol/L for NT-ANP ; all p < 0.001 ) . At cut-off values chosen to give negative predictive values for heart failure of 98 % ( ANP > or = 18.1 pmol/L , NT-ANP > or = 537.6 pmol/L , BNP > or = 22.2 pmol/L ) , the sensitivity , specificity , and positive predictive value for ANP were 97 % , 72 % , and 55 % ; for NT-ANP 97 % , 66 % , and 54 % ; and for BNP 97 % , 84 % , and 70 % . Addition of ANP or NT-ANP concentration or both did not improve the predictive power of a logistic regression model containing BNP concentration alone . INTERPRETATION In patients with symptoms suspected by a general practitioner to be due to heart failure , plasma BNP concentration seems to be a useful indicator of which patients are likely to have heart failure and require further clinical assessment BACKGROUND Although echocardiography is the gold Output:
Conclusion Findings from the clinical history and examination are insufficient to " rule in " or " rule out " a diagnosis of LVSD in primary care setting s. BNP and ECG measurement appear to have similar diagnostic utility and are most useful in " ruling out " LVSD with a normal test result when the probability of LVSD is in the intermediate range
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: CONTEXT Pregnancy has historically been described as a time of emotional well-being , providing " protection " against psychiatric disorder . However , systematic delineation of risk of relapse in women who maintain or discontinue pharmacological treatment during pregnancy is necessary . OBJECTIVE To describe risk of relapse in pregnant women who discontinued antidepressant medication proximate to conception compared with those who maintained treatment with these medications . DESIGN , SETTING , AND PATIENTS A prospect i ve naturalistic investigation using longitudinal psychiatric assessment s on a monthly basis across pregnancy ; a survival analysis was conducted to determine time to relapse of depression during pregnancy . A total of 201 pregnant women were enrolled between March 1999 and April 2003 from 3 centers with specific expertise in the treatment of psychiatric illness during pregnancy . The cohort of women was recruited from ( 1 ) within the hospital clinics , ( 2 ) self-referral via advertisements and community outreach detailing the study , and ( 3 ) direct referrals from the community . Participants were considered eligible if they ( 1 ) had a history of major depression prior to pregnancy , ( 2 ) were less than 16 weeks ' gestation , ( 3 ) were euthymic for at least 3 months prior to their last menstrual period , and ( 4 ) were currently or recently ( < 12 weeks prior to last menstrual period ) receiving antidepressant treatment . Of the 201 participants , 13 miscarried , 5 electively terminated their pregnancy , 12 were lost to follow-up prior to completion of pregnancy , and 8 chose to discontinue participation in the study . MAIN OUTCOME MEASURE Relapse of major depression defined as fulfilling Structured Clinical Interview for DSM-IV [ Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition ] Diagnosis ( SCID ) criteria . RESULTS Among the 201 women in the sample , 86 ( 43 % ) experienced a relapse of major depression during pregnancy . Among the 82 women who maintained their medication throughout their pregnancy , 21 ( 26 % ) relapsed compared with 44 ( 68 % ) of the 65 women who discontinued medication . Women who discontinued medication relapsed significantly more frequently over the course of their pregnancy compared with women who maintained their medication ( hazard ratio , 5.0 ; 95 % confidence interval , 2.8 - 9.1 ; P<.001 ) . CONCLUSIONS Pregnancy is not " protective " with respect to risk of relapse of major depression . Women with histories of depression who are euthymic in the context of ongoing antidepressant therapy should be aware of the association of depressive relapse during pregnancy with antidepressant discontinuation OBJECTIVE Loss of response to a previously effective antidepressant is a common clinical problem . Retrospective analyses have shown that the pattern of response during antidepressant treatment ( late onset and persistent versus other patterns ) can be used to predict relapse during continuation and maintenance treatment and possibly to identify placebo responses to treatment . This study was design ed to test the predictive value of response pattern prospect ively and to examine the data for other predictors of relapse . METHOD Five hundred seventy persons with major depressive disorder were treated with fluoxetine for 12 weeks and their pattern of response was determined . Those who responded ( N=292 ) underwent r and om assignment , under double-blind conditions , to continue taking fluoxetine or to switch to placebo for 52 weeks or until relapse . Survival analysis was used to examine the effect of covariates on relapse . RESULTS Although fluoxetine was significantly more effective than placebo during maintenance treatment , this chronically ill group had a high rate of relapse . Contrary to previous findings , a pattern of acute response was not predictive of relapse . Chronicity , symptom severity , a neurovegetative symptom pattern , and female gender were all associated with a significantly greater risk of relapse , with no difference observed between fluoxetine and placebo . CONCLUSIONS The pattern of response to acute treatment appears to be inconsistently predictive of relapse . There is a high rate of relapse with both active medication and placebo in patients with chronic depression . Illness characteristics predict loss of response both to fluoxetine and to placebo . No variable examined was predictive of differential relapse rates between fluoxetine and placebo OBJECTIVE Duloxetine doses of 80 and 120 mg/day were assessed for efficacy and safety in the treatment of major depressive disorder ( MDD ) . METHODS In this r and omized , double-blind trial , patients age > or = 18 meeting DSM-IV criteria for MDD were r and omized to placebo ( N=99 ) , duloxetine 80 mg/day ( N=93 ) , duloxetine 120 mg/day ( N=103 ) , or paroxetine 20 mg/day ( N=97 ) . The primary outcome measure was mean change from baseline in the 17-item Hamilton rating scale for depression ( HAMD(17 ) ) total score after 8 weeks of treatment ; a number of secondary efficacy measures also were assessed . Safety and tolerability were assessed via collection and analysis of treatment-emergent adverse events ( TEAEs ) , vital signs , and weight . The Arizona sexual experiences scale was used to assess sexual functioning . Patients who had a > or = 30 % reduction from baseline in the HAMD(17 ) total score at the end of the acute phase entered a 6-month continuation phase where they remained on the same treatment as they had taken during the acute phase ; efficacy and safety/tolerability outcomes were assessed during continuation treatment . RESULTS More than 87 % of patients completed the acute phase in each treatment group . Duloxetine-treated patients ( both doses ) showed significantly greater improvement ( P<0.05 ) in the HAMD(17 ) total score at week 8 compared with placebo . Paroxetine was not significantly different from placebo ( P=0.089 ) on mean change on the HAMD(17 ) . Duloxetine 120 mg/day also showed significant improvement on most secondary efficacy measures ( six of nine ) compared with placebo while duloxetine 80 mg/day ( three of nine ) and paroxetine ( three of nine ) were significantly superior to placebo on fewer secondary measures . HAMD(17 ) mean change data from this study and an identical sister study were pooled as defined a priori for the purpose s of performing a non-inferiority test versus paroxetine . Both duloxetine doses met statistical criteria for non-inferiority to paroxetine . TEAE reporting rates were low in all treatment groups and no deaths occurred in the acute or continuation phases . CONCLUSIONS The efficacy of duloxetine at doses of 80 and 120 mg/day in the treatment of MDD was demonstrated . Tolerability , as measured by TEAEs , and safety were similar to paroxetine 20 mg/day and consistent with previous published data on duloxetine in the treatment of MDD BACKGROUND One of the strongest predictors of depression recurrence in those who respond to treatment is the presence of residual depressive symptoms . Our goal was to examine stressful life event exposure as a mechanism of recurrence in previously depressed patients with residual depression symptoms . That is , we predicted that higher levels of residual symptoms will significantly predict exposure to acute life events that will then heighten prospect i ve recurrence risk . METHODS Participants included 68 adult out patients with major depression ( 42 women ; age 18 - 60 ) who completed a 12-month naturalistic follow-up after achieving remission in a 20-week r and omized , open label trial of interpersonal psychotherapy , cognitive-behavioral therapy , or antidepressant medication . Depression recurrence was defined as the reemergence of an episode of major depression as determined by structured interview . Acute life events and chronic stressors were assessed at the end of follow-up using a context ual interview . RESULTS Posttreatment depression scores significantly prospect ively predicted an increased risk for recurrence , and acute life events in the follow-up period . Cox regression survival analyses modeling life events as time-dependent covariates showed that life event exposure mediated the relation of residual symptoms to recurrence even controlling for chronic stress . CONCLUSIONS Our findings implicate residual symptoms in heightening depression recurrence risk through exposure to stressful life events . Depression recurrence adds significantly to the burden of the disorder . Therefore , rigorous follow-up of patients targeting the stressful context has the potential to prevent a lifelong pattern of illness The efficacy and safety of Hypericum extract WS 5570 in preventing relapse during 6 months ' continuation treatment and 12 months ' long-term maintenance treatment after recovery from an episode of recurrent depression were investigated in a double-blind , placebo controlled multicenter trial . Adult out- patients with a recurrent episode of moderate major depression , a 17-item Hamilton Depression Rating Scale ( HAMD ) total score > or = 20 and > or =3 previous episodes in 5 years participated . After 6 weeks of single-blind treatment with 3 x 300 mg/day WS 5570 patients with score < or = 2 on item ' Improvement ' of the Clinical Global Impressions ( CGI ) scale and a HAMD total score decrease > or = 50 % versus baseline were r and omized to 3 x 300 mg/day WS 5570 or placebo for 26 weeks . 426 patients were evaluated for efficacy . Relapse rates during continuation treatment were 51/282 ( 18.1 % ) for WS 5570 and 37/144 ( 25.7 % ) for placebo . Average time to relapse was 177+/-2.8 and 163+/-4.4 days for WS 5570 and placebo , respectively ( time-to-event analysis ; p=0.034 ; alpha=0.025 one-sided ) . Patients treated with WS 5570 showed more favorable HAMD and Beck Depression Inventory time courses and greater over-all improvement ( CGI ) than those r and omized to placebo . In long-term maintenance treatment a pronounced prophylactic effect of WS 5570 was observed in patients with an early onset of depression as well as in those with a high degree of chronicity . Adverse event rates under WS 5570 were comparable to placebo . WS 5570 showed a beneficial effect in preventing relapse after recovery from acute depression . Tolerability in continuation and long-term maintenance treatment was on the placebo level Objective : We compared mindfulness-based cognitive therapy ( MBCT ) with both cognitive psychological education ( CPE ) and treatment as usual ( TAU ) in preventing relapse to major depressive disorder ( MDD ) in people currently in remission following at least 3 previous episodes . Method : A r and omized controlled trial in which 274 participants were allocated in the ratio 2:2:1 to MBCT plus TAU , CPE plus TAU , and TAU alone , and data were analyzed for the 255 ( 93 % ; MBCT = 99 , CPE = 103 , TAU = 53 ) retained to follow-up . MBCT was delivered in accordance with its published manual , modified to address suicidal cognitions ; CPE was modeled on MBCT , but without training in meditation . Both treatments were delivered through 8 weekly classes . Results : Allocated treatment had no significant effect on risk of relapse to MDD over 12 months follow-up , hazard ratio for MBCT vs. CPE = 0.88 , 95 % CI [ 0.58 , 1.35 ] ; for MBCT vs. TAU = 0.69 , 95 % CI [ 0.42 , 1.12 ] . However , severity of childhood trauma affected relapse , hazard ratio for increase of 1 st and ard deviation = 1.26 ( 95 % CI [ 1.05 , 1.50 ] ) , and significantly interacted with allocated treatment . Among participants above median severity , the hazard ratio was 0.61 , 95 % CI [ 0.34 , 1.09 ] , for MBCT vs. CPE , and 0.43 , 95 % CI [ 0.22 , 0.87 ] , for MBCT vs. TAU . For those below median severity , there were no such differences between treatment groups . Conclusion : MBCT provided significant protection against relapse for participants with increased vulnerability due to history of childhood trauma , but showed no significant advantage in comparison to an active control treatment and usual care over the whole group of patients with recurrent depression BACKGROUND Previous studies indicate that depressed patients with partial remission and residual symptoms following antidepressant treatment are common and have high rates of relapse . There is evidence that cognitive therapy may reduce relapse rates in depression . METHODS One hundred fifty-eight patients with recent major depression , partially remitted with antidepressant treatment ( mean daily doses equivalent to 185 mg of amitriptyline or 33 mg of fluoxetine ) but with residual symptoms of 2 to 18 months ' duration , were included in a controlled trial . Subjects were r and omized to receive clinical management alone or clinical management plus cognitive therapy for 16 sessions during 20 weeks , with 2 subsequent booster sessions . Subjects were assessed regularly throughout the 20 weeks ' treatment and for a further year . They received continuation and maintenance antidepressants at the same dose throughout . RESULTS Cognitive therapy reduced relapse rates for acute major depression and persistent severe residual symptoms , in both intention to treat and treated per protocol sample s. The cumulative relapse rate at 68 weeks was reduced significantly , from 47 % in Output:
Placebo substitution trial methodology represents only one approach to assess ADM maintenance .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: The MAGE gene is selectively expressed in cancer tissues such as melanoma or gastrointestinal carcinomas , whereas no expression is observed in normal tissues except testis . There are several reports of successful induction of HLA class I-restricted antitumor CTLs using MAGE peptides , and some clinical trials with these immunogenic peptides were reported as effective for some patients with malignant melanoma . However , there are no similar studies in gastrointestinal carcinomas , which are important neoplasms . Autologous dendritic cells ( DCs ) were generated ex vivo and were pulsed with MAGE-3 peptide , depending on the patient 's HLA haplotype ( HLA-A2 or A24 ) . Patients were immunized with DC pulsed with MAGE-3 peptide every 3 weeks at four times . Twelve patients with advanced gastrointestinal carcinoma ( six stomach , three esophagus , and three colon ) were treated , and no toxic side effects were observed . Peptide-specific CTL responses after vaccination were observed in four of eight patients . Improvement in performance status was recognized in four patients . Tumor markers decreased in seven patients . In addition , minor tumor regressions evidence d by imaging studies were seen in three patients . These results suggested that DC vaccination with MAGE-3 peptide is a safe and promising approach in the treatment of gastrointestinal carcinomas Carcinoembryonic antigen ( CEA ) is expressed in a wide variety of adenocarcinomas , and it is well recognized that cancer patients are immunologically " tolerant " to CEA . The purpose of this study was to determine whether we could break immune tolerance to CEA by vaccinating patients with a monoclonal anti-idiotype antibody that is the internal image of CEA and to determine what impact this might have on patient survival . Twenty-four patients with advanced CEA-positive colorectal cancer who failed st and ard therapies except for two were entered into this Phase Ib trial . One patient was considered not assessable , because on the day of entering into the study , she was diagnosed with acute myelogenous leukemia . Patients were treated with 1 , 2 , or 4 mg of aluminum hydroxide-precipitated 3H1 anti-idiotype antibody every other week for four injections and then monthly until tumor progression was observed . Immunological monitoring included humoral and cellular idiotypic and CEA responses , and all patients were evaluated for toxicity , response , and survival . Hyperimmune sera from 17 of 23 patients demonstrated an anti-anti-idiotypic Ab3 response , and 13 of these responses were demonstrated to be true anti-CEA responses ( Ab1 ' ) . The antibody response was polyclonal , and 11 mediated antibody-dependent cellular cytotoxicity . Ten patients had idiotypic T-cell responses , and five had specific T-cell responses to CEA . None of the patients had objective clinical responses , but overall median survival for the 23 evaluable patients was 11.3 months , with 44 % 1-year survival ( 95 % confidence interval , 23 - 64 % ) . Toxicity was limited to local swelling and minimal pain . Anti-idiotype monoclonal antibody 3H1 that mimics CEA was able to break immune tolerance in the majority of treated patients . Overall survival of 11.3 months was comparable to other phase II data with advanced colorectal cancer patients treated with a variety of chemotherapy agents , including irinotecan , with considerably less toxicity . Although it is not clear that the vaccine itself had an impact on survival , this should be determined in a Phase III r and omized trial Most tumor-associated antigens represent self-proteins and as a result are poorly immunogenic due to immune tolerance . Here we show that tolerance to carcinoembryonic antigen ( CEA ) , which is overexpressed by the majority of lethal malignancies , can be reversed by immunization with a CEA-derived peptide . This peptide was altered to make it a more potent T cell antigen and loaded onto dendritic cells ( DCs ) for delivery as a cellular vaccine . Although DCs are rare in the blood , we found that treatment of advanced cancer patients with Flt3 lig and , a hematopoietic growth factor , exp and ed DCs 20-fold in vivo . Immunization with these antigen-loaded DCs induced CD8 cytotoxic T lymphocytes that recognized tumor cells expressing endogenous CEA . Staining with peptide-MHC tetramers demonstrated the expansion of CD8 T cells that recognize both the native and altered epitopes and possess an effector cytotoxic T lymphocyte phenotype ( CD45RA+CD27−CCR7− ) . After vaccination , two of 12 patients experienced dramatic tumor regression , one patient had a mixed response , and two had stable disease . Clinical response correlated with the expansion of CD8 tetramer+ T cells , confirming the role of CD8 T cells in this treatment strategy Despite an abundance of pre clinical data , relatively little is known regarding the efficacy of DNA vaccination in humans . Here , we present results from a dose-escalation clinical trial of a dual expression plasmid encoding carcinoembryonic antigen ( CEA ) and hepatitis B surface antigen ( HBsAg ) in 17 patients with metastatic colorectal carcinoma . CEA was selected as a prototypic tumor-associated self-antigen , and the HBsAg cDNA was included as a positive control for immune response to the DNA vaccine without relying upon breaking tolerance to a self-antigen . Groups of 3 patients received escalating single i.m . doses of the DNA vaccine at 0.1 , 0.3 , and 1.0 mg . Subsequent groups of 3 patients received three repetitive 0.3- or 1.0-mg doses at 3-week intervals . A final group of 2 patients received three repetitive 2.0 mg doses at 3-week intervals . Toxicity was limited to transient grade 1 injection site tenderness , fatigue , and creatine kinase elevations , each affecting a minority of patients in a non-dose-related manner . Repetitive dosing of the DNA vaccine induced HBsAg antibodies in 6 of 8 patients , with protective antibody levels achieved in four of these patients . CEA-specific antibody responses were not observed , but 4 of 17 patients developed lymphoproliferative responses to CEA after vaccination . No objective clinical responses to the DNA vaccine were observed among this population of patients with widely metastatic colorectal carcinoma . Nevertheless , this pilot trial has provided encouraging human immune response data in support of this vaccine technology We report here the adoptive transfer , to patients with metastatic melanoma , of highly selected tumor-reactive T cells directed against overexpressed self-derived differentiation antigens after a nonmyeloablative conditioning regimen . This approach result ed in the persistent clonal re population of T cells in those cancer patients , with the transferred cells proliferating in vivo , displaying functional activity , and trafficking to tumor sites . This led to regression of the patients ' metastatic melanoma as well as to the onset of autoimmune melanocyte destruction . This approach presents new possibilities for the treatment of patients with cancer as well as patients with human immunodeficiency virus – related acquired immunodeficiency syndrome and other infectious diseases BACKGROUND Colon cancer is curable by surgery , but cure rate depends on the extent of disease . We investigated whether adjuvant active specific immunotherapy ( ASI ) with an autologous tumour cell-BCG vaccine with surgical resection was more beneficial than resection alone in stage II and III colon cancer . METHODS In a prospect i ve r and omised trial , 254 patients with colon cancer were r and omly assigned postoperative ASI or no adjuvant treatment . ASI was three weekly vaccinations starting 4 weeks after surgery , with a booster vaccination at 6 months with 10(7 ) irradiated autologous tumour cells . The first vaccinations contained 10(7 ) BCG organisms . We followed up patients for time to recurrence , and recurrence-free and overall survival . Analysis was by intention to treat . FINDINGS The 5.3 year median follow-up ( range 8 months to 8 years 11 months ) showed 44 % ( 95 % CI 7 - 66 ) risk reduction for recurrence in the recurrence-free period in all patients receiving ASI ( p=0.023 ) . Overall , there were 40 recurrences in the control group and 25 in the ASI group . Analysis by stage showed no significant benefit of ASI in stage III disease . The major impact of ASI was seen in patients with stage II disease , with a significantly longer recurrence-free period ( p=0.011 ) and 61 % ( 18 - 81 ) risk reduction for recurrences . Recurrence-free survival was significantly longer with ASI ( 42 % risk reduction for recurrence or death [ 0 - 68 ] , p=0.032 ) and there was a trend towards improved overall survival . INTERPRETATION ASI gave significant clinical benefit in surgically resected patients with stage II colon cancer . ASI has minimal adverse reactions and should be considered in the management of stage II colon cancer The purpose of this study was to determine the safety , toxicity , and antitumor immune response following S.C. immunizations with a mixture of irradiated , autologous tumor cells and autologous fibroblasts that were genetically modified to express the gene for interleukin 2 ( IL-2 ) in patients with colorectal carcinoma . Ten patients were treated with a fixed dose of tumor cells ( 10(7 ) ) and escalating doses of fibroblasts secreting IL-2 ( per 24 h ) : 100 units ( three patients ) , 200 units ( three patients ) , 400 units ( three patients ) , and 800 units ( one patient ) . Pre- and posttreatment peripheral blood mononuclear cells were evaluated for evidence of antitumor immune responses . Fatigue and /or flu-like symptoms were experienced by seven patients and delayed-type hypersensitivity-like skin reactions were observed at the sites of the second or subsequent vaccinations in five patients . Low frequencies of tumor cytotoxic T-cell precursors ( range , 1/190,000 - 1/1,320,000 peripheral blood mononuclear cells ) were detected prior to therapy in four of seven patients . There was a 5-fold increase following treatment in the frequency of tumor cytotoxic T-cell precursors in two of six evaluable patients . Some patients with colorectal cancer have low frequencies of tumor cytotoxic T-cell precursors that may be increased by this well-tolerated form of IL-2 gene therapy , which warrants continued clinical evaluation Purpose : We intranodally immunized metastatic colorectal carcinoma patients , who had failed st and ard chemotherapy , with dendritic cells ( DCs ) pulsed with HLA-A*0201- or HLA-A*2402-restricted carcinoembryonic antigen ( CEA ) peptides to evaluate the safety of this treatment and the immune response against CEA peptides before and after the treatment . Experimental Design : Six patients with the HLA-A*2402 genotype and 4 patients with the HLA-A*0201 genotype were enrolled . A single CEA peptide ( YLSGANLNL ) or two CEA peptides ( QYSWFVNGTF and TYACFVSNL ) were used for patients with the HLA-A*0201 or HLA-A*2402 genotype , respectively . Autologous DCs were generated by culturing adherent mononuclear cells with interleukin 4 and granulocyte macrophage colony-stimulating factor for 6 days . Maturation of DCs was then induced with tumor necrosis factor α for 40 h. Mature DCs were pulsed with appropriate CEA peptides for 2 h. After washing , 1 million peptide-pulsed DCs were injected into one inguinal lymph node under sonographic guidance . Each patient received four injections . Results : No grade II/III toxicity or autoimmunity was observed . An increase in the number of CEA-specific T cells after DC vaccination could be detected in 7 of 10 ( 70 % ) patients . Two ( 20 % ) patients had stable disease for at least 12 weeks . One of these 2 patients experienced a transient decrease in CEA levels during the treatment period and also had the most significant T-cell response against the immunizing CEA peptides . Conclusions : These results suggest that our vaccination procedure can generate or boost specific T-cell responses and may provide clinical benefit in certain cancer patients In most protocol s of peptide-based vaccination , no consideration has been paid to whether or not peptide-specific cytotoxic T-lymphocyte ( CTL ) precursors are pre-existent in cancer patients . Initiation of immune boosting through vaccination is better than that of immune priming to induce prompt and strong immunity . In this study , 10 human histocompatibility leukocyte antigen-A24 + patients with advanced colorectal carcinomas were treated with up to four peptides that had been positive for pre-vaccination measurement of peptide-specific CTL precursors in the circulation ( CTL precursor-oriented peptide vaccine ) . No severe adverse effect was observed , although local pain and fever of grade I or II were observed . Post-vaccination peripheral blood mononuclear cells ( P BMC s ) from five patients demonstrated an increased peptide-specific immune response to the peptides . Increased CTL response to cancer cells was detected in post-vaccination P BMC s of five patients . Antipeptide immunog Output:
Pooled results of clinical trials reveal a very weak clinical response rate of < 1 % for active specific immunization procedures currently available for advanced colorectal cancer .
MS2_1shot229
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: The aim of this study was to characterise the pharmacokinetics of the anticancer agent topotecan , and explore the influence of patient covariates and interoccasion variability on drug disposition . Data were obtained from 190 patients who received the drug as a 30-min infusion ( N=72 ) or orally ( N=118 ) . The population model was built with the use of NONMEM to identify c and i date covariates , and obtain models for clearance ( CL ) and volume of distribution . The final models were based on first-order absorption with lag-time ( oral data ) , and a two-compartment model with linear elimination from the central compartment . The Cockcroft – Gault creatinine clearance ( CrCl ) and WHO performance status ( PS ) were the only significant covariates : CL=(12.8 + 2.1 × CrCl ) × ( 1−0.12 × PS ) . For the volume of distribution , a correlation was found between body weight and the central volume (V1)=0.58 × body weight . Based on the structural models , a limited-sampling strategy was developed with minor bias and good precision that can be applied a posteriori using timed sample s obtained at 1.5 , and 6 h after the administration of topotecan . In conclusion , a population pharmacokinetic model for topotecan has been developed that incorporates measures of renal function and PS to predict CL . In combination with drug monitoring , the limited sampling strategy allows individualised treatment for patients receiving oral topotecan Imatinib mesylate ( imatinib ) has been shown to be highly efficacious in the treatment of chronic myeloid leukemia ( CML ) . Continuous and adequate dosing is essential for optimal outcomes and with imatinib treatment possibly being lifelong , patient adherence is critical . The ADAGIO ( Adherence Assessment with Glivec : Indicators and Outcomes ) study aim ed to assess prospect ively over a 90-day period the prevalence of imatinib nonadherence in patients with CML ; to develop a multivariate canonical correlation model of how various determinants may be associated with various measures of nonadherence ; and to examine whether treatment response is associated with adherence levels . A total of 202 patients were recruited from 34 centers in Belgium , of whom 169 were evaluable . One-third of patients were considered to be nonadherent . Only 14.2 % of patients were perfectly adherent with 100 % of prescribed imatinib taken . On average , patients with suboptimal response had significantly higher mean percentages of imatinib not taken ( 23.2 % , st and ard deviation [ SD ] = 23.8 ) than did those with optimal response ( 7.3 % , SD = 19.3 , P = .005 ; percentages calculated as proportions x 100 ) . Nonadherence is more prevalent than patients , physicians , and family members believe it is , and therefore should be assessed routinely . It is associated with poorer response to imatinib . Several determinants may serve as alert signals , many of which are clinical ly modifiable Purpose In this prospect i ve multi-centre observational cohort study , we investigated the effect of an intensified multidisciplinary pharmaceutical care programme on the adherence of cancer patients treated with capecitabine , a prodrug of fluorouracil . Patients and methods Twenty-four colorectal and 24 breast cancer patients participated in this study . Patients of the control group ( n = 24 ) received st and ard care , patients of the intervention group ( n = 24 ) received intensified pharmaceutical care consisting of written and spoken information . Adherence to capecitabine chemotherapy was measured using an electronic medication event monitoring system ( MEMS ™ ) . Results Patients in the intervention group exhibited an enhanced but not significantly different mean overall adherence compared to the control group ( 97.9 % vs 90.5 % , p = 0.069 ) . Mean daily adherence was significantly higher in the intervention group ( 96.8 % vs 87.2 % , p = 0.029 ) . Variability of both adherence parameters was considerably reduced when pharmaceutical care was provided . At the end of the observation period of 126 days , the probability of still being treated with capecitabine was found to be 48 % in the control group and 83 % in the intervention group ( p = 0.019 , log-rank test ) . The relative risk for a deviating drug intake interval , i.e. < 10 or > 14 instead of 12 h , in the intervention group was found to be 0.51 ( 95 % CI , 0.46–0.56 ) compared with the control group ( p < 0.05 , Chi-square test ) . Conclusions The provision of intensified pharmaceutical care can enhance adherence to and prolong treatment with capecitabine . The results underline the importance of multidisciplinary care to assure the effectiveness of oral chemotherapy BACKGROUND The cause of chronic myeloid leukemia ( CML ) is a constitutively active BCR-ABL tyrosine kinase . Imatinib inhibits this kinase , and in a short-term study was superior to interferon alfa plus cytarabine for newly diagnosed CML in the chronic phase . For 5 years , we followed patients with CML who received imatinib as initial therapy . METHODS We r and omly assigned 553 patients to receive imatinib and 553 to receive interferon alfa plus cytarabine and then evaluated them for overall and event-free survival ; progression to accelerated-phase CML or blast crisis ; hematologic , cytogenetic , and molecular responses ; and adverse events . RESULTS The median follow-up was 60 months . Kaplan-Meier estimates of cumulative best rates of complete cytogenetic response among patients receiving imatinib were 69 % by 12 months and 87 % by 60 months . An estimated 7 % of patients progressed to accelerated-phase CML or blast crisis , and the estimated overall survival of patients who received imatinib as initial therapy was 89 % at 60 months . Patients who had a complete cytogenetic response or in whom levels of BCR-ABL transcripts had fallen by at least 3 log had a significantly lower risk of disease progression than did patients without a complete cytogenetic response ( P<0.001 ) . Grade 3 or 4 adverse events diminished over time , and there was no clinical ly significant change in the profile of adverse events . CONCLUSIONS After 5 years of follow-up , continuous treatment of chronic-phase CML with imatinib as initial therapy was found to induce durable responses in a high proportion of patients . ( Clinical Trials.gov number , NCT00006343 [ Clinical Trials.gov ] . Abstract . Background : The aim of this study was to explore the characteristics and efficacy of psychoeducational family intervention for persons with schizophrenia in rural China . Methods : A cluster r and omised controlled trial of psychoeducational family intervention for families experiencing schizophrenia ( three groups , 326 cases ) was conducted in Xinjin County , Chengdu . Treatment groups consisted of family intervention and medication , medication alone , and a control . Results : The results showed a gain in knowledge , a change in the relatives ' caring attitudes towards the patients , and an increase in treatment compliance in the psychoeducational family intervention group ( p < 0.05 , 0.001 ) . Most importantly , the relapse rate over 9 months in this group ( 16.3 % ) was half that of the drug-only group ( 37.8 % ) , and just over one-quarter of that of the control group ( 61.5 % ) ( p < 0.05 ) . Antipsychotic drug treatment and families ' attitudes towards patients after the 9-month follow-up were significantly associated with clinical outcome ( p < 0.05 ) . Conclusions : In rural China , family intervention should focus on improving the relatives ' recognition of illness , the caring attitude towards the patients , treatment compliance , relapse prevention , and the training of the patients ' social functioning . This trial , one of the largest in the literature , has shown that psychoeducational family intervention is effective and suitable for psychiatric rehabilitation in Chinese rural communities Output:
Studies that used both tailored and educational interventions showed significant relationship between adherence and clinical outcomes ; however , the study that used dosage simplification did not . Interventions to improve adherence with oral chemotherapies in hematological malignancies remain limited . Though they were heterogeneous in nature , interventions tested in the retained studies suggested a positive impact on the adherence outcome ; some established a significant relationship between adherence and clinical outcomes .
MS2_1shot230
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Introduction Inadequate initial treatment and delayed hemodynamic stabilization ( HDS ) may be associated with increased risk of death in severe sepsis patients . Methods In order to compare the hemodynamic efficacy and safety of 6 % HES 130/0.4 and NaCl 0.9 % for HDS in patients with severe sepsis , we design ed a prospect i ve , multicenter , active-controlled , double-blind , r and omized study in intensive care units . Results 174 out of 196 patients reached HDS ( 88 and 86 patients for HES and NaCl , respectively ) . Significantly less HES was used to reach HDS vs. NaCl ( 1,379 ±886 ml in the HES group and 1,709 ±1,164 ml in the NaCl group ( mean difference = -331± 1,033 , 95 % CI -640 to -21 , P = 0.0185 ) . Time to reach HDS was 11.8 10.1 hours vs. 14.3 ±11.1 hours for HES and NaCl , respectively . Total quantity of study drug infused over four consecutive days , ICU and hospital LOS , and area under the curve of SOFA score were comparable . Acute renal failure occurred in 24 ( 24.5 % ) and 19 ( 20 % ) patients for HES and NaCl , respectively ( P = 0.454 ) . There was no difference between AKIN and RIFLE criteria among groups and no difference in mortality , coagulation , or pruritus up to 90 days after treatment initiation . Conclusion Significantly less volume was required to achieve HDS for HES vs. NaCl in the initial phase of fluid resuscitation in severe sepsis patients without any difference for adverse events in both groups . Clinical Trials.gov Objective Both albumin and synthetic colloids such as hydroxyethyl starch ( HES ) solution are used to optimize hemodynamics in the critically ill . The influence of different long-term infusion regimes on platelet function was studied . Design Prospect i ve , r and omized study . Setting Clinical investigation on a university hospital surgical intensive care unit . Patients Twenty-eight consecutive trauma patients ( injury severity score>15 points ) and 28 consecutive nontraumatized surgical patients with sepsis . Interventions The patients received either 20 % human albumin ( HA trauma , n=14 ; HA sepsis , n=14 ) or 10 % low-molecular-weight HES solution HES 200/0.5 ( HES trauma , n=14 ; HES sepsis;n=14 ) for 5 days to maintain central venous pressure and /or pulmonary capillary wedge pressure between 12 and 16 mmHg . Measurements and results Platelet function was assessed by aggregometry ( = turbidimetric technique ) using adenosine diphosphate 2.0 μmol/l , collagen 4 μl/ml , and epinephrine 25 μmol/l as inductors . Arterial blood was sample d on the day of admission or the day of diagnosis of sepsis ( = baseline value ) and over the next 5 days . St and ard coagulation parameters ( antithrombin III , fibrinogen , partial thromboplastin time ) were also measured . Total use of HES by the 5th day totalled 4870±990 ml in the trauma and 3260±790 ml in the sepsis patients ( HA trauma : 1850±380 ml ; HA sepsis : 1790±400 ml ) . Maximum platelet aggregation decreased significantly during the first 2–3 days after baseline in all groups . At the end of the investigation period , platelet aggregation variables had recovered and reached ( or even exceeded ) baseline values . Within the entire investigation period , the course of platelet aggregation variables did not differ significantly between HA and HES-treated patients irrespective of whether they were trauma or sepsis patients . Conclusions Alterations in hemostasis may occur for several reasons in the critically ill . Human albumin is the preferred first-line volume therapy in patients at risk for coagulation disorders . With respect to platelet function , volume replacement with ( lower-priced ) low-molecular-weight HES solutions can be recommended in this situation without any risk PURPOSE The aim of this study was to show that 6 % hydroxyethyl starch ( HES ) 130/0.4 achieves a better resuscitation of the microcirculation than normal saline solution ( SS ) , during early goal -directed therapy ( EGDT ) in septic patients . MATERIAL S AND METHODS Patients with severe sepsis were r and omized for EGDT with 6 % HES 130/0.4 ( n = 9 ) or SS ( n = 11 ) . Sublingual microcirculation was evaluated by sidestream dark field imaging 24 hours after the beginning of EGDT . RESULTS On admission , there were no differences in Sequential Organ Failure Assessment score , mean arterial pressure , lactate , or central venous oxygen saturation . After 24 hours , no difference arose in those parameters . Sublingual capillary density was similar in both groups ( 21 ± 8 versus 20 ± 3 vessels/mm(2 ) ) ; but capillary microvascular flow index , percent of perfused capillaries , and perfused capillary density were higher in 6 % HES 130/0.4 ( 2.5 ± 0.5 versus 1.6 ± 0.7 , 84 ± 15 versus 53 ± 26 % , and 19 ± 6 versus 11 ± 5 vessels/mm(2 ) , respectively , P < .005 ) . CONCLUSIONS Fluid resuscitation with 6 % HES 130/0.4 may have advantages over SS to improve sublingual microcirculation . A greater number of patients would be necessary to confirm these findings BACKGROUND The safety and efficacy of hydroxyethyl starch ( HES ) for fluid resuscitation have not been fully evaluated , and adverse effects of HES on survival and renal function have been reported . METHODS We r and omly assigned 7000 patients who had been admitted to an intensive care unit ( ICU ) in a 1:1 ratio to receive either 6 % HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 ( 130/0.4 , Voluven ) in 0.9 % sodium chloride or 0.9 % sodium chloride ( saline ) for all fluid resuscitation until ICU discharge , death , or 90 days after r and omization . The primary outcome was death within 90 days . Secondary outcomes included acute kidney injury and failure and treatment with renal-replacement therapy . RESULTS A total of 597 of 3315 patients ( 18.0 % ) in the HES group and 566 of 3336 ( 17.0 % ) in the saline group died ( relative risk in the HES group , 1.06 ; 95 % confidence interval [ CI ] , 0.96 to 1.18 ; P=0.26 ) . There was no significant difference in mortality in six predefined subgroups . Renal-replacement therapy was used in 235 of 3352 patients ( 7.0 % ) in the HES group and 196 of 3375 ( 5.8 % ) in the saline group ( relative risk , 1.21 ; 95 % CI , 1.00 to 1.45 ; P=0.04 ) . In the HES and saline groups , renal injury occurred in 34.6 % and 38.0 % of patients , respectively ( P=0.005 ) , and renal failure occurred in 10.4 % and 9.2 % of patients , respectively ( P=0.12 ) . HES was associated with significantly more adverse events ( 5.3 % vs. 2.8 % , P<0.001 ) . CONCLUSIONS In patients in the ICU , there was no significant difference in 90-day mortality between patients resuscitated with 6 % HES ( 130/0.4 ) or saline . However , more patients who received resuscitation with HES were treated with renal-replacement therapy . ( Funded by the National Health and Medical Research Council of Australia and others ; CHEST Clinical Trials.gov number , NCT00935168 . ) Background : It is unknown whether fluid resuscitation with colloid or crystalloid in patients with severe sepsis or septic shock is associated with an improvement in clinical outcome . This r and omized controlled trial determined the feasibility of conducting a large trial testing resuscitation with pentastarchvs normal saline in early septic shock , powered for a difference in mortality . Methods : At three Canadian and one New Zeal and academic centre , 40 patients with early septic shock defined by at least two systemic inflammatory response syndrome criteria , infectious source , and persistent hypotension after ≥ 1 L of crystalloid fluid were recruited . Feasibility measures were patient recruitment , blinding of the study fluids , and acceptability of the goal directed algorithms . Boluses of blinded normal saline or pentastarch ( 500 mL − maximum 3 L or 28 mL·kg−1 ) were administered within goal directed care for the first 12 hr . Results : Of 161 patients screened , 121 were excluded and 40 patients were enrolled , for a recruitment rate of 0.75 patients / site/month . Only 57 % of physicians and 54 % of nurses correctly guessed the study fluid ( P = 0.46 and P = 0.67 , respectively ) . The goal directed algorithms were acceptable to 97 % of physicians . Conclusion : The ability to recruit patients in this pilot r and omized controlled trial was below expectations . Blinding of study fluids was adequate , and resuscitation algorithms were acceptable to most physicians . Methods to improve recruitment are required to enhance the feasibility of conducting a multicentre fluid resuscitation trial in early septic shock . Résumé Context e : Nous ne savons pas si la réanimation liquidienne avec des colloïdes ou des cristalloïdes chez les patients présentant un sepsis grave ou un choc septique est associée à un devenir clinique meilleur . Cette étude r and omisée contrôlée a déterminé la faisabilité d’une étude d’envergure testant la réanimation avec le pentastarch par rapport au sérum physiologique en début de choc septique , avec pour objectif primaire de détecter une différence dans les taux de mortalité . Method e : Quarante patients en début de choc septique , défini comme au moins deux critères du syndrome de réaction inflammatoire , une source d’infection et une hypotension persistante après ≥ 1 L de cristalloïde ont été recrutés dans trois centres universitaires canadiens et un centre néo-zél and ais . Les mesures de faisabilite étaient : le recrutement des patients , le masquage des liquides à l’étude , et I’acceptabilité des algorithmes dirigés vers des objectifs . Des bolus de normal sal in ou de pentastarch ( 500 mL — maximum 3 L ou 28 mL·kg−1 ) ont été administrés en aveugle dans le cadre de soins guidés dirigés vers des objectifs durant les 12 premieres heures . Result ats : Sur 161 patients dépistés , 121 ont été exclus et 40 patients recrutés dans le cadre de I’étude , avec un taux de recrutement de 0,75 patient/site/mois . Seulement 57 % des médecins et 54 % des infirmières ont réussi à deviner correctement le type de liquide à I’étude ( P = 0,46 etP = 0,67 , respectivement ) . Les algorithmes ont été jugés acceptables par 97 % des médecins . Conclusion : La capacité à recruter des patients pour cette étude pilote r and omisée contrôlée était moins importante qu’attendue . Le masquage des liquides était satisfaisant , et les algorithmes de réanimation ont été jugés acceptables par la majorité des médecins . Des méthodes dans le but d’améliorer le recrutement sont nécessaire pour accroître la faisabilité d’une étude multicentrique sur la réanimation liquidienne en début de choc septique OBJECTIVE To evaluate the effect of 7.5 % hypertonic saline ( HS ) and 6 % hydroxyethyl starch ( HES ) 130/0.4 on early fluid resuscitation for severe sepsis . METHODS Prospect i ve r and omized control trial was carried out in intensive care unit ( ICU ) of the Affiliated Hospital of Jianghan University . One hundred and thirty five patients with severe sepsis were r and omly divided into three groups , each group consisted of 45 patients . Patients in HS+HES group received lactated Ringer solution following 4 ml/kg of 7.5 % HS and 6 % HES 130/0.4 500 ml , those in HES group received lactated Ringer solution following 6 % HES 130/0.4 500 ml , and those in the lactated Ringer group ( RL group ) received lactated Ringer solution only . Mean arterial pressure ( MAP ) , oxygenation index (PaO₂/FiO₂),arterial lactate (Lac),lactate clearance rate , acute physiology and chronic health evaluation II(APACHEII ) score , fluid infusion volume , urine output as well as incidence of multiple organ dysfunction syndrome ( MODS ) , and mortality were compared among three groups at 6 hours and 24 hours after ICU admission . RES Output:
AND RELEVANCE In critically ill patients requiring acute volume resuscitation , use of hydroxyethyl starch compared with other resuscitation solutions was not associated with a decrease in mortality . Moreover , after exclusion of 7 trials performed by an investigator whose research has been retracted because of scientific misconduct , hydroxyethyl starch was associated with a significant increased risk of mortality and acute kidney injury .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVE To determine whether daily self-weighing ( DSW ) is associated with disordered eating ( DE ) symptoms within an adult lifestyle intervention ( LI ) , and to examine changes in DE symptoms during the 18-month trial . METHOD One-hundred and seventy-eight adults ( 53 % female , 90 % White , 52.0 ± 8.6 years , BMI = 35.0 ± 4.4 kg/m2 ) were enrolled in a r and omized trial testing 2 dietary prescriptions within a LI ( st and ard vs. limited dietary variety ) . Both arms were taught DSW and had the same contact schedule and calorie and activity goals . Frequency of weighing and DE were assessed at 0 , 6 , 12 , and 18 months . Analyses controlled for treatment arm . RESULTS At baseline , 16.3 % of participants reported weighing ≥ daily compared with 83.7 % , 72.3 % , and 68.2 % at 6 , 12 , and 18 months , respectively . There was no relationship between change in frequency of self-weighing and change in DE symptoms at any time point . Further , there were no significant differences between those who weighed ≥ daily versus < daily on DE composite scores at baseline or 6 months ; at 12 and 18 months participants who weighed ≥ daily reported lower DE scores compared with those who weighed < daily ( p = .008 and .043 at 12 and 18 months , respectively ) . Participants who weighed ≥ daily achieved better weight losses than those weighing < daily at 12 and 18 months ( p = .003 and < .001 ) . There was a significant reduction over time in DE symptoms ( p < .0001 ) and a reduction in odds of meeting criteria for Binge Eating Disorder ( BED ; ps < .001 ) . CONCLUSIONS Daily self-weighing did not appear to be related to increased disordered eating behavior and was associated with better weight loss outcomes Background : Although the optimization of behavioral interventions offers the potential of both public health and research benefits , currently there is no widely agreed-upon principled procedure for accomplishing this . Purpose : This article suggests a multiphase optimization strategy ( MOST ) for achieving the dual goals of program optimization and program evaluation in the behavioral intervention field . Methods : MOST consists of the following three phases : ( a ) screening , in which r and omized experimentation closely guided by theory is used to assess an array of program and /or delivery components and select the components that merit further investigation ; ( b ) refining , in which interactions among the identified set of components and their interrelationships with covariates are investigated in detail , again via r and omized experiments , and optimal dosage levels and combinations of components are identified ; and ( c ) confirming , in which the result ing optimized intervention is evaluated by means of a st and ard r and omized intervention trial . To make the best use of available re sources , MOST relies on design and analysis tools that help maximize efficiency , such as fractional factorials . Results : A slightly modified version of an actual application of MOST to develop a smoking cessation intervention is used to develop and present the ideas . Conclusions : MOST has the potential to husb and program development re sources while increasing our underst and ing of the individual program and delivery components that make up interventions . Considerations , challenges , open questions , and other potential benefits are discussed BACKGROUND Since many successful dieters regain the weight they lose , programs that teach maintenance skills are needed . We developed a maintenance program based on self-regulation theory and tested the efficacy of delivering the program face to face or over the Internet . METHODS We r and omly assigned 314 participants who had lost a mean of 19.3 kg of body weight in the previous 2 years to one of three groups : a control group , which received quarterly newsletters ( 105 participants ) , a group that received face-to-face intervention ( 105 ) , and a group that received Internet-based intervention ( 104 ) . The content of the programs in the two intervention groups was the same , emphasizing daily self-weighing and self-regulation , as was the frequency of contact with the groups . The primary outcome was weight gain over a period of 18 months . RESULTS The mean ( + /-SD ) weight gain was 2.5+/-6.7 kg in the face-to-face group , 4.7+/-8.6 kg in the Internet group , and 4.9+/-6.5 kg in the control group , with a significant difference between the face-to-face group and the control group ( 2.4 kg ; 95 % confidence interval [ CI ] , 0.002 to 10.8 ; P=0.05 ) . The proportion of participants who regained 2.3 kg or more over the 18-month period was significantly higher in the control group ( 72.4 % ) than in the face-to-face group ( 45.7 % ; absolute difference , 27 % ; 95 % CI , 14 to 39 ; P<0.001 ) or the Internet group ( 54.8 % ; absolute difference , 18 % ; 95 % CI , 5 to 30 ; P=0.008 ) . Daily self-weighing increased in both intervention groups and was associated with a decreased risk of regaining 2.3 kg or more ( P<0.001 ) . CONCLUSIONS As compared with receiving quarterly newsletters , a self-regulation program based on daily weighing improved maintenance of weight loss , particularly when delivered face to face . ( Clinical Trials.gov number , NCT00067145 [ Clinical Trials.gov ] . OBJECTIVE To examine the effect of self-weighing frequency on weight change and body satisfaction . DESIGN Observational study based on findings from a 6-month r and omized controlled telephone-based weight loss trial . Data collected at baseline and 6 months . SETTING Metropolitan community-based sample . PARTICIPANTS Sixty-three obese adults . Mean age 49.5 years , 82 % percent white , and 79 % female . Mean body mass index at baseline was 34.2 kg/m(2 ) . MAIN OUTCOME MEASURES Change in weight and body satisfaction . ANALYSIS General linear model regression was used to assess the effect of self-weighing on outcomes of interest . Statistical significance was set at alpha level .05 . Treatment group and baseline values of dependent variables included as covariates in all analyses . RESULTS Participants who increased their frequency of self-weighing over the 6-month period demonstrated significantly better weight loss outcomes than those who maintained or decreased their frequency of self-weighing ( -6.8 kg vs -3.1 kg , F = 8.59 , P = .006 ) . There were no significant associations between self-weighing frequency and body satisfaction at 6 months ( F = 0.55 , P = .58 ) . CONCLUSIONS AND IMPLICATION S These findings support frequent self-weighing for weight control . There appears to be little or no effect of self-weighing on body satisfaction . Future research should replicate these findings across a larger , more diverse population of overweight adults Few studies have examined predictors of weight regain after significant weight losses . This prospect i ve study examined behavioral and psychological predictors of weight regain in 261 successful weight losers who completed an 18-month trial of weight regain prevention that compared a control condition with self-regulation interventions delivered face-to-face or via the Internet . Linear mixed effect models were used to examine behavioral and psychological predictors of weight regain , both as main effects and as interactions with treatment group . Decreases in physical activity were related to weight regain across all 3 groups , and increased frequency of self-weighing was equally protective in the 2 intervention groups but not in the control group . Increases in depressive symptoms , disinhibition , and hunger were also related to weight regain in all groups . Although the impact of changes in restraint was greatest in the Internet group and weakest in the face-to-face group , the latter was the only group with increases in restraint over time and consequent decreases in magnitude of weight regain . Future programs should focus on maintaining physical activity , dietary restraints , and frequent self-weighing and should include stronger components to modify psychological parameters PURPOSE : The present study evaluated the cross-section and prospect i ve associations between the Eating Inventory 's ( EI ) total , flexible and rigid dietary restraint scales and changes in weight and behaviors in a community sample of adults enrolled in a 3 y weight gain prevention study . METHODS : Subjects were participants in the Pound of Prevention ( POP ) study , a community-based weight gain prevention trial . RESULTS : Higher levels of baseline total , flexible and rigid dietary restraint were related to lower weight and more weight-controlling behaviors at the baseline assessment . Baseline restraint measures positively predicted increases in weighing frequency over the 3 y follow-up . Increases in restraint over the follow-up period were related to decreases in weight , energy intake and television watching , and increases in self-weighing and physical activity . CONCLUSION : The EI 's total , flexible and rigid restraint scales were not differently associated with weight and behaviors in this heterogeneous sample of adults who were attempting to lose weight . Developing methods to increase behavioral and cognitive strategies to control weight may help to prevent weight gain in clinical and community sample s . International Journal of Obesity ( 2001 ) 25 , Several recent studies suggest that daily weighing is important for long-term weight control , but concerns have been raised about possible adverse psychological effects . The " STOP Regain " clinical trial provides a unique opportunity to examine this issue both cross-sectionally and prospect ively . Successful weight losers ( N = 314 ) were r and omly assigned to a control or to a face-to-face or Internet intervention design ed to help them maintain their weight loss and were then followed for 18 months . The intervention groups reported increases in daily self-weighing , which were associated with successful weight loss maintenance . We found no evidence that increases in frequency of weighing or daily weighing per se had any adverse effects in this study population . Rather , increases in self-weighing were associated with increases in dietary restraint ( p < .001 ) , decreases in disinhibition ( p < .003 ) , and decreases in depressive symptoms ( p < .002 ) . Moreover , those who weighed daily at 18 months were less likely to report having > or=4 binge episodes per month ( p = .03 ) . Daily weighing appears to be an important aspect of weight loss maintenance and was not associated with adverse psychological effects BACKGROUND Frequent self-weighing has been proposed as an adjuvant strategy to promote weight loss . Not all experts agree on its utility , and the literature supporting its effectiveness is somewhat limited by method ologic shortcomings related to the subjective assessment of self-weighing frequency . DESIGN A prospect i ve cohort design was utilized to examine 100 participants enrolled in a weight-loss trial that encouraged frequent , objective ly measured self-weighing at home . Measurements were made at pretreatment and at follow-up visits at 6 and 12 months . SETTING / PARTICIPANTS Participants were employed , obese adults enrolled in the Weigh By Day trial . Study data were collected between October 2005 and May 2007 . INTERVENTION The intervention consisted of a 6-month behavioral weight-loss program that employed telephone counseling , a written manual , and a home telemonitoring scale . MAIN OUTCOME MEASURES The primary outcomes of interest were body weight and clinical ly meaningful weight loss ( i.e. , > or = 5 % ) . Analyses were performed in March 2008 . RESULTS Self-weighing was a significant predictor of body weight over time . Participants lost about 1 extra pound for every 11 days they self-weighed during treatment . In addition , participants who self-weighed at least weekly were 11 times more likely to lose at least 5 % of their pretreatment weight after 6 months . Improvements attenuated after 12 months . CONCLUSIONS Self-weighing may be a strategy to enhance behavioral weight-loss programs . Weekly self-weighing seems to be a reasonable , evidence -supported recommendation for successful weight loss , but more research is warranted to determine the independent contribution of self-weighing to successful weight loss , as well as its potential risk of negative psychological impact OBJECTIVE To investigate the effectiveness of self-weighing twice a day with a supportive program installed on a body composition monitor in overweight adults . SUBJECTS Sixty adults with BMI > 24 kg/m(2 ) were r and omly assigned to either a group that weighed themselves once per day ( group 1 , n = 30 ) or a group that weighed themselves twice per day ( group 2 , n = 30 ) . INTERVENTION Group 1 was instructed to self-weigh at the same time once per day and group 2 was instructed to self-weigh immediately after waking up in the morning and immediately before going to bed every day for twelve weeks . In addition , participants in group 2 was received the daily target setting during morning weighing and the difference between the measured weight and the target weight during bedtime weighing . RESULTS Average weight reduction in group 1 was significantly lower than that in group 2 ( 1.0 ± 1.4 kg vs. 2.7 ± 2.1 kg , p < 0.05 ) . The proportion of participants who lost ≥ 5 % of their pre-program weight in group 2 was significantly higher than that in group 1 ( 28.6 % vs. 3.6 % , p < 0.05 ) . CONCLUSION A self-weighing twice per day plus daily target setting and feedback is more effective in promoting weight loss than once-daily self-measurement Background : Improved self-care behaviour is a goal in educational programmes for patients with heart failure , especially in regard to daily self-weighing and salt and fluid restriction . Aims : The objectives of the present study were to : ( 1 ) describe self-care with special regard to daily self-weighing and salt and fluid restriction Output:
Self-weighing is likely to improve weight outcomes , particularly when performed daily or weekly , without causing untoward adverse effects .
MS2_1shot232
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Because no completely effective antiemetic exists for the prevention of postoperative nausea and vomiting ( PONV ) , we hypothesize that a multimodal approach to management of PONV may reduce both vomiting and the need for rescue antiemetics in high-risk patients . After IRB approval , women undergoing outpatient laparoscopy were r and omized to one of three groups . Group I ( n = 60 ) was managed by using a predefined multimodal clinical care algorithm . Patients undergoing the same surgical procedure who received a st and ard balanced outpatient anesthetic with ondansetron 4 mg ( Group II , n = 42 ) or placebo ( Group III , n = 37 ) prophylaxis were chosen to establish baseline incidence of nausea and vomiting . None of the Group I patients vomited before discharge , compared with 7 % in Group II ( P = 0.07 ) and 22 % in Group III ( P = 0.0003 ) . However , one patient ( 2 % ) in Group I required treatment for symptoms in the postanesthesia care unit , compared with 24 % in Group II ( P < 0.0001 ) and 41 % in Group III ( P < 0.0001 ) . Time to discharge-ready was significantly shorter in Group I ( 128 , 118–139 min ; mean , 95 % confidence interval ) versus Group II ( 162 , 145–181 min;P = 0.0015 ) and Group III ( 192 , 166–222 min;P = 0.0001 ) . Patient satisfaction with control of PONV was not different between Group I and Group II . Return to normal daily activity and overall satisfaction were not different among groups . Multimodal management result ed in a 98 % complete response rate and a 0 % incidence of vomiting before discharge ; however , this improvement did not result in an increased level of patient satisfaction when compared with routine monotherapy prophylaxis . We conclude that both multimodal management and routine monotherapy antiemetic prophylaxis result ed in an increased level of patient satisfaction than symptomatic treatment in this high-risk population . Implication s Use of a multimodal clinical care algorithm eliminates predischarge vomiting and improves satisfaction in patients undergoing outpatient laparoscopy Two hundred adults undergoing laparoscopic cholecystectomy were enrolled in a prospect ively r and omized , double-blind investigation comparing ondansetron , 4 mg ( Group O ) with the combination of droperidol , 0.625 mg , and metoclopramide , 10 mg ( Group DM ) . Antiemetic drugs were administered intravenously ( IV ) after induction of general anesthesia ( propofol , desflurane ) . Moderate or severe nausea in the postanesthesia care unit was treated with the crossover drug , i.e. , ondansetron for patients in Group DM or droperidol plus metoclopramide for patients in Group O. Data were analyzed using t-tests and chi squared analyses , with P < 0.05 considered statistically significant . The groups were similar with respect to gender , age , weight , duration of surgery , number receiving intraoperative atropine or ephedrine , number admitted overnight , and time to discharge home . Of 102 patients in Group O , 44 required antiemetics in the postanesthesia care unit , compared with 24 of 98 patients in Group DM ( P < 0.01 ) . One patient ( in Group DM ) was admitted for persistent nausea . In conclusion , droperidol 0.625 mg IV in combination with metoclopramide 10 mg IV was more effective in preventing postoperative nausea than was ondansetron 4 mg IV in patients undergoing laparoscopic cholecystectomy , with no difference in the time to discharge . ( Anesth Analg 1996;83:1081 - 3 STUDY OBJECTIVE To evaluate the efficacy of a two-dose combination of droperidol and ondansetron as compared with single-dose droperidol alone , single-dose combined droperidol and ondansetron , and two-dose droperidol alone , for management of postoperative nausea and vomiting ( PONV ) among gynecologic laparoscopy out patients . DESIGN R and omized , double-blind comparison trial . SETTING Tertiary outpatient gynecologic unit . PATIENTS A total of 120 female patients scheduled for gynecologic laparoscopy were enrolled . Patients who had experienced nausea or vomiting , or who had taken drugs with antiemetic action in the 24-hour period prior to the study , as well as breast-feeding mothers , were excluded from participation . INTERVENTIONS Patients were assigned to four treatment groups : i ) single dose of droperidol 1.25 mg , ii ) two doses of droperidol 1.25 mg , iii ) single dose of droperidol 1.25 mg and ondansetron 4 mg in combination , and iv ) two doses of droperidol 1.25 mg and ondansetron 4 mg in combination . The first dose of antiemetic was administered prior to induction and the second dose was given by infusion 4 hours later , prior to discharge . MEASUREMENTS AND MAIN RESULTS A visual analogue scale ( VAS , 10 cm ) was used to obtain patients ' experience of nausea , vomiting , and pain at 0.5 , 1.5 , 2.5 , and 3.5 hours after arrival at the postanesthetic care unit ( PACU ) . Following discharge , approximately 24 hours after arrival at the PACU , the same measures were obtained by a follow-up interview using a verbal 10-point scale . No significant differences in incidence of PONV were noted among the four treatment groups ( p = 0.419 ) . However , both single- and two-dose droperidol and ondansetron combination therapy demonstrated attenuation of PONV severity in the 3.5- to 24-hour postinduction period ( p < 0.05 ) . CONCLUSIONS The findings of this study suggest that prophylactic two-dose combined ondansetron and droperidol offers no added benefit over single-dose therapy for routine use in the gynecologic outpatient population STUDY OBJECTIVES To investigate the hypothesis that the combination of ondansetron and droperidol would be more effective than droperidol alone in reducing nausea and vomiting . DESIGN R and omized , doubleblind study . SETTING Magee-Womens Hospital , Pittsburgh , Pennsylvania . PATIENTS 160 healthy , ASA physical status I and II , female patients scheduled for total abdominal hysterectomy . INTERVENTIONS After induction of anesthesia with propofol , Group 1 received intravenous ( i.v . ) droperidol 1.25 mg plus i.v . ondansetron 4 mg . Group 2 received i.v . droperidol plus i.v . saline . MEASUREMENTS AND MAIN RESULTS The complete response ( no emesis , no rescue ) for Group 1 was 36 of 80 patients ( 45 % ) versus 30 of 80 patients ( 38 % ) in Group 2 ( p = 0.21 ) . In Group 1 , 42 of 80 patients ( 53 % ) required rescue antiemetic as compared with 44 of 80 patients ( 55 % ) in Group 2 ( p = 0.43 ) . There were 72 total rescues in Group 1 versus 73 in Group 2 , ( p = 0.24 ) . Mean time until first rescue was 578 + /- 429 minutes in Group 1 and 418 + /- 354 minutes in Group 2 , ( p = 0.03 ) . In Group 1 , 81 % ( 34/42 ) were rescued for nausea only versus 90 % ( 39/44 ) of Group 2 ( p = 0.16 ) . In Group 1 , 21 % of patients ( 17/80 ) had at least one emetic episode versus 34 % ( 27/80 ) of Group 2 patients ( p = 0.05 ) . There were 31 emetic episodes in Group 1 versus 72 episodes in Group 2 . ( p = 0.02 ) . Mean time to the first emetic episode was 699 + /- 403 minutes in Group 1 and 616 + /- 376 minutes in Group 2 , ( p = 0.23 ) . CONCLUSION For patients undergoing total abdominal hysterectomies , the addition of ondansetron to droperidol increases the time until first rescue and reduces the number of emetic episodes , as well as the percentage of patients , having at least one emetic episode PURPOSE A relatively high incidence of postoperative nausea and vomiting ( PONV ) occurs in patients undergoing laparoscopic cholecystectomy . This study was undertaken to compare the efficacy of granisetron-droperidol combination with each drug alone for the prevention of PONV after laparoscopic cholecystectomy . METHODS In a r and omized , double-blind manner , 150 female in patients received 3 mg granisetron ( Group G ) , 1.25 mg droperidol ( Group D ) or 3 mg granisetron plus 1.25 mg droperidol ( Group GD)(n = 50 for each ) i.v . immediately before the induction of anaesthesia . The same st and ard general anaesthetic technique , which consisted of isoflurane and nitrous oxide in oxygen , was used . Nausea , vomiting and safety assessment s were performed continuously during the first 24 hr after anaesthesia . RESULTS Complete response , defined as no PONV and no administration of rescue antiemetic medication , was 86 % in Group G , 64 % in Group D and 98 % in Group GD ( P = 0.03 vs Group G , P = 0.001 vs Group D ) . No clinical ly adverse events were observed in any group . CONCLUSION Granisetron-droperidol combination is more effective than each antiemetic alone in the prevention of PONV after laparoscopic cholecystectomy Drugs with anti-emetic properties can exert their actions at more than one receptor site , histamine H1 , muscarinic cholinergic or dopaminergic D2 receptors . This study was design ed to test the hypothesis that a combination of drugs acting at different receptor sites in lower than st and ard doses would be at least as effective as a st and ard therapeutic dose of a single anti-emetic agent . A combination of droperidol , hyoscine and metoclopramide in subtherapeutic doses has been shown to be at least as effective as droperidol ( 1.25 mg ) alone . In both groups there was a low incidence of emetic sequelae in the first 3 hours postoperatively Purpose This study tested the hypothesis that the antiemetic effects of a combination of ondansetron and propofol were superior to propofol alone in children undergoing tonsillectomy surgery . Methods A prospect i ve , r and omized , double-blind , placebo-controlled study design was employed . Young children underwent mask induction with halothane , nitrous oxide and oxygen and then hadiv access established : older children hadiv induction with propofol . All patients received 0.3 mg·kg−1 mivacurium and 2–4 μg·kg−1 fentanyliv and 30 mg·kg−1 acetaminophenpr to a maximum dose of 650 mg . Following induction , patients received either 100 μg·kg−1 ondansetron or placebo . Anaesthesia was maintained with 120 – 140 μg·kg−1·min−1 propofol , nitrous oxide and oxygen to maintain vital signs within 20 % of baseline . After surgery , in all patients the tracheas were extubated in the operating room without use of neuromuscular reversing agents . Episodes of emesis were recorded by PACU nurses for four to six hours . A telephone interview on the following day was also used for data recovery . Groups were compared in relation to age using the Mann-Whitney test , and with respect to sex and number of episodes of vomiting using the Fisher Exact Test . Results Three of the 45 patients who received ondansetron vomited ( 6.7 % ) , whereas 10 of the 45 patients who received placebo vomited ( 22.2 % ) . ( P = 0.035 ) Conclusion Ondansetron in a dose of 100 μg·kg−1 , when combined with propofol for children undergoing ton-sillectomy reduced the incidence of postoperative vomiting to very low levels . RésuméObjectifVérifier l’hypothèse voulant que les effets antiémétiques d’une combinaison d’ondansétron et de propofol soit supérieure à ceux du propofol seul chez des enfants qui subissent une amygdalectomie . MéthodeOn a utilisé une étude prospect i ve , r and omisée et en double aveugle contre placebo . Chez les jeunes enfants , l’induction au masque s’est faite avec de l’halothane et un mélange de protoxyde d’azote et d’oxygène , et on a établi ensuite l’accèsiv ; chez les enfants plus âgés , c’était une inductioniv avec du propofol . Tous les patients ont reçu 0,3 mg·kg−1 de mivacurium et 2 — Output:
The 5-HT3 receptor antagonists are considered to be effective antiemetics with an acceptable side effects profile . Ondansetron was the most commonly studied member of this group . Another effective antiemetic is droperidol . A single dose of dexamethasone has been reported to be effective for PONV prophylaxis without evidence of significant side effects . It has also been suggested that dexamethasone might be especially effective against late PONV .
MS2_1shot233
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVE To assess the optimal duration of daily wear for a laterally wedged insole with subtalar strapping in subjects with medial compartment osteoarthritis of the knee ( knee OA ) . DESIGN The setting was an outpatient clinic . Eighty-one patients with knee OA were prospect ively r and omized according to birth date and to either 2 weeks of treatment with a lateral wedge with subtalar strapping for less than 5 h ( the short group ) , 5 - 10 h ( the medium group ) or greater than 10 h ( the long group ) each day , or to treatment with a subtalar strapping b and without lateral wedge ( the placebo group ) . St and ing radiographs were used to analyze the femorotibial angle for each subject , both with and without their respective orthotic device . The remission scores of Lequesne index were compared among the four groups at the conclusion . RESULTS The short ( n=21 ) , medium ( n=20 ) and long ( n=18 ) groups demonstrated a significant greater valgus correction of the femorotibial angle than the placebo group ( n=22 ) ( P<0.0001 ) . The remission score was significantly improved in the medium group compared to the placebo ( P=0.001 ) and long ( P=0.001 ) groups . CONCLUSIONS An optimal duration of insole with subtalar strapping wear for patients with varus deformity knee OA may be between 5 and 10 h each day Objective To assess the effect of lateral wedge insoles compared with flat control insoles on improving symptoms and slowing structural disease progression in medial knee osteoarthritis . Design R and omised controlled trial . Setting Community in Melbourne , Australia . Participants 200 people aged 50 or more with clinical and radiographic diagnosis of mild to moderately severe medial knee osteoarthritis . Interventions Full length 5 degree lateral wedged insoles or flat control insoles worn inside the shoes daily for 12 months . Main outcome measures Primary symptomatic outcome was change in overall knee pain ( past week ) measured on an 11 point numerical rating scale . Primary structural outcome was change in volume of medial tibial cartilage from magnetic resonance imaging scans . Secondary clinical outcomes included changes in measures of pain , function , stiffness , and health related quality of life . Secondary structural outcomes included progression of medial cartilage defects and bone marrow lesions . Results Between group differences did not differ significantly for the primary outcomes of change in overall pain ( −0.3 points , 95 % confidence intervals −1.0 to 0.3 ) and change in medial tibial cartilage volume ( −0.4 mm3 , 95 % confidence interval −15.4 to 14.6 ) , and confidence intervals did not include minimal clinical ly important differences . None of the changes in secondary outcomes showed differences between groups . Conclusion Lateral wedge insoles worn for 12 months provided no symptomatic or structural benefits compared with flat control insoles . Trial registration Australian New Zeal and Clinical Trials Registry ACTR12605000503628 and Clinical Trials.gov NCT00415259 BACKGROUND AND PURPOSE Footwear is not consistently st and ardized in the administration of the Functional Reach Test ( FRT ) , Timed Up & Go Test ( TUG ) , and 10-Meter Walk Test ( TMW ) . This study was conducted to determine whether footwear affected performance on these tests in older women . SUBJECTS Thirty-five women , aged 65 to 93 years , were recruited from assisted living facilities and retirement communities . METHODS Each subject performed the FRT , TUG , and TMW wearing walking shoes , wearing dress shoes , and barefooted . Because of space constraints at the facilities where the testing was performed , 22 subjects performed the FRT and TUG on a linoleum floor and 13 subjects performed the tests on a firm , low-pile , carpeted floor . All 35 subjects completed the TMW on a firm , low-pile , carpeted floor . One-way repeated- measures analyses of variance ( ANOVAs ) and a Tukey Honestly Significant Difference test were used to compare the outcomes for the 3 footwear conditions , with separate ANOVAs conducted for the different floor surfaces for the FRT and TUG . RESULTS Subjects performed better on the FRT when barefooted or wearing walking shoes compared with when they wore dress shoes , regardless of floor surface . Differences were found among all footwear conditions for the TUG performed on the linoleum floor and for the TMW . For these tests , the women moved fastest in walking shoes , slower barefooted , and slowest wearing dress shoes . CONCLUSION AND DISCUSSION Footwear should be documented and should remain constant from one test occasion to another when the FRT , TUG , and TMW are used in the clinic and in research . Footwear intervention may improve performance of balance and gait tasks in older women OBJECTIVE To determine the minimal perceptible clinical improvement ( MPCI ) in patients with osteoarthritis ( OA ) with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) question naire , and patient and investigator global assessment of disease status in r and omized clinical trials for treatment of OA . METHODS Subjects with OA of the knee or hip were r and omized to receive either rofecoxib 12.5 or 25 mg once daily , ibuprofen 800 mg 3 times daily , or placebo for 6 weeks . The WOMAC and global assessment s were completed at baseline and Weeks 2 , 4 , and 6 . A patient global assessment of response to therapy ( 0 to 4 scale ) was used to " anchor " the WOMAC scores . MPCI was defined as the difference in mean change from baseline in WOMAC ( 100 mm normalized visual analog scale , VAS ) between patients with 0 = " None " global response to therapy and patients with 1 = " Poor " global response to therapy . RESULTS MPCI was determined to be 9.7 , 9.3 , and 10.0 mm for the WOMAC pain , physical function and stiffness subscales , respectively , and 11.1 mm for WOMAC question 1 : Pain walking on a flat surface . The MPCI for the investigator was 0.4 with investigator assessment of disease status reported on a 0 to 4 Likert scale . Of note , the estimated MPCI for the WOMAC and investigator globals were similar irrespective of treatment , sex , age , or geographic region . CONCLUSION In this analysis , mean changes of roughly 9 to 12 mm ( 100 mm normalized VAS ) on WOMAC scales were perceptible changes to patients with hip and knee OA . A mean decrease of 0.4 in global disease status ( 0 to 4 Likert scale ) as assessed by the investigator corresponded to the patients ' MPCI . Underst and ing the minimal perceptible differences may permit a better assessment of the clinical relevance of therapeutic interventions in OA OBJECTIVE To compare the clinical effects of laterally wedged insoles and neutrally wedged insoles ( used as control ) in patients with medial femoro-tibial knee osteoarthritis . METHODS STUDY DESIGN 24-month prospect i ve r and omized controlled study . PATIENTS Out patients with painful medial femoro-tibial knee osteoarthritis . OUTCOME MEASURES Patient 's overall assessment of disease activity ( 5 grade scale ) , WOMAC index subscales and concomitant treatments . STATISTICAL ANALYSIS Performed as an intention-to-treat analysis , with the last observation carried forward ( LOCF ) . Main symptomatic criterion : Improvement in the patient 's assessment of activity ( defined as a reduction of one grade or more at the end of the study as compared to baseline , and no intra-articular injection or lavage during the 6 months previous to the last visit ) . Secondary criteria for assessment : ( a ) Changes in the WOMAC subscales at month 24 , and ( b ) concomitant therapies ( analgesics , NSAIDs and intra-articular injections or lavages ) . Structural criterion : Joint space width ( JSW ) at the narrowest point . Non-compliance was defined as intermittent or lack of insole fitting at two consecutive visits . Compliance within groups was compared by using a life table analysis technique ( Log-Rank ) . RESULTS The baseline characteristics of the 156 recruited patients ( 41 males , 115 females , mean age 64.8 years ) were not different in the 2 treatment groups . At year 2 , there was no statistically significant difference between the 2 groups concerning the percentages of patients with improvement in both global assessment of disease activity and in WOMAC subscales ( pain , stiffness , function ) . The number of days with NSAIDs intake was lower in the group with laterally wedged insoles than in the neutrally wedged group ( 71+/-173 days vs. 127+/-193 days , P=0.003 , Mann-Whitney test ) . The mean joint space narrowing rate did not differ between the two groups : 0.21+/-0.59 mm/year in the laterally wedged group vs 0.12+/-0.32 mm/year in the neutrally wedged group . Compliance and tolerance were satisfactory . Compliance was different between the 2 groups at month 24 , with a greater frequency of patients who wore insoles permanently in the laterally wedged insole group than in the other group ( 85.8 % vs 71.9 % , P=0.023 ) . CONCLUSION This study failed to demonstrate a relevant symptomatic and /or structural effect of laterally-wedged insoles in medial femoro-tibial OA . However , the reduced NSAIDs intake and the better compliance in the treatment group are in favor of a beneficial effect of laterally-wedged insoles in medial femoro-tibial OA An articular index was devised for the sequential assessment of patients with osteoarthritis ( OA ) . Forty-eight joint units , chosen to reflect the characteristic pattern of the disease , were scored for tenderness on pressure or movement on a 4-point scale . Four observers examined patients to assess inter- and intraobserver error . The index was highly reproducible both within and between observers ; intraobserver error was , however , significantly smaller . In a double-blind , cross-over trial the index was sufficiently sensitive to detect a statistically significant difference between the responses of patients with OA to an anti-inflammatory agent and to a simple analgesic . It is likely to be a useful addition to current methods of measurement in osteoarthritis A Physical Activity Scale for the Elderly ( PASE ) was evaluated in a sample of community-dwelling , older adults . Respondents were r and omly assigned to complete the PASE by mail or telephone before or after a home visit assessment . Item weights for the PASE were derived by regressing a physical activity principal component score on responses to the PASE . The component score was based on 3-day motion sensor counts , a 3-day physical activity dairy and a global activity self- assessment . Test-retest reliability , assessed over a 3 - 7 week interval , was 0.75 ( 95 % CI = 0.69 - 0.80 ) . Reliability for mail administration ( r = 0.84 ) was higher than for telephone administration ( r = 0.68 ) . Construct validity was established by correlating PASE scores with health status and physiologic measures . As hypothesized , PASE scores were positively associated with grip strength ( r = 0.37 ) , static balance ( r = + 0.33 ) , leg strength ( r = 0.25 ) and negatively correlated with resting heart rate ( r = -0.13 ) , age ( r = -0.34 ) and perceived health status ( r = -0.34 ) ; and overall Sickness Impact Profile score ( r = -0.42 ) . The PASE is a brief , easily scored , reliable and valid instrument for the assessment of physical activity in epidemiologic studies of older people We assessed the validity of the Physical Activity Scale for the Elderly ( PASE ) in a sample of sedentary adults ( 56 men , 134 women , mean age + /- [ SD ] 66.5+/-5.3 years ) who volunteered to participate in a r and omized controlled trial on the effect of aerobic conditioning on psychological function . Construct validity was established by correlating PASE scores with physiologic and performance characteristics : peak oxygen uptake , resting heart rate and blood pressure , percent body fat , and balance . The mean PASE scores were higher in men than in women ( men = 145.8+/-78.0 ; women = 123.9+/-66.3 , P<0.05 ) , and in those age 55 - 64 years compared with those age 65 years and over ( 55 - 64 = 144.2+/-75.8 ; 65 and over = 118.9+/-63.9 , P<0.05 ) . PASE scores were also significantly higher in those who did not report a chronic health condition ( cardiovascular disease , hypertension , cancer , or recent surgery ) . PASE scores were significantly associated ( P<0.05 ) with peak oxygen uptake ( r = 0.20 ) , systolic blood pressure ( r = -0.18 ) and balance score ( r = 0.20 ) . No significant associations of PASE score and diastolic blood pressure , resting heart rate , or percent body fat were noted . These results provide additional evidence for the validity of the PASE as a measure of physical activity suitable for use in epidemiology studies on the association of physical activity , health , and physical function in older individuals OBJECTIVE To compare the influence of concomitant heeled footwear when wearing a lateral wedged Output:
Two r and omized controlled trials and 3 quasiexperimental studies reported lateral wedge insoles may have at least some pain-relieving effects and improved functional mobility in older adults at 4 weeks to 2 years ' follow-up , particularly when used with subtalar and ankle strapping . Discussion and Conclusion : Because of the limited number of r and omized control trials , it is not possible to make a definitive conclusion about the long-term effects of footwear on lower extremity joint pain caused by OA . There is mounting evidence that shock-absorbing insoles , subtalar strapping , and avoidance of high heels and s and als early in life may prevent lower extremity joint pain in older adults , but no conclusive evidence exists to show that lateral wedge insoles will provide long-term relief from knee joint pain and improved mobility in older adults with OA .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: BACKGROUND This study examined the nurse outcomes of a cancer pain education program for nurses of patients from 11 different ethnic groups . METHODS Four hundred ninety six home , hospital , and hospice nurses participated in a one-day workshop or two half-day workshops on cancer pain assessment and management . Of these , 116 were r and omized to participate in a bedside-precepted visit with an oncology nurse specialist with pain specialization and a focus group to discuss attitudinal issues . Eighty-six nurses served as controls . Pre- , post- and one-year follow-up tests were administered . RESULTS Attitudes , knowledge , and application skills significantly improved for workshop-only and enriched-model nurses relative to controls . CONCLUSION For postgraduate nurses , daylong cancer pain education workshops were , in the group studied , as effective as h and s-on experience in improving cancer pain knowledge and changing attitudes . Both the workshop-only and the enriched-model nurses relative to controls had significantly improved knowledge and changed attitudes towards optimal pain management Abstract The changes in attitudes towards cultural difference of seventeen participants in a three-week community health study abroad program to Nepal were compared with the changes in attitudes of a similar group who did not participate in the tour . Participants in the tour group were surveyed eight weeks prior to departure and in the last week of the tour using a twenty-six item question naire employing a six-point forced-choice response scale . The responses of participants in the lour group showed significant shifts in relation to eight items compared while the responses for the control group showed no significant shifts . Observed student advantages of participation in this study tour included the development of independent behaviour and positive cultural adjustment and adaptation The purpose of this two group intervention study ( N = 94 ) was to determine if RNs who participated in " culture school " improved levels of cultural competence to a greater extent than RNs who attended nursing informatics classes . The Giger and Davidhizar Transcultural Assessment Model/Theory ( GDTAMT ) was the study 's theoretical foundation ( Giger & Davidhizar , 1995 ) . A sample of 94 participants , was identified from a r and omized group of all Jefferson County , Alabama RNs . R and omly assigned participants ( stratified by race ) experienced 8.5 hours of either culture school or nursing informatics classes and completed survey tools in three phases ( pre-intervention , immediate post intervention , three week follow-up ) . The Cultural Self-Efficacy Scale ( CSES ) by Bernal and Froman ( 1987 ) , knowledge base questions by Rooda ( 1990 ) , and demographic profiles were used . Concepts empirically measured using these tools were analyzed by transcultural nursing experts for their congruence with GDTAMT . Using repeated measures analyses of convariance ( race ) , significant differences between groups for both scales were found . Culture school participants demonstrated significantly more cultural self-efficacy and cultural knowledge , and these improvements remained during phase three . Further research is recommended to allow for greater generalizability of findings , an examination of client perceptions , and actual nurse behaviors The objective of the present study was to prepare new doctors with an awareness of cultural and health issues to facilitate positive experiences with indigenous patients . The study incorporated the 1998 intern orientation programs in Queensl and public hospitals . The study method included tier one of the Three Tiered Plan , which was implemented and audited . Indigenous liaison officers , directors of clinical training and medical education officers were surveyed prior to this implementation to determine whether any or similar initiatives had been carried out in previous years and /or were planned . Post-implementation feedback from interns was obtained by using question naires . Follow-up telephone interviews with the directors of clinical training , medical education officers and indigenous hospital liaison officers detailed the format and content of tier one at each hospital . The results indicate that this active intervention improved the implementation rate of tier one from nine of 19 ( 47 % ) Queensl and public hospitals in 1997 to 17 ( 90 % ) in 1998 . The 14 indigenous hospital liaison officers ( 100 % ) involved in the intervention perceived it as beneficial . Forty-three ( 67 % ) of interns who responded to the survey indicated they had encountered an indigenous patient within the last 2 - 4 months . The level of knowledge of indigenous health and culture self-reported by interns was between the categories ' enough to get by ' and ' inadequate ' . In conclusion , it appears that tier one has been successful and is to be a formal component of intern orientations in Queensl and public hospitals . Further initiatives in indigenous health and culture targeting medical staff ( i.e. tier two and tier three ) , are needed Output:
Studies targeted at physicians more often described providers and interventions . Lack of method ological rigor limits the evidence for the impact of cultural competence training on minority health care quality .
MS2_1shot235
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: BACKGROUND Some children allergic to cow 's milk proteins ( CMPs ) experience exceptionally severe reactions after ingesting only trace amounts of antigen . Avoiding the food and carrying self-injectable epinephrine are the current strategies for their management . OBJECTIVE The aim of this study was to evaluate the safety and efficacy of specific oral tolerance induction ( SOTI ) for children with severe CMP-induced systemic reactions . METHODS Ninety-seven children aged 5 years or older with a history of severe allergic reactions and very high CMP-specific IgE levels were selected for a double-blind , placebo-controlled food challenge . Sixty had positive test results to very small amounts of milk and were r and omly divided in 2 different groups . Thirty children ( group A ) immediately began SOTI , whereas the remaining 30 ( group B ) were kept on a milk-free diet and followed for 1 year . RESULTS After 1 year , 11 ( 36 % ) of 30 children in group A had become completely tolerant , 16 ( 54 % ) could take limited amounts of milk ( 5 - 150 mL ) , and 3 ( 10 % ) were not able to complete the protocol because of persistent respiratory or abdominal complaints . In group B the result of the double-blind , placebo-controlled food challenge performed after a year was positive in all 30 cases ( P < .001 ) . CONCLUSIONS In this study SOTI was effective in a significant percentage of cases BACKGROUND Food allergy may be life-threatening , and patients affected need to receive accurate diagnoses and treatment . Hazelnut has often been implicated as responsible for allergic reactions , and trace quantities can induce systemic reactions . OBJECTIVE The aim of this study was to evaluate the efficacy and tolerance of sublingual immunotherapy with a st and ardized hazelnut extract in patients allergic to hazelnut . METHODS This was a r and omized , double-blind , placebo-controlled study . Inclusion criteria were a history of hazelnut allergy and positive skin prick test and double-blind placebo-controlled food challenge results . Patients were then r and omly assigned into 2 treatment groups ( hazelnut immunotherapy or placebo ) . Efficacy was assessed by double-blind , placebo-controlled food challenge after 8 to 12 weeks of treatment . Blood sample s were drawn for measurement of specific IgE , IgG(4 ) , and serum cytokines before and after treatment . RESULTS Twenty-three patients were enrolled and divided into 2 treatment groups . Twenty-two patients reached the planned maximum dose at 4 days . Systemic reactions were observed in only 0.2 % of the total doses administered . Mean hazelnut quantity provoking objective symptoms increased from 2.29 g to 11.56 g ( P = .02 ; active group ) versus 3.49 g to 4.14 g ( placebo ; NS ) . Moreover , almost 50 % of patients who underwent active treatment reached the highest dose ( 20 g ) , but only 9 % in the placebo . Laboratory data showed an increase in IgG(4 ) and IL-10 levels after immunotherapy in only the active group . CONCLUSION Our data confirm significant increases in tolerance to hazelnut after sublingual immunotherapy as assessed by double-blind , placebo-controlled food challenge , and good tolerance to this treatment Background : Oral immunotherapy ( OIT ) is an effective experimental food allergy treatment that is limited by treatment withdrawal and the frequent reversibility of desensitization if interrupted . Newly diagnosed preschool children may have clinical and immunological characteristics more amenable to treatment . Objective : We sought to test the safety , effectiveness , and feasibility of early OIT ( E‐OIT ) in the treatment of peanut allergy . Methods : We enrolled 40 children aged 9 to 36 months with suspected or known peanut allergy . Qualifying subjects reacted to peanut during an entry food challenge and were block‐r and omized 1:1 to receive E‐OIT at goal maintenance doses of 300 or 3000 mg/d in a double‐blinded fashion . The primary end point , sustained unresponsiveness at 4 weeks after stopping early intervention oral immunotherapy ( 4‐SU ) , was assessed by double‐blinded , placebo‐controlled food challenge either upon achieving 4 prespecified criteria , or after 3 maintenance years . Peanut‐specific immune responses were serially analyzed . Outcomes were compared with 154 matched st and ard‐care controls . Results : Of 40 consented subjects , 3 ( 7.5 % ) did not qualify . Overall , 29 of 37 ( 78 % ) in the intent‐to‐treat analysis achieved 4‐SU ( 300‐mg arm , 17 of 20 [ 85 % ] ; 3000 mg , 12 of 17 [ 71 % ] , P = .43 ) over a median of 29 months . Per‐ protocol , the overall proportion achieving 4‐SU was 29 of 32 ( 91 % ) . Peanut‐specific IgE levels significantly declined in E‐OIT‐treated children , who were 19 times more likely to successfully consume dietary peanut than matched st and ard‐care controls , in whom peanut‐specific IgE levels significantly increased ( relative risk , 19.42 ; 95 % CI , 8.7‐43.7 ; P < .001 ) . Allergic side effects during E‐OIT were common but all were mild to moderate . Conclusions : At both doses tested , E‐OIT had an acceptable safety profile and was highly successful in rapidly suppressing allergic immune responses and achieving safe dietary re introduction BACKGROUND The mechanisms contributing to clinical immune tolerance remain incompletely understood . This study provides evidence for specific immune mechanisms that are associated with a model of operationally defined clinical tolerance . OBJECTIVE Our overall objective was to study laboratory changes associated with clinical immune tolerance in antigen-induced T cells , basophils , and antibodies in subjects undergoing oral immunotherapy ( OIT ) for peanut allergy . METHODS In a phase 1 single-site study , we studied participants ( n = 23 ) undergoing peanut OIT and compared them with age-matched allergic control subjects ( n = 20 ) undergoing st and ard of care ( abstaining from peanut ) for 24 months . Participants were operationally defined as clinical ly immune tolerant ( IT ) if they had no detectable allergic reactions to a peanut oral food challenge after 3 months of therapy withdrawal ( IT , n = 7 ) , whereas those who had an allergic reaction were categorized as nontolerant ( NT ; n = 13 ) . RESULTS Antibody and basophil activation measurements did not statistically differentiate between NT versus IT participants . However , T-cell function and demethylation of forkhead box protein 3 ( FOXP3 ) CpG sites in antigen-induced regulatory T cells were significantly different between IT versus NT participants . When IT participants were withdrawn from peanut therapy for an additional 3 months ( total of 6 months ) , only 3 participants remained classified as IT participants , and 4 participants regained sensitivity along with increased methylation of FOXP3 CpG sites in antigen-induced regulatory T cells . CONCLUSION In summary , modifications at the DNA level of antigen-induced T-cell subsets might be predictive of a state of operationally defined clinical immune tolerance during peanut OIT BACKGROUND There are presently no available therapeutic options for patients with peanut allergy . OBJECTIVE We sought to investigate the safety , efficacy , and immunologic effects of peanut sublingual immunotherapy ( SLIT ) . METHODS After a baseline oral food challenge ( OFC ) of up to 2 g of peanut powder ( approximately 50 % protein ; median successfully consumed dose [ SCD ] , 46 mg ) , 40 subjects , aged 12 to 37 years ( median , 15 years ) , were r and omized 1:1 across 5 sites to daily peanut or placebo SLIT . A 5-g OFC was performed after 44 weeks , followed by unblinding ; placebo-treated subjects then crossed over to higher dose peanut SLIT , followed by a subsequent crossover Week 44 5-g OFC . Week 44 OFCs from both groups were compared with baseline OFCs ; subjects successfully consuming 5 g or at least 10-fold more peanut powder than the baseline OFC threshold were considered responders . RESULTS After 44 weeks of SLIT , 14 ( 70 % ) of 20 subjects receiving peanut SLIT were responders compared with 3 ( 15 % ) of 20 subjects receiving placebo ( P < .001 ) . In peanut SLIT responders , median SCD increased from 3.5 to 496 mg . After 68 weeks of SLIT , median SCD significantly increased to 996 mg ( compared with Week 44 , P = .05 ) . The median SCD at the Week 44 Crossover OFC was significantly higher than baseline ( 603 vs 71 mg , P = .02 ) . Seven ( 44 % ) of 16 crossover subjects were responders ; median SCD increased from 21 to 496 mg among responders . Of 10,855 peanut doses through the Week 44 OFCs , 63.1 % were symptom free ; excluding oral-pharyngeal symptoms , 95.2 % were symptom free . CONCLUSIONS Peanut SLIT safely induced a modest level of desensitization in a majority of subjects compared with placebo . Longer duration of therapy showed statistically significant increases in the SCD BACKGROUND Cow 's milk allergy ( CMA ) in children is a important problem in medical practice . Oral desensitization has been proposed as a therapeutic approach , but current protocol s are time-consuming and impractical . OBJECTIVES To establish a patient-friendly desensitization regimen with weekly up-dosing and to evaluate it in a r and omized controlled trial . METHODS Thirty children with IgE-mediated CMA confirmed by double-blind placebo-controlled food challenge were equally r and omized to desensitization with CM or soy milk as control . The weekly up-dosing lasted 18 weeks . The occurrence and severity of reactions after each dose was evaluated , and the desensitization was stopped if severe reactions occurred . Specific IgE and IgG4 levels to CM were measured at baseline , after 8 weeks , and at the end of the study . The double-blind food challenge was repeated once the desensitization was completed or after premature discontinuation . RESULTS Two active and 1 control patient dropped out . Full tolerance to CM ( 200 mL ) was achieved in 10 active patients and partial tolerance in 1 . Two active patients discontinued the desensitization after experiencing severe reactions , whereas no reactions occurred in controls , whose sensitivity to CM remained unchanged . A significant increase in specific IgG4 levels was found only in the active group . CONCLUSIONS This weekly up-dosing desensitization protocol for CMA performed under medical supervision was effective and reasonably safe and induced consistent immunologic changes BACKGROUND Open-label oral immunotherapy ( OIT ) protocol s have been used to treat small numbers of patients with peanut allergy . Peanut OIT has not been evaluated in double-blind , placebo-controlled trials . OBJECTIVE To investigate the safety and effectiveness of OIT for peanut allergy in a double-blind , placebo-controlled study . METHODS In this multicenter study , children ages 1 to 16 years with peanut allergy received OIT with peanut flour or placebo . Initial escalation , build-up , and maintenance phases were followed by an oral food challenge ( OFC ) at approximately 1 year . Titrated skin prick tests ( SPTs ) and laboratory studies were performed at regular intervals . RESULTS Twenty-eight subjects were enrolled in the study . Three peanut OIT subjects withdrew early in the study because of allergic side effects . During the double-blind , placebo-controlled food challenge , all remaining peanut OIT subjects ( n = 16 ) ingested the maximum cumulative dose of 5000 mg ( approximately 20 peanuts ) , whereas placebo subjects ( n = 9 ) ingested a median cumulative dose of 280 mg ( range , 0 - 1900 mg ; P < .001 ) . In contrast with the placebo group , the peanut OIT group showed reductions in SPT size ( P < .001 ) , IL-5 ( P = .01 ) , and IL-13 ( P = .02 ) and increases in peanut-specific IgG(4 ) ( P < .001 ) . Peanut OIT subjects had initial increases in peanut-specific IgE ( P < .01 ) but did not show significant change from baseline by the time of OFC . The ratio of forkhead box protein 3 (FoxP3)(hi ) : FoxP3(intermediate ) CD4 + CD25 + T cells increased at the time of OFC ( P = .04 ) in peanut OIT subjects . CONCLUSION These results conclusively demonstrate that peanut OIT induces desensitization and concurrent immune modulation . The current study continues and is evaluating the hypothesis that peanut OIT causes long-term immune tolerance BACKGROUND There are no treatments currently available for peanut allergy . Sublingual immunotherapy ( SLIT ) is a novel approach to the treatment of peanut allergy . OBJECTIVE We sought to investigate the safety , clinical effectiveness , and immunologic changes with SLIT in children with peanut allergy . METHODS In this double- Output:
Meta-analyses revealed that the risk of experiencing a systemic adverse reaction was higher in those receiving AIT , with a more marked increase in the risk of local adverse reactions . Sensitivity analysis excluding those studies judged to be at high risk of bias demonstrated the robustness of summary estimates of effectiveness and safety of AIT for food allergy . AIT may be effective in raising the threshold of reactivity to a range of foods in children with IgE-mediated food allergy whilst receiving ( i.e. desensitization ) and post-discontinuation of AIT . It is , however , associated with a modest increased risk in serious systemic adverse reactions and a substantial increase in minor local adverse reactions .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Osseointegrated implants as anchors for various prosthetic reconstructions have become a predictable treatment alternative . It was expected that implants required submucosal placement during the healing period for successful tissue integration . However , it has been demonstrated that healing and long-term health of implants could be achieved with equal predictability in a 1-stage , non-submerged approach . This prospect i ve 5-year study not only calculates implant success by life table analysis , but also evaluates the correlation between observed bone level changes with clinical parameters as measured by suppuration , plaque indices , bleeding indices , probing depth , attachment level and mobility . A total of 112 ITI dental implants were inserted in different areas of the jaws . Clinical and radiographic parameters were evaluated annually for 5 years , whereas a portion of the study group for which 6-year evaluations were available were included in the life-table analysis . The overall success rate after 5 years in service was 99.1 % , while after 6 years it was reduced to 95.5 % due to the fracture of 3 implants in 1 patient . The mean crestal bone loss experienced during the first year was 0.6 mm followed by an annual yearly loss of approximately 0.05 mm . No significant differences could be found between the amount of bone loss measured at each of the yearly follow-up visits . This suggests that statistically the followed implants did not show any radiographically measurable bone loss following the initial period of bone loss associated with implant placement and osseointegration . Low levels of correlation between the individual and cumulative clinical parameters with radiographically measured bone loss suggests that these parameters are of limited clinical value in assessing and predicting future peri-implant bone loss Thirty patients with extremely resorbed maxillae had reconstructive bone grafts from the ala iliaca and endosseous implants in a one-stage procedure . The first ten patients constituted a development group and the following 20 patients a routine group . The marginal bone level and implants success rate was evaluated in a prospect i ve long-term follow-up for a minimum of 10 years ( 10 - 13 years ) . Clinical and radiographic examinations were performed at 6 months and then annually up to 5 years . The final examinations were performed at the 10-year follow-up . The bridges were removed at every clinical examination . Marginal bone loss was seen up to the 3-year examination , where it averaged 4.6 mm in the routine group . Between the 3- and 10-year follow-up no significant change was registered . The initial bone loss was probably due to the design of the 3.6 mm conical unthreaded marginal part of the implant . The implant success rate was 83.1 % in the routine group . Failures mostly occurred during the first 2 years ( 14 out of 20 ) . A substantial amount of bone can be gained in patients with extremely resorbed maxillae , when treated with bone graft according to the procedure described in this study The present follow-up study evaluated clinical and radiographic parameters of dental implants placed with simultaneous guided bone regeneration with exp and ed polytetrafluoroethylene ( e-PTFE ) membranes . All implants were functioning well 24 months after insertion . In all , 63 patients with a total of 91 e-PTFE-augmented implants were integrated in a regular maintenance protocol . Modified periodontal data of 85 implants in 59 patients were recorded at 24 months and indicated no difference to implants placed in sufficient pristine bone . The mean plaque score ( mplI ) was 0.29 , 74 % of the sites showed no plaque . The sulcular probing depth ranged from 1 to 7 mm with a mean of 2.6 mm ( SD + /- 0.8 ) . Of the sites 96.5 % were < or = 4 mm deep , in 49 % of them probing result ed in bleeding . Periotest values 6 and 24 months ( mean : -3.4 and -3.4 ) after placement revealed stable peri-implant conditions and sustained osseointegration . The radiographic evaluation performed 6 , 12 and 24 months post insertion yielded a mean bone loss of 0.93 , 1.36 and 1.51 mm ranging from 0 to 4 mm . The short-term results of our clinical study demonstrated stable peri-implant conditions 2 years after membrane-protected osseous regeneration . The newly formed bone seemed to be able to withst and functional loading in a predictable manner after 18 months OBJECTIVES The purpose s of this study were to compare : ( a ) autogenous bone grafts ( ABG ) and distraction osteogenesis ( DO ) for their ability in correcting vertically deficient m and ibular ridges and their capability in maintaining over time the vertical bone gain obtained before and after implant placement ; and ( b ) the survival and success rates of implants placed in the reconstructed or distracted areas . MATERIAL AND METHODS In a 2-year period ( 2001 - 2002 ) , 17 patients presenting with vertically atrophied partially edentulous m and ibles requiring implant-supported prosthetic rehabilitation , were included in this study . Patients were r and omly assigned to two groups . Eight patients ( group 1 ) were treated with ABG harvested from the m and ibular ramus , while nine patients ( group 2 ) were treated by means of DO . In group 1 , patients received implants 4 - 5 months after the reconstructive procedure , while in group 2 implants were placed at the time of distraction device removal ( approximately 3 months after the completion of distraction ) . A total of 19 endosseous implants were placed in group 1 , and 21 implants were placed in group 2 patients . For both groups , after an additional 3 - 5-month period , prosthetic rehabilitation was started . RESULTS Bone resorption before implant placement was significantly higher in group 1 ( P=0.01 ) , while no statistically significant differences were found between the two groups as far as survival and success rates of implants and peri-implant bone resorption after the start of prosthetic loading were concerned . CONCLUSION The results suggested that : ( a ) both techniques may effectively improve the deficit of vertically resorbed edentulous ridges ; ( b ) survival and success rates of implants placed in the reconstructed/distracted areas are consistent with those of implants placed in native bone In the present multi-center study , non-submerged ITI implants were prospect ively followed to evaluate their long-term prognosis in fully and partially edentulous patients . In a total of 1003 patients , 2359 implants were consecutively inserted . Following a healing period of 3 - 6 months , the successfully integrated implants were restored with 393 removable and 758 fixed restorations . Subsequently , all consecutive implants were documented annually up to 8 years . At each examination , the clinical status of all implants was evaluated according to predefined criteria of success . Therefore , the data base allowed the evaluation of 8-year cumulative survival and success rates for 2359 implants . In addition , cumulative success rates were calculated for implant subgroups divided per implant type , implant length , and implant location . Furthermore , the actual 5-year survival and success rates could be determined for 488 implants . During the healing period , 13 implants did not successfully integrate , whereas 2346 implants fulfilled the predefined criteria of success . This corresponds with an early failure rate of 0.55 % . During follow-up , 19 implants were classified as failures due to several reasons . In addition , 17 implants ( approximately 0.8 % ) demonstrated at the last annual examination a suppurative periimplant infection . Including 127 drop out implants (= 5.4 % drop out rate ) into the calculation , the 8-year cumulative survival and success rates result ed in 96.7 % and 93.3 % , respectively . The analysis of implant subgroups showed slightly more favorable cumulative success rates for screw type implants ( > 95 % ) compared to hollow-cylinder implants ( 91.3 % ) , and clearly better success rates for m and ibular implants ( approximately 95 % ) when compared to maxillary implants ( approximately 87 % ) . The actual 5-year survival and success rates of 488 implants with 98.2 % and 97.3 % , respectively , were slightly better than the estimated 5-year cumulative survival and success rates of 2359 implants indicating that the applied life table analysis is a reliable statistical method to evaluate the long-term prognosis of dental implants . It can be concluded that non-submerged ITI implants maintain success rates well above 90 % in different clinical centers for observation periods up to 8 years A total of 114 ITI solid-screw implants was consecutively placed in 55 partially edentulous patients and restored with 68 fixed prostheses . The patients were followed for at least 5 years in a prospect i ve study that focused on implant success and longitudinal reactions of the peri-implant hard and soft tissues . During the study period , 5 implants failed and 15 implants were lost to follow-up , result ing in a cumulative survival rate of 95.3 % after 5 years of loading . The success analysis included additional strictly defined events ( " first occurrence of marginal bone loss > or = 4 mm , " " first occurrence of pocket depth > or = 4 mm , " and " first occurrence of crevicular fluid volume > or = 2.5 mm " ) and result ed in a cumulative 5-year success rate of 89.0 % . Median loss of marginal bone , as observed on radiographs , was 0.7 mm between implant placement and prosthetic treatment and 0.5 mm between prosthesis placement and the 5-year evaluation . Compared to the previous year 's value , the annual increase in marginal bone loss did not reach a level of statistical significance between 1 and 5 years of function , so that a steady state prevailed . The incidence of lingual-palatal surfaces affected with remarkable plaque deposits increased from 13 % after prosthesis placement to 23 % after 5 years . Sulcus Bleeding index , probing depth , attachment level , and crevicular fluid volume were used to describe the health of the peri-implant soft tissues . The research parameters remained almost unchanged and indicated a soft tissue response within physiologic levels . Most mechanical complications were experienced during the first year of loading and were related to loosening of occlusal screws , which occurred in 8 ( 12 % ) of 68 restorations In this prospect i ve study 47 edentulous patients were treated with m and ibular fixed prostheses supported by osseointegrated Brånemark implants and followed for 12 to 15 years . Three ( 1 % ) of the 273 inserted implants were lost , two before and one six years after placement of the fixed prosthesis . The cumulative success rate ( CSR ) of the implants was 98.9 % both after 10 and 15 years . None of the fixed prostheses was lost and at the last follow-up , all patients had stable fixed prostheses in function ( CSR 100 % ) . The marginal bone loss around the implants was small , on average 0.5 mm during the first post surgical year and thereafter about 0.05 mm annually . More bone was lost around the anterior implants than around the most posterior ones . Smoking and poor oral hygiene had significant influence on bone loss , while occlusal loading factors such as maximal bite force , tooth clenching and length of cantilevers were of minor importance . It is concluded that the long-term results of the m and ibular implant treatment were extremely successful , regarding both the fixed prostheses and implant stability . Bone resorption around the implants , albeit limited , was influenced by several factors , smoking and oral hygiene appeared to be most important This report of the 1st 2 prospect i ve studies using the Astra Tech Implant System and fixed detachable bridges for rehabilitation of m and ibular edentulism , presents clinical and radiographic data at the 5-year follow-up . The original material comprised 109 subjects , 56 of whom had been included in the original study , using the 1st generation Astra Tech Implant . Two subjects were excluded and the 3-year follow-up report was based on the remaining 54 subjects and 310 fixtures . After some minor changes to the fixture and the abutment , the 2nd generation Astra Tech Implant was used in 53 subjects and 308 fixtures . In all 16 subjects were lost to follow-up and the 5-year results are based on the remaining 91 subjects with 517 fixtures in function : 5 fixtures were lost due to mobility at abutment installation and during the 1st year , 2 fixtures were removed due to pain , and after 4 years in situ 1 fixture failed . As no clinical or radiographic differences were obvious in the annual registration s of the 2 studies the results have been combined . The fixed bridges were removed at 3 and 5 years to test each fixture and none was mobile . The cumulative fixture survival rate at 5 years was 98.7 % and the bridge survival rate was 100 % . Of the sites 82 % were plaque free , and 96.8 % showed no signs of inflammation . Over the 5-year period after bridge insertion , i.e. from baseline registration , there was only minor deterioration in marginal bone levels as measured on st and ardized intraoral radiographs : the mean differences in mm and st and ard deviations ( SD ) were -0.09 ( 0.27 ) in the 1st year , -0.20 ( 0.40 ) in the 3rd year , and -0.26 ( 0.53 ) in the 5th year . According to the stringent clinical and radiographic criteria by Albrektsson and co-workers , the successful treatment outcome and the survival rate in 91 subject over 5 years , indicates that the Astra Tech Output:
Even though the current review revealed that there are not many studies reporting data relevant to the analyzed topic , the data obtained suggest that the delayed positioning of implants should be considered more predictable than the immediate positioning .
MS2_1shot237
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background Progressive cell-mediated immunodeficiency with decrease of CD4 + lymphocyte count to less than or equal to 200 cells/mm3 is a major risk factor for colonization with C and ida species and development of c and idiasis . Oropharyngeal c and idiasis may occur in up to 90 % of human immunodeficiency virus (HIV)-infected patients during the course of the disease . This study is to determine the effect of prolonged highly active antiretroviral therapy ( HAART ) on oropharyngeal colonization with C and ida species and oral c and idiasis . Methods A prospect i ve , longitudinal follow-up study in HIV-infected patients receiving HAART . Results The mean CD4 + count increased from 232.5 to 316 cells/mm3 and the proportion of patients whose CD4 + count less than 200 cells/mm3 decreased from 50.0 % to 28.9 % ( p = 0.0003 ) in patients receiving HAART for at least 2 years . The prevalence of oral c and idiasis decreased from 10.6 % to 2.1 % ( p = 0.004 ) . The decrease in C and ida colonization was less impressive , falling from 57.8 % to 46.5 % ( p = 0.06 ) . Of the 142 patients enrolled in at least two surveys , 48 ( 33.8 % ) remained colonized with C and ida and 42 ( 29.6 % ) remained negative . In the remaining 52 patients , 34 switched from culture positive to negative , and an increase in CD4 + lymphocytes was noted in 91.2 % of them . Among the 18 patients who switched from culture negative to positive , 61.1 % also demonstrated an increase in CD4 + lymphocyte count ( p = 0.01 ) . Conclusion These findings indicate that HAART is highly effective in decreasing oral c and idiasis in association with a rise in CD4 + lymphocyte counts , but only marginally effective in eliminating C and ida from the oropharynx Objective : To evaluate the efficacy of itraconazole cyclodextrin solution in fluconazole-refractory oropharyngeal c and idiasis ( OPC ) , and to correlate clinical outcome with in vitro susceptibility and serum azole levels . Design : A prospect i ve , open-label , intervention study . Setting : A university hospital , which serves as the provincial HIV referral center . Patients and interventions : Thirty-six HIV-infected individuals referred for fluconazole-refractory OPC were evaluated prospect ively between May 1993 and March 1995 , including clinical assessment , serum azole levels , and susceptibility testing of C and ida spp . isolates . Itraconazole solution was administered orally at a daily dose of 200 mg for 14 days , followed by suppressive therapy . Thirty-four patients were evaluable . Main outcome measure : Resolution of oral pseudomembranous lesions . Results : Initial isolates were C and ida albicans ( n = 33 ) , C. glabrata ( n = 1 ) , C. krusei ( n = 1 ) , and mixed infection with C. albicans and C. krusei ( n = 1 ) . Fluconazole serum levels obtained at the time of failed therapy ranged from 4.7 to 40 mg/l ( median , 12.9 mg/l ) . Itraconazole was generally well tolerated . Clinical responses were observed in 65 % ( 22 out of 34 ) of evaluable cases . Among the responders , relapse had occurred within 2 months for four ( 36 % ) out of 11 cases who continued with follow-up . The median fluconazole minimal inhibitory concentration ( MIC ) was 64 mg/l for isolates from fluconazole-refractory cases , compared with a median of 0.5 mg/l for control isolates ( P = 0.002 ) . The median itraconazole MIC for isolates from fluconazole-refractory cases was 1.25 mg/l , compared with a median of 0.078 mg/l for controls ( P = 0.011 ) . Conclusion : A correlation between clinical response and in vitro susceptibility was clearly demonstrated for fluconazole , but not for itraconazole . Itraconazole cyclodextrin solution may be effective for fluconazole-refractory OPC and should be considered prior to salvage therapy with intravenous amphotericin OBJECTIVES --To compare the tolerance , efficacy , and pharmacokinetics of amphotericin deoxycholate ( Fungizone ) prepared in a parenteral fat emulsion ( Intralipid 20 % ) or glucose in HIV patients with c and idiasis . DESIGN --Non-blind r and omised controlled trial . SETTING --University hospital ; tertiary clinical care . PATIENTS --22 HIV positive patients with oral c and idiasis . INTERVENTIONS --Amphotericin 1 mg/kg/day given on four consecutive days as a one hour infusion dissolved in either 5 % glucose ( amphotericin-glucose ) or parenteral fat emulsion at a final concentration of 2 g/l fat emulsion ( amphotericin-fat emulsion ) . MAIN OUTCOME MEASURES -- Clinical tolerance ( fever , chills , sweats , nausea , arterial pressure , and pulse rate ) ; biological tolerance ( serum creatinine , electrolyte , and magnesium values ) ; clinical score of c and idiasis ; and serum concentrations of amphotericin . RESULTS --11 patients were enrolled in each group . All the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment ( n = 3 ) or severe chills ( n = 2 ) , or both . For patients completing the amphotericin-glucose treatment creatine concentration increased by 42 mumol/l ; four of seven patients had at least one creatinine value > or = 133 mumol/l versus one of 11 receiving amphotericin-fat emulsion . Magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion . Clinical side effects were noted in 36/38 infusions with amphotericin-glucose but 10/44 with amphotericin-fat emulsion . Oral c and idiasis score was reduced similarly in both groups . Serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose . CONCLUSIONS -- Clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion . Preparation is simple and cost effective . Its efficacy is similar to that of conventional amphotericin In an open multicentre study the efficacy and safety of fluconazole versus ketoconazole were evaluated in the treatment of 46 pediatric patients with oropharyngeal c and idiasis and AIDS or HIV infection . Twenty-four subjects received oral fluconazole in a dosage of 3 mg/kg/day and 22 subjects received oral ketoconazole in a dosage of 7 mg/kg/day . The treatment duration ranged from 5 to 49 days . Results showed that fluconazole and ketoconazole have comparable efficacy and safety in the treatment of oropharyngeal c and idiasis in HIV-infected children . Patients treated with fluconazole had higher clinical and mycological cure rates at the end of therapy ( 88 % and 71 % respectively ) than those treated with ketoconazole ( 81 % and 57 % respectively ) . One case of drug-related side effects ( diarrhea and abdominal pain ) in a patient receiving ketoconazole result ed in discontinuation of treatment . Follow-up examinations 2 and 4 weeks post-treatment showed a comparably high rate of relapse in both patient groups BACKGROUND We evaluated the efficacy and safety of oral posaconazole for human immunodeficiency virus (HIV)-infected subjects with oropharyngeal c and idiasis ( OPC ) and /or esophageal c and idiasis ( EC ) who were clinical ly refractory to treatment with oral fluconazole or itraconazole . METHODS Subjects with confirmed OPC or EC who did not improve after receiving st and ard courses of fluconazole or itraconazole treatment were eligible for study enrollment . Subjects received either oral posaconazole ( 400 mg twice daily ) for 3 days followed by oral posaconazole ( 400 mg once daily ) for 25 days ( regimen A ; 103 patients ) or oral posaconazole ( 400 mg twice daily ) for 28 days ( regimen B ; 96 patients ) . The primary end point was cure or improvement after 28 days . Primary efficacy analyses were performed on the subset of treated subjects with refractory disease ( e.g. , baseline culture positive for fluconazole- or itraconazole-resistant C and ida species or persistent or progressive clinical signs or symptoms consistent with treatment failure ) . RESULTS Of the modified intent-to-treat population , 132 ( 75 % ) of 176 subjects achieved a clinical response to posaconazole treatment . Clinical response rates were similar between regimen A recipients ( 75.3 % ) and regimen B recipients ( 74.7 % ) . Clinical responses occurred in 67 ( 73 % ) of 92 subjects with baseline isolates resistant to fluconazole , 49 ( 74 % ) of 66 subjects with baseline isolates resistant to itraconazole , and 42 ( 74 % ) of 57 subjects with isolates resistant to both . Clinical response was achieved in 32 ( 74.4 % ) of 43 subjects with endoscopically documented EC . The most common treatment-related adverse events were diarrhea ( 11 % ) , neutropenia ( 7 % ) , flatulence ( 6 % ) , and nausea ( 6 % ) . Eight subjects ( 4 % ) discontinued therapy as a result of a treatment-related adverse event . CONCLUSIONS Posaconazole offers a safe and effective treatment option for HIV-infected subjects with azole-refractory OPC and /or EC CONTEXT Multiple options are now available for prophylaxis of opportunistic infections related to the acquired immunodeficiency syndrome ( AIDS ) . However , because of differences in incidence rates as well as drug efficacy , toxicity , and costs , the role of different types of prophylaxis remains uncertain . OBJECTIVE To determine the clinical impact , cost , and cost-effectiveness of strategies for preventing opportunistic infections in patients with advanced human immunodeficiency virus ( HIV ) disease . DESIGN We developed a Markov simulation model to compare different strategies for prophylaxis of Pneumocystis carinii pneumonia ( PCP ) , toxoplasmosis , Mycobacterium avium complex ( MAC ) infection , fungal infections , and cytomegalovirus ( CMV ) disease in HIV-infected patients . Data for the model were derived from the Multicenter AIDS Cohort Study , r and omized controlled trials , and the national AIDS Cost and Services Utilization Survey . MAIN OUTCOME MEASURES Projected life expectancy , quality -adjusted life expectancy , total lifetime direct medical costs , and cost-effectiveness in dollars per quality -adjusted life-year ( QALY ) saved . RESULTS For patients with CD4 cell counts of 0.200 to 0.300 x 10(9)/L ( 200 - 300/microL ) who receive no prophylaxis , we projected a quality -adjusted life expectancy of 39.08 months and average total lifetime costs of $ 40288 . Prophylaxis for PCP and toxoplasmosis with trimethoprim-sulfamethoxazole for patients with CD4 cell counts of 0.200 x 10(9)/L ( 200/microL ) or less increased quality -adjusted life expectancy to 42.56 months , implying an incremental cost of $ 16000 per QALY saved . Prophylaxis for MAC for patients with CD4 cell counts of 0.050 x 10(9)/L ( 50/microL ) or less produced smaller gains in quality -adjusted life expectancy ; incremental cost-effectiveness ratios were $ 35000 per QALY saved for azithromycin and $ 74000 per QALY saved for rifabutin . Oral ganciclovir for the prevention of CMV infection was the least cost-effective prophylaxis ( $ 314000 per QALY saved ) . Results were most sensitive to the risk of developing an opportunistic infection , the impact of opportunistic infection history on long-term survival , and the cost of prophylaxis . CONCLUSIONS The cost-effectiveness of prophylaxis against HIV-related opportunistic infections varies widely , but prophylaxis against PCP or toxoplasmosis and against MAC delivers the greatest comparative value . In an era of limited re sources , these results can be used to set priorities and explore new alternatives for improving HIV patient care Over 37 months , we conducted a prospect i ve double-blind , r and omized study in a cohort of 138 HIV-infected patients to Output:
Implication s for practice Due to only one study in children it is not possible to make recommendations for treatment or prevention of OC in children . Due to insufficient evidence no conclusion could be made about the effectiveness of clotrimazole , nystatin , amphotericin B , itraconazole or ketoconazole with regard to OC prophylaxis . In comparison to placebo , fluconazole is an effective preventative intervention . However , the potential for resistant C and ida organisms to develop , as well as the cost of prophylaxis , might impact the feasibility of implementation . Direction of findings suggests that ketoconazole , fluconazole , itraconazole and clotrimazole improved the treatment outcomes . There is also a strong need for more research to be done on the treatment and prevention of OC in children as it is reported that OC is the most frequent fungal infection in children and adolescents who are HIV positive .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Abstract The longitudinal observations for ten years on 5209 men and women aged 30–62 in Framingham , Massachusetts , have been used for a prospect i ve investigation of the epidemiology of gallbladder disease . ‘ Definite ’ gallbladder disease was diagnosed in 427 persons on the evidence of pathology reports , surgery , X-ray and hospital admissions and 116 were ‘ doubtful ’ , having only the diagnosis suggested by a physician without further verification . The overall incidence of gallbladder disease was about twice as high in women as in men , and it increased with age in both sexes without any evidence of an excess in the forties . Gallbladder disease was not related to ‘ fairness ’ as measured by national origin . Increase in weight and number of pregnancies were each associated with increased incidence . Despite the presence of cholesterol in many gallstones and the elevation of serum cholesterol often noted with obesity and during pregnancy , no relationship was demonstrated between serum cholesterol level and gallbladder disease . Hemoglobin level was also not related in the population studied . Women with lower systolic blood pressures showed a somewhat reduced risk of gallbladder disease , but the possibility that a mutual relationship to weight could explain this has not been excluded . Slight negative correlations were noted between the disease incidence and height , and alcohol and cigarette consumption . These were small and in general not statistically significant . Dietary fat , protein and cholesterol intake , level of physical activity , age at menopause , marital status and precinct of residence were not related to gallbladder disease . Nor was an excess incidence noted in persons whose spouses had gallbladder disease . Persons entering the study with gallbladder disease showed no excess mortality . It is not yet clear whether such persons develop coronary heart disease at an excess rate . Potent environmental factors influencing the rate of development of gallbladder disease have yet to be identified . On the basis of present evidence , it would appear that more attention should be devoted to the anatomy and pathological physiology of the biliary tract in seeking a better underst and ing of the pathogenesis of gallbladder disease Ten healthy volunteers ( six men and four women , aged 22 - 41 years ) were studied in a crossover trial . The study was divided into three one week periods . During each period the subjects either ran on a treadmill , cycled on a bicycle ergometer , or rested in a chair for 1 hour every day . The exercise was performed at two thirds predicted maximum heart rate ( equivalent to 50 % VO2 max ) . The sequences were rotated ; no studies were performed in the perimenstrual period . Transit was measured by the method of measuring the excretion of a single dose of radio-opaque markers ; all stools were collected , weighed , and x rayed after the ingestion of radio-opaque markers . Dietary fibre and fluid intake were measured on the fourth day of each test period by 24 hour record . Lifestyle was otherwise unchanged . Transit time was dramatically accelerated by moderate exercise ( both jogging and cycling ) ; however , stool weight , defecation frequency , dietary fibre intake , and fluid intake did not change significantly . Whole gut transit changed from 51.2 hours ( 95 % confidence intervals 41.9 to 60.5 ) at rest to 36.6 hours ( 31.6 to 39.2 ) when riding and 34.0 hours ( 28.8 to 39.2 ) when jogging . Riding and running both differed significantly from resting ( p less than 0.01 ) ; the difference between riding and running was not significant PURPOSE Regular exercise reduces cardiovascular risk in humans by reducing cholesterol levels , but the underlying mechanisms have not been fully explored . Exercise might provoke changes in cholesterol and bile acid metabolism and thereby reduce cardiovascular risk . We examined whether voluntary wheel running in mice modulates cholesterol and bile acid metabolism . METHODS Male mice ( 10 wk old ) were r and omly assigned to have access to a voluntary running wheel for 2 wk ( RUN group ) or remained sedentary ( SED group ) . Running wheel activity was recorded daily . In a first experiment , fecal sterol outputs , fecal bile acid profiles , plasma parameters , and expression levels of genes involved in cholesterol and bile acid metabolism were determined . In a second experiment , bile flow , biliary bile acid profile , and biliary secretion rates of cholesterol , phospholipids , and bile acids were determined . RESULTS The RUN group ran an average of 10 km.d and displayed lower plasma cholesterol compared with SED ( P = 0.030 ) . Fecal bile acid loss was induced by approximately 30 % in running mice compared with SED ( P = 0.0012 ) . A approximately 30 % increase in fecal cholesterol output in RUN ( P = 0.014 ) was consistent with changes in parameters of cholesterol absorption , such as reduced plasma plant sterol-cholesterol ratio ( P = 0.044 ) and decreased jejunal expression of Npc1l1 ( P = 0.013 ) . Supportive of an increased cholesterol synthesis to compensate for fecal sterol loss were increased hepatic mRNA levels of HMGCoA reductase ( P = 0.006 ) and an increased plasma lathosterol-cholesterol ratio ( P = 0.0011 ) in RUN . CONCLUSIONS Voluntary wheel running increased cholesterol turnover in healthy mice owing to an increased fecal bile acid excretion and a decreased intestinal cholesterol absorption . Enhanced cholesterol turnover may contribute to the established reduction of cardiovascular risk induced by regular exercise Despite the high prevalence of gallbladder disease in industrialized countries , little is known about the predictors of the disease , especially in men . The authors prospect ively studied 16,785 alumni of Harvard University , aged 15 - 24 years , who were followed for up to 61 years . The health characteristics of these men were ascertained from their college entrance physical examination done in 1916 - 1950 , and up date d via mailed question naires in 1962 or 1966 ( 1962/1966 ) . Alumni subsequently self-reported physician-diagnosed gallbladder disease on further mailed question naires in 1972 or 1977 . Between college time and 1962/1966 , 371 gallbladder disease cases occurred . An additional 314 cases occurred after 1962/1966 . With respect to college characteristics , after adjustment for potential confounders , the authors found that body mass index ( BMI ) , smoking , physical activity , blood pressure , and consumption of alcohol , coffee , or tea were unrelated to risk . However , BMI in 1962/1966 was directly related to risk of subsequent gallbladder disease , as was BMI gain since college ( p , trend = 0.002 and 0.013 , respectively ) . Compared with men with BMI < 22.0 , men with BMI > or = 27.0 had a rate ratio of 2.71 ( 95 % confidence interval ( CI ) 1.57 - 4.66 ) for risk of contracting the disease . Men who gained > or = 6.0 BMI units since college had a rate ratio of 1.46 ( 95 % CI 0.86 - 2.46 ) compared with men who gained -0.9 to + 0.9 BMI units . Compared with never smokers , men who smoked pipes or cigars or < 1 pack of cigarettes daily in 1962/1966 had a rate ratio of 1.43 ( 95 % CI 1.00 - 2.06 ) , while heavier cigarette smokers had a rate ratio of 1.52 ( 95 % CI 1.03 - 2.24 ) . Neither physical activity nor physician-diagnosed hypertension or diabetes mellitus in 1962/1966 predicted risk Background Animal experiments have shown a protective effect of vitamin C on the formation of gallstones . Few data in humans suggest an association between reduced vitamin C intake and increased prevalence of gallstone disease . The aim of this study was to assess the possible association of regular vitamin C supplementation with gallstone prevalence . Methods An observational , population -based study of 2129 subjects aged 18 - 65 years r and omly selected from the general population in southern Germany was conducted . Abdominal ultrasound examination , completion of a st and ardized question naire , compilation of anthropometric data and blood tests were used . Data were collected in November and December 2002 . Data analysis was conducted between December 2005 and January 2006 . Results Prevalence of gallstones in the study population was 7.8 % ( 167/2129 ) . Subjects reporting vitamin C supplementation showed a prevalence of 4.7 % ( 11/232 ) , whereas in subjects not reporting regular vitamin C supplementation , the prevalence was 8.2 % ( 156/1897 ) . Female gender , hereditary predisposition , increasing age and body-mass index ( BMI ) were associated with increased prevalence of gallstones . Logistic regression with backward elimination adjusted for these factors showed reduced gallstone prevalence for vitamin C supplementation ( odds ratio , OR 0.34 ; 95 % confidence interval , CI 0.14 to 0.81 ; P = 0.01 ) , increased physical activity ( OR 0.62 ; 95 % CI , 0.42 to 0.94 ; P = 0.02 ) , and higher total cholesterol ( OR 0.65 ; 95 % CI , 0.52 to 0.79 ; P < 0.001 ) . Conclusion Regular vitamin C supplementation and , to a lesser extent , increased physical activity and total cholesterol levels are associated with a reduced prevalence of gallstones . Regular vitamin C supplementation might exert a protective effect on the development of gallstones BACKGROUND Gallstones are a highly prevalent condition ; however , the nutritional and lifestyle risk factors of this disease are not well understood . OBJECTIVE We evaluated the association between diet , physical activity , and incident cases of gallstones diagnosed by ultrasound in a population -based , case-control study . DESIGN One hundred patients with newly diagnosed gallstones and 290 r and omly selected control subjects without gallstones were enrolled in the study . The presence of gallstones was determined by ultrasonography . Both patients and control subjects completed a question naire about their usual diet and physical activity for the 12 mo before the ultrasonography . The association between diet and physical activity and risk of gallstone formation was analyzed by using multiple logistic regression . RESULTS Body mass index and intake of refined sugars were directly associated with risk of gallstone formation , whereas physical activity , dietary monounsaturated fats , dietary cholesterol , and dietary fibers from cellulose were inversely associated with risk of gallstone formation . Saturated fats were a risk factor for gallstone formation and the association appeared to be stronger for men than for women . CONCLUSION These findings suggest that a sedentary lifestyle and a diet rich in animal fats and refined sugars and poor in vegetable fats and fibers are significant risk factors for gallstone formation By means of loxiglumide , a potent and highly specific antagonist for cholecystokinin ( CCK ) , the effects of blocking CCK receptors on gastrointestinal motility were investigated in a placebo-controlled study in healthy young men ( aged 21 - 39 , mean 24 years ) . Gallbladder contraction stimulated by ingestion of a liquid test meal was completely abolished by oral administration of loxiglumide 30 min before the test meal . Gastric emptying of radio-opaque markers ingested with the test meal was significantly accelerated by loxiglumide ( area under the curve [ markers x h ] 33.3 [ SEM 3.8 ] vs 17.9 [ 2.7 ] after placebo ) . No effect of loxiglumide was found on small-bowel transit time , but 7 days ' treatment with oral loxiglumide ( 800 mg three times daily ) significantly shortened colonic transit time ( 29.4 [ 4.1 ] h after placebo , 15.0 [ 3.4 ] h after loxiglumide ) . It is concluded that CCK is an important mediator of meal-induced gallbladder contraction and is involved in the regulation of gastrointestinal motility in man Background The effects of vegetable preference and leisure-time physical activity ( LPA ) on cancer have been inconsistent . We examined the effects of dietary preference and physical activity , as well as their combined effect on cancer risk . Methods This prospect i ve cohort study included 444,963 men , older than 40 years , who participated in a national health examination program begun in 1996 . Based on the answer to the question " What kind of dietary preference do you have ? " we categorized dietary preference as ( 1 ) vegetables , ( 2 ) mixture of vegetables and meat , and ( 3 ) meats . We categorized LPA as low ( < 4 times/wk , < 30 min/session ) , moderate ( 2–4 times/wk , ≥ 30 min/session or ≥ 5 times/wk , < 30 min/session ) , or high ( ≥ 5 times/wk , ≥ 30 min/session ) . We obtained cancer incidence data for 1996 through 2002 from the Korean Central Cancer Registry . We used a st and ard Poisson regression model with a log link function and person-time offset Output:
Results The impact of physical activity upon gallbladder function remains unclear ; acute activity could augment emptying by stimulating cholecystokinin release , and one of two training experiments found a small increase in gallbladder motility . The largest and most recent cross-sectional and case-control trials show a reduced risk of gallbladder disease in active individuals . Conclusions Although there remains a need for further research , regular physical activity seems likely to reduce the risk of both gallstones and gallbladder cancer . A substantial number of individuals must be persuaded to exercise in order to avoid one case of gallbladder disease , but the attempt appears warranted because of the other health benefits of regular physical activity
MS2_1shot239
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: The aim of this study was to investigate if cognitive behavior therapy ( CBT ) based on exposure and mindfulness exercises delivered via the Internet would be effective in treating participants with irritable bowel syndrome ( IBS ) . Participants were recruited through self-referral . Eighty-six participants were included in the study and r and omized to treatment or control condition ( an online discussion forum ) . One participant was excluded after r and omization . The main outcome measure was IBS-symptom severity and secondary measures included IBS-related quality of life , GI-specific anxiety , depression and general functioning . Participants were assessed at pre-treatment , post-treatment and 3 month follow-up ( treatment condition only ) . Four participants ( 5 % of total sample ) in the treatment condition did not participate in post-treatment assessment . Participants in the treatment condition reported a 42 % decrease and participants in the control group reported a 12 % increase in primary IBS-symptoms . Compared to the control condition , participants in the treatment group improved on all secondary outcome measures with a large between group effect size on quality of life ( Cohen 's d = 1.21 ) . We conclude that CBT-based on exposure and mindfulness delivered via the Internet can be effective in treating IBS- patients , alleviating the total burden of symptoms and increasing quality of life BACKGROUND Subthreshold depression is a highly prevalent condition and a risk factor for developing a major depressive episode . Internet-based cognitive behaviour therapy may be a promising approach for the treatment of subthreshold depression . The current study had two aims : ( 1 ) to determine whether an internet-based cognitive behaviour therapy intervention and a group cognitive behaviour therapy intervention are more effective than a waiting-list control group ; and ( 2 ) to determine whether the effect of the internet-based cognitive behaviour therapy differs from the group cognitive behaviour therapy intervention . METHOD A total of 191 women and 110 men with subthreshold depression were r and omized into internet-based treatment , group cognitive behaviour therapy ( Lewinsohn 's Coping With Depression course ) , or a waiting-list control condition . The main outcome measure was treatment response after 10 weeks , defined as the difference in pre- and post-treatment scores on the Beck Depression Inventory ( BDI ) . Missing data , a major limitation of this study , were imputed using the Multiple Imputation ( MI ) procedure Data Augmentation . RESULTS In the waiting-list control group , we found a pre- to post-improvement effect size of 0.45 , which was 0.65 in the group cognitive behaviour therapy condition and 1.00 within the internet-based treatment condition . Helmert contrasts showed a significant difference between the waiting-list condition and the two treatment conditions ( p=0.04 ) and no significant difference between both treatment conditions ( p=0.62 ) . CONCLUSIONS An internet-based intervention may be at least as effective as a commonly used group cognitive behaviour therapy intervention for subthreshold depression in people over 50 years of age The effectiveness of a therapist-supported Internet intervention program for tinnitus distress in an industrial setting was evaluated using a cluster r and omised design . Fifty-six Australian employees of two industrial organisations were r and omly assigned , based on their work site ( 18 work sites from BP Australia and five from BHP Billiton ) , to either a cognitive behavioural therapy ( CBT ) program or an information-only control program . Participants were assessed at pre- and postprogram , measuring tinnitus distress , depression , anxiety , stress , quality of life , and occupational health . The CBT program was not found to be superior to the information program for treating tinnitus distress . A high attrition rate and small sample size limit the generalisability of the findings , and further developments of the program and assessment process are needed to enhance engagement and compliance BACKGROUND Therapist-delivered online cognitive-behavioural therapy ( CBT ) has been found to be effective for depression in primary care . AIMS To determine the cost-effectiveness of online CBT compared with usual care . METHOD Economic evaluation at 8 months alongside a r and omised controlled trial . Cost to the National Health Service ( NHS ) , personal costs , and the value of lost productivity , each compared with outcomes based on the Beck Depression Inventory and quality -adjusted life-years ( QALYs ) . Incremental analysis indicated the NHS cost per QALY gain . RESULTS Online CBT was more expensive than usual care , although the outcomes for the CBT group were better . Cost per QALY gain based on complete case data was £ 17,173 , and £ 10,083 when missing data were imputed . CONCLUSIONS Online CBT delivered by a therapist in real time is likely to be cost-effective compared with usual care if society is willing to pay at least £ 20,000 per QALY ; it could be a useful alternative to face-to-face CBT The present study investigated the efficacy of self-help based on cognitive behaviour therapy in combination with Internet support in the treatment of bulimia nervosa and binge eating disorder . After confirming the diagnosis with an in-person interview , 73 patients were r and omly allocated to treatment or a waiting list control group . Treated individuals showed marked improvement after 12 weeks of self-help compared to the control group on both primary and secondary outcome measures . Intent-to-treat analyses revealed that 37 % ( 46 % among completers ) had no binge eating or purging at the end of the treatment and a considerable number of patients achieved clinical ly significant improvement on most of the other measures as well . The results were maintained at the 6-month follow-up , and provide evidence to support the continued use and development of self-help programmes BACKGROUND Although hypochondriasis is generally thought to be a chronic and stable condition with a relatively low remission rate , this disorder remains understudied . METHODS This is a 4- to 5-year prospect i ve case-control study of DSM-III-R hypochondriasis . Medical out patients meeting DSM diagnostic criteria for hypochondriasis completed an extensive research battery assessing hypochondriacal symptoms , medical and psychiatric comorbidity , functional status and role impairment , and medical care . A comparison group of nonhypochondriacal patients from the same setting underwent the same battery . Four to 5 years later , both cohorts were re-interviewed . RESULTS One hundred twenty hypochondriacal and 133 nonhypochondriacal comparison patients were originally studied . Follow-up was obtained on 73.5 % ( n = 186 ) of all patients . At follow-up , the hypochondriacal sample was significantly ( P<.001 ) less hypochondriacal and had less somatization ( P<.001 ) and disability than at inception , but 63.5 % ( n = 54 ) still met DSM-III-R diagnostic criteria . When compared with the comparison group using repeated measures multivariate analysis of variance , these changes remained statistically significant ( P<.0001 ) . Changes in medical and psychiatric comorbidity did not differ between the 2 groups . When hypochondriacal patients who did and did not meet diagnostic criteria at follow-up were compared , the latter had significantly less disease conviction ( P<.05 ) and somatization ( P<.01 ) at inception , and their incidence of major medical illness during the follow-up period was significantly ( P<.05 ) greater . CONCLUSIONS Hypochondriacal patients show a considerable decline in symptoms and improvement in role functioning over 4 to 5 years but two thirds of them still meet diagnostic criteria . Hypochondriasis , therefore , carries a very substantial , long-term burden of morbidity , functional impairment , and personal distress Online therapy offers many advantages over face-to-face therapy . Interapy includes psychoeducation , screening , effect measures , and a protocol -driven treatment via the Internet for people suffering from posttraumatic stress . The present article reports the results of a controlled trial on the Internet-driven treatment of posttraumatic stress and grief in a group of people who manifested mild to relatively severe trauma symptoms . Participants in the treatment condition ( n=69 ) improved significantly more than participants in the waiting-list control condition ( n=32 ) on trauma-related symptoms and general psychopathology . The effect sizes were large . On most subscales , more than 50 % of the treated participants showed reliable change and clinical ly significant improvement , with the highest percentages being found for depression and avoidance BACKGROUND Major depression can be treated by means of cognitive-behavioural therapy , but as skilled therapists are in short supply there is a need for self-help approaches . Many individuals with depression use the internet for discussion of symptoms and to share their experience . AIMS To investigate the effects of an internet-administered self-help programme including participation in a monitored , web-based discussion group , compared with participation in web-based discussion group only . METHOD A r and omised controlled trial was conducted to compare the effects of internet-based cognitive-behavioural therapy with minimal therapist contact ( plus participation in a discussion group ) with the effects of participation in a discussion group only . RESULTS Internet-based therapy with minimal therapist contact , combined with activity in a discussion group , result ed in greater reductions of depressive symptoms compared with activity in a discussion group only ( waiting-list control group ) . At 6 months ' follow-up , improvement was maintained to a large extent . CONCLUSIONS Internet-delivered cognitive cognitive-behavioural therapy should be pursued further as a complement or treatment alternative for mild-to-moderate depression This study evaluated a targeted intervention design ed to alleviate body image and eating problems in adolescent girls that was delivered over the internet so as to increase access to the program . The program consisted of six , 90-minute weekly small group , synchronous on-line sessions and was facilitated by a therapist and manual . Participants were 73 girls ( mean age=14.4 years , SD=1.48 ) who self-identified as having body image or eating problems and were r and omly assigned to an intervention group ( n=36 ) ( assessed at baseline , post-intervention and at 2- and 6-months follow-up ) or a delayed treatment control group ( n=37 ) ( assessed at baseline and 6–7 weeks later ) . Clinical ly significant improvements in body dissatisfaction , disordered eating , and depression were observed at post-intervention and maintained at follow-up . Internet delivery was enthusiastically endorsed . The program offers a promising approach to improve body image and eating problems that also addresses geographic access problems Background Self-help therapies are often effective in reducing mental health problems . We developed a new Web-based self-help intervention based on problem-solving therapy , which may be used for people with different types of comorbid problems : depression , anxiety , and work-related stress . Objective The aim was to study whether a Web-based self-help intervention is effective in reducing depression , anxiety , and work-related stress ( burnout ) . Methods A total of 213 participants were recruited through mass media and r and omized to the intervention ( n = 107 ) or a waiting list control group ( n = 106 ) . The Web-based course took 4 weeks . Every week an automated email was sent to the participants to explain the contents and exercises for the coming week . In addition , participants were supported by trained psychology students who offered feedback by email on the completed exercises . The core element of the intervention is a procedure in which the participants learn to approach solvable problems in a structured way . At pre-test and post-test , we measured the following primary outcomes : depression ( CES-D and MDI ) , anxiety ( SCL-A and HADS ) , and work-related stress ( MBI ) . Quality of life ( EQ-5D ) was measured as a secondary outcome . Intention-to-treat analyses were performed . Results Of the 213 participants , 177 ( 83.1 % ) completed the baseline and follow-up question naires ; missing data were statistically imputed . Of all 107 participants in the intervention group , 9 % ( n = 10 ) dropped out before the course started and 55 % ( n = 59 ) completed the whole course . Among all participants , the intervention was effective in reducing symptoms of depression ( CES-D : Cohen ’s d = 0.50 , 95 % confidence interval ( CI ) 0.22 - 0.79 ; MDI : d = 0.33 , 95 % CI 0.03 - 0.63 ) and anxiety ( SCL-A : d = 0.42 , 95 % CI 0.14 - 0.70 ; HADS : d = 0.33 , 95 % CI 0.04 - 0.61 ) as well as in enhancing quality of life ( d = 0.31 , 95 % CI 0.03 - 0.60 ) . Moreover , a higher percentage of patients in the intervention group experienced a significant improvement in symptoms ( CES-D : odds ratio [ OR ] = 3.5 , 95 % CI 1.9 - 6.7 ; MDI : OR = 3.7 , 95 % CI 1.4 - 10.0 ; SCL-A : OR = 2.1 , 95 % CI 1.0 - 4.6 ; HADS : OR = 3.1 , 95 % CI 1.6 - 6.0 ) . Patients in the intervention group also recovered more often ( MDI : OR = 2.2 ; SCL-A : OR = 2.0 ; HADS < 8) , although these results were not statistically significant . The course was less effective for work-related stress , but participants in the intervention group recovered more often from burnout than those in the control group ( OR = 4.0 , 95 % CI 1.2 - 13.5 ) . Conclusions We demonstrated statistically and clinical ly significant effects on symptoms of Output:
Results showed that ICBT has been tested for 25 different clinical disorders , whereas most r and omized controlled trials have been aim ed at depression , anxiety disorders and chronic pain . Effect sizes were large in the treatment of depression , anxiety disorders , severe health anxiety , irritable bowel syndrome , female sexual dysfunction , eating disorders , cannabis use and pathological gambling . For other clinical problems , effect sizes were small to moderate . Comparison to conventional CBT showed that ICBT produces equivalent effects . Cost-effectiveness data were relatively scarce but suggested that ICBT has more than 50 % probability of being cost effective compared with no treatment or to conventional CBT when willingness to pay for an additional improvement is zero . Although ICBT is a promising treatment option for several disorders , it can only be regarded as a well-established treatment for depression , panic disorder and social phobia . It seems that ICBT is as effective as conventional CBT for respective clinical disorder , that is , if conventional CBT works then ICBT works . The large effects and the limited therapist time required suggest that the treatment is highly cost effective for well-established indications
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Cervical artificial disc replacement ( ADR ) is indicated for the treatment of severe radiculopathy permitting neural decompression and maintenance of motion . We evaluated the clinical and radiographic outcomes in cervical ADR patients using the ProDisc-C device ( DePuy Synthes , West Chester , PA , USA ) with a 5 - 9 year follow-up . Data were collected through a prospect i ve registry , with retrospective analysis performed on 24 consecutive patients treated with cervical ADR by a single surgeon . All patients underwent single- or two-level ADR with the ProDisc-C device . Outcome measures included neck and arm pain ( visual analogue scale ) , disability ( neck disability index [ NDI ] ) , complications and secondary surgery rates . Flexion-extension cervical radiographs were performed to assess range of motion ( ROM ) of the device and adjacent segment disease ( ASD ) . Average follow-up was 7.7 years . Neck and arm pain improved 60 % and 79 % , respectively , and NDI had an improvement of 58 % . There were no episodes of device migration or subsidence . Mean ROM of the device was 6.4 ° . Heterotopic ossification was present in seven patients ( 37 % ) . Radiographic ASD below the device developed in four patients ( 21 % ) ( one single-level and three two-level ADR ) . No patient required secondary surgery ( repeat operations at the index level or adjacent levels ) . Fourteen out of 19 patients ( 74 % ) were able to return to employment , with a median return to work time of 1.3 months . The ProDisc-C device for cervical ADR is a safe option for patients providing excellent clinical outcomes , satisfactory return to work rates and maintenance of segmental motion despite radiographic evidence of heterotopic ossification and ASD on long-term follow-up Background Neck pain caused by cervical spondylosis has become a common health problem worldwide among > 40-year-old adults . Acupuncture intervention is one of the most popular treatment measures for this disorder . However , evidence for its efficacy in relieving neck pain and recovering neck physiological function has not been established in r and omized , placebo-controlled trials . The primary aim of this trial is to assess the efficacy and safety of active acupuncture compared with sham acupuncture intervention for neck pain caused by cervical spondylosis . Methods / Design We will conduct a r and omized , double-blind , parallel-group , placebo-controlled trial comparing active acupuncture with placebo ( sham acupuncture ) . A total of 456 patients with neck pain caused by cervical spondylosis who meet the eligibility criteria from outpatient clinics of the Second People ’s Hospital of Fujian Province and the Affiliated Rehabilitation Hospital , Fujian University of Traditional Chinese Medicine will be recruited and r and omized into an active acupuncture or sham acupuncture group . The participants will undergo treatment sessions with either active or sham acupuncture intervention five times a week for 2 weeks . Evaluation by blinded assessors at baseline and at intervention for 1 and 2 weeks will include demographic characteristics , vali date d question naires ( Northwick Park Neck Pain Question naire ( NPQ ) scale , Short-Form 36 ( SF-36 ) scale , and McGill pain scale ) , examination of neck physiological function , and adverse events . All included patients will be followed up and investigated for relapse of neck pain at 4 , 8 , and 12 weeks after intervention . Discussion This paper describes the rationale and design of a r and omized double-blind , placebo-controlled trial that aims to determine the efficacy and safety of acupuncture intervention for neck pain caused by cervical spondylosis . The primary outcomes are changes in the NPQ score and neck physiological function . Secondary outcome measures include quality of life , adverse events , and relapse of neck pain . If successful , this project will provide evidence of the efficacy and safety of acupuncture for neck pain caused by cervical spondylosis . Trial registration Chinese Clinical Trial Registry : ChiCTR-TRC-12002206 . Registration date : 11 May 2012 BACKGROUND CONTEXT Cervical total disc replacement ( TDR ) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease ( SCDD ) . PURPOSE The purpose of this trial is to compare the safety and efficacy of cervical TDR , ProDisc-C ( Synthes Spine Company , L.P. , West Chester , PA ) , to anterior cervical discectomy and fusion ( ACDF ) surgery for the treatment of one-level SCDD between C3 and C7 . STUDY DESIGN / SETTING The study was conducted at 13 sites . A noninferiority design with a 1:1 r and omization was used . PATIENT SAMPLE Two hundred nine patients were r and omized and treated ( 106 ACDF ; 103 ProDisc-C ) . OUTCOME MEASURES Visual analog scale ( VAS ) pain and intensity ( neck and arm ) , VAS satisfaction , neck disability index ( NDI ) , neurological exam , device success , adverse event occurrence , and short form-36 ( SF-36 ) st and ardized question naires . METHODS A prospect i ve , r and omized , controlled clinical trial was performed . Patients were enrolled and treated in accordance with the US Food and Drug Administration ( FDA ) -approved protocol . Patients were assessed pre- and postoperatively at six weeks , 3 , 6 , 12 , 18 , and 24 months . RESULTS Demographics were similar between the two patient groups ( ProDisc-C : 42.1+/-8.4 years , 44.7 % males ; Fusion : 43.5 + /- 7.1 years , 46.2 % males ) . The most commonly treated level was C5-C6 ( ProDisc-C : 56.3 % ; Fusion=57.5 % ) . NDI and SF-36 scores were significantly less compared with presurgery scores at all follow-up visits for both the treatment groups ( p<.0001 ) . VAS neck pain intensity and frequency as well as VAS arm pain intensity and frequency were statistically lower at all follow-up timepoints compared with preoperative levels ( p<.0001 ) but were not different between treatments . Neurologic success ( improvement or maintenance ) was achieved at 24 months in 90.9 % of ProDisc-C and 88.0 % of Fusion patients ( p=.638 ) . Results show that at 24 months postoperatively , 84.4 % of ProDisc-C patients achieved a more than or equal to 4 degrees of motion or maintained motion relative to preoperative baseline at the operated level . There was a statistically significant difference in the number of secondary surgeries with 8.5 % of Fusion patients needing a re-operation , revision , or supplemental fixation within the 24 month postoperative period compared with 1.8 % of ProDisc-C patients ( p=.033 ) . At 24 months , there was a statistically significant difference in medication usage with 89.9 % of ProDisc-C patients not on strong narcotics or muscle relaxants , compared with 81.5 % of Fusion patients . CONCLUSIONS The results of this clinical trial demonstrate that ProDisc-C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy because of single-level disease . By all primary and secondary measures evaluated , clinical outcomes after ProDisc-C implantation were either equivalent or superior to those same clinical outcomes after Fusion Study Design Prospect i ve , r and omized , controlled . Level 1 evidence . Objective To report functional outcomes at 48 months follow-up on prospect ively r and omized patients to either the Bryan cervical disc prosthesis or anterior cervical discectomy and fusion ( ACDF ) at a single site . Summary of Background Data Surgical treatment of cervical disc pathology can involve discectomy and fusion ( ACDF ) , the gold st and ard technique . The safety and effectiveness of this procedure has been established and demonstrated in the literature , however , limitations have evolved and alternatives such as disc replacement are being investigated . Intervertebral disc replacement is design ed to preserve motion , both at affected and adjacent levels avoiding limitations of fusion such as adjacent level degeneration . New onset degenerative changes and possible recurring neurologic symptoms may be deferred or eliminated with cervical disc replacement . A recent multicenter trial with 24 months follow-up has shown the Bryan disc to compare favorably with ACDF . Continued follow-up is needed to further evaluate and compare functional outcomes in both these cohorts . Methods A total of 47 patients were enrolled at our site as part of an ongoing multicenter prospect ively r and omized study investigating ACDF versus Bryan cervical disc prosthesis . Functional outcomes are now reported at 48 months follow-up for our cohort of participants . Neck disability index score ( NDI ) , VAS neck and arm and SF-36 both physical and mental as well as complications and reoperations will be reported . Results Functional outcome data collected at routine follow-up for 48-months has favorably demonstrated improved functional outcomes for NDI , neck/arm pain VAS scores , and the SF-36 physical/mental health component scores for the Bryan arthroplasty and ACDF cohorts . The NDI scores for the Bryan arthroplasty preoperatively was 51 and at 48 months 10 . For ACDF preoperative NDI score was also 51 and at 48 months 16.7 . At 48 months NDI success , measured by ≥15 points NDI improvement demonstrated a 93.3 % success for Bryan arthroplasty and an 82.4 % success for ACDF . VAS neck pain scores for the Bryan arthroplasty preoperatively was 76.2 and at 48 months was 13.6 . VAS neck pain scores for ACDF preoperatively was 80.6 and at 48 months was 28.1 . Arm Pain scores were also measured and for the Bryan arthroplasty preoperatively measured 78.8 and at 48 months 10.8 . For ACDF arm pain scores preoperatively measured 77.1 and at 48 months 21.7 . These outcomes have not been associated with any degradation of outcome measures from 2 to 4 years . During the 48 months of follow-up at our institution we also report 6 secondary surgeries in our control group ( ACDF ) and only 1 in our investigational group ( Bryan ) . Of the 6 surgeries in the control group performed , 3 or 12 % to date were for adjacent level degenerative disease and 1 or 4 % for remote level degenerative disc disease . The remaining 2 surgeries were performed on the same patient for a pseudarthrosis . In the investigational group there was only 1 secondary surgery performed to date for adjacent level disease 5 % . Conclusions At 48 months , cervical arthroplasty with the Bryan cervical disc prosthesis continues to compare favorably to ACDF at our institution . There has been no degradation of functional outcomes from 24 to 48 months for NDI , VAS of neck and arm , and SF-36 . There has been a lower incidence of secondary surgeries for the Bryan arthroplasty cohort to date OBJECT The purpose of this study was to determine long-term clinical outcomes in patients undergoing anterior cervical surgery in which a cervical disc prosthesis was used to treat single-level degenerative cervical disc disease . METHODS In this prospect i ve , nonblinded study , 541 patients at 32 investigational sites were r and omly assigned to 1 of 2 treatment groups . The results of the investigational group , in which patients received the Prestige disc prosthesis , were compared with those of the control group , in which patients underwent an instrumented interbody fusion . Data were collected preoperatively , intraoperatively , and at 1.5 , 3 , 6 , 12 , 24 , 36 , and 60 months postoperatively . To date , 271 patients have completed 5 years of clinical follow-up ( 144 investigational and 127 control patients ) . RESULTS Significant improvements in Neck Disability Index ( NDI ) scores , Physical Component Summary scores of the 36-Item Short-Form Health Survey , and neck and arm pain scores were achieved by 1.5 months in both groups and sustained at 5 years . The mean NDI improvements from preoperative scores were 35.4 , 36.3 , and 38.4 at 24 , 36 , and 60 months , respectively , in the investigational group . The corresponding mean NDI improvements were 33.9 , 31.3 , and 34.1 in the control group . The intergroup differences at both 36 and 60 months were significant ( p = 0.008 and 0.022 , respectively ) . The overall rates of maintenance or improvement in neurological status in the investigational group were 91.6 % , 92.8 % , and 95.0 % , respectively , at 24 , 36 , and 60 months compared with 83.6 % , 83.2 % , and 88.9 % in the control group ( p = 0.006 , 0.004 , and 0.051 , respectively ) . The implant effectively maintained angular motion , averaging more than 7.3 degrees at 36 months and 6.5 degrees at 60 months after surgery . No implant migration was observed up to 60 months . There were statistically significant differences between the investigational and control groups with regard to the rate of revision and supplemental fixation surgical procedures performed subsequent to the index procedure . Additional surgical procedures for adjacent-segment disease were observed in both treatment groups . Rates for surgery at adjacent levels trended lower in the investigational group ( 8 patients [ 11 surgeries ] ) compared with those in the control group ( 13 patients [ 16 surger Output:
Taken together , these results suggested that CDA and ACDF are efficient and safe methods for dealing with cervical spondylosis . However , with respect to certain specific indicators , such as the reoperation rate of adjacent levels following surgery , the former has several advantages
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: The aim of our study was to evaluate the effect of a st and ardized formulation of a polyphenolic extract of grapes ( Leucoselect-Phytosome [ LP ] ) on low-density lipoprotein ( LDL ) susceptibility to oxidation in a group of heavy smokers . A r and omized , double-blind , crossover study was undertaken in 24 healthy male heavy smokers , aged > or = 50 years . Enrolled subjects were given 2 capsules twice daily for 4 weeks ( phase 1 ) . Each capsule contained 75 mg of a grape procyanidin extracts and soy-phosphatidlcholine or placebo consisiting of 75 mg lactose and soy-phosphatidlcholine . A wash out period of 3 weeks was then followed by 4 weeks of the opposite treatment ( phase 2 ) . Blood sample s were taken at baseline and at the end of each phase and assayed for plasma lipids and LDL susceptibility to oxidation . Compliance was good , and no adverse effects were recorded . Subjects did not show significant modification of total cholesterol ( TC ) , triglycerides ( TG ) , high-density lipoprotein-cholesterol ( HDL-C ) and LDL-C during LP treatment . Among oxidative indices , thiobarbituric acid reactive substances ( TBARS ) concentration was significantly reduced in subjects taking LP ( -14.7 % + /- 21.1 % v + 5.0 % + /- 18.1 % , P < .01 ) , and the lag phase prolonged ( + 15.4 % + /- 24.4 % v -0.1 % + /- 16.0 % , P < .05 ) compared with placebo and basal values . The antioxidant potential of grape seed extract polyphenols may prove effective in a model of oxidative stress ( smoking ) ; however more investigational data are needed before use in wider clinical setting Background Raisins are a significant source of dietary fiber and polyphenols , which may reduce cardiovascular disease ( CVD ) risk by affecting lipoprotein metabolism and inflammation . Walking represents a low intensity exercise intervention that may also reduce CVD risk . The purpose of this study was to determine the effects of consuming raisins , increasing steps walked , or a combination of these interventions on blood pressure , plasma lipids , glucose , insulin and inflammatory cytokines . Results Thirty-four men and postmenopausal women were matched for weight and gender and r and omly assigned to consume 1 cup raisins/d ( RAISIN ) , increase the amount of steps walked/d ( WALK ) or a combination of both interventions ( RAISINS + WALK ) . The subjects completed a 2 wk run-in period , followed by a 6 wk intervention . Systolic blood pressure was reduced for all subjects ( P = 0.008 ) . Plasma total cholesterol was decreased by 9.4 % for all subjects ( P < 0.005 ) , which was explained by a 13.7 % reduction in plasma LDL cholesterol ( LDL-C ) ( P < 0.001 ) . Plasma triglycerides ( TG ) concentrations were decreased by 19.5 % for WALK ( P < 0.05 for group effect ) . Plasma TNF-α was decreased from 3.5 ng/L to 2.1 ng/L for RAISIN ( P < 0.025 for time and group × time effect ) . All subjects had a reduction in plasma sICAM-1 ( P < 0.01 ) . Conclusion This research shows that simple lifestyle modifications such as adding raisins to the diet or increasing steps walked have distinct beneficial effects on CVD risk BACKGROUND Patients treated with hemodialysis frequently experience cardiovascular complications attributed , among other causes , to dyslipidemia , increased oxidative stress , and inflammation . OBJECTIVE The aim of the study was to study the effects of dietary supplementation with concentrated red grape juice ( RGJ ) , a source of polyphenols , on lipoprotein profile , antioxidant capacity , LDL oxidation , and inflammatory biomarkers . DESIGN Twenty-six patients receiving hemodialysis and 15 healthy subjects were instructed to drink 100 mL RGJ/d for 14 d. Blood was drawn at baseline , twice during RGJ supplementation , and twice during the 6-mo follow-up period . As a control , 12 other r and omly recruited hemodialysis patients not receiving RGJ were studied . Lipids , apolipoproteins , oxidized LDL , and antioxidant vitamins were measured in plasma . The bioavailability of RGJ polyphenols was assessed in healthy subjects . RESULTS The maximum plasma concentration of quercetin was achieved 3 h after RGJ ingestion , which indicates that supplement-derived polyphenols are rapidly absorbed . In both healthy subjects and hemodialysis patients , RGJ consumption increased the antioxidant capacity of plasma without affecting concentrations of uric acid or ascorbic acid ; reduced the concentration of oxidized LDL ; and increased the concentration of cholesterol-st and ardized alpha-tocopherol . RGJ supplementation also caused a significant decrease in LDL-cholesterol and apolipoprotein B-100 concentrations , while increasing the concentrations of HDL cholesterol and apolipoprotein A-I. In a further study in hemodialysis patients , RGJ supplementation for 3 wk significantly reduced plasma monocyte chemoattractant protein 1 , an inflammatory biomarker associated with cardiovascular disease risk . CONCLUSION Dietary supplementation with concentrated RGJ improves the lipoprotein profile , reduces plasma concentrations of inflammatory biomarkers and oxidized LDL , and may favor a reduction in cardiovascular disease risk To evaluate the effects of grape polyphenols on plasma lipids , inflammatory cytokines , and oxidative stress , 24 pre- and 20 postmenopausal women were r and omly assigned to consume 36 g of a lyophilized grape powder ( LGP ) or a placebo for 4 wk . The LGP consisted of 92 % carbohydrate and was rich in flavans , anthocyanins , quercetin , myricetin , kaempferol , and resveratrol . After a 3-wk washout period , subjects were assigned to the alternate treatment for an additional 4 wk . The placebo consisted of an equal ratio of fructose and dextrose and was similar in appearance and energy content ( 554 kJ ) to LGP . Plasma triglyceride concentrations were reduced by 15 and 6 % in pre- and postmenopausal women , respectively ( P < 0.01 ) after LGP supplementation . In addition , plasma LDL cholesterol and apolipoproteins B and E were lower due to LGP treatment ( P < 0.05 ) . Further , cholesterol ester transfer protein activity was decreased by approximately 15 % with intake of LGP ( P < 0.05 ) . In contrast to these beneficial effects on plasma lipids , LDL oxidation was not modified by LGP treatment . However , whole-body oxidative stress as measured by urinary F(2)-isoprostanes was significantly reduced after LGP supplementation . LGP also decreased the levels of plasma tumor necrosis factor-alpha , which plays a major role in the inflammation process . Through alterations in lipoprotein metabolism , oxidative stress , and inflammatory markers , LGP intake beneficially affected key risk factors for coronary heart disease in both pre- and postmenopausal women BACKGROUND Atherosclerotic cardiovascular disease is the most common cause of death among hemodialysis patients ; it has been attributed to increased oxidative stress , dyslipidemia , malnutrition , and chronic inflammation . Activation of neutrophils is a well-recognized feature in dialysis patients , and superoxide-anion production by neutrophil NADPH oxidase may contribute significantly to oxidative stress . OBJECTIVE The aim of the study was to compare the effects of dietary supplementation with concentrated red grape juice ( RGJ ) , a source of polyphenols , and vitamin E on neutrophil NADPH oxidase activity and other cardiovascular risk factors in hemodialysis patients . DESIGN Thirty-two patients undergoing hemodialysis were recruited and r and omly assigned to groups to receive dietary supplementation with RGJ , vitamin E , or both or a control condition without supplementation or placebo . Blood was obtained at baseline and on days 7 and 14 of treatment . RESULTS RGJ consumption but not vitamin E consumption reduced plasma concentrations of total cholesterol and apolipoprotein B and increased those of HDL cholesterol . Both RGJ and vitamin E reduced plasma concentrations of oxidized LDL and ex vivo neutrophil NADPH oxidase activity . These effects were intensified when the supplements were used in combination ; in that case , reductions in the inflammatory biomarkers intercellular adhesion molecule 1 and monocyte chemoattractant protein 1 also were observed . CONCLUSIONS Regular ingestion of concentrated RGJ by hemodialysis patients reduces neutrophil NADPH-oxidase activity and plasma concentrations of oxidized LDL and inflammatory biomarkers to a greater extent than does that of vitamin E. This effect of RGJ consumption may favor a reduction in cardiovascular risk Grape seed extract ( GSE ) has in vitro antioxidant activity but whether or not it works in vivo is not clear . In a fully r and omised , crossover trial with 4-week treatment periods on 36 men and women with above-average vascular risk , we aim ed to demonstrate that 2 g/day of GSE ( 1 g of polyphenols ) alone , or with 1 g/day of added quercetin in yoghurt , favourably alters vascular function , endothelial function , and degree of oxidative damage in comparison to a control yoghurt . GSE alone improved flow-mediated dilatation determined ultrasonically by an absolute 1.1 % compared with control . There was no effect of the combination of GSE with quercetin . No other blood or urine measure was altered . Thus sufficient polyphenols from GSE appear to be absorbed to influence endothelial nitric oxide production , and GSE has the potential to favourably influence vascular function OBJECTIVE The objective of the study was to evaluate the effects of a grape product rich in dietary fiber and natural antioxidants on cardiovascular disease risk factors . METHODS A r and omized , controlled parallel-group trial was carried out . Thirty-four non-smoking ( 21 normocholesterolemic and 13 hypercholesterolemic ) adults were supplemented for 16 wk with 7.5 g/d of grape antioxidant dietary fiber , a natural product containing 5.25 g of dietary fiber and 1400 mg of polyphenols . Nine non-supplemented non-smokers were followed as a control group . Fasting blood sample s , blood pressure , and anthropometric readings were obtained at baseline and at week 16 . Subjects were allowed to consume their regular diet , which was monitored weekly . RESULTS Grape antioxidant dietary fiber ( 7.5 g/d ) reduced significantly ( P < 0.05 ) total cholesterol ( 9 % ) , low-density lipoprotein cholesterol ( 9 % ) , and systolic and diastolic blood pressures ( 6 % and 5 % respectively ) . Greater reductions in total cholesterol ( 14.2 % ) and low-density lipoprotein cholesterol ( 11.6 % , P < 0.05 ) were observed in hypercholesterolemic subjects . No changes were observed in the control group . There was a reduction of 2.5 points in the Framingham Global Risk Score in the supplemented group . A significant reduction in triacylglycerol concentration took place in the supplemented hypercholesterolemic subjects ( 18.6 % , P < 0.05 ) . CONCLUSION Grape antioxidant dietary fiber showed significant reducing effects in lipid profile and blood pressure . The effects appear to be higher than the ones caused by other dietary fibers , such as oat fiber or psyllium , probably due to the combined effect of dietary fiber and antioxidants The aim of this study was to evaluate the effects of Eminol ® , the polyphenol-rich grape extract supplement ( 700 mg ) , on cardiovascular risk and oxidant stress indicators in a sample of volunteers . A r and omized , double-blind , placebo-controlled clinical trial was performed over 56 days and included 60 volunteers . Thirty volunteers took 700 mg of the grape extract , Eminol ® ( E ) , and 30 took the placebo ( P ) . On comparison of the results , a decrease in total cholesterol ( E : 213.77 ± 4.1 mg/dl and P : 245.57 ± 4.1 mg/dl ; p = 0.01 ) and LDL cholesterol ( E : 142.17 ± 3.1 mg/dl and P : 165.13 ± 3.1 mg/dl ; p = 0.02 ) levels as well as an increase in antioxidant capacity ( E : 65.63 ± 5.8 μmol TE/mg and P : 57.80 ± 7.7 μmol TE/mg ; p < Output:
Subgroup analyses indicated larger reduction was identified in the intake of low-dose of grape polyphenols ( < 733 mg/day , median level of the included studies ) or patients with metabolic syndrome . Contrarily , diastolic blood pressure was not significantly decreased in the grape polyphenols group as compared to controls . No significant heterogeneity or publication bias was detected in the meta- analysis of either systolic or diastolic blood pressure . CONCLUSIONS Daily grape polyphenol intake can significantly reduce the systolic blood pressure in humans , although the reduction is modest when compared with anti-hypertensive medications .
MS2_1shot242
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Recently , our group has shown that a 3-month course of intravenous immunoglobulin ( 2 g/kg/monthly ) followed by 6 months of intramuscular immunoglobulins ( IMIG , 16.5 % , 0.35 ml/kg every 15 days ) was able to slow or to stop the decline in the glomerular filtration rate , to reduce proteinuria , hematuria , leukocyturia and the histological index of activity on renal biopsy in patients with severe forms of IgA nephropathy ( IGAN ) and Henoch-Schönlein purpura ( HSP ) . The aim of this open prospect i ve trial was to evaluate the efficacy and safety of low-dose immunoglobulin therapy in moderate IGAN and HSP with permanent proteinuria . Fourteen patients with moderate IGAN [ idiopathic IGAN : n = 11 ; chronic idiopathic HSP : n = 3 ] and permanent albuminuria were treated with polyvalent IMIG ( 16.5 % ) for 9 months ( 0.35 ml/kg once a week for 1 month , followed by 0.35 ml/kg every 15 days for a further 8 months ) . Eligibility criteria in the study were Lee histological stage I , II or III , albuminuria between 300 and 2,000 mg/day and a glomerular filtration rate > 70 ml/min/1.73 m2 . IMIG were well tolerated and only 1 patient withdrew from the trial . No viral , renal or immunological side effects were observed . IMIG induced a significant decrease in albuminuria as well as in the histological activity index in the 11 cases in which a follow-up biopsy was performed . There was also a decrease in serum IgA , serum beta 2-microglobulin and IgA immune complex levels , and an increase in serum IgG1 levels . Twelve of the 13 evaluable patients improved during treatment Protein trafficking across the glomerular capillary has a pathogenic role in subsequent renal damage . Despite evidence that angiotensin-converting enzyme ( ACE ) inhibitors improve glomerular size-selectivity , whether this effect is solely due to ANG II blocking or if other mediators also play a contributory role is not clear yet . We studied 20 proteinuric patients with IgA nephropathy , who received either enalapril ( 20 mg/day ) or the ANG II receptor blocker irbesartan ( 100 mg/day ) for 28 days in a r and omized double-blind study . Measurements of blood pressure , renal hemodynamics , and fractional clearance of neutral dextran of grade d sizes were performed before and after 28 days of treatment . Both enalapril and irbesartan significantly reduced blood pressure over baseline . This reduction reached the maximum effect 4 - 6 h after drug administration but did not last for the entire 24-h period . Despite transient antihypertensive effect , proteinuria was effectively reduced by both treatments to comparable extents . Neither enalapril nor irbesartan modified the sieving coefficients of small dextran molecules , but both effectively reduced transglomerular passage of large test macromolecules . Theoretical analysis of sieving coefficients showed that neither drug affected significantly the mean pore radius or the spread of the pore-size distribution , but both importantly and comparably reduced the importance of a nonselective shunt pathway . These data suggest that antagonism of ANG II is the key mechanism by which ACE inhibitors exert their beneficial effect on glomerular size-selective function and consequently on glomerular filtration and urinary output of plasma proteins IgA nephropathy is the world 's most common primary glomerulonephropathy . Recent evidence in a rat model implicated excessive production of oxygen-free radicals in the pathogenesis and suggested that vitamin E-treatment ameliorated progression . We studied this antioxidant therapy on the glomerular filtration rate ( GFR ) , proteinuria and hematuria in biopsy-proven IgA nephropathy in children . The duration of treatment or placebo was 2 years , with vitamin E treatment consisting of 400 IU/day in children weighing < 30 kg , and twice that dose for those > 30 kg . We measured GFR at entry , midpoint and exit . At baseline and at 4-month intervals after r and omization , urinary protein/creatinine ratios and urinalysis were examined . The mixed model procedure with log transformation was used in data analysis to test treatment difference as well as the potential time effect . Fifty-five patients were r and omized and 38 completed at least 1 year of follow-up . At entry , the clinical characteristics were not different between the treatment and placebo groups . There was a trend toward better preservation of GFR in vitamin E-treated versus placebo patients , 127±50 vs. 112±31 ml/min/1.73 m2 , respectively ( P=0.09 ) . The urinary protein/creatinine ratio was significantly lower in the vitamin E-treated group vs. placebo ; 0.24±0.38 vs. 0.61±1.37 ( P<0.013 ) . However , there was no difference in the prevalence of hematuria between the groups . Vitamin E treatment in our study patients was associated with significantly lower proteinuria , but no effect on hematuria . While there was a trend toward stabilization of GFR in the vitamin E-treated patients , long-term treatment and follow-up are needed to determine whether antioxidant therapy is associated with preservation of renal function in IgA nephropathy This study investigates the ability of low doses of angiotensin-converting-enzyme inhibitors , in combination with angiotensin II receptor blockers , to exert antiproteinuric effects in normotensive and proteinuric out patients with immunoglobulin A ( IgA ) nephropathy confirmed by biopsy . We performed a prospect i ve , r and omized , 6-month study of the effects of temocapril 1 mg ( n=10 ) , losartan 12.5 mg ( n=10 ) , and both ( n=11 ) on mild-to-moderate proteinuria 0.76+/-0.35 g/day ( range , 0.4 to 1.6 g/day ) and renal function . The study subjects comprised 31 normotensive and proteinuric out patients with IgA nephropathy accompanied by normal , or mild-to-moderately reduced but stable renal function ( glomerular filtration rate>50 ml/min ) without steroid or immunosuppressive therapy . We prospect ively evaluated blood pressure , proteinuria , renal function and biochemical parameters before and after 6 months of therapy . The combination therapy significantly reduced proteinuria ( 63.2 % ) compared with either temocapril or losartan alone ( 41.3 % and 36.6 % , respectively , p=0.04 and 0.01 , respectively ) . Blood pressure was most decreased in the group that received combination therapy . The reduced proteinuria did not correlate with reduced systolic or diastolic blood pressure or mean arterial pressure in any of the groups . The glomerular filtration rate fell during the first 3 months of combined therapy , but became reversible after a further 3 months of therapy . The combination significantly decreased angiotensin II ( p < 0.01 ) , and this decrease was greater than that by either drug alone . In conclusion , the effectiveness of the combined therapy may have been at least partly due to the greater inhibition of the action of angiotensin II in patients with IgA nephropathy . This strategy apparently reduced mild-to-moderate proteinuria in patients with normotensive IgA nephropathy Some retrospective studies have suggested a beneficial influence of angiotensin-converting enzyme ( ACE ) inhibitors on the progression of IgA nephropathy ( IgAN ) , but prospect i ve and controlled studies demonstrating this effect are lacking . Forty-four patients with biopsy-proven IgAN , proteinuria > or = 0.5 g/d , and serum creatinine ( SCr ) < or = 1.5 mg/dl were r and omly assigned either to receive enalapril ( n = 23 ) or to a control group ( n = 21 ) in whom BP was controlled with antihypertensives other than ACE inhibitors . Primary outcome was renal survival estimated by a 50 % increase in baseline SCr . Secondary outcomes were the presence of a SCr > 1.5 mg/dl at the last visit and the evolution of proteinuria . Baseline clinical findings were similar at baseline between enalapril-treated and control group , and there were no differences in BP control during follow-up . Mean follow-up was 78 + /- 37 mo in the enalapril group and 74 + /- 36 mo in the control group . Three patients ( 13 % ) in the enalapril group and 12 ( 57 % ) in the control group reached the primary end point ( P < 0.05 ) . Kaplan-Meier renal survival was significantly better in enalapril group than in control group : 100 % versus 70 % after 4 yr and 92 % versus 55 % after 7 yr ( P < 0.05 ) . Three patients in the enalapril group ( 13 % ) and 11 ( 52 % ) in the control group showed SCr > 1.5 mg/dl at the last visit ( P < 0.05 ) . Proteinuria significantly decreased in the enalapril group , whereas it tended to increase in the control group ( P < 0.001 between groups ) . In conclusion , ACE inhibitors significantly improve renal survival in proteinuric IgAN with normal or moderately reduced renal function Twenty children and adolescents with IgA glomerulonephritis were enrolled in a crossover trial . Each received 12 weeks of prednisone therapy and 12 weeks of placebo dosing . Urinary protein and erythrocyte excretion were monitored during both courses . There was no evidence that , under the conditions of the study , corticosteroid therapy was effective in IgA nephropathy BACKGROUND Because humoral immunity is believed to play a pivotal role in the pathogenesis of IgA nephropathy ( IgAN ) , a prospect i ve placebo-controlled r and omized study was started in patients with IgAN using mycophenolate mofetil ( MMF ) . METHODS A total of 34 patients with IgAN were treated with salt intake restriction , angiotensin-converting enzyme ( ACE ) inhibition and MMF 2 g per day ( N= 21 ) or placebo ( N= 13 ) . After 36 months of follow-up clinical , biochemical , and radiologic data were analyzed using linear mixed models for longitudinal data and Kaplan-Meier survival analysis . RESULTS Therapy had to be stopped prematurely in five patients . Two patients ( MMF group ) evolved to end-stage renal disease ( ESRD ) . There was no difference between groups in the percentage of patients with a decrease of 25 % or more in the inulin clearance or with a serum creatinine increase of 50 % or more over 3 years . There was also no significant difference between groups in annualized rate of change of serum creatinine , computed by linear regression analysis . No significant difference was noted between groups for inulin clearance , serum creatinine , proteinuria , blood pressure , or other parameters of renal function . Hemoglobin and C-reactive protein were significantly lower in the MMF group compared with the placebo group . As a function of time , a significant decline in both groups was noted of proteinuria , parenchymal thickness of the kidneys and C3d . CONCLUSION In patients with IgAN at risk for progressive disease , no beneficial effect of 3-year treatment with MMF 2 g per day could be demonstrated on renal function/ outcome or proteinuria . However , larger r and omized studies are needed to confirm or reject these results The role of immunosuppressive therapy in the management of IgA nephropathy ( IgAN ) remains controversial . No consensushas yet emerged on the specific treatment of IgAN and this ismostly related to the lack of complete underst and ing of themultifactorial pathogenesis of the disease . Choice of appropriatetherapeutic agents is further limited by the difficulty inidentifying patients who would most likely benefit from therapy . Immunosuppressive therapy has not been recommended in patients with isolated hematuria and well preserved renal function becauseof their generally favourable prognosis and there are no clinical trials in this area . Considering that mild IgAN may be an earlystage of the disease and can be reversed by immunosuppressiveagents we have used prednisolone and azathioprine in patients with isolated hematuria in a prospect i ve , r and omized , controlled study since 1988 . In this prospect i ve study we have evaluated theeffect of prednisolone with azathioprine on the clinical courseof IgAN and its impact on histologic parameters and preventionof progression in patients with isolated hematuria . We studied 43biopsy-proven IgAN patients ( 29 males and 14 females , agedbetween 13–63 years , mean age 28 ± 6 ) with isolated hematuria and well-preserved renal function ( Ccr 89.2 ± 10.2 ml/min ) . The patients were assigned to two groups : 21 patients receivedprednisolone ( 40 mg/day ) and azathioprine ( 100 mg/day ) orally forfour months ( group A ) and 22 patients received no specifictreatment for IgAN and served as a control group ( group B ) . InGroup A prednisolone was reduced to 20 mg/day at the end of thesecond month , then slowly tapered over a two-month period and stopped . The median duration of follow-up was 60 months ( range12–12 Output:
In patients with IgAN and normal or mildly impaired renal function , steroids significantly delay the progression to end stage kidney disease ( evidence from SR ) and improve proteinuria . Associating steroids and cytotoxic agents ( cyclophosphamide followed by oral azathioprine ) proves effective in patients with rapidly progressive renal disease ( evidence from RCT ) . Angiotensin converting enzyme inhibitors and angiotensin II receptor blockers significantly improve proteinuria ( evidence from RCT ) , but there are no conclusive data on efficacy on hard patient level endpoints . There are no conclusive data available on the use of a therapy combining these agents . In IgAN patients current evidence supports the hypothesis that immunosuppressive agents delay the progression to end stage renal disease .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVES To investigate the importance of medical and dental factors in aspiration pneumonia in an older veteran population . DESIGN Prospect i ve enrollment of subjects with retrospective analysis of data . SETTING Department of Veterans Affairs outpatient clinic , inpatient ward , and nursing home . PARTICIPANTS 358 veterans age 55 and older ; 50 subjects with aspiration pneumonia . MEASUREMENTS Demographic and medical data ; functional status ; health-related behaviors ; dental care utilization ; personal oral hygiene ; comprehensive dental examination ; salivary assays including IgA antibodies ; and cultures of saliva , throat , and dental plaques . RESULTS Two logistic regression models produced estimates of significant risk factors . One model using dentate patients included : requiring help with feeding ( odds ratio ( OR ) = 13.9 ) , chronic obstructive pulmonary disease ( COPD ) ( OR = 4.7 ) , diabetes mellitus ( OR = 3.5 ) , number of decayed teeth ( OR = 1.2 ) , number of functional dental units ( OR = 1.2 ) , presence of important organisms for decay , Streptococcus sobrinus in saliva ( OR = 6.2 ) , and periodontal disease , Porphyromonous gingivalis in dental plaque ( OR = 4.2 ) , and Staphylococcus aureus presence in saliva ( OR = 7.4 ) . The second model , containing both dentate and edentulous patients included : requiring help with feeding ( OR = 4.7 ) , COPD ( OR = 2.5 ) , diabetes mellitus ( OR = 1.7 ) , and presence of S. aureus in saliva ( OR = 8.3 ) . CONCLUSION This study supports the significance of oral and dental factors while controlling for established medical risk factors in aspiration pneumonia incidence Objective : To assess the prevalence of oral colonization by respiratory pathogens in a group of ICU patients , with specific attention to dental plaque and the oral mucosa . Design : Prospect i ve , nonr and omized study with age-matched controls . Setting s : Medical ICU in a tertiary-care Veterans Affairs Medical Center and a dental school outpatient preventive dentistry clinic . Patients : Nonconsecutive , unselected patients admitted to the medical ICU during a 2-month period ; controls were age-matched patients seen for the first time in the preventive dentistry clinic . Interventions : None . Measurements : Oral hygienic status was assessed in both groups using a semiquantitative system . Quantitative cultures of dental plaque and buccal mucosa were done within 12 hrs of medical ICU admission and every third day thereafter until discharge/death from the medical ICU . In controls , cultures of plaque and buccal mucosa were done on the initial visit only . Severity of illness of medical ICU patients was quantitated using the Acute Physiology and Chronic Health Evaluation ( APACHE II ) system and McCabe-Jackson criteria . Main Results : Oral hygiene of medical ICU patients was poor . These patients had a mean plaque score ( 1.9 ± 0.2 ) that was significantly greater than that same score seen in out patients of the preventive dentistry clinic ( 1.4 ± 0.1 ; p < .005 ) . Plaque and /or oral mucosa of 22 ( 65 % ) of 34 medical ICU patients were colonized by respiratory pathogens , in contrast to only four ( 16 % ) of 25 preventive dentistry clinic patients ( p < .005 ) . The potential respiratory pathogens cultured from medical ICU patients included methicillinresistant Staphylococcus aureus , Pseudomonas aeruginosa , and ten genera of Gram-negative bacilli . Colonization by respiratory pathogens was statistically associated with concomitant antibiotic therapy within the medical ICU group of patients , but not with severity of illness . Although medical ICU patients tended to have more dental plaque than preventive dentistry clinic patients , there was no statistically significant association noted between the presence of dental plaque and respiratory pathogen colonization . Conclusions : These findings suggest that bacteria commonly causing nosocomial pneumonia colonize the dental plaque and oral mucosa of intensive care patients . In many cases , this colonization occurs by large numbers of bacteria . Dental plaque may be an important reservoir of these pathogens in medical ICU patients . Efforts to improve oral hygiene in medical ICU patients could reduce plaque load and possibly reduce oropharyngeal colonization OBJECTIVE To study the dental status and colonization of dental plaque by aerobic pathogens and their relation with nosocomial infections in intensive care unit ( ICU ) patients . DESIGN A prospect i ve study in a medical ICU of a university-affiliated hospital . PATIENTS Consecutive patients admitted to the ICU during a 3-mo period . INTERVENTIONS Dental status was assessed by the same investigator using a score adapted from the " Caries-Absent-Occluded " ( CAO ) index ( referred to in the U.S. as DMFT [ Decayed-Missing-Filled Teeth ] index ) . The amount of dental plaque on premolars was assessed using a semiquantitative score . Quantitative cultures of dental plaque , nasal secretions , tracheal aspirates , and urine were done at admission ( day 0 ) and every fifth day until death or discharge . An additional study was done in eight patients to serially compare dental plaque , salivary , and tracheal aspirate cultures during a 2-wk period . MEASUREMENTS AND MAIN RESULTS Fifty-seven patients were included in the main study . Due to the variability in their ICU stay , 29 patients could be examined on day 0 only ( group A ) , 15 patients on days 0 and 5 ( group B ) , and 13 patients on days 0 , 5 , and 10 ( group C ) . The mean dental CAO score was 16 + /- 8 and did not change during the ICU stay . The dental plaque score was < or = 1 in 70 % of patients on day 0 ; > or = 2 in 50 % of patients on day 5 ; and > or = 2 in 90 % of patients on day 10 . Dental plaque cultures were positive at 10(3 ) colony-forming units/mL for aerobic pathogens in 23 % of patients on day 0 ; 39 % of patients on day 5 ; and 46 % of patients on day 10 . In groups B and C , mean dental plaque score and frequency of plaque colonization increased from days 0 to 5 and from days 5 to 10 . A high bacterial concordance was found between dental plaque and tracheal aspirate cultures , and in the additional study , between salivary and dental plaque cultures . Twenty-one patients developed a nosocomial infection in the ICU . Dental plaque colonization on days 0 and 5 was significantly associated with the occurrence of nosocomial pneumonia and bacteremia ( sensitivity 0.77 ; specificity 0.96 ; positive predictive value 0.87 ; negative predictive value 0.91 ; relative risk 9.6 ) . In six cases of nosocomial infection , the pathogen isolated from dental plaque was the first identified source of nosocomial infection . CONCLUSIONS The amount of dental plaque increased during the ICU stay . Colonization of dental plaque was either present on admission or acquired in 40 % of patients . A positive dental plaque culture was significantly associated with subsequent nosocomial infections . Dental plaque colonization by aerobic pathogens might be a specific source of nosocomial infection in ICU patients BACKGROUND Pneumonia is one of the most common nosocomial infections in hospitalized patients . The risk of nosocomial pneumonia increases with age , severity of acute illness and preexisting co-morbid conditions . Ventilator-associated pneumonia ( VAP ) significantly increases morbidity , length of stay , re source utilization and mortality . The purpose of this study was to determine whether adherence to a ventilator weaning protocol ( WP ) and the use of chlorhexidine gluconate ( CH ) oral rinse for oral hygiene would decrease the incidence of VAP in surgical ICU patients . METHODS A prospect i ve study was conducted over a period of 10 months ( October 1998-July 1999 ) in surgical ICU patients requiring mechanical ventilation ( n = 95 ) . During the first 5 months , a WP was applied to all patients requiring mechanical ventilation . During the following 5 months , a CH 0.12 % oral rinse administered twice daily was added to the protocol , initiated on ICU admission in all intubated patients . The data collection included age , gender , race , risk factors , co-morbid conditions , severity of the acute illness ( APACHE II ) at admission , duration of ventilation , ICU and total-hospital length of stay , and incidence of VAP and in-hospital mortality rates . Both WP and WP+CH groups were compared using the National Nosocomial Infection Surveillance ( NNIS ) and hospital data bases as historic controls . RESULTS The institution of the WP alone led only to a slight decrease in the incidence of VAP but a significant reduction in the median duration of mechanical ventilation by 40 % ( 4.5 days , p < 0.008 ) . The addition of CH to the WP led to a significant reduction and delay in the occurrence of VAP ( 37 % overall , 75 % for late VAP , p < 0.05 ) . The median duration of mechanical ventilation in this group was similar to that of the WP group . There was no significant difference in the overall hospital or ICU length of stay between the groups . CONCLUSIONS Improved oral hygiene via topical CH application in conjunction with the use of a WP is effective in reducing the incidence of VAP and the duration of mechanical ventilation in surgical ICU patients OBJECTIVES Aspiration of oral secretions and their bacteria is increasingly being recognized as an important factor in pneumonia . We investigated whether oral care lowers the frequency of pneumonia in institutionalized older people . DESIGN Survey . SETTING Eleven nursing homes in Japan . PARTICIPANTS Four hundred seventeen patients r and omly assigned to an oral care group or a no oral care group . INTERVENTION Nurses or caregivers cleaned the patients ' teeth by toothbrush after each meal . Swabbing with povidone iodine was additionally used in some cases . Dentists or dental hygienists provided professional care once a week . MEASUREMENTS Pneumonia , febrile days , death from pneumonia , activities of daily living , and cognitive functions . RESULTS During follow-up , pneumonia , febrile days , and death from pneumonia decreased significantly in patients with oral care . Oral care was beneficial in edentate and dentate patients . Activities of daily living and cognitive functions showed a tendency to improve with oral care . CONCLUSION We suggest that oral care may be useful in preventing pneumonia in older patients in nursing homes Abstract Objectives : To document in intensive care unit ( ICU ) patients the effect of dental plaque antiseptic decontamination on the occurrence of plaque colonization by aerobic nosocomial pathogens and nosocomial infections . Design : Single-blind r and omized comparative study . Setting : A 16-bed adult intensive care unit in a university hospital . Patients : Patients consecutively admitted in the ICU with a medical condition suggesting an ICU stay of 5 days and requiring mechanical ventilation . Interventions : After r and omization , the treated group received dental plaque decontamination with 0.2 % chlorhexidine gel , three times a day during the ICU stay . The control group received st and ard oral care . Specific measurements : Dental status was assessed by the Caries-Absent-Occluded index ; the amount of dental plaque was assessed by a semi-quantitative plaque index . Bacterial sampling of dental plaque , nasal and tracheal aspirate , blood , and urine cultures were done on days 0 , 5 , 10 , and every week . Main results : Sixty patients were included ; 30 in the treated group and 30 in the control one ( mean age : 51±16 years ; mean Simplified Acute Physiological Score II : 35±14 points ) . On admission , no significant differences were found between both groups for all clinical and dental data . Compared with the control group , the nosocomial infection rate and the incidence densities related to risk exposition were significantly lower in the treated group ( 18 vs 33‰ days in the ICU and 10.7 vs 32.3‰ days of mechanical ventilation ; P<0.05 ) . These results were consistent with a significant preventive effect of the antiseptic decontamination ( Odds Ratio : 0.27 ; 95 % CI : 0.09 ; 0.80 ) with a 53 % relative risk reduction . There was a trend to a reduction of mortality , length of stay , and duration of mechanical ventilation . Conclusions : An antiseptic decontamination of dental plaque with a 0.2 % chlorhexidine gel decreases dental bacterial colonization , and may reduce the incidence of nosocomial infections in ICU patients su bmi tted to mechanical ventilation BACKGROUND Decreasing the levels of bacteria in the oropharynx should reduce the prevalence of nosocomial pneumonia . OBJECTIVES To test the effectiveness of 0.12 % chlorhexidine gluconate oral rinse in decreasing microbial colonization of the respiratory tract and nosocomial pneumonia in patients undergoing open heart surgery . M Output:
REVIEW ERS ' CONCLUSIONS 1 . Oral colonization by respiratory pathogens , fostered by poor oral hygiene and periodontal diseases , appears to be associated with nosocomial pneumonia . 2 .
MS2_1shot244
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background / Aims : We investigated whether urinary podocytes are present in septic patients with methicillin-resistant Staphylococcus aureus (MRSA)-associated glomerulonephritis and whether polymyxin B-immobilized fiber ( PMX-F ) treatment affects proteinuria and urinary podocyte excretion in these patients . Methods : Twenty septic patients with MRSA-associated glomerulonephritis ( mean age : 63.7 years ) and 80 septic patients whose MRSA infection was not followed by glomerulonephritis ( mean age : 60.5 years ) were included in this study . All septic patients were treated with fosfomycin sodium , β-lactams , arbekacin sulfate , and teicoplanin , or a combination of these . Twenty septic patients with MRSA-associated glomerulonephritis were r and omly assigned to one of two treatments : PMX-F treatment ( group A , n = 10 ) and conventional treatment ( group B , n = 10 ) . PMX-F treatment was repeated twice . Results : Urinary podocytes and urinary protein excretion were not detected in MRSA septic patients without glomerulonephritis . However , urinary podocytes ( 1.7 ± 0.6 cells/ml ) and proteinuria ( 2.6 ± 0.6 g/d ) were detected in the 20 septic patients with MRSA-associated glomerulonephritis . Plasma endotoxin levels were decreased from 13.6 ± 4.6 pg/ml to 6.6 ± 2.2 pg/ml ( p < 0.05 ) in group A. Levels in group B , however , showed little difference after treatment . Urinary podocytes were reduced in group A ( from 1.8 ± 0.6 cells/ml to 0.4 ± 0.2 cells/ml , p < 0.01 ) as was urinary protein excretion ( from 3.0 ± 0.5 g/d to 0.8 ± 0.4 g/d , p < 0.01 ) but urinary podocytes and protein excretion levels showed little difference after treatment in group B. Conclusion : PMX-F treatment may be effective in reducing urinary protein and urinary podocyte excretion in septic patients with MRSA-associated glomerulonephritis Introduction The objective of this study was to clarify the efficacy and mechanism of action of direct hemoperfusion with an immobilized polymyxin B fiber column ( DHP-PMX ) in patients with acute lung injury or acute respiratory distress syndrome caused by sepsis . Method Thirty-six patients with sepsis were included . In each patient a thermodilution catheter was inserted , and the oxygen delivery index and oxygen consumption index were measured . DHP-PMX was performed in patients with a normal oxygen delivery index and oxygen consumption index ( > 500 ml/minute per m2 and > 120 ml/minute per m2 , respectively ) . The Acute Physiology and Chronic Health Evaluation II score was used as an index of the severity of sepsis , and survival was assessed after 1 month . The humoral mediators measured were the chemokine IL-8 , plasminogen activator inhibitor-1 , and neutrophil elastase ( NE ) . These mediators were measured before DHP-PMX treatment , and at 24 , 48 , and 78 hours after the start of treatment . The arterial oxygen tension (PaO2)/fractional inspired oxygen ( FiO2 ) ratio was measured before DHP-PMX treatment and at 24 , 48 , 72 , 92 , and 120 hours after the start of treatment . Results All patients remained alive after 1 month . Before DHP-PMX treatment , the Acute Physiology and Chronic Health Evaluation II score was 24 ± 2.0 , the IL-8 level was 54 ± 15.8 pg/ml , plasminogen activator inhibitor-1 was 133 ± 28.1 ng/ml , and NE was 418 ± 72.1 μg/l . These three humoral mediators began to decrease from 24 hours after DHP-PMX treatment , and the decline became significant from 48 hours onward . The PaO2/FiO2 ratio was 244 ± 26.3 before DHP-PMX treatment but improved significantly from 96 hours onward . There were significant negative correlations between the PaO2/FiO2 ratio and blood levels of NE and IL-8 . Conclusion The mechanism of action of DHP-PMX is still not fully understood , but we report the following findings . The mean blood levels of plasminogen activator inhibitor-1 , NE , and IL-8 were significantly decreased from 48 hours after DHP-PMX treatment . The mean PaO2/FiO2 ratio was significantly improved from 96 hours after DHP-PMX treatment . Improvement in the PaO2/FiO2 ratio appeared to be related to the decreases in blood NE and IL-8 levels OBJECTIVE the aim of the present study was to determine whether serum neopterin and soluble interleukin (IL)-2 receptor levels were related to the development of septic shock and whether polymyxin B-immobilized fibre ( PMX-F ) treatment affects these levels . METHODS we examined 24 patients admitted to our intensive care unit with Gram-negative septic shock . Serum neopterin and soluble IL-2 receptor levels were measured using commercially available test kits . Patients were treated with direct hemoperfusion using PMX-F columns . RESULTS fifteen out of 24 patients ( 63 % ) survived and were discharged from our hospitals within 30 days after PMX-F treatment . Blood endotoxin levels decreased significantly from 49.2+/-8.6 pg/ml to 13.2+/-4.4 pg/ml after PMX-F treatment . The pretreatment serum concentrations of neopterin and IL-2 receptor were significantly higher in the nine non-surviving patients with septic shock than in the 15 surviving patients ( P<0.01 ) and 20 control subjects ( P<0.001 ) . Serum concentrations of neopterin and IL-2 receptor in patients with septic shock decreased significantly after PMX-F treatment ( P<0.01 ) . CONCLUSIONS these data suggest that serum neopterin and IL-2 receptor concentrations may be prognostic indicators in patients with septic shock . PMX-F treatment may be effective for reducing serum neopterin and IL-2 receptor concentrations Endotoxin plays an important role in the pathogenesis of septic shock . Exposure of endothelial cells to endotoxin activates endothelial cells and increases the surface expression of adhesion molecules , markers of endothelial damage in organ dysfunction . Endotoxin adsorption therapy by polymyxin B-immobilized fiber column ( PMX ) hemoperfusion has been used for the treatment of septic shock patients . In this study , we measured plasma concentrations of endotoxin and soluble adhesion molecules in septic shock patients before and after the PMX treatment then observed on the relationships between actual duration of use and various outcomes . Sixteen patients with septic shock were studied . The 28-day mortality rate was 50 % . The elevated plasma concentrations of endotoxin decreased after the PMX treatment in the survivors but not in the nonsurvivors . The norepinephrine dose and plasma concentrations of soluble endothelial leukocyte adhesion molecule 1 and soluble intercellular adhesion molecule 1 significantly ( P < 0.05 ) decreased in the PMX greater-than-2-h ( prolonged ) group than in the PMX 2-h ( conventional ) group ( −17.8 ± 14.6 vs. −1.8 ± 2.7 & mgr;g/min , −143.0 ± 111.0 vs. 0 ± 2.8 ng/mL , and −126.2 ± 144.9 vs. 16.5 ± 108.1 ng/mL , respectively ) . Changes in the PaO2-FiO2 ratio and the Sequential Organ Failure Assessment score were significantly ( P < 0.05 ) more improved in the PMX greater-than-2-h group than in the PMX 2-h group ( 75.4 ± 80.7 vs. 1.2 ± 49.2 and −0.8 ± 1.8 vs. 2.2 ± 1.9 torr , respectively ) . We thus suggest that a longer duration of PMX treatment may improve the pulmonary oxygenation associated with decreased adhesion molecules in septic shock Background : CD16 + CD14 + monocytes dramatically increase in number in patients with severe infection . Hemoperfusion with PMX-F ( direct hemoperfusion with polymyxin B immobilized fibers ) has been reported to be a safe and effective treatment for patients with septic shock , although the molecular mechanism that accounts for its effectiveness is still unclear . The purpose of this study was to quantify the number of CD16+CD14 + monocytes in patients with an intra-abdominal infection and to evaluate the effects of PMX-F treatment on clinical parameters and leukocyte surface antigen expression in these patients . Material s and Methods : Seventeen septic patients who had an intra-abdominal infection were enrolled in this study ; 7 of these patients received PMX-F treatment . Peripheral blood sample s were obtained immediately after admission , and were also collected from the above 7 patients before , during , and immediately after their PMX-F treatment . The expression of CD14 , CD16 , and Toll-like receptor (TLR)-4 on these patients ' monocytes was evaluated using flow cytometry . In addition , lipopolysaccharide (LPS)-induced production of TNF-α and IL-1β by these cells was measured by ELISA . Results : Monocytic expression of CD16 and TLR-4 was significantly greater in septic patients than in healthy controls , and their proportion of CD16+CD14 + monocytes was similarly elevated . LPSinduced production of TNF-α and IL-1β by peripheral blood mononuclear cells ( P BMC s ) of septic patients was significantly reduced compared to controls . Furthermore , there was a reduction in the proportion of CD 16+CD 14 + monocytes during PMX-F treatment , and in the expression of TLR-4 on monocytes after PMX-F treatment . Conclusions : These results showed that the number of peripheral blood CD16+CD14 + monocytes and monocytic TLR-4 expression were markedly increased , and the production of pro-inflammatory cytokines in response to LPS significantly reduced in patients with sepsis . PMX-F treatment was found to be effective in reducing the number of CD 16+CD 14 + monocytes and in decreasing the monocytic expression of TLR-4 in patients with septic shock Objective : To determine the impact of a thyroid hormone infusion ( T4 ) on the vasopressor requirements in children with cessation of neurologic function ( i.e. , brain death ) during evaluation for organ recovery Design : Retrospective cohort study . Setting : The 1998–2002 data base of a regional organ recovery program . Patients : Children ≤18 yrs with cessation of neurologic function during evaluation for organ recovery ( n = 171 ) were included . The treated group ( n = 91 ) received a weight-based bolus and continuous infusion of T4 according to the organ procurement agency protocol . All other children ( n = 80 ) were considered untreated . Interventions : T4 was administered at the clinician ’s discretion . All children ( treated and untreated ) had identical goals for fluids , blood pressure , and organ function criteria . Vasopressor score ( [ dopamine × 1 ] + [ dobutamine × 1 ] + [ epinephrine × 100 ] + [ norepinephrine × 100 ] + [ phenylephrine × 100 ] ) at the time of the program ’s involvement ( T0 ) and at organ recovery ( TOR ) were recorded . The Wilcoxon rank sum and Student ’s two- sample t-test were used to compare the average vasopressor score at T0 vs. TOR . The Wilcoxon signed rank test was used to analyze the difference in median vasopressor score at T0 vs. TOR . Multivariable linear regression was used to assess the impact of T4 on the ability to wean vasopressor support while accounting for the effects of several potential confounders . Measurements and Main Results : One hundred seventy-one subjects were included in the final analysis . T4 administration was associated with an unadjusted decrease in the vasopressor score of 32 ( 95 % confidence interval , 12–53 ; p = .002 ) . After adjusting for steroid administration , fluid balance , and baseline vasopressor score , T4 administration was associated with a decrease in vasopressor score of 24 ( 95 % confidence interval , 6–43 ; p = .011 ) . Conclusions : T4 reduced vasopressor needs in children with cessation of neurologic function and hemodynamic instability . A prospect i ve study of T4 in critically ill and hemodynamically unstable children appears warranted Objective To analyze the effects of polymyxin B-immobilized fiber ( PMX-F ) on bone resorption in septic patients . Design and setting Observational prospect i ve study in intensive care units of a general hospital . Patients and participants 25 patients with severe sepsis and 20 healthy controls . Measurements and results Septic patients were r and omly assigned to two groups : PMX-F treatment group ( n=15 ) and conventional treatment group ( n=10 ) . Total pyridinium crosslink pyridinoline ( PYD ) and deoxypyridinoline ( DPD ) in urine were determined by Output:
This systematic review found positive effects of PMX-DHP on mean arterial pressure and dopamine/ dobutamine use , PaO2/FiO2 ratio , endotoxin removal , and mortality . The EUPHAS study , a multicenter RCT performed in ten Italian intensive care units in 2009 , found that PMX-DHP improved 28-day survival , blood pressure , vasopressor requirement , and degree of organ failure .
MS2_1shot245
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: BACKGROUND Pertuzumab ( P ) combined with trastuzumab (H)-based chemotherapy improves efficacy in early and advanced HER2-positive breast cancer . We assessed the tolerability , with particular focus on cardiac safety , of H and P with chemotherapy in the neoadjuvant treatment of HER2-positive early breast cancer . PATIENTS AND METHODS In this multicenter , open-label phase II study , patients with operable , locally advanced , or inflammatory breast cancer were r and omized 1 : 1 : 1 to receive six neoadjuvant cycles q3w ( Arm A : 5-fluorouracil , epirubicin , cyclophosphamide [ FEC ] + H + P ×3 → docetaxel [ T ] + H + P ×3 ; Arm B : FEC ×3 → T + H + P ×3 ; Arm C : T + carboplatin + H [TCH]+P ×6 ) . pCR was assessed at surgery and adjuvant therapy given to complete 1 year of H. RESULTS Two hundred twenty-five patients were r and omized . During neoadjuvant treatment , two patients ( 2.7 % ; Arm B ) experienced symptomatic left ventricular systolic dysfunction ( LVSD ) and 11 patients ( Arm A : 4 [ 5.6 % ] ; Arm B : 4 [ 5.3 % ] ; Arm C : 3 [ 3.9 % ] ) had declines in left ventricular ejection fraction of ≥10 % points from baseline to < 50 % . Diarrhea was the most common adverse event . pCR ( ypT0/is ) was reported for 61.6 % ( Arm A ) , 57.3 % ( Arm B ) , and 66.2 % ( Arm C ) of patients . CONCLUSION The combination of P with H and st and ard chemotherapy result ed in low rates of symptomatic LVSD BACKGROUND Neoadjuvant chemotherapy with trastuzumab for patients with HER2-positive breast cancer can produce a pathological complete response in the breast in 30 - 65 % of patients . We investigated the effect of the timing of trastuzumab administration with anthracycline and taxane neoadjuvant chemotherapy . METHODS This r and omised trial was done at 36 centres in the USA and Puerto Rico . Women with operable HER2-positive invasive breast cancer were r and omly assigned ( 1:1 ) with a biased coin minimisation algorithm , stratified for age , tumour size , and hormone receptor status . Neither patients nor investigators ( except for a cardiac safety review panel ) were masked to treatment assignment . Patients r and omly assigned to sequential treatment received fluorouracil 500 mg/m(2 ) , epirubicin 75 mg/m(2 ) , and cyclophosphamide 500 mg/m(2 ) ( FEC-75 ) on day 1 of a 21-day cycle for four cycles followed by paclitaxel 80 mg/m(2 ) and trastuzumab 2 mg/kg ( after a 4 mg/kg loading dose ) once per week for 12 weeks , while those r and omly assigned to the concurrent treatment group received paclitaxel and trastuzumab once per week for 12 weeks followed by four cycles of FEC-75 ( on day 1 of each 21-day cycle ) and once-weekly trastuzumab , in the same doses as the sequential group . Surgery , including evaluation of the axilla , was done within 6 weeks of completion of neoadjuvant treatment . The primary outcome was the percentage of patients who had a pathological complete response in the intention-to-treat population . The study is registered with Clinical Trials.gov , number NCT00513292 . FINDINGS From Sept 15 , 2007 , to Dec 15 , 2011 , 282 women were enrolled ( 140 in the sequential group , 142 in the concurrent group ) . Two patients in the sequential group withdrew consent before starting treatment . 78 of 138 ( 56·5 % , 95 % CI 47·8 - 64·9 ) patients who received sequential treatment had a pathological complete response in the breast versus 77 of 142 ( 54·2 % , 95 % CI 45·7 - 62·6 ) who received concurrent treatment ( difference 2·3 % , 95 % CI -9·3 to 13·9 ) . No treatment-related deaths occurred . The most common severe toxic effects were neutropenia ( 35 [ 25·3 % ] of 138 patients in the sequential group vs 45 [ 31·7 % ] of 142 patients in the concurrent group ) and fatigue ( six [ 4·3 % ] vs 12 [ 8·5 % ] ) . Left ventricular ejection fraction dropped below the institutional lower limit of normal at week 12 in one ( 0·8 % ) of 130 patients who received sequential treatment and four ( 2·9 % ) of 137 patients who received concurrent treatment ; by week 24 , it had dropped below this limit in nine ( 7·1 % ) of 126 patients and in six ( 4·6 % ) of 130 patients , respectively . INTERPRETATION Concurrent administration of trastuzumab with anthracyclines offers no additional benefit and is not warranted . FUNDING US National Cancer Institute PURPOSE This study sought to estimate cardiac dysfunction ( CD ) risk for patients receiving trastuzumab ; to characterize observed CD by severity , treatment , and clinical outcome ; to assess effects of baseline clinical risk factors on CD ; and to assess effects of cumulative doses of anthracyclines and trastuzumab on CD . PATIENTS AND METHODS A retrospective review of records for patients enrolled onto any of seven phase II and III trastuzumab clinical trials was performed . Predefined criteria were used for the diagnosis , and the New York Heart Association functional classification system was used to document CD severity . Product-limit estimates were used to summarize the cumulative anthracycline and trastuzumab doses at the time of CD onset . RESULTS Patients treated with trastuzumab were found to be at an increased risk for CD . The incidence was greatest in patients receiving concomitant trastuzumab and anthracycline plus cyclophosphamide ( 27 % ) . The risk was substantially lower in patients receiving paclitaxel and trastuzumab ( 13 % ) or trastuzumab alone ( 3 % to 7 % ) ; however , most of these patients had received prior anthracycline therapy . CD was noted in 8 % of patients receiving anthracycline plus cyclophosphamide and 1 % receiving paclitaxel alone . Most trastuzumab-treated patients developing CD were symptomatic ( 75 % ) , and most improved with st and ard treatment for congestive heart failure ( 79 % ) . CONCLUSION Trastuzumab is associated with an increased risk of CD , which is greatest in patients receiving concurrent anthracyclines . In most patients with metastatic breast cancer , the risk of CD can be justified given the improvement in overall survival previously reported with trastuzumab Background A r and omized Phase II study evaluated the activity of weekly paclitaxel versus its combination with trastuzumab for treatment of patients with advanced breast cancer overexpressing HER-2 . Patients and methods Among 124 patients r and omized , 123 are assessable for toxicity and 118 for response . Patients received weekly paclitaxel single agent ( 80 mg/m2 ) or combined with trastuzumab ( 4 mg/kg loading dose , then weekly 2 mg/kg ) . HER-2 overexpression was determined by immunohistochemistry ( IHC ) . Patients with 2+/3 + IHC scores were eligible . IHC was compared with HER-2 serum extracellular domain ( ECD ) . Results Patient characteristics were similar in the two arms . Both treatments were feasible and well tolerated with no grade 4 hematologic toxicity . No patient developed cardiac toxicity . The combined treatment was statistically significant superior for overall response rate ( ORR ) ( 75 % vs. 56.9 % ; P = 0.037 ) , particularly in the subset of IHC 3 + patients ( 84.5 % vs. 47.5 % ; P = 0.00050 ) . A statistically significant better median time to progression was seen in the subgroup with IHC 3 + ( 369 vs. 272 days ; P = 0.030 ) and visceral disease ( 301 vs. 183 days ; P = 0.0080 ) treated with combination . Multivariable analysis of predictive factors showed that only IHC score retained statistically significant value for ORR ( P = 0.0035 ) . Conclusion Weekly paclitaxel plus trastuzumab is highly active and safe and it is superior to paclitaxel alone in patients with IHC score of 3 + Despite important progress in underst and ing the molecular factors underlying the development of cancer and the improvement in response rates with new drugs , long-term survival is still disappointing for most common solid tumours . This might be because very little of the modest gain for patients is the result of the new compounds discovered and marketed recently . An assessment of the regulatory agencies ' performance may suggest improvements . The present analysis summarizes and evaluates the type of studies and end points used by the EMEA to approve new anticancer drugs , and discusses the application of current regulations . This report is based on the information available on the EMEA web site . We identified current regulatory requirements for anticancer drugs promulgated by the agency and retrieved them in the relevant directory ; information about empirical evidence supporting the approval of drugs for solid cancers through the central ised procedure were retrieved from the European Public Assessment Report ( EPAR ) . We surveyed documents for drug applications and later extensions from January 1995 , when EMEA was set up , to December 2004 . We identified 14 anticancer drugs for 27 different indications ( 14 new applications and 13 extensions ) . Overall , 48 clinical studies were used as the basis for approval ; r and omised comparative ( clinical ) trial ( RCT ) and Response Rate were the study design and end points most frequently adopted ( respectively , 25 out of 48 and 30 out of 48 ) . In 13 cases , the EPAR explicitly reported differences between arms in terms of survival : the range was 0–3.7 months , and the mean and median differences were 1.5 and 1.2 months . The majority of studies ( 13 out of 27 , 48 % ) involved the evaluation of complete and /or partial tumour responses , with regard to the end points supporting the 27 indications . Despite the recommendations of the current EMEA guidance documents , new anticancer agents are still often approved on the basis of small single arm trials that do not allow any assessment of an ‘ acceptable and extensively documented toxicity profile ’ and of end points such as response rate , time to progression or progression-free survival which at best can be considered indicators of anticancer activity and are not ‘ justified surrogate markers for clinical benefit ’ . Anticipating an earlier than ideal point along the drug approval path and the use of not fully vali date d surrogate end points in nonr and omised trials looks like a dangerous shortcut that might jeopardise consumers ' health , leading to unsafe and ineffective drugs being marketed and prescribed . The present Note for Guidance for new anticancer agents needs revising . Drugs must be rapidly released for patients who need them but not be at the expense of adequate knowledge about the real benefit of the drugs PURPOSE Trastuzumab shows clinical activity in human epidermal growth factor receptor 2 (HER-2)-positive early and advanced breast cancer . In the German Breast Group 26/Breast International Group 03 - 05 trial , we investigated if trastuzumab treatment should be continued beyond progression . METHODS Patients with HER-2-positive breast cancer that progresses during treatment with trastuzumab were r and omly assigned to receive capecitabine ( 2,500 mg/m(2 ) body-surface area on days 1 through 14 [ 1,250 mg/m(2 ) semi-daily ] ) alone or with continuation of trastuzumab ( 6 mg/kg body weight ) in 3-week cycles . The primary end point was time to progression . RESULTS We r and omly assigned 78 patients to capecitabine and 78 patients to capecitabine plus trastuzumab . Sixty-five events and 38 deaths in the capecitabine group and 62 events and 33 deaths in the capecitabine-plus-trastuzumab group occurred during 15.6 months of follow-up . Median times to progression were 5.6 months in the capecitabine group and 8.2 months in the capecitabine-plus-trastuzumab group with an unadjusted hazard ratio of 0.69 ( 95 % CI , 0.48 to 0.97 ; two-sided log-rank P = .0338 ) . Overall survival rates were 20.4 months ( 95 % CI , 17.8 to 24.7 ) in the capecitabine group and 25.5 months ( 95 % CI , 19.0 to 30.7 ) in the capecitabine-plus-trastuzumab group ( P = .257 ) . Overall response rates were 27.0 % with capecitabine and 48.1 % with capecitabine plus trastuzumab ( odds ratio , 2.50 ; P = .0115 ) . Continuation of trastuzumab beyond progression was not associated with increased toxicity . CONCLUSION Continuation of trastuzumab plus capecit Output:
For haematological toxicities , such as neutropenic fever and anaemia , there was no clear evidence that risks differed between groups , while trastuzumab seemed to raise the risk of neutropenia . The overall survival improvement was maintained when considering patients treated as first-line or patients receiving taxane-based regimens . The progression-free survival improvement was maintained when considering patients receiving taxane-based regimens , and patients treated as first-line or subsequent lines . Trastuzumab improved overall survival and progression-free survival in HER2-positive women with metastatic breast cancer , but it also increased the risk of cardiac toxicities , such as congestive heart failure and LVEF decline .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background Research and practice partnerships have the potential to enhance the translation of research findings into practice . Purpose This paper describes such a partnership in the development of Walk Kansas ( WK ) and highlights individual and organizational level outcomes . Method Phase 1 examined : ( a ) the reach of WK , ( b ) physical activity changes , and ( c ) maintenance of physical activity changes 6 months after the program was completed . Phase 2 explored WK adoption and sustainability over 5 years . Results WK attracted a large number of participants who were more likely to be female , more active , and older than the adult population within the counties where they resided . Inactive or insufficiently active participants at baseline experienced significant increases in both moderate ( p < 0.001 ) and vigorous ( p < 0.001 ) physical activity . A r and om selection of participants who were assessed 6 months post-program did not demonstrate a significant decrease in moderate or vigorous activity between program completion and 6-month follow-up . The number of counties adopting the program increased across years , peaking at 97 in 2006 and demonstrated the sustainability of the WK over 5 years . Conclusions WK is effective , has a broad reach , and enables participants to maintain increased activity . It also shows promise for broad adoption and sustainability It is becoming increasingly common for community teams or coalitions to implement programming for children and families design ed to promote positive youth development and prevent adolescent problem behaviors . However , there has been only limited rigorous study of the effectiveness of community teams ’ programming efforts to produce positive outcomes . This study employed a community-level r and omized control design to examine protective parent and youth skills outcomes of evidence -based preventive interventions selected from a menu and delivered by community teams supported by a community – university partnership model called PROSPER . Twenty-eight rural communities in two states were r and omized across intervention and control conditions . Data were collected through written question naires that were completed by approximately 12,000 middle school students in the fall of the 6th grade , prior to intervention delivery , and again in the spring of the 7th , 8th , and 9th grade s. Positive intervention effects were found for youth , parent , and family outcomes ( e.g. , association with antisocial peers , child management , parent – child affective quality ) at each post-intervention assessment point . Improvements in these family and youth skill outcomes are expected to support long-term reductions of adolescent problem behaviors , such as substance abuse . Editors ’ Strategic Implication s : In this important and well controlled trial , the authors demonstrate that university partnership-supported community teams , especially when supported with ongoing technical assistance , can continue to produce positive outcomes even after much of the control over delivery of programs is turned over to representatives of the communities in which they are implemented This study examined the longitudinal predictors of quality of functioning of community prevention teams during the “ operations ” phase of team development . The 14 community teams were involved in a r and omized-trial of a university-community partnership project , PROSPER ( Spoth et al. , Prevention Science , 5(1 ) : 31–39 , 2004b ) , that implements evidence -based interventions intended to support positive youth development and reduce early substance use , as well as other problem behaviors . The study included a multi-informant approach to measurement of constructs , and included data from 137 team members , 59 human service agency directors and school administrators , 16 school principals , and 8 Prevention Coordinators ( i.e. technical assistance providers ) . We examined how community demographics and social capital , team level characteristics , and team member attributes and attitudes are related to local team functioning across an 18-month period . Findings indicate that community demographics ( poverty ) , social capital , team member attitudes towards prevention , and team members ’ views of the acceptability of teen alcohol use played a substantial role in predicting various indicators of the quality of team functioning 18 months later BACKGROUND If positive- outcome bias exists , it threatens the integrity of evidence -based medicine . METHODS We sought to determine whether positive- outcome bias is present during peer review by testing whether peer review ers would ( 1 ) recommend publication of a " positive " version of a fabricated manuscript over an otherwise identical " no-difference " version , ( 2 ) identify more purpose fully placed errors in the no-difference version , and ( 3 ) rate the " Methods " section in the positive version more highly than the identical " Methods " section in the no-difference version . Two versions of a well- design ed r and omized controlled trial that differed only in the direction of the finding of the principal study end point were su bmi tted for peer review to 2 journals in 2008 - 2009 . Of 238 review ers for The Journal of Bone and Joint Surgery and Clinical Orthopaedics and Related Research r and omly allocated to review either a positive or a no-difference version of the manuscript , 210 returned review s. RESULTS Review ers were more likely to recommend the positive version of the test manuscript for publication than the no-difference version ( 97.3 % vs 80.0 % , P < .001 ) . Review ers detected more errors in the no-difference version than in the positive version ( 0.85 vs 0.41 , P < .001 ) . Review ers awarded higher methods scores to the positive manuscript than to the no-difference manuscript ( 8.24 vs 7.53 , P = .005 ) , although the " Methods " sections in the 2 versions were identical . CONCLUSIONS Positive- outcome bias was present during peer review . A fabricated manuscript with a positive outcome was more likely to be recommended for publication than was an otherwise identical no-difference manuscript Using community-based participatory research methods , a community- research coalition in Santa Clara County , California ( SCC ) conducted a quasi-experimental , controlled trial to increase Pap test receipt and to build community capacity among Vietnamese-American women . From 1999 to 2004 , the Coalition planned and implemented an Action Plan with six components : multimedia campaign , lay health worker outreach , Vietnamese Pap clinic with patient navigation , registry and reminder system , continuing medical education for Vietnamese physicians , and restoring a Breast and Cervical Cancer Control Program site . Components were evaluated individually . Community-wide , cross-sectional telephone surveys of Vietnamese women in SCC ( intervention community ) and Harris County , Texas ( comparison community ) measured overall project impact . Receipt and currency of Pap tests increased significantly in the intervention compared with the comparison community . Community involvement , system changes , community and research capacity building , dissemination of results , and program sustainability were also demonstrated . Community-based participatory research is feasible and effective in Vietnamese-American communities BACKGROUND Traditional research approaches frequently fail to yield representative numbers of people of color in research . Community-based participatory research ( CBPR ) may be an important strategy for partnering with and reaching population s that bear a greater burden of illness but have been historically difficult to engage . The Community Action Board , consisting of 20 East Harlem residents , leaders , and advocates , used CBPR to compare the effectiveness of various strategies in recruiting and enrolling adults with prediabetes into a peer-led , diabetes prevention intervention . METHODS The board created five recruitment strategies : recruiting through clinicians ; recruiting at large public events such as farmers markets ; organizing special local recruitment events ; recruiting at local organizations ; and recruiting through a partner-led approach , in which community partners developed and managed the recruitment efforts at their sites . RESULTS In 3 months , 555 local adults were approached ; 249 were appropriate c and i date s for further evaluation ( overweight , nonpregnant , East Harlem residents without known diabetes ) ; 179 consented and returned in a fasting state for 1/2 day of prediabetes testing ; 99 had prediabetes and enrolled in a pilot r and omized trial . The partner-led approach was highly successful , recruiting 68 % of those enrolled . This strategy was also the most efficient ; 34 % of those approached through partners were ultimately enrolled , versus 0%-17 % enrolled through the other four strategies . Participants were predominantly low-income , uninsured , undereducated , Spanish-speaking women . CONCLUSIONS This CBPR approach highlights the value of partner-led recruitment to identify , reach out to , and motivate a vulnerable population into participation in research , using techniques that may be unfamiliar to research ers but are nevertheless rigorous and effective Many promising technology-based programs design ed to promote healthy behaviors such as physical activity and healthy eating have not been adapted for use with diverse communities , including Latino communities . We design ed a community-based health kiosk program for English- and Spanish-speaking Latinos . Users receive personalized feedback on nutrition , physical activity , and smoking behaviors from computerized role models that guide them in establishing goals in 1 or more of these 3 areas . We found significant improvements in nutrition and physical activity among 245 Latino program users ; however , no changes were observed with respect to smoking behaviors . The program shows promise for extending the reach of chronic disease prevention and self-management programs OBJECTIVES Our community-academic partnership employed community-based participatory research to develop and pilot a simple , peer-led intervention to promote weight loss , which can prevent diabetes and eliminate racial/ethnic disparities in incident diabetes among overweight adults with prediabetes . METHODS We recruited overweight adults at community sites , performed oral glucose tolerance testing to identify persons with blood glucose levels in the prediabetes range , and r and omized eligible people to a peer-led lifestyle intervention group or delayed intervention in 1 year . Outcomes , including weight , blood pressure , and health behaviors , were measured at baseline and 3 , 6 , and 12 months . RESULTS More than half of those tested ( 56 % , or 99 of 178 ) had prediabetes and enrolled in the study . Participants were predominantly Spanish-speaking , low-income , undereducated women . The intervention group lost significantly more weight than the control group and maintained weight loss at 12 months ( 7.2 versus 2.4 pounds ; P < .01 ) . One fourth ( 24 of 99 ) of participants progressed to diabetes . CONCLUSIONS In underserved minority communities , prediabetes prevalence may be higher than previously reported . Low-cost , community-based interventions can succeed in encouraging weight loss to prevent diabetes This study investigated the effectiveness of a community-academic health center partnership , utilizing nurse-supervised indigenous community health workers , in decreasing the blood pressure in an urban African-American population . A four-year r and omized clinical trial was conducted in the S and town-Winchester community , which has an excess prevalence of high blood pressure , in order to test the effectiveness of 2 different levels of intervention intensity on increasing the control of high blood pressure . Community health workers were trained and certified in blood pressure management , monitoring , education and counseling , social support mobilization , and community outreach and follow up . The primary results were a significant decrease in mean systolic and diastolic pressures after both levels of intervention , and a significant increase in the percentage of individuals with controlled high blood pressure . Surprisingly , no differences in results were observed between the 2 levels of intervention intensity . This study supports the use of community-based partnership efforts , and the utilization of indigenous health workers , to enhance the control of high blood pressure in a high-risk , African-American urban population This project evaluated an intervention for preventing peer rejection in middle school that promoted social acceptance in the classroom environment . The systems-level and preventive focus of this intervention differed markedly from traditional interventions that target putative deficits within individual rejected children . In collaboration with 24 teachers and their classrooms , the intervention team led mixed groups of accepted and rejected children in cooperative games that required teamwork and mutual respect among all members in order to succeed . To reinforce these alliances between children , as well as to prevent future peer rejection , teachers were encouraged to use cooperative , teamwork-based group activities for academic instruction . The intervention was evaluated using a r and omized control ( waitlist ) design . Results suggested that the intervention reduced the amount of self-reported peer rejection in classrooms . Implication s for the further development and evaluation of systems-level interventions to prevent peer rejection are discussed . Editors ’ Strategic Implication s : The use of a systems-based prevention program shows promise for the prevention of children ’s perceived peer rejection . The authors demonstrate a model of university-community collaboration with a plan for sustainability and a focus on low-income and minority population s. Educators , school administrators , and research ers will be intrigued by the positive experiences of non-rejected peers and teachers in promoting a socially accepting school climate There has been relatively little research on effects of interventions aim ed directly at improving internal community coalition functioning , particularly in the area of planning for adoption of evidence -based prevention programs . The current study investigated the effect of Project STEP , a prevention diffusion trial , on three factors hypothesized to improve coalition prevention planning ( quality of coalition plans , extent of plan implementation , and committee internal functioning in meetings ) . Cities were r and omly assigned to one of three conditions ( televised training with limited technical assistance , televised training alone , or control ; n = 24 ) . Results demonstrated that at 1.5 year follow-up , coalitions in the two intervention groups showed more effective prevention plans , plan implementation , and functioning in meetings than control coalitions . Group differences were maintained at 3-year follow-up , albeit at decreased levels , for quality of planning and implementation . The findings suggest that building coalition capacity to diffuse evidence -based prevention programs works at least partially by increasing the effectiveness of coalition functioning , and that booster training may be warranted within 3 years after initial training Nearly 2 million children live or work on America 's farms and ranches . Despite the increasing mechanization of production agriculture in the United States , children still constitute a considerable portion of the work force on farms and ranches . When adjusted for actual work exposure time , adolescent injury rates on agricultural establishments surpass those of adults ( Castillo , D. N. , L and en , D. D. , & Layne , L. A. ( 1994 ) . American Journal of Output:
Although CBPR trials examined a wide range of behavioral and clinical outcomes , such trials had very high success rates in recruiting and retaining minority participants and achieving significant intervention effects . CONCLUSIONS Significant publication gaps remain between CBPR and other interventional research methods . CBPR may be effective in increasing participation of racial and ethnic minority subjects in research and may be a powerful tool in testing the generalizability of effective interventions among these population s. CBPR holds promise as an approach that may contribute greatly to the study of health care delivery to disadvantaged population
MS2_1shot247
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: BACKGROUND Some observational studies suggest that the use of pulmonary-artery catheters to guide therapy is associated with increased mortality . METHODS We performed a r and omized trial comparing goal -directed therapy guided by a pulmonary-artery catheter with st and ard care without the use of a pulmonary-artery catheter . The subjects were high-risk patients 60 years of age or older , with American Society of Anesthesiologists ( ASA ) class III or IV risk , who were scheduled for urgent or elective major surgery , followed by a stay in an intensive care unit . Outcomes were adjudicated by observers who were unaware of the treatment-group assignments . The primary outcome was in-hospital mortality from any cause . RESULTS Of 3803 eligible patients , 1994 ( 52.4 percent ) underwent r and omization . The base-line characteristics of the two treatment groups were similar . A total of 77 of 997 patients who underwent surgery without the use of a pulmonary-artery catheter ( 7.7 percent ) died in the hospital , as compared with 78 of 997 patients in whom a pulmonary-artery catheter was used ( 7.8 percent)--a difference of 0.1 percentage point ( 95 percent confidence interval , -2.3 to 2.5 ) . There was a higher rate of pulmonary embolism in the catheter group than in the st and ard-care group ( 8 events vs. 0 events , P=0.004 ) . The survival rates at 6 months among patients in the st and ard-care and catheter groups were 88.1 and 87.4 percent , respectively ( difference , -0.7 percentage point [ 95 percent confidence interval , -3.6 to 2.2 ] ; negative survival differences favor st and ard care ) ; at 12 months , the rates were 83.9 and 83.0 percent , respectively ( difference , -0.9 percentage point [ 95 percent confidence interval , -4.3 to 2.4 ] ) . The median hospital stay was 10 days in each group . CONCLUSIONS We found no benefit to therapy directed by pulmonary-artery catheter over st and ard care in elderly , high-risk surgical patients requiring intensive care Introduction Several studies have shown that goal -directed hemodynamic and fluid optimization may result in improved outcome . However , the methods used were either invasive or had other limitations . The aim of this study was to perform intraoperative goal -directed therapy with a minimally invasive , easy to use device ( FloTrac/Vigileo ) , and to evaluate possible improvements in patient outcome determined by the duration of hospital stay and the incidence of complications compared to a st and ard management protocol . Methods In this r and omized , controlled trial 60 high-risk patients scheduled for major abdominal surgery were included . Patients were allocated into either an enhanced hemodynamic monitoring group using a cardiac index based intraoperative optimization protocol ( FloTrac/Vigileo device , GDT-group , n = 30 ) or a st and ard management group ( Control-group , n = 30 ) , based on st and ard monitoring data . Results The median duration of hospital stay was significantly reduced in the GDT-group with 15 ( 12 - 17.75 ) days versus 19 ( 14 - 23.5 ) days ( P = 0.006 ) and fewer patients developed complications than in the Control-group [ 6 patients ( 20 % ) versus 15 patients ( 50 % ) , P = 0.03 ] . The total number of complications was reduced in the GDT-group ( 17 versus 49 complications , P = 0.001 ) . Conclusions In high-risk patients undergoing major abdominal surgery , implementation of an intraoperative goal -directed hemodynamic optimization protocol using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of complications compared to a st and ard management protocol .Trial Registration Clinical trial registration information : Unique identifier : BACKGROUND Patients with proximal femoral fracture ( PFF ) are at high risk of postoperative complications . Goal -directed haemodynamic treatment ( GDHT ) in other high-risk surgical patients reduces postoperative complications . We aim ed to compare effects of GDHT and routine fluid treatment ( RFT ) on postoperative outcomes after PFF surgery . METHODS PFF patients ( ≥70 yr ) were enrolled in this single-centre , open , r and omized , controlled , parallel-group superiority trial with concealed allocation using computer-generated r and omization . TREATMENTS ( i ) GDHT to attain oxygen delivery index > 600 ml min(-1 ) m(-2 ) using fluids and dobutamine and ( ii ) a protocol -guided RFT . After 150 enrolled patients , the trial was stopped due to slow recruitment . The short-term primary outcome measure was the relative risk ( RR ) of postoperative complications ; secondary measures were ( i ) administered fluid levels , ( ii ) vasopressor requirements , and ( iii ) haemodynamic responses . RESULTS For the GDHT group , 74 and for the RFT group 75 patients were design ated . The RR of postoperative complications ( GDHT vs RFT ) was 0.79 ( 95 % confidence interval 0.54 - 1.16 ) ; the volumes of i.v . fluids decreased ( 1078 vs 1440 ml , P=0.01 ) ; fewer patients required treatment of hypotension ( 18.5 % vs 75 % , P<0.005 ) ; there were more patients with increased oxygen delivery at the end of operation ( 28 % vs 8 % , P=0.04 ) , but the haemodynamic goal was achieved in only 27 % of patients in the GDHT group . CONCLUSIONS The magnitude of risk reduction of postoperative complications is clinical ly relevant , but the trial was underpowered and the null hypothesis can not be rejected Introduction Little is known about mortality rates following general surgical procedures in the United Kingdom . Deaths are most common in the ' high-risk ' surgical population consisting mainly of older patients , with coexisting medical disease , who undergo major surgery . Only limited data are presently available to describe this population . The aim of the present study was to estimate the size of the high-risk general surgical population and to describe the outcome and intensive care unit ( ICU ) re source use . Methods Data on inpatient general surgical procedures and ICU admissions in 94 National Health Service hospitals between January 1999 and October 2004 were extracted from the Intensive Care National Audit & Research Centre data base and the CHKS data base . High-risk surgical procedures were defined prospect ively as those for which the mortality rate was 5 % or greater . Results There were 4,117,727 surgical procedures ; 2,893,432 were elective ( 12,704 deaths ; 0.44 % ) and 1,224,295 were emergencies ( 65,674 deaths ; 5.4 % ) . A high-risk population of 513,924 patients was identified ( 63,340 deaths ; 12.3 % ) , which accounted for 83.8 % of deaths but for only 12.5 % of procedures . This population had a prolonged hospital stay ( median , 16 days ; interquartile range , 9–29 days ) . There were 59,424 ICU admissions ( 11,398 deaths ; 19 % ) . Among admissions directly to the ICU following surgery , there were 31,633 elective admissions with 3,199 deaths ( 10.1 % ) and 24,764 emergency admissions with 7,084 deaths ( 28.6 % ) . The ICU stays were short ( median , 1.6 days ; interquartile range , 0.8–3.7 days ) but hospital admissions for those admitted to the ICU were prolonged ( median , 16 days ; interquartile range , 10–30 days ) . Among the ICU population , 40.8 % of deaths occurred after the initial discharge from the ICU . The highest mortality rate ( 39 % ) occurred in the population admitted to the ICU following initial postoperative care on a st and ard ward . Conclusion A large high-risk surgical population accounts for 12.5 % of surgical procedures but for more than 80 % of deaths . Despite high mortality rates , fewer than 15 % of these patients are admitted to the ICU Background Our aim was to determine whether substitution of goal -directed fluid therapy ( GDT ) ( perioperative fluid administration ) for traditional therapy to manage elderly patients with coronary heart disease scheduled for gastrointestinal ( GI ) surgery was advantageous . We determined if it would reduce cardiac complications and shorten time to recovery and discharge . Methods Altogether , 60 of these elderly patients were r and omized into GDT ( n = 30 ) and control ( n = 30 ) groups . In the GDT group , fluid management was carried out under guidance of hemodynamic status indicators . Types and quantities of fluids administered , blood loss , intraoperative urine output , time of extubation , intensive care unit ( ICU ) stay , hospital stay , postoperative adverse cardiac events , and GI complications were recorded . Results Total fluids infused were 2,910 ± 645 ml ( GDT group ) and 3,640 ± 771 ml ( control group ) ( p < 0.05 ) . Numbers of adverse cardiac events in the two groups were not significantly different ( p = 0.121 ) . Return of GI function was significantly faster in the GDT group ( p < 0.001 ) . Median ICU stay was 32.5 h in the GDT group and 47.5 h in the control group ( p < 0.001 ) . Median hospital stay was 18 days in the GDT group and 22 days in the control group ( p < 0.001 ) . Conclusions GDT was associated with shorter ICU stay and time to discharge and faster return of GI function compared to traditional fluid therapy . The number of adverse cardiac events was similar in the two groups OBJECTIVES : This pilot study was design ed to utilize stroke volume variation and cardiac index to ensure fluid optimization during one-lung ventilation in patients undergoing thoracoscopic lobectomies . METHODS : Eighty patients undergoing thoracoscopic lobectomy were r and omized into either a goal -directed therapy group or a control group . In the goal -directed therapy group , the stroke volume variation was controlled at 10%±1 % , and the cardiac index was controlled at a minimum of 2.5 L.min-1.m-2 . In the control group , the MAP was maintained at between 65 mm Hg and 90 mm Hg , heart rate was maintained at between 60 BPM and 100 BPM , and urinary output was greater than 0.5 mL/kg-1/h-1 . The hemodynamic variables , arterial blood gas analyses , total administered fluid volume and side effects were recorded . RESULTS : The PaO2/FiO2-ratio before the end of one-lung ventilation in the goal -directed therapy group was significantly higher than that of the control group , but there were no differences between the goal -directed therapy group and the control group for the PaO2/FiO2-ratio or other arterial blood gas analysis indices prior to anesthesia . The extubation time was significantly earlier in the goal -directed therapy group , but there was no difference in the length of hospital stay . Patients in the control group had greater urine volumes , and they were given greater colloid and overall fluid volumes . Nausea and vomiting were significantly reduced in the goal -directed therapy group . CONCLUSION : The results of this study demonstrated that an optimization protocol , based on stroke volume variation and cardiac index obtained with a FloTrac/Vigileo device , increased the PaO2/FiO2-ratio and reduced the overall fluid volume , intubation time and postoperative complications ( nausea and vomiting ) in thoracic surgery patients requiring one-lung ventilation BACKGROUND A prospect i ve , r and omized controlled trial comparing conventional intraoperative fluid management with two differing methods of invasive haemodynamic monitoring to optimize intraoperative fluid therapy , in patients undergoing proximal femoral fracture repair under general anaesthesia . METHODS Ninety patients r and omized to three groups ; conventional intraoperative fluid management ( Gp CON , n=29 ) , and two groups receiving additional repeated colloid fluid challenges guided by central venous pressure ( Gp CVP , n=31 ) or oesophageal Doppler ultrasonography ( Gp DOP , n=30 ) . Primary outcome measures were time to medical fitness to discharge , hospital stay and postoperative morbidity . RESULTS The fluid challenge result ed in significantly greater perioperative changes in central venous pressure between Gp CVP and Gp CON ( mean 5 ( 95 % confidence interval 3 - 7 ) mm Hg ) ( P<0.0001 ) . Important perioperative changes were also shown in Gp DOP with increases of 49.4 ms ( 19.7 - 79.1 ms ) in the corrected flow time , 13.5 ml ( 7.4 - 19.6 ml ) in stroke volume , and 0.9 ( 0.49 - 1.39 ) litre min(-1 ) in cardiac output . As a result , fewer patients in Gp CVP and Gp DOP experienced severe intraoperative hypotension ( Gp CON 28 % ( 8/29 ) , Gp CVP 9 % ( 3/31 ) , Gp DOP 7 % ( 2/30 ) , P=0.048 ( chi-squared , 2 degrees of freedom ( df ) . Output:
Intraoperative goal directed hemodynamic therapy with minimally invasive monitoring decreases postoperative complications in noncardiac surgery , although it was not able to show a significant decrease in mortality rate
MS2_1shot248
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVES The purpose of this study was to investigate the 2-year outcome of percutaneous coronary intervention ( PCI ) guided by fractional flow reserve ( FFR ) in patients with multivessel coronary artery disease ( CAD ) . BACKGROUND In patients with multivessel CAD undergoing PCI , coronary angiography is the st and ard method for guiding stent placement . The FAME ( Fractional Flow Reserve Versus Angiography for Multivessel Evaluation ) study showed that routine FFR in addition to angiography improves outcomes of PCI at 1 year . It is unknown if these favorable results are maintained at 2 years of follow-up . METHODS At 20 U.S. and European medical centers , 1,005 patients with multivessel CAD were r and omly assigned to PCI with drug-eluting stents guided by angiography alone or guided by FFR measurements . Before r and omization , lesions requiring PCI were identified based on their angiographic appearance . Patients r and omized to angiography-guided PCI underwent stenting of all indicated lesions , whereas those r and omized to FFR-guided PCI underwent stenting of indicated lesions only if the FFR was < or=0.80 . RESULTS The number of indicated lesions was 2.7+/-0.9 in the angiography-guided group and 2.8+/-1.0 in the FFR-guided group ( p=0.34 ) . The number of stents used was 2.7+/-1.2 and 1.9+/-1.3 , respectively ( p<0.001 ) . The 2-year rates of mortality or myocardial infa rct ion were 12.9 % in the angiography-guided group and 8.4 % in the FFR-guided group ( p=0.02 ) . Rates of PCI or coronary artery bypass surgery were 12.7 % and 10.6 % , respectively ( p=0.30 ) . Combined rates of death , nonfatal myocardial infa rct ion , and revascularization were 22.4 % and 17.9 % , respectively ( p=0.08 ) . For lesions deferred on the basis of FFR>0.80 , the rate of myocardial infa rct ion was 0.2 % and the rate of revascularization was 3.2 % after 2 years . CONCLUSIONS Routine measurement of FFR in patients with multivessel CAD undergoing PCI with drug-eluting stents significantly reduces mortality and myocardial infa rct ion at 2 years when compared with st and ard angiography-guided PCI . ( Fractional Flow Reserve Versus Angiography for Multivessel Evaluation [ FAME ] ; NCT00267774 ) Background Regadenoson is a selective A2A adenosine receptor agonist and vasodilator used to increase the heterogeneity of distribution of coronary blood flow during myocardial perfusion imaging . This study characterized the dose dependence of regadenoson-induced coronary hyperemia . Methods and Results An open-label , dose-escalation study of regadenoson ( 10–500μg , rapid intravenous bolus ) was performed in 34 subjects ; in 4 additional subjects , the effect of aminophylline to reverse the response to regadenoson was determined . Intracoronary peak blood flow velocity in either the left anterior descending or left circumflex artery was measured by continuous Doppler , signal recording , heart rate , central aortic blood pressure , and adverse effects were recorded . Regadenoson increased peak blood flow velocity by up to 3.4-fold in a dose-dependent manner . The mean duration of the increase in flow velocity of 2.5-fold or greater caused by 400 to 500 μg of regadenoson was 2.3 to 2.4 minutes . Regadenoson ( 400–500 μg ) increased heart rate by up to 21±6 beats/min and decreased systolic blood pressure ( −5±8 mm Hg to −24±16 mm Hg ) and diastolic blood pressure ( −8±4 mm Hg to −15±14 mm Hg ) . Aminophylline ( 100 mg ) attenuated the increase in peak flow velocity but not tachycardia caused by 400 μg of regadenoson . Conclusion The results of this study demonstrate the utility of regadenoson as a coronary vasodilator for myocardial perfusion imaging OBJECTIVES The purpose of this study was to investigate the appropriateness of stenting a functionally nonsignificant stenosis . BACKGROUND Percutaneous coronary intervention ( PCI ) of an intermediate stenosis without evidence of ischemia is often performed , but its benefit is unproven . Coronary pressure-derived fractional flow reserve ( FFR ) is an invasive index used to identify a stenosis responsible for reversible ischemia . METHODS In 325 patients scheduled for PCI of an intermediate stenosis , FFR was measured just before the planned intervention . If FFR was > or = 0.75 , patients were r and omly assigned to deferral ( Defer group ; n = 91 ) or performance ( Perform group ; n = 90 ) of PCI . If FFR was < 0.75 , PCI was performed as planned ( Reference group ; n = 144 ) . Clinical follow-up was 5 years . RESULTS There were no differences in baseline clinical characteristics between the 3 groups . Complete follow-up was obtained in 98 % of the patients . Event-free survival was not different between the Defer and Perform groups ( 80 % and 73 % , respectively ; p = 0.52 ) , but was significantly worse in the Reference group ( 63 % ; p = 0.03 ) . The composite rate of cardiac death and acute myocardial infa rct ion in the Defer , Perform , and Reference groups was 3.3 % , 7.9 % , and 15.7 % , respectively ( p = 0.21 for Defer vs. Perform group ; p = 0.003 for the Reference vs. both other groups ) . The percentage of patients free from chest pain at follow-up was not different between the Defer and Perform groups . CONCLUSIONS Five-year outcome after deferral of PCI of an intermediate coronary stenosis based on FFR > /=0.75 is excellent . The risk of cardiac death or myocardial infa rct ion related to this stenosis is < 1 % per year and not decreased by stenting Background Earlier phase 1 and 2 studies have shown that regadenoson has desirable features as a stress agent for myocardial perfusion imaging . Methods and Results This multicenter , double-blinded phase 3 trial involved 784 patients at 54 sites . Each patient underwent 2 sets of gated single photon emission computed tomography myocardial perfusion imaging studies : an initial qualifying study with adenosine and a subsequent r and omized study with either regadenoson ( 2/3 of patients ) or adenosine . Regadenoson was administered as a rapid bolus ( < 10 seconds ) of 400 μg . The primary endpoint was to demonstrate noninferiority by showing that the difference in the strength of agreement in detecting reversible defects , based on blinded reading , between sequential adenosine-regadenoson images and adenosine-adenosine images , lay above a prespecified noninferiority margin . Other prospect ively defined safety and tolerability comparisons and supporting analyses were also performed . The average agreement rate based on the median of 3 independent blinded readers was 0.63±0.03 for regadenoson-adenosine and 0.64±0.04 for adenosine-adenosine — a 1 % absolute difference with the lower limit of the 95 % confidence interval lying above the prespecified noninferiority margin . Side-by-side interpretation of regadenoson and adenosine images provided comparable results for detecting reversible defects . The peak increase in heart rate was greater with regadenoson than adenosine , but the blood pressure nadir was similar . A summed symptom score of flushing , chest pain , and dyspnea was less with regadenoson than adenosine ( P=.013 ) . Conclusions This phase 3 trial shows that regadenoson provides diagnostic information comparable to a st and ard adenosine infusion . There were no serious drug-related side effects , and regadenoson was better tolerated than adenosine OBJECTIVES To compare the effects of age , gender , body mass index , and diabetes on the safety and efficacy of regadenoson stress myocardial perfusion imaging , and to assess the noninferiority of regadenoson to adenosine for the detection of reversible myocardial perfusion defects . BACKGROUND Previous reports have shown that a fixed unit bolus of regadenoson is safe and noninferior to adenosine for the detection of reversible perfusion defects by radionuclide imaging . METHODS Using a data base of 2,015 patients , we evaluated the effects of age , gender , body mass index , and diabetes on the safety and efficacy of regadenoson compared to adenosine . RESULTS For detection of ischemia relative to adenosine , noninferiority was demonstrated for all patients ( agreement rate difference 0 % , 95 % CI -6.2 % to + 6.8 % ) . The average agreement rate between adenosine-adenosine and adenosine-regadenoson were 0.62 + /- 0.03 and 0.63 + /- 0.02 . Detection of ischemia was also comparable in specific subgroups . Agreement was less for both agents in women versus men with moderate and large areas of ischemia . Compared to adenosine , regadenoson had a lower combined symptom score and less chest pain , flushing , and throat , neck , or jaw pain , but more headache and gastrointestinal discomfort . This was true in nearly all subgroups . Regadenoson patients reported feeling more comfortable ( 1.7 + /- .02 vs. 1.9 + /- 0.03 , p < 0.001 ) . Based on the overall tolerability score , women felt less comfortable than men with both stress agents . Image quality was rated good or excellent in 92 % for both agents . CONCLUSIONS Regadenoson can be safely administered as a fixed unit bolus and is as efficacious as adenosine in detecting ischemia regardless of age , gender , body mass index , and diabetes . Regadenoson is better tolerated overall and across various subgroups Background . Patients with reactive airways are at risk for adenosine-induced bronchoconstriction , mediated via A2B and /or A3 adenosine receptors . Methods and Results . In this r and omized , double-blind , placebo-controlled crossover trial , we examined the safety of regadenoson , a selective adenosine A2A receptor agonist , in patients with moderate chronic obstructive pulmonary disease ( COPD ) ( n=38 ) and patients with severe COPD ( n=11 ) with a baseline mean forced expiratory volume in 1 second ( FEV1 ) of 1.74±0.50 L and 1.0±0.35 L , respectively , 37 % of whom had dyspnea during activities of daily living . Patients receiving glucocorticoids or oxygen and those with pretreatment wheezing were included . Short-acting bronchodilators were withheld for at least 8 hours before treatment . No differences emerged between regadenoson and placebo on multiple lung function parameters , including repeated FEV1 and forced vital capacity , respiratory rate , pulmonary examinations , and oxygen saturation . The mean maximum decline in FEV1 was 0.11±0.02 L and 0.12±0.02 L ( P=.55 ) in patients after regadenoson and placebo , respectively , and new-onset wheezing was observed in 6 % and 12 % , respectively ( P=.33 ) . No patient required acute treatment with bronchodilators or oxygen . Conclusions . This pilot study showed the overall safety of regadenoson in 49 compromised out patients with clinical ly stable moderate and severe chronic obstructive pulmonary disease AIMS The aim of this study was to compare the hyperaemic effect of a single bolus regadenoson injection to a central venous adenosine infusion for inducing hyperaemia in the measurement of fractional flow reserve ( FFR ) . METHODS AND RESULTS One hundred patients scheduled for FFR measurement were enrolled . FFR was first measured by IV adenosine ( 140 µg/kg/min ) , thereafter by IV bolus regadenoson injection ( 400 µg ) , followed by another measurement by IV adenosine and bolus injection of regadenoson . The regadenoson injections were r and omised to central or peripheral intravenous . Hyperaemic response and duration of steady state maximum hyperaemia were studied , central versus peripheral venous regadenoson injections were compared , and safety and reproducibility of repeated injections were investigated . Mean age was 66±8 years , 75 % of the patients were male . The target stenosis was located in the LM , LAD , LCX , and RCA in 7 % , 54 % , 20 % and 19 % , respectively . There was no difference in FFR measured by adenosine or by regadenoson ( ΔFFR=0.00±0.01 , r=0.994 , p<0.001 ) . Duration of maximum hyperaemia after regadenoson was variable ( 10 - 600 s ) . No serious side effects of either drug were observed . CONCLUSIONS Maximum coronary hyperaemia can be achieved easily , rapidly , and safely by one single intravenous bolus of Output:
IV regadenoson and IC nitroprusside produce similar pressure-derived FFR measurements compared to IV adenosine and have a favorable side effect profile . Both can be considered as alternative agents to IV adenosine for FFR measurement .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: We have compared the effects of dexmedetomidine and propofol on endocrine , metabolic , inflammatory and cardiovascular responses in patients in the intensive care unit ( ICU ) after major surgery . Twenty patients who were expected to require 8 h of post-operative sedation and ventilation were allocated r and omly to receive either an infusion of dexmedetomidine 0.2 - 2.5 microg kg(-1 ) h(-1 ) or propofol 1 - 3 mg kg(-1 ) h(-1 ) . Arterial pressure , heart rate and sequential concentrations of circulating cortisol , adrenocorticotrophic hormone ( ACTH ) , growth hormone , prolactin , insulin , glucose and interleukin 6 were measured . An ACTH stimulation test was performed in all patients who received dexmedetomidine . Heart rate was significantly lower in the dexmedetomidine patients . There were no differences in arterial pressure , cortisol , ACTH , prolactin and glucose concentrations between the two groups . A positive response to the ACTH stimulation test varied depending on the diagnostic criteria used . The insulin concentration was significantly lower in the dexmedetomidine group at 2 h ( P=0.021 ) , although this did not affect blood glucose concentrations . Growth hormone concentrations were significantly higher in dexmedetomidine-treated patients overall ( P=0.036 ) , but circulating concentrations remained in the physiological range . Interleukin 6 decreased in the dexmedetomidine group . We conclude that dexmedetomidine infusion does not inhibit adrenal steroidogenesis when used for short-term sedation after surgery Introduction Sepsis , a systemic inflammatory response to infective etiologies , has a high mortality rate that is linked both to excess cytokine activity and apoptosis of critical immune cells . Dexmedetomidine has recently been shown to improve outcome in a septic cohort of patients when compared to patients r and omized to a benzodiazepine-based sedative regimen . We sought to compare the effects of dexmedetomidine and midazolam , at equi-sedative doses , on inflammation and apoptosis in an animal model of severe sepsis . Methods After central venous access , Sprague Dawley rats underwent cecal ligation and intestinal puncture ( CLIP ) with an 18 G needle without antibiotic cover and received either saline , or an infusion of comparable volume of saline containing midazolam ( 0.6 mg.kg-1.h-1 ) or dexmedetomidine ( 5 ug.kg-1.h-1 ) for 8 hours . Following baseline measurements and CLIP , blood was sample d for cytokine measurement ( tumour necrosis factor (TNF)-alpha and interleukin (IL)-6 ; n = 4 - 6 per group ) at 2 , 4 and 5 hours , and animal mortality rate ( MR ) was monitored ( n = 10 per group ) every 2 hours until 2 hours had elapsed . In addition , spleens were harvested and apoptosis was assessed by immunoblotting ( n = 4 per group ) . Results The 24 hour MR in CLIP animals ( 90 % ) was significantly reduced by sedative doses of either dexmedetomidine ( MR = 20 % ) or midazolam ( MR = 30 % ) . While both sedatives reduced systemic levels of the inflammatory cytokine TNF-alpha ( P < 0.05 ) ; only dexmedetomidine reduced the IL-6 response to CLIP , though this narrowly missed achieving significance ( P = 0.05 ) . Dexmedetomidine reduced splenic caspase-3 expression ( P < 0.05 ) , a marker of apoptosis , when compared to either midazolam or saline . Conclusions Sedation with midazolam and dexmedetomidine both improve outcome in polymicrobial severely septic rats . Possible benefits conveyed by one sedative regimen over another may become evident over a more prolonged time-course as both IL-6 and apoptosis were reduced by dexmedetomidine but not midazolam . Further studies are required to evaluate this hypothesis Background Some studies have demonstrated dexmedetomidine has anti-inflammatory effect on septic rats . However , the mechanism of how dexmedetomidine exerts these effects is still remained unknown . This study was design ed to investigate the mechanism of how dexmedetomidine inhibits the production of inflammatory mediators in cecal ligation and puncturinduced septic rats . Methods 48 Sprague-Dawley rats were r and omly divided into six groups : sham-operated ( sham ) group , cecal ligation and puncture ( CLP ) group , dexmedetomidine 5 μg/kg ( DEX5 ) group , dexmedetomidine 10 μg/kg ( DEX10 ) group , dexmedetomidine + yohimbine ( DEX10 + Yoh ) group and yohimibine group ( Yoh ) . Blood , bronchoalveolarlavage fluid ( BALF ) and lung tissues in each group were collected at six hours after dexmedetomidine or yohimbine treatment , . Tumor necrosis factor-α ( TNF-α ) and interleukin-6 ( IL-6 ) in BALF and plasma were measured by enzyme-linked immunosorbent assay ( ELISA ) . Toll-like receptor-4(TLR4 ) and myeloid differerntiation factor(MyD88 ) expression were measuredby quantitative PCR , and extracellular signal-regulated kinase ( ERK ) 1/2 phosphorylation were determined by western blott . Results Compared with CLP group , dexmedetomidine significantly decreased not only the production of TNF-α and IL-6 both in plasma and BALF , but also inhibited the expression of TLR4 and MyD88 in mRNA level and the activation of ERK1/2 and NF-κB in the lung tissues of CLP-induced septic rats . All these effects could not be reversed by yohimibine . Conclusions Dexmedetomidine treatment can effectively reduce the generation of inflammatory mediators in the plasma and BALF of CLP-induced septic rats . These effects of dexmedetomidine rely on TLR4/MyD88/MAPK/ NF-κB signaling pathway and are independent of α2-adrenoceptor Rationale : Dexmedetomidine is associated with less delirium than benzodiazepines and better sleep architecture than either benzodiazepines or propofol ; its effect on delirium and sleep when administered at night to patients requiring sedation remains unclear . Objectives : To determine if nocturnal dexmedetomidine prevents delirium and improves sleep in critically ill adults . Methods : This two‐center , double‐blind , placebo‐controlled trial r and omized 100 delirium‐free critically ill adults receiving sedatives to receive nocturnal ( 9:30 p.m. to 6:15 a.m. ) intravenous dexmedetomidine ( 0.2 & mgr;g/kg/h , titrated by 0.1 & mgr;g /kg/h every 15 min until a goal Richmond Agitation and Sedation Scale score of −1 or maximum rate of 0.7 & mgr;g/kg/h was reached ) or placebo until ICU discharge . During study infusions , all sedatives were halved ; opioids were unchanged . Delirium was assessed using the Intensive Care Delirium Screening Checklist every 12 hours throughout the ICU admission . Sleep was evaluated each morning by the Leeds Sleep Evaluation Question naire . Measurements and Main Results : Nocturnal dexmedetomidine ( vs. placebo ) was associated with a greater proportion of patients who remained delirium‐free during the ICU stay ( dexmedetomidine [ 40 ( 80 % ) of 50 patients ] vs. placebo [ 27 ( 54 % ) of 50 patients ] ; relative risk , 0.44 ; 95 % confidence interval , 0.23‐0.82 ; P = 0.006 ) . The average Leeds Sleep Evaluation Question naire score was similar ( mean difference , 0.02 ; 95 % confidence interval , 0.42‐1.92 ) between the 34 dexmedetomidine ( average seven assessment s per patient ) and 30 placebo ( six per patient ) group patients able to provide one or more assessment s. Incidence of hypotension , bradycardia , or both did not differ significantly between groups . Conclusions : Nocturnal administration of low‐dose dexmedetomidine in critically ill adults reduces the incidence of delirium during the ICU stay ; patient‐reported sleep quality appears unchanged . Clinical trial registered with www . clinical trials.gov ( NCT01791296 ) The aim was to verify that dexmedetomidine ( DEX ) can attenuate CLP-induced intestinal injury via inhibition of inflammation . Male Sprague-Dawley ( SD ) rats were r and omly allocated into Sham group and the other three CLP model groups , in terms of different treatments : placebo , DEX , and yohimbine plus DEX ( DEX + YOH ) groups . Pathology examination was conducted with HE stain . To identify differences among groups , the levels of DAO , and D-lactate in serum were measured by spectrophotometry , and the levels of TNF-α , IL-1β , and IL-6 in serum and organ were measured by ELISA . The expressions of occludin and TLR4 in tissue were detected by Western blot . The survival rate of an additional group of animals within 7 d was recorded . In DEX group , mortality was lower , histology change was minor , DAO , and D-lactate levels were reduced , and occludin expression was increased ; the expressions of TNF-α , IL-1β , IL-6 , and TLR4 were also decreased in DEX group . These results indicated that acute intestinal injury induced by CLP was mitigated by DEX treatment . However , these effects of DEX were significantly attenuated by yohimbine in DEX + YOH group . Our study indicated the protective effects of DEX on CLP-induced injury , which may be associated with the inhibition of inflammation via modulating TLR4 pathway and can be blocked by yohimbine Background : Dexmedetomidine , an & agr;-2 adrenergic receptor agonist , has already been used in septic patients although few studies have examined its effects on microcirculatory dysfunction , which may play an important role in perpetuating sepsis syndrome . Therefore , the authors have design ed a controlled experimental study to characterize the microcirculatory effects of dexmedetomidine in an endotoxemia rodent model that allows in vivo studies of microcirculation . Methods : After skinfold chamber implantation , 49 golden Syrian hamsters were r and omly allocated in five groups : ( 1 ) control animals ; ( 2 ) nonendotoxemic animals treated with saline ; ( 3 ) nonendotoxemic animals treated with dexmedetomidine ( 5.0 & mgr;g kg−1 h−1 ) ; ( 4 ) endotoxemic ( lipopolysaccharide 1.0 mg/kg ) animals treated with saline ; and ( 5 ) endotoxemic animals treated with dexmedetomidine . Intravital microscopy of skinfold chamber preparations allowed quantitative analysis of microvascular variables and venular leukocyte rolling and adhesion . Mean arterial blood pressure , heart rate , arterial blood gases , and lactate concentrations were also documented . Results : Lipopolysaccharide administration increased leukocyte rolling and adhesion and decreased capillary perfusion . Dexmedetomidine significantly attenuated these responses : compared with endotoxemic animals treated with saline , those treated with dexmedetomidine had less leukocyte rolling ( 11.8 ± 7.2 % vs. 24.3 ± 15.0 % ; P < 0.05 ) and adhesion ( 237 ± 185 vs. 510 ± 363 ; P < 0.05 ) and greater functional capillary density ( 57.4 ± 11.2 % of baseline values vs. 45.9 ± 11.2 % ; P < 0.05 ) and erythrocyte velocity ( 68.7 ± 17.6 % of baseline values vs. 54.4 ± 14.8 % ; P < 0.05 ) at the end of the experiment . Conclusions : Dexmedetomidine decreased lipopolysaccharide-induced leukocyte – endothelial interactions in the hamster skinfold chamber microcirculation . This was accompanied by a significant attenuation of capillary perfusion deficits , suggesting that dexmedetomidine yields beneficial effects on endotoxemic animals ’ microcirculation BACKGROUND Dexmedetomidine reduced mortality and inhibited the inflammatory response during endotoxemia in rats . The aim of this study was to clarify the effect of dexmedetomidine-regulating inflammation on a noninfectious , ventilator-induced lung injury ( VILI ) in dogs . METHODS Thirty healthy Beagles weighing between 8 and 12 kg were r and omly divided into five groups : control group ( group C , n = 6 ) , mechanical ventilation ( group MV , n = 6 ) , and three different doses of dexmedetomidine group ( group DEX1 - 3 , n = 6 ) . Output:
Conclusion Evidence supports potential anti-inflammatory effects from α2 agonists , but the relevance to clinical ly important outcomes is uncertain .
MS2_1shot250
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Distinguishing cohort studies from case series is difficult . We propose a conceptualization of cohort studies in systematic review s of comparative studies . The main aim of this conceptualization is to clarify the distinction between cohort studies and case series . We discuss the potential impact of the proposed conceptualization on the body of evidence and workload . All studies with exposure-based sampling gather multiple exposures ( with at least two different exposures or levels of exposure ) and enable calculation of relative risks that should be considered cohort studies in systematic review s , including non-r and omized studies . The term “ enables/can ” means that a predefined analytic comparison is not a prerequisite ( i.e. , the absolute risks per group and /or a risk ratio are provided ) . Instead , all studies for which sufficient data are available for re analysis to compare different exposures ( e.g. , sufficient data in the publication ) are classified as cohort studies .There are possibly large numbers of studies without a comparison for the exposure of interest but that do provide the necessary data to calculate effect measures for a comparison . Consequently , more studies could be included in a systematic review . Therefore , on the one h and , the outlined approach can increase the confidence in effect estimates and the strengths of conclusions . On the other h and , the workload would increase ( e.g. , additional data extraction and risk of bias assessment , as well as reanalyses ) Gravity compensation ( GC ) of the arm is used to facilitate arm movements in conventional therapy as well as in robot-assisted rehabilitation of neurologically impaired persons . Positive effects of GC on Range of Motion ( ROM ) have been demonstrated in stroke . In Multiple Sclerosis ( MS ) , research regarding this topic is lacking . Since an active participation of the patient is required for effective training , full support of the arm might not be advisable . The present study reports on the development of a procedure to measure actively the individual need for GC and to estimate the influence of GC on ROM during reaching , lifting and transporting in severely affected Persons with MS ( PwMS ) . Ten PwMS were tested with the procedure for determination of GC . Maximal reaching movements were performed in a 3D space in three conditions : No support ( NS ) , with GC by the HapticMaster ( GC-HM ) and with GC by the HapticMaster combined with a sling suspension system ( GC-HMS ) . For the total sample , significant correlations were found between the amount of GC and clinical tests for upper limb function . In four subjects with severe arm dysfunction it was found that mean ROM is larger in the GC-HMS condition compared to the GC-HM condition , and in the GC-HM condition compared to the NS condition , suggesting positive effects of GC on active ROM in PwMS . Therefore , GC could have a positive effect on arm rehabilitation by enabling the PwMS to actively reach a larger ROM during training The objective of this study was to determine the utility of a passive gravity-balanced arm orthosis , the Wilmington robotic exoskeleton ( WREX ) , for patients with neuromuscular diseases . The WREX , a four-degrees-of-freedom functional orthosis , is energized by rubber b and s to eliminate gravity and is attached to the wheelchair . The development and clinical testing of WREX is described in this report . Seventeen patients ( 14 boys and 3 girls ) with muscular disabilities participated in the study . Ages ranged from 4 to 20 years . Criteria for inclusion included a weakened arm , use of a wheelchair , the ability to grasp and release objects , and the ability to provide feedback on device use . Testing consisted of administering the Jebsen test of h and function without WREX and then testing again after approximately two weeks of wearing the WREX orthosis . The timed results of each task within the test then were compared . Specific tasks related to vertical movement required less time to perform with the WREX . A large number of subjects were able to perform the Jebsen tasks with the WREX , where they were unable to perform the task without the WREX . Patients can benefit from WREX because it increases their performance in daily living activities and makes many tasks possible . The range-of-motion in the patients ' arms increased considerably , while the time required to complete some of the Jebsen test tasks decreased . Most patients were very receptive to WREX , although a few were ambivalent Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Therapeutic trials in muscular dystrophy have often been inconclusive . A protocol has been design ed which selects patients with Duchenne muscular dystrophy and permits accurate measurement of their status . An integral part of the protocol is a system for checking on the consistency of the data obtained using a computer program OBJECTIVE To provide guidance on how systematic review authors , guideline developers , and health technology assessment practitioners should approach the use of the risk of bias in nonr and omized studies of interventions ( ROBINS-I ) tool as a part of GRADE 's certainty rating process . STUDY DESIGN AND SETTING The study design and setting comprised iterative discussion s , testing in systematic review s , and presentation at GRADE working group meetings with feedback from the GRADE working group . RESULTS We describe where to start the initial assessment of a body of evidence with the use of ROBINS-I and where one would anticipate the final rating would end up . The GRADE accounted for issues that mitigate concerns about confounding and selection bias by introducing the upgrading domains : large effects , dose-effect relations , and when plausible residual confounders or other biases increase certainty . They will need to be considered in an assessment of a body of evidence when using ROBINS-I. CONCLUSION The use of ROBINS-I in GRADE assessment s may allow for a better comparison of evidence from r and omized controlled trials ( RCTs ) and nonr and omized studies ( NRSs ) because they are placed on a common metric for risk of bias . Challenges remain , including appropriate presentation of evidence from RCTs and NRSs for decision-making and how to optimally integrate RCTs and NRSs in an evidence assessment Output:
Results : An overall effect size of 1.06 ( 95 % CI = 0.76 - 1.36 , p < 0.00001 ) was obtained , demonstrating that upper limbs assistive devices significantly improve the performance in activities of daily living in people with neuromuscular diseases .
MS2_1shot251
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background Prefrontal repetitive transcranial magnetic stimulation ( rTMS ) has been used to induce side-specific mood changes in volunteers and patients . To clarify inconsistencies between reports that used different stimulation frequencies , we conducted a controlled study with a low ( 1 Hz ) frequency , comparing left with right-sided stimulation Methods Nineteen healthy volunteers received r and omised left or right prefrontal rTMS at a frequency of 1 Hz and 100 % of motor threshold in two sessions two weeks apart . Results There were significant improvements with TMS for performance in the digit symbol substitution and verbal fluency tests , but no change of mood on a number of measures . There was also a reduction of pulse rate after TMS . The only side-specific TMS-effect was on mean arterial pressure , which decreased pressure after left , but not after right prefrontal TMS . Conclusions Apart from the unexpected and so far unreplicated effect on mean arterial pressure , there were no side-specific effects on mood in volunteers . It is unlikely that a simple laterality model of mood together with the assumed activating effect of higher and ' quenching ' effect of lower stimulation frequency can account for the effects of TMS on mood Background Behavioral and psychological symptoms of dementia ( BPSD ) occur in 70 - 90 % of patients at different stages of Alzheimer ’s Disease ( AD ) , but the available methods for managing these problems are of limited effectiveness . Aim Assess the effects of high-frequency repetitive transcranial magnetic stimulation ( rTMS ) , applied over the left dorsolateral prefrontal cortex ( DLPFC ) , on BPSD and cognitive function in persons with AD . Methods Fifty-four patients with AD and accompanying BPSD were r and omly divided into an intervention group ( n=27 ) and a control group ( n=27 ) . In addition to st and ard antipsychotic treatment , the intervention group was treated with 20Hz rTMS five days a week for four weeks , while the control group was treated with sham rTMS.The Behavioral Pathology in Alzheimer 's Disease Rating Scale ( BEHAVE-AD ) , the Alzheimer 's Disease Assessment Scale-Cognitive ( ADAS-Cog ) , and the Treatment Emergent Symptom Scale ( TESS ) were administered by raters who were blind to the group assignment of patients before and after four weeks of treatment . Results Twenty-six subjects from each group completed the study . After four weeks of antipsychotic treatment with adjunctive real or sham rTMS treatment , the mean ( sd ) total BEHAVE-AD scores and mean total ADAS-Cog scores of both groups significantly decreased from baseline . After adjusting for baseline values , the intervention group had significantly lower scores ( i.e. , greater improvement ) than the control group on the BEHAVE-AD total score , on five of the seven BEHAVE-AD factor scores ( activity disturbances , diurnal rhythm , aggressiveness , affective disturbances , anxieties and phobias ) , on the ADAS-Cog total score , and on all four ADAS-Cog factor scores ( memory , language , constructional praxis , and attention ) . The proportion of individuals whose behavioral symptoms met a predetermined level of improvement ( i.e. , a drop in BEHAVE-AD total score of > 30 % from baseline ) in the intervention group was greater than that in the control group ( 73.1 % vs.42.3 % , X2=5.04 , p=0.025 ) . Conclusion Compared to treatment of AD with low-dose antipsychotic medications alone , the combination of low-dose antipsychotic medication with adjunctive treatment with high frequency rTMS can significantly improve both cognitive functioning and the behavioral and psychological symptoms that often accompany AD Cranial electrotherapy stimulation ( CES ) is reported to aid in relieving symptoms of depression and anxiety , though the mechanism underlying this effect remains unclear . Therefore , the present study aim ed to evaluate changes in the hypothalamic-pituitary-adrenal ( HPA ) axis response and levels of neurotrophic factors , as well as changes in mood state , in patients undergoing CES therapy . Fifty healthy postmenopausal women were r and omly assigned to either a Sham CES group ( n = 25 ) or an Active CES group ( n = 25 ) . CES treatment was conducted in 20-minute sessions , three times per week for 8 weeks , using a micro current cranial electrotherapy stimulator . Blood sample s were collected prior to and following the 8-week treatment period for measurement of cortisol , adrenocorticotropic hormone ( ACTH ) , brain-derived neurotrophic factor ( BDNF ) , and nerve growth factor ( NGF ) levels . Changes in mood state were also examined at the time of blood collection using the Profile of Mood States ( POMS ) . No significant differences in cortisol , ACTH , BDNF , or NGF were observed between the two participant groups ( p > 0.05 ) following the treatment period . However , those in the Active CES group exhibited significantly decreased Tension-Anxiety and Depression-Dejection scores on the POMS relative to pre-treatment scores ( p < 0.05 ) . Furthermore , Depression-Dejection scores following treatment were significantly lower in the Active CES group than in the Sham CES group ( p < 0.05 ) . No significant differences were observed in any other POMS scores such as Anger-Hostility , Vigor-Activity , Fatigue-Inertia , and Confusion-Bewilderment ( p > 0.05 ) . These results suggest that 8 weeks of CES treatment does not induce changes in blood levels of neurotrophic factors or HPA-axis-related hormones , though such treatment may be effective in treating symptoms of anxiety and depression Background : Data from the human motor cortex suggest that , depending on polarity , direct current ( DC ) brain polarization can depress or activate cortical neurons . Activating effects on the frontal lobe might be beneficial for patients with frontal lobe disorders . This phase 1 study tested the safety of frontal DC , including its effects on frontal and other brain functions . Methods : The authors applied 20 minutes of anodal , cathodal , or sham DC to the left prefrontal cortex in three groups of right-h and ed subjects and looked for effects on global measures of processing and psychomotor speed , emotion , and verbal fluency , a measure of local cortical function . In one experiment ( n = 30 ) , the authors tested before and after 1 mA DC and monitored EEG in 9 subjects . In two other experiments using 1 mA ( n = 43 ) and 2 mA ( n = 30 ) , the authors tested before and then starting 5 minutes after the onset of DC . Results : All subjects tolerated DC well . There were no significant effects on performance with 1 mA DC . At 2 mA , verbal fluency improved significantly with anodal and decreased mildly with cathodal DC . There were no clinical ly significant effects on the other measures . Conclusions : Limited exposure to direct current polarization of the prefrontal cortex is safe and can enhance verbal fluency selectively in healthy subjects . As such , it deserves consideration as a procedure to improve frontal lobe function in patients Research has demonstrated that left-prefrontal cortical activity is associated with positive affect , or approach motivation , and that right-prefrontal cortical activity is associated with negative affect , or withdrawal motivation . In past research , emotional valence ( positive-negative ) has been confounded with motivational direction ( approach-withdrawal ) , such that , for instance , the only emotions examined were both positive and approach related . Recent research has demonstrated that trait anger , a negative but approach-related emotion , is associated with increased left-prefrontal and decreased right-prefrontal activity , suggesting that prefrontal asymmetrical activity is associated with motivational direction and not emotional valence . The present experiment tested whether state-induced anger is associated with relative left-prefrontal activity and whether this prefrontal activity is also associated with aggression . Results supported these hypotheses The central nervous system seems to have an important role in fatigue and exercise tolerance . Novel noninvasive techniques of neuromodulation can provide insights on the relationship between brain function and exercise performance . The purpose of this study was to determine the effects of transcranial direct current stimulation ( tDCS ) on physical performance and physiological and perceptual variables with regard to fatigue and exercise tolerance . Eleven physically active subjects participated in an incremental test on a cycle simulator to define peak power output . During 3 visits , the subjects experienced 3 stimulation conditions ( anodal , cathodal , or sham tDCS — with an interval of at least 48 h between conditions ) in a r and omized , counterbalanced order to measure the effects of tDCS on time to exhaustion at 80 % of peak power . Stimulation was administered before each test over 13 min at a current intensity of 2.0 mA. In each session , the Brunel Mood State question naire was given twice : after stimulation and after the time-to-exhaustion test . Further , during the tests , the electromyographic activity of the vastus lateralis and rectus femoris muscles , perceived exertion , and heart rate were recorded . RM-ANOVA showed that the subjects performed better during anodal primary motor cortex stimulation ( 491 ± 100 s ) compared with cathodal stimulation ( 443 ± 11 s ) and sham ( 407 ± 69 s ) . No significant difference was observed between the cathodal and sham conditions . The effect sizes confirmed the greater effect of anodal M1 tDCS ( anodal x cathodal = 0.47 ; anodal x sham = 0.77 ; and cathodal x sham = 0.29 ) . Magnitude-based inference suggested the anodal condition to be positive versus the cathodal and sham conditions . There were no differences among the three stimulation conditions in RPE ( p = 0.07 ) or heart rate ( p = 0.73 ) . However , as hypothesized , RM- ANOVA revealed a main effect of time for the two variables ( RPE and HR : p < 0.001 ) . EMG activity also did not differ during the test accross the different conditions . We conclude that anodal tDCS increases exercise tolerance in a cycling-based , constant-load exercise test , performed at 80 % of peak power . Performance was enhanced in the absence of changes in physiological and perceptual variables Aggressive behavior is aim ed at causing damage or pain to another individual . Aggression has been associated with structural and functional deficits in numerous brain areas , including the dorsolateral region of the prefrontal cortex ( DLPFC ) , typically related to inhibition and impulse control . In this study , we used inhibitory continuous theta-burst magnetic stimulation ( cTBS ) to explore the role of the right and left DLPFC in aggression . Sixteen healthy right-h and ed volunteers underwent two sessions involving r and om , real and sham , right and left DLPFC stimulations . These sessions were followed by the Social Orientation Paradigm ( SOP ) , a monetary task that was specially design ed to assess participants ' aggressive tendencies by measuring the patterns of their reactive aggression ( a response to a perceived provocation ) and proactive aggression ( an aggressive act with goal -oriented purpose s ) . Results indicate that using cTBS to target the left DLPFC was associated with a greater increase in aggressive responses than right DLPFC stimulation . This pattern of results was found for both reactive and proactive types of aggressive reactions . It is concluded that DLPFC asymmetry is involved in modulating reactive and proactive aggression . Our results are in line with recent studies suggesting that the left DLPFC plays a major role in aggressive behavior Clinical and functional imaging studies suggest that the cerebellar vermis is involved in the regulation of a range of nonsomatic functions including cardiovascular control , thirst , feeding behavior , and primal emotions . Cerebello-hypothalamic circuits have been postulated to be a potential neuroanatomical substrate underlying this modulation . We tested this putative relationship between the cerebellar vermis and nonsomatic functions by stimulating the cerebellum noninvasively via neuronavigated transcranial magnetic stimulation . In this r and omized , counter-balanced , within-subject study , intermittent theta burst stimulation ( TBS ) was applied on three different days to the vermis and the right and left cerebellar hemispheres of 12 right-h and ed normal subjects with the aim of modulating activity in the targeted cerebellar structure . TBS-associated changes were investigated via cardiovascular monitoring , a series of emotionally arousing picture stimuli , subjective analog scales for primal emotions , and the Profile of Mood States test . All 36 sessions of cerebellar stimulation were tolerated well without serious adverse events . Cardiovascular monitoring pointed to a mild but significant decrease in heart rate subsequent to vermal stimulation ; no changes were detected in systolic or diastolic blood pressure measurements . Subjective ratings detected a significant increase in Thirst and a trend toward increased Appetite following vermal stimulation . These observations are consistent with existing neurophysiological and neuroimaging data indicating a role for the cerebellum in the regulation of visceral responses . In conjunction with the modulatory function of the cerebellum , our results suggest a role for the vermis in somatovisceral integration likely through cerebello-hypothalamic pathways . Further research is warranted to eluci date the potential mechanisms underlying the cerebellar modulation of nonsomatic functions Although negative results have been reported , an important aspect of the physiology of repetitive transcranial magnetic stimulation ( rTMS ) could be related to the endocrinological response of the hypothalamic-pituitary-adrenal ( HPA ) axis , such as cortisol secretion . Because endocrinological responses are influenced by anxiety states , this could influence the effect of rTMS in healthy individuals . In this sham-controlled , " single blind " crossover study , we exam Output:
Nevertheless , the application of non-invasive brain stimulation techniques , especially transcranial direct current stimulation , over the right PFC seemed to reduce violent reactions in these individuals by interfering with the interpretation of the unfavourable situations ( e.g. , threating signals ) or inner states that evoked anger . The main conclusion of these studies was that bilateral stimulation of the PFC satisfactorily reduced anger and irritability only in inmates , patients with autism spectrum disorders ( ASD ) , people who suffered a closed-head injury , and agitated patients with Alzheimer 's disease . Moreover , combining these techniques with risperidone considerably reduced aggressiveness in these patients .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Introduction Early protein and energy feeding in critically ill patients is heavily debated and early protein feeding hardly studied . Methods A prospect i ve data base with mixed medical-surgical critically ill patients with prolonged mechanical ventilation ( > 72 hours ) and measured energy expenditure was used in this study . Logistic regression analysis was used to analyse the relation between admission day-4 protein intake group ( with cutoffs 0.8 , 1.0 , and 1.2 g/kg ) , energy overfeeding ( ratio energy intake/measured energy expenditure > 1.1 ) , and admission diagnosis of sepsis with hospital mortality after adjustment for APACHE II ( Acute Physiology and Chronic Health Evaluation II ) score . Results A total of 843 patients were included . Of these , 117 had sepsis . Of the 736 non-septic patients 307 were overfed . Mean day-4 protein intake was 1.0 g/kg pre-admission weight per day and hospital mortality was 36 % . In the total cohort , day-4 protein intake group ( odds ratio ( OR ) 0.85 ; 95 % confidence interval ( CI ) 0.73 to 0.99 ; P = 0.047 ) , energy overfeeding ( OR 1.62 ; 95%CI 1.07 to 2.44 ; P = 0.022 ) , and sepsis ( OR 1.77 ; 95%CI 1.18 to 2.65 ; P = 0.005 ) were independent risk factors for mortality besides APACHE II score . In patients with sepsis or energy overfeeding , day-4 protein intake was not associated with mortality . For non-septic , non-overfed patients ( n = 419 ) , mortality decreased with higher protein intake group : 37 % for < 0.8 g/kg , 35 % for 0.8 to 1.0 g/kg , 27 % for 1.0 to 1.2 g/kg , and 19 % for ≥1.2 g/kg ( P = 0.033 ) . For these , a protein intake level of ≥1.2 g/kg was significantly associated with lower mortality ( OR 0.42 , 95%CI 0.21 to 0.83 , P = 0.013 ) . Conclusions In non-septic critically ill patients , early high protein intake was associated with lower mortality and early energy overfeeding with higher mortality . In septic patients early high protein intake had no beneficial effect on mortality OBJECTIVES To describe current enteral nutrition-prescribing practice s for critically ill patients , and to identify factors associated with initiation of , and tolerance to , enteral nutrition . DESIGN A prospect i ve , cohort study . SETTING Two tertiary care medical-surgical intensive care units ( ICU ) in Ontario , Canada . PATIENTS We enrolled 99 consecutive patients who were expected to stay in the ICU for > 3 days and who were unable to tolerate oral nutrition . We followed patients for 21 days or until they tolerated enteral nutrition , tolerated oral nutrition , were discharged from the ICU , or died . MEASUREMENTS AND MAIN RESULTS We recorded time elapsed from ICU admission to initiation and tolerance of enteral feedings , and examined factors associated with these events . We defined tolerance as receiving 90 % of estimated daily energy requirements for > 48 hrs without gastrointestinal dysfunction ( i.e. , high gastric residuals , vomiting , diarrhea , abdominal distention ) . Seventy-three ( 74 % ) of 99 patients were started on enteral feedings an average 3.1 days ( range 1 to 18 ) after ICU admission . Of 26 patients never started on enteral nutrition , three ( 12.5 % ) patients eventually tolerated oral nutrition , 14 ( 54.0 % ) patients were discharged from the ICU , and seven ( 27.0 % ) patients died . Reasons for not initiating enteral nutrition included absence of bowel sounds ( 27.0 % ) , high nasogastric drainage ( 16.9 % ) , contraindication to enteral nutrition ( 16.7 % ) , tolerance of oral nutrition ( 6.8 % ) , and no apparent reason ( 5.1 % ) . Abdominal surgery , use of vasoactive drugs , and admission to one hospital made initiation of enteral nutrition less likely , whereas presence of bowel sounds and admission to the other hospital made initiation of enteral nutrition more likely . Thirty-five ( 42.9 % ) of 73 patients started on enteral nutrition achieved tolerance of the regimen . The average time from ICU admission to tolerance of feedings was 5.8 days ( range 1 to 14 ) . Once started on enteral nutrition , the most common reasons for decreasing or discontinuing feedings included high gastric residuals ( 51.0 % ) , mechanical feeding tube problems ( 15.4 % ) , medical or surgical procedures ( 5.4 % ) , and vomiting ( 5.1 % ) . Use of paralytic agents and the presence of high gastric residuals were associated with intolerance . Of 38 patients who did not achieve tolerance , 20 ( 52.6 % ) patients were discharged from the ICU , eight ( 21.0 % ) patients died , and eight ( 21.0 % ) patients eventually tolerated oral nutrition . CONCLUSIONS Enteral nutrition is not started in all eligible ICU patients . Approximately half of those patients receiving enteral nutrition achieved tolerance of the regimen . Gastrointestinal dysfunction causing intolerance to enteral nutrition is a common reason for not starting , or discontinuing , feedings BACKGROUND Our goal is to define nutrition therapy in critically ill patients after surgical repair of acute ruptured or dissecting aortic aneurysm to identify opportunities for quality improvement . METHODS International , prospect i ve studies in 2007 - 2009 and 2011 were combined . Sites provided institutional and patient characteristics including from intensive care units ( ICUs ) admission to ICU discharge for a maximum of 12 days . We selected patients with aortic aneurysmal rupture or acute dissection staying in the ICU for ≥ 3 days . RESULTS There were 104 eligible patients from 72 distinct ICUs analyzed . Overall , 86.5 % received artificial nutrition . There were 50.0 % patients who received enteral nutrition ( EN ) only , 29.8 % patients received a combination of EN and parenteral nutrition ( PN ) , 6.7 % patients received PN only , and 13.5 % did not receive any nutrition . The mean time from admission to initiation of EN was 3.0 days ( SD ± 2.4 days ) . The adequacy of calories from nutrition support was 46.8 % ( range 0%-111 % ) with a mean of 10.0 kcal/kg/day . Of the total of 83 patients who received EN , 53 patients ( 63.8 % ) had interruption of EN . The reasons included fasting , intolerance , patients deemed too sick for enteral feeding , and loss of enteral feeding route . For patients with gastrointestinal intolerance , 3/30 patients ( 10 % ) received small bowel feeding and 23/30 patients ( 76.7 % ) of patients received motility agents . CONCLUSION Postoperative critically ill patients with aortic aneurysmal rupture or acute dissection are at high risk for inadequate nutrition therapy , and there may be inadequate utilization of strategies to improve nutrition uptake BACKGROUND The open abdomen is a requisite component of a damage control operation and treatment of abdominal compartment syndrome . Enteral nutrition ( EN ) has proven beneficial for patients with critical injury , but its application in those with an open abdomen has not been defined . The purpose of this study was to analyze the use of EN for patients with an open abdomen after trauma and the effect of EN on fascial closure rates and nosocomial infections . METHODS We review ed patients with an open abdomen after injury from January 2002 to January 2009 from 11 trauma centers . RESULTS During the 7-year study period , 597 patients required an open abdomen after trauma . Most were men ( 77 % ) sustaining blunt trauma ( 72 % ) , with a mean ( SD ) age of 38 ( 0.7 ) years , an Injury Severity Score of 31 ( 0.6 ) , an abdominal injury score of 3.8 ( 0.1 ) , and an Abdominal Trauma Index score of 26.8 ( 0.6 ) . Of the patients , 548 ( 92 % ) had an open abdomen after a damage control operation , whereas the remainder experienced an abdominal compartment syndrome . Of the 597 patients , 230 ( 39 % ) received EN initiated before the closure of the abdomen at mean ( SD ) day 3.6 ( 1.2 ) after injury . EN was started with an open abdomen in one quarter of the 290 patients with bowel injuries . For the 307 patients without a bowel injury , logistic regression indicated that EN is associated with higher fascial closure rates ( odds ratio [ OR ] , 5.3 ; p < 0.01 ) , decreased complication rates ( OR , 0.46 ; p = 0.02 ) , and decreased mortality ( OR , 0.30 ; p = 0.01 ) . For the 290 patients who experienced a bowel injury , regression analysis showed no significant association between EN and fascial closure rate ( OR , 0.6 ; p = 0.2 ) , complication rate ( OR , 1.7 ; p = 0.19 ) , or mortality ( OR , 0.79 ; p = 0.69 ) . CONCLUSION EN in the open abdomen after injury is feasible . For patients without a bowel injury , EN in the open abdomen is associated with increased fascial closure rates , decreased complication rates , and decreased mortality . EN should be initiated in these patients once resuscitation is completed . Although EN for patients with bowel injuries did not seem to affect the outcome in this study , prospect i ve r and omized controlled trials would further clarify the role of EN in this subgroup . LEVEL OF EVIDENCE Therapeutic study , level III BACKGROUND The purpose of this study was to determine the effects of early postoperative tube feeding on outcomes of liver transplant recipients . METHODS Fifty transplant patients were r and omized prospect ively to receive enteral formula via nasointestinal feeding tubes ( tube-feeding [ TF ] group ) or maintenance i.v . fluid until oral diets were initiated ( control group ) . Thirty-one patients completed the study . Resting energy expenditure , nitrogen balance , and grip strength were measured on days 2 , 4 , 7 , and 12 after liver transplantation . Calorie and protein intakes were calculated for 12 days posttransplant . RESULTS Tube feeding was tolerated in the TF group ( n = 14 ) . The TF patients had greater cumulative 12-day nutrient intakes ( 22,464 + /- 3554 kcal , 927 + /- 122 g protein ) than did the control patients ( 15,474 + /- 5265 kcal , 637 + /- 248 g protein ) ( p < .002 ) . Nitrogen balance was better in the TF group on posttransplant day 4 than in the control group ( p < .03 ) . There was a rise in the overall mean resting energy expenditure in the first two posttransplant weeks from 1487 + /- 338 to 1990 + /- 367 kcal ( p = .0002 ) . Viral infections occurred in 17.7 % of control patients compared with 0 % of TF patients ( p = .05 ) . Although other infections tended to occur more frequently in the control group vs the TF group ( bacterial , 29.4 % vs 14.3 % ; overall infections , 47.1 % vs 21.4 % ) , these differences were not statistically significant . Early posttransplant tube feeding did not influence hospitalization costs , hours on the ventilator , lengths of stay in the intensive care unit and hospital , rehospitalizations , or rejection during the first 21 posttransplant days . CONCLUSIONS Early posttransplant tube feeding was tolerated and promoted improvements in some outcomes and should be considered for all liver transplant patients This document represents the first collaboration between 2 organizations — the American Society for Parenteral and Enteral Nutrition and the Society of Critical Care Medicine — to describe best practice s in nutrition therapy in critically ill children . The target of these guidelines is intended to be the pediatric critically ill patient ( > 1 month and 2–3 days in a PICU admitting medical , surgical , and cardiac patients . In total , 2032 citations were scanned for relevance . The PubMed / MEDLINE search result ed in 960 citations for clinical trials and 925 citations for cohort studies . The EMBASE search for clinical trials culled 1661 citations . In total , the search for clinical trials yielded 1107 citations , whereas the cohort search yielded 925 . After careful review , 16 r and omized controlled trials and 37 cohort studies appeared to answer 1 of the 8 preidentified question groups for this guideline . We used the GRADE criteria ( Grading of Recommendations , Assessment Output:
EEN reduced infectious complications in unselected critically ill patients , in patients with severe acute pancreatitis , and after GI surgery . We did not detect any evidence of superiority for early PN or delayed EN over EEN . Conclusions We suggest using EEN in the majority of critically ill under certain pre caution s. In the absence of evidence , we suggest delaying EN in critically ill patients with uncontrolled shock , uncontrolled hypoxaemia and acidosis , uncontrolled upper GI bleeding , gastric aspirate > 500 ml/6 h , bowel ischaemia , bowel obstruction , abdominal compartment syndrome , and high-output fistula without distal feeding access
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background Adolescents need access to effective sexual and reproductive health ( SRH ) interventions , but face barriers accessing them through traditional health systems . School-based approaches might provide accessible , complementary strategies . We investigated whether a 21-session after-school SRH education programme and school health service attracted adolescents most at risk for adverse SRH outcomes and explored motivators for and barriers to attendance . Methods Grade 8 adolescents ( average age 13 years ) from 20 schools in the intervention arm of an HIV prevention cluster r and omised controlled trial in the Western Cape Province of South Africa , were invited to participate in an after-school SRH program and to attend school health services . Using a longitudinal design , we surveyed participants at baseline , measured their attendance at weekly after-school sessions for 6 months and surveyed them post-intervention . We examined factors associated with attendance using bivariate and multiple logistic and Poisson regression analyses , and through thematic analysis of qualitative data . Results The intervention was fully implemented in 18 schools with 1576 trial participants . The mean attendance of the 21-session SRH programme was 8.8 sessions ( S.D. 7.5 ) among girls and 6.9 ( S.D. 7.2 ) among boys . School health services were visited by 17.3 % ( 14.9 % of boys and 18.7 % of girls ) . Adolescents who had their sexual debut before baseline had a lower rate of session attendance compared with those who had not ( 6.3 vs 8.5 , p < .001 ) . Those who had been victims of sexual violence or intimate partner violence ( IPV ) , and who had perpetrated IPV also had lower rates of attendance . Participants were motivated by a wish to receive new knowledge , life coaching and positive attitudes towards the intervention . The unavailability of safe transport and domestic responsibilities were the most common barriers to attendance . Only two participants cited negative attitudes about the intervention as the reason they did not attend . Conclusions Reducing structural barriers to attendance , after-school interventions are likely to reach adolescents with proven-effective SRH interventions . However , special attention is required to reach vulnerable adolescents , through offering different delivery modalities , improving the school climate , and providing support for adolescents with mental health problems and neurodevelopmental academic problems . Trial registration Current Controlled Trials IS RCT N56270821 ; Registered 13 February 2013 Recent evidence suggests that conditional cash transfer programs for schooling are effective in raising school enrollment and attendance . However , there is also reason to believe that such programs can affect other outcomes , such as the sexual behavior of their young beneficiaries . Zomba Cash Transfer Program is a r and omized , ongoing conditional cash transfer intervention targeting young women in Malawi that provides incentives ( in the form of school fees and cash transfers ) to current schoolgirls and recent dropouts to stay in or return to school . An average offer of US$ 10/month conditional on satisfactory school attendance – plus direct payment of secondary school fees – led to significant declines in early marriage , teenage pregnancy , and self-reported sexual activity among program beneficiaries after just one year of program implementation . For program beneficiaries who were out of school at baseline , the probability of getting married and becoming pregnant declined by more than 40 percent and 30 percent , respectively . In addition , the incidence of the onset of sexual activity was 38 percent lower among all program beneficiaries than the control group . Overall , these results suggest that conditional cash transfer programs not only serve as useful tools for improving school attendance , but may also reduce sexual activity , teen pregnancy , and early marriage Background Only four out of 31 completed r and omized controlled trials ( RCTs ) of HIV prevention strategies against sexual transmission have shown significant efficacy . Poor adherence may have contributed to the lack of effect in some of these trials . In this paper we explore the impact of various levels of adherence on measured efficacy within an RCT . Analysis We used simple quantitative methods to illustrate the impact of various levels of adherence on measured efficacy by assuming a uniform population in terms of sexual behavior and the binomial model for the transmission probability per partnership . At 100 % adherence the measured efficacy within an RCT is a reasonable approximation of the true biological efficacy . However , as adherence levels fall , the efficacy measured within a trial substantially under-estimates the true biological efficacy . For example , at 60 % adherence , the measured efficacy can be less than half of the true biological efficacy . Conclusion Poor adherence during a trial can substantially reduce the power to detect an effect , and improved methods of achieving and maintaining high adherence within trials are needed . There are currently 12 ongoing HIV prevention trials , all but one of which require ongoing user-adherence . Attention must be given to methods of maximizing adherence when piloting and design ing RCTs and HIV prevention programmes A seven-year r and omized evaluation suggests education subsidies reduce adolescent girls ' dropout , pregnancy , and marriage but not sexually transmitted infection ( STI ) . The government 's HIV curriculum , which stresses abstinence until marriage , does not reduce pregnancy or STI . Both programs combined reduce STI more , but cut dropout and pregnancy less , than education subsidies alone . These results are inconsistent with a model of schooling and sexual behavior in which both pregnancy and STI are determined by one factor ( unprotected sex ) , but consistent with a two-factor model in which choices between committed and casual relationships also affect these outcomes Objective To assess the impact of a theoretically based sex education programme ( SHARE ) delivered by teachers compared with conventional education in terms of conceptions and terminations registered by the NHS . Design Follow-up of cluster r and omised trial 4.5 years after intervention . Setting NHS records of women who had attended 25 secondary schools in east Scotl and . Participants 4196 women ( 99.5 % of those eligible ) . Intervention SHARE programme ( intervention group ) v existing sex education ( control group ) . Main outcome measure NHS recorded conceptions and terminations for the achieved sample linked at age 20 . Results In an “ intention to treat ” analysis there were no significant differences between the groups in registered conceptions per 1000 pupils ( 300 SHARE v 274 control ; difference 26 , 95 % confidence interval −33 to 86 ) and terminations per 1000 pupils ( 127 v 112 ; difference 15 , −13 to 42 ) between ages 16 and 20 . Conclusions This specially design ed sex education programme did not reduce conceptions or terminations by age 20 compared with conventional provision . The lack of effect was not due to quality of delivery . Enhancing teacher led school sex education beyond conventional provision in eastern Scotl and is unlikely to reduce terminations in teenagers . Trial registration IS RCT N48719575 An exigent need exists for HIV prevention intervention research targeting young men who have sex with men (MSM)-a group of young adults that , despite composing the highest and most racially disproportionate rates of HIV incidence , have been least often the focus of behavioral intervention research . This pilot study tested a group-based HIV primary prevention intervention for young MSM to evaluate its initial efficacy , feasibility , and acceptability . Participants were r and omized ( N = 101 ; aged 16–20 years ) to one of two group-level , HIV and STI education programs : controls participated in a non-interactive , lecture-based program , while intervention participants took part in a highly interactive program tailored to young MSM aged 16–20 . Sexual risk and social cognitive outcomes were assessed at baseline , 6- , and 12-weeks post-intervention . Over the entire follow-up period , intervention participants were less likely than controls to engage in any sexual behavior while under the influence of substances ( p < .05 ) , and a decreasing trend in unprotected anal sex while under the influence of substances was also observed in this group ( p = .08 ) . Follow-up differences between groups on social cognitive outcomes favored the intervention group , though these differences were non-significant . Acceptability ratings were modest . A 6-session behavioral intervention tailored to young MSM , aged 16–20 , is feasible , acceptable , and demonstrates evidence of preliminary efficacy in reducing sexual risk , specifically sexual risk while under the influence of substances Abstract Objective : To determine whether a theoretically based sex education programme for adolescents ( SHARE ) delivered by teachers reduced unsafe sexual intercourse compared with current practice . Design : Cluster r and omised trial with follow up two years after baseline ( six months after intervention ) . A process evaluation investigated the delivery of sex education and broader features of each school . Setting : Twenty five secondary schools in east Scotl and . Participants : 8430 pupils aged 13 - 15 years ; 7616 completed the baseline question naire and 5854 completed the two year follow up question naire . Intervention : SHARE programme ( intervention group ) versus existing sex education ( control programme ) . Main outcome measures : Self reported exposure to sexually transmitted disease , use of condoms and contraceptives at first and most recent sexual intercourse , and unwanted pregnancies . Results : When the intervention group was compared with the conventional sex education group in an intention to treat analysis there were no differences in sexual activity or sexual risk taking by the age of 16 years . However , those in the intervention group reported less regret of first sexual intercourse with most recent partner ( young men 9.9 % difference , 95 % confidence interval −18.7 to −1.0 ; young women 7.7 % difference , −16.6 to 1.2 ) . Pupils evaluated the intervention programme more positively , and their knowledge of sexual health improved . Lack of behavioural effect could not be linked to differential quality of delivery of intervention . Conclusions : Compared with conventional sex education this specially design ed intervention did not reduce sexual risk taking in adolescents OBJECTIVE To evaluate the efficacy of an abstinence-only intervention in preventing sexual involvement in young adolescents . DESIGN R and omized controlled trial . SETTING Urban public schools . PARTICIPANTS A total of 662 African American students in grade s 6 and 7 . INTERVENTIONS An 8-hour abstinence-only intervention targeted reduced sexual intercourse ; an 8-hour safer sex-only intervention targeted increased condom use ; 8-hour and 12-hour comprehensive interventions targeted sexual intercourse and condom use ; and an 8-hour health-promotion control intervention targeted health issues unrelated to sexual behavior . Participants also were r and omized to receive or not receive an intervention maintenance program to extend intervention efficacy . OUTCOME MEASURES The primary outcome was self-report of ever having sexual intercourse by the 24-month follow-up . Secondary outcomes were other sexual behaviors . RESULTS The participants ' mean age was 12.2 years ; 53.5 % were girls ; and 84.4 % were still enrolled at 24 months . Abstinence-only intervention reduced sexual initiation ( risk ratio [ RR ] , 0.67 ; 95 % confidence interval [ CI ] , 0.48 - 0.96 ) . The model-estimated probability of ever having sexual intercourse by the 24-month follow-up was 33.5 % in the abstinence-only intervention and 48.5 % in the control group . Fewer abstinence-only intervention participants ( 20.6 % ) than control participants ( 29.0 % ) reported having coitus in the previous 3 months during the follow-up period ( RR , 0.94 ; 95 % CI , 0.90 - 0.99 ) . Abstinence-only intervention did not affect condom use . The 8-hour ( RR , 0.96 ; 95 % CI , 0.92 - 1.00 ) and 12-hour comprehensive ( RR , 0.95 ; 95 % CI , 0.91 - 0.99 ) interventions reduced reports of having multiple partners compared with the control group . No other differences between interventions and controls were significant . CONCLUSION Theory-based abstinence-only interventions may have an important role in preventing adolescent sexual involvement . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00640653 INTRODUCTION With the rising threat of HIV in India , youth are an important group to reach for prevention education . This pilot study tested the efficacy of STEP ( School-based Teenage Education Program focusing on HIV Prevention ) for school children . METHOD This pilot study r and omized 25 schools in Mumbai to receive STEP ( N = 1846 ) . We trained forty two undergraduates from local colleges to deliver the , ( six-session ) program over a six-week period to eighth grade rs ( age 13 - 15 years ) . Outcome measures collected at six weeks were HIV knowledge , attitudes toward abstinence/condom use , peer pressure , and confidence in dealing with risky social situations . A repeated measures analysis of variance was conducted with pretest and posttest scores with knowledge , beliefs , attitudes , and confidence as the within-group measures and gender as the between-group measure . RESULTS Both boys and girls significantly improved on knowledge , attitudes , and beliefs regarding HIV/AIDS and in their confidence level in dealing with risky behavior . However girls increased more on knowledge ( P < .05 ) , agreement with abstinence ( P < .05 ) , and agreement with condom use ( P < .001 ) . Girls had significantly less need to follow peers ( P < .05 ) , better underst and ing of pre caution s against HIV ( P < .001 ) , and a higher confidence level in dealing with risky social situations ( P < .05 ) . CONCLUSIONS Overall , girls benefited more from the STEP intervention than boys . The literature documents strong gender disparities in HIV/AIDS knowledge , information sources , and consequences of sex for youth in India . However , more work is needed to define and Output:
There is little evidence that educational curriculum‐based programmes alone are effective in improving sexual and reproductive health outcomes for adolescents .
MS2_1shot254
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement IMPORTANCE In sub-Saharan Africa , malaria is a leading cause of childhood morbidity and iron deficiency is among the most prevalent nutritional deficiencies . In 2006 , the World Health Organization and the United Nations Children 's Fund released a joint statement that recommended limiting use of iron supplements ( tablets or liquids ) among children in malaria-endemic areas because of concern about increased malaria risk . As a result , anemia control programs were either not initiated or stopped in these areas . OBJECTIVE To determine the effect of providing a micronutrient powder ( MNP ) with or without iron on the incidence of malaria among children living in a high malaria-burden area . DESIGN , SETTING , AND PARTICIPANTS Double-blind , cluster r and omized trial of children aged 6 to 35 months ( n = 1958 living in 1552 clusters ) conducted over 6 months in 2010 in a rural community setting in central Ghana , West Africa . A cluster was defined as a compound including 1 or more households . Children were excluded if iron supplement use occurred within the past 6 months , they had severe anemia ( hemoglobin level < 7 g/dL ) , or severe wasting ( weight-for-length z score < -3 ) . INTERVENTIONS Children were r and omized by cluster to receive a MNP with iron ( iron group ; 12.5 mg/d of iron ) or without iron ( no iron group ) . The MNP with and without iron were added to semiliquid home-prepared foods daily for 5 months followed by 1-month of further monitoring . Insecticide-treated bed nets were provided at enrollment , as well as malaria treatment when indicated . MAIN OUTCOMES AND MEASURES Malaria episodes in the iron group compared with the no iron group during the 5-month intervention period . RESULTS In intention-to-treat analyses , malaria incidence overall was significantly lower in the iron group compared with the no iron group ( 76.1 and 86.1 episodes/100 child-years , respectively ; risk ratio ( RR ) , 0.87 [ 95 % CI , 0.79 - 0.97 ] ) , and during the intervention period ( 79.4 and 90.7 episodes/100 child-years , respectively ; RR , 0.87 [ 95 % CI , 0.78 - 0.96 ] ) . In secondary analyses , these differences were no longer statistically significant after adjusting for baseline iron deficiency and anemia status overall ( adjusted RR , 0.87 ; 95 % CI , 0.75 - 1.01 ) and during the intervention period ( adjusted RR , 0.86 ; 95 % CI , 0.74 - 1.00 ) . CONCLUSION AND RELEVANCE In a malaria-endemic setting in which insecticide-treated bed nets were provided and appropriate malaria treatment was available , daily use of a MNP with iron did not result in an increased incidence of malaria among young children . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01001871 In a cluster r and omized controlled trial , Anthony Shakeshaft and colleagues measure the effectiveness of a multi-component community-based intervention for reducing alcohol-related harm Loss to follow-up is often hard to avoid in r and omised trials . This article suggests a framework for intention to treat analysis that depends on making plausible assumptions about the missing data and including all participants in sensitivity Abstract s Background The objective of this simulation study is to compare the accuracy and efficiency of population -averaged ( i.e. generalized estimating equations ( GEE ) ) and cluster-specific ( i.e. r and om-effects logistic regression ( RELR ) ) models for analyzing data from cluster r and omized trials ( CRTs ) with missing binary responses . Methods In this simulation study , clustered responses were generated from a beta-binomial distribution . The number of clusters per trial arm , the number of subjects per cluster , intra-cluster correlation coefficient , and the percentage of missing data were allowed to vary . Under the assumption of covariate dependent missingness , missing outcomes were h and led by complete case analysis , st and ard multiple imputation ( MI ) and within-cluster MI strategies . Data were analyzed using GEE and RELR . Performance of the methods was assessed using st and ardized bias , empirical st and ard error , root mean squared error ( RMSE ) , and coverage probability . Results GEE performs well on all four measures — provided the downward bias of the st and ard error ( when the number of clusters per arm is small ) is adjusted appropriately — under the following scenarios : complete case analysis for CRTs with a small amount of missing data ; st and ard MI for CRTs with variance inflation factor ( VIF ) <3 ; within-cluster MI for CRTs with VIF≥3 and cluster size>50 . RELR performs well only when a small amount of data was missing , and complete case analysis was applied . Conclusion GEE performs well as long as appropriate missing data strategies are adopted based on the design of CRTs and the percentage of missing data . In contrast , RELR does not perform well when either st and ard or within-cluster MI strategy is applied prior to the analysis Background Intention-to-treat analysis is used in the analysis of r and omized controlled trials to preserve trial power in the presence of missing subject data as well as to control for both known and unknown confounding factors . One form of intention-to-treat analysis is last-observation-carried-forward ( LOCF ) . Concerns exist regarding whether it is appropriate to use LOCF in analyses involving progressive conditions or in situations where missing data are non-r and om ( e.g. , subjects drop out because of treatment side effects or differing disease severity ) . Objective To examine the use of intention-to-treat imputation of missing data techniques , and specifically LOCF , in r and omized controlled trials of the use of cholinesterase inhibitors and memantine to treat Alzheimer ’s disease , vascular dementia , mixed dementia and mild cognitive impairment . Methods We conducted a systematic electronic search of MEDLINE and the Cochrane Central Register of Controlled Trials from 1984 to 2008 for double-blinded , r and omized controlled trials of cholinesterase inhibitors or memantine that examined progressive symptoms in Alzheimer ’s disease , vascular dementia , mixed dementia and mild cognitive impairment . We collected data on the use of intention-to-treat and non-intention-to-treat analyses and on contraindications to the use of LOCF analysis and we performed quality assessment s of included trials . Results Of the 57 studies that met the inclusion criteria , 12 did not report intention-to-treat analyses . Of the 34 studies that employed LOCF as the only form of intention-to-treat analysis , 24 reported conditions that could produce biased LOCF analyses favouring the drug under study . The latter finding was more common in cholinesterase inhibitor trials than in memantine studies . Conclusions The published results of some r and omized controlled trials of dementia drugs may be inaccurate ( i.e. , drug effectiveness may be exaggerated ) or invalid ( i.e. , there may be false-positive results ) because of bias introduced through the inappropriate use of LOCF analyses . This bias favours cholinesterase inhibitors , potentially preventing funding of and patient access to less toxic treatment options such as memantine . Licensing agencies should consider whether to accept LOCF analyses in research on dementias and other chronic progressive conditions BACKGROUND Cluster r and omized trials increasingly are being used in health services research and in primary care , yet the majority of these trials do not account appropriately for the clustering in their analysis . OBJECTIVES We review the main implication s of adopting a cluster r and omized design in primary care and highlight the practical application of appropriate analytical techniques . METHODS The application of different analytical techniques is demonstrated through the use of empirical data from a primary care-based case study . CONCLUSION Inappropriate analysis of cluster trials can lead to the presentation of inaccurate results and hence potentially misleading conclusions . We have demonstrated that adjustment for clustering can be applied to real-life data and we encourage more routine adoption of appropriate analytical techniques Background Attrition , which leads to missing data , is a common problem in cluster r and omized trials ( CRTs ) , where groups of patients rather than individuals are r and omized . St and ard multiple imputation ( MI ) strategies may not be appropriate to impute missing data from CRTs since they assume independent data . In this paper , under the assumption of missing completely at r and om and covariate dependent missing , we compared six MI strategies which account for the intra-cluster correlation for missing binary outcomes in CRTs with the st and ard imputation strategies and complete case analysis approach using a simulation study . Method We considered three within-cluster and three across-cluster MI strategies for missing binary outcomes in CRTs . The three within-cluster MI strategies are logistic regression method , propensity score method , and Markov chain Monte Carlo ( MCMC ) method , which apply st and ard MI strategies within each cluster . The three across-cluster MI strategies are propensity score method , r and om-effects ( RE ) logistic regression approach , and logistic regression with cluster as a fixed effect . Based on the community hypertension assessment trial ( CHAT ) which has complete data , we design ed a simulation study to investigate the performance of above MI strategies . Results The estimated treatment effect and its 95 % confidence interval ( CI ) from generalized estimating equations ( GEE ) model based on the CHAT complete data set are 1.14 ( 0.76 1.70 ) . When 30 % of binary outcome are missing completely at r and om , a simulation study shows that the estimated treatment effects and the corresponding 95 % CIs from GEE model are 1.15 ( 0.76 1.75 ) if complete case analysis is used , 1.12 ( 0.72 1.73 ) if within-cluster MCMC method is used , 1.21 ( 0.80 1.81 ) if across-cluster RE logistic regression is used , and 1.16 ( 0.82 1.64 ) if st and ard logistic regression which does not account for clustering is used . Conclusion When the percentage of missing data is low or intra-cluster correlation coefficient is small , different approaches for h and ling missing binary outcome data generate quite similar results . When the percentage of missing data is large , st and ard MI strategies , which do not take into account the intra-cluster correlation , underestimate the variance of the treatment effect . Within-cluster and across-cluster MI strategies ( except for r and om-effects logistic regression MI strategy ) , which take the intra-cluster correlation into account , seem to be more appropriate to h and le the missing outcome from CRTs . Under the same imputation strategy and percentage of missingness , the estimates of the treatment effect from GEE and RE logistic regression models are similar Sometimes interventions in r and omized clinical trials are not allocated to individual patients , but rather to patients in groups . This is called cluster allocation , or cluster r and omization , and is particularly common in health services research . Similarly , in some types of observational studies , patients ( or observations ) are found in naturally occurring groups , such as neighborhoods . In either situation , observations within a cluster tend to be more alike than observations selected entirely at r and om . This violates the assumption of independence that is at the heart of common methods of statistical estimation and hypothesis testing . Failure to account for the dependence between individual observations and the cluster to which they belong can have profound implication s on the design and analysis of such studies . Their p-values will be too small , confidence intervals too narrow , and sample size estimates too small , sometimes to a dramatic degree . This problem is similar to that caused by the more familiar " unit of analysis error " seen when observations are repeated on the same subjects , but are treated as independent . The purpose of this paper is to provide an introduction to the problem of clustered data in clinical research . It provides guidance and examples of methods for analyzing clustered data and calculating sample sizes when planning studies . The article concludes with some general comments on statistical software for cluster data and principles for planning , analyzing , and presenting such studies Introduction Cluster r and omised trials ( CRTs ) r and omise participants in groups , rather than as individuals , and are key tools used to assess interventions in health research where treatment contamination is likely or if individual r and omisation is not feasible . Missing outcome data can reduce power in trials , including in CRTs , and is a potential source of bias . The current review focuses on evaluating methods used in statistical analysis and h and ling of missing data with respect to the primary outcome in CRTs . Methods and analysis We will search for CRTs published between August 2013 and July 2014 using PubMed , Web of Science and Psyc Output:
Conclusions High rates of missing outcome data are present in the majority of CRTs , yet h and ling missing data in practice remains suboptimal .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Objective To analyze the clinical outcomes of arthroscopic anterior cruciate ligament ( ACL ) reconstruction with irradiated bone-patellar tendon-bone ( BPTB ) allograft compared with non-irradiated allograft and autograft . Methods All BPTB allografts were obtained from a single tissue bank and the irradiated allografts were sterilized with 2.5 mrad of irradiation prior to distribution . A total of 68 patients undergoing arthroscopic ACL reconstruction were prospect ively r and omized consecutively into one of the two groups ( autograft and irradiated allograft groups ) . The same surgical technique was used in all operations done by the same senior surgeon . Before surgery and at the average of 31 months of follow-up ( ranging from 24 to 47 months ) , patients were evaluated by the same observer according to objective and subjective clinical evaluations . Results Of these patients , 65 ( autograft 33 , irradiated allograft 32 ) were available for full evaluation . When the irradiated allograft group was compared to the autograft group at the 31-month follow-up by the Lachman test , the anterior drawer test ( ADT ) , the pivot shift test , and KT-2000 arthrometer test , statistically significant differences were found . Most importantly , 87.8 % of patients in the autograft group and just only 31.3 % in the irradiated allograft group had a side-to-side difference of less than 3 mm according to KT-2000 . The failure rate of the ACL reconstruction with irradiated allograft ( 34.4 % ) was higher than that with autograft ( 6.1 % ) . The anterior and rotational stabilities decreased significantly in the irradiated allograft group . According to the overall International Knee Documentation Committee ( IKDC ) , functional and subjective evaluations , and activity level testing , no statistically significant differences were found between the two groups . Besides , patients in the irradiated allograft group had a shorter operation time and a longer duration of postoperative fever . When the patients had a fever , the laboratory examinations of all patients were almost normal . Blood routine was normal , the values of erythrocyte sedimentation rate ( ESR ) were 5∼16 mm/h and the contents of C reactive protein ( CRP ) were 3∼10 mg/L. Conclusion We conclude that the short term clinical outcomes of the ACL reconstruction with irradiated BPTB allograft were adversely affected . The less than satisfactory results led the senior authors to discontinue the use of irradiated BPTB allograft in ACL surgery and not to advocate using the gamma irradiation as a secondary sterilizing method Delayed rather than early reconstruction of the anterior cruciate ligament is the current recommended treatment for injury to this ligament since it is thought to give a better functional outcome . We r and omised 105 consecutive patients with injury associated with chondral lesions no more severe than grade s 1 and 2 and /or meniscal tears which only required trimming , to early ( < two weeks ) or delayed ( > four to six weeks ) reconstruction of the anterior cruciate ligament using a quadrupled hamstring graft . All operations were performed by a single surgeon and a st and ard rehabilitation regime was followed in both groups . The outcomes were assessed using the Lysholm score , the Tegner score and measurement of the range of movement . Stability was assessed by clinical tests and measurements taken with the KT-1000 arthrometer , with all testing performed by a blinded uninvolved experienced observer . A total of six patients were lost to follow-up , with 48 patients assigned to the delayed group and 51 to the early group . None was a competitive athlete . The mean interval between injury and the surgery was seven days ( 2 to 14 ) in the early group and 32 days ( 29 to 42 ) in the delayed group . The mean follow-up was 32 months ( 26 to 36 ) . The results did not show a statistically significant difference for the Lysholm score ( p = 0.86 ) , Tegner activity score ( p = 0.913 ) or the range of movement ( p = 1 ) . Similarly , no distinction could be made for stability testing by clinical examination ( p = 0.56 ) and measurements with the KT-1000 arthrometer ( p = 0.93 ) . Reconstruction of the anterior cruciate ligament gave a similar clinical and functional outcome whether performed early ( < two weeks ) or late at four to six weeks after injury The Losee repair controls rotational subluxation of the lateral femoral condyle , or pivot shift , but does not reliably eliminate Lachman laxity . Despite this surgical limitation , many patients who were operated on continued to do high-dem and activities at the last followup . We hypothesized that Lachman findings alone did not predict poor surgical outcome or progression to osteoarthritis . We report on 87 patients evaluated at an average of 9 years ( range , 5 - 21 years ) postoperatively . Prospect ively collected examinations and radiographic , subjective , and objective outcome measures were recorded and statistically evaluated . The presence of a postoperative pivot shift or residual varus laxity correlated with poor patient subjective evaluations and poor scoring outcomes . Lachman laxity with an absent pivot shift had no correlation with the outcome measures or onset of radiographic progression to osteoarthritis . Meniscectomy , additional knee surgery , increased valgus or varus laxity , and time from injury until the final radiograph positively correlated with the onset of osteoarthritis . Elimination of the pivot shift was necessary to achieve successful relief of symptoms and functional outcome . In the absence of a pivot shift , Lachman laxity was not solely predictive of poor outcomes . Level of Evidence : Prognostic study , Level II-1 ( retrospective study ) . See the Guidelines for Authors for a complete description of levels of evidence The purpose of this study is to clinical ly evaluate hamstring tendon anterior cruciate ligament (ACL)-reconstruction using femoral fixation with bioresorbable interference screws and with a bioresorbable transfixation device . The ACL-reconstruction using the transfixation device at the femoral side leads to less knee laxity and therefore to a better clinical outcome for the patient . Prospect i ve r and omized clinical outcome study . From February 2002 to December 2002 , a total of 68 patients with hamstring ACL reconstruction using a femoral fixation once with TransFix ( n=38 ; m:22 and f:16 ; median age=28.5 range 15–47 ) and the second with bioscrew ( BS ) ( n=30 ; m:20 , f:10 ; median age=25.5 range 13–61 ) completed the follow-up period . Patients in each group got a clinical assessment at 3 , 6 , and 12 months after surgery . The measurement of anterior translation of the tibia has been performed using the Rolimeter ® device . No significant differences in the knee laxity testing using the Rolimeter device were seen between both groups and over time within these groups . Ninety percent of all patients had functionally normal or near normal International Knee Documentation Committee ( IKDC ) knee ligament ratings . The TF-group included 17 grade A , 19 grade B , and 2 grade C knees , and the BS-group had 12 grade A , 13 grade B , and 5 grade C knees . The IKDC rating , the OAK-score , the Tegner-activity-score , and the Lysholm-score did not show significant differences between the TF-group and the BS-group . We disproved our hypothesis that the transfixation technique leads to less laxity and therefore to a better clinical outcome when compared to the use of BS . The clinical results in this study clarified that this technique is an effective and safe method for femoral hamstring fixation in ACL-reconstruction . However , this technique revealed no advantage compared to the bioscrew fixation technique within the short-term follow-up BACKGROUND There are no controlled , prospect i ve studies comparing the 10-year outcomes of anterior cruciate ligament ( ACL ) reconstruction using patellar tendon ( PT ) and 4-str and hamstring tendon ( HT ) autografts . HYPOTHESIS Comparable results are possible with HT and PT autografts . STUDY DESIGN Cohort study ; Level of evidence , 2 . METHODS One hundred eighty ACL-deficient knees that met inclusion criteria underwent ACL reconstruction ( 90 HT autograft , 90 PT autograft ) by one surgeon and were treated with an accelerated rehabilitation program . All knees were observed in a prospect i ve fashion with subjective , objective , and radiographic evaluation at 2 , 5 , 7 , and 10-year intervals . RESULTS At 10 years , there were no differences in graft rupture rates ( 7/90 PT vs. 12/90 HT , P = .24 ) . There were 20 contralateral ACL ruptures in the PT group , compared with 9 in the HT group ( P = .02 ) . In all patients , graft rupture was associated with instrumented laxity > 2 mm at 2 years ( P = .001 ) . Normal or near-normal function of the knee was reported in 97 % of patients in both groups . In the PT group , harvest-site symptoms ( P = .001 ) and kneeling pain ( P = .01 ) were more common than in the HT group . More patients reported pain with strenuous activities in PT knees than in HT knees ( P = .05 ) . Radiographic osteoarthritis was more common in PT knees than the HT-reconstructed knees ( P = .04 ) . The difference , however , was composed of patients with mild osteoarthritis . Other predictors of radiographic osteoarthritis were < 90 % single-legged hop test at 1 year and the need for further knee surgery . An " ideal " outcome , defined as an overall International Knee Documentation Committee grade of A or B and a radiographic grade of A at 10 years after ACL reconstruction , was associated with <3 mm of instrumented laxity at 2 years , the absence of additional surgery in the knee , and HT grafts . CONCLUSIONS It is possible to obtain excellent results with both HT and PT autografts . We recommend HT reconstructions to our patients because of decreased harvest-site symptoms and radiographic osteoarthritis Introduction Correct placement of both tibial and femoral tunnels is one of the main factors for a favorable clinical outcome after anterior cruciate ligament ( ACL ) reconstruction . We used an original system of computer assisted surgery ( CAS ) . The system , based on fluoroscopic guidance combined with special graphical software of image analyzing , showed to the surgeon , before drilling , the recommended placement of tibial and femoral tunnel centers . We compared the first anatomical and clinical results of this procedure to the usual one single incision technique . Material s and methods We conducted a prospect i ve study on 73 patients ; 37 patients were operated on with CAS and 36 without CAS , by the same senior surgeon . The mean age was 27 years for both groups . Every patient was review ed at an average of 2.2 years ( range 1–4.5 ) by an independent observer , using IKDC scoring system , KT-1000 , and passive stress radiographs . Results Time between ACL rupture and reconstruction averaged 30 months for both groups . CAS needed 9.3 min extra surgery time . Clinical evaluation was grade d from A to C as per the IKDC scoring system : 67.6 % A , 29.7 % B , 2.7 % C with CAS ; and 60 % A , 37.1 % B , 2.9 % C without CAS . IKDC subjective knee evaluation score averaged 89.7 with CAS and 89.5 without CAS . Pre operative KT-1000 maxi manual differential laxity averaged 7 . At revision time , all the patients after CAS had a differential laxity less than 2 and 97.7 % without CAS . Stress X-rays differential laxity averaged 2.4 mm with CAS and 3 mm without CAS . The area of dispersion of the tunnels ’ center was smaller on the femoral side using the CAS method . There was no statistically significant difference between both groups using IKDC score , KT-1000 and passive stress radiographs . Conclusions The CAS method provided a more accurate and reproducible tunnels placement without clinical significant effect PURPOSE The aim of this study was to evaluate whether a change in the femoral graft insertion site between the 1-o'clock ( high ) and 2-o'clock ( low ) positions could change the laxity , the score on the 2000 International Knee Documentation Committee ( IKDC ) Knee Examination Form , or the score on the 2000 subjective IKDC Knee Evaluation Form in the anterior cruciate ligament (ACL)-reconstructed knee . METHODS The study was design ed as a prospect i ve , r and omized , double-blind investigation . We r and omized 30 patients to the low tunnel position group and 30 to the high tunnel position group . Four-str and ed semitendinosus and gracilis single-bundle grafts were used . At follow-up , the patients were examined according to the IKDC evaluation form and the IKDC examination form . The exact measurements of laxity at 25 degrees and 70 degrees were performed by use of the Rolimeter ( Aircast , Boca Raton , FL ) . St and ardized radiographs were evaluated . RESULTS In total , 26 patients in the low tunnel position group and 25 in the high tunnel position group completed the study . At follow-up , we found no significant difference in the laxity at 25 degrees and 70 degrees or scores on Output:
Conclusion The pivot shift test is an important test following ACL reconstruction , and it correlates with functional outcomes
MS2_1shot256
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Study Design . Prospect i ve , r and omized controlled study . Objective . To compare the functional outcomes and extent of paraspinal muscle damage between 2 decompressive techniques for lumbar canal stenosis . Summary of Background Data . Lumbar spinous process splitting decompression ( LSPSD ) preserves the muscular and liga-mentous attachments of the posterior elements of the spine . It can potentially avoid problems such as paraspinal muscle atrophy and trunk extensor weakness that can occur after conventional midline decompression . However , large series prospect i ve r and omized controlled studies are lacking . Methods . Patients with lumbar canal stenosis were r and omly allocated into 2 groups : LSPSD ( 28 patients ) and conventional midline decompression ( 23 patients ) . The differences in operative time , blood loss , time to comfortable mobilization , and hospital stay were studied . Paraspinal muscle damage was assessed by postoperative rise in creatine phosphokinase and C-reactive protein levels . Functional outcome was evaluated at 1 year by Japanese Orthopaedic Association score , neurogenic claudication outcome score , and visual analogue scale for back pain and neurogenic claudication . Results . Fifty-one patients of mean age 56 years were followed-up for a mean 14.2 ± 2.9 months . There were no significant differences in the operative time , blood loss , and hospital stay . Both the groups showed significant improvement in the functional outcome scores at 1 year . Between the 2 groups , the Japanese Orthopaedic Association score , neurogenic claudication outcome score improvement , visual analogue scale for back pain , neurogenic claudication visual analogue scale , and the postoperative changes in serum C-reactive protein and creatine phosphokinase levels did not show any statistically significant difference . On the basis of the Japanese Orthopaedic Association recovery rate , it was found that 73.9 % of conventional midline decompression group had good outcomes compared with only 60.7 % after LSPSD . Conclusion . The functional outcome scores , back pain , and claudication pain in the immediate period and at the end of 1 year are similar in both the techniques . More patients had better functional outcomes after conventional decompression than the LSPSD technique . On the basis of this study , the superiority of one technique compared with the other is not established , m and ating the need for further long-term studies . Level of Evidence : Study Design . A prospect i ve clinical study of M-ULBD of lumbar spinal stenosis ( LSS ) . Objective . In this article , the authors describe the technique of M-ULBD for lumbar spinal stenosis , and reported 2-year follow-up results . Summary of Background Data . Recent reports showed that atrophy of multifidus muscles and chronic low back pain after conventional laminectomy may relate to disturbance of the arterial supply caused by long duration of muscle retraction , extensive muscle stripping , and damage to the dorsal rami of the posterior branches . Methods . A total of 56 patients with LSS were r and omly divided into group A and B. The 27 patients in group A ( 15 males and 12 females ) underwent M-ULBD . The other 29 patients in group B ( 18 males and 11 females ) received conventional laminectomy . Japanese Orthopaedic Association score of low back pain , 10-cm visual analogue scale , creatine phosphokinase 3 days after operation , pre- and postoperative cross-sectional areas of multifidus were used to evaluate the clinical results . Results . There was no significant difference in preoperative data between both groups . A total of 54 patients ( 27 in each group A and B ) completed 2 years of follow-up . The postoperative Japanese Orthopaedic Association and visual analogue scale scores in both groups were improved significantly compared with the corresponding preoperative ones ( P < 0.05 ) . The postoperative creatine phosphokinase , visual analogue scale score of low back pain , and atrophy rate of multifidus CSA in group A are lower than those in group B ( P < 0.05 ) . Dural tear at the contralateral side occurred in 3 cases ( 11.1 % ) in group A and 1 case in group B ( 3.4 % ) . Conclusion . Our 2 years of follow-up shows that this method is efficient for lumbar spinal stenosis treatment ; however , it still needs long-term follow-up and needs to be compared with other modified methods . Level of Evidence : Abstract Study design Prospect i ve clinical observational study of low back pain ( LBP ) in patients undergoing laminectomy or laminotomy surgery for lumbar spinal stenosis ( LSS ) . Objectives To quantify any change in LBP following laminectomy or laminotomy spinal decompression surgery . Patients and methods 119 patients with LSS completed Oswestry Disability Index question naire ( ODI ) and Visual Analogue Scale for back and leg pain , preoperatively , 6 weeks and 1 year postoperatively . Results There was significant ( p < 0.0001 ) reduction in mean LBP from a baseline of 5.14/10 to 3.03/10 at 6 weeks . Similar results were seen at 1 year where mean LBP score was 3.07/10 . There was a significant ( p < 0.0001 ) reduction in the mean ODI at 6 weeks and 1 year postoperatively . Mean ODI fell from 44.82 to 25.13 at 6 weeks and 28.39 at 1 year . Conclusion The aim of surgery in patients with LSS is to improve the result ing symptoms that include radicular leg pain and claudication . This observational study reports statistically significant improvement of LBP after LSS surgery . This provides frequency distribution data , which can be used to inform prospect i ve patients of the expected outcomes of such surgery Study Design . A prospect i ve study to evaluate the outcomes of 2 different decompressive techniques for lumbar spinal stenosis . Objective . To explore a more effective and less invasive decompression technique without instrument and fusion for lumbar spinal stenosis . Summary of Background Data . The traditional surgical decompression of spinal stenosis involves laminectomy or unilateral laminotomy . Even in unilateral laminotomy cases , 85.3 % had an excellent-to-fair operative result , and the incidence of complications was 9.8 % . Although the addition of instrumentation does not increase the complication rate , but compared to the efficiency , the higher costs was controversial . Minimal invasion and destabilization are recommended . Methods . This prospect i ve study included 152 consecutive patients , sequentially divided into 2 groups , underwent Windows technique ( group A ) and decompressive laminectomy ( group B ) by 2 groups of surgeons . Results . The evaluation of the back pain , leg pain , walking tolerance , and neurologic recovery were performed before surgery and after surgery . In group A , at the final evaluation , the overall results were good to excellent in 89 % ( 68/76 ) of the patients , fair 11 % ( 8/76 ) , and poor 0 % . In group B , at the final evaluation , the overall results were good to excellent in 63 % ( 48/76 ) of the patients , fair 30 % ( 23/76 ) , and poor 7 % ( 5/76 ) . Conclusion . Degenerative spinal stenosis can be decompressed adequately with preserving the posterior elements . The “ Windows technique ” laminoforaminotomy , which obtained satisfactory long-term outcomes with few complications and low cost , can be a st and ard procedure for the surgical treatment of the degenerative spinal stenosis even with slight congenital spinal stenosis Introduction This observational study is design ed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis . Lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly , and as the oldest segment of the population continues to grow its prevalence is likely to increase . However , data on surgical outcomes are limited . Open or wide decompressive laminectomy , often combined with medial facetectomy and foraminotomy , was formerly the st and ard treatment . In recent years a growing tendency towards less invasive decompressive procedures has emerged . At present , many spine surgeons perform microdecompression for central lumbar spinal stenosis . Methods and analysis Prospect ively registered treatment and outcome data are obtained from the Norwegian Registry for Spine Surgery . The primary outcome measure is change in Oswestry disability index between baseline and 12-month follow-up . Secondary outcome measures are changes in health-related quality of life measured by the Euro-Qol-5D between baseline and 12-month follow-up , perioperative complications , and duration of surgical procedures and length of hospital stay . Ethics and dissemination The study has been evaluated and approved by the regional committee for medical research in central Norway and all participants provided written informed consent . The findings of this study will be disseminated through peer- review ed publications . Trial registration number Clinical trials.gov ( NCT02006901 ) Study Design The 2 groups of patients with severe lumbar spinal stenosis were prospect ively compared as a case control study . Objectives This prospect i ve case control study sought to evaluate bilateral microdecompressive laminatomy ( MDL ) for treatment of severe lumbar spinal stenosis . Summary of Background Data Total laminectomy is a general consensus on the therapy of severe spinal stenosis . The authors tried to investigate a new minimal invasive approach . Methods Patients were r and omly divided into 2 groups . In first group , 34 patients underwent total laminectomy ( TL ) for severe lumbar spinal stenosis . In the second group , 37 patients with the same diagnosis underwent bilateral MDL . The groups were compared for disability , walking distance , degree of postoperative back and leg pain , perioperative complications , and postoperative instability . Radiographic analyses were performed at regular intervals to demonstrate satisfactory decompression . Results Mean follow-up was 5 years . Postoperative computerized tomography and magnetic resonance imaging demonstrated adequate decompressions in both groups . The walking distance , pain control , and disability scores were slightly higher among patients in the MDL group , although these results did not achieve statistical significance . Perioperative complications and postoperative instability were significantly higher in the TL group ( P<0.05 ) . Conclusions Compared with classic approaches , bilateral MDL provides adequate and safe decompression in lumbar spinal stenosis . It significantly reduces clinical symptoms and disability . However , TL shows higher perioperative complications and postoperative instability . To the best of our knowledge , this is the first study to define a bilateral MDL approach to treat the stenotic lumbar spine without a herniated disc We assigned 67 patients with central lumbar stenosis alternately to either multiple laminotomy or total laminectomy . The protocol , however , allowed multiple laminotomy to be changed to total laminectomy if it was thought that the former procedure might not give adequate neural decompression . There were therefore three treatment groups : group I consisting of 26 patients su bmi tted to multiple laminotomy ; group II , 9 patients scheduled for laminotomy but su bmi tted to laminectomy ; and group III , 32 patients scheduled for , and su bmi tted to , laminectomy . The mean follow-up was 3.7 years . Bilateral laminotomy at two or three levels required a longer mean operating time than total laminectomy at an equal number of levels . The mean blood loss at surgery and the clinical results did not differ in the three groups . The mean subjective improvement score for low back pain was higher in group I but there was also a higher incidence of neural complications in this group . No patient in group I had postoperative vertebral instability , whereas this occurred in three patients in groups II and III , who had lumbar scoliosis or degenerative spondylolisthesis preoperatively . Multiple laminotomy is recommended for all patients with developmental stenosis and for those with mild to moderate degenerative stenosis or degenerative spondylolisthesis . Total laminectomy is to be preferred for patients with severe degenerative stenosis or marked degenerative spondylolisthesis STUDY DESIGN A cohort of 100 patients with symptomatic lumbar spinal stenosis , characterized in a previous article , were given surgical or conservative treatment and followed for 10 years . OBJECTIVES To identify the short- and long-term results after surgical and conservative treatment , and to determine whether clinical or radiologic predictors for the treatment result can be defined . SUMMARY OF BACKGROUND DATA Surgical decompression has been considered the rational treatment . However , clinical experience indicates that many patients do well with conservative treatment . METHODS In this study , 19 patients with severe symptoms were selected for surgical treatment and 50 patients with moderate symptoms for conservative treatment , whereas 31 patients were r and omized between the conservative ( n = 18 ) and surgical ( n = 13 ) treatment groups . Pain was decisive for the choice of treatment group . All patients were observed for 10 years by clinical evaluation and question naires . The results , evaluated by patient and physician , were rated as excellent , fair , unchanged , or worse . RESULTS After a period of 3 months , relief of pain had occurred in most patients . Some had relief earlier , whereas for others it took 1 year . After a period of 4 years , excellent or fair results were found in half of the patients selected for conservative treatment , and in four fifths of the patients selected for surgery . Patients with an unsatisfactory result from conservative treatment were offered delayed surgery after 3 to 27 months ( median , 3.5 months ) . The treatment result of delayed surgery was essentially similar to that of the initial group . The treatment result for the patients r and omized for surgical treatment was considerably better than for the patients r and omized for conservative treatment . Clinical ly significant deterioration of symptoms during the final 6 years of the follow-up period was not observed . Patients with multilevel afflictions , Output:
Evidence of low or very low quality suggests that different techniques of posterior decompression and conventional laminectomy have similar effects on functional disability and leg pain . Only perceived recovery at final follow-up was better in patients that underwent bilateral laminotomy compared with conventional laminectomy . Unilateral laminotomy for bilateral decompression and bilateral laminotomy result ed in numerically fewer cases of iatrogenic instability , although in both cases , the incidence of instability was low . We found no evidence to show that the incidence of complications , length of the procedure , length of hospital stay and postoperative walking distance differed between techniques of posterior decompression .
MS2_1shot257
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Healthcare delivery is reliant on a team‐based approach , and interprofessional education ( IPE ) provides a means by which such collaboration skills can be fostered prior to entering the workplace . IPE within healthcare programs has been associated with improved collaborative behavior , patient care and satisfaction , reduced clinical error , and diminished negative professional stereotypes . An intensive interprofessional gross anatomy dissection course was created in 2009 to facilitate IPE at McMaster University . Data were collected from five cohorts over five years to determine the influence of this IPE format on the attitudes and perceptions of students towards other health professions . Each year , 28 students from the medicine , midwifery , nursing , physician 's assistant , physiotherapy , and occupational therapy programs were r and omly assigned into interprofessional teams for 10 weeks . Sessions involved an anatomy and scope‐of‐ practice presentation , a small‐group case‐based session , and a dissection . A before/after design measured changes in attitudes and perceptions , while focus group data elaborated on the student experience with the course . Pre‐ and postmatched data revealed significant improvements in positive professional identity , competency and autonomy , role clarity and attitudes toward other health professions . Qualitative analysis of intraprofessional focus group interviews revealed meaningful improvements in a number of areas including learning anatomy , role clarity , and attitudes towards other health professions . Anat Sci Educ 8 : 305–316 . © 2015 American Association of Anatomists Background The present study was design ed to implement an interprofessional simulation-based education program for nursing students and evaluate the influence of this program on nursing students ’ attitudes toward interprofessional education and knowledge about operating room nursing . Methods Nursing students were r and omly assigned to either the interprofessional simulation-based education or traditional course group . A before- and -after study of nursing students ’ attitudes toward the program was conducted using the Readiness for Interprofessional Learning Scale . Responses to an open-ended question were categorized using thematic content analysis . Nursing students ’ knowledge about operating room nursing was measured . Results Nursing students from the interprofessional simulation-based education group showed statistically different responses to four of the nineteen questions in the Readiness for Interprofessional Learning Scale , reflecting a more positive attitude toward interprofessional learning . This was also supported by thematic content analysis of the open-ended responses . Furthermore , nursing students in the simulation-based education group had a significant improvement in knowledge about operating room nursing . Conclusions The integrated course with interprofessional education and simulation provided a positive impact on undergraduate nursing students ’ perceptions toward interprofessional learning and knowledge about operating room nursing . Our study demonstrated that this course may be a valuable elective option for undergraduate nursing students in operating room nursing education EXECUTIVE SUMMARY Implementing interprofessional collaborative practice s in primary care is challenging , and research about its facilitating factors remains scarce . The goal of this participatory action research study was to better underst and the driving forces during the early stage of the implementation process of a community‐driven and patient‐focused program in primary care titled “ TRANSforming InTerprofessional cardiovascular disease prevention in primary care ” ( TRANSIT ) . Eight primary care clinics in Quebec , Canada , agreed to participate by creating and implementing an interprofessional facilitation team ( IFT ) . Sixty‐three participants volunteered to be part of an IFT , and 759 patients agreed to participate . We r and omized six clinics into a supported facilitation ( “ supported ” ) group , with an external facilitator ( EF ) and financial incentives for participants . We assigned two clinics to an unsupported facilitation ( “ unsupported ” ) group , with no EF or financial incentives . After 3 months , we held one interview for the two EFs . After 6 months , we held eight focus groups with IFT members and another interview with each EF . The analyses revealed three key forces : ( 1 ) opportunity for dialogue through the IFT , ( 2 ) active role of the EF , and ( 3 ) change implementation budgets . Decisionmakers design ing implementation plans for interprofessional programs should ensure that these driving forces are activated . Further research should examine how these forces affect interprofessional practice s and patient outcomes BACKGROUND Effective teamwork in the operating room ( OR ) is often undermined by the " silo mentality " of the differing professions . Such thinking is formed early in one 's professional experience and is fostered by undergraduate medical and nursing curricula lacking interprofessional education . We investigated the immediate impact of conducting interprofessional student OR team training using high-fidelity simulation ( HFS ) on students ' team-related attitudes and behaviors . STUDY DESIGN Ten HFS OR interprofessional student team training sessions were conducted involving 2 st and ardized HFS scenarios , each of which was followed by a structured debriefing that targeted team-based competencies . Pre- and post-session mean scores were calculated and analyzed for 15 Likert-type items measuring self-efficacy in teamwork competencies using the t-test . Additionally , mean scores of observer ratings of team performance after each scenario and participant ratings after the second scenario for an 11-item Likert-type teamwork scale were calculated and analyzed using one-way ANOVA and t-test . RESULTS Eighteen nursing students , 20 nurse anesthetist students , and 28 medical students participated in the training . Statistically significant gains from mean pre- to post-training scores occurred on 11 of the 15 self-efficacy items . Statistically significant gains in mean observer performance scores were present on all 3 subscales of the teamwork scale from the first scenario to the second . A statistically significant difference was found in comparisons of mean observer scores with mean participant scores for the team-based behaviors subscale . CONCLUSIONS High-fidelity simulation OR interprofessional student team training improves students ' team-based attitudes and behaviors . Students tend to overestimate their team-based behaviors Medical and nursing students organized a context ual interprofessional learning experience involving observation of surgical safety practice s according to the parameters of the World Health Organization ( WHO ) surgical safety checklist . Students were oriented to patient safety principles , operating room ( OR ) protocol , and the WHO surgical safety checklist . One hundred thirty students participated in interprofessional OR visitations . Selected students participated in focus groups , during which feedback regarding educational value and OR observations was obtained : Students thought that patient safety education was more meaningful in a clinical setting , and the degree of interprofessional collaboration appeared related to individual factors . Focus group data collected provides a foundation on which future research can build . Areas of inquiry may include development of teamwork within the context of interprofessional education , examination of the role of students in developing their own curricula , and r and omized comparisons of clinical -based and classroom-based approaches to surgical safety education Output:
Findings suggest that more studies with rigorous research design s are needed to compare outcomes for interprofessional interventions and to determine the effectiveness of IPE on patient outcomes
MS2_1shot258
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Context Quality -of-care evaluation often focuses on how often patients receive certain tests or treatments . Theoretically , the content of care should predict patient survival , but the evidence is inconclusive . Contribution This study used 207 criteria to assess good care in 372 vulnerable elderly patients . When care did not meet these st and ards , patients were more likely to die during the 3 years of follow-up . Implication s In vulnerable older patients , the content of care is associated with mortality . This finding supports the use of process measures in the evaluation of quality of care and shows that good care may prolong life . The Editors As clinicians , the public , and health systems become more aware that many Americans do not receive necessary care , the importance of measuring and improving quality of care has gained increasing attention ( 1 - 3 ) . Although quality of care can theoretically be measured by outcomes ( what happens to patients ) , process ( what providers do ) is often preferred ( 3 - 5 ) because process is under relatively greater control of providers , needs a shorter time frame , can directly inform improvement , and may not require statistical adjustment for severity of illness ( 6 , 7 ) . Typically , process measures evaluate the proportion of eligible patients who receive care as recommended ( for example , the proportion of patients 65 years of age receiving pneumococcal vaccine ) . To be a meaningful measure of quality , a process of care must be related to improved patient outcomes . For many quality indicators , this relationship is based on evidence of efficacy from r and omized , controlled trials , usually among a select patient population . However , the relationship between performance on process of care quality indicators and better health outcomes remains a largely untested assumption for general population s of patients receiving care in community setting s. The lack of a demonstrated relationship between performance on process quality measures and outcome advantage in a cohort of patients has hindered the acceptance of quality indicators as a way to measure and improve health outcomes ( 8) . The Assessing Care of Vulnerable Elders ( ACOVE ) project developed a set of process quality criteria that were judged by clinical experts to improve patient outcomes on the basis of clinical evidence and professional opinion ( 9 - 11 ) . Combined with mortality information available through the National Death Index , our study evaluated the process outcome relationship . While the development method conferred content validity on the process measures , we aim ed to assess the predictive validity of the quality measurement system by examining the relationship between the quality of care received by sample d participants and their subsequent survival . Methods The ACOVE Project The ACOVE project developed and implemented a set of quality indicators that focuses on process of care for clinical conditions important in the care of vulnerable older patients . Details of the methods of selecting conditions and developing quality indicators have been described in previous reports ( 9 , 10 ) 12 ) . We selected quality indicators by using systematic review s of the medical literature followed by deliberations by several panels of clinical experts using formal consensus methods to assess the validity of quality indicators . This process result ed in 236 quality indicators covering 22 clinical areas ( continuity of care , dementia , depression , diabetes mellitus , end-of-life care , falls and mobility problems , hearing loss , heart failure , hospital care , hypertension , ischemic heart disease , malnutrition , medication management , osteoarthritis , osteoporosis , pain management , pneumonia , pressure ulcer , screening and prevention , stroke and atrial fibrillation , urinary incontinence , and vision care ) across the continuum of care , including prevention , diagnosis , treatment , and follow-up . Each quality indicator contains an if clause that defines the patient who is eligible to receive it and a then clause that describes what care is recommended ( for example : If a vulnerable elder has had a myocardial infa rct ion , then he or she should be offered a -blocker ) . If the medical record describes a contraindication to the recommended care , the patient is not eligible for the quality indicator . Furthermore , we explicitly defined certain indicators as being not applicable , and therefore not included , when assessing the care of patients with advanced dementia or poor prognosis ( 13 ) . We applied the ACOVE quality indicators to a sample of vulnerable older patients in 2 large managed care organizations , 1 in the northeastern United States and the other in the southwestern United States ( 11 ) . Each managed care plan had more than 20000 senior members and contracted with a network of providers for delivery of care . Eligibility criteria included continuous enrollment in the managed care organization with no out-of-network care during the 13-month study period and no active treatment for malignant conditions except for nonmelanoma skin cancer . We identified vulnerable older persons by telephone interview using the Vulnerable Elders Survey-13 ( VES-13 ) ( 14 ) . The VES-13 is a 13-item question naire that produces a vulnerability score ranging from 0 to 10 based on age , self-reported health , and function . Patients with scores of 3 or higher are at 4 times the risk for death or functional decline over the next 2 years and are therefore defined as vulnerable . We excluded nonEnglish- language speakers because interviews were available only in English . Among 3207 community-dwelling patients 65 years of age and older who were r and omly selected from the 2 managed care plans , we conducted screening interviews with 2278 patients ( 9 % through proxies ) and identified 475 ( 21 % ) patients as vulnerable . Among them , 420 ( 88 % ) patients consented to participate in the study and 372 ( 78 % ) patients had medical records for the 13-month period from 1 July 1998 to 31 July 1999 that were able to be abstract ed . We collected all participants ' medical records , including those for inpatient care , outpatient care , nursing home care , home care , and mental health care . Trained nurses abstract ed charts to apply quality indicators . A senior nurse review er assessed completed abstract ions , and physician overreaders review ed them for clinical assessment . We evaluated inter-rater reliability by re abstract ion of 10 % of the medical records , which contained 698 quality indicators . Agreement was 97 % for quality indicator eligibility and 95 % for overall quality score . We collected patient characteristics , including age , sex , cognitive function measured by the Blessed OrientationMemoryConcentration test ( 15 ) , and mental health score derived from Medical Outcomes Study Short Form-36 items ( 16 ) , at the time of the recruitment telephone interview . The R AND institutional review board approved the study protocol . Among the 236 ACOVE quality indicators , 207 could be implemented in the field trial either by medical record ( 183 indicators ) or patient interview ( 24 indicators ) . Because some patients died before the interview was conducted , we used only quality indicators for which information was available in medical records . Among these , 160 quality indicators had at least 1 eligible patient ; 43 focused on prevention , 42 on diagnosis , 47 on treatment , and 28 on follow-up care . These 160 quality indicators covered all 22 conditions . The Appendix Table contains the list of quality indicators used in our report , the number of eligible patients , and the pass rate for each indicator . Appendix Table . Quality Indicators Using Medical Records as the Information Source , Eligible Patients , and Pass Rates Statistical Analysis We calculated quality scores for each patient on the basis of the percentage of ACOVE quality indicators for which an eligible patient received recommended care . We obtained death , date , and cause-of-death data for ACOVE participants from the National Death Index during 3 years after the quality measurement period ( from August 1999 to September 2002 ) . We used both unadjusted and adjusted analyses to examine the link between patient survival and quality score . For the unadjusted analysis , we first divided the sample in half on the basis of quality score ( that is , median and < median ) and examined the difference in survival curves between patients with higher quality and patients with lower quality by using the log-rank test . Second , we calculated survival for 10 equal intervals of quality score from the lowest quality score to the highest quality score in the sample and graphically assessed the grade d relationship between quality score and survival . We used the Cox proportional hazards survival model in adjusted analyses . Because the proportional hazards assumption for the multivariate survival analysis did not hold for the entire observation period , we used a piecewise model that allowed the coefficients for quality to vary between 500 days or less and more than 500 days , as suggested by the KaplanMeier survival curve in the unadjusted analysis . Covariates included sex , VES-13 score ( including age ) , mental health , number of hospitalizations and office visits during the quality measurement period , and number of conditions that patients had during the quality measurement period among 13 comorbid conditions ( dementia , depression , diabetes mellitus , heart failure , hypertension , ischemic heart disease , osteoarthritis , osteoporosis , pressure ulcer , atrial fibrillation , urinary incontinence , chronic obstructive pulmonary disease , and chronic renal failure ) . The mental health score ranged from 1 to 6 , and we created 3 categories on the basis of the score ( < 2 , very good ; 2 to 3 , good ; and > 3 , fair ) . An indicator variable design ated patients who were not interviewed for mental health items because of cognitive impairment . To further examine a plausible mechanism for the quality survival link , we examined the relationship between survival and OBJECTIVE To evaluate the pain experience of very old hospitalized patients during and up to 1 year after hospitalization . To underst and the relationship of level of pain to demographic , psychological , and illness-related variables . DESIGN Prospect i ve cohort study . SETTING Four teaching hospitals . PARTICIPANTS 1266 patients at least 80 years of age in the Hospitalized Elderly Longitudinal Project ( HELP ) . MEASUREMENTS Pain interviews during hospitalization and 2 and 6 months later . Ordinal logistic regression was used to study the association of variables with level of pain . RESULTS Interviews about symptoms were available for 806 ( 64.6 % of survivors ) patients during hospitalization , 614 ( 57.9 % of survivors ) at 2-months , and 416 ( 48.0 % of survivors ) at 12 months ; of these , 45.8 , 49.8 and 53.6 % , respectively , reported pain , and 12.9 % of those with pain during hospitalization were dissatisfied with its control . Multivariable analysis revealed that study hospital , admission diagnosis , depressed mood , alertness , and level of activity 2 weeks before admission were associated with pain during hospitalization , and pain reported during hospitalization , study site , patient level of activity 2 weeks before hospital admission , and patient education were associated with pain 2 months later . CONCLUSIONS Frequency of pain among very old hospitalized patients and at follow-up is similar to that reported for other hospitalized patients . Further studies of strategies to better control pain during and after hospitalization in very old patients are needed . These studies will have to adjust for other variables associated with pain in the oldest-old OBJECTIVE Long-term pain is a common sequela of thoracotomy , occurring in approximately 50 % of patients 2 years after thoracic surgery . Despite this alarming statistic , little is known about the factors responsible for the transition of acute to chronic pain . The aim of the present study is to identify predictors of long-term post-thoracotomy pain . DESIGN Follow-up was for 1.5 years for patients who had participated in a prospect i ve , r and omized , controlled trial of preemptive , multimodal analgesia . SETTING Subjects were recruited from a tertiary care center . PATIENTS Thirty patients who had undergone lateral thoracotomy were followed up by telephone , administered a structured interview , and classified according to long-term pain status . MAIN OUTCOME MEASURES Present pain status was measured by a verbal rating scale ( VAS ) . Measures obtained within the first 48 h after surgery were compared between patients with and without pain 1.5 years later . These include VAS pain scores at rest and after movement , McGill Pain Question naire data , patient-controlled morphine consumption ( mg ) , and pain thresholds to pressure applied to a rib contralateral to the thoracotomy incision . RESULTS Fifty-two percent of patients reported long-term pain . Early postoperative pain was the only factor that significantly predicted long-term pain . Pain intensity 24 h after surgery , at rest , and after movement was significantly greater among patients who developed long-term pain compared with pain-free patients . A significant predictive relationship was also found at 24 and 48 h using the McGill Pain Question naire . Cumulative morphine was comparable for the two groups . Pain thresholds to pressure applied to a rib contralateral to the incision did not differ significantly between the groups . CONCLUSION Aggressive management of early postoperative pain may reduce the likelihood of long-term post-thoracotomy pain OBJECTIVE To compare the experience of pain and treatment of pain in cognitively impaired and cognitively intact older adults after surgical repair of a hip fracture . DESIGN Prospect i ve comparative survey design . PARTICIPANTS A convenience sample of 88 hip fracture patients ( 53 cognitively impaired , 35 cognitively intact ) from three Midwestern urban hospital orthopedic units was interviewed between days 2 and 5 postoperatively . Subjects whose Folstein Mini-Mental State Exam ( MMSE ) score was less than or equal to 23 were categorized as impaired . RESULTS Pain report and intensity did not differ significantly between the two groups . One-third of the subjects in both groups rated pain as severe or worse . Cognitively impaired subjects scored significantly higher on the Checklist of Nonverbal Pain Indicators observed with movement ( CNPI-m ) than did cognitively intact subjects . Cognitively impaired subjects received significantly less opioid analgesics than cognitively intact subjects in the first and second 48 hours postoperatively . Both groups received less than 2 Output:
These quality indicators will help research ers and clinicians target quality improvement efforts .
MS2_1shot259
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Acne vulgaris can affect adolescents at a time of profound physical , social , and psychological change . The negative impact of acne on self-image and self-confidence can be severe , leading to potential psychiatric problems and limiting social interactions , even in adults . Adherence is necessary for successful treatment of acne , and patient satisfaction is crucial for adherence . The Measuring Acne Outcomes in a Real-World Experience ( MORE ) trial enrolled 1979 subjects who used combination acne treatments , all containing adapalene gel 0.1 % . Among other measures , subjects were surveyed regarding their satisfaction with treatment . Adherence to treatment protocol was high throughout the study ( 94.5 % and 88.0 % at weeks 6 and 12 , respectively , determined by self-report , and 93.7 % and 80.3 % , respectively , determined by filled prescriptions ) . Of the subjects who completed preference surveys , more than 70 % rated adapalene gel 0.1 % as much superior or superior to other acne treatments ; more than 85 % of subjects were very satisfied or satisfied with adapalene gel 0.1 % to treat their acne ; and more than 85 % of subjects reported feeling more confident or positive after using this treatment . About 75 % of subjects planned to continue using adapalene gel 0.1 % and /or use it in the future if they needed acne treatment , and close to 75 % of subjects indicated that they would recommend this treatment to a friend . The high level of patient satisfaction with adapalene gel 0.1 % as an acne treatment is likely to translate into a high level of adherence to treatment , including maintenance treatment , and a major improvement in quality of life ( QOL ) for patients with acne Background Patient adherence is an important component of the treatment of chronic disease . An underst and ing of patient adherence and its modulating factors is necessary to correctly interpret treatment efficacy and barriers to therapeutic success . Purpose This meta- analysis aims to systematic ally review published r and omized controlled trials of reminder interventions to assist patient adherence to prescribed medications . Methods A Medline search was performed for r and omized controlled trials published between 1968 and June 2011 , which studied the effect of reminder-based interventions on adherence to self-administered daily medications . Results Eleven published r and omized controlled trials were found between 1999 and 2009 which measured adherence to a daily medication in a group receiving reminder interventions compared to controls receiving no reminders . Medication adherence was measured as the number of doses taken compared to the number prescribed within a set period of time . Meta- analysis showed a statistically significant increase in adherence in groups receiving a reminder intervention compared to controls ( 66.61 % versus 54.71 % , 95 % CI for mean : 0.8 % to 22.4 % ) . Self-reported and electronically monitored adherence rates did not significantly differ ( 68.04 % versus 63.67 % , P = 1.0 ) . Eight of eleven studies showed a statistically significant increase in adherence for at least one of the reminder group arms compared to the control groups receiving no reminder intervention . Limitations The data are limited by imperfect measures of adherence due to variability in data collection methods . It is also likely that concomitant educational efforts in the study population s , such as instructions regarding proper administration and importance of correct dosing schedules , contributed to improved patient adherence , both in reminder and control arms . The search strategy could have missed relevant studies which were categorized by disease rather than adherence . Conclusions Reminder-based interventions may improve adherence to daily medications . However , the interventions used in these studies , which included reminder phone calls , text messages , pagers , interactive voice response systems , videotelephone calls , and programmed electronic audiovisual reminder devices , are impractical for widespread implementation , and their efficacy may be optimized when combined with alternative adherence-modifying strategies . More practical reminder-based interventions should be assessed to determine their value in improving patient adherence and treatment outcomes The US Food and Drug Administration has approved adapalene gel 0.1 % for use in the treatment of acne vulgaris . The objective of our study was to evaluate the efficacy and tolerability of adapalene gel 0.1 % in the treatment of acne vulgaris in a clinical practice . We used a 12-week , multicenter , open-label , noncomparative phase 4 study of adapalene gel 0.1 % . The study involved approximately 600 dermatologists in the United States and included 2,545 healthy men and nonpregnant women older than 14 years who had mild or moderate acne vulgaris . Of the patients enrolled , 75 % completed the study and most of them ( 89 % ) showed an improvement in their acne ( clear of acne or marked , definite , or minimal improvement ) from baseline . Most patients ( 69 % ) were satisfied or very satisfied with adapalene therapy , and most ( 80 % ) wished to continue treatment . Only 3.7 % of patients enrolled reported treatment-related adverse events ( n=94 ) , the most common being skin irritation ( 2.2 % ) . We conclude from this open-label trial in a dermatology practice setting that adapalene gel 0.1 % was effective and well tolerated and had a favorable safety profile . Furthermore , compliance with once-daily application of adapalene was rated as high by 92 % of patients who responded to a self- assessment question naire It is well known that the setting of clinical trials for registration studies do not necessarily represent efficacy seen in clinical practice , where physicians have the flexibility to select , combine , and change the acne treatment prescription . In this phase 4 , open-label , multicenter , community-based study , 544 patients who were dissatisfied with their current acne treatment received tretinoin gel microsphere ( TGM ) 0.04 % or 0.1 % in a pump dispenser for 12 weeks . Patients were allowed the use of up to 2 other concurrent acne therapies , not including other retinoids . A total of 361 patients received TGM 0.04 % and 183 received TGM 0.1 % . Compliance was high ( defined as 75 % to 100 % of prescribed doses taken ) for approximately 95 % of patients in both groups at every evaluation . At week 12 , the mean modified Global Acne Grade score ( mGAGs ) and the investigator global evaluation ( IGE ) demonstrated significant ( P<.0001 ) improvement from baseline for both concentrations , with 72 % having at least moderate improvement . In approximately 25 % of patients , acne was assessed as cleared or almost cleared . Most side effects were characteristic of topical retinoids . These results indicate TGM in a pump dispenser as an effective , well-tolerated acne treatment that is associated with a high rate of compliance Background : Adherence to treatment is a mayor issue in dermatology , and its relationship to quality of life has barely been studied . Objective : To evaluate the relationship between scores on the Skindex-29 skin disease assessment scale and adherence to treatment in patients with acne . Methods : An observational , prospect i ve study of 1,628 patients carried out by 252 clinicians in Spain . Results : Adherence was related to better objective and subjective severity index scores and better Skindex-29 scale scores at the end of the study . Young , male and unemployed patients had the worst adherence scores . Baseline and final Skindex-29 scale scores were significantly worse in non-adherent females , while non-adherent males scored better . Reasons for non-adherence were side effects for older patients and forgetfulness for younger ones . Conclusion : Dermatologists should explain that adherence to treatment is linked to better outcomes and better quality of life . Young females with high Skindex-29 scale scores and males with low Skindex scores are especially prone to non-adherence BACKGROUND : Topical retinoid therapy has been shown to be an effective means of treating both the inflammatory and non-inflammatory lesions of acne vulgaris . AIM : To assess the efficacy and safety of the test product , a gel containing isotretinoin 0.1 % w/w and erythromycin 4.0 % w/w , with a currently used and effective treatment for mild to moderate acne vulgaris , a gel containing benzoyl peroxide 5.0 % w/w and erythromycin 3.0 % w/w . METHODS : This multi-centre , single-blind ( investigator blind ) , parallel group study compared the efficacy and safety of isotretinoin/erythromycin gel ( Double Strength IsotrexinA ) once daily against benzoyl peroxide/erythromycin gel ( Benzamycin ® ) twice daily in the topical treatment of mild to moderate acne vulgaris . Patients ( n = 188 ) with a history ( mean duration 3.3 years ) of facial acne vulgaris and with 15 - 100 inflammatory lesions and /or 15 - 100 non-inflammatory lesions , but not more than three nodulocystic lesions , were included . At baseline and weeks 2 , 4 , 8 and 12 , the investigator assessed efficacy ( total number and severity of inflammatory and non-inflammatory lesions and acne grade ) while subjective global change assessment s of facial acne from baseline and symptom-specific skin tolerance were assessed by the patient . The investigator recorded an overall global assessment of skin tolerability at week 12 . Adverse events were recorded throughout . RESULTS : The treatments were comparable with regard to their effects on inflammatory and non-inflammatory lesions and acne grade . Few adverse events were considered to be treatment-related . Both the isotretinoin/erythromycin and benzoyl peroxide/erythromycin gels were generally well tolerated . Compliance was better with the isotretinoin/erythromycin gel , which had the advantages of not requiring mixing or storage in a refrigerator , and was applied once rather than twice daily . CONCLUSIONS : Isotretinoin/erythromycin gel given only once daily showed comparable efficacy with benzoyl peroxide/erythromycin given twice daily in the treatment of mild to moderate acne vulgaris of the face Introduction : A topical acne treatment in which clindamycin phosphate equivalent to 1 % clindamycin is presented in a gel formulation has received marketing authorizations in a number of EU and non‐EU countries . Clindamycin/zinc gel contains zinc acetate in a formulation that reduces systemic absorption of clindamycin through the skin . Objectives : To compare the efficacy and safety of a 1 % clindamycin/zinc gel when applied to the face once daily or twice daily with a 1 % clindamycin lotion applied twice daily for 16 weeks in patients with mild to moderate acne vulgaris . Methods : This was a r and omized , comparative , observer‐blind , parallel‐group , multicentre study involving 246 acne patients . Results : The study demonstrated therapeutic similarity between clindamycin/zinc gel applied once and twice daily with clindamycin lotion applied twice daily . All three regimens produced a gradual and time‐dependent reduction in inflamed lesions , non‐inflamed lesions and overall grade . Side effects were similar and minimal , consisting predominantly of mild irritant dermatitis . All regimes produced a time‐related significant reduction in skin surface and follicular Propionibacterium spp . and Micrococcaceae . The emergence of resistant strains was less than 5 % and was similar with all three regimes . Conclusion : The equivalent efficacy and safety of clindamycin/zinc gel either once or twice daily to clindamycin lotion twice daily has been demonstrated . It is suggested that a treatment regime of one application per day may significantly enhance compliance and thus treatment success in acne patients BACKGROUND The efficacy of topical medications is limited by non-adherence . Interventions to improve adherence to topical treatments are not well characterized . OBJECTIVE To assess the impact of office visits on patients ' adherence to topical treatment . METHODS Twenty-nine subjects enrolled in a clinical trial for psoriasis and were followed for up to 8 weeks . Subjects were told to apply 6 % salicylic acid gel twice daily . Electronic monitors were used to assess adherence . Results were compared to adherence in clinical trials of h and dermatitis and atopic dermatitis . RESULTS Adherence rates were significantly higher around the time of office visits ( P < .05 ) . LIMITATIONS This is a small study in a limited patient population . The study was observational and not a r and omized trial of the effect of increased office visits . CONCLUSION Frequent follow-up visits in clinical trials increase patients ' adherence to medications . The use of a follow-up visit shortly after initiating treatment may be an effective way to boost patients ' use of their medication and achieve better treatment outcomes Output:
The occurrence of side effects and young age were cited as the top reasons for poor adherence , followed by forgetfulness . Conclusions Overall , the values reflected a population adherent to both topical and oral medications , with no significant difference in adherence between the two . However , the method ologies used by many of the studies were weak , and the findings are not consistent with results of more objective measures of adherence .
MS2_1shot260
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Objective To evaluate the ability of international point of care information summaries to up date evidence relevant to medical practice . Design Prospect i ve cohort bibliometric analysis . Setting Top five point of care information summaries ( Clinical Evidence , EBM Guidelines , eMedicine , Dynamed , UpTo Date ) ranked for coverage of medical conditions , editorial quality , and evidence based methodology . Main outcome measures From June 2009 to May 2010 we measured the incidence of research findings relating to potentially eligible newsworthy evidence . As sample s , we chose systematic review s rated as relevant by international research networks ( such as , Evidence -Based Medicine , ACP Journal Club , and the Cochrane Collaboration ) . Every month we assessed whether each sample d review was cited in at least one chapter of the five summaries . The cumulative updating rate was analysed with Kaplan-Meier curves . Results From April to December 2009 , 128 review s were retrieved ; 53 % ( 68 ) from the literature surveillance journals and 47 % ( 60 ) from the Cochrane Library . At nine months , Dynamed had cited 87 % of the sample d review s , while the other summaries had cited less than 50 % . The updating speed of Dynamed clearly led the others . For instance , the hazard ratios for citations in EBM Guidelines and Clinical Evidence versus the top performer were 0.22 ( 95 % confidence interval 0.17 to 0.29 ) and 0.03 ( 0.01 to 0.05 ) . Conclusions Point of care information summaries include evidence relevant to practice at different speeds . A qualitative analysis of updating mechanisms is needed to determine whether greater speed corresponds to more appropriate incorporation of new information Background The use of PubMed to answer daily medical care questions is limited because it is challenging to retrieve a small set of relevant articles and time is restricted . Knowing what aspects of queries are likely to retrieve relevant articles can increase the effectiveness of PubMed search es . The objectives of our study were to identify queries that are likely to retrieve relevant articles by relating PubMed search techniques and tools to the number of articles retrieved and the selection of articles for further reading . Methods This was a prospect i ve observational study of queries regarding patient-related problems sent to PubMed by residents and internists in internal medicine working in an Academic Medical Centre . We analyzed queries , search results , query tools ( Mesh , Limits , wildcards , operators ) , selection of abstract and full-text for further reading , using a portal that mimics PubMed . Results PubMed was used to solve 1121 patient-related problems , result ing in 3205 distinct queries . Abstract s were viewed in 999 ( 31 % ) of these queries , and in 126 ( 39 % ) of 321 queries using query tools . The average term count per query was 2.5 . Abstract s were selected in more than 40 % of queries using four or five terms , increasing to 63 % if the use of four or five terms yielded 2–161 articles . Conclusion Queries sent to PubMed by physicians at our hospital during daily medical care contain fewer than three terms . Queries using four to five terms , retrieving less than 161 article titles , are most likely to result in abstract viewing . PubMed search tools are used infrequently by our population and are less effective than the use of four or five terms . Methods to facilitate the formulation of precise queries , using more relevant terms , should be the focus of education and research OBJECTIVES The research sought to determine the value of PubMed filters and combinations of filters in literature selected for systematic review s on therapy-related clinical questions . METHODS References to 35,281 included and 48,514 excluded articles were extracted from 2,629 review s published prior to January 2008 in the Cochrane Data base of Systematic Review s and sent to PubMed with and without filters . Sensitivity , specificity , and precision were calculated from the percentages of unfiltered and filtered references retrieved for each review and averaged over all review s. RESULTS Sensitivity of the Sensitive Clinical Queries filter was reasonable ( 92.7 % , 92.1 - 93.3 ) ; specificity ( 16.1 % , 15.1 - 17.1 ) and precision were low ( 49.5 % , 48.5 - 50.5 ) . The Specific Clinical Queries and the Single Term Medline Specific filters performed comparably ( sensitivity , 78.2 % , 77.2 - 79.2 vs. 78.0 % ; 77.0 - 79.0 ; specificity , 52.0 % , 50.8 - 53.2 vs. 52.3 % , 51.1 - 53.5 ; precision , 60.4 % , 59.4 - 61.4 vs. 60.6 % , 59.6 - 61.6 ) . Combining the Abridged Index Medicus ( AIM ) and Single Term Medline Specific ( 65.2 % , 63.8 - 66.6 ) , Two Terms Medline Optimized ( 64.2 % , 62.8 - 65.6 ) , or Specific Clinical Queries filters ( 65.0 % , 63.6 - 66.4 ) yielded the highest precision . CONCLUSIONS Sensitive and Specific Clinical Queries filters used to answer questions about therapy will result in a list of clinical trials but can not be expected to identify only method ologically sound trials . The Specific Clinical Queries filters are not suitable for questions regarding therapy that can not be answered with r and omized controlled trials . Combining AIM with specific PubMed filters yields the highest precision in the Cochrane data set Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results Background Search filters or hedges play an important role in evidence -based medicine but their development depends on the availability of a " gold st and ard " – a reference st and ard against which to establish the performance of the filter . We demonstrate the feasibility of using relative recall of included studies from multiple systematic review s to vali date method ological search filters as an alternative to validation against a gold st and ard formed through h and search ing . Methods We identified 105 Cochrane review s that used the Highly Sensitive Search Strategy ( HSSS ) , included r and omized or quasi-r and omized controlled trials , and reported their included studies . We measured the ability of two published and one novel variant of the HSSS to retrieve the MEDLINE -index studies included in these review s. Results The systematic review s were comprehensive in their search es . 72 % of included primary studies were indexed in MEDLINE . Relative recall of the three strategies ranged from .98 to .91 across all review s and more comprehensive strategies showed higher recall . Conclusion An approach using relative recall instead of a h and search ing gold st and ard proved feasible and produced recall figures that were congruent with previously published figures for the HSSS . This technique would permit validation of a method ological filter using a collection of approximately 100 studies of the chosen design drawn from the included studies of multiple systematic review s that used comprehensive search strategies Background The explosion of biomedical information has led to an ‘ information paradox’—the volume of biomedical information available has made it increasingly difficult to find relevant information when needed . It is thus increasingly critical for physicians to acquire a working knowledge of biomedical informatics . Aim To evaluate four search tools commonly used to answer clinical questions , in terms of accuracy , speed , and user confidence . Methods From December 2008 to June 2009 , medical students , resident physicians , and attending physicians at the authors ' institution were asked to answer a set of four anaesthesia and /or critical care based clinical questions , within 5 min , using Google , Ovid , PubMed , or UpTo Date ( only one search tool per question ) . At the end of each search , participants rated their results on a four point confidence scale . One to 3 weeks after answering the initial four questions , users were r and omised to one of the four search tools , and asked to answer eight questions , four of which were repeated . The primary outcome was defined as a correct answer with the highest level of confidence . Results Google was the most popular search tool . Users of Google and UpTo Date were more likely than users of PubMed to answer questions correctly . Subjects had the most confidence in UpTo Date . Search es with Google and UpTo Date were faster than search es with PubMed or Ovid . Conclusion Non- Medline based search tools are not inferior to Medline based search tools for purpose s of answering evidence based anaesthesia and critical care questions Background Rather than search ing the entire MEDLINE data base , clinicians can perform search es on a filtered set of articles where relevant information is more likely to be found . Members of our team previously developed two types of MEDLINE filters . The ' methods ' filters help identify clinical research of high method ological merit . The ' content ' filters help identify articles in the discipline of renal medicine . We will now test the utility of these filters for physician MEDLINE search ing . HypothesisWhen a physician search es MEDLINE , we hypothesize the use of filters will increase the number of relevant articles retrieved ( increase ' recall , ' also called sensitivity ) and decrease the number of non-relevant articles retrieved ( increase ' precision , ' also called positive predictive value ) , compared to the performance of a physician 's search unaided by filters . Methods We will survey a r and om sample of 100 nephrologists in Canada to obtain the MEDLINE search that they would first perform themselves for a focused clinical question . Each question we provide to a nephrologist will be based on the topic of a recently published , well-conducted systematic review . We will examine the performance of a physician 's unaided MEDLINE search . We will then apply a total of eight filter combinations to the search ( filters used in isolation or in combination ) . We will calculate the recall and precision of each search . The filter combinations that most improve on unaided physician search es will be identified and characterized . Discussion If these filters improve search performance , physicians will be able to search MEDLINE for renal evidence more effectively , in less time , and with less frustration . Additionally , our methodology can be used as a proof of concept for the evaluation of search filters in other disciplines Purpose Many educational programs seek to develop skills in evidence -based medicine ( EBM ) . The authors examined the efficacy of teaching the EBM skill of efficiently search ing the research literature . They compared students who received brief training in EBM search ing skills with those who did not , and assessed the quality of literature search ing one month after that training . Method The authors used a nonr and omized control group study design to quantify the impact of a single , brief ( two-hour ) instructional intervention on EBM-based techniques for search ing Medline for evidence related to a clinical problem provided to the students . Ninety-two fourth-year medical students ( 34 intervention , 58 control ) at the University of Michigan participated in a four-week EBM elective between 2001 and 2003 . The authors conducted a preintervention assessment of search ing skills , followed by a repeat assessment one month after the intervention . Search quality was judged by medical librarians using a structured clinical scenario and scoring algorithm . Results Data for 30 intervention and 40 control students could be analyzed . Intervention students had fewer search errors and correspondingly higher quality search es than did control students . The educational intervention accounted for approximately 8 % of the variance in both of these outcomes . The most common search errors were a lack of Medical Subject Headings ( MeSH ) explosion , missing MeSH terms , lack of appropriate limits , failure to search for best evidence , and inappropriate combination of all search concepts . Conclusions This study provides evidence that a single , brief training session can have a marked beneficial effect on the quality of subsequent , short-term EBM literature search ing performance outcomes Background To practice Evidence -Based Medicine ( EBM ) , physicians must quickly retrieve evidence to inform medical decisions . Internal Medicine ( IM ) residents receive little formal education in electronic data base search ing , and have identified poor search ing skills as a barrier to practicing EBM . Objective To design and implement a data base search ing tutorial for IM residents on inpatient rotations and to evaluate its impact on residents ’ skill and comfort search ing MEDLINE and filtered EBM re sources . Design R and omized controlled trial . Residents r and omized to the search ing tutorial met Output:
Results The performance of the search strategies varied widely according to the clinical question . This benefit was consistent for most clinical questions . Conclusions The Clinical Queries narrow filter , along with well-formulated queries based on the PICO framework , provided the greatest aid in retrieving relevant clinical trials within the 2 first PubMed pages .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Summary A total of 101 out patients with acute or subacute low-back pain was r and omly allocated to one of two treatment groups . One group was given st and ardised conventional and optimised activating treatment by primary health care teams . The other group received , according to a pragmatic approach , another treatment programme including manipulation , specific mobilisation , muscle stretching , autotraction and cortisone injections . The treatment effect was evaluated by st and ardised telephone interviews 3 , 7 , 14 , 21 and 90 days after the start of treatment . The two groups were similar in most of the pretrial variables , including age , sex , occupation , education , previous low-back pain problems , previous treatment , sickleave , findings at the physical examination , quality -of-life score , presence of common symptoms , disability rating and pain score . In the early phase as well as at the 90 days ' follow-up , the group receiving manual therapy had significantly less pain , less disability , faster rate of recovery and lower drug consumption , indicating that this type of treatment is superior to conventional treatment A total of 132 infants and children with grade s III and IV primary vesicoureteral reflux was entered into a prospect i ve trial comparing medical to surgical management . Inclusion criteria were an age not exceeding 10 years and a glomerular filtration rate of at least 70 ml . per minute per 1.73 m.2 . Children with significant urinary tract malformations and clinical signs/symptoms of dysfunctional voiding were not accepted into the trial . Medical therapy consisted of continuous low dose antibiotic prophylaxis until vesicoureteral reflux resolved . The type of surgical procedure used for the correction of reflux was left to the discretion of the surgeon . Outcome variables included the appearance or progression of renal lesions , rate of renal growth , recurrence rate of urinary tract infection or pyelonephritis , changes in total kidney glomerular filtration rate , development of hypertension and resolution rate of vesicoureteral reflux . Followup at 6 , 18 , 36 and 54 months after entry included , in addition to history and physical examination , voiding cystourethrography , excretory urography and a urine culture . Of the patients 68 were allocated to the medical group and 64 to the surgical group . They were stratified for age , sex and preexisting renal scarring . Of the patients 10 % were boys , 47 % were between 2 and 6 years old at entry , 93 % had a history of pyelonephritis , 67 % had either scarring or thinning of the parenchyma at entry , 87 % had grade IV vesicoureteral reflux in at least 1 unit and 56 % had bilateral reflux . There were no significant differences in the frequency distribution of entry characteristics between the patients allocated to either group . New renal scarring developed in 22 % of medical and 31 % of surgical patients ( p < 0.4 ) . Growth of kidneys with grade IV vesicoureteral reflux was slightly less than normal in the medical ( -0.67 + /- 0.15 st and ard deviation ) and surgical ( -0.42 + /- 0.11 st and ard deviation ) groups ( p < 0.7 ) . Pyelonephritis occurred in 15 medical patients versus 5 surgical patients ( p < 0.05 ) . There was no significant change in glomerular filtration rate within each treatment group and no difference in glomerular filtration rate between groups . No patient had hypertension during the followup period . The disappearance rate of vesicoureteral reflux in patients with grade IV reflux was approximately 8 % per year . Of the medical patients 75 % still had vesicoureteral reflux after 3 years of observation . ( ABSTRACT TRUNCATED AT 400 WORDS Objective : To evaluate if a comprehensive manual therapy programme reduces sick leave due low back pain and facilitates return to work more than the conventional optimized activating care . Design : A r and omized controlled trial over a 10-week period with a two-year follow-up . Setting : Primary health care and Visby Hospital , Municipality of Gotl and , Sweden . Subjects : One hundred and sixty patients ( 70 women , 90 men , ages 20—55 years ) with acute or subacute low back pain with or without pain radiation into the legs . Interventions : St and ardized optimized activating care ( n = 71 ) versus a comprehensive pragmatic manual therapy programme including specific corticosteroid injections ( n = 89 ) . Main measures : Sick leave measured as net sick leave volume , point prevalence and return to work . Results : After 10 weeks , significantly more manual therapy patients than reference patients had returned to work ( hazards ratio 1.62 , 95 % confidence interval ( CI ) 1.006—2.60 , P<0.05 ) , and among those on sick leave at baseline , significantly fewer were still on sick leave ( 8/58 versus 13/40 , ratio 0.35 , 95 % CI 0.13—0.97 , P<0.05 ) . For all other measures there were inconclusive differences in favour of the manual therapy group . No significant differences remained after two years . Conclusions : The manual therapy programme used in this study decreased sick leave and increased return to work more than the st and ardized optimized activating care only up to 10 weeks but not up to two years Study Design . A prospect i ve clinic‐based survey . Objectives . To study the type , frequency , and characteristics of unpleasant side effects after spinal manipulative therapy . Summary of Background Data . Spinal manipulative therapy is a commonly used treatment , but there is little knowledge of its side effects . Methods . Information regarding unpleasant reactions after spinal manipulative therapy was collected after 4712 treatments on 1058 new patients by 102 Norwegian chiropractors ( response rate , 70 % ) through structured interviews . Results . At least one reaction was reported by 55 % of the patients some time during the course of a maximum of six treatments . Of the reported reactions , the most common were local discomfort ( 53 % ) , headache ( 12 % ) , tiredness ( 11 % ) , or radiating discomfort ( 10 % ) . Reactions were mild or moderate in 85 % of patients . Sixty‐four percent of reactions appeared within 4 hours of treatment , and 74 % had disappeared within 24 hours . Uncommon reactions were dizziness , nausea , hot skin , or " other " complaints , each accounting for 5 % or less of reactions . It was unusual that symptoms commenced later than on the day of or the day after treatment , were of long duration ( not gone at the latest on the day after onset ) , described as severe , or that they result ed in reduced activities of daily living . There were no reports of serious complications in this study . Conclusions . Profiles now are described of common and uncommon reactions to spinal manipulative therapy and their latency , duration , and severity Background The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy . The aim of this r and omized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists ( i.e. chiropractors , naprapaths , osteopaths , physicians and physiotherapists ) for patients seeking care for back and /or neck pain . In addition women and men were compared regarding the occurrence of adverse events . Methods Participants were recruited among patients , ages 18–65 , seeking care at the educational clinic of the Sc and inavian College of Naprapathic Manual Medicine in Stockholm . The patients ( n = 767 ) were r and omized to one of three treatment arms 1 ) manual therapy ( i.e. spinal manipulation , spinal mobilization , stretching and massage ) ( n = 249 ) , 2 ) manual therapy excluding spinal manipulation ( n = 258 ) and 3 ) manual therapy excluding stretching ( n = 260 ) . Treatments were provided by students in the seventh semester of total eight . Adverse events were measured with a question naire after each return visit and categorized in to five levels ; 1 ) short minor , 2 ) long minor , 3 ) short moderate , 4 ) long moderate and 5 ) serious adverse events , based on the duration and /or severity of the event . Generalized estimating equations were used to examine the association between adverse event and treatments arms . Results The most common adverse events were soreness in muscles , increased pain and stiffness . No differences were found between the treatment arms concerning the occurrence of adverse event . Fifty-one percent of patients , who received at least three treatments , experienced at least one adverse event after one or more visits . Women more often had short moderate adverse events ( OR = 2.19 ( 95 % CI : 1.52 - 3.15 ) ) , and long moderate adverse events ( OR = 2.49 ( 95 % CI : 1.77 - 3.52 ) ) compared to men . Conclusion Adverse events after manual therapy are common and transient . Excluding spinal manipulation or stretching do not affect the occurrence of adverse events . The most common adverse event is soreness in the muscles . Women reports more adverse events than men . Trial registration This trial was registered in a public registry ( Current Controlled Trials ) ( IS RCT N92249294 ) Fifty-four subjects volunteered to participate in a controlled study contrasting spinal manipulation with spinal mobilization without the rotational forces and leverage required to move facet joints . All suffered from regional low-back pain for less than 1 month , were ages 18–40 , had never previously undergone any form of spinal manipulation , and denied a prior episode of backache within the previous 6 months . R and omization was stratified at outset into those who suffered for less than 2 weeks and those whose discomfort had persisted for 2–4 weeks . Outcome was monitored by a question naire assessing functional impairment . A treatment effect of manipulation was demonstrated only in the strata with more prolonged illness at entry . In the first week following manipulation , these patients improved to a greater degree ( P=.009 , t test ) and more rapidly ( P < .025 , Wilcoxon rank-sum test ) Spinal manipulative therapy ( SMT ) and exercise have demonstrated effectiveness for neck pain ( NP ) . Adverse events ( AE ) reporting in trials , particularly among elderly participants , is inconsistent and challenges informed clinical decision making . This paper provides a detailed report of AE experienced by elderly participants in a r and omized comparative effectiveness trial of SMT and exercise for chronic NP . AE data , consistent with CONSORT recommendations , were collected on elderly participants who received 12 weeks of SMT with home exercise , supervised plus home exercise , or home exercise alone . St and ardized questions were asked at each treatment ; participants were additionally encouraged to report AE as they occurred . Qualitative interviews documented participants ' experiences with AE . Descriptive statistics and content analysis were used to categorize and report these data . Compliance was high among the 241 r and omized participants . Non-serious AE were reported by 130/194 participants . AE were reported by three times as many participants in supervised plus home exercise , and nearly twice as many as in SMT with home exercise , as in home exercise alone . The majority of AE were musculoskeletal in nature ; several participants associated AE with specific exercises . One incapacitating AE occurred when a participant fell during supervised exercise session and fractured their arm . One serious adverse event of unknown relationship occurred to an individual who died from an aneurysm while at home . Eight serious , non-related AE also occurred . Musculoskeletal AE were common among elderly participants receiving SMT and exercise interventions for NP . As such , they should be expected and discussed when developing care plans IMPORTANCE Low back pain ( LBP ) is common in primary care . Guidelines recommend delaying referrals for physical therapy . OBJECTIVE To evaluate whether early physical therapy ( manipulation and exercise ) is more effective than usual care in improving disability for patients with LBP fitting a decision rule . DESIGN , SETTING , AND PARTICIPANTS R and omized clinical trial with 220 participants recruited between March 2011 and November 2013 . Participants with no LBP treatment in the past 6 months , aged 18 through 60 years ( mean age , 37.4 years [ SD , 10.3 ] ) , an Oswestry Disability Index ( ODI ) score of 20 or higher , symptom duration less than 16 days , and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit . INTERVENTIONS All participants received education . Early physical therapy ( n = 108 ) consisted of 4 physical therapy sessions . Usual care ( n = 112 ) involved no additional interventions during the first 4 weeks . MAIN OUTCOMES AND MEASURES Primary outcome was change in the ODI score ( range : 0 - 100 ; higher scores indicate greater disability ; minimum clinical ly important difference , 6 points ) at 3 months . Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up , and change in pain intensity , Pain Catastrophizing Scale ( PCS ) score , fear-avoidance beliefs , quality of life , patient-reported success , and health care utilization at 4-week , 3-month , and 1-year follow-up . RESULTS One-year follow-up was completed by 207 participants ( 94.1 % ) . Using analysis of covariance , early physical therapy showed improvement relative to usual care in disability after 3 months ( mean ODI score : early physical therapy group , 41.3 [ 95 % CI , 38.7 to 44.0 ] at baseline to 6.6 [ 95 % CI , 4.7 to 8.5 ] at 3 months ; usual care group , 40.9 [ 9 Output:
Conclusions and Relevance Among patients with acute low back pain , spinal manipulative therapy was associated with modest improvements in pain and function at up to 6 weeks , with transient minor musculoskeletal harms .
MS2_1shot262
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: The PIONEER AF-PCI trial ( Open-Label , R and omized , Controlled , Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects with AF who Undergo Percutaneous Coronary Intervention ) is an ambitious , open-label comparison of 3 regimens , almost exclusively in Caucasians , all of whom had coexisting atrial fibrillation and atherosclerotic coronary artery disease requiring stenting ( PCI-S ) . These 2 conditions when they coexist pose a clinical challenge , necessitating concurrent usage of dual antiplatelet and anticoagulation therapy , a cocktail which presents major bleeding risks . Because anticoagulation therapy is suboptimal in preventing stent thrombosis and dual anti platelet therapy is inadequate in averting embolic stroke in atrial fibrillation , neither treatment is sufficient and they must be combined . The study has a unique design and consists of 2 treatment arms and a control ( see Figure 1 for trial design ) , each with about 700 patients and a 20 % dropout rate in groups 1 and 2 but a statistically greater rate of 29 % in group 3 . Both treatment arms are modeled upon previous studies , which involved patients with the need for both antiplatelet therapy and anticoagulation ( see Figure 2 for derivation of trial from WOEST and ATLAS-TIMI 51 ) . The control arm , design ated group 3 in the trial , consists of the US st and ard of practice regimen , in this situation , called “ triple therapy , ” consisting of aspirin 100 mg/d , clopidogrel 75 mg/d , and warfarin maintaining the INR between 2 and 3 . About 7 % of patients in groups 1 and 2 received a different P2Y12 inhibitor , either prasugrel or ticagrelor , and about 4 % in group 3 . Prominent among the numerous exclusions were patients with a previous stroke and a creatinine clearance of under 30 mL/min . In arm 1 , patients with a creatinine clearance between 30 and 60 mL/min received a lower dose of 10 mg of rivaroxaban . The first treatment arm , called arm 1 , is a reprisal of the treatment arm of the Belgian 2013 WOEST trial which showed that clopidogrel 75 mg and warfarin , maintaining an INR of 2 to 3 , were associated with less combined TIMI major and minor bleeding as well as no increase in cardiac or neurological thrombotic complications when compared to the same control arm as is in this study . Despite having studied only 573 patients for just a year , WOEST was influential in generating the recommendation ( level B ) from the European Society of Cardiology to use this regimen in some people at high risk for bleeding with stents who also require anticoagulation . Furthermore in PIONEER , arm 1 , rivaroxaban 15 mg has been substituted for warfarin ; otherwise , the other trial drugs are identical to those in WOEST . A compelling question posed by this arm of the study , although not the primary end point of the study , is whether equivalent stent patency or prevention of atherosclerotic or thromboembolic complications can be achieved with only a single antiplatelet drug throughout the entire 12 months of treatment , including the vital first month poststent . Also addressed is whether the WOEST results can be replicated substituting rivaroxaban , a drug that offers several advantages over warfarin . In treatment group 1 , one would intuitively expect confirmation of the bleeding advantage observed in WOEST , since it contains 2 drugs versus the 3 in the control group , and therefore would be expected to be associated with less bleeding in group 1 versus group 3 . The second treatment group is based on the 2012 ATLAS ACS 2-TIMI 51 trial and consists of very-low-dose rivaroxaban 2.5 mg twice a day along with clopidogrel 75 mg/d and aspirin 100 mg/d . An interesting point of arm 2 versus 3 , although again not the primary end point , is if a dosage of rivaroxaban , which is only 25 % of the FDA -approved dose of that needed to treat atrial fibrillation , would be adequate in preventing embolic strokes . One would anticipate in group 2 that the dual antiplatelet therapy would be equally effective in preventing stent occlusion and recurrent coronary events as the BACKGROUND Patients receiving oral anticoagulation ( OAC ) who undergo drug-eluting stent ( DES ) implantation require additional dual antiplatelet therapy with aspirin and clopidogrel . Such triple therapy confers an elevated bleeding risk , and its optimal duration is not known . OBJECTIVES The goal of this study was to evaluate whether shortening the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation was associated with a superior net clinical outcome in patients receiving concomitant aspirin and OAC . METHODS In this r and omized , open-label trial , we enrolled patients receiving OAC who underwent DES implantation at 3 European centers between September 2008 and December 2013 . A total of 614 patients receiving concomitant aspirin and OAC were r and omized to either 6-week clopidogrel therapy ( n=307 ) or 6-month clopidogrel therapy ( n=307 ) . The primary endpoint was a composite of death , myocardial infa rct ion ( MI ) , definite stent thrombosis , stroke , or Thrombolysis In Myocardial Infa rct ion ( TIMI ) major bleeding at 9 months . RESULTS The primary endpoint occurred in 30 patients ( 9.8 % ) in the 6-week group compared with 27 patients ( 8.8 % ) in the 6-month group ( hazard ratio [ HR ] : 1.14 ; 95 % CI : 0.68 to 1.91 ; p=0.63 ) . There were no significant differences for the secondary combined ischemic endpoint of cardiac death , MI , definite stent thrombosis , and ischemic stroke ( 12 [ 4.0 % ] vs. 13 [ 4.3 % ] ; HR : 0.93 ; 95 % CI : 0.43 to 2.05 ; p=0.87 ) or the secondary bleeding endpoint of TIMI major bleeding ( 16 [ 5.3 % ] vs. 12 [ 4.0 % ] ; HR : 1.35 ; 95 % CI : 0.64 to 2.84 ; p=0.44 ) . CONCLUSIONS Six weeks of triple therapy was not superior to 6 months with respect to net clinical outcomes . These results suggest that physicians should weigh the trade-off between ischemic and bleeding risk when choosing the shorter or longer duration of triple therapy . ( Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation [ ISAR-TRIPLE ] ; NCT00776633 ) Background Triple antithrombotic therapy with warfarin plus two antiplatelet agents is the st and ard of care after percutaneous coronary intervention ( PCI ) for patients with atrial fibrillation , but this therapy is associated with a high risk of bleeding . Methods In this multicenter trial , we r and omly assigned 2725 patients with atrial fibrillation who had undergone PCI to triple therapy with warfarin plus a P2Y12 inhibitor ( clopidogrel or ticagrelor ) and aspirin ( for 1 to 3 months ) ( triple‐therapy group ) or dual therapy with dabigatran ( 110 mg or 150 mg twice daily ) plus a P2Y12 inhibitor ( clopidogrel or ticagrelor ) and no aspirin ( 110‐mg and 150‐mg dual‐therapy groups ) . Outside the United States , elderly patients ( ≥80 years of age ; ≥70 years of age in Japan ) were r and omly assigned to the 110‐mg dual‐therapy group or the triple‐therapy group . The primary end point was a major or clinical ly relevant nonmajor bleeding event during follow‐up ( mean follow‐up , 14 months ) . The trial also tested for the noninferiority of dual therapy with dabigatran ( both doses combined ) to triple therapy with warfarin with respect to the incidence of a composite efficacy end point of thromboembolic events ( myocardial infa rct ion , stroke , or systemic embolism ) , death , or unplanned revascularization . Results The incidence of the primary end point was 15.4 % in the 110‐mg dual‐therapy group as compared with 26.9 % in the triple‐therapy group ( hazard ratio , 0.52 ; 95 % confidence interval [ CI ] , 0.42 to 0.63 ; P<0.001 for noninferiority ; P<0.001 for superiority ) and 20.2 % in the 150‐mg dual‐therapy group as compared with 25.7 % in the corresponding triple‐therapy group , which did not include elderly patients outside the United States ( hazard ratio , 0.72 ; 95 % CI , 0.58 to 0.88 ; P<0.001 for noninferiority ) . The incidence of the composite efficacy end point was 13.7 % in the two dual‐therapy groups combined as compared with 13.4 % in the triple‐therapy group ( hazard ratio , 1.04 ; 95 % CI , 0.84 to 1.29 ; P=0.005 for noninferiority ) . The rate of serious adverse events did not differ significantly among the groups . Conclusions Among patients with atrial fibrillation who had undergone PCI , the risk of bleeding was lower among those who received dual therapy with dabigatran and a P2Y12 inhibitor than among those who received triple therapy with warfarin , a P2Y12 inhibitor , and aspirin . Dual therapy was noninferior to triple therapy with respect to the risk of thromboembolic events . ( Funded by Boehringer Ingelheim ; RE‐DUAL PCI Clinical Trials.gov number , NCT02164864 . OBJECTIVES Optimal antithrombotic/anticoagulation therapy in patients on chronic oral anticoagulation ( OAC ) undergoing drug-eluting stent ( DES ) implantation is unknown . We investigated the efficacy and safety of two regimens of antithrombotic/anticoagulation therapy in patients who present for DES implantation whilst on OAC . METHODS We included a series of 515 patients on OAC who underwent DES implantation between 2002 and 2007 . Based on predefined clinical and echocardiographic criteria , 306 patients continued OAC ( triple therapy ) and 209 patients discontinued OAC ( dual therapy ) for the time they received antiplatelet therapy with clopidogrel and aspirin [ stent-related antithrombotic treatment ( SRAT ) ] . The primary end point was a composite of death , myocardial infa rct ion , stent thrombosis or stroke . RESULTS During SRAT the primary endpoint was observed in 13 patients in the group with triple therapy versus 15 patients in the group with dual therapy [ Kaplan-Meier estimates 4.2 % and 7.2 % , odds ratio ( OR ) = 0.61 , 95 % confidence interval ( CI ) 0.29 - 1.28 ; P = 0.19 ] . At 2 years of follow-up , the primary endpoint was observed in 35 patients in the group with triple therapy versus 36 patients in the group with dual therapy ( Kaplan-Meier estimates 14.1 % and 18.0 % , OR = 0.76 , 95 % CI : 0.48 - 1.21 ; P = 0.25 ) . Two-year incidence of major bleeding was 1.4 % ( n = 4 , triple therapy ) versus 3.1 % ( n = 6 , dual therapy ) ( P = 0.34 ) . CONCLUSIONS In patients on chronic OAC undergoing DES implantation , clinical and echocardiographic criteria help to define postprocedural antithrombotic/anticoagulation therapy . Based on these criteria , both a double antiplatelet therapy ( clopidogrel plus aspirin ) and a triple therapy ( OAC plus clopidogrel plus aspirin ) are associated with favourable safety and efficacy Most evidence regarding the efficacy and safety of the antithrombotic regimens for patients with atrial fibrillation ( AF ) undergoing percutaneous coronary intervention with stent ( PCI‐S ) derives from small , single‐center , retrospective data sets . To obtain further data on this issue , we carried out the prospect i ve , multicenter , observational Management of patients with Atrial Fibrillation undergoing Coronary Artery Stenting ( AFCAS ) registry ( Clinical trials.gov identifier NCT00596570 ) BACKGROUND If percutaneous coronary intervention ( PCI ) is required in patients taking oral anticoagulants , antiplatelet therapy with aspirin and clopidogrel is indicated , but such triple therapy increases the risk of serious bleeding . We investigated the safety and efficacy of clopidogrel alone compared with clopidogrel plus aspirin . METHODS We did an open-label , multicentre , r and omised , controlled trial in 15 centres in Belgium and the Output:
No significant differences of coronary events were found .
MS2_1shot263
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background Research has shown that treatments that solely addressed intimate partner violence ( IPV ) perpetration were not very effective in reducing IPV , possibly due to neglecting individual differences between IPV perpetrators . A large proportion of IPV perpetrators is diagnosed with co-occurring substance use disorders and it has been demonstrated that successful treatment of alcohol dependence among alcohol dependent IPV perpetrators also led to less IPV . The current study investigated the relative effectiveness of Integrated treatment for Substance abuse and Partner violence ( I-StoP ) to cognitive behavioral treatment addressing substance use disorders including only one session addressing partner violence ( CBT-SUD+ ) among patients in substance abuse treatment who repeatedly committed IPV . Substance use and IPV perpetration were primary outcome measures . Method Patients who entered substance abuse treatment were screened for IPV . Patients who disclosed at least 7 acts of physical IPV in the past year ( N = 52 ) were r and omly assigned to either I-StoP or CBT-SUD+ . Patients in both conditions received 16 treatment sessions . Substance use and IPV perpetration were assessed at pretreatment , halfway treatment and posttreatment in blocks of 8 weeks . Both completers and intention-to-treat ( ITT ) analyses were performed . Results Patients ( completers and ITT ) in both conditions significantly improved regarding substance use and IPV perpetration at posttreatment compared with pretreatment . There were no differences in outcome between conditions . Completers in both conditions almost fully abstained from IPV in 8 weeks before the end of treatment . Conclusions Both I-StoP and CBT-SUD+ were effective in reducing substance use and IPV perpetration among patients in substance abuse treatment who repeatedly committed IPV and self-disclosed IPV perpetration . Since it is more cost and time-effective to implement CBT-SUD+ than I-StoP , it is suggested to treat IPV perpetrators in substance abuse treatment with CBT-SUD+.Trial registration Clinical Trials.gov : Background : Domestic violence is a major problem in society . In spite of this , there are few studies on the treatment of men who voluntarily seek help to stop their violent behaviour towards intimate partners . Most studies are performed on court-ordered individuals . Aim : The objective of this study was to evaluate results of a manualized cognitive – behaviour group therapy for voluntarily treatment-seeking men , aware of and willing to change their abusive behaviour . Methods : Thirty-six men recruited on a voluntary basis were offered a 15-week manualized group therapy . After initial assessment but before group therapy sessions they were r and omly selected for immediate treatment or treatment after 4 months on a “ waiting list ” . All 26 who started group therapy treatment fulfilled the programme . Changes in violent behaviour , before and after treatment , were assessed by self-reports using the Conflict Tactic Scales . Also , the men on the waiting list were compared after 4 months without treatment with the men receiving treatment immediately . Results : All kinds of self-reported partner related violence were significantly reduced by treatment , but being on a waiting list for 4 months did not reduce violent behaviour compared with those immediately receiving treatment . The results indicate that that the group treatment had an effect in itself beyond the wish and intention from the men to reduce their partner violence OBJECTIVE We evaluated the efficacy of the Strength at Home Men 's Program ( SAH-M ) , a trauma-informed group intervention based on a social information processing model to end intimate partner violence ( IPV ) use in a sample of veterans/service members and their partners . To date , no r and omized controlled trial has supported the efficacy of an IPV intervention in this population . METHOD Participants included 135 male veterans/service members and 111 female partners . Recruitment was conducted from February 2010 through August 2013 , and participation occurred within 2 Department of Veterans Affairs hospitals . Male participants completed an initial assessment that included diagnostic interviews and measures of physical and psychological IPV using the Revised Conflict Tactics Scales and were r and omly assigned to an enhanced treatment as usual ( ETAU ) condition or SAH-M. Those r and omized to SAH-M were enrolled in this 12-week group immediately after baseline . Those r and omized to ETAU received clinical referrals and re sources for mental health treatment and IPV services . All male participants were reassessed 3 and 6 months after baseline . Female partners completed phone assessment s at the same intervals that were focused both on IPV and on the provision of safety information and clinical referrals . RESULTS Primary analyses using hierarchical linear modeling indicated significant time-by-condition effects such that SAH-M participants compared with ETAU participants evidence d greater reductions in physical and psychological IPV use ( β = -0.135 [ SE = 0.061 ] , P = .029 ; β = -0.304 [ SE = 0.135 ] , P = .026 ; respectively ) . Additional analyses of a measure that disaggregated forms of psychological IPV showed that SAH-M , relative to ETAU , reduced controlling behaviors involving isolation and monitoring of the partner ( β = -0.072 [ SE = 0.027 ] , P = .010 ) . CONCLUSIONS Results provide support for the efficacy of SAH-M in reducing and ending IPV in male veterans and service members . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT01435512 Men who are violent toward their partners tend to have a dual problem with alcohol and drug use , yet little is known about differences between men with single rather than dual problems . This study was one of the first to evaluate differences between alcohol dependent men who were arrested for Intimate Partner Violence ( IPV ) with and without concurrent illicit drug use . Seventy-eight participants were r and omly assigned to manual-guided group behavioral therapies ( Cognitive Behavioral Therapy or Twelve Step Facilitation ) and assessed across 12 weeks of treatment . Despite denying drug use at baseline , thirty-two clients ( 43 % ) tested positive for illicit drug use ( cocaine and marijuana ) during the 12 weeks of treatment . The study specifically addressed whether there were differences between clients using alcohol only versus individuals using both alcohol + drugs in terms of 1 ) baseline characteristics ; 2 ) treatment compliance ( e.g. , attendance and substance use during treatment ; and 3 ) treatment outcomes ( alcohol , drug use , anger management , and aggression at the completion of treatment ) . The results showed that there were comparatively few differences between the alcohol versus the alcohol + drug using groups at baseline . Regarding treatment compliance and retention , alcohol + drug using participants attended significantly fewer sessions , had significantly fewer percent days abstinence from alcohol use , significantly more total days of positive breathalyzer results . Regarding treatment outcomes across anger management and aggression scores , the alcohol + drug using participants had significantly more impairments in anger management styles from pre- to post-treatment . However , there were no differences between the groups across verbal or physical aggression . Both groups improved in their verbal aggression from pre- to post-treatment . The findings suggest that alcohol dependent men who continue to use illicit drugs may require additional interventions to effectively control their drug use and , their anger management styles Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field OBJECTIVE Behaviorally based therapies for the treatment of perpetrators who initiate intimate partner violence ( IPV ) have generally shown minimal therapeutic efficacy . To explore a new treatment approach for IPV , we examined the effects of a selective serotonin reuptake inhibitor on the irritability subscale score of the Modified Overt Aggression Scale . This score served as a surrogate marker for the anger and physical aggression that characterize perpetrators of IPV . METHOD A 12-week , double-blind , r and omized , placebo-controlled intervention study employing fluoxetine , alcohol treatment , and cognitive-behavioral therapy was performed . Sixty ( 46 men ) non-court-m and ated , DSM-IV-diagnosed alcoholic perpetrators of IPV with a history of at least 2 episodes of IPV in the year prior to participation in the study were evaluated . The primary outcome measure was the score on the irritability subscale of the Modified Overt Aggression Scale . Secondary measures included anxiety , depression , and ratings by the perpetrator 's spouse/significant other . The study was conducted from January 2002 through December 2007 . RESULTS A repeated- measures analysis of variance using the irritability subscale scores obtained from perpetrators who completed the 12-week study ( n = 24 ) showed a significant drug effect ( F(1,21 ) = 12.09 , P = .002 ) . Last observation carried forward ( F(1,32 ) = 4.24 , P = .048 ) as well as intent-to-treat analysis ( F(1,54 ) = 5.0 , P = .034 ) also showed a significant drug effect . Spouses'/significant others ' physical and nonphysical Partner Abuse Scale ratings showed a significant reduction of abuse over time ( F(1,11 ) = 10.2 , P = .009 and F(1,11 ) = 24.2 , P = .0005 , respectively ) . CONCLUSION This is the first controlled study to show that a pharmacologic intervention employing a selective serotonin reuptake inhibitor , in conjunction with alcohol treatment and cognitive-behavioral therapy , can reduce measures of anger and physical aggression in alcoholic perpetrators of IPV Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies A r and omized clinical trial tested the hypothesis that a flexible , case formulation – based , individual treatment approach integrating motivational interviewing strategies with cognitive-behavioral therapy ( ICBT ) is more efficacious than a st and ardized group cognitive-behavioral approach ( GCBT ) for perpetrators of intimate partner violence ( IPV ) . Forty-two men presenting for services at a community domestic violence agency were r and omized to receive 20 sessions of ICBT or a 20-week group cognitive-behavioral therapy ( CBT ) program . Participants and their relationship partners completed assessment s of relationship abuse and relationship functioning at baseline and quarterly follow-ups for 1 year . Treatment uptake and session attendance were significantly higher in ICBT than GCBT . However , contrary to the study hypothesis , GCBT produced consistently equivalent or greater benefits than ICBT . Participant self-reports revealed significant reductions in abusive behavior and injuries across conditions with no differential benefits between conditions . Victim partner reports revealed more favorable outcomes for group treatment , including a statistically significant difference in psychological aggression , and differences exceeding a medium effect size for physical assault , emotional abuse , and partner relationship adjustment . In response to hypothetical relationship scenarios , GCBT was associated with greater reductions than ICBT ( exceeding a medium effect ) in articulated cognitive distortions and aggressive intentions . Treatment competence ratings suggest that flexible , individualized administration of CBT creates challenges in session agenda setting , homework implementation , and formal aspects of relationship skills training . Although caution is needed in generalizing findings from this small-scale trial , the results suggest that the mutual support and positive social influence available in group intervention may be particularly helpful for IPV perpetrators Three different 12-month interventions for servicemen who had been substantiated as having physically assaulted their wives were used and the outcomes examined . The 861 couples of the study were r and omly assigned to 4 groups : a men 's group , a conjoint group , a rigorously monitored group , and a control group . Cognitive-behavioral interventions were implemented for the men 's and conjoint groups , and outcome data were gathered from male perpetrators and female victims at roughly 6-month intervals over the approximately 18-month experimental period . Data analyses revealed nons Output:
Conclusions There is still insufficient evidence to confirm that cognitive behavioural group therapy for perpetrators of intimate partner violence has a positive effect .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Objective : To investigate the effect of a combiphasic oral contraceptive containing ethinylestradiol and desogestrel ( combiphasic EE/DSG ) on acne , compared with a preparation containing ethinylestradiol and cyproterone acetate ( EE35/CPA ) . Methods : An open , r and omized , group-comparative , multicenter study was carried out , with 172 women r and omized to treatment with either combiphasic EE/DSG ( 25 μg desogestrel and 40 μg ethinylestradiol for 7 days followed by 125 μg desogestrel and 30 μg ethinylestradiol for 15 days ) or EE35/CPA ( 2.0 mg cyproterone acetate and 35 μg ethinylestradiol for 21 days ) . Assessment s were performed at pretreatment and after cycles 3 and 6 . Results : The number of comedones , papules , pustules and nodules significantly decreased in both groups over the 6-month study . Compared with pretreatment (= 100 % ) , the relative numbers of comedones , papules , pustules and nodules at cycle 6 significantly decreased to 37 % , 38 % , 19 % and 12.5 % in the combiphasic EE/DSG group and to 24 % , 36 % , 17 % and 1 % in the EE35/CPA group , respectively . All reductions were statistically significant ( p ≤ 0.003 ) at both cycles 3 and 6 , except for nodules at cycle 6 with combiphasic EE/DSG , which probably result ed from differences between the treatment groups at baseline . There were no statistically significant differences between the two treatments . In both groups , the majority of women with severe acne shifted to a less severe acne category . Conclusions : Combiphasic EE/DSG progressively reduced the number and severity of acne lesions during the six cycles of treatment . The reduction in acne with the combiphasic oral contraceptive was comparable to a preparation containing the anti and rogen cyproterone acetate Abstract ▴ Ethinylestradiol/chlormadinone acetate 0.03/2 mg ( EE/CMA ) is a combined monophasic contraceptive pill with anti and rogenic properties . ▴ In a large , noncomparative , multicentre trial ( ≤24 cycles of treatment per woman ) and two ( 6- and 12-cycle ) postmarketing surveillance studies , EE/ CMA was effective in preventing pregnancy . ▴ EE/CMA was significantly more effective than EE/ levonorgestrel 0.03/0.15 mg/day in treating women with mild-to-moderate papulopustular acne of the face and related disorders in a r and omised , single-blind , multicentre trial . ▴ EE/CMA was well tolerated in clinical trials and the postmarketing surveillance studies . Adverse events were those commonly reported with oral contraceptives . As expected , the most common menstrual disturbances were breakthrough bleeding , spotting and amenorrhoea To study the question of whether one br and of oral contraceptives may be as acceptable as another for use of publicly-assisted family planning programs , a double blind study of two well-known br and s , Ovral and Norinyl , was undertaken in Costa Rica and Trinidad . The pills were r and omly assigned to 1,200 women . Common side effects - nausea , dizziness , vomiting , headaches - were associated with both Norinyl and Ovral . Differences in event rates for these conditions were much more marked by country than by the pill used . Ovral was associated with increases in skin problems , notably chloasma , in Cost Rica . A higher percentage of women using Norinyl reported intermenstrual bleeding and spotting in both countries . In Costa Rica continuation rates for Norinyl were adversely affected by this . With these exceptions there appear to be no important differences between the br and s that would affect their use in family planning programs OBJECTIVE To investigate the effects of an ethinylestradiol ( EE ) 20 μg/drospirenone ( drsp ) 3 mg combined oral contraceptive ( COC ) administered in a 24/4 regimen ( 24 active tablets/4 inert tablets per cycle ) for the treatment of moderate acne vulgaris , based on a pooled analysis of two identically design ed US studies . STUDY DESIGN Healthy females ( n=893 ) aged 14 - 45 years with moderate facial acne were r and omised to EE 20 μg/drsp 3 mg COC ( n=451 ) or placebo ( n=442 ) for six cycles . Primary outcome measures were mean percent change in acne lesion counts and the investigators ' assessment of acne from baseline to endpoint . RESULTS There were significantly greater reductions in the mean percent change from baseline to endpoint in inflammatory , non-inflammatory and total lesion counts in the EE 20 μg/drsp 3 mg 24/4 COC group compared with the placebo group ( P<0.0001 ) . The odds of women in the EE 20 μg/drsp 3 mg 24/4 COC group having ' clear ' or ' almost clear ' skin as rated by the investigators at endpoint were around three-fold greater than in the placebo group ( odds ratio 3.41 ; 95 % CI : 2.15 - 5.43 ; P<0.0001 ) . CONCLUSIONS A low-dose COC containing EE 20 μg/drsp 3 mg ( 24/4 ) more effectively reduced acne lesions than placebo and demonstrated greater improvement in the investigator global assessment of acne OBJECTIVE To compare the effects of a low-dose oral contraceptive containing desogestrel ( Marvelon ) and an anti- and rogenic preparation containing cyproterone acetate ( Diane ) in Oriental women suffering from acne . METHODS In an open-label , bi-center , r and omized study , 32 women using Marvelon and 34 using Diane were followed for 6 treatment cycles . The measured variables were objective and subjective severity of acne , and related biochemical variables such as sex hormone-binding globulin and free and total testosterone . RESULTS In Center A , with both preparations a decrease in mean objective acne score was observed , reaching statistical significance with Diane ( P < .05 ) . In addition , there was a significant between group difference at cycle 6 ( P < .05 ) . In Center B , a consistent and significant decrease in mean acne score was observed with Marvelon after three and six treatment cycles ( P < .05 and P < .01 ) and with Diane after six treatment cycles ( P < .001 ) . There were no significant between-group differences . The decrease in percentage of severe/moderate acne was statistically significant with Marvelon in Center B ( P = 0.002 ) and with Diane in Centers A ( P = 0.014 ) and B ( P = 0.004 ) . Both preparations increased plasma levels of sex hormone binding globulin and seemed to decrease those of total and free testosterone , but no statistically significant relationships between acne severity and biochemical variables could be detected . CONCLUSION Both Marvelon and Diane are effective in the treatment of acne in Oriental women who also need reliable contraception , without marked differences between the preparations A multicenter r and omized study was carried out to compare the efficacy of combined therapy with a GnRH analog ( goserelin ) + an oral contraceptive ( OC ) containing ethinyl estradiol and cyproterone acetate and same OC alone in the treatment of severe hirsutism . The effect of these two therapies was assessed in a subjective and an objective evaluation of hair growth . According to the subjective evaluation , judged by physician and patient . 95 % of patients obtained a partial response . The objective response was assessed by measuring the mean diameter of hair from 3 different areas and 1 control area . The decrease in hair diameter compared to pretreatment was statistically significant for both treatments , mainly for the abdomen and face . The difference between the two groups did not reach statistical significance . Therefore , we assume that OC alone remains the treatment of choice for hirsutism . However , the addition of the GnRH analog to OC needs further investigation and could be justified for patients with no response to st and ard monotherapy BACKGROUND An excess of and rogen is believed to contribute to development of acne in some patients . Because oral contraceptives ( OCs ) may reduce the active and rogen level , hormonal therapy with OCs has been used successfully to treat patients with acne , although this treatment has previously not been studied in placebo-controlled trials . OBJECTIVE Our purpose was to evaluate the efficacy of a triphasic , combination OC ( ORTHO TRI-CYCLEN [ Ortho-McNeil Pharmaceutical , Raritan , N.J. ] , norgestimate/ethinyl estradiol ) compared with placebo in the treatment of moderate acne vulgaris . METHODS Two hundred fifty-seven healthy female subjects , 15 to 49 years of age with moderate acne vulgaris , were enrolled in a multicenter , r and omized , double-blind , placebo-controlled clinical trial . Each month for 6 months , subjects received either 3 consecutive weeks of the OC ( i.e. , tablets containing a fixed dose of ethinyl estradiol [ 0.035 mg ] and increasing doses of norgestimate [ 0.180 mg , 0.215 mg , 0.250 mg ] ) followed by 7 days of inactive drug or placebo ( color-matched tablets ) . Efficacy was assessed by facial acne lesion counts , an investigator 's global assessment , a subject 's self- assessment , and an analysis of within-cycle variation ( cycle 6 ) in lesion counts . RESULTS Of the 160 subjects in whom efficacy could be evaluated , the OC group showed a statistically significantly greater improvement than the placebo group for all primary efficacy measures . The mean decrease in inflammatory lesion count from baseline to cycle 6 was 11.8 ( 62.0 % ) versus 7.6 ( 38.6 % ) ( p = 0.0001 ) , and the mean decrease in total lesion count was 29.1 ( 53.1 % ) versus 14.1 ( 26.8 % ) ( p = 0.0001 ) in the OC and placebo groups , respectively . In the investigator 's global assessment , 93.7 % of the active treatment group versus 65.4 % of the placebo group were rated as improved at the end of the study ( p < 0.001 ) . Six of the seven secondary efficacy measures ( total comedones , open comedones , closed comedones , papules , pustules , and the subject 's self- assessment of study treatment ) were also significantly more favorable in the OC group compared with the placebo group . CONCLUSION An OC containing 0.035 mg of ethinyl estradiol combined with the triphasic regimen of norgestimate is a safe and effective treatment of moderate acne vulgaris in women with no known contraindication to OC therapy The early days of oral contraceptives showed some evidence that these medications may have caused undesirable side effects on the voice , mainly in terms of virilization . In a r and om study carried out at the university hospitals of Jena and Berlin ( Charité ) , two more recent drugs were tested in this regard , one containing cyproterone acetate ( Diane-35 ) and the other one levonorgestrel ( Microgynon ) , both from Schering . Ninety-one patients took part in extensive clinical and instrumental phoniatric investigations of voice function over a period of one year . No significant side effects on the voice could be proven for the two preparations . Gynecological and clinical effects of both Diane-35 and Microgynon were similar during the one-year study period . Women taking Diane-35 had less intracyclic bleedings and amenorrhea . Also , acne was more favorably influenced by Diane-35 The aim for improving the progestogen component of oral contraceptives is both to increase their selectivity by obtaining a highly effective contraceptive action and to decrease the side effects related to the existing progestogens . The and rogenic activity of the existing progestogens modifies the lipid metabolism , particularly a decrease in the high density lipoprotein ( HDL ) level , which increases the risks of cardiovascular diseases . Thus , the discovery of a progestogen with good anti-ovulatory and minimal and rogenic properties would constitute an important progress in the field of oral contraception . Norgestimate ( NGM ) is a new progestogen presenting an exceptional profile of biological activity , and has proved to be extremely selective , as observed during the clinical trials . The studies described below have been carried out in order to confirm clinical ly the low and rogenic activity of NGM . In two clinical trials , Norgestimate ( 0.25 mg ) associated with 0.035 mg of ethinyloestradiol ( NGM 0.25/35 ) was compared to norgestrel ( 0.30 mg ) associated with 0.030 mg of ethinyloestradiol ( Lo/Ovral ) . In the first trial ( 1,261 women ) , the following observations were made : an important increase in the HDL level compared to the base levels in the subjects taking NGM 0.25/35 , and an important decrease in the HDL level in those taking Lo/Ovral . The low density lipoprotein ( LDL ) level increased slightly in the NGM 0.25/35 group , while a higher increase was observed in the Lo/Ovral group . Moreover Output:
A CMA-COC group had more ' responders , ' those with 50 % or greater decrease in facial papules and pustules ( OR 2.31 ; 95 % CI 1.50 to 3.55)Differences in the comparative effectiveness of COCs containing varying progestin types and dosages were less clear , and data were limited for any particular comparison . COCs that contained chlormadinone acetate or cyproterone acetate improved acne better than levonorgestrel . Likewise , levonorgestrel showed a slight improvement over desogestrel in acne outcomes , but results were not consistent . A drospirenone COC appeared to be more effective than norgestimate or nomegestrol acetate plus 17β-estradiol but less effective than cyproterone acetate . The six COCs evaluated in placebo-controlled trials are effective in reducing inflammatory and non-inflammatory facial acne lesions . Few important and consistent differences were found between COC types in their effectiveness for treating acne .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: We tested the hypothesis that active and passive airway humidification minimize hypothermia in infants , but that maintaining normothermia does not decrease the duration of postoperative recovery . A circle system was used to ventilate the lungs of anesthetized , intubated infants who were r and omly assigned to active airway humidification and warming with use of an MR450 Servo airway heater and humidifier set at 37 ° C ( n = 10 ) , passive airway humidification with use of the Humid-Vent Mini heat and moisture exchanger placed between the Y-piece of the circle and the endotracheal tube ( n = 10 ) , or no airway humidification and heating ( control , n = 10 ) . Anesthesia was induced with thiopental and maintained with isoflurane and nitrous oxide in oxygen . The relative humidity of inspired respiratory gases was ∼35 % in the control group and ∼90 % in the group undergoing active airway humidification . Initial inspired humidity in the passive humidification group ( 45 % ) increased to ∼80 % after 1 h of anesthesia . Humidity differed significantly across groups at all times ( P ≤ 0.05 ) . Steady-state rectal temperatures ( 100 - -120 min after induction ) were 36.2 ± 0.7 ° C in patients given active humidification and heating , 35.7 ± 0.9 ° C in the passively humidified group , and 35.2 ± 0.4 ° C in the control group ( P ≤ 0.05 between each group ) . Recovery from general anesthesia was rapid in all patients and did not correlate with central temperature changes or type of humidification ( P = NS ) . We conclude that heat and moisture exchangers are less effective than active heating and humidification , but significantly better than no humidification BACKGROUND The purpose of this study was to compare the performance of heat and moisture exchanger filters with heated humidifying systems in the mechanical ventilator circuit on the incidence of ventilator-associated pneumonia ( VAP ) and bacterial colonization . METHOD Two hundred and forty-three consecutive patients who required mechanical ventilation for 48 hours or more in the adult intensive care unit were r and omized to either a heat and moisture exchanger ( HME ) or a heated humidifying breathing circuit . RESULTS The VAP rate among the group with HME was 11.4 % ; the rate among the group with heated humidifying system ( HHS ) was 15.8 % . The difference was not statistically significant . Approximately 68 % of the patients in the HME group had no pathogen isolated compared with 50 % of the patients in the HHS group . This difference was statistically significant ( P = .006 ) . However , the distribution of the pathogens among those patients who had the isolated pathogens was mostly identical in the 2 groups . CONCLUSION Even though the study did not find HME to be significantly advantageous over the HHS , in as much as VAP rate is concerned , other advantages such as reduced nurses workload , reduced financial cost , and better safety made HME a more favorable device for use in our adult intensive care unit STUDY OBJECTIVE Determine the utility of a proposed algorithm in allowing safe , efficient humidification in mechanically ventilated patients using both a hygroscopic condenser humidifier ( HCH ) and heated humidifier ( HH ) . DESIGN A prospect i ve study using an algorithm to chose humidification devices based on physical examination and sputum characteristics . SETTING All patients admitted to the surgical ICU . PATIENTS One hundred twenty consecutive patients requiring mechanical ventilation ( MV ) were studied . INTERVENTIONS Patients were examined by the attending respiratory care practitioner and given either an HCH or HH . If patients demonstrated any of the following -- thick or tenacious secretions , core temperature < 32 degrees C , or bloody secretions -- they were given an HH . All others used an HCH . If any of the above conditions occurred during HCH use , the patient was given an HH . MEASUREMENTS AND RESULTS Duration of ventilation , incidence of nosocomial pneumonia , ventilator circuit colonization , and mortality were determined for patients in each group . Cost of humidification devices , number of suctioning procedures per day , and volume of saline solution instilled were also recorded . Initially , 27 percent ( 32/120 ) of patients used an HH and 73 percent ( 88/120 ) used an HCH . During the study , ten patients required changing to an HH during HCH use . Patients in the HH group were more likely to have preexisting lung disease and had a longer duration of ventilation ( 83 + /- 21 h ) and higher mortality ( 21 percent ) . Patients in the HCH group were more likely to be postoperative , had shorter duration s of ventilation ( 38 + /- 14 h ) , and lower mortality ( 9 percent ) . There was no difference in the incidence of nosocomial pneumonia between the two groups ( 9 percent vs 6 percent ) and endotracheal tube occlusion did not occur in either group . Circuit colonization was common in the HH group ( 64 percent ) but rate in the HCH group ( 5 percent ) . Cost per day was significantly less for the HCH group ( $ 4 vs $ 19.80 ) . Patients who required a change from HCH to HH did so at a mean of 5 days . CONCLUSION The proposed algorithm result ed in cost-efficient and safe application of humidification devices in patients in the surgical ICU Critically ill patients in the intensive care unit ( ICU ) are at high risk for infections associated with increased morbidity , mortality , and health care costs ( 1 - 3 ) . The overall infection rate in critically ill patients approaches 40 % and may be as high as 50 % or 60 % in patients who remain in the ICU for more than 5 days ( 4 , 5 ) . Respiratory tract infections account for 30 % to 60 % of all such infections . The incidence of pneumonia acquired in the ICU ranges from 10 % to 65 % ( 6 - 11 ) . Among patients at high risk for ventilator-associated pneumonia ( VAP ) are those who have chronic obstructive pulmonary disease , burns , neurosurgical conditions , the acute respiratory distress syndrome , and witnessed aspiration ; those who are reintubated ; and those who receive paralytic agents or enteral nutrition ( 12 , 13 ) . The attributable morbidity and mortality of VAP are clinical ly important . In a prospect i ve , matched cohort study , patients with VAP remained in the ICU 4.3 days ( 95 % CI , 1.5 to 7.0 days ) longer than patients who did not have VAP and had a trend toward an increased risk for death ( absolute risk increase , 5.8 % [ CI , 2.4 % to 14.0 % ] ) ( 14 ) . Six other studies using a matching strategy found a prolonged length of ICU stay associated with VAP ( range , 5 to 13 days ) and attributable mortality ranging from an absolute risk increase of 0 % to 50 % ( 15 - 20 ) . Therefore , strategies to decrease the incidence of VAP could decrease morbidity , mortality , and health care costs and improve patient safety . A survey of the use of VAP prevention strategies identified differences across countries ( 21 ) . For example , changing the ventilator circuit for each new patient was reported more frequently by French ICU directors than those in Canada ( 21 ) . This survey also showed that some effective strategies were used infrequently , suggesting inadequate translation of r and omized trial results into practice . One potential catalyst for knowledge translation is an evidence -based clinical practice guideline . Therefore , a Joint Planning Group of the Canadian Critical Care Society and Canadian Critical Care Trials Group commissioned the development of an evidence -based clinical practice guideline for the prevention of VAP . In this paper , we describe the methods used to create the guideline and the recommendations generated . Methods The Joint Planning Group selected an 11-member VAP Prevention Guideline Panel made up of 9 intensivists from university-affiliated and community hospitals , an ICU nurse , and an ICU respiratory therapist . Panel members were experts in critical care medicine ( n= 9 ) , VAP ( n= 4 ) , evidence -based medicine ( n= 4 ) , and guideline development ( n= 3 ) . The context was mechanically ventilated adult patients cared for in the ICU . The target audience was ICU clinicians in university-affiliated and community hospitals . To identify potentially relevant evidence , we search ed 3 bibliographic data bases ( MEDLINE , EMBASE , and the Cochrane Data base of Systematic Review s ) to 1 April 2003 for r and omized trials that evaluated interventions influencing VAP ( Appendix ) . We had no language restrictions . We also review ed personal files and practice guidelines on this subject previously published by the Centers for Disease Control and Prevention ( 22 ) and the American Thoracic Society ( 23 ) . We included r and omized trials and systematic review s of r and omized trials that 1 ) studied adult critically ill patients ; 2 ) had VAP as an outcome ; and 3 ) evaluated any of the following interventions : physical strategies ( route of endotracheal intubation , systematic search for maxillary sinusitis , frequency of ventilator circuit changes , type of airway humidification , frequency of humidifier changes , endotracheal suctioning system , subglottic secretion drainage , chest physiotherapy , and tracheostomy timing ) , positional strategies ( kinetic beds , semi-recumbent positioning , and prone positioning ) , and pharmacologic strategies ( stress ulcer prophylaxis and prophylactic antibiotics , including selective decontamination of the digestive tract ) . Since study authors used various definitions of VAP , we used the definitions they provided . The most common definition was a new or persistent radiographic infiltrate plus fever , leukocytosis , change in the volume or color of sputum , or isolation of a pathogen . If available , histologic evidence of pneumonia was also used . A priori , we decided to review only systematic review s of r and omized clinical trials for antibiotic prophylaxis and only r and omized clinical trials for all other topics . We excluded crossover and beforeafter studies . We also excluded r and omized trials of ventilator weaning , including noninvasive mechanical ventilation , and nutritional interventions evaluating VAP because guidelines addressing these topics have recently been published ( 24 , 25 ) . In duplicate and independently , 3 pairs of panel members critically appraised each trial ( 26 , 27 ) and systematic review ( 28 ) . Each member of a pair compared his or her independent appraisal of a given trial or systematic review with that of the other member of the pair . For each r and omized trial , we abstract ed sample , allocation , intervention , co- interventions , exclusions after r and omization , blinding of outcome assessment , definition of VAP , crude VAP events , relative risk for VAP , and other outcomes . For each intervention , we summarized the risk differences and calculated a pooled risk difference . For each systematic review , we abstract ed number of trials , population , intervention , selection criteria , search strategy , validity assessment , method of pooling results , homogeneity assessment , VAP definition , pooled event rates , and other outcomes . Before the panel meeting , each pair of appraisers achieved consensus on the validity and results of the trials they review ed . One month before the panel meeting , panel members received the evidence tables for review prepared by the 3 pairs of appraisers . A priori , panel members agreed to read all circulated documents and evidence tables in advance , to use levels of evidence to generate a status statement for each item , and to abide by the group process and consensus methods . The Canadian Critical Care Society appointed a chair to ensure that the panel achieved its objectives through group process ( 29 ) . At the panel meeting , each member recorded any potential conflicts of interest ( 30 ) . The pair of panel members responsible for critical appraisal of each intervention provided a structured written and oral presentation of the evidence . After the panel discussion , the initial evidence summary was revised if necessary . The panel members assigned levels of evidence , semi-quantitative scores to summarize the evidence and describe the intervention , and a status statement . We classified trials as level 1 if they had all of the following : concealed r and omization , blinded outcome adjudication , an intention-to-treat analysis , and an explicit definition of VAP . Trials were classified as level 2 if any one of these characteristics was unfulfilled and as level 3 if allocation was not strictly r and omized . We used a semi-quantitative score ( 0 , 1 , 2 , or 3 ) to evaluate each intervention with respect to the validity of the r and omized trials ; the effect size of each intervention ; the confidence intervals around the estimate of effect ; the homogeneity of the trial results ; and the safety , feasibility , and economic consequences of the intervention . The language of the status statement for each item was keyed to the levels of evidence and the semi-quantitative scores . We used the term recommended if there were no reservations about endorsing an intervention and the term considered if the evidence supported an intervention but there were minor uncertainties about the benefits , harms , or costs . No recommendation was made if evidence regarding an intervention was inadequate or if there were major uncertainties about the benefits , harms , or costs . After the panel meeting , the chair compiled the summaries and status statements and sent them to all panel members to check accuracy and clarity . In addition , the pairs of evidence appraisers wrote background documents for the interventions they appraised , including the rationale for each intervention , appraisal of r and omized trials and systematic review s , and harms and costs of the interventions . The chair and the writing committee organized the background documents , the evidence summaries , a table of the semi-quantitative scores , and the status statement for each Output:
There was no overall effect on artificial airway occlusion , mortality , pneumonia , or respiratory complications ; however , the PaCO(2 ) and minute ventilation were increased when HMEs were compared to HHs and body temperature was lower . The cost of HMEs was lower in all studies that reported this outcome . There was some evidence that hydrophobic HMEs may reduce the risk of pneumonia and that blockages of artificial airways may be increased with the use of HMEs in certain subgroups of patients . There is little evidence of an overall difference between HMEs and HHs . However , hydrophobic HMEs may reduce the risk of pneumonia and the use of an HME may increase artificial airway occlusion in certain subgroups of patients . Therefore , HMEs may not be suitable for patients with limited respiratory reserve or prone to airway blockage .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: BACKGROUND Febuxostat , a novel nonpurine selective inhibitor of xanthine oxidase , is a potential alternative to allopurinol for patients with hyperuricemia and gout . METHODS We r and omly assigned 762 patients with gout and with serum urate concentrations of at least 8.0 mg per deciliter ( 480 micromol per liter ) to receive either febuxostat ( 80 mg or 120 mg ) or allopurinol ( 300 mg ) once daily for 52 weeks ; 760 received the study drug . Prophylaxis against gout flares with naproxen or colchicine was provided during weeks 1 through 8 . The primary end point was a serum urate concentration of less than 6.0 mg per deciliter ( 360 micromol per liter ) at the last three monthly measurements . The secondary end points included reduction in the incidence of gout flares and in tophus area . RESULTS The primary end point was reached in 53 percent of patients receiving 80 mg of febuxostat , 62 percent of those receiving 120 mg of febuxostat , and 21 percent of those receiving allopurinol ( P<0.001 for the comparison of each febuxostat group with the allopurinol group ) . Although the incidence of gout flares diminished with continued treatment , the overall incidence during weeks 9 through 52 was similar in all groups : 64 percent of patients receiving 80 mg of febuxostat , 70 percent of those receiving 120 mg of febuxostat , and 64 percent of those receiving allopurinol ( P=0.99 for 80 mg of febuxostat vs. allopurinol ; P=0.23 for 120 mg of febuxostat vs. allopurinol ) . The median reduction in tophus area was 83 percent in patients receiving 80 mg of febuxostat and 66 percent in those receiving 120 mg of febuxostat , as compared with 50 percent in those receiving allopurinol ( P=0.08 for 80 mg of febuxostat vs. allopurinol ; P=0.16 for 120 mg of febuxostat vs. allopurinol ) . More patients in the high-dose febuxostat group than in the allopurinol group ( P=0.003 ) or the low-dose febuxostat group discontinued the study . Four of the 507 patients in the two febuxostat groups ( 0.8 percent ) and none of the 253 patients in the allopurinol group died ; all deaths were from causes that the investigators ( while still blinded to treatment ) judged to be unrelated to the study drugs ( P=0.31 for the comparison between the combined febuxostat groups and the allopurinol group ) . CONCLUSIONS Febuxostat , at a daily dose of 80 mg or 120 mg , was more effective than allopurinol at the commonly used fixed daily dose of 300 mg in lowering serum urate . Similar reductions in gout flares and tophus area occurred in all treatment groups Objectives : To investigate the efficacy and tolerability of allopurinol as the first-choice antihyperuricaemic treatment for gout , and compare the efficacy and tolerability of benzbromarone and probenecid as second-choice treatment . Methods : Prospect i ve , multicentre , open-label , two-stage r and omised controlled trial in gout patients with normal renal function . Enrolled patients were given 300 mg allopurinol for 2 months ( stage 1 ) . Those patients who could not tolerate allopurinol or who did not attain the target serum urate concentration ( sUr ) ⩽0.30 mmol/l ( 5.0 mg/dl ) , which was defined as successful , were r and omised to benzbromarone 200 mg/day or probenecid 2 g/day for another 2 months ( stage 2 ) . Results : 96 patients were enrolled in stage 1 . 82 patients ( 85 % ) were eligible for the analysis at the end of stage 1 : there was a mean ( SD ) decrease in sUr concentration of 35 (11)% from baseline ; 20 patients ( 24 % ) attained target sUr ⩽0.30 mmol/l ; and 9 patients ( 11 % ) stopped allopurinol because of adverse drug reactions . 62 patients were enrolled in stage 2 . 27 patients received benzbromarone ( 3 patients not eligible for analysis ) and 35 received probenecid ( 4 patients not eligible for analysis ) . Treatment with benzbromarone was successful in 22/24 patients ( 92 % ) and with probenecid in 20/31 patients ( 65 % ) ( p = 0.03 compared with benzbromarone ) . Compared with baseline values , there was a mean ( SD ) decrease of sUr concentration of 64 (9)% with benzbromarone and 50 (7)% with probenecid ( p<0.001 ) . Conclusion : This study showed that allopurinol 300 mg/day has a poor efficacy and tolerability profile when used to attain a biochemical predefined target level of sUr ⩽0.30 mmol/l , following 2 months of treatment . In stage 2 , benzbromarone 200 mg/day was more effective and better tolerated than probenecid 2 g/day . Trial registration number : IS RCT N21473387 Fifty-nine patients with primary gout were treated with either a combination of colchicine and allopurinol or colchicine alone . Assessment s of renal function over 2 years revealed a statistically significant fall of glomerular filtration rate an urine concentrating ability in those receiving only colchicine . The renal function of patients given allopurinol did not change . Treatment with allopurinol result ed ina significant reduction of ammonium excretion , a phenomenon which could not be readily explained . Urate clearance also declined during allopurinol treatment , and the impaired urate clearance associated with gout became more evident . The most important observation was that allopurinol retarded an apparent decline of renal function . Presumably this was achieved through its hypouricaemic effect and implies that the hyperuricaemia of gouty patients is deleterious to the kidneys Introduction The purpose of this study was to compare urate-lowering ( UL ) efficacy and safety of daily febuxostat and allopurinol in subjects with gout and serum urate ( sUA ) ≥ 8.0 mg/dL in a six-month trial . Methods Subjects ( n = 2,269 ) were r and omized to febuxostat 40 mg or 80 mg , or allopurinol 300 mg ( 200 mg in moderate renal impairment ) . Endpoints included the proportion of all subjects with sUA < 6.0 mg/dL and the proportion of subjects with mild/moderate renal impairment and sUA < 6.0 mg/dL. Safety assessment s included blinded adjudication of each cardiovascular ( CV ) adverse event ( AE ) and death . Results Comorbidities included : renal impairment ( 65 % ) ; obesity ( 64 % ) ; hyperlipidemia ( 42 % ) ; and hypertension ( 53 % ) . In febuxostat 40 mg , febuxostat 80 mg , and allopurinol groups , primary endpoint was achieved in 45 % , 67 % , and 42 % , respectively . Febuxostat 40 mg UL was statistically non-inferior to allopurinol , but febuxostat 80 mg was superior to both ( P < 0.001 ) . Achievement of target sUA in subjects with renal impairment was also superior with febuxostat 80 mg ( 72 % ; P < 0.001 ) compared with febuxostat 40 mg ( 50 % ) or allopurinol ( 42 % ) , but febuxostat 40 mg showed greater efficacy than allopurinol ( P = 0.021 ) . Rates of AEs did not differ across treatment groups . Adjudicated ( APTC ) CV event rates were 0.0 % for febuxostat 40 mg and 0.4 % for both febuxostat 80 mg and allopurinol . One death occurred in each febuxostat group and three in the allopurinol group . Conclusions Urate-lowering efficacy of febuxostat 80 mg exceeded that of febuxostat 40 mg and allopurinol ( 300/200 mg ) , which were comparable . In subjects with mild/moderate renal impairment , both febuxostat doses were more efficacious than allopurinol and equally safe . At the doses tested , safety of febuxostat and allopurinol was comparable . Clinical Trial Registration This study was aim ed to evaluate the efficacy of benzbromarone compared to allopurinol in lowering serum uric acid level in hyperuricemic patients with normal renal function ( serum creatinine < or = 1.5 ) . The authors conducted a crossover study consisting of two four-week treatment periods of allopurinol 300 mg/day and benzbromarone 100 mg/day separated by a four-week washout period . Fourteen patients with mean age and duration of hyperuricemia of 60.78 + /- 8.62 and 6.93 + /- 3.69 years , respectively , were recruited and all completed our study protocol . This study was a crossover design consisting of two four-week treatments of allopurinol and benzbromarone separated by a four-week washout period . The serum uric acid level was reduced from 9.89 + /- 1.43 mg/dl to 5.52 + /- 0.83 mg/dl and from 9.53 + /- 1.48 to 4.05 + /- 0.87 mg/dl by allopurinol and benzbromarone , respectively . The efficacy of benzbromarone in lowering serum uric acid level was significantly superior to allopurinol ( p=0.005 ) . No patient reported clinical side effects during treatment with either drug . In conclusion , the authors have shown that benzbromarone is more effective than allopurinol in the reduction of serum uric acid levels in hyperuricemic patients with normal renal function OBJECTIVE To observe the clinical effect of a modified Simiao Tang ( Modified Decoction of Four Wonderful Drugs ) for gouty arthritis and its influence on uric acid in blood . METHODS 120 cases of gouty arthritis were r and omly divided into the treatment group and control group with 60 cases in each group . Modified Simiao Tang ( MST ) was orally administered to the patients in the treatment group and allopurinol tablet was orally administered to the patients in the control group . The clinical effects of two groups were evaluated after one-week treatment and uric acid ( UA ) and C-reactive protein ( CRP ) levels in blood were determined after 1-month treatment . RESULTS The total effective rate in the treatment group was significantly higher than in the control group , 86.7 % vs. 68.3 % ( P < 0.01 ) . And the treatment group was also significantly better than the control group in decreasing UA and CRP ( P < 0.05 or P < 0.01 ) . CONCLUSIONS MST can significantly improve the symptoms and signs of gouty arthritis and decrease the levels of UA and CRP . It is good for gouty arthritis Objectives : To compare the efficacy and tolerability of allopurinol 300–600 mg/day versus benzbromarone 100–200 mg/day used to attain a target serum urate concentration ( sUr ) ⩽0.30 mmol/l ( 5 mg/dl ) . Methods : A r and omised , controlled , open-label , multicentre trial in gout patients with renal function defined as a calculated creatinine clearance ⩾50 ml/min . Patients were treated with 300 mg allopurinol or 100 mg benzbromarone once a day ( stage 1 ) . If sUr ⩽0.30 mmol/l was not attained after 2 months , the dose was doubled to allopurinol 300 mg twice a day or benzbromarone 200 mg once a day ( stage 2 ) . The primary end point was treatment success in either of the two stages , defined as clinical tolerability and attainment of biochemical target sUr . Results : Sixty-five patients were enrolled in stage 1 ; 36 received allopurinol and 29 received benzbromarone . Fifty-five patients ( 85 % ) were analysed at stage 1 : the success rates were 8/31 ( 26 % ) and 13/25 ( 52 % ) , respectively , and the difference was −0.26 ( 95 % CI from −0.486 to −0.005 ) , p = 0.049 . At stage 2 , the success rates were 21/27 ( 78 % ) and 18/23 ( 78 % ) , respectively , and the difference was −0.005 Output:
They did not report tophi regression , pain and function . There was moderate- quality evidence of little or no difference in the proportion of participants achieving target serum urate when allopurinol was compared with benzbromarone .
MS2_1shot267
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background Few studies have investigated both the self-perceived and measured environment with objective ly determined physical activity in older adults . Accordingly , the aim of this study was to examine measured and perceived environmental associations with physical activity of older adults residing across different neighborhood types . Methods One-hundred and forty-eight older individuals , mean age 64.3 ± 8.4 , were r and omly recruited from one of four neighborhoods that were pre-determined as either having high- or low walkable characteristics . Individual residences were geocoded and 200 m network buffers established . Both objective environment audit , and self-perceived environmental measures were collected , in conjunction with accelerometer derived physical activity behavior . Using both perceived and objective environment data , analysis consisted of a macro-level comparison of physical activity levels across neighborhood , and a micro-level analysis of individual environmental predictors of physical activity levels . Results Individuals residing in high-walkable neighborhoods on average engaged in 11 min of moderate to vigorous physical activity per day more than individuals residing in low-walkable neighborhoods . Both measured access to non-residential destinations ( b = .11 , p < .001 ) and self-perceived access to non-residential uses ( b = 2.89 , p = .031 ) were significant predictors of time spent in moderate to vigorous physical activity . Other environmental variables significantly predicting components of physical activity behavior included presence of measured neighborhood crime signage ( b = .4785 , p = .031 ) , measured street safety ( b = 26.8 , p = .006 ) , and perceived neighborhood satisfaction ( b = .5.8 , p = .003 ) . Conclusions Older adult residents who live in high-walkable neighborhoods , who have easy and close access to nonresidential destinations , have lower social dysfunction pertinent to crime , and generally perceive the neighborhood to a higher overall satisfaction are likely to engage in higher levels of physical activity behavior . Efforts aim ed at promoting more walkable neighborhoods could influence activity levels in older adults OBJECTIVES . Physical activity may be constrained or facilitated by local environments . The availability of neighborhood facilities for physical activity may be particularly relevant for youth , who are unable to drive and whose activity is often limited to the immediate distance they are able to walk or bicycle . Several studies have shown that proximity to recreational facilities and parks is one of the most important predictors of physical activity . Because the United States already has an extensive infrastructure of parks , with 70 % of adults indicating that they live within walking distance of a park or playground , parks may be a potential venue for increasing physical activity . This might be particularly important for adolescent girls , whose physical activity levels decline substantially as they go through puberty . The goal of this study was to examine the association between park proximity , park type , and park features and physical activity in adolescent girls . PATIENTS AND METHODS . This was a cross-sectional study using baseline data from the Trial of Activity for Adolescent Girls . It included 1556 grade 6 girls who were r and omly selected from 6 middle schools in each of the following 6 field site areas : Washington , DC , and Baltimore , Maryl and ; Columbia , South Carolina ; Minneapolis , Minnesota ; New Orleans , Louisiana ; Tucson , Arizona ; and San Diego , California . Girls wore accelerometers for 6 days to measure metabolic equivalent – weighted moderate-to-vigorous physical activity , a measure accounting for the volume and intensity of activity . Metabolic equivalent – weighted moderate-to-vigorous physical activity was calculated for the hours outside of school time using 2 different cutpoints , activity levels ≥3.0 metabolic equivalents and ≥4.6 metabolic equivalents , the latter indicating activity at the intensity of a brisk walk or higher . We mapped all of the parks within 1 mile of each girl 's home . Trained staff used a checklist to document the presence of facilities and amenities at each park , including passive amenities , such as drinking fountains , restrooms , and areas with shade , as well as active amenities like basketball courts , multi purpose fields , playgrounds , and tennis courts . RESULTS . Mean nonschool metabolic equivalent – weighted moderate/vigorous physical activity , using the 4.6 metabolic equivalent cutoff , was 611.1 minutes ( range : 49.7–4718.6 metabolic equivalent minutes per 6 days ) and 1704.8 metabolic equivalent minutes per 6 days ( range : 276.2–5792.6 metabolic equivalent minutes per 6 days ) when using the 3.0 metabolic equivalent cutpoint . Many girls had multiple parks within a 1-mile radius of their homes : 57 % had ≥1 type of park , the majority being neighborhood or community parks ; 42 % had between 1 and 3 parks , 37 % had ≥4 parks , and 14 % had ≥8 parks . The type , number , and specific parks features were associated with girls ' nonschool metabolic equivalent – weighted moderate/vigorous physical activity . At the 4.6 metabolic equivalent cutpoint , higher levels of nonschool metabolic equivalent – weighted moderate/vigorous physical activity were associated with both neighborhood and community parks ( 22 metabolic equivalent minutes ) and miniparks ( 40 metabolic equivalent minutes ) . Each park , regardless of type , in the half-mile around each girl 's home was associated with an increase in nonschool metabolic equivalent – weighted moderate/vigorous physical activity by 2.8 % or 17.2 nonschool minutes of metabolic equivalent – weighted moderate/vigorous physical activity per 6 days . Beyond a half-mile , each park increased nonschool metabolic equivalent – weighted moderate/vigorous physical activity by 1.1 % or 6.7 metabolic equivalent minutes per 6 days . For the average girl with 3.5 parks within a 1-mile radius of home , the presence of parks accounted for 36.5 extra nonschool metabolic equivalent minutes per 6 days , ∼6 % of total nonschool metabolic equivalent – weighted moderate/vigorous physical activity . Using the 3.0 metabolic equivalent cutpoint , this sums to an additional 68 metabolic equivalent minutes of nonschool metabolic equivalent – weighted moderate/vigorous physical activity over 6 days , or 4 % of the total . The most common amenities in the parks were playgrounds , multi purpose fields , and picnic areas . Slightly more than one third of girls lived within a half-mile of a park with a basketball court , and > 20 % had access to walking paths and tennis courts in their local park . Higher levels of nonschool metabolic equivalent – weighted moderate/vigorous physical activity per 6 days were associated with walking paths ( 13 metabolic equivalent minutes ) , running tracks ( 82 metabolic equivalent minutes ) , playgrounds ( 28 metabolic equivalent minutes ) , and basketball courts ( 30 metabolic equivalent minutes ) . Parks with streetlights and floodlights were also associated with an increase of 18 and 22 minutes of nonschool metabolic equivalent – weighted moderate/vigorous physical activity , respectively . With the 3.0 metabolic equivalent cutoff for metabolic equivalent – weighted moderate/vigorous physical activity , additional nonschool metabolic equivalent minutes more than doubled when girls had miniparks ( 92 metabolic equivalent minutes ) , natural re source areas ( 36 metabolic equivalent minutes ) , walking paths ( 59 metabolic equivalent minutes ) , and running tracks ( 208 metabolic equivalent minutes ) within a half-mile of their homes . Skateboard areas and special-use parks were negatively associated with nonschool metabolic equivalent – weighted moderate/vigorous physical activity in adolescent girls . CONCLUSIONS . Adolescent girls who live near more parks , particularly near those with amenities that are conducive to walking and with active features , engage in more nonschool metabolic equivalent – weighted moderate/vigorous physical activity than those with fewer parks . Whether this is because of actual use of the parks or neighborhood choice could not be determined . Although the magnitude of the association between parks and additional minutes of metabolic equivalent – weighted moderate/vigorous physical activity was small for an individual , amounting to an average of 4%–6 % of a girl 's total nonschool metabolic equivalent – weighted moderate/vigorous physical activity , it is likely to have a large population -level association . Because of the potential population level impact , the use of parks to promote physical activity should be further studied BACKGROUND Regular physical activity is known to help prevent chronic disease and promote healthy aging . Yet , most older women are not regularly active . This study attempts to identify objective ly measured attributes of the neighborhood environment that may be associated with physical activity levels in older women . METHODS Sociodemographics and physical activity level , as measured by pedometer , were assessed in 158 overweight Caucasian and African-American postmenopausal women from southwestern Pennsylvania at the baseline evaluation of a r and omized clinical trial in 2002 - 2003 . Geographic information systems technology was used to obtain neighborhood-level data , including neighborhood socioeconomic status ( SES ) indicators , the median year that homes were built ( as a proxy measure for urban form ) , and proximity to businesses and facilities . Multiple linear regression was used to test associations between individuals ' physical activity level and neighborhood characteristics . RESULTS After controlling for individual age , race/ethnicity , education , smoking status , and body mass index , indicators of low neighborhood SES , living in a neighborhood with homes built between 1950 and 1969 ( representing an urban form that is more pedestrian-friendly than after 1969 ) , and living within walking distance ( 1500 m ) of specific types of businesses and facilities were positively associated with individuals ' physical activity level measured by pedometer ( p < 0.05 ) . CONCLUSIONS Results suggest that certain aspects of the neighborhood environment may have an important influence on the physical activity levels of postmenopausal women . Results warrant future research to clarify the role of these environmental attributes in other population Locational data , logged on portable GPS units and matched with accelerometer data , was used to examine associations of the built environment with physical activity and sedentary behaviors of adolescent females . In a sample of 293 adolescent females aged 15 to 18 years old in Minneapolis and San Diego , the built environment around each GPS point and its corresponding sedentary , light , and moderate-to-vigorous intensity physical activity was examined using r and om intercept multinomial logistic regression models . The odds of higher physical activity intensity ( 3-level outcome : sedentary , light , MVPA ) were higher in places with parks , schools , and high population density , during weekdays , and lower in places with more roads and food outlets . Underst and ing the places where physical activity and sedentary behaviors occur appears to be a promising strategy to clarify relationships and inform policy aim ed at increasing physical activity and reducing sedentary behaviors BACKGROUND This study examined predictors of adoption and maintenance of vigorous physical activity over time in a sample of 1,719 r and omly selected women and men . METHODS Based on reported frequency of vigorous exercise in a mail survey at baseline , subjects were classified as sedentary ( zero sessions per week ) , intermediate ( one to two sessions per week ) , or active ( three or more sessions per week ) . RESULTS On the same survey subjects reported on 25 potential determinants of physical activity based on a comprehensive learning model . Twenty-four months later , 85 % of subjects were resurveyed , and their physical activity levels were classified . Within each baseline category and gender subgroup , predictors of follow-up physical activity were identified . In multivariate analyses , adoption of vigorous exercise by sedentary men was predicted by self-efficacy , age ( inverse ) , and neighborhood environment ( inverse ) . Adoption by sedentary women was predicted by education , self-efficacy , and friend and family support for exercise . Maintenance of vigorous physical activity was predicted by self-efficacy and age ( inverse ) for initially active men and by education for initially active women . CONCLUSION These results suggest that factors influencing adoption are different for men and women , and there may be different factors influencing adoption versus maintenance of vigorous physical activity Output:
Our review found that even among studies with objective ly measured physical activity , the association between access to parks and physical activity varied between studies , possibly due to heterogeneity of exposure measurement . Self-reported ( vs. independently-measured ) neighborhood park environment characteristics and smaller ( vs. larger ) buffer sizes were more predictive of physical activity .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: BACKGROUND Recent studies suggest that high-dose MgSO4 therapy is safe and reduces the incidence of DIND and subsequent poor outcome after SAH . We intended to assess the safety and efficacy of high-dose MgSO4 therapy after SAH as means to prevent DIND and to evaluate the impact on clinical outcome . METHODS This was a prospect i ve , r and omized , single-blind , placebo-controlled study . The MgSO4 infusion was adjusted every 12 hours until day 12 according to the target serum Mg2 + level . The occurrence of DIND , secondary infa rct ion , side effects , and the outcome after 3 and 12 months were assessed . RESULTS Fifty-eight patients were r and omized ; 27 received placebo and 31 MgSO4 . The difference in occurrence of DIND and secondary infa rct ion was not significant . The intention-to-treat analysis revealed a trend toward better outcome ( P = .083 ) after 3 months . On-treatment analysis showed a significantly better outcome after 3 months ( P = .017 ) and a trend toward better outcome after 1 year ( P = .083 ) . Significantly more often hypotension ( P = .040 ) and hypocalcemia ( P = .005 ) occurred as side effects in the treatment group . In 16 patients ( 52 % ) , the MgSO4 therapy had to be stopped before day 12 because of side effects . No predictive factor leading to termination was found in a postr and omization analysis . CONCLUSIONS High-dose MgSO4 therapy might be efficient as a prophylactic adjacent therapy after SAH to reduce the risk for poor outcome . Nevertheless , because of the high frequency of the side effects , patients should be observed in an intensive or intermediate care setting Background and Purpose — Pilot clinical trials using magnesium sulfate in patients with acute aneurysmal subarachnoid hemorrhage have reported trends toward improvement in clinical outcomes . This Phase III study aim ed to compare intravenous magnesium sulfate infusion with saline placebo among such patients . Methods — We recruited patients with aneurysmal subarachnoid hemorrhage within 48 hours of onset from 10 participating centers . The patients were r and omly assigned to magnesium sulfate infusion titrated to a serum magnesium concentration twice the baseline concentration or saline placebo for 10 to 14 days . Patients and assessors were blinded to treatment allocation . The study is registered at www.strokecenter.org/trials ( as Intravenous Magnesium Sulphate for Aneurysmal Subarachnoid Hemorrhage [ IMASH ] ) and www . Clinical Trials.gov ( NCT00124150 ) . Results — Of the 327 patients recruited , 169 were r and omized to receive treatment with intravenous magnesium sulfate and 158 to receive saline ( placebo ) . The proportions of patients with a favorable outcome at 6 months ( Extended Glasgow Outcome Scale 5 to 8) were similar , 64 % in the magnesium sulfate group and 63 % in the saline group ( OR , 1.0 ; 95 % CI , 0.7 to 1.6 ) . Secondary outcome analyses ( modified Rankin Scale , Barthel Index , Short Form 36 , and clinical vasospasm ) also showed no significant differences between the 2 groups . Predefined subgroups included age , admission World Federation of Neurological Surgeons grade , pre-existing hypertension , intracerebral hematoma , intraventricular hemorrhage , location of aneurysm , size of aneurysm , and mode of aneurysm treatment . In none of the subgroups did the magnesium sulfate group show a better outcome at 6 months . Conclusions — The results do not support a clinical benefit of intravenous magnesium sulfate infusion over placebo infusion in patients with acute aneurysmal subarachnoid hemorrhage OBJECT Despite the application of current st and ard therapies , vasospasm continues to result in death or major disability in patients treated for ruptured aneurysms . The authors investigated the effectiveness of continous MgSO4 infusion for vasospasm prophylaxis . METHODS Seventy-six adults ( mean age 54.6 years ; 71 % women ; 92 % Caucasian ) were included in this comparative matched-cohort study of patients with aneurysmal subarachnoid hemorrhage on the basis of computed tomography ( CT ) findings . Thirty-eight patients who received continuous MgSO4 infusion were matched for age , race , sex , treatment option , Fisher grade , and Hunt and Hess grade to 38 historical control individuals who did not receive MgSO4infusion . Twelve grams of MgSO4 in 500 ml normal saline was given intravenously daily for 12 days if the patient presented within 48 hours of aneurysm rupture . Vasospasm was diagnosed on the basis of digital substraction angiography , CT angiography , and transcranial Doppler ultrasonography , and evidence of neurological deterioration . Symptomatic vasospasm was present at a significantly lower frequency in patients who received MgSO4 infusion ( 18 % ) compared with patients who did not receive MgSO4 ( 42 % ) ( p = 0.025 ) . There was no significant difference in mortality rate at discharge ( p = 0.328 ) . A trend toward improved outcome as measured by the modifed Rankin Scale ( p = 0.084 ) , but not the Glasgow Outcome Scale ( p = 1.0 ) , was seen in the MgSO4 treated group . CONCLUSIONS Analysis of the results suggests that MgSO4 infusion may have a role in cerebral vasospasm prophylaxis if therapy is initiated within 48 hours of aneurysm rupture Objective : To examine whether the maintenance of elevated magnesium serum concentrations by intravenous administration of magnesium sulfate can reduce the occurrence of cerebral ischemic events after aneurysmal subarachnoid hemorrhage . Design : Prospect i ve , r and omized , placebo-controlled study . Setting : Neurosurgical intensive care unit of a University hospital . Interventions : One hundred ten patients were r and omized to receive intravenous magnesium sulfate or to serve as controls . Magnesium treatment was started with a bolus of 16 mmol , followed by continuous infusion of 8 mmol/hr . Serum concentrations were measured every 8 hrs , and infusion rates were adjusted to maintain target levels of 2.0–2.5 mmol/L. Intravenous administration was continued for 10 days or until signs of vasospasm had resolved . Thereafter , magnesium was administered orally and tapered over 12 days . Measurements and Main Results : Delayed ischemic infa rct ion ( primary end point ) was assessed by analyzing serial computed tomography scans . Transcranial Doppler sonography and digital subtraction angiography were used to detect vasospasm . Delayed ischemic neurologic deficit was determined by continuous detailed neurologic examinations ; clinical outcome after 6 months was assessed using the Glasgow outcome scale . Good outcome was defined as Glasgow outcome scale score 4 and 5 . The incidence of delayed ischemic infa rct ion was significantly lower in magnesium-treated patients ( 22 % vs. 51 % ; p = .002 ) ; 34 of 54 magnesium patients and 27 of 53 control patients reached good outcome ( p = .209 ) . Delayed ischemic neurologic deficit was nonsignificantly reduced ( 9 of 54 vs. 15 of 53 patients ; p = .149 ) and transcranial Doppler-detected/angiographic vasospasm was significantly reduced in the magnesium group ( 36 of 54 vs. 45 of 53 patients ; p = .028 ) . Fewer patients with signs of vasospasm had delayed cerebral infa rct ion . Conclusion : These data indicate that high-dose intravenous magnesium can reduce cerebral ischemic events after aneurysmal subarachnoid hemorrhage by attenuating vasospasm and increasing the ischemic tolerance during critical hypoperfusion We performed a r and omized , double-blind , pilot study on magnesium sulfate ( MgSO4 ) infusion for aneurysmal subarachnoid hemorrhage ( SAH ) . Sixty patients with SAH were r and omly allocated to receive either MgSO4 80 mmol/day or saline infusion for 14 days . Patients also received intravenous nimodipine . Episodes of vasospasm were treated with hypertensive and hypervolemic therapy . Neurologic status was assessed 6 months after hemorrhage using the Barthel index and Glasgow Outcome Scale . Incidences of cardiac and pulmonary complications were also recorded . Patient characteristics , severity of SAH , and surgical treatment did not differ between groups . The incidence of symptomatic vasospasm decreased from 43 % in the saline group to 23 % in patients receiving MgSO4 infusion , but it did not reach statistical significance , P=0.06 . For patients who had transcranial Doppler-detected vasospasm , defined as mean flow velocity > 120 cm/s and a Lindegaard index > 3 , the duration was shorter in the magnesium group compared with controls ( P<0.01 ) . There was , however , no difference between groups in functional recovery or Glasgow Outcome Scale score . The incidence of adverse events such as brain swelling , hydrocephalus , and nosocomial infection was also similar in patients receiving MgSO4 or saline . In this small pilot study , MgSO4 infusion for aneurysmal SAH is feasible . On the basis of the preliminary data , a larger study recruiting approximately 800 patients is required to test for a possible neuroprotective effect of magnesium after SAH Summary Background Magnesium sulphate is a neuroprotective agent that might improve outcome after aneurysmal subarachnoid haemorrhage by reducing the occurrence or improving the outcome of delayed cerebral ischaemia . We did a trial to test whether magnesium therapy improves outcome after aneurysmal subarachnoid haemorrhage . Methods We did this phase 3 r and omised , placebo-controlled trial in eight centres in Europe and South America . We r and omly assigned ( with computer-generated r and om numbers , with permuted blocks of four , stratified by centre ) patients aged 18 years or older with an aneurysmal pattern of subarachnoid haemorrhage on brain imaging who were admitted to hospital within 4 days of haemorrhage , to receive intravenous magnesium sulphate , 64 mmol/day , or placebo . We excluded patients with renal failure or bodyweight lower than 50 kg . Patients , treating physicians , and investigators assessing outcomes and analysing data were masked to the allocation . The primary outcome was poor outcome —defined as a score of 4–5 on the modified Rankin Scale—3 months after subarachnoid haemorrhage , or death . We analysed results by intention to treat . We also up date d a previous meta- analysis of trials of magnesium treatment for aneurysmal subarachnoid haemorrhage . This study is registered with controlled-trials.com ( IS RCT N 68742385 ) and the EU Clinical Trials Register ( EudraCT 2006 - 003523 - 36 ) . Findings 1204 patients were enrolled , one of whom had his treatment allocation lost . 606 patients were assigned to the magnesium group ( two lost to follow-up ) , 597 to the placebo ( one lost to follow-up ) . 158 patients ( 26·2 % ) had poor outcome in the magnesium group compared with 151 ( 25·3 % ) in the placebo group ( risk ratio [ RR ] 1·03 , 95 % CI 0·85–1·25 ) . Our up date d meta- analysis of seven r and omised trials involving 2047 patients shows that magnesium is not superior to placebo for reduction of poor outcome after aneurysmal subarachnoid haemorrhage ( RR 0·96 , 95 % CI 0·86–1·08 ) . Interpretation Intravenous magnesium sulphate does not improve clinical outcome after aneurysmal subarachnoid haemorrhage , therefore routine administration of magnesium can not be recommended . Funding Netherl and s Heart Foundation , UK Medical Research Council Background : There is limited information about the long-term consequences of subarachnoid hemorrhage ( SAH ) . Methods : Data were obtained from a population -based study of aneurysmal SAH conducted in Australia and New Zeal and between 1995 and 1998 . The authors report health outcomes for survivors 1 year after the onset of SAH . Results : From a total of 432 first-ever cases of SAH ( 76 % due to confirmed cerebral aneurysm rupture ) registered in four cities in Australia and New Zeal and , 242 ( 56 % ) were alive approximately 1 year later ( mean time 1.2 years ) , with 230 ( 95 % ) available for interview . Of those interviewed , 105 ( 46 % ) reported an incomplete recovery , with ongoing problems with memory ( 50 % ) , mood ( 39 % ) , speech ( 14 % ) , and self-care ( 10 % ) . Compared with age- and sex-adjusted Australian population norms , health-related quality of life , as determined by Short Form–36 , was significantly lower for cases in the domains of role limitations that result from physical problems . However , there were no patient or disease characteristics that predicted complete recovery from SAH . Conclusions : A high proportion Output:
We identified a benefit in the role of magnesium to reduce the incidence of cerebral vasospasm in patients with an aneurysmal SAH . However no benefit was found regarding improved favourable functional outcome or a reduction of mortality
MS2_1shot269
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Introduction The rate of weaning of vasopressors drugs is usually an empirical choice made by the treating in critically ill patients . We applied fuzzy logic principles to modify intravenous norepinephrine ( noradrenaline ) infusion rates during norepinephrine infusion in septic patients in order to reduce the duration of shock . Methods Septic patients were r and omly assigned to norepinephrine infused either at the clinician 's discretion ( control group ) or under closed-loop control based on fuzzy logic ( fuzzy group ) . The infusion rate changed automatically after analysis of mean arterial pressure in the fuzzy group . The primary end-point was time to cessation of norepinephrine . The secondary end-points were 28-day survival , total amount of norepinephine infused and duration of mechanical ventilation . Results Nineteen patients were r and omly assigned to fuzzy group and 20 to control group . Weaning of norepinephrine was achieved in 18 of the 20 control patients and in all 19 fuzzy group patients . Median ( interquartile range ) duration of shock was significantly shorter in the fuzzy group than in the control group ( 28.5 [ 20.5 to 42 ] hours versus 57.5 [ 43.7 to 117.5 ] hours ; P < 0.0001 ) . There was no significant difference in duration of mechanical ventilation or survival at 28 days between the two groups . The median ( interquartile range ) total amount of norepinephrine infused during shock was significantly lower in the fuzzy group than in the control group ( 0.6 [ 0.2 to 1.0 ] μg/kg versus 1.4 [ 0.6 to 2.7 ] μg/kg ; P < 0.01 ) . Conclusions Our study has shown a reduction in norepinephrine weaning duration in septic patients enrolled in the fuzzy group . We attribute this reduction to fuzzy control of norepinephrine infusion . Trial registration Trial registration : Clinical trials.gov NCT00763906 The effect of Shenfu on biochemical parameters and survival during resuscitation in patients with septic shock was examined . This was a multicenter , controlled , r and omized , open-label trial carried out in 210 patients with septic shock from seven medical centers in China . They were r and omized to Shenfu or saline . The primary outcome was lactate clearance . The secondary outcomes were shock index normalization , dose of vasopressors , ICU stay , hospital stay , and mortality . A total of 199 patients completed the trial . Blood pressure , heart rate , and other routine lab tests showed no difference between the groups . Lactate levels and lactate clearance were similar between the two groups . Hospital and ICU stay were similar between the two groups . When considering all patients , the 7- and 28-day mortality were similar between the two groups , but when considering only patients with lactate levels ≥4.5 mmol/L , the Shenfu group showed a better 7-day survival than the control group ( 7 days : 83.3 % versus 54.5 % , P = 0.034 ; 28 days : 72.7 % versus 47.6 % , P = 0.092 ) . Shenfu may improve the 7-day survival in patients with impaired lactate clearance ( ≥4.5 mmol/L ) , but the mechanism for this effect is unclear . Additional studies are necessary to characterize the hemodynamic changes after Shenfu infusion . This trial is registered with ChiCTR-TRC-11001369 CONTEXT AND OBJECTIVE Sepsis and septic shock are very common conditions among critically ill patients that lead to multiple organ dysfunction syndrome ( MODS ) and death . Our purpose was to investigate the efficacy of early administration of dexamethasone for patients with septic shock , with the aim of halting the progression towards MODS and death . DESIGN AND SETTING Prospect i ve , r and omized , double-blind , single-center study , developed in a surgical intensive care unit at Hospital das Clínicas , Faculdade de Medicina da Universidade de São Paulo . METHODS The study involved 29 patients with septic shock . All eligible patients were prospect ively r and omized to receive either a dose of 0.2 mg/kg of dexamethasone ( group D ) or placebo ( group P ) , given three times at intervals of 36 hours . The patients were monitored over a seven-day period by means of the sequential organ failure assessment score . RESULTS Patients treated with dexamethasone did not require vasopressor therapy for as much time over the seven-day period as did the placebo group ( p = 0.043 ) . Seven-day mortality was 67 % in group P ( 10 out of 15 ) and 21 % in group D ( 3 out of 14 ) ( relative risk = 0.31 , 95 % confidence interval 0.11 to 0.88 ) . Dexamethasone enhanced the effects of vasopressor drugs . CONCLUSIONS Early treatment with dexamethasone reduced the seven-day mortality among septic shock patients and showed a trend towards reduction of 28-day mortality Introduction In septic shock , pulse pressure or cardiac output variation during passive leg raising are preload dependence indices reliable at predicting fluid responsiveness . Therefore , they may help to identify those patients who need intravascular volume expansion , while avoiding unnecessary fluid administration in the other patients . However , whether their use improves septic shock prognosis remains unknown . The aim of this study was to assess the clinical benefits of using preload dependence indices to titrate intravascular fluids during septic shock . Methods In a single-center r and omized controlled trial , 60 septic shock patients were allocated to preload dependence indices-guided ( preload dependence group ) or central venous pressure-guided ( control group ) intravascular volume expansion with 30 patients in each group . The primary end point was time to shock resolution , defined by vasopressor weaning . Results There was no significant difference in time to shock resolution between groups ( median ( interquartile range ) 2.0 ( 1.2 to 3.1 ) versus 2.3 ( 1.4 to 5.6 ) days in control and preload dependence groups , respectively ) . The daily amount of fluids administered for intravascular volume expansion was higher in the control than in the preload dependence group ( 917 ( 639 to 1,511 ) versus 383 ( 211 to 604 ) mL , P = 0.01 ) , and the same held true for red cell transfusions ( 178 ( 82 to 304 ) versus 103 ( 0 to 183 ) mL , P = 0.04 ) . Physiologic variable values did not change over time between groups , except for plasma lactate ( time over group interaction , P < 0.01 ) . Mortality was not significantly different between groups ( 23 % in the preload dependence group versus 47 % in the control group , P = 0.10 ) . Intravascular volume expansion was lower in the preload dependence group for patients with lower simplified acute physiology score II ( SAPS II ) , and the opposite was found for patients in the upper two SAPS II quartiles . The amount of intravascular volume expansion did not change across the quartiles of severity in the control group , but steadily increased with severity in the preload dependence group . Conclusions In patients with septic shock , titrating intravascular volume expansion with preload dependence indices did not change time to shock resolution , but result ed in less daily fluids intake , including red blood cells , without worsening patient outcome .Trial registration Clinical trials.gov NCT01972828 . Registered 11 October 2013 Introduction Sepsis is associated with the generation of oxygen free radicals and ( lacking ) decreased selenium plasma concentrations . High doses of sodium selenite might reduce inflammation by a direct pro-oxidative effect and may increase antioxidant cell capacities by selenium incorporation into selenoenzymes . We investigated the effects of a continuous administration of high doses of selenium in septic shock patients . Methods A prospect i ve , multicentre , placebo-controlled , r and omized , double-blind study was performed with an intention-to-treat analysis in severe septic shock patients with documented infection . Patients received , for 10 days , selenium as sodium selenite ( 4,000 μg on the first day , 1,000 μg/day on the nine following days ) or matching placebo using continuous intravenous infusion . The primary endpoint was the time to vasopressor therapy withdrawal . The duration of mechanical ventilation , the mortality rates in the intensive care unit , at hospital discharge , and at 7 , 14 , 28 and 180 days and 1 year after r and omization , and adverse events were recorded . Results Sixty patients were included ( placebo , n = 29 ; selenium , n = 31 ) . The median time to vasopressor therapy withdrawal was 7 days in both groups ( 95 % confidence interval = 5–8 and 6–9 in the placebo and selenium groups , respectively ; log-rank , P = 0.713 ) . The median duration of mechanical ventilation was 14 days and 19 days in the placebo and selenium groups , respectively ( P = 0.762 ) . Mortality rates did not significantly differ between groups at any time point . Rates of adverse events were similar in the two groups . Conclusion Continuous infusion of selenium as sodium selenite ( 4,000 μg on the first day , 1,000 μg/day on the nine following days ) had no obvious toxicity but did not improve the clinical outcome in septic shock patients . Trial Registration = NCT00207844 BACKGROUND In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock , mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal -directed therapy ( EGDT ) , in which intravenous fluids , vasopressors , inotropes , and blood transfusions were adjusted to reach central hemodynamic targets , than among those receiving usual care . We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary . METHODS In 31 emergency departments in the United States , we r and omly assigned patients with septic shock to one of three groups for 6 hours of resuscitation : protocol -based EGDT ; protocol -based st and ard therapy that did not require the placement of a central venous catheter , administration of inotropes , or blood transfusions ; or usual care . The primary end point was 60-day in-hospital mortality . We tested sequentially whether protocol -based care ( EGDT and st and ard-therapy groups combined ) was superior to usual care and whether protocol -based EGDT was superior to protocol -based st and ard therapy . Secondary outcomes included longer-term mortality and the need for organ support . RESULTS We enrolled 1341 patients , of whom 439 were r and omly assigned to protocol -based EGDT , 446 to protocol -based st and ard therapy , and 456 to usual care . Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids , vasopressors , inotropes , and blood transfusions . By 60 days , there were 92 deaths in the protocol -based EGDT group ( 21.0 % ) , 81 in the protocol -based st and ard-therapy group ( 18.2 % ) , and 86 in the usual-care group ( 18.9 % ) ( relative risk with protocol -based therapy vs. usual care , 1.04 ; 95 % confidence interval [ CI ] , 0.82 to 1.31 ; P=0.83 ; relative risk with protocol -based EGDT vs. protocol -based st and ard therapy , 1.15 ; 95 % CI , 0.88 to 1.51 ; P=0.31 ) . There were no significant differences in 90-day mortality , 1-year mortality , or the need for organ support . CONCLUSIONS In a multicenter trial conducted in the tertiary care setting , protocol -based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes . ( Funded by the National Institute of General Medical Sciences ; ProCESS Clinical Trials.gov number , NCT00510835 . ) Purpose : The Surviving Sepsis Campaign guidelines recommend hydrocortisone in septic shock only when fluid resuscitation and vasopressors fail to restore hemodynamic stability . Hydrocortisone administration modalities are supported only by low- grade recommendations . Our main objective here was to determine differences in 28-day mortality between two low-dose hydrocortisone regimens for the treatment of septic shock . Methods : We performed a multicenter , prospect i ve , r and omized , double-blind , pilot study in four adult medical intensive care units . Patients presenting septic shock were rapidly administered one of two regimens of hydrocortisone , either a 50-mg intravenous bolus every 6 h during 7 days ( 200-mg group ; n = 59 ) or a 100-mg initial bolus followed by a continuous infusion of 300 mg daily for 5 days ( 300-mg group ; n = 63 ) . Hydrocortisone was stopped abruptly at the end of treatment . Results : There were no significant differences between the 200-mg and 300-mg groups as concerns 28-day mortality ( respectively 52.5 % vs. 44.4 % [ RR 0.84 , 95 % CI , 0.58–1. Output:
Conclusions Among 65 septic shock trials , there was a clinical ly relevant amount of heterogeneity in control group mortality rates which was explained only partly by differences in inclusion criteria and reported baseline characteristics
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: We performed yearly MRI analyses on 327 of the total 372 patients in a multicenter , r and omized , double-blind , placebo-controlled trial of interferon beta-1b ( IFNB ) . Clinical results are presented in the preceding companion paper . Baseline MRI characteristics were the same in all treatment groups . Fifty-two patients at one center formed a cohort for frequent MRIs ( one every 6 weeks ) for analysis of disease activity . The MRI results support the clinical results in showing a significant reduction in disease activity as measured by numbers of active scans ( median 80 % reduction , p = 0.0082 ) and appearance of new lesions . In addition , there was an equally significant reduction in MRI-detected burden of disease in the treatment as compared with placebo groups ( mean group difference of 23 % , p = 0.001 ) . These results demonstrate that IFNB has made a significant impact on the natural history of MS in these patients Fifty-eight patients with severe , progressive multiple sclerosis were prospect ively r and omized to one of three treatments : 20 received intravenous ACTH , 20 received high-dose intravenous cyclophosphamide plus ACTH , and 18 were placed on a regimen consisting of plasma exchange , low-dose oral cyclophosphamide , and ACTH . The three groups were similar in age , sex , duration and type of disease , and degree of disability . Before treatment and six months and one year after treatment , a disability-status score , ambulation index , and functional-status score were determined , and a quantitative neurologic examination was performed . In the ACTH group , the number of patients stabilized or improved was 8 of 20 at six months and 4 of 20 at one year ; in the cyclophosphamide-ACTH group , 18 of 20 at six months and 16 of 20 at one year ; and in the plasma exchange group , 11 of 18 at six months and 9 of 18 at one year . High-dose cyclophosphamide plus ACTH was most effective in halting progression of the disease at both 6 and 12 months ( at 12 months , cyclophosphamide-ACTH vs. ACTH , P = 0.0004 ; cyclophosphamide-ACTH vs. plasma exchange , P = 0.087 ) . Thus , progressive multiple sclerosis may be stabilized by short-term , intensive immunosuppression with cyclophosphamide plus ACTH Background and Objective : A phase III double-blind , placebo-controlled clinical trial demonstrated that interferon beta-la ( IFNβ-1a ) ( Avonex , Biogen ) significantly delayed progression of disability in relapsing MS patients . The primary clinical outcome was time from study entry until disability progression , defined as≥1.0 point worsening from baseline Kurtzke Exp and ed Disability Status Scale ( EDSS ) score persisting for at least two consecutive scheduled visits separated by 6 months . The objective of this study was to examine the magnitude of benefit on EDSS and its clinical significance . Methods : Post hoc analyses related to disability outcomes using data collected during the double-blind , placebo-controlled phase III clinical trial . Results : ( 1 ) Clinical efficacy related to disability did not depend on the definition of disability progression . A significant benefit in favor of IFNβ-1a was observed when ≥2.0 point worsening from baseline EDSS was required or when worsening was required to persist for ≥1.0 year . ( 2 ) Placebo recipients who reached the primary clinical outcome worsened by a larger amount from baseline EDSS than did IFNβ-1a recipients who reached the primary study outcome . ( 3 ) Significantly fewer IFNβ-1a recipients progressed to EDSS milestones of 4.0 ( relatively severe impairment ) or 6.0(unilateral assistance needed to walk ) . ( 4 ) Cox proportional hazards models demonstrated that the only baseline characteristic strongly correlated with longer time to disability progression was IFNβ-1a treatment . Conclusions : The primary clinical outcome for the IFNβ-1a clinical trial underestimated clinical benefits of treatment . Results in this report demonstrate that IFNβ-1a treatment is associated with robust , clinical ly important beneficial effects on disability progression in relapsing MS patients BACKGROUND The Multiple Sclerosis Functional Composite ( MSFC ) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation ( Timed 25-Foot Walk ) , arm function ( 9-Hole Peg Test ) , and cognitive function ( Paced Auditory Serial Addition Test ) . The MSFC is the primary outcome measure in the ongoing multinational phase 3 trial of interferon beta-1a ( Avonex ) in patients with secondary progressive MS . OBJECTIVE To assess the practice effects , reliability , and validity of the MSFC clinical outcome measure . DESIGN Examining technicians underwent formal training using st and ardized material s. The MSFC was performed according to a st and ardized protocol . The 436 patients enrolled in the International Multiple Sclerosis Secondary Progressive Avonex Controlled Trial underwent 3 prebaseline MSFC testing sessions before r and omization . RESULTS Practice effects were evident initially for the MSFC but stabilized by the fourth administration . The Paced Auditory Serial Addition Test demonstrated the most prominent practice effects . The reliability of the MSFC was excellent , with an intraclass correlation coefficient for session 3 ( final prebaseline session ) vs session 4 ( baseline ) of 0.90 . The MSFC at baseline correlated moderately strongly with the Kurtzke Exp and ed Disability Status Scale . Among the MSFC components , the Timed 25-Foot Walk correlated most closely . Correlations among the 3 MSFC components were weak , suggesting they assess distinct aspects of neurologic function in patients with MS . CONCLUSIONS The MSFC demonstrated excellent intrarater reliability in this multinational phase 3 trial . Three prebaseline testing sessions were sufficient to compensate for practice effects . The pattern of correlations among the MSFC , its components , and the Kurtzke Exp and ed Disability Status Scale supported the validity of the MSFC BACKGROUND Although the risk of clinical attacks of multiple sclerosis seems to be significantly increased with viral upper respiratory tract infections ( URTI ) , serological evidence for the reported association remains controversial . In addition , although MRI is six to 10 times more sensitive than clinical exacerbations in indexing disease activity , any possible association between URTI and MRI activity has yet to be investigated . OBJECTIVES To examine the relation between URTI and disease activity , in multiple sclerosis patients participating in a placebo controlled trial of interferon β-1a , as indexed both by clinical exacerbation rate and by the number and volume of gadolinium - diethylenetriaminepenta acetic acid ( Gd-DTPA ) enhancing lesions on MRI . “ At risk ” periods were defined around symptomatic URTI , with or without serological confirmation . RESULTS The relative risk of clinical relapse for serologically unconfirmed symptomatic URTI was 2.1 ( p=0.004 ) . Raised antiviral antibody titres conferred a relative risk of multiple sclerosis exacerbations that was 3.4 times higher than the “ not at risk ” periods ( annual attack rates of 5.7 v 1.6 , respectively , p=0.006 ) . There was no definite relation between the number or the volume of active lesions on MRI and either symptomatic or serologically defined at risk periods . CONCLUSIONS These results confirm the previously reported association between viral infections and multiple sclerosis exacerbations and indicate that the relative risk may be even higher when viral infection is serologically confirmed . However , the results , perhaps because of the confounding effects of interferon β-1a , do not provide convincing evidence of increased blood-brain barrier breakdown or inflammation during periods of virally induced immune stimulation OBJECTIVE : To evaluate whether recombinant human interferon-beta-1a significantly affects disease activity as measured by a reduction in the number and volume of Gd enhancing lesions on monthly MRI . The study also evaluated the effect on six-monthly T2 weighted abnormality and relapse frequency . METHODS : After a baseline scan and a six month pretreatment period , 68 patients were r and omly assigned to receive either 3 MIU or 9 MIU of interferon-beta-1a by subcutaneous injection three times a week for six months . All patients were examined by Gd enhanced MRI every month in both pretreatment and treatment periods . The evaluation of Gd enhancing lesions was performed blind at the end of the study . RESULTS : The mean number of Gd enhancing lesions was higher during the pretreatment period than during treatment . This difference was statistically significant for the two different dose subgroups ( 3.5 v 1.8 , P < 0.001 for the 3 MIU group and 2.4 v 0.9 , P < 0.001 for the 9 MIU group , corresponding to a reduction of 49 % and 64 % respectively ) . The mean volume of Gd enhancing lesions also significantly decreased by 61 % ( 3 MIU group ) and 73 % ( 9 MIU group ) . These reductions were evident only after the first month of treatment . The six-monthly rate of new lesions as seen in T2 weighted images showed a similar trend of reduction with treatment ( 65 % and 70 % respectively ) . Lesion volume on T2 scans significantly increased during the pretreatment period whereas it remained almost stable during the treatment period in both groups . Clinical relapse rate was significantly reduced by treatment ( 53 % for the 3 MIU group , P < 0.001 ; 69 % for the 9 MIU group , P < 0.001 ) . CONCLUSION : Interferon-beta-1a seemed effective in reducing disease activity in relapsing-remitting multiple sclerosis at both the doses used A pilot study was undertaken to test the safety and establish the side effect profile of recombinant human interferon-beta 1b ( Betaseron , Berlex Laboratories , Richmond , CA ) , in patients with relapsing-remitting multiple sclerosis ( RRMS ) . During the initial dose finding period ( 24 weeks ) , five groups of 6 patients each were treated by subcutaneous injection three times each week with either 0.8 , 4 , 8 , or 16 million units ( mU ) of Betaseron or placebo ( WHO St and ard ) . Although some side effects were noted in all groups , a dose-related trend in reduction of exacerbation frequency and side-effect profile was noted . Patients given 16 mU had no exacerbations during the initial dosing period , but associated side effects led to dose reduction or dropout . An 8 mU dose was selected for further study after 24 weeks , and continuous dosing at 8 mU in 15 patients has now exceeded 6 years . Side effects abated over time . Neutralizing antibody developed in most patients , but titers were variable , fluctuated independently of clinical course , and tended to fall with prolonged treatment . A dose-dependent rise in neopterin levels was observed during the initial dosing period . This pilot study has demonstrated responsiveness to Betaseron , shown a stable safety profile over time , and established guidelines for a dosing regimen to evaluate and optimize further the efficacy of Betaseron in RRMS The immunological effects of long-term treatment with recombinant alpha-2 interferon ( rIFN-alpha 2 ) were investigated in multiple sclerosis ( MS ) patients treated with 2 X 10(6 ) units of IFN or a placebo three times per week for one year . A mild lymphopenia was observed in IFN patients who also showed a decrease in the absolute number of total T cells in the blood ( OKT3 binding cells ) ; however , the percentage of cells reacting with OKT3 , OKT4 , and OKT8 antibodies did not change significantly during the study . The percentage of cells reacting with the Leu-7 antibody , which recognizes NK cells , was unchanged . During MS exacerbations , placebo patients showed a tendency for decreased levels of OKT3 and OKT8 cells . In contrast , IFN patients did not demonstrate a decrease in either OKT3 or OKT8 cells during disease attacks . Concanavalin A (ConA)-induced suppressor cell activity was depressed in both IFN and placebo-treated patients during attacks . Lymphoproliferative responses to phytohemagglutinin , pokeweed mitogen , and ConA were unchanged . These studies demonstrate that long-term treatment with rIFN-alpha 2 induces a generalized T-cell lymphopenia , but at this dose does not significantly affect the profiles of T-cell subsets and suppressor cell function in MS patients Background : Episodic inflammation in the CNS during the early stages of MS results in progressive disability years later , presumably due to myelin and axonal injury . MRI demonstrates ongoing disease activity during the early disease stage , even in some patients who are stable clinical ly . The optimal MRI measure for the destructive pathologic process is uncertain , however . Methods : In this post-hoc study , MRI scans were analyzed from patients with relapsing MS participating in a placebo-controlled trial of interferon β-1a . The brain parenchymal fraction , defined as the ratio of brain parenchymal volume to the total volume within the brain surface contour , was used to measure whole brain atrophy . The relationship between disease features and brain atrophy and effect of interferon β-1a were determined . Results : MS patients had significant brain atrophy that worsened during each of 2 years of observation . In many patients , brain atrophy worsened without clinical disease activity . Baseline clinical and MRI abnormalities were not strongly related to the rate of brain atrophy during the subsequent 2 years . Treatment with interferon β-1a result ed in a reduction in brain atrophy progression during the second year of the clinical trial . Conclusions : Patients with relapsing Output:
However , the correct assignment of dropouts was essential to the demonstration of efficacy , most conspicuously concerning the effect of the drug on disease progression . REVIEW ER 'S CONCLUSIONS The efficacy of interferon on exacerbations and disease progression in patients with relapsing remitting MS was modest after one and two years of treatment .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: The efficacy of group parent training was assessed in improving compliance and time on task in preschoolers with attention-deficit disorder with hyperactivity . Positive effects were obtained on measures of child compliance , but not on measures of attention . Parental compliance-management skills and overall style of interaction were also positively affected . The use of parent training for early intervention with ADDH children is discussed Aims : To assess the effectiveness of a parenting programme , delivered by health visitors in primary care , in improving the mental health of children and their parents among a representative general practice population . Methods : Parents of children aged 2–8 years who scored in the upper 50 % on a behaviour inventory were r and omised to the Webster-Stratton 10 week parenting programme delivered by trained health visitors , or no intervention . Main outcome measures were the Eyberg Child Behaviour Inventory and the Goodman Strengths and Difficulties Question naire to measure child behaviour , and the General Health Question naire , Abidin ’s Parenting Stress Index , and Rosenberg ’s Self Esteem Scale to measure parents ’ mental health . These outcomes were measured before and immediately after the intervention , and at six months follow up . Results : The intervention was more effective at improving some aspects of the children ’s mental health , notably conduct problems , than the no intervention control condition . The Goodman conduct problem score was reduced at immediate and six month follow up , and the Eyberg Child Behaviour Inventory was reduced at six months . The intervention also had a short term impact on social dysfunction among parents . These benefits were seen among families with children scoring in the clinical range for behaviour problems and also among children scoring in the non- clinical ( normal ) range . Conclusion : This intervention could make a useful contribution to the prevention of child behaviour problems and to mental health promotion in primary care This study evaluated the relative efficacy of two promising treatments of child abuse and child ne-glect : parent training and multisystemic therapy . Subjects included 18 abusive families and 15 ne-glectful families who were r and omly assigned to the treatment conditions . Self-report and observa-tional measures were used to evaluate the effects of treatment at three levels that have been associatedwith child maltreatment : individual functioning , family relations , and stress/social support . Statisti-cal analyses revealed that families who received either treatment showed decreased parental psychiat-ric symptomology , reduced overall stress , and a reduction in the severity of identified problems . Analyses of sequential observational measures revealed that multisystemic therapy was more effec-tive than parent training at restructuring parent-child relations . Parent training was more effectivethan multisystemic therapy at reducing identified social problems . The differentia ] inOuences of thetwo treatments were probably associated with differences in their respective treatment context s and epistemologies This study evaluated the effects of problem-solving skills training ( PSST ) and parent management training ( PMT ) on children ( N = 97 , ages 7 - 13 years ) referred for severe antisocial behavior . Children and families were assigned r and omly to 1 of 3 conditions : PSST , PMT , or PSST and PMT combined . It was predicted that ( a ) each treatment would improve child functioning ( reduce overall deviance and aggressive , antisocial , and delinquent behavior , and increase prosocial competence ) ; and ( b ) PSST and PMT combined would lead to more marked , pervasive , and durable changes in child functioning and greater changes in parent functioning ( parental stress , depression , and overall symptoms ) . Expectations were supported by results at posttreatment and 1-year follow-up . PSST and PMT combined led to more marked changes in child and parent functioning and placed a greater proportion of youth within the range of nonclinic ( normative ) levels of functioning OBJECTIVE To evaluate two different parent-based therapies for preschool attention-deficit/hyperactivity disorder ( ADHD ) in a community sample . METHOD Three-year-old children displaying a preschool equivalent of ADHD ( n = 78 ) were r and omly assigned to either a parent training ( PT ; n = 30 ) , a parent counseling and support ( PCO&S ; n = 28 ) , or a waiting-list control group ( n = 20 ) . The PT group received coaching in child management techniques . The PC&S group received nondirective support and counseling . Measures of child symptoms and mothers ' well-being were taken before and after intervention and at 15 weeks follow-up . RESULTS ADHD symptoms were reduced ( F2,74 = 11.64 ; p < .0001 ) and mothers ' sense of well-being was increased by PT relative to both other groups ( F2,74 = 10.32 ; p < .005 ) . Fifty-three percent of children in the PT group displayed clinical ly significant improvement ( chi 2 = 4.08 ; p = .048 ) . CONCLUSIONS PT is a valuable treatment for preschool ADHD . PC&S had little effect on children 's behavior . Constructive training in parenting strategies is an important element in the success of parent-based interventions . Psychostimulants are not a necessary component of effective treatment for many children with preschool ADHD OBJECTIVE The purpose was to report preliminary behavioral , social , and emotional results , and to project some potential economic results of a parenting and anger management program in a mountain state . METHOD Following local and state-wide needs assessment s , child abuse prevention was identified as the number two critical issue . An effective , research -based , preventive educational workshop program -- RETHINK Parenting and Anger Management -- was selected for testing and program evaluation . Measurable outcome objectives were written and assessment s were developed and tested . A one-group pretest-posttest design with a convenience sample of parents was used for the study . Seventy-five of 99 parents completed pretests before and posttests after participating in the 6-week series of skill-enhancing workshops . RESULTS Using a repeated measures analysis of variance , participants ' group mean anger control levels increased ( p = .016 ) . Their family conflict levels fell ( p = .006 ) . Their overall anger levels fell ( p = .000 ) . Their violence levels fell , verbal aggression levels fell ( p = .002 ) . Their partners ' violence levels also fell , verbal aggression levels fell ( p = .004 ) , and physical aggression levels fell ( p = .032 ) . In addition , participants reported increased knowledge levels ( 100 % ) , improved attitudes ( 97.3 % ) , improved behaviors ( 94.7 % ) , and decreased unrealistic expectations of their children ( 69.3 % ) . CONCLUSION The findings suggest that professional preventive education specialists may now have an effective program to assist parents in managing their anger . Further research is encouraged . When parents participate in 6 weeks of skill building with well-trained professionals , positive changes in parenting and anger management are possible This study examined the effects of parent training in music and multimodal stimulation on the quantity and quality of parent-neonate interactions and the weight gain and length of hospitalization of premature and low birthweight ( LBW ) infants in a Neonatal Intensive Care Unit ( NICU ) . Twenty sets of parents and premature LBW infants participated in the study . Parents in the experimental group ( n = 10 ) received approximately one hour of instruction in appropriate uses of music , multimodal stimulation including massage techniques , and signs of infant overstimulation and techniques for its avoidance . Parent-neonate interactions , specifically parent actions and responses and infant stress and nonstress behaviors , were observed for subjects in both groups . Infant stress behaviors were significantly fewer and appropriateness of parent actions and responses were significantly greater for experimental infants and parents than for control subjects . Parents in the experimental group also self-reported spending significantly more time visiting in the NICU than did parents of control infants . In addition , length of hospitalization was shorter and average daily weight gain was greater for infants whose parents received training , although these differences were not significant . A one month , postdischarge follow-up showed little difference between experimental and control group parent-infant interactions in the home Parents of 114 conduct-problem children , aged 3 - 8 years , were r and omly assigned to one of four groups : an individually administered videotape modeling treatment ( IVM ) , a group discussion videotape modeling treatment ( GDVM ) . a group discussion treatment ( GD ) , and a waiting-list control group . Compared ~4th the control group , all three treatment groups of mothers reported significantly fewer child behavior problems , more prosocial behaviors , and less spanking . Fathers in the GDVM and IVM conditions and teachers of children whose parents were in the GDVM and GD conditions also reported significant reductions in behavior problems compared ~4th control subjects . Home visit data indicated that all treatment groups of mothers , fathers , and children exhibited significant behavioral changes . There were relatively few differences between treatment groups on most outcome measures , although the differences found consistently favored the GDVM treatment . However , cost effectiveness was the major advantage of the IVM treatment This study provides evidence of the effectiveness of behaviorally based parenting skills classes provided by carefully trained and supervised group leaders who were not mental health clinicians . A program for parents of at-risk middle school students was evaluated in a r and omized controlled trial in 8 small Oregon communities . Parents ( N = 303 ) were r and omly assigned to immediate treatment or a wait-list condition . Data were analyzed using latent growth modeling . Participation in the program led to significant improvements in problem-solving interactions as indicated by parent reports and a Taped Situations Test . Parents ' over-reactivity and laxness toward their children 's behavior were reduced and their feelings toward their children improved significantly as a function of treatment . Parent-reported child antisocial behavior was also reduced Two family therapies were compared using teens with attention-deficit/hyperactivity disorder . Ninety-seven families were assigned to either 18 sessions of problem-solving communication training ( PSCT ) alone or behavior management training ( BMT ) for 9 sessions followed by PSCT for 9 sessions ( BMT/PSCT ) . Both treatments demonstrated significant improvement in ratings of parent-teen conflicts at the midpoint but did not differ . By posttreatment , both produced improvement on ratings and observations but did not differ . Significantly more families dropped out of PSCT alone than out of BMT/PSCT . At most , 23 % of families showed reliable change either by midpoint or by posttreatment , with no differences between therapies . Yet 31%-70 % of families were normalized . Group-level change and normalization rates support treatment efficacy , whereas indices of reliable change are less impressive The effectiveness of a parent training program for promoting positive parent-child relationships was examined among families of 2-year-olds . Forty-six mothers and fathers and their toddlers were assigned to either an intervention or comparison group . Intervention group parents participated in a 10-week program that focused on principles for effectively interacting with their toddlers . Parents completed measures of parenting self-efficacy , depression , stress , and perceptions of their toddler 's behaviors and were videotaped playing with their toddlers preintervention , postintervention , and 3 months following the intervention . Repeated measures ANOVAs showed that the parent training program led to significant increases in maternal self-efficacy , decreases in maternal stress , and improvements in the quality of mother-toddler interactions . No significant effects were found among fathers . Explanations for obtaining different outcomes for mothers and fathers are discussed and directions for future research are recommended A significant percentage of children with disruptive behavior disorders do not receive mental health assistance . Utilization is lowest among groups whose children are at greatest risk . To increase the availability , accessibility , and cost efficacy of parent training programs , this prospect i ve r and omized trial compared a large group community-based parent training program to a clinic-based individual parent training ( PT ) programs . All families of junior kindergartners in the Hamilton public and separate school boards were sent a checklist regarding problems at home . Those returning question naires above the 90th percentile were block r and omly assigned to : ( 1 ) a 12-week clinic-based individual parent training ( Clinic/Individual ) , ( 2 ) a 12-week community-based large group parent training ( Community/Group ) , or ( 3 ) a waiting list control condition . Immigrant families , those using English as a second language , and parents of children with severe behaviour problems were significantly more likely to enroll in Community/Groups than Clinic/Individual PT . Parents in Community/Groups reported greater improvements in behaviour problems at home and better maintenance of these gains at 6-month follow-up . A cost analysis showed that , with groups of 18 families , Community/Groups are more than six times as cost effective as Clinic/Individual programs The effectiveness of a behavioral parent training ( BPT ) intervention for improving maternal self-efficacy , maternal stress , and the quality of mother-toddler interactions has been demonstrated ( Gross , Fogg , & Tucker , 1995 ) . The 1-year follow-up of the 46 parents of toddlers ( assigned to an intervention or comparison group ) who participated in that study is reported . It was hypothesized that ( a ) BPT would lead to enduring positive changes in parenting self-efficacy , parenting stress , and parent-toddler interactions ; and ( b ) the amount of parent participation in the intervention would be correlated with greater gains in parent-child outcomes at 1 year . All the families were retained and significant gains in maternal self-efficacy , maternal stress , and mother-child interactions were maintained . Minimal BPT effects were found for fathers . BPT dosage was related to reductions in mother critical statements and negative physical behaviors at 1-year postintervention . The findings are consistent with self-efficacy theory and support parenting self-efficacy as a target for BPT in families of young children This study assessed the role of social support in the outcome of child management training ( CMT ) for single parents of conduct problem children and assessed the impact of adjunctive ally support training ( AST ) on treatment outcome . Single parents ( N = 22 ) with a child diagnosed as oppositional or conduct-disordered received CMT or CMT plus AST . Each group received the same 6-week parent training program and the AST group received an extra social support intervention . Measures of parent behavior , child deviance , social support ( SS ) , and parental depression were obtained at pre- and posttreat Output:
REVIEW ER 'S CONCLUSIONS It is suggested that parenting programmes can make a significant contribution to the improvement of psychosocial health in mothers . While the critical appraisal suggests some variability in the quality of the included studies , it is concluded that there is sufficient evidence to support their use with diverse groups of parents .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: CONTEXT Adults with Klinefelter 's syndrome ( KS ) are known to present disturbances of language skills and delayed learning abilities . OBJECTIVES The aim of this study was to assess brain morphometry in KS and to correlate eventual volumetric changes with performance on neuropsychological tests . PATIENTS Patients included 18 KS adults and 20 age-matched controls . METHODS All participants underwent prospect ively double-spin-echo brain magnetic resonance imaging and neuropsychological testing of verbal and nonverbal domains . On the axial stack of magnetic resonance imaging slices , regional brain volumes were measured either by automated segmentation ( full brain , total cerebrospinal fluid , and ventricular volume ) or manual drawing with help of a neuroanatomy atlas ( frontal , temporal , and parietal lobes , gray matter component of the lobes , cerebellar hemispheres , and hippocampal complexes ) . RESULTS KS patients performed significantly lower than controls on language -related tasks exploring verbal processing speed and verbal executive function . They were diagnosed with significant enlargement of ventricular volume and bilateral reduction of cerebellar hemispheres . Furthermore , after separation of participants according to h and edness and after correction of regional brain volumes for atrophy , a significant reduction of left temporal lobe volume was found in KS compared with controls . Ventricular volume was inversely correlated with cognitive function , whereas left temporal lobe volume was positively correlated with language -related tasks . CONCLUSION This study hypothesizes that supernumerary X-chromosome and /or congenital hypogonadism provoke structural alterations in the subcortical pathways involved in language processing , thus providing a neurobiological substrate for cognitive deficits in KS Inhibition is a central construct to the frontal lobe theory of ageing , yet its construct validity remains unproven . Furthermore , age effects on measures of inhibition are often reported without adequate control for the effects of global slowing on performance . We investigated inhibitory function in older adults in two experiments . In Experiment 1 , 49 people with ages between 59 and 86 ( mean=70 years 9 months S.D.=7.54 ) completed four analogues of the Stroop interference paradigm . To control for global slowing and to enable comparisons across all measures , we used a r and om effects model based on log-transformed response times . Age did not contribute significantly to the model and the estimated correlation between tasks was not significant . In Experiment 2 , 33 people with ages between 62 and 86 ( mean=73 years 4 months , S.D.=6.57 ) were compared on two measures of Stroop-like interference which were very similar in surface task dem and s. Age did not contribute significantly to the model but the estimated correlation between tasks was robust ( r=0.714 ) . We conclude that age may make little contribution to inhibitory function independently of other factors such as speed and intelligence . Second , that the level of individual consistency in the performance of measures of inhibition will depend on the similarity of the tasks used Objective : This study focuses on variation in brain morphology associated with supernumerary X chromosome and Klinefelter syndrome ( KS ) . Using an unselected birth cohort of KS subjects and high-resolution MRI , the authors investigated the neuroanatomic consequences of the 47,XXY karyotype in the presence and absence of exogenous testosterone supplementation . Methods : Regional brain volumes were measured in 10 subjects with KS and 10 age-matched control men . Five of the KS subjects had received testosterone supplementation since puberty ( KS+T ) and five had not ( KS−T ) . Results : KS subjects showed significant ( p < 0.01 ) reduction in left temporal lobe gray matter volumes compared with normal control subjects . Differences in left temporal gray volumes were also significant between the KS+T and KS−T groups ( p < 0.01 ) . Verbal fluency scores were significantly different between the KS+T and KS−T groups as well . Conclusion : Supernumerary X chromosome material in men is associated with a reduction in left temporal lobe gray matter , a finding that is consistent with the verbal and language deficits associated with KS . Also , relative preservation of gray matter in the left temporal region is associated with exposure to exogenous and rogen during development . A history of testosterone supplementation also appears to be associated with increased verbal fluency scores in KS patients This double-blind , controlled study of XYY and XXY men found in a birth cohort of 4,591 tall men born in Copenhagen assessed evidence of delinquent and aggressive behavior and explored the role of hormonal determinants in the behavioral and psychological differences noted among groups . Information from social records , a structured psychological interview , and projective tests did not support the notion that men with sex chromosome anomalies are particularly violent or aggressive . Hormonally , XYY men had significantly higher concentrations of testosterone , luteinizing hormone ( LH ) , and follicle-stimulating hormone ( FSH ) than matched control groups . In contrast , XXY men had higher levels of LH , FSH , and prolactin , but low concentrations of testosterone . There was a significantly positive relation among all subjects as well as XY controls alone between plasma testosterone level and evidence of criminal convictions . A proportionate increase in testosterone levels was noted when subjects were divided into nondelinquents , delinquents without violent convictions , and delinquents with violent convictions . The relation between testosterone level and criminal behavior was not reflected in measures of aggression derived from the psychological interview and projective tests . There was no specific evidence that testosterone is a mediating factor in the criminal behavior of XYY men Children with sex chromosome abnormalities ( SCA ) are known to be at risk for developmental delays . These risks were identified 2 decades ago by seven international research groups who prospect ively followed children ascertained after birth . Subsequently , some of these investigators suggested the course of prenatally identified children with SCA may be different from children in earlier studies . The first such evidence was published by Robinson et al. [ 1992 : Am J Med Genet 44:365 - 368 ] , who compared 20 prenatally diagnosed children to the original postnatally diagnosed cohort . The following report presents an up date and expansion of that research and includes 51 children and adolescents prenatally diagnosed with SCA , now 7 - 18 years of age . Results confirm that this cohort of prenatally diagnosed children has a milder developmental course than children ascertained postnatally . The study provides new information to health professionals counseling families faced with prenatal diagnosis of SCA A prospect i ve study was made of 42 children who were found at birth to have sex chromosome aberrations . The mean developmental quotient of the XXY and XXX groups was in the dull-normal range , whereas developmental quotients of 3 XYY children were low normal . The commonest deficits were in language and gross motor skills , with highest incidence in the XXX group . Many of the children had behavior problems , but no specific pattern was associated with an individual chromosome aberration . The XXX group experienced a linear growth spurt after 4 years of age . With one exception there were only mild dysmorphic features , none of them specifically associated with any subgroup . Of 17 children followed up to school age , almost two thirds evidence d learning and /or behavior problems . There was a high incidence of birth problems particularly in XXX children ( seven of ten ) , and of social problems , psychiatric illness and learning difficulties in their families . In 14 cases , the parent-child relationship was disturbed , result ing in behavior problems . These findings make it improbable that the children 's generally poor developmental and behavioral performance were solely attributable to their chromosomal constitution Output:
Individuals with an additional X chromosome had mean IQs that were within broadly normal limits but lower than the respective comparison groups , with verbal IQ most affected . Cognitive outcomes were poorest for females with XXX . Males with XYY had normal-range IQs , but all three SCT groups ( XXX , XXY , and XYY ) had marked difficulties in speech and language , motor skills , and educational achievement . Nevertheless , most adults with SCTs lived independently . Less evidence was available for brain structure and for attention , social , and psychiatric outcomes . INTERPRETATION Individuals with SCTs are at risk of cognitive and behavioural difficulties .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Recognizing the need to offer alternative methods of brief interventions , this study developed correspondence treatments for low-dependent problem drinkers and evaluated their impact . One hundred and twenty-one problem drinkers were recruited by media advertisements and were r and omly allocated to a full cognitive-behavioural treatment programme ( CBT ) or to a minimal intervention condition ( MI ) that gave information regarding alcohol misuse and instructions to record drinking++ . As predicted , CBT was more effective than MI in reducing alcohol consumption over the 4-month controlled trial period . CBT produced a 50 % fall in consumption , bringing the average intake of subjects within recommended maximum levels . Treatment gains at 6 months were well maintained to 12 months . High levels of consumer satisfaction , a high representation of women and a substantial participation from isolated rural areas attested to the feasibility of the correspondence programme as an alternative treatment . However , some drinking occasions still involved high intake for a significant subgroup of subjects , and this issue will be addressed in future programmes . The results supported the use of correspondence delivery as a means of promoting early engagement and equity of access between city and country areas Alcoholics from two hospital-based treatment centers participated in an experimental test of the effects of extended aftercare on inpatient recovery rates . At discharge from inpatient treatment , subjects were r and omly assigned either to an experimental group scheduled to be called by a center counselor every 2 weeks for 1 year or to a control group that experienced only the usual treatment . Follow-up interviews conducted approximately 12 months after hospital discharge found that the experimental group had no higher recovery rates than the control group . There was weak evidence that the calls reduced the burden that alcoholics place on community control and service agencies . There was no evidence that either the phone calls were more effective for some patients than for others or that some kinds of phone calls were more effective than others . Although most subjects said they liked the calls , wanted them to continue and perceived them as " good treatment , " only one subject gave the calls credit for helping him maintain sobriety BACKGROUND Alcohol use in older adults is common . It is associated with depression , hypertension , diabetes , drug interactions , accidents , and increased rates of emergency department visits and hospitalizations . METHODS A controlled clinical trial ( Project GOAL --Guiding Older Adult Lifestyles ) tested the efficacy of brief physician advice in reducing the alcohol use and use of health care services of older adult problem drinkers . Twenty-four community-based primary care practice s in Wisconsin ( 43 family physicians and internists ) participated in the trial . Of the 6073 patients screened , 105 men and 53 women met inclusion criteria and were r and omized into a control group ( n = 71 ) or an intervention group ( n = 87 ) . Intervention group patients received two 10- to 15-minute physician-delivered counseling sessions that included advice , education , and contracting using a scripted workbook . A total of 146 patients ( 92.4 % ) participated in the 12-month follow-up procedure . RESULTS No significant differences were found between the control and intervention groups at baseline in alcohol use , age , socioeconomic status , depression , onset of alcohol use , smoking status , activity level , or use of mood-altering drugs . The older adults who received the physician intervention demonstrated a significant reduction in 7-day alcohol use , episodes of binge drinking , and frequency of excessive drinking ( P < .005 ) compared with the control group at 3 , 6 , and 12 months after the intervention . There was a 34 % reduction in 7-day alcohol use , 74 % reduction in mean number of binge-drinking episodes , and 62 % reduction in the percentage of older adults drinking more than 21 drinks per week in the intervention group compared with the control group . There were no significant changes in health status . Patterns of health care utilization were not extensively analyzed because of the small number of events . CONCLUSIONS This study provides the first direct evidence that brief physician advice can decrease alcohol use by older adults in community-based primary care practice BACKGROUND Studies suggest that 14 % of women age 18 to 40 drink alcohol above recommended limits . Of special concern is the increasing use of alcohol by women during pregnancy . This article reports 48 month follow-up data from a sub analysis of a trial for early alcohol treatment ( Project TrEAT ) focused on women of childbearing age . METHODS Project TrEAT was conducted in the offices of 64 primary care , community-based physicians from 10 Wisconsin counties . Of 5979 female patients ages 18 to 40 who were screened for problem drinking , 205 were r and omized into an experimental group ( n = 103 ) or control group ( n = 102 ) . The intervention consisted of two 15 min , physician-delivered counseling visits that included advice , education , and contracting by using a scripted workbook . A total of 174 subjects ( 85 % ) completed the 48 month follow-up procedures . RESULTS No significant differences were found between the experimental and control groups at baseline for alcohol use , age , socioeconomic status , smoking , depression or anxiety , conduct disorder , lifetime drug use , or health care utilization . The trial found a significant treatment effect in reducing both 7 day alcohol use ( p = 0.0039 ) and binge drinking episodes ( p = 0.0021 ) over the 48 month follow-up period . Women in the experimental group who became pregnant during the follow-up period had the most dramatic decreases in alcohol use . A logistic regression model based on a 20 % or greater reduction in drinking found an odds ratio of 1.93 ( confidence interval 1.07 - 3.46 ) in the sample exposed to physician intervention . Age , smoking , depression , conduct disorder , antisocial personality disorder , and illicit drug use did not reduce drinking significantly . No significant differences were found in health care utilization and health status between groups . CONCLUSIONS This trial provides the first direct evidence that brief intervention is associated with sustained reductions in alcohol consumption by women of childbearing age . The results have enormous implication s for the U.S. health care system The mortality experience of convicted drinking drivers ( second offenders ) ( N = 347 ) r and omly assigned to rehabilitation and control groups in two Ontario cities was examined . Over a follow-up period ranging between 8 and 13 years , 14 ( 11.0 % ) of the controls and 17 ( 7.7 % ) of the rehabilitation group died . Direct comparisons of the r and omly assigned control and treatment groups revealed a tendency for lower total mortality and significantly lower mortality from accidental and violent death in those assigned to rehabilitation . Additional comparisons involving a combined rehabilitation group ( N = 487 ) ( rehabilitation participants r and omly and not r and omly assigned ) confirmed these observations BACKGROUND Employee-assistance programs sponsored by companies or labor unions identify workers who abuse alcohol and refer them for care , often to inpatient rehabilitation programs . Yet the effectiveness of inpatient treatment , as compared with a variety of less intensive alternatives , has repeatedly been called into question . In this study , anchored in the work site , we compared the effectiveness of m and atory in-hospital treatment with that of required attendance at the meetings of a self-help group and a choice of treatment options . METHODS We r and omly assigned a series of 227 workers newly identified as abusing alcohol to one of three rehabilitation regimens : compulsory inpatient treatment , compulsory attendance at Alcoholics Anonymous ( AA ) meetings , and a choice of options . Inpatient backup was provided if needed . The groups were compared in terms of 12 job-performance variables and 12 measures of drinking and drug use during a two-year follow-up period . RESULTS All three groups improved , and no significant differences were found among the groups in job-related outcome variables . On seven measures of drinking and drug use , however , we found significant differences at several follow-up assessment s. The hospital group fared best and that assigned to AA the least well ; those allowed to choose a program had intermediate outcomes . Additional inpatient treatment was required significantly more often ( P less than 0.0001 ) by the AA group ( 63 percent ) and the choice group ( 38 percent ) than by subjects assigned to initial treatment in the hospital ( 23 percent ) . The differences among the groups were especially pronounced for workers who had used cocaine within six months before study entry . The estimated costs of inpatient treatment for the AA and choice groups averaged only 10 percent less than the costs for the hospital group because of their higher rates of additional treatment . CONCLUSIONS Even for employed problem drinkers who are not abusing drugs and who have no serious medical problems , an initial referral to AA alone or a choice of programs , although less costly than inpatient care , involves more risk than compulsory inpatient treatment and should be accompanied by close monitoring for signs of incipient relapse OBJECTIVE Alcoholism is the leading risk factor for injury . The authors hypothesized that providing brief alcohol interventions as a routine component of trauma care would significantly reduce alcohol consumption and would decrease the rate of trauma recidivism . METHODS This study was a r and omized , prospect i ve controlled trial in a level 1 trauma center . Patients were screened using a blood alcohol concentration , gamma glutamyl transpeptidase level , and short Michigan Alcoholism Screening Test ( SMAST ) . Those with positive results were r and omized to a brief intervention or control group . Reinjury was detected by a computerized search of emergency department and statewide hospital discharge records , and 6- and 12-month interviews were conducted to assess alcohol use . RESULTS A total of 2524 patients were screened ; 1153 screened positive ( 46 % ) . Three hundred sixty-six were r and omized to the intervention group , and 396 to controls . At 12 months , the intervention group decreased alcohol consumption by 21.8+/-3.7 drinks per week ; in the control group , the decrease was 6.7+/-5.8 ( p = 0.03 ) . The reduction was most apparent in patients with mild to moderate alcohol problems ( SMAST score 3 to 8) ; they had 21.6+/-4.2 fewer drinks per week , compared to an increase of 2.3+/-8.3 drinks per week in controls ( p < 0.01 ) . There was a 47 % reduction in injuries requiring either emergency department or trauma center admission ( hazard ratio 0.53 , 95 % confidence interval 0.26 to 1.07 , p = 0.07 ) and a 48 % reduction in injuries requiring hospital admission ( 3 years follow-up ) . CONCLUSION Alcohol interventions are associated with a reduction in alcohol intake and a reduced risk of trauma recidivism . Given the prevalence of alcohol problems in trauma centers , screening , intervention , and counseling for alcohol problems should be routine OBJECTIVE The study aim was to test whether a brief motivational intervention , with or without a booster session , would improve drinking-related outcomes more than st and ard Emergency Department ( ED ) treatment . METHOD The study population consisted of 539 ( 78 % male ) injured patients treated in the ED and discharged to the community following their treatment . Injured patients met inclusion criteria if they were assessed as hazardous or harmful drinkers by scoring eight or more on the AUDIT and /or having alcohol in their system at the time of their injury or ED visit . Patients were r and omly assigned to either st and ard care ( SC ) , brief intervention ( BI ) or brief intervention plus a booster session ( BIB ) . At 1-year follow-up , 447 patients ( 83 % of the sample ) were re-interviewed to measure alcohol-related negative consequences , injuries and drinking . RESULTS Patients receiving BIB , but not B1 patients , reduced alcohol-related negative consequences and alcohol-related injuries more than did those in the SC group . All three groups reduced their days of heavy drinking . Patients with histories of hazardous drinking responded to BIB , whether or not they had consumed alcohol prior to their injury . CONCLUSIONS Together , these results indicate that the effects of a booster session that is added to a brief intervention in the ED can be helpful to injured patients with a history of hazardous or harmful drinking , irrespective of whether they have consumed alcohol prior to their injury The ' Pressures to Change ' approach to working with the partners of drinkers is a structured procedure for promoting change in resistant drinkers . In this study 22 women and one man were r and omly allocated to two treatment conditions and one no-treatment waiting list control condition in an experimental evaluation of the procedure . Group 1 was treated individually and Group 2 was treated as a group . Almost two-thirds of the drinking partners of clients in treatment made a significant move towards change , compared with none of the drinkers in the waiting list control condition OBJECTIVE Project TrEAT ( Trial for Early Alcohol Treatment ) was design ed to test the efficacy of brief physician advice in reducing alcohol use and health care utilization in problem drinkers . DESIGN R and omized controlled clinical trial with 12-month follow-up . SETTING A total of 17 community-based primary care practice s ( 64 physicians ) located in 10 Wisconsin counties . PARTICIPANTS Of the 17695 patients screened for problem drinking , 482 men and 292 women met inclusion criteria and were r and omized into a control ( n=382 ) or an experimental ( n=392 ) group . A total of 723 subjects ( 93 % ) participated in the 12-month follow-up procedures . INTERVENTION The intervention consisted of two 10- to 15-minute counseling visits delivered by physicians using a scripted workbook that included advice , education , and contracting information . MAIN OUTCOME MEASURES Alcohol use measures , emergency department visits , and hospital days . RESULTS There were no significant differences between groups at baseline on alcohol use , age , Output:
Completed trials of problem drinkers that compared interventions for problem drinking to no intervention reported reduced motor-vehicle crashes and related injuries , falls , suicide attempts , domestic violence , assaults and child abuse , alcohol-related injuries and injury emergency visits , hospitalizations and deaths . REVIEW ERS ' CONCLUSIONS Interventions for problem drinking appear to reduce injuries and their antecedents ( e.g. falls , motor vehicle crashes , suicide attempts ) . Because injuries account for much of the morbidity and mortality from problem drinking , larger studies are warranted to evaluate the effect of treating problem drinking on injuries
MS2_1shot274
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: INTRODUCTION The limitations of clinical methods for appraising foot posture are well documented . A new measure , the Foot Posture Index is proposed , and its development and validation described . METHODS A four-phase development process was used : ( i ) to derive a series of c and i date measures , ( ii ) to define an appropriate scoring system , ( iii ) to evaluate the validity of components and modify the instrument as appropriate , and ( iv ) to investigate the predictive validity of the finalised instrument relative to static and dynamic kinematic models . Methods included initial concurrent validation using Rose 's Valgus Index , determination of inter-item reliability , factor analysis , and benchmarking against three dimensional kinematic models derived from electromagnetic motion tracking of the lower limb . RESULTS Thirty-six c and i date components were reduced to six in the final instrument . The draft version of the instrument predicted 59 % of the variance in concurrent Valgus Index scores and demonstrated good inter item reliability ( Cronbach 's alpha = 0.83 ) . The relevant variables from the motion tracking lower limb model predicted 58 - 80 % of the variance in the six components retained in the final instrument . The finalised instrument predicted 64 % of the variance in static st and ing posture , and 41 % of the variance in midstance posture during normal walking . CONCLUSION The Foot Posture Index has been subjected to thorough evaluation in the course of its development and a final version is proposed comprising six component measures that performed satisfactorily during the validation process . The Foot Posture Index assessment is quick and simple to perform and allows a multiple segment , multiple plane evaluation that offers some advantages over existing clinical measures of foot posture Previous methods of measuring footprints for the purpose of classifying foot type are review ed . A planimetric method is presented for characterizing footprints using the ratio of the area of the middle third of the footprint to the entire footprint area ( excluding the toes ) . This ' arch index ' during 50 % body weight st and ing provides an objective measure for comparative purpose s with a measured reliability , within day and between day , of 0.96 and 0.94 respectively . Values measured from footprints taken during other activities show variable responses in different subjects . Examples of the arch index taken from static footprints of various feet are presented and data are reported from 107 r and omly selected subjects during half body weight stance . Criteria are suggested for the classification of footprints as high , normal , and flat arch Objective : Although boys are frequently reported to have flatter feet than girls , there has been little systematic research to confirm or explain this structural difference between the genders . The objective of this study was to determine whether flat-footedness was moderated by gender in Australian preschool children and , if so , to determine the cause of this between-gender difference in structure of the plantar surface of the foot . Methods : Foot anthropometry , Arch Index derived from plantar footprints , and midfoot plantar fat pad thickness measured by ultrasound were obtained for the left and right feet of 52 girls and 36 boys ( mean age , 4.2 ± 0.6 years ) . The children were recruited from 10 r and omly selected preschools from the Illawarra region of New South Wales , Australia . Results : In agreement with previous research , the preschool boys displayed significantly flatter feet than the girls ( P ≤ 0.04 ) . Although there were no between-gender differences in structural foot dimensions , the boys had a significantly thicker midfoot fat pad than the girls by approximately 0.4 and 0.5 mm on both the right and left feet , respectively . Conclusions : The increased incidence of flat-footedness in boys compared with girls of the same age seems to be caused by a thicker plantar fat pad in the medial midfoot in boys . This suggests that the development of the medial longitudinal arch may be progressing at a slower rate in boys than in girls , and that intervention for a flexible flat foot , particularly for young boys , may be unnecessary Developmental Coordination Disorder ( DCD ) is a neurodevelopmental disorder characterised by impaired motor co-ordination and awkward gait . Despite self-reported findings of pes planus and joint hypermobility in children with DCD , there is little objective evidence regarding the clinical management of the foot in children with DCD . The aims of this research were to report clinical findings of foot posture and lower limb hypermobility in children with DCD and to evaluate the impact of foot orthoses on spatio-temporal gait parameters . Children with DCD were recruited into the study . Participants were r and omly assigned to an intervention group who received foot orthoses at the start of their rehabilitation programme or to a second group who received foot orthoses at the end of their intervention programme . Foot posture was assessed with the Foot Posture Index and lower limb hypermobility assessed with the Lower Limb Assessment Score . The effect of foot orthoses was evaluated through assessment of spatio-temporal gait characteristics at baseline and post-rehabilitation programme . Fourteen children were recruited ( mdn age 7.5 years ) with nine children assigned to the group receiving orthoses early ( mdn age 8 years ) and five children assigned to the post-rehabilitation orthoses group ( mdn age 6.5 years ) . A pes planus foot posture ( FPI score=8 ) and lower limb hypermobility ( LLAS score=11 ) were observed . Changes in spatio-temporal gait parameters failed to reach significance ( p>.012 ) following orthotic invention but demonstrated a trend towards a decreased cadence and increased double support duration . Despite non-significant findings this work offers preliminary support for podiatric intervention in the rehabilitation of children with DCD . Further work is required to underst and the biomechanics of gait in children with DCD and appreciate the role of podiatry as a component of multidisciplinary care BACKGROUND Flatfoot , or pes planus , is one of the most common foot posture problems in children that may lead to lower-extremity pain owing to a potential increase in plantar pressure . First , we compared plantar pressure distribution between children with and without flatfoot . Second , we examined the reliability and accuracy of a simple metric for characterization of foot posture : the Clarke angle . Third , we proposed a mathematical model to predict plantar pressure magnitude under the medial arch using body mass and the Clarke angle . METHODS Sixty children with flatfoot and 33 aged-matched controls were recruited . Measurements included in-shoe plantar pressure distribution , ground reaction force , Clarke angle , and radiography assessment . The measured Clarke angle was compared with radiographic measurements , and its test-retest reliability was determined . A mathematical model was fitted to predict plantar pressure distribution under the medial arch using easy-to-measure variables ( body mass and the Clarke angle ) . RESULTS A high correlation was observed between the Clarke angle and radiography measurements ( r > 0.9 ; P < 10(-6 ) ) . Excellent between- and within-day test-retest reliability for Clarke angle measurement ( intraclass correlation coefficient , > 0.9 ) was observed . Results also suggest that pressure magnitude under the medial arch can be estimated using the Clarke angle and body mass ( R(2 ) = 0.95 ; error , < 0.04 N/cm(2 ) [ 2 % ] ) . CONCLUSIONS This study suggests that the Clarke angle is a practical , reliable , and sensitive metric for quantification of medial arch height in children and could be recommended for research and clinical applications . It can also be used to estimate plantar pressure under the medial arch , which , in turn , may assist in the timely intervention and prognosis of prospect i ve problems associated with flatfoot posture Both feet of two hundred and seventy two children aged between five years six months and ten years and eleven months were studied using a footprint technique called the arch index ( Al ) , and the vertical height of the navicular ( NH ) as non invasive techniques of objective measures of the medial longitudinal arch ( MLA ) . In addition to age the study investigated the influence of gender , limb dominance , and body weight . The study found the existence of a relationship between the two measures of the MLA . There was no significant difference in NH measures between males and females and body weight did not affect the NH . The NH changed with age , suggesting it provides a useful , easily obtained clinical measure . The Al measures were slightly more reliable than the NH but showed less change with age Flat feet in children are common , and at times symptomatic , but the relationship between function and symptoms or impairment is still unclear . We undertook a prospect i ve , observational study comparing children with paediatric flexible flat foot ( PFF ) and children with neutral feet ( NF ) using three dimensional gait analysis ( 3DGA ) . It was hypothesised that children with PFF would demonstrate differences in both spatio-temporal parameters of gait and foot and ankle kinematics compared to the NF group and that these differences would correlate with impaired quality of life ( QoL ) . The kinematic differences were expected to be most marked in hindfoot coronal plane motion and forefoot sagittal and transverse plane motion . Eighty-three children between the ages of 8 and 15 were recruited in this study : Forty-two were classified as having PFF and forty-one as NF . Each child underwent 3DGA and completed the Oxford Ankle Foot Question naire for Children ( OxAFQ_C ) . Reduced OxAFQ_C physical domain scores in the PFF children were associated with slower walking speed ( p=0.014 ) and reduced normalised stride length ( p=0.008 ) . PFF children also demonstrated significantly increased hindfoot eversion and forefoot supination during gait . Significant differences between groups were not observed for other foot and ankle joint motions . Increased maximum hindfoot eversion and increased forefoot supination correlated strongly with lower QoL scores in PFF children . These data further our underst and ing of the functional characteristics that lead to impaired QoL in PFF children . These findings will help guide the surveillance and management of children with this ubiquitous condition Childhood obesity exerts abnormally high stresses on developing foot structures which can lead to structural deformity of the foot . Screening for foot problems in children with overweight helps detect interior risks restricting normal lifestyle in these individuals . The purpose of this study was to investigate the effects of excess weight on the structure and function of the developing foot in students aged 7–14 years . A total of 667 participants were recruited for this cross‐sectional study via a multi‐level cluster sampling method ( r and omization was used within each cluster ) . All subjects ( 340 boys and 327 girls ) attended primary and secondary schools in Isfahan City , Iran . The children 's feet were evaluated using clinical assessment s and footprint‐based measures whilst fully weight bearing . Significant differences were observed in the frequency of flatfoot between normal weight , overweight and obese groups ( P < 0.001 ) ; participants who were more overweight had flatter feet . Children with higher weight also had a more pronated heel , less dorsiflexion range and higher reported pain within physical activity . This study indicated that childhood obesity is associated with structural foot and ankle deformities and activity‐related foot pain In making treatment decisions , doctors and patients must take into account relevant r and omised controlled trials ( RCTs ) and systematic review s. Relevance depends on external validity ( or generalisability)--ie , whether the results can be reasonably applied to a definable group of patients in a particular clinical setting in routine practice . There is concern among clinicians that external validity is often poor , particularly for some pharmaceutical industry trials , a perception that has led to underuse of treatments that are effective . Yet research ers , funding agencies , ethics committees , the pharmaceutical industry , medical journals , and governmental regulators alike all neglect external validity , leaving clinicians to make judgments . However , reporting of the determinants of external validity in trial publications and systematic review s is usually inadequate . This review discusses those determinants , presents a checklist for clinicians , and makes recommendations for greater consideration of external validity in the design and reporting of RCTs BACKGROUND The purpose s of this study were 1 ) to determine the intrarater and interrater reliability of the arch height index measurement system device , 2 ) to establish population normative values for the arch height index in recreational runners , and 3 ) to compare arch height index values between the right and left feet and between genders . METHODS Eleven subjects were used to establish intrarater and interrater reliability of the arch height index measurement system . This system was then used to measure the arch height index of 100 recreational runners . RESULTS Measurements taken with the arch height index measurement system device exhibited high intrarater and interrater reliability . The mean + /- SD arch height index of the recreational runners was 0.340 + /- 0.030 . Men had larger feet than women , but the arch height index between genders was similar . CONCLUSIONS The arch height index measurement system device is reliable to use between testers while simplifying the measurement procedure for recording the arch height index . The arch height index may be helpful in identifying potential structural factors that predispose individuals to lower-extremity injuries OBJECTIVE . To analyse the association between overweight and obesity and foot structure in children older than 9 years of age , whose longitudinal medial arch ( MLA ) should be practically established . DESIGN , SETTING AND SUBJECT . A cross-sectional study of 245 children ( age : 13.22±1.8 years ) from four r and omly selected schools ( Zaragoza , Spain ) . Body mass index ( BMI ) was calculated and normal-weight , overweight and obese groups were defined . Footprints for both feet were collected . MEASUREMENTS . Foot angle ( FA ) and Chippaux-Smirak index ( CSI ) were calculated from the footprints . Height and body mass were measured to calculate the BMI . RESULTS . Mean values of FA and CSI in the normal-weight group indicated the presence of a normal MLA ; however , in the overweight they indicated an intermediary MLA and in the obese group , a low MLA . Comparison among the groups showed a decrease of FA ( p<0.01 ) and an increase of CSI ( p<0.01 ) with increasing weight associated with a lower MLA . A low but significant correlation ( p<0.0001 ) was found between the z-score BMI and footprint parameters . CONCLUSIONS . In children aged 9 to 16.5 years , the increase of Output:
Conclusion No universally accepted criteria for diagnosing paediatric flat foot was found within existing literature , and psychometric data for foot posture measures and definitions used was limited .
MS2_1shot275
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: BACKGROUND The most severe diabetic foot ulcers are those related with critical ischemia , which is primarily diagnosed with non-invasive diagnostics . However , these diagnostics have several disadvantages . For example , they only provide global indications of the (macro)level of ischemia . A potential solution can be found in novel optical imaging techniques for local assessment of the microcirculation in diabetic foot ulcers . This review provides an overview of these imaging techniques ( Laser Doppler Perfusion Imaging , Laser Speckle Contrast Imaging , Photoacoustic Imaging and Hyperspectral Imaging ) and their applicability for the diagnostic assessment of microcirculation in diabetic foot ulcers . METHOD For each technique , the following parts are described : a ) their technical background ; b ) general clinical applications ; and , c ) its application for microcirculation assessment in diabetic foot ulcers . Parts a-b are based on a narrative review of the literature , part c on a systematic review that was performed in the data base Scopus , covering the period from January 1 , 2000 to November 31 , 2017 . RESULTS Each of these techniques has specific advantages and disadvantages for imaging microcirculation . Potential clinical use depends on measurement aims , and clinical relevance . However , none of the techniques has a strongly established clinical relevance yet : we found a limited number of publications describing clinical outcomes . Future research is needed to determine which technique is the most clinical ly relevant for the assessment of microcirculation in diabetic foot ulcers . CONCLUSION Although promising , the currently available novel optical techniques need to be further improved technically and prospect i ve trials are necessary to evaluate their clinical value AIMS Diagnosis of vascular involvement in diabetic foot ulceration ( DFU ) remains challenging . We conducted a proof of concept study to investigate the feasibility of microwave radiometry ( MWR ) thermometry for non-invasive differential diagnosis of critical limb ischemia ( CLI ) in subjects with DFU . METHODS This prospect i ve , multi-center , study included 80 participants , divided into four groups ( group N : normal control subjects ; group DN : participants with diabetes and verified neuropathic ulcers without vascular involvement ; group DC : participants with diabetes and CLI and group NDC : participants with CLI without diabetes ) . Vascular disease was confirmed with angiography . All patients underwent MWR ( RTM-01-RES : University of Bolton , UK ) to record mean tissue temperatures at various pre-determined foot sites . Comparisons of temperature measurements between study groups were performed using one-way ANOVA and Dunn tests . ROC analysis was performed to determine sensitivity , specificity and cut-off value of MWR for CLI diagnosis . RESULTS Temperatures recorded in vicinity to the foot ulcers of participants with diabetes and CLI were similar to those with CLI without diabetes , but significantly lower than in subjects with neuropathic ulcers without vascular involvement and normal controls ( group DC:29.30 ° C±1.89 vs. group NDC:29.18 ° C±1.78vs . group N:33.01 ° C±0.45 vs. group DN:33.39 ° C±1.37;P<.0001 ) . According to ROC analysis , cut-off temperature value to diagnose CLI was < 31.8 ° C ( area under the curve : 0.984 ; 95 % CI : 0.965 - 1.005;P<.001 ) , with a sensitivity of 100.0 % ( 95%CI : 90.26 - 100.0 ) and specificity of 88.37 % ( 95 % CI : 74.92 - 96.11 ) . CONCLUSIONS Tissue temperatures in vicinity to ulcers were significantly lower in participants with CLI , with or without diabetes , compared to non-ischemic controls . MWR could be used for differential diagnosis of arterial ischemia in subjects with DFU OBJECTIVE Foot ulceration remains a major health problem for diabetic patients and has a major impact on the cost of diabetes treatment . We tested a hyperspectral imaging technology that quantifies cutaneous tissue hemoglobin oxygenation and generated anatomically relevant tissue oxygenation maps to assess the healing potential of diabetic foot ulcers ( DFUs ) . RESEARCH DESIGN AND METHODS A prospect i ve single-arm blinded study was completed in which 66 patients with type 1 and type 2 diabetes were enrolled and followed over a 24-week period . Clinical , medical , and diabetes histories were collected . Transcutaneous oxygen tension was measured at the ankles . Superficial tissue oxyhemoglobin ( oxy ) and deoxyhemoglobin ( deoxy ) were measured with hyperspectral imaging from intact tissue bordering the ulcer . A healing index derived from oxy and deoxy values was used to assess the potential for healing . RESULTS Fifty-four patients with 73 ulcers completed the study ; at 24 weeks , 54 ulcers healed while 19 ulcers did not heal . When using the healing index to predict healing , the sensitivity was 80 % ( 43 of 54 ) , the specificity was 74 % ( 14 of 19 ) , and the positive predictive value was 90 % ( 43 of 48 ) . The sensitivity , specificity , and positive predictive values increased to 86 , 88 , and 96 % , respectively , when removing three false-positive osteomyelitis cases and four false-negative cases due to measurements on a callus . The results indicate that cutaneous tissue oxygenation correlates with wound healing in diabetic patients . CONCLUSIONS Hyperspectral imaging of tissue oxy and deoxy may predict the healing of DFUs with high sensitivity and specificity based on information obtained from a single visit BACKGROUND Hyperspectral imaging technology is a novel method of using transcutaneous measurement of oxyhemoglobin ( HT-Oxy ) and deoxyhemoglobin ( HT-Deoxy ) concentrations to create a two-dimensional , color-coded " oxygen map . " The aims of this study were to compare the use of a hyperspectral imaging device with the transcutaneous oxygen measurement ( TCOM ) , ankle-brachial index ( ABI ) , and severity of peripheral vascular disease ( PVD ) and to assess their correlations . METHODS This prospect i ve study recruited 294 participants divided into three distinct groups composed of healthy volunteers and patients with PVD . Patients underwent measurements of lower limbs at a st and ardized point over the head of the first metatarsal on the plantar aspect using the hyperspectral imaging device , generating four outputs including HT-Oxy , HT-Deoxy , oxygen saturation ( HT-Sat ) , and skin temperature , and the TCOM system , generating transcutaneous partial pressure of oxygen ( TcpO2 ) and carbon dioxide ( TcpCO2 ) . Demographic data , severity of PVD , ABI , and other pertinent information were obtained from both the participants and medical records . RESULTS Interoperator reliability ranged from 86 % to 94 % across the four hyperspectral imaging device outputs , whereas intraoperator reliability ranged from 92 % to 94 % . The HT-Oxy , HT-Sat , TcpCO2 , and ABI of the diseased limb correlated significantly with the severity of PVD . HT-Sat significantly correlated with TcpO2 ( R = 0.19 ) , TcpCO2 ( R = -0.26 ) , ABI ( R = 0.42 ) , and skin temperature ( R = 0.56 ) . HT-Deoxy also correlated with TcpCO2 ( R = 0.27 ) . CONCLUSIONS This study demonstrates the reliability of hyperspectral imaging in comparison to TCOM , ABI , skin temperature , and severity of PVD in a series of patients . Its correlation to other established modalities and low interoperator and intraoperator variability could enable this modality to be a useful screening tool in PVD Background The early diagnosis of atherosclerotic disease is essential for developing preventive strategies in population s at high risk and acting when the disease is still asymptomatic . A low ankle-arm index is a good marker of vascular events and may be diminished without presenting symptomatology ( silent peripheral arterial disease ) . The aim of the study is to know the prevalence and associated risk factors of peripheral arterial disease in the general population . Methods We performed a cross-sectional , multicentre , population -based study in 3786 individuals > 49 years , r and omly selected in 28 primary care centres in Barcelona ( Spain ) . Peripheral arterial disease was evaluated using the ankle-arm index . Values < 0.9 were considered as peripheral arterial disease . Results The prevalence ( 95 % confidence interval ) of peripheral arterial disease was 7.6 % ( 6.7 - 8.4 ) , ( males 10.2 % ( 9.2 - 11.2 ) , females 5.3 % ( 4.6 - 6.0 ) ; p < 0.001).Multivariate analysis showed the following risk factors : male sex [ odds ratio ( OR ) 1.62 ; 95 % confidence interval 1.01 - 2.59 ] ; age OR 2.00 per 10 years ( 1.64 - 2.44 ) ; inability to perform physical activity [ OR 1.77 ( 1.17 - 2.68 ) for mild limitation to OR 7.08 ( 2.61 - 19.16 ) for breathless performing any activity ] ; smoking [ OR 2.19 ( 1.34 - 3.58 ) for former smokers and OR 3.83 ( 2.23 - 6.58 ) for current smokers ] ; hypertension OR 1.85 ( 1.29 - 2.65 ) ; diabetes OR 2.01 ( 1.42 - 2.83 ) ; previous cardiovascular disease OR 2.19 ( 1.52 - 3.15 ) ; hypercholesterolemia OR 1.55 ( 1.11 - 2.18 ) ; hypertriglyceridemia OR 1.55 ( 1.10 - 2.19 ) . Body mass index ≥25 Kg/m2 OR 0.57 ( 0.38 - 0.87 ) and walking > 7 hours/week OR 0.67 ( 0.49 - 0.94 ) were found as protector factors . Conclusions The prevalence of peripheral arterial disease is low , higher in males and increases with age in both sexes . In addition to previously described risk factors we found a protector effect in physical exercise and overweight OBJECTIVE To vali date micro-lightguide spectrophotometry ( O2C ) in patients with lower limb ischemia and to compare results with those obtained from toe blood pressure . METHODS We prospect ively examined 59 patients , 24 of whom complained of claudication , 31 had critical ischemia , and four were asymptomatic . Diabetes was present in 19 ( 32 % ) patients . Saturation ( SO(2 ) ) and flow measured with O2C were determined with the limb in the horizontal position followed by a 55-cm elevation . Toe pressures were determined in the horizontal position only . In addition , 13 patients were examined before and , on average , 3 days after revascularization . RESULTS Median SO(2 ) was 62 % ( 25%-75 % percentile : 37%-75 % ) with the limb in the horizontal position and 16 % ( 3%-41 % ) with the limb elevated . Comparing the individual toe pressures with SO(2 ) values measured in the horizontal position and elevated position revealed a significant correlation ( r(s ) = 0.40 ; P < .01 and r(s ) = 0.56 ; P < .01 , respectively ) . A low SO(2 ) ( ie , < 40 % in the horizontal position and < 20 % in the elevated position ) was highly predictive of a toe pressure of 40 mm Hg or less . In the horizontal position , the positive predictive value was 100 % , whereas the negative predictive value was 47 % . The similar figures in the elevated position were a positive predictive value of 97 % and a negative predictive value of 68 % . Postoperatively , SO(2 ) increased significantly from 27 % ( P25%-75 % : 11%-75 % ) to 79 % ( 68%-87 % ) in the horizontal position ( P = .008 ) and from 14 % ( P25%-75 % : 2%-39 % ) to 55 % ( 30%-73 % ) in the elevated position ( P = .011 ) , respectively . Looking at the individual 13 cases in which revascularization was performed , three patients had a partial reconstruction ( ie , superficial femoral artery occlusion distal to a central reconstruction or reconstruction to a popliteal blind segment ) . These patients had significantly lower postoperative SO(2 ) as well as toe pressure compared with the 10 patients with unobstructed flow to the foot . CONCLUSIONS O2C was easy to use , fast , and painless . The most useful finding was the high predictive value of a low saturation and the rise in O2C values after successful revascularization OBJECTIVE Vascular optical tomographic imaging ( VOTI ) is a novel imaging modality that is capable of detecting hemoglobin concentrations in tissue . VOTI is non-invasive , non-ionizing and does not require contrast injection . This technology was applied to the diagnosis of peripheral arterial disease ( PAD ) within lower extremities of diabetic patients with calcified arter Output:
Expert opinion : So far , transcutaneous oxygen measurements are most often used to measure tissue oxygenation in PAD patients , but evidence seems too low to define this technique as a gold st and ard , and implementing this technique for home monitoring is difficult .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Objective Metformin has had a ' black box ' contraindication in diabetic patients with heart failure ( HF ) , but many believe it to be the treatment of choice in this setting . Therefore , we attempted to conduct a pilot study to evaluate the feasibility of undertaking a large r and omized controlled trial with clinical endpoints . Study Design The pilot study was a r and omized double blinded placebo controlled trial . Patients with HF and type 2 diabetes were screened in hospitals and HF clinics in Edmonton , Alberta , Canada ( population ~1 million ) . Major exclusion criteria included the current use of insulin or high dose metformin , decreased renal function , or a glycosylated hemoglobin < 7 % . Patients were to be r and omized to 1500 mg of metformin daily or matching placebo and followed for 6 months for a variety of functional outcomes , as well as clinical events . Results Fifty-eight patients were screened over a six month period and all were excluded . Because of futility with respect to enrollment , the pilot study was ab and oned . The mean age of screened patients was 77 ( SD 9 ) years and 57 % were male . The main reasons for exclusion were : use of insulin therapy ( n = 23 ; 40 % ) , glycosylated hemoglobin < 7 % ( n = 17 ; 29 % ) and current use of high dose metformin ( n = 12 ; 21 % ) . Overall , contraindicated metformin therapy was the most commonly prescribed oral antihyperglycemic agent ( n = 27 ; 51 % ) . On average , patients were receiving 1,706 mg ( SD 488 mg ) of metformin daily and 12 ( 44 % ) used only metformin . Conclusion Despite uncertainty in the scientific literature , there does not appear to be clinical uncertainty with regards to the safety or effectiveness of metformin in HF making a definitive r and omized trial virtually impossible . Trial registration Clinical Trials.gov Identifier : Objectives Pre clinical and clinical studies suggested cardioprotective effects of metformin treatment . In the GIPS-III trial , 4 months of metformin treatment did not improve left ventricular ejection fraction in patients presenting with ST-elevation myocardial infa rct ion ( STEMI ) . Here , we report the 2-year follow-up results . Methods Between January 2011 and May 2013 , 379 STEMI patients without diabetes undergoing primary percutaneous coronary intervention were r and omized to a 4-month treatment with metformin ( 500 mg twice daily ) ( N = 191 ) or placebo ( N = 188 ) in the University Medical Center Groningen . Two-year follow-up data was collected to determine its effect on predefined secondary endpoints : the incidence of major adverse cardiac events ( MACE ) , its individual components , all-cause mortality , and new-onset diabetes . Results For all 379 patients all-cause mortality data were available . For seven patients ( 2 % ) follow-up data on MACE was limited , ranging from 129 to 577 days . All others completed the 2-year follow-up visit . Incidence of MACE was 11 ( 5.8 % ) in metformin and 6 ( 3.2 % ) in placebo treated patients [ hazard ratio ( HR ) 1.84 , confidence interval ( CI ) 0.68–4.97 , P = 0.22 ] . Three patients died in the metformin group and one in the placebo treatment group . Individual components of MACE were also comparable between both groups . New-onset diabetes mellitus was 34 ( 17.8 % ) in metformin and 32 ( 17.0 % ) in placebo treated patients ( odds ratio 1.15 , CI 0.66–1.98 , P = 0.84 ) . After multivariable adjustment the incidence of MACE was comparable between the treatment groups ( HR 1.02 , CI 0.10–10.78 , P = 0.99 ) . Conclusions Four months metformin treatment initiated at the time of hospitalization in STEMI patients without diabetes did not exert beneficial long-term effects . Trial registration clinical trials.gov Identifier : NCT01217307 OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity Thiazolidinediones ( TZD ) have become a powerful tool for lowering insulin resistance . The problem of cardiovascular adverse events including fluid retention and risk of heart failure should be well known and recognised . We aim ed to evaluate the long-term effects of rosiglitazone on cardiac function and fluid dynamics . Forty-six type 2 diabetic patients were r and omised to treatment with rosiglitazone or metformin or to a control group . There are no significant differences between the groups in the duration of diabetes , HbA1c , plasma brain natriuretic peptide ( BNP ) levels , body mass index and myocardial performance indexes ( MPIs ) before the treatment . After three and six months all these parameters were repeated . Rosiglitazone increased plasma BNP levels and worsened MPIs 3 months after the start of treatment . Also left ventricular end-systolic volume increased and weight gain was observed . But these results were statistically non-significant ( all p>0.05 ) . When we continued rosiglitazone treatment to six months the increase in BNP levels became soft and statistically significant improvements were seen in MPIs ( p<0.01 ) . Also left ventricular end-systolic volume decreased significantly ( p=0.004 ) and weight gain was stopped . In patients with type 2 diabetes , TZD treatment might have slight adverse effects on ventricular contractility and fluid dynamics at the beginning of the therapy . However , these changes seem to stabilise in the long term BACKGROUND The efficacy of thiazolidinediones , as compared with other oral glucose-lowering medications , in maintaining long-term glycemic control in type 2 diabetes is not known . METHODS We evaluated rosiglitazone , metformin , and glyburide as initial treatment for recently diagnosed type 2 diabetes in a double-blind , r and omized , controlled clinical trial involving 4360 patients . The patients were treated for a median of 4.0 years . The primary outcome was the time to monotherapy failure , which was defined as a confirmed level of fasting plasma glucose of more than 180 mg per deciliter ( 10.0 mmol per liter ) , for rosiglitazone , as compared with metformin or glyburide . Prespecified secondary outcomes were levels of fasting plasma glucose and glycated hemoglobin , insulin sensitivity , and beta-cell function . RESULTS Kaplan-Meier analysis showed a cumulative incidence of monotherapy failure at 5 years of 15 % with rosiglitazone , 21 % with metformin , and 34 % with glyburide . This represents a risk reduction of 32 % for rosiglitazone , as compared with metformin , and 63 % , as compared with glyburide ( P<0.001 for both comparisons ) . The difference in the durability of the treatment effect was greater between rosiglitazone and glyburide than between rosiglitazone and metformin . Glyburide was associated with a lower risk of cardiovascular events ( including congestive heart failure ) than was rosiglitazone ( P<0.05 ) , and the risk associated with metformin was similar to that with rosiglitazone . Rosiglitazone was associated with more weight gain and edema than either metformin or glyburide but with fewer gastrointestinal events than metformin and with less hypoglycemia than glyburide ( P<0.001 for all comparisons ) . CONCLUSIONS The potential risks and benefits , the profile of adverse events , and the costs of these three drugs should all be considered to help inform the choice of pharmacotherapy for patients with type 2 diabetes . ( Clinical Trials.gov number , NCT00279045 [ Clinical Trials.gov ] . ) Output:
Although summarized evidence showed that metformin did not affect left ventricular function , this antidiabetic drug could improve myocardial oxygen consumption concomitant to reducing prominent markers of heart failure such as n-terminal pro-brain natriuretic peptide and low-density lipoprotein levels , inconsistently between diabetic and nondiabetic patients . Effective modulation of some heart failure – related outcomes with metformin treatment was related to its beneficial effects in ameliorating insulin resistance and blocking pro-inflammatory markers such as the aging-associated cytokine CCL11 ( C-C motif chemokine lig and 11 ) .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVES : To determine the prevalence and characteristics of fetal alcohol spectrum disorders ( FASD ) among first grade students ( 6- to 7-year-olds ) in a representative Midwestern US community . METHODS : From a consented sample of 70.5 % of all first grade rs enrolled in public and private schools , an over sample of small children ( ≤25th percentile on height , weight , and head circumference ) and r and omly selected control c and i date s were examined for physical growth , development , dysmorphology , cognition , and behavior . The children ’s mothers were interviewed for maternal risk . RESULTS : Total dysmorphology scores differentiate significantly fetal alcohol syndrome ( FAS ) and partial FAS ( PFAS ) from one another and from unexposed controls . Alcohol-related neurodevelopmental disorder ( ARND ) is not as clearly differentiated from controls . Children who had FASD performed , on average , significantly worse on 7 cognitive and behavioral tests and measures . The most predictive maternal risk variables in this community are late recognition of pregnancy , quantity of alcoholic drinks consumed 3 months before pregnancy , and quantity of drinking reported for the index child ’s father . From the final multidisciplinary case findings , 3 techniques were used to estimate prevalence . FAS in this community likely ranges from 6 to 9 per 1000 children ( midpoint , 7.5 ) , PFAS from 11 to 17 per 1000 children ( midpoint , 14 ) , and the total rate of FASD is estimated at 24 to 48 per 1000 children , or 2.4 % to 4.8 % ( midpoint , 3.6 % ) . CONCLUSIONS : Children who have FASD are more prevalent among first grade rs in this Midwestern city than predicted by previous , popular estimates Objectives To determine the prevalence , patterns , and predictors of alcohol consumption prior to and during various intervals of pregnancy in the U.S. Methods Alcohol-related , pregnancy-related , and demographic data were derived from computer-assisted telephone interviews with 4,088 r and omly selected control mothers from the National Birth Defects Prevention Study who delivered live born infants without birth defects during 1997–2002 . Alcohol consumption rates and crude and adjusted odds ratios ( OR ) were calculated . Results 30.3 % of all women reported drinking alcohol at some time during pregnancy , of which 8.3 % reported binge drinking ( 4 + drinks on one occasion ) . Drinking rates declined considerably after the first month of pregnancy , during which 22.5 % of women reported drinking , although 2.7 % of women reported drinking during all trimesters of pregnancy and 7.9 % reported drinking during the 3rd trimester . Pre-pregnancy binge drinking was a strong predictor of both drinking during pregnancy ( adjusted OR = 8.52 , 95 % CI = 6.67–10.88 ) and binge drinking during pregnancy ( adjusted OR = 36.02 , 95 % CI = 24.63–52.69 ) . Other characteristics associated with both any drinking and binge drinking during pregnancy were non-Hispanic white race/ethnicity , cigarette smoking during pregnancy , and having an unintended pregnancy . Conclusions Our study revealed that drinking during pregnancy is fairly common , three times the levels reported in surveys that ask only about drinking during the month before the survey . Women who binge drink before pregnancy are at particular risk for drinking after becoming pregnant . Sexually active women of childbearing ages who drink alcohol should be advised to use reliable methods to prevent pregnancy , plan their pregnancies , and stop drinking before becoming pregnant BACKGROUND In Canada the incidence of Fetal Alcohol Spectrum Disorder ( FASD ) is estimated to be 1 in 100 live births . FASD is the leading cause of developmental and cognitive disabilities in Canada . Only one study has examined the cost of FASD in Canada . In that study we did not include prospect i ve data for infants under the age of one year , costs for adults beyond 21 years or costs for individuals living in institutions . OBJECTIVE To calculate a revised estimate of direct and indirect costs associated with FASD at the patient level . METHODS Cross-sectional study design was used . Two-hundred and fifty ( 250 ) participants completed the study tool . Participants included caregivers of children , youth and adults , with FASD , from day of birth to 53 years , living in urban and rural communities throughout Canada participated . Participants completed the Health Services Utilization Inventory ( HSUI ) . Key cost components were elicited : direct costs : medical , education , social services , out-of-pocket costs ; and indirect costs : productivity losses . Total average costs per individual with FASD were calculated by summing the costs for each in each cost component , and dividing by the sample size . Costs were extrapolated to one year . A stepwise multiple regression analysis was used to identify significant determinants of costs and to calculate the adjusted annual costs associated with FASD . RESULTS Total adjusted annual costs associated with FASD at the individual level was $ 21,642 ( 95 % CI , $ 19,842 ; $ 24,041 ) , compared to $ 14,342 ( 95 % CI , $ 12,986 ; $ 15,698 ) in the first study . Severity of the individual 's condition , age , and relationship of the individual to the caregiver ( biological , adoptive , foster ) were significant determinants of costs ( p < 0.001 ) . Cost of FASD annually to Canada of those from day of birth to 53 years old , was $ 5.3 billion ( 95 % CI , $ 4.12 billion ; $ 6.4 billion ) . CONCLUSIONS Study results demonstrated the cost burden of FASD in Canada was profound . Inclusion of infants aged 0 to 1 years , adults beyond the age of 21 years and costs associated with residing in institutions provided a more accurate estimate of the costs of FASD . Implication s for practice , policy , and research are discussed . Key words : Alcohol , pregnancy , cost , economic burden , fetal alcohol spectrum disorder OBJECTIVE We examined the use of alcohol during early pregnancy in urban Swedish women , the ability of Swedish antenatal care to identify alcohol-related risk pregnancies and the utility of some potential tools for improving its performance . METHOD Women attending regular antenatal care were r and omized to regular assessment only ( control , n = 156 ) or intensified screening ( intervention , n = 147 ) . In the intervention group , alcohol use was determined using the Timeline Followback ( TLFB ) interview , alcohol use habits with the Alcohol Use Disorder Inventory Test ( AUDIT ) , and biomarkers for alcohol use were analyzed . Data were typically obtained in pregnancy week 12 . RESULTS In the intervention group as a whole , average absolute alcohol consumption during the first 6 weeks of pregnancy was low but highly variable ( mean [ SD ] = 24.9 [ 50.5 ] g/week ; 4.8 [ 6.0 ] episodes for the entire 6 week period ) ; 22 women ( 15 % ) drank at levels exceeding 70 g/week during any 2 or more weeks and /or in a heavy episodic drinking pattern , 60 g/episode , on 2 or more episodes . The AUDIT had a moderate sensitivity ( 54 % ) to identify these subjects . Biomarkers identified subjects with somatic illness rather than high alcohol consumption . In the control group , only 4 ( 3 % ) were identified as using alcohol , indicating a probable underestimation of alcohol use by regular antenatal screening procedures ( p = .0001 ) . CONCLUSIONS An unexpected proportion of pregnant women in urban Sweden consume alcohol at levels likely to produce adverse effects . Regular antenatal care did not identify most of these risk pregnancies . The TLFB identified pregnant women with risk use of alcohol during pregnancy who were only partly identified by analyzing prepregnancy alcohol use patterns with the AUDIT . Elevated laboratory markers likely indicated somatic illness rather than harmful drinking BACKGROUND The prevalence and characteristics of fetal alcohol spectrum disorders ( FASD ) were determined in this fourth study of first- grade children in a South African community . METHODS Active case ascertainment methods were employed among 747 first- grade pupils . The detailed characteristics of children within the continuum of FASD are contrasted with r and omly selected , normal controls on ( i ) physical growth and dysmorphology ; ( ii ) cognitive/behavioral characteristics ; and ( iii ) maternal risk factors . RESULTS The rates of specific diagnoses within the FASD spectrum continue to be among the highest reported in any community in the world . The prevalence ( per 1,000 ) is as follows : fetal alcohol syndrome (FAS)-59.3 to 91.0 ; partial fetal alcohol syndrome (PFAS)-45.3 to 69.6 ; and alcohol-related neurodevelopmental disorder (ARND)-30.5 to 46.8 . The overall rate of FASD is therefore 135.1 to 207.5 per 1,000 ( or 13.6 to 20.9 % ) . Clinical profiles of the physical and cognitive/behavioral traits of children with a specific FASD diagnosis and controls are provided for underst and ing the full spectrum of FASD in a community . The spectral effect is evident in the characteristics of the diagnostic groups and summarized by the total ( mean ) dysmorphology scores of the children : FAS = 18.9 ; PFAS = 14.3 ; ARND = 12.2 ; and normal controls , alcohol exposed = 8.2 and unexposed = 7.1 . Documented drinking during pregnancy is significantly correlated with verbal ( r = -0.253 ) and nonverbal ability ( r = -0.265 ) , negative behaviors ( r = 0.203 ) , and total dysmorphology score ( r = 0.431 ) . Other measures of drinking during pregnancy are significantly associated with FASD , including binge drinking as low as 3 drinks per episode on 2 days of the week . CONCLUSIONS High rates of specific diagnoses within FASD were well documented in this new cohort of children . FASD persists in this community . The data reflect an increased ability to provide accurate and discriminating diagnoses throughout the continuum of FASD OBJECTIVE To study the activities of serum gamma-glutamyltransferase ( GGT ) , aspartate and alanine aminotransferases ( AST , ALT ) , and their ratio ( AST/ALT ) , mean erythrocyte cell volume ( MCV ) and urinary dolichol output in alcohol-abusing pregnant women , and compare the results to those of abstinent pregnant women . DESIGN Prospect i ve descriptive study . SETTING Special outpatient clinic for pregnant problem-drinkers in the department of Obstetrics and Gynaecology , Helsinki University Central Hospital , Finl and . SUBJECTS 25 pregnant women referred to the special clinic at between 12 and 24 weeks gestation , they consumed at least 150 g of ethanol weekly , and a control group of 20 abstinent pregnant women matched for age , parity and smoking habits . INTERVENTIONS The women were encouraged to visit the clinic at 2 - 4 week intervals . At each visit blood and urine sample s were obtained , and the women were interviewed on their alcohol consumption during the previous weeks and encouraged to abstain in the future . MEAN OUTCOME MEASURES Neonatal condition , fetal alcohol effects ( FAE ) in the newborn . Serum activities of GGT , AST and ALT , the AST/ALT ratio , the MCV , and the urinary concentration of dolichol in alcohol-abusing women with either healthy or FAE infants , compared with those of abstinent women with healthy infants . RESULTS Of the 25 alcohol-abusing women 13 gave birth to infants with FAE and 12 to healthy infants . All the women in the control group gave birth to healthy infants . GGT , AST and ALT activities were increased in all alcohol-abusing women , regardless whether the infant had FAE or not . GGT was the best of these markers , GGT activities above the 95th normal centile were found in 33 % of the sample s from all alcohol-abusing women . The AST/ALT ratio , MCV and urinary dolichol concentration were poor indicators of abusive drinking . CONCLUSIONS Maternal alcohol abuse is difficult to assess by laboratory tests . Of the commonly used and easily available tests , GGT proved to be the best in our study In order to investigate prospect ively in pregnant women a correlation between serum levels of a biological marker of alcohol and the clinical status of the newborn , we measured the gamma-glutamyltransferase ( GGT ) in 630 women between 14 and 20 weeks of pregnancy . In 7 % of the cases , an elevated value was observed while history confirmed alcohol consumption in only 1 % . Preliminary statistical analysis established upon the blind examination of 308 newborns show a correlation between maternal GGT levels and birthweight as well as the pre- and perinatal complications . However , the sensitivity of this test is weak BACKGROUND The prevalence and characteristics of fetal alcohol syndrome ( FAS ) and partial FAS ( PFAS ) in the United States ( US ) are not well known . METHODS This active case ascertainment study in a Rocky Mountain Region City assessed the prevalence and traits of children with FAS and PFAS and linked them to maternal risk factors . Diagnoses made by expert clinical dysmorphologists in multidisciplinary case conferences utilized all components Output:
Although all of the studies were rated of good method ological quality , none of the biomarkers had both high sensitivity and specificity when compared to self-report . There was some evidence that a combination of biomarkers , or combining biomarkers with self-report , increases accuracy . In summary , the blood biomarkers examined were of limited use in screening for low and moderate alcohol consumption in pregnancy when compared to self-report . However , certain biomarkers , such and CDT and PEth may complement self-report and help improve the accuracy of diagnosis
MS2_1shot278
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: The efficacy of low-dose heparin in preventing fatal postoperative pulmonary embolism has been investigated in a multicentre prospect i ve r and omised trial . 4121 patients over the age of forty years undergoing a variety of elective major surgical procedures were included in the trial ; 2076 of these were in the control group and 2045 patients received heparin . The two groups were well matched for age , sex , weight , blood-group , and other factors which could predispose to the development of venous thromboembolism . 180 ( 4 - 4 % ) patients died during the postoperative period , 100 in the control and 80 in the heparin group : 72 % of deaths in the control and 66 % in the heparin group had necropsy examination . 16 patients in the control group and 2 in the heparin group were found at necropsy to have died due to acute massive pulmonary embolism ( P smaller than 0 - 005 ) . In addition , emboli found at necropsy in 6 patients in the control group and 3 in the heparin group were considered either contributory to death or an incidental finding since death in these patients was attributed to other causes . Taking all pulmonary emboli together , the findings were again significant ( P smaller than 0 - 005 ) . Of 1292 patients in whom the 125-I-fibrinogen test was performed to detect deep-vein thrombosis ( D.V.T. ) 667 were in the control group and 625 in the heparin group . The frequency of isotopic D.V.T. was reduced from 24 - 6 % in the control group 7 - 7 % in the heparin group ( P smaller 0 - 005 ) . In 30 patients D.V.T. was detected at necropsy ; 24 in the control and 6 in the heparin group ( P smaller 0 - 005 ) . 32 patients in the control group and 11 in the heparin group developed clinical ly diagnosed D.V.T. which was confirmed by venography ( P smaller than 0 - 005 ) . In addition , 24 patients in the control and 8 in the heparin group were treated for clinical ly suspected pulmonary emoblism . The difference in the number of patients requiring treatment for D.V.T. and /or pulmonary embolism in the two groups was again significant ( P smaller than 0 - 005 ) . 9 patients were found at necropsy to have died from haemorrhage ; 5 were in the control and 4 in the heparin group . A careful objective analysis of operative and postoperative bleeding in 1475 patients showed no statistically significant difference in the blood-transfusion requirements or in the fall in the postoperative haemoglobin level either in the individual operative groups or in the group as a whole . However , the difference in the number of patients who developed wound haematoma in the heparin and control groups was significant ( P smaller 0 - 01 ) . The results of the trial indicate that this form of prophylaxis can now be recommended for use on a large scale in " high-risk " patients undergoing major surgery Venous thromboembolism is a serious complication following gynecologic surgery and is particularly common in patients with malignancy . A previous study of subcutaneous low-dose heparin given as one dose preoperatively and every 12 hours postoperatively failed to show a benefit in gynecologic oncology patients . In the present study , two more intense regimens of low-dose heparin were evaluated . Three hundred four patients were assigned r and omly to receive no prophylaxis ( controls ) , subcutaneous heparin 5000 units 2 hours before surgery and every 8 hours postoperatively ( low-dose heparin ) ( regimen I ) , or 5000 units heparin subcutaneously every 8 hours preoperatively ( between two and nine doses ) and every 8 hours postoperatively ( regimen II ) . All patients had thromboembolism surveillance with the fibrinogen uptake test and clinical evaluation . Eighty-four percent had a malignancy . Thromboemboli were diagnosed in 19 of 103 control patients , ten of 104 regimen I patients , and six of 97 regimen II patients , a statistically significant difference ( P < .008 ) . When compared with the control group , the study groups had no evidence of increased bleeding complications or alteration of laboratory coagulation indicators . ( Obstet Gynecol 75 : 684 , 1990 Summary Background Data : The epidemiology of venous thromboembolism ( VTE ) after cancer surgery is based on clinical trials on VTE prophylaxis that used venography to screen deep vein thrombosis ( DVT ) . However , the clinical relevance of asymptomatic venography-detected DVT is unclear , and the population of these clinical trials is not necessarily representative of the overall cancer surgery population . Objective : The aim of this study was to evaluate the incidence of clinical ly overt VTE in a wide spectrum of consecutive patients undergoing surgery for cancer and to identify risk factors for VTE . Methods : @RISTOS was a prospect i ve observational study in patients undergoing general , urologic , or gynecologic surgery . Patients were assessed for clinical ly overt VTE occurring up to 30 ± 5 days after surgery or more if the hospital stay was longer than 35 days . All outcome events were evaluated by an independent Adjudication Committee . Results : A total of 2373 patients were included in the study : 1238 ( 52 % ) undergoing general , 685 ( 29 % ) urologic , and 450 ( 19 % ) gynecologic surgery . In-hospital prophylaxis was given in 81.6 % and postdischarge prophylaxis in 30.7 % of the patients . Fifty patients ( 2.1 % ) were adjudicated as affected by clinical ly overt VTE ( DVT , 0.42 % ; nonfatal pulmonary embolism , 0.88 % ; death 0.80 % ) . The incidence of VTE was 2.83 % in general surgery , 2.0 % in gynecologic surgery , and 0.87 % in urologic surgery . Forty percent of the events occurred later than 21 days from surgery . The overall death rate was 1.72 % ; in 46.3 % of the cases , death was caused by VTE . In a multivariable analysis , 5 risk factors were identified : age above 60 years ( 2.63 , 95 % confidence interval , 1.21–5.71 ) , previous VTE ( 5.98 , 2.13–16.80 ) , advanced cancer ( 2.68 , 1.37–5.24 ) , anesthesia lasting more than 2 hours ( 4.50 , 1.06–19.04 ) , and bed rest longer than 3 days ( 4.37 , 2.45–7.78 ) . Conclusions : VTE remains a common complication of cancer surgery , with a remarkable proportion of events occurring late after surgery . In patients undergoing cancer surgery , VTE is the most common cause of death at 30 days after surgery A prospect i ve study of a series of 77 patients on adjuvant radiochemotherapy following surgery for high- grade gliomas was conducted to evaluate the risk of deep vein thrombosis and identify risk factors . We found a 20.8 % risk of deep vein thrombosis at 12 months ( st and ard error = 4.8 % ) and a 31.7 % risk ( st and ard error = 7.4 % ) at 24 months ( Kaplan-Meier method ) . Twenty patients ( 26 % ) developed deep vein thrombosis with a maximum incidence within the first 7 months after surgery when chemotherapy was still being administered , often with corticosteroids . The risk factors identified were histology ( glioblastoma versus anaplastic astrocytoma , P = 0.032 , log rank test ; 0.0485 L-ratio ) and the presence of paresis ( P = 0.010 , log rank test ; 0.0161 L-ratio ) . A borderline tendency was found for an association between the deep vein thrombosis site and the side of paresis ( P = 0.103 , Fisher 's exact test ) . Four patients ( 5 % ) had massive pulmonary embolism , which was fatal in 3 ( 4 % ) BACKGROUND Hemato-oncology patients treated with intensive chemotherapy usually require the placement of a central venous catheter ( CVC ) . CVCs are frequently complicated by catheter-related central venous thrombosis ( CVT ) , which has been associated with an increased risk of pulmonary embolism and catheter-related infection . OBJECTIVES To determine the efficacy and safety of thromboprophylaxis with s.c . low-molecular-weight heparin ( nadroparin ) administered once daily in a r and omized placebo-controlled , double-blind trial in patients with hematologic malignancies . PATIENTS AND METHODS Consecutive patients with hematologic malignancies requiring intensive chemotherapy including autologous stem cell transplantation were eligible . The patients were r and omized to receive nadroparin 2850 antifactor Xa units once daily or placebo s.c . for 3 weeks . Venography was performed on day 21 after CVC insertion . Secondary outcomes were bleeding and catheter-related infection . RESULTS In total , 113 patients were r and omized to nadroparin or placebo , and 87 patients ( 77 % ) underwent venography . In total , 11 venographically proven catheter-related CVTs were diagnosed . The frequency of catheter-related CVT was not significantly different between study groups , namely four catheter-related CVTs in the placebo group [ 9 % ; 95 % CI : 0.002 - 0.16 ] vs. seven catheter-related CVTs in the nadroparin group ( 17 % ; 95 % CI : 0.06 - 0.28 ) . In addition , no difference in the incidence of catheter-related infection or bleeding was observed between the groups . CONCLUSION This study showed that the actual risk for catheter-related CVT in patients with hematologic malignancies is lower than suggested in earlier studies in cancer patients . Although prophylactic administration of nadroparin appeared to be safe in this group of patients with a high risk of bleeding , it can not be recommended for the prevention of catheter-related CVT or catheter-related infection in patients with hematologic malignancies BACKGROUND An intravenous course of st and ard ( unfractionated ) heparin with the dose adjusted to prolong the activated partial-thromboplastin time to a desired length is the st and ard initial in-hospital treatment for patients with deep-vein thrombosis , but fixed-dose subcutaneous low-molecular-weight heparin appears to be as effective and safe . Because the latter treatment can be given on an outpatient basis , we compared the two treatments in symptomatic out patients with proximal-vein thrombosis but no signs of pulmonary embolism . METHODS We r and omly assigned patients to adjusted-dose intravenous st and ard heparin administered in the hospital ( 198 patients ) or fixed-dose subcutaneous low-molecular-weight heparin administered at home , when feasible ( 202 patients ) . We compared the treatments with respect to recurrent venous thromboembolism , major bleeding , quality of life , and costs . RESULTS Seventeen of the 198 patients who received st and ard heparin ( 8.6 percent ) and 14 of the 202 patients who received low-molecular-weight heparin ( 6.9 percent ) had recurrent thromboembolism ( difference , 1.7 percentage points ; 95 percent confidence interval , -3.6 to 6.9 ) . Major bleeding occurred in four patients assigned to st and ard heparin ( 2.0 percent ) and one patient assigned to low-molecular-weight heparin ( 0.5 percent ; difference , 1.5 percentage points ; 95 percent confidence interval , -0.7 to 2.7 ) . Quality of life improved in both groups . Physical activity and social functioning were better in the patients assigned to low-molecular-weight heparin . Among the patients in that group , 35 percent were never admitted to the hospital at all , and 40 percent were discharged early . This treatment was associated with a mean reduction in hospital days of 67 percent , ranging from 29 percent to 86 percent in the various study centers . CONCLUSIONS In patients with proximal-vein thrombosis , treatment with low-molecular-weight heparin at home is feasible , effective , and safe BACKGROUND The finding of a decrease in contralateral breast cancer incidence following tamoxifen administration for adjuvant therapy led to the concept that the drug might play a role in breast cancer prevention . To test this hypothesis , the National Surgical Adjuvant Breast and Bowel Project initiated the Breast Cancer Prevention Trial ( P-1 ) in 1992 . METHODS Women ( N=13388 ) at increased risk for breast cancer because they 1 ) were 60 years of age or older , 2 ) were 35 - 59 years of age with a 5-year predicted risk for breast cancer of at least 1.66 % , or 3 ) had a history of lobular carcinoma in situ were r and omly assigned to receive placebo ( n=6707 ) or 20 mg/day tam Output:
Marik PE , And rews L , Maini B. The incidence of deep venous thrombosis in ICU patients . Cook D , Meade M , Guyatt G , et al. Dalteparin versus unfractionated heparin in critically ill patients .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Microleakage is related to recurrent decay , inflammation of vital pulps , and reinfection of previously treated root canals . The purpose of this investigation was to compare the abilities of new adhesive cements and conventional nonadhesive controls to prevent microleakage under stainless steel crowns on primary anterior teeth . St and ardized preparations were made , and stainless steel crowns were adapted . Specimens were assigned r and omly to cement groups : zinc phosphate ( ZP ) , polycarboxylate ( PC ) , glass-ionomer ( GI ) , resin-modified glass-ionomer ( RMGI ) , RMGI with a dentin bonding agent ( RMGI + DBA ) , adhesive composite resin ( ACR ) and zinc oxide eugenol ( ZOE ) . Specimens were stored in water , aged artificially , stained , embedded , and sectioned , and the microleakage was measured . Group means and st and ard errors were calculated . ANOVA discerned differences among groups ( P < 0.0001 ) , and Turkey 's multiple comparisons testing ( P < 0.05 ) ranked the groups from least to most microleakage as follows : [ RMGI + DBA , RMGI , ACR , GI ] , [ ZP ] , and [ PC , ZOE ] . The adhesive cements significantly reduced microleakage In the last years several dental adhesives have been developed . They are supposed to chemically adhere to dentin and a liner to protect the pulp is not used . The aim of this study was to compare the short-term pulpal reaction , in an intra-toothpair study , between a dental adhesive , Scotchbond 2 , and a lining system , Tubulitec , in combination with P-50 in surface-sealed cavities . Deep buccal cavities in 16 human pairs of premolars , 32 teeth , were restored in vivo with a light cured composite resin , P-50 . To minimize bacterial contamination all cavities were treated with a cleanser , Tubulicid , and the cavities were surface-sealed with temporary cement , Coltosol . One tooth in each pair , the test , was treated with Scotchprep Dentin Primer and Scotchbond 2 Light Cure Dental Adhesive . In the other tooth in the pair , the control , Tubulitec Primer and Liner were used . The teeth were extracted after 6 - 14 days . The sections were evaluated for degree of inflammation and the presence of bacteria . Irrespective of treatment of dentin the majority of teeth , 23 , including one pulpal exposure , revealed no inflammation or a few inflammatory cells . In four test teeth , including one pulpal exposure , and two controls , growth of bacteria was found on the cavity walls and slight or moderate inflammation was seen in the corresponding pulps . In one test and two control teeth slight inflammation was seen but no bacteria could be detected . In the absence of bacteria Scotchbond 2 did not seem to irritate the pulp . ( ABSTRACT TRUNCATED AT 250 WORDS Three intermediary base material s , a zinc oxide-eugenol ( Cavitec ) and two calcium hydroxide liners ( Life and Dycal ) , were selected at r and om for use as a base beneath amalgam or composite restorations on humans following complete caries removal . Life and Dycal , selected at r and om , were also used as direct and indirect pulp capping agents as clinical ly indicated . Clinical evaluations of signs and symptoms were made before treatment and at one-week , six-month , and one-year intervals following treatment . Histological evaluations were performed on three complete caries removal teeth and 18 direct pulp capping teeth six months following treatment . No significant differences in clinical symptomatology result ed between the material s in the complete caries removal group or the indirect and direct pulp capping groups Concern about the survival of microorganisms in deep carious lesions may often lead to unnecessary exposure of the pulp during final excavation . There are reasons , therefore , to initiate systematic studies on the alternative procedure known as stepwise excavation . Clinical evaluation of stepwise excavation was performed on 31 deep carious lesions considered to result in pulp perforation by traditional excavation . This study examines the clinical and microbiological alterations during the final excavation performed during long intervals ( 6 - 12 months ) after the initial treatment that included peripheral dentine excavation and removal of the central cariogenic biomass and the superficial necrotic dentine . The dentine colour and consistency were assessed by means of st and ardized scales before application of a Ca(OH)2 compound and a temporary sealing for 6 - 12 months . Re assessment s were performed before the after final excavation . Microbiological dentine sample s were obtained in 19 r and omly selected lesions by a sterile bur , transferred to and diluted in reduced transport fluid , and plated on tryptic soy agar . After anaerobic incubation at 37 degrees C for 7 days , total colony-forming units per millilitre were counted from ( 1 ) peripheral excavated and hard dentine ( control ) , ( 2 ) central demineralized dentine before and final excavation , and ( 3 ) central dentine after the final excavation . Six sample s of central demineralized dentine were without any cultivable flora increasing to 9 sample s after the final excavation . The clinical dentine changes occurring during stepwise excavation were characterized by enhanced hardness of the dentine which was associated with a marked reduction in bacterial growth after the final excavation . Despite the presence of bacteria in the excavated dentine none of the carious lesions result ed in pulp perforation , suggesting that the initial removal of the cariogenic biomass appears to be essential for control of caries progression . Stepwise excavation is not only an appropriate treatment of deep carious lesions but is also considered a suitable model for microbiological studies to determine the bacteria persisting in clinical ly excavated lesions In a prospect i ve study , partial pulpotomy was performed on six permanent molars with deep carious lesions and pulpal involvement . The bleeding pulp was irrigated with normal tap water until bleeding had stopped and the exposed pulp was covered with calcium hydroxide followed by zinc oxide eugenol , and finally covered with a semipermanent restoration . All teeth showed hard tissue barrier formation , both clinical ly and radiographically , within three months and were free from subjective and objective symptoms through the observation period ( average observation period was 26 months ) . The patients also experienced the therapy positively . These findings and those of others have helped gain more recognition for partial pulpotomy as a strong possible alternative therapy when pulps are exposed by deep carious lesions and a bleeding pulp is exposed during the excavation process . The rationale for this therapy is to remove the infected and /or inflamed pulpal areas beneath the carious lesion and disintegrated tissue . A rapid and simplified procedure would allow the general practitioner to perform this procedure when necessary at dental clinics , without specialist facilities under conditions that avoid unnecessary contamination of the pulp STATEMENT OF PROBLEM The penetration of oral fluids and bacteria at the interface between the cavity walls and amalgam restorations , which is known as marginal leakage , is one of the problems facing restorative dentistry today . This may cause secondary caries and the irritation of the pulp . PURPOSE This in vitro study tested and compared the sealing ability of a cavity varnish and a dental adhesive for decreasing the marginal leakage of high copper amalgam fillings by chemical diffusion technique . MATERIAL AND METHODS The sample s were r and omly divided into three groups . The cavities in the first group were filled with high copper amalgam . In the second and third groups , the cavities were treated with Copalite and Panavia EX adhesives , respectively , before the amalgam fillings were performed . After the periods of 2 hours , 48 hours , 1 week , and 1.5 and 6 months , the amount of calcium diffused through the interface area into the deionized water was measured with inductively coupled plasma . RESULTS Six-month results revealed that using a dental adhesive as an interfacial sealer had significant advantages to reduce microleakage when compared with a conventional copal varnish PURPOSE The purpose of this prospect i ve and r and omized in vivo study was to compare the clinical and radiographic outcomes of an adhesive resin system vs a calcium hydroxide liner for protection of the dentin-pulp complex of primary molars treated with indirect pulp treatment . METHODS Forty-eight primary molars with deep occlusal caries , but without preoperative signs and symptoms of irreversible pulpitis , received indirect pulp treatment and were restored with a composite resin ( Z100 ) . The teeth were r and omly divided into 2 groups according to the material used for protection of the dentin-pulp complex : ( 1 ) adhesive resin system ( Scotchbond Multi Purpose ) ; and ( 2 ) calcium hydroxide liner ( Dycal ) . These teeth were evaluated clinical ly and radiographicaly for 2 years . RESULTS After 2 years , 83 % ( 19/23 ) of the teeth treated with calcium hydroxide and 96 % ( 24/25 ) of teeth treated with only the adhesive resin system presented a successful outcome , as determined by clinical and radiographic examination . Interradicular and /or periapical lesions were the most predominant signs of treatment failure , since 3 out of 23 teeth treated with calcium hydroxide and 1 out of 25 teeth treated with only adhesive resin presented this outcome . One tooth treated with the calcium hydroxide liner was diagnosed with internal root resorption at the 18-month examination . Of the 5 teeth diagnosed from radiographs as a failure of the indirect pulp treatment , none presented clinical signs/symptoms of pulpitis or necrosis such as the presence of fistula , enhanced tooth mobility , or pain . CONCLUSIONS This study demonstrates that protection of the dentin-pulp complex of primary molars with an adhesive resin system results in similar clinical and radiographic 2-year outcomes as compared to calcium hydroxide when indirect pulp treatment is performed in Class I composite restorations OBJECTIVES To analyze the relationship between the cavity depth and liners with postoperative sensitivity of resin composite restorations . METHODS A clinical follow-up was conducted on 319 resin composite restorations made in the final year of an undergraduate program over a 3-year period . Along with the analyses of cavity type , cavity depth , type of pulpal protection and the material s used , the postoperative sensitivity was also examined on each restoration . RESULTS Thirty-nine percent of the restorations had no protective layer ( Group 1 ) . As the depth of the prepared cavities increased , the restorations received one of the three pulpal protection methods ; a calcium hydroxide base ( Group 2 ) , glass ionomer cement ( Group 3 ) , or protection with a calcium hydroxide base in combination with glass ionomer cement ( Group 4 ) . The incidence of postoperative sensitivity showed no significant difference among Groups 1 , 2 and 3 , but was significantly lower in Group 1 than in Group 4 . The restorations made in shallow and medium depth cavities demonstrated significantly less-postoperative sensitivity than those made in deep cavities . The newer generation dentine-bonding agents showed a significantly lower incidence of postoperative sensitivity than the early generation group . CONCLUSIONS Postoperative sensitivity in resin composite restorations was not related to the absence of protective layers but increased with the depth of cavities restored with the resin composite . The type of dentine-bonding agents could also be responsible for postoperative sensitivity PURPOSE To evaluate clinical ly and microscopically the human pulp response when directly capped with an adhesive system or calcium hydroxide over short ( 9 - 12 days ) and long ( 53 - 204 days ) experimental periods . MATERIAL S AND METHODS Fifty-one sound human premolars scheduled for orthodontic extraction , had their pulp horns gently exposed with a diamond point . Debris in the pulp wound was washed out with a sterile saline solution . The pulps were then capped with either an adhesive system ( Scotchbond Multi- Purpose Plus ) or calcium hydroxide . All teeth were subsequently restored with resin-based composite ( Z-100 ) according to the manufacturer 's instructions . After the experimental periods , the teeth were extracted and processed for light microscopic examination . RESULTS Short-term : the pulp tissue capped with SBMP-P exhibited dilated and congested blood vessels associated with a moderate inflammatory response and blanching of pulp cell nuclei . Long-term : no evidence of healing and bridge formation was observed . A persistent mild inflammatory pulp response was present . Micro-abscesses were detected in three cases associated with bacterial infiltration . Calcium hydroxide stimulated early pulp repair and dentin bridging which extended into the longest period The aim of this research was to analyse the long-term clinical behaviour of two dental material s applied as filling under silver amalgam restorations : glass-ionomer cement ( GIC ) and composite resin with adhesive system ( CR ) . In this study , 117 posterior teeth ( 29 premolars and 88 molars ) were selected with carious lesions which result ed in great loss of dentin and cusps with unsupported enamel . After caries removal , cavities were prepared and totally filled with GIC or with CR . In a following visit , new cavities were prepared , leaving the employed filling material as a base and support for the enamel , which were then restored with silver amalgam . Restorations were evaluated periodically after 6 months and up to 5 years . Both fracture and pulpal involvement rates were low . Although differences could be observed in the behaviour of the material s , statistical survival estimation showed that the performances of GIC and CR as filling material were similar . There was a significant association both between kind of tooth ( mol Output:
The findings from this review do not suggest that there should be any significant change from accepted conventional practice procedures when the pulp of the carious tooth is considered .
MS2_1shot280
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVES To study the efficacy of alfuzosin compared with tamsulosin in the management of lower ureteral stones . METHODS A total of 102 patients with stones < 1 cm size and located in the lower ureter were enrolled in the present study and r and omized into 3 equal groups . Group 1 patients ( n = 34 ) received 0.4 mg tamsulosin daily , group 2 patients ( n = 34 ) received 10 mg alfuzosin daily , and group 3 patients ( n = 34 ) received placebo ( control group ) . The patients were given 75 mg diclofenac injection intramuscularly on dem and and were followed up for 4 weeks . RESULTS The average stone size for groups 1 , 2 , and 3 was comparable ( 6.17 , 6.70 , and 6.35 mm , respectively ) . Stone expulsion was observed in 28 of 34 patients ( 82.3 % ) in group 1 , 24 of 34 patients ( 70.5 % ) in group 2 , and 12 of 34 patients ( 35.2 % ) in group 3 . The average expulsion time for groups 1 , 2 , and 3 was 12.3 , 14.5 , and 24.5 days , respectively . The results of both study groups ( groups 1 and 2 ) were superior to those in the placebo group ( P = .003 and P = .001 , respectively ) , but the study failed to show any statistically significant differences between tamsulosin and alfuzosin ( P = .25 ) . Alfuzosin was associated with fewer side effects than tamsulosin , especially in terms of retro grade ejaculation . CONCLUSIONS Medical treatment of lower ureteral calculi with tamsulosin and alfuzosin result ed in a significantly increased stone expulsion rate , decreased expulsion time , and a reduced need for analgesic therapy Purpose We evaluated and compared the efficacy of tamsulosin and alfuzosin in the medical treatment of symptomatic , uncomplicated distal ureteral stones . Material s and Methods A total of 87 patients with distal ureteral stones of ≤10 mm were r and omly divided into 3 groups . Group I patients ( n=29 ) received 0.4 mg tamsulosin daily , group II patients ( n=30 ) received 10 mg alfuzosin daily , and group III patients ( n=28 ) were not given tamsulosin or alfuzosin . Patients in all groups received Diclofenac sodium regularly for 1 week and then on dem and . Follow-up was done on a weekly basis for 30 days . Results The mean stone size was comparable in the 3 groups ( 4.97±2.24 , 5.47±2.13 , and 5.39±1.81 mm , respectively ) . The stone expulsion rate was 86.2 % , 76.6 % , and 50 % in groups I , II , and III , respectively . The difference in groups I and II with respect to group III was significant ( p=0.0028 and 0.035 ) . The mean expulsion time for groups I to III was 7.52±7.06 , 8.26±7.34 , and 13.90±6.99 days , respectively . The expulsion time was significantly shorter in groups I and II than in group III ( p=0.0097 and 0.026 ) . Patients taking tamsulosin and alfuzosin had fewer pain attacks than did group III patients ( 1.24±0.57 vs. 1.43±0.67 vs. 1.75±1.17 ) . Only 3 cases of drug side effects , 2 in group I and 1 in group II , were recorded . Conclusions The use of tamsulosin or alfuzosin for the medical treatment of lower ureteric stones proved to be safe and effective . Moreover , tamsulosin did not have any significant benefits over alfuzosin Background : Alpha – 1 blockers decrease the tension and release the spasm of smooth muscles and thus lessen the obstruction and irritation symptoms in the lower urinary tract ( LUTS ) . They make a faster passing of calculi from the terminal part of the ureters possible . Objectives : The goal of this study was to objective ly assess the improvement of difficulties caused by obstructions in ureterolithiasis localized in the lower part of the ureters of 104 r and omly chosen patients ( pts . ) in a double-blind study . Methods : During a period of 2 and half years ( June 1999–January 2002 ) 104 pts . suffering from ureterolithiasis of the lower urinary tract were treated and observed . Patients were divided into two groups : A ( n:53 ; later only 51 were evaluated ) which was subjected to st and ard treatment and group B ( n:51 ) where the st and ard treatment was supplemented by the alpha – 1 blocker . As alpha – 1 blocker one capsule of Tamsulosin /OMNIC 0.4 / was administered daily . Results : With alpha – 1 blocker , we have registered a more speedy passing of calculi from the terminal parts of ureters in 17.6 % of pts . Recurrence of renal colics was less frequent and occurred in one of eight pts . as compared with group A ( without the alpha – 1 blocker ) where a recurrence of the renal colic was observed in about every fifth pts . In group A ( n:51 ) , 62.8 % of the pts . passed the calculi , whereas in group B ( n:51 ) , where st and ard treatment was supplemented by the administration of the alpha – 1 blocker Tamsulosin , this percentage increased to 80.4 % . Conclusion : The treatment by alpha – 1 blockers considerably decreased not only LUTS but also helped to accelerate the passing of minor calculi from the terminal parts of the ureters of 80.4 % of pts . It seems that alpha – 1 blockers potentiate the spasmoanalgetic action of drugs used in st and ard methods of treatment BACKGROUND Numerous r and omised trials have confirmed the efficacy of medical expulsive therapy with tamsulosin in patients with distal ureteral stones ; however , to date , no r and omised , double-blind , placebo-controlled trials have been performed . OBJECTIVE The objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a r and omised , double-blind , placebo-controlled setting . DESIGN , SETTING , AND PARTICIPANTS Patients presenting with single distal ureteral stones < or = 7 mm were included in this trial . INTERVENTION Patients were r and omised in a double-blind fashion to receive either tamsulosin or placebo for 21 d. The medication was discontinued after either stone expulsion or intervention . Abdominal computed tomography was performed to assess the initial and final stone status . MEASUREMENTS AND LIMITATIONS : The primary end point was the stone expulsion rate . Secondary end points were time to stone passage , the amount of analgesic required , the maximum daily pain score , safety of the therapy , and the intervention rate . RESULTS Ten of 100 r and omised patients were excluded from the analysis . No statistically significant differences in patient characteristics and stone size ( median : 4.1 mm [ tamsulosin arm ] vs 3.8 mm [ placebo arm ] , p=0.3 ) were found between the two treatment arms . The stone expulsion rate was not significantly different between the tamsulosin arm ( 86.7 % ) and the placebo arm ( 88.9 % ; p=1.0 ) . Median time to stone passage was 7 d in the tamsulosin arm and 10 d in the placebo arm ( log-rank test , p=0.36 ) . Patients in the tamsulosin arm required significantly fewer analgesics than patients in the placebo arm ( median : 3 vs 7 , p=0.011 ) . A caveat is that the exact time of stone passage was missing for 29 patients . CONCLUSIONS Tamsulosin treatment does not improve the stone expulsion rate in patients with distal ureteral stones < or = 7 mm . Nevertheless , patients may benefit from a supportive analgesic effect . CLINICAL TRIALS.GOV : NCT00831701 PURPOSE To evaluate the efficacy of the addition of tamsulosin to our st and ard expulsive pharmacologic therapy for the treatment of distal-ureteral stones . PATIENTS AND METHODS A series of 96 patients referred to our department for the management of symptomatic distal-ureteral calculi were r and omly divided into group 1 ( N = 46 ) who received diclofenac ( 100 mg/daily ) plus aescin ( 80 mg/daily ) and group 2 ( N = 50 ) who received the same therapy plus tamsulosin ( 0.4 mg/daily ) for a maximum of 2 weeks . There were no differences between the groups with respect to age , sex , or stone size . The primary endpoint was the expulsion rate . Expulsion time , need for analgesics , need for hospitalization , and drug side effects were the secondary endpoints . RESULTS The expulsion rate was significantly higher in group 2 ( 90 % ) than in group 1 ( 58.7 % ; P = 0.01 ) , and group 2 achieved stone passage in a shorter time ( mean 4.4 v 7.5 days , respectively ; P = 0.005 ) . Lower analgesic use was found in group 2 ( P = 0.003 ) , as well as significantly fewer hospitalizations for recurrent colic ( P = 0.01 ) . Both groups experienced few side effects associated with expulsive therapy . CONCLUSIONS A conservative approach should be considered as an option in the management of uncomplicated distal-ureteral stones . Even if the best pharmacologic expulsive regimen remains to be established , the use of the selective alpha-blocker tamsulosin is recommended in this setting OBJECTIVES To evaluate whether alpha1-blockers have any impact on stone clearance in patients with lower ureteral stones who underwent either shock wave lithotripsy ( SWL ) or were followed up with st and ard hydration , analgesics , and anti-inflammatory treatment . METHODS A total of 78 patients ( 56 men and 22 women ) who had lower ureteral stones located at the distal 5 cm of the ureter were divided into four groups . The first group consisted of 30 patients ( 38.5 % ) with stones less than 5 mm ( range 3 to 5 ) who were r and omly divided into two subgroups . Group 1 consisted of 15 patients ( 19.2 % ) who were followed up with oral hydration and diclofenac sodium . Group 2 consisted of 15 patients ( 19.2 % ) who received tamsulosin 0.4 mg daily in addition to the st and ard regimens . The second two groups consisted of 48 patients ( 61.5 % ) with stones greater than 5 mm ( range 6 to 15 ) who underwent SWL . These patients were also r and omly divided between those who did not ( group 3 , n = 24 ) and those who did ( group 4 , n = 24 ) receive tamsulosin 0.4 mg daily . All patients were re-evaluated with plain abdominal x-rays and helical computed tomography 15 days after the beginning of treatment . RESULTS Of the 78 patients , 36 ( 46.2 % ) became stone free . The stone-free rate was 20 % , 53.3 % , 33.3 % , and 70.8 % for group 1 , 2 , 3 , and 4 , respectively . The best results were achieved in those who underwent SWL plus tamsulosin treatment ( group 4 ) . The differences between the stone-free rates for groups 3 versus 4 ( P = 0.019 ) and the tamsulosin versus control groups ( P = 0.0015 ) were statistically significant . CONCLUSIONS The addition of tamsulosin to conventional treatment seemed beneficial in terms of stone clearance of lower ureteral stones , and this effect was more evident for larger stones , especially when combined with SWL Low-dose ( 0.2 mg/day ) and st and ard-dose ( 0.4 mg/day ) tamsulosin were studied in a r and omized controlled trial of 75 out patients with distal ureteroliths in Thail and . Group 1 ( n = 25 ; control ) received oral sodium diclofenac 50 mg twice a day for 10 days ; group 2 ( n = 25 ) received oral sodium diclofenac 50 mg twice a day for 10 days , with oral tamsulosin 0.2 mg once a day up to 28 days ; and group 3 ( n = 25 ) received oral sodium diclofenac 50 mg twice a day for 10 days , with oral tamsulosin 0.4 mg once a day up to 28 days . For groups 1 , 2 and 3 , respectively , the expulsion rates were 4 % , 40 % and 68 % ( significantly different for group 1 vs group 2 , and for group 1 vs group 3 ) and mean expulsion times were 23.00 , 9.30 and 10.76 days . Both doses of tamsulosin increased stone expulsion rate and decreased expulsion time in comparison with the control , and have been shown to be safe and effective in Asian patients PURPOSE Recent studies show the interesting efficacy of different drug combinations for the spontaneous expulsion of distal ureteral stones . We performed a r and omized , prospect i ve study to assess and compare the efficacy of 3 drugs as medical expulsive therapy for distal ureteral calculi . MAT Output:
CONCLUSION Tamsulosin increases the rate of spontaneous passage of distal ureterolithiasis ( ≤ 10 mm )
MS2_1shot281
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: R and omized controlled trials have yielded promising results for internet-delivered cognitive behavior therapy ( iCBT ) for patients with social anxiety disorder ( SAD ) . The present study investigated anxiety-related neural changes after iCBT for SAD . The amygdala is a critical hub in the neural fear network , receptive to change using emotion regulation strategies and a putative target for iCBT . Twenty-two subjects were included in pre- and post-treatment functional magnetic resonance imaging at 3 T assessing neural changes during an affective face processing task . Treatment outcome was assessed using social anxiety self-reports and the Clinical Global Impression-Improvement ( CGI-I ) scale . ICBT yielded better outcome than ABM ( 66 % vs. 25 % CGI-I responders ) . A significant differential activation of the left amygdala was found with relatively decreased reactivity after iCBT . Changes in the amygdala were related to a behavioral measure of social anxiety . Functional connectivity analysis in the iCBT group showed that the amygdala attenuation was associated with increased activity in the medial orbitofrontal cortex and decreased activity in the right ventrolateral and dorsolateral ( dlPFC ) cortices . Treatment-induced neural changes with iCBT were consistent with previously reported studies on regular CBT and emotion regulation in general Background : Cognitive behavioral therapy ( CBT ) is an effective treatment for panic disorder with agoraphobia ( PD/AG ) . It is unknown , how variants of CBT differentially modulate brain networks involved in PD/AG . This study was aim ed to evaluate the effects of therapist-guided ( T+ ) versus self-guided ( T- ) exposure on the neural correlates of fear conditioning in PD/AG . Method : In a r and omized , controlled multicenter clinical trial in medication-free patients with PD/AG who were treated with 12 sessions of manualized CBT , functional magnetic resonance imaging ( fMRI ) was used during fear conditioning before ( t1 ) and after CBT ( t2 ) . Quality -controlled fMRI data from 42 patients and 42 healthy subjects ( HS ) were obtained . Patients were r and omized to two variants of CBT ( T+ , n = 22 , and T- , n = 20 ) . Results : The interaction of diagnosis ( PD/AG , HS ) , treatment group ( T+ , T- ) , time point ( t1 , t2 ) and stimulus type ( conditioned stimulus : yes , no ) revealed activation in the left hippocampus and the occipitotemporal cortex . The T+ group demonstrated increased activation of the hippocampus at t2 ( t2 > t1 ) , which was positively correlated with treatment outcome , and a decreased connectivity between the left inferior frontal gyrus and the left hippocampus across time ( t1 > t2 ) . Conclusion : After T+ exposure , contingency-encoding processes related to the posterior hippocampus are augmented and more decoupled from processes of the left inferior frontal gyrus , previously shown to be dysfunctionally activated in PD/AG . Linking single procedural variants to neural substrates offers the potential to inform about the optimization of targeted psychotherapeutic interventions IMPORTANCE Cognitive behavioral therapy ( CBT ) for social anxiety disorder ( SAD ) is thought to enhance cognitive re appraisal in patients with SAD . Such improvements should be evident in cognitive re appraisal -related prefrontal cortex responses . OBJECTIVE To determine whether CBT for SAD modifies cognitive re appraisal -related prefrontal cortex neural signal magnitude and timing when implementing cognitive re appraisal with negative self-beliefs . DESIGN R and omized clinical trial of CBT for SAD vs wait-list control group during a study that enrolled patients from 2007 to 2010 . SETTING University psychology department . PARTICIPANTS Seventy-five patients with generalized SAD r and omly assigned to CBT or wait list . INTERVENTION Sixteen sessions of individual CBT for SAD . MAIN OUTCOME MEASURES Negative emotion ratings and functional magnetic resonance imaging blood oxygen-level dependent signal when reacting to and cognitively reappraising negative self-beliefs embedded in autobiographical social anxiety situations . RESULTS During reactivity trials , compared with wait list , CBT produced ( 1 ) greater reduction in negative emotion ratings and ( 2 ) greater blood oxygen-level dependent signal magnitude in the medial prefrontal cortex . During cognitive re appraisal trials , compared with wait list , CBT produced ( 3 ) greater reduction in negative emotion ratings , ( 4 ) greater blood oxygen level-dependent signal magnitude in the dorsolateral and dorsomedial prefrontal cortex , ( 5 ) earlier temporal onset of dorsomedial prefrontal cortex activity , and ( 6 ) greater dorsomedial prefrontal cortex-amygdala inverse functional connectivity . CONCLUSIONS AND RELEVANCE Modulation of cognitive re appraisal -related brain responses , timing , and functional connectivity may be important brain changes that contribute to the effectiveness of CBT for social anxiety . This study demonstrates that clinical ly applied neuroscience investigations can eluci date neurobiological mechanisms of change in psychiatric conditions . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00380731 Social anxiety disorder patients suffer from excessive anxious responses in social interaction leading to avoidance behavior and social impairment . Although the amygdala has a central role in perception and processing of threatening cues , little is known about the involved networks and corresponding dysfunctions in social anxiety . Therefore , this study aims to investigate the functional connectivity network of the amygdala in patients with social anxiety disorder and to identify regions that might influence amygdalar reactivity via modulatory pathways . Ten patients with anxiety disorders ( social and /or panic ) and 27 healthy controls underwent a facial emotion processing task as well as 6-min functional MRI at resting state . Individual voxel-wise functional connectivity maps were calculated using the amygdala as seed region . Group comparisons were done by r and om-effects analysis in SPM . Patients exhibited an amygdala hyperactivation during the emotional task and decreased functional coupling of the left amygdala with the medial orbitofrontal cortex and the posterior cingulate cortex/precuneus . The strength of this functional connectivity showed a negative association with the severity of state anxiety . In addition , an exploratory analysis revealed further reduced functional connectivity and a marked functional separation between the medial orbitofrontal and anterior cingulate cortices in the patient group . Our results suggest alterations within the amygdalar functional connectivity network in social anxiety disorder . Combined with the amygdalar hyperactivation our findings corroborate the proposed dysfunction of the fronto-amygdalar inhibition in anxiety disorders and indicate a modulatory influence of the anterior and posterior cingulate cortices on threat perception and processing BACKGROUND Learning by conditioning is a key ability of animals and humans for acquiring novel behavior necessary for survival in a changing environment . Aberrant conditioning has been considered a crucial factor in the etiology and maintenance of panic disorder with agoraphobia ( PD/A ) . Cognitive-behavioral therapy ( CBT ) is an effective treatment for PD/A. However , the neural mechanisms underlying the effects of CBT on conditioning processes in PD/A are unknown . METHODS In a r and omized , controlled , multicenter clinical trial in medication-free patients with PD/A who were treated with 12 sessions of manualized CBT , functional magnetic resonance imaging ( fMRI ) was used during fear conditioning before and after CBT . Quality -controlled fMRI data from 42 patients and 42 healthy subjects were obtained . RESULTS After CBT , patients compared to control subjects revealed reduced activation for the conditioned response ( CS+ > CS- ) in the left inferior frontal gyrus ( IFG ) . This activation reduction was correlated with reduction in agoraphobic symptoms from t1 to t2 . Patients compared to control subjects also demonstrated increased connectivity between the IFG and regions of the " fear network " ( amygdalae , insulae , anterior cingulate cortex ) across time . CONCLUSIONS This study demonstrates the link between cerebral correlates of cognitive ( IFG ) and emotional ( " fear network " ) processing during symptom improvement across time in PD/A. Further research along this line has promising potential to support the development and further optimization of targeted treatments One component of mindfulness training ( MT ) is the development of interoceptive attention ( IA ) to visceral bodily sensations , facilitated through daily practice s such as breath monitoring . Using functional magnetic resonance imaging ( fMRI ) , we examined experience-dependent functional plasticity in accessing interoceptive representations by comparing graduates of a Mindfulness-Based Stress Reduction course to a waitlisted control group . IA to respiratory sensations was contrasted against two visual tasks , controlling for attentional requirements non-specific to IA such as maintaining sensation and suppressing distraction . In anatomically partitioned analyses of insula activity , MT predicted greater IA-related activity in anterior dysgranular insula regions , consistent with greater integration of interoceptive sensation with external context . MT also predicted decreased recruitment of the dorsomedial prefrontal cortex ( DMPFC ) during IA , and altered functional connectivity between the DMPFC and the posterior insula , putative primary interoceptive cortex . Furthermore , meditation practice compliance predicted greater posterior insula and reduced visual pathway recruitment during IA . These findings suggest that interoceptive training modulates task-specific cortical recruitment , analogous to training-related plasticity observed in the external senses . Further , DMPFC modulation of IA networks may be an important mechanism by which MT alters information processing in the brain , increasing the contribution of interoception to perceptual experience Background Given the variable response to cognitive – behavioral therapy ( CBT ) when added to antipsychotic medication in psychosis and the evidence for a role of pretherapy level of frontal lobe – based cognitive function in responsiveness to CBT in other disorders , this study examined whether pretherapy brain activity associated with working memory neural network predicts clinical responsiveness to CBT in schizophrenia . Methods Fifty-two out patients stable on medication with at least one distressing symptom of schizophrenia and willing to receive CBT in addition to their usual treatment and 20 healthy participants underwent functional magnetic resonance imaging during a parametric n-back task . Subsequently , 26 patients received CBT for psychosis ( CBT+treatment-as-usual [ TAU ] , 19 completers ) for 6–8 months , and 26 continued with TAU alone ( 17 completers ) . Symptoms in both patient groups were assessed ( blindly ) at entry and follow-up . Results The CBT+TAU and TAU-alone groups did not differ clinical ly or in performance at baseline . The CBT+TAU group showed significant improvement in relation to the TAU-alone group , which showed no change , at follow-up . Stronger dorsolateral prefrontal cortex ( DLPFC ) activity ( within the normal range ) and DLPFC – cerebellum connectivity during the highest memory load condition ( 2-back > 0-back ) were associated with post-CBT clinical improvement . Conclusions DLPFC activity and its connectivity with the cerebellum predict responsiveness to CBT for psychosis in schizophrenia . These effects may be mediated by PFC – cerebellum contributions to executive processing Neuroimaging research has demonstrated that ventromedial prefrontal cortex ( vmPFC ) encodes value signals that can be modulated by top-down cognitive input such as semantic knowledge , price incentives , and monetary favors suggesting that such biases may have an identified biological basis . It has been hypothesized that mindfulness training ( MT ) provides one path for gaining control over such top-down influences ; yet , there have been no direct tests of this hypothesis . Here , we probe the behavioral and neural effects of MT on value signals in vmPFC in a r and omized longitudinal design of 8 weeks of MT on an initially naïve subject cohort . The impact of this within-subject training was assessed using two paradigms : one that employed primary rewards ( fruit juice ) in a simple conditioning task and another that used a well-vali date d art-viewing paradigm to test bias of monetary favors on preference . We show that MT behaviorally censors the top-down bias of monetary favors through a measurable influence on value signals in vmPFC . MT also modulates value signals in vmPFC to primary reward delivery . Using a separate cohort of subjects we show that 8 weeks of active control training ( ACT ) generates the same behavioral impact also through an effect on signals in the vmPFC . Importantly , functional connectivity analyses show that value signals in vmPFC are coupled with bilateral posterior insula in the MT groups in both paradigms , but not in the ACT groups . These results suggest that MT integrates interoceptive input from insular cortex in the context of value computations of both primary and secondary rewards Output:
Conclusion : While the evidence base is still in its infancy for other therapy approaches , there was clearer evidence that functional connectivity both predicts and is altered by cognitive behavioural therapy . Connections from prefrontal cortex appear especially key , perhaps given their role in cognitive appraisal of lower order affective , motivational and cognitive processes .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVE There is conflicting evidence regarding the benefit of intravenous insulin therapy on mortality following acute myocardial infa rct ion ( AMI ) . The goal of the current study was to determine whether improved glycemic control , achieved through an insulin/dextrose infusion with a variable rate of insulin , reduces mortality among hyperglycemic patients with AMI . RESEARCH DESIGN AND METHODS Subjects suffering AMI with either known diabetes or without diabetes but blood glucose level ( BGL ) > or = 7.8 mmol/l were r and omized to receive insulin/dextrose infusion therapy for at least 24 h to maintain a BGL < 10 mmol/l or conventional therapy . RESULTS A total of 240 subjects were recruited . Insulin/dextrose infusion did not reduce mortality at the inpatient stage ( 4.8 vs. conventional 3.5 % , P = 0.75 ) , 3 months ( 7.1 vs 4.4 % , P = 0.42 ) , or 6 months ( 7.9 vs. 6.1 % , P = 0.62 ) . There was , however , a lower incidence of cardiac failure ( 12.7 vs. 22.8 % , P = 0.04 ) and reinfa rct ion within 3 months ( 2.4 vs. 6.1 % , P = 0.05 ) . When analyzed by mean BGL achieved during the first 24 h , mortality was lower among subjects with a mean BGL < or = 8 mmol/l , compared with subjects with a mean BGL > 8 mmol/l ( 2 vs. 11 % at 6 months , P = 0.02 ) . CONCLUSIONS We did not find a reduction in mortality among patients who received insulin/dextrose infusion therapy . However , it remains possible that tight glycemic control with insulin therapy following AMI improves outcomes PURPOSE Hospitalized patients with type 2 diabetes mellitus traditionally receive insulin on a sliding-scale regimen , but the benefits of this approach are unclear . The purpose of this study was to compare the effects of the sliding scale insulin regimen with those of routine diabetes medications on hyperglycemia , hypoglycemia and length of hospitalization in diabetic patients hospitalized for other conditions . METHODS This was a multicenter , r and omized controlled trial conducted in family medicine inpatient services . One hundred fifty-three patients with type 2 diabetes mellitus hospitalized for other conditions were r and omized to receive routine diabetes medications ( control ) or the combination of a st and ard sliding-scale insulin regimen and routine diabetes medications ( intervention ) . The outcome measures included frequency of hyperglycemia and hypoglycemia ( glycemic events ) , and length of hospitalization . RESULTS No differences were identified between treatment groups in the frequency of glycemic events . In the intervention group , 33.3 % of patients developed hyperglycemia compared to 34.6 % in the control group ( P = .87 ) . Six patients developed hypoglycemia in the intervention group , compared with 7 in the control group ( P = .83 ) . There was no difference in length of hospitalization ( P = .86 ) . Regardless of treatment assignment , patients receiving intermediate-acting insulin ( OR , 2.8 ; 95 % CI , 1.2–6.5 ) , those with blood glucose values greater than 250 mg/dL at baseline ( OR , 6.3 ; 95 % CI , 2.3 – 17.2 ) and those receiving corticosteroids ( OR , 9.1 ; 95 % CI , 3.1 – 27.0 ) were more likely to have glycemic events . CONCLUSIONS The use of the sliding scale insulin regimen in combination with routine diabetes medications does not affect the rate of hyperglycemia , hypoglycemia or length of hospitalization in patients with type 2 diabetes mellitus hospitalized for other conditions OBJECTIVE Recent studies suggest that strict perioperative glycemic control improves clinical outcomes after cardiothoracic surgery . However , optimal methods and targets for controlling blood glucose ( BG ) levels in this setting have not been established . Currently published intensive insulin infusion protocol s ( IIPs ) have important practical limitations , which may affect their utility . In this article , the authors present their experience with a safe , effective , nurse-driven IIP , which was implemented simultaneously in 2 cardiothoracic intensive care units ( CTICUs ) . DESIGN Prospect i ve cohort study . SETTING Tertiary referral hospital and community teaching hospital . PARTICIPANTS CTICU patients . INTERVENTIONS A st and ardized , intensive IIP was used for all patients admitted to both CTICUs . Hourly BG levels , relevant baseline variables , and clinical interventions were collected prospect ively from the active hospital chart and CTICU nursing records . MEASUREMENTS AND MAIN RESULTS The IIP was used 137 times in 118 patients . The median time required to reach target BG levels ( 100 - 139 mg/dL ) was 5 hours . Once BG levels decreased below 140 mg/dL , 58 % of 2,242 subsequent hourly BG values fell within the narrow target range , 73 % within a " clinical ly desirable " range of 80 to 139 mg/dL , and 94 % within a " clinical ly acceptable " range of 80 to 199 mg/dL. Only 5 ( 0.2 % ) BG values were less than 60 mg/dL , with no associated adverse clinical events . CONCLUSIONS The IIP safely and effectively improved glycemic control in 2 CTICUs , with minimal hypoglycemia . Based on prior studies showing the benefits of strict glycemic control , the implementation of this IIP should help to reduce morbidity and mortality in CTICU patients OBJECTIVES We tested how insulin-glucose infusion followed by multidose insulin treatment in diabetic patients with acute myocardial infa rct ion affected mortality during the subsequent 12 months of follow-up . BACKGROUND Despite significant improvements in acute coronary care , diabetic patients with acute myocardial infa rct ion still have a high mortality rate . METHODS A total of 620 patients were studied : 306 r and omized to treatment with insulin-glucose infusion followed by multidose subcutaneous insulin for > or = 3 months and 314 to conventional therapy . RESULTS The two groups were well matched for baseline characteristics . Blood glucose decreased from 15.4 + /- 4.1 to 9.6 + /- 3.3 mmol/liter ( mean + /- SD ) in the infusion group during the 1st 24 h , and from 15.7 + /- 4.2 to 11.7 + /- 4.1 among control patients ( p < 0.0001 ) . After 1 year 57 subjects ( 18.6 % ) in the infusion group and 82 ( 26.1 % ) in the control group had died ( relative mortality reduction 29 % , p = 0.027 ) . The mortality reduction was particularly evident in patients who had a low cardiovascular risk profile and no previous insulin treatment ( 3-month mortality rate 6.5 % in the infusion group vs. 13.5 % in the control group [ relative reduction 52 % , p = 0.046 ] ; 1-year mortality rate 8.6 % in the infusion group vs. 18.0 % in the control group [ relative reduction 52 % , p = 0.020 ] ) . CONCLUSIONS Insulin-glucose infusion followed by a multidose insulin regimen improved long-term prognosis in diabetic patients with acute myocardial infa rct ion CONTEXT While glucose control is recommended by professional societies for patients with hyperglycemia hospitalized with acute myocardial infa rct ion ( AMI ) , enthusiasm for glucose lowering is tempered , in part , by concerns of inducing hypoglycemia . Yet , whether episodic hypoglycemia that occurs as a result of glucose-lowering therapy is harmful in patients with AMI is unknown . OBJECTIVE To determine whether the mortality risk associated with hypoglycemic events is similar in patients who develop hypoglycemia spontaneously and those who develop it as a result of insulin therapy . DESIGN , SETTING , AND PATIENTS Retrospective cohort study using data from Health Facts , a contemporary data base of patients hospitalized across the United States in 40 hospitals between January 1 , 2000 , and December 31 , 2005 . Of all the patients in the data base , 7820 patients were hospitalized with AMI and were hyperglycemic on admission ( glucose level > or = 140 mg/dL ) . Patients were stratified based on whether they developed a hypoglycemic event ( r and om glucose level < 60 mg/dL ) during subsequent hospitalization . Logistic regression models were used to evaluate the association between hypoglycemia and in-hospital mortality within subgroups of patients who were and were not treated with insulin therapy . MAIN OUTCOME MEASURE All-cause in-hospital mortality . RESULTS Among patients treated or not treated with insulin , those with hypoglycemia were older and had more comorbidity . Hypoglycemia was associated with increased mortality in patients not treated with insulin ( 18.4 % [ 25/136 ] mortality in patients with hypoglycemia vs 9.2 % [ 425/4639 ] in those without hypoglycemia ; P<.001 ) , but not in those treated with insulin ( 10.4 % [ 36/346 ] mortality in patients with hypoglycemia vs 10.2 % [ 276/2699 ] in those without hypoglycemia ; P = .92 ) . After multivariable adjustment , there was a significant interaction between hypoglycemia and insulin therapy ( P value for interaction = .01 ) . Hypoglycemia was a predictor of higher mortality in patients who were not treated with insulin ( odds ratio , 2.32 [ 95 % confidence interval , 1.31 - 4.12 ] vs patients without hypoglycemia ) , but not in patients treated with insulin ( odds ratio , 0.92 [ 95 % confidence interval , 0.58 - 1.45 ] vs patients without hypoglycemia ) . CONCLUSIONS While hypoglycemia was associated with increased mortality in patients with AMI , this risk was confined to patients who developed hypoglycemia spontaneously . In contrast , iatrogenic hypoglycemia after insulin therapy was not associated with higher mortality risk CONTEXT Hyperglycemia is common in critically ill patients , even in those without diabetes mellitus . Aggressive glycemic control may reduce mortality in this population . However , the relationship between mortality , the control of hyperglycemia , and the administration of exogenous insulin is unclear . OBJECTIVE To determine whether blood glucose level or quantity of insulin administered is associated with reduced mortality in critically ill patients . DESIGN , SETTING , AND PATIENTS Single-center , prospect i ve , observational study of 531 patients ( median age , 64 years ) newly admitted over the first 6 months of 2002 to an adult intensive care unit ( ICU ) in a UK national referral center for cardiorespiratory surgery and medicine . MAIN OUTCOME MEASURES The primary end point was intensive care unit ( ICU ) mortality . Secondary end points were hospital mortality , ICU and hospital length of stay , and predicted threshold glucose level associated with risk of death . RESULTS Of 531 patients admitted to the ICU , 523 underwent analysis of their glycemic control . Twenty-four-hour control of blood glucose levels was variable . Rates of ICU and hospital mortality were 5.2 % and 5.7 % , respectively ; median lengths of stay were 1.8 ( interquartile range , 0.9 - 3.7 ) days and 6 ( interquartile range , 4.5 - 8.3 ) days , respectively . Multivariable logistic regression demonstrated that increased administration of insulin was positively and significantly associated with ICU mortality ( odds ratio , 1.02 [ 95 % confidence interval , 1.01 - 1.04 ] at a prevailing glucose level of 111 - 144 mg/dL [ 6.1 - 8.0 mmol/L ] for a 1-IU/d increase ) , suggesting that mortality benefits are attributable to glycemic control rather than increased administration of insulin . Also , the regression models suggest that a mortality benefit accrues below a predicted threshold glucose level of 144 to 200 mg/dL ( 8.0 - 11.1 mmol/L ) , with a speculative upper limit of 145 mg/dL ( 8.0 mmol/L ) for the target blood glucose level . CONCLUSIONS Increased insulin administration is positively associated with death in the ICU regardless of the prevailing blood glucose level . Thus , control of glucose levels rather than of absolute levels of exogenous insulin appear to account for the mortality benefit associated with intensive insulin therapy demonstrated by others Good blood glucose control in hospitalized adults leads to reduced mortality . Intravenous ( IV ) insulin has been shown to be an effective way to achieve tight control of blood glucose . Managing IV insulin is a labor-intensive task for nurses Output:
No consistent evidence showed that IIT reduced long-term mortality , infection rates , length of stay , or the need for renal replacement therapy . Risk for IIT-associated hypoglycemia was increased in all hospital setting s. LIMITATIONS Method ological shortcomings and inconsistencies limit the data in perioperative care , myocardial infa rct ion , and stroke or brain injury setting s. Differences in insulin protocol s and patient and hospital characteristics may affect generalizability across treatment setting s. CONCLUSION No consistent evidence demonstrates that IIT targeted to strict glycemic control compared with less strict glycemic control improves health outcomes in hospitalized patients . Furthermore , IIT is associated with an increased risk for severe hypoglycemia .
MS2_1shot283
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Background A large , district-wide , home-based HIV counselling and testing ( HBHCT ) programme was implemented in Bushenyi district of Ug and a from 2004 to 2007 . This programme provided free HBHCT services to all consenting adults of Bushenyi district and had a very high uptake and acceptability . We measured population -level changes in knowledge of HIV status , stigma and HIV-risk behaviours before and after HBHCT to assess whether widespread HBHCT had an effect on trends of risky sexual behaviours and on stigma and discrimination towards HIV . Methods Serial cross-sectional surveys were carried out before and after the implementation of HBHCT programme in Bushenyi district of Ug and a. A total of 1402 r and omly selected adults ( 18 to 49 years ) were interviewed in the baseline survey . After the implementation , a different set of r and omly selected 1562 adults was interviewed using the same question naire . Data was collected on socio-demographic characteristics , sexual behaviour , whether respondents had ever tested for HIV and stigma and discrimination towards HIV/AIDS . Results The proportion of people who had ever tested for HIV increased from 18.6 % to 62 % ( p<0.001 ) . Among people who had ever tested , the proportion of people who shared HIV test result with a sexual partner increased from 41 % to 57 % ( p<0.001 ) . The proportion of persons who wanted infection status of a family member not to be revealed decreased from 68 % to 57 % ( p<0.001 ) . Indicators of risk behaviour also improved ; the proportion of people who exchanged money for sex reduced from 12 % to 4 % ( p<0.001 ) , who used a condom when money was exchanged during a sexual act increased from 39 % to 80 % ( p<0.001 ) and who reported genital ulcer/discharge decreased from 22 % to 10 % ( p<0.001 ) . Conclusion These data suggest that HBHCT rapidly increased the uptake of HCT and may have led to reduction in high-risk behaviours at population level as well as reduction in stigma and discrimination . Because HBCT programmes are cost-effective , they should be considered for implementation in delivery of HIV services especially in areas where access to HCT is low Objective : Effective behavioral HIV prevention is needed for stable HIV-discordant couples at risk for HIV , especially those without access to biomedical prevention . This analysis addressed whether HIV testing and counseling with ongoing counseling and condom distribution lead to reduced unprotected sex in HIV-discordant couples . Methods : Partners in Prevention HSV/HIV Transmission Study was a r and omized trial conducted from 2004 to 2008 assessing whether acyclovir reduced HIV transmission from HSV-2/HIV-1–coinfected persons to HIV-uninfected sex partners . This analysis relied on self-reported behavioral data from 508 HIV-infected South African participants . The exposure was timing of first HIV testing and counseling : 0–7 , 8–14 , 15–30 , or > 30 days before baseline . In each exposure group , predicted probabilities of unprotected sex in the last month were calculated at baseline , month 1 , and month 12 using generalized estimating equations with a logit link and exchangeable correlation matrix . Results : At baseline , participants who knew their HIV status for less time experienced higher predicted probabilities of unprotected sex in the last month : 0–7 days , 0.71 ; 8–14 days , 0.52 ; 15–30 days , 0.49 ; > 30 days , 0.26 . At month 1 , once all participants had been aware of being in HIV-discordant relationships for ≥1 month , predicted probabilities declined : 0–7 days , 0.08 ; 8–14 days , 0.08 ; 15–30 days , 0.15 ; > 30 days , 0.14 . Lower predicted probabilities were sustained through month 12 : 0–7 days , 0.08 ; 8–14 days , 0.11 ; 15–30 days , 0.05 ; > 30 days , 0.19 . Conclusions : Unprotected sex declined after HIV-positive diagnosis and declined further after awareness of HIV discordance . Identifying HIV-discordant couples for behavioral prevention is important for reducing HIV transmission risk Introduction Hope is an essential dimension of successful coping in the context of illnesses such as HIV/AIDS , because positive expectations for the future alleviate emotional distress , enhance quality of life and have been linked to the capacity for behavioural change . The social environment ( e.g. family , peers ) is a regulator of hope for people living with HIV/AIDS ( PLWHA ) . In this regard , the dual aim of this article is ( 1 ) to analyze the influence of a peer adherence support ( PAS ) intervention and the family environment on the state of hope in PLWHA and ( 2 ) to investigate the interrelationship between the two determinants . Methods The Effective AIDS Treatment and Support in the Free State study is a prospect i ve r and omized controlled trial . Participants were recruited from 12 public antiretroviral treatment ( ART ) clinics across five districts in the Free State Province of South Africa . Each of these patients was assigned to one of the following groups : a control group receiving st and ard care , a group receiving additional biweekly PAS or a group receiving PAS and nutritional support . Latent cross-lagged modelling ( Mplus ) was used to analyse the impact of PAS and the family environment on the level of hope in PLWHA . Results The results of the study indicate that neither PAS nor the family environment has a direct effect on the level of hope in PLWHA . Subsequent analysis reveals a positive significant interaction between family functioning and PAS at the second follow-up , indicating that better family functioning increases the positive effect of PAS on the state of hope in PLWHA . Conclusions The interplay between well-functioning families and external PAS generates higher levels of hope , which is an essential dimension in the success of lifelong treatment . This study provides additional insight into the important role played by family dynamics in HIV/AIDS care , and it underscores the need for PAS interventions that are sensitive to the context s in which they are implemented Background Among people living with HIV ( PLHIV ) on antiretroviral therapy ( ART ) , it is important to determine how quality of life ( QOL ) may be improved and HIV-related stigma can be lessened over time . This study assessed the effect of peer support on QOL and internal stigma during the first year after initiating ART among a cohort of PLHIV in north-eastern Vietnam . Methods A sub- sample study of a r and omised controlled trial was implemented between October 2008 and November 2010 in Quang Ninh , Vietnam . In the intervention group , participants ( n = 119 ) received adherence support from trained peer supporters who visited participants ’ houses biweekly during the first two months , thereafter weekly . In the control group , participants ( n = 109 ) were treated according to st and ard guidelines , including adherence counselling , monthly health check and drug refills . Basic demographics were measured at baseline . QOL and internal stigma were measured using a Vietnamese version of the WHOQOL-HIVBREF and Internal AIDS-related Stigma Scale instruments at baseline and 12 months . T-tests were used to detect the differences between mean values , multilevel linear regressions to determine factors influencing QOL . Results Overall , QOL improved significantly in the intervention group compared to the control group . Among participants initiating ART at clinical stages 3 and 4 , education at high school level or above and having experiences of a family member dying from HIV were also associated with higher reported QOL . Among participants at clinical stage 1 and 2 , there was no significant effect of peer support , whereas having children was associated with an increased QOL . Viral hepatitis was associated with a decreased QOL in both groups . Lower perceived stigma correlated significantly but weakly with improved QOL , however , there was no significant relation to peer support . Conclusion The peer support intervention improved QOL after 12 months among ART patients presenting at clinical stages 3 and 4 at baseline , but it had no impact on QOL among ART patients enrolled at clinical stages 1 and 2 . The intervention did not have an effect on Internal AIDS-related stigma . To improve QOL for PLHIV on ART , measures to support adherence should be context ualized in accordance with individual clinical and social needs An extensive multi-disciplinary literature examines the effects of learning one 's HIV status on subsequent risky sexual behaviors . However , many of these studies rely on non-experimental design s ; use self-reported outcome measures , or both . This study investigates the effects of a r and omly assigned home based HIV testing and counseling ( HTC ) intervention on risky sexual behaviors and schooling investments among school-age females in Malawi . The study finds no overall effects on HIV , Herpes Simplex Virus ( HSV-2 ) , or achievement test scores at follow-up . However , among the small group of individuals who tested positive for HIV , a large increase in the probability of contracting HSV-2 is found , with this effect stronger among those surprised by their test results . Similarly , those surprised by HIV-negative test results see a significant improvement in achievement test scores , consistent with increased returns to investments in human capital . The finding of increased HSV-2 prevalence among HIV-positive individuals suggests that the conventional wisdom that those who learn they are HIV-positive will adopt safer sexual practice s should be treated with caution This paper evaluates an experiment in which individuals in rural Malawi were r and omly assigned monetary incentives to learn their HIV results after being tested . Distance to the HIV results centers was also r and omly assigned . Without any incentive , 34 percent of the participants learned their HIV results . However , even the smallest incentive doubled that share . Using the r and omly assigned incentives and distance from results centers as instruments for the knowledge of HIV status , sexually active HIV-positive individuals who learned their results are three times more likely to purchase condoms two months later than sexually active HIV-positive individuals who did not learn their results ; however , HIV-positive individuals who learned their results purchase only two additional condoms than those who did not . There is no significant effect of learning HIV-negative status on the purchase of condoms OBJECTIVE Antiretroviral therapy ( ART ) significantly decreases HIV-associated morbidity , mortality , and HIV transmission through HIV viral load suppression . In high HIV prevalence setting s , outreach strategies are needed to find asymptomatic HIV positive persons , link them to HIV care and ART , and achieve viral suppression . METHODS We conducted a prospect i ve intervention study in two rural communities in KwaZulu-Natal , South Africa , and Mbabara district , Ug and a. The intervention included home HIV testing and counseling ( HTC ) , point-of-care CD4 count testing for HIV positive persons , referral to care , and one month then quarterly lay counselor follow-up visits . The outcomes at 12 months were linkage to care , and ART initiation and viral suppression among HIV positive persons eligible for ART ( CD4≤350 cells/μL ) . FINDINGS 3,393 adults were tested for HIV ( 96 % coverage ) , of whom 635 ( 19 % ) were HIV positive . At baseline , 36 % of HIV positive persons were newly identified ( 64 % were previously known to be HIV positive ) and 40 % were taking ART . By month 12 , 619 ( 97 % ) of HIV positive persons visited an HIV clinic , and of 123 ART eligible participants , 94 ( 76 % ) initiated ART by 12 months . Of the 77 participants on ART by month 9 , 59 ( 77 % ) achieved viral suppression by month 12 . Among all HIV positive persons , the proportion with viral suppression ( < 1,000 copies/mL ) increased from 50 % to 65 % ( p=<0.001 ) at 12 months . INTERPRETATION Community-based HTC in rural South Africa and Ug and a achieved high testing coverage and linkage to care . Among those eligible for ART , a high proportion initiated ART and achieved viral suppression , indicating high adherence . Implementation of this HTC approach by existing community health workers in Africa should be evaluated to determine effectiveness and costs Home-based voluntary HIV counselling and testing ( HB-VCT ) has been reported to have a high uptake , but it has not been rigorously evaluated . We design ed a model for HB-VCT appropriate for wider scale-up , and investigated the acceptance of home-based counselling and testing , equity in uptake and negative life events with a cluster-r and omized trial . Thirty six rural clusters in southern Zambia were pair-matched based on baseline data and r and omly assigned to the intervention or the control arm . Both arms had access to st and ard HIV testing services . Adults in the intervention clusters were offered HB-VCT by local lay counsellors . Effects were first analysed among those participating in the baseline and post-intervention surveys and then as intention-to-treat analysis . The study was registered with www.controlled-trials.com , number IS RCT N53353725 . A total of 836 and 858 adults were assigned to the intervention and control clusters , respectively . In the intervention arm , counselling was accepted by 85 % and 66 % were tested ( n = 686 ) . Among counselled respondents who were cohabiting with the partner , 62 % were counselled together with the partner . At follow-up eight months later , the proportion of adults reporting to have been tested the year prior Output:
Home-based HCT is protective against intimate partner violence , stigmatizing behavior , having multiple sexual partners , and having casual sexual partners .
MS2_1shot284
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Examination of differences between primary alcohol and drug abusing adolescents can provide valuable direction to intervention efforts , though little research in this area has been conducted . The current study compared primary alcohol and primary drug abusing runaway adolescents who were r and omly assigned to family therapy or treatment as usual . Baseline differences , as well as response to treatment , were examined separately for alcohol and drug use and by gender . Although few baseline differences were found , hierarchical linear modeling indicated that alcohol and drug abusing male and female adolescents responded differently to therapy . Primary drug using males showed poorer alcohol use outcomes than did primary alcohol abusers . Specifically , alcohol use increased for primary drug using males receiving family therapy , while drug use decreased in all groups . Findings suggest that alcohol and drug use outcomes might be improved at treatment planning through consideration of client 's gender and primary alcohol versus drug use PURPOSE We evaluate the efficacy of a short family intervention in reducing sexual risk behavior , drug use , and delinquent behaviors among homeless youth . METHODS A r and omized controlled trial of 151 families with a homeless adolescent aged 12 to 17 years . Between March 2006 and June 2009 , adolescents were recruited from diverse sites in Southern California and were assessed at recruitment ( baseline ) , and at 3 , 6 , and 12 months later . Families were r and omly assigned to an intervention condition with five weekly home-based intervention sessions or a control condition ( st and ard care ) . Main outcome measures reflect self-reported sexual risk behavior , substance use , and delinquent behaviors over the past 90 days . RESULTS Sexual risk behavior ( e.g. , mean number of partners ; p < .001 ) , alcohol use ( p = .003 ) , hard drug use ( p < .001 ) , and delinquent behaviors ( p = .001 ) decreased significantly more during 12 months in the intervention condition compared with the control condition . Marijuana use , however , significantly increased in the intervention condition compared with the control condition ( p < .001 ) . CONCLUSIONS An intervention to reengage families of homeless youth has significant benefits in reducing risk over 12 months Runaway youth report a broader range and higher severity of substance-related , mental health and family problems relative to non-runaway youth . Most studies to date have collected self-report data on the family and social history ; virtually no research has examined treatment effectiveness with this population . This study is a treatment development project in which 124 runaway youth were r and omly assigned to ( 1 ) ecologically based family therapy ( EBFT ) or ( 2 ) service as usual ( SAU ) through a shelter . Youth completed an intake , posttreatment , 6 and 12 months follow-up assessment . Youth assigned to EBFT reported greater reductions in overall substance abuse compared to youth assigned to SAU while other problem areas improved in both conditions . Findings suggest that EBFT is an efficacious intervention for this relatively severe population of youth This prospect i ve review was design ed to determine the effectiveness of a broad-spectrum health intervention program for homeless and runaway youth . Diagnosis , treatment , and counseling for drug use , sexually transmitted diseases ( STDs ) , and other health issues were provided all new admissions to a residential care facility during a 2-month enrollment . Education was continued during a 9-month follow-up period based on the program entitled Bright Futures , previously developed and published by the National Center for Education in Maternal and Child Health . Sixty percent of the 106 study residents had STDs on admission and 7 % developed new STDs after completing therapy and undergoing counseling . Drug dependence was reduced from 41 % to 3 % , and 42 % achieved full-time or part-time employment . Fifty-nine percent completed hepatitis B immunization with the 3-dose series . This experience suggests that an organized program of interventions in a residential care facility for homeless teenagers can significantly reduce drug dependence and STDs The broad objective of this study was to underst and the incidence and severity of aggression among sexually abused girls who were trafficked and who were then further used for commercial sexual exploitation ( referred to subsequently as sexually abused trafficked girls ) . In addition , the impact of counseling for minimizing aggression in these girls was investigated . A group of 120 sexually abused trafficked Indian girls and a group of 120 nonsexually abused Indian girls , aged 13 to 18 , participated in the study . The sexually abused trafficked girls were purposively selected from four shelters located in and around Kolkata , India . The nonsexually abused girls were selected r and omly from four schools situated near the shelters , and these girls were matched by age with the sexually abused trafficked girls . Data were collected using a Background Information Schedule and a st and ardized psychological test , that is , The Aggression Scale . Results revealed that 16.7 % of the girls were first sexually abused between 6 and 9 years of age , 37.5 % between 10 and 13 years of age , and 45.8 % between 14 and 17 years of age . Findings further revealed that 4.2 % of the sexually abused trafficked girls demonstrated saturated aggression , and 26.7 % were highly aggressive , that is , extremely frustrated and rebellious . Across age groups , the sexually abused trafficked girls suffered from more aggression ( p < .05 ) , compared with the nonvictimized girls . Psychological interventions , such as individual and group counseling , were found to have a positive impact on the sexually abused trafficked girls . These findings should motivate counselors to deal with sexually abused children . It is also hoped that authorities in welfare homes will underst and the importance of counseling for sexually abused trafficked children , and will appoint more counselors for this purpose Homeless youth face various health challenges . The effectiveness of a short intervention to promote sexual health in 572 homeless 16—23-year-olds ( M = 19.467 + 1.89 ) was conducted using a quasi-experimental repeated measures design . Data collected at three time points ( pre-intervention , immediately post-intervention and follow-up ) via laptop computers were analyzed using multivariate general linear mixed models . A significant condition by time interaction was found for self-reported AIDS/STD knowledge ; intervention participants had higher scores at first post-test . Females scored significantly higher on cognitive and behavioral outcomes while males reported significantly more sexual risk-taking behaviors . Findings support gender-specific interventions Runaway youth are 6–12 times more likely to become infected with HIV than other youth . Using a quasi-experimental design , the efficacy of an HIV prevention program was evaluated over 2 years among 2 groups of runaways : ( 1 ) those at 2 shelters who received Street Smart , an intensive HIV intervention program , and ( 2 ) youth at 2 control shelters . Street Smart provided youth with access to health care and condoms and delivered a 10-session skill-focused prevention program based on social learning theory to youth . Prior to analysis of the intervention 's outcomes , propensity scores were used to identify comparable subgroups of youth in the intervention ( n = 101 ) and control conditions ( n = 86 ) . Compared to females in the control condition , females in the intervention condition significantly reduced their unprotected sexual acts at 2 years and alcohol use , marijuana use , and the number of drugs used over 12 months . Male adolescents in the intervention condition showed significant reductions in marijuana use over 6 months compared to control youth . Adolescent HIV prevention programs must proactively identify mechanisms for maintaining behavior change over the long-term , and innovative research design s are needed to allow examination of agency-level interventions While many studies provide useful information on the risk behaviors in which homeless youth engage , few prior studies evaluate Human Immunodeficiency Virus ( HIV ) risk related reduction strategies . In this study , homeless youth ( n = 180 ) were recruited from a drop-in center and r and omly assigned to one of two conditions , either an integrated individual cognitive-behavioral treatment and HIV prevention intervention that focused on skills building and education or to treatment as usual . All youth were assessed at entry into the program and at 3 and 6 month follow-up points . Findings showed an interaction between treatment condition , age and time . In the interaction , youth assigned to the integrated treatment reported greater condom usage than youth assigned to treatment as usual , with younger youth assigned to treatment as usual showing no change in condom use . The number of sexual partners reported by youth in both treatment conditions was also reduced over time . However , youth in both conditions continued to engage in other high-risk behaviors . The integrated treatment findings are promising and suggest that interventions which target both HIV risk behavior in addition to other life areas ( substance use , mental health and housing ) among homeless youth may be necessary in order to significantly impact high-risk behaviors among this unique group The short-term results of a r and omized trial testing a brief feedback and motivational intervention for substance use among homeless adolescents are presented . Homeless adolescents ages 14 - 19 ( N = 285 ) recruited from drop-in centers at agencies and from street intercept were r and omly assigned to either a brief motivational enhancement ( ME ) group or 1 of 2 control groups . The 1-session motivational intervention presented personal feedback about patterns of risks related to alcohol or substance use in a style consistent with motivational interviewing . Follow-up interviews were conducted at 1 and 3 months postintervention . Youths who received the motivational intervention reported reduced illicit drug use other than marijuana at 1-month follow-up compared with youths in the control groups . Treatment effects were not found with respect to alcohol or marijuana . Post hoc analyses within the ME group suggested that those who were rated as more engaged and more likely to benefit showed greater drug use reduction than did those rated as less engaged . Limitations of the study are discussed as are implication s for development of future substance use interventions for this high-risk group This prospect i ve review was design ed to determine the effectiveness of a broad-spectrum health intervention program for homeless and runaway youth . Diagnosis , treatment , and counseling for drug use , sexually transmitted diseases ( STDs ) , and other health issues were provided to all new admissions to a residential care facility during a 7(1/2)-year enrollment . Education was continued during a minimum follow-up period of 9 months based on the program entitled Bright Futures , previously developed and published by the National Center for Education in Maternal and Child Health . Fifty-four percent of the study residents had STDs on admission , and 9 % developed new STDs after completing therapy and undergoing counseling . Drug dependence was reduced from 47 % to 4 % , and 46 % achieved full-time or part-time employment . Sixty-three percent completed hepatitis B immunization with the 3-dose series . This experience suggests that an organized program of interventions in a residential care facility for homeless teenagers can significantly reduce drug dependence and STDs ABSTRACT This study compared the costs and outcomes associated with three treatment programs that served 149 individuals with dual disorders ( i.e. , individuals with co-occurring severe mental illness and substance use disorders ) who were homeless at baseline . The three treatment programs were : Integrated Assertive Community Treatment ( IACT ) , Assertive Community Treatment only ( ACTO ) , and st and ard care ( Control ) . Participants were r and omly assigned to treatment and followed for a period of 24 months . Clients in the IACT and ACTO programs were more satisfied with their treatment program and reported more days in stable housing than clients in the Control condition . There were no significant differences between treatment groups on psychiatric symptoms and substance use . The average total costs associated with the IACT and Control conditions were significantly less than the average total costs for the ACTO condition A brief motivational intervention with 117 homeless adolescents was evaluated using a r and omized design and 3-month follow-up . The intervention was design ed to raise youths ' concerns about their substance use , support harm reduction , and encourage greater service utilization at a collaborating agency . The study was design ed to strengthen initial promising results of an earlier study ( P. L. Peterson , J. S. Baer , E. A. Wells , J. A. Ginzler , & S. B. Garrett , 2006 ) . Several modifications in the clinical protocol were included to enhance engagement with the intervention . Analyses revealed no significant benefits for intervention participants when homeless youths ' substance use rates were compared with those of control participants . Service utilization during the intervention period increased for those receiving the intervention but returned to baseline levels at follow-up . Participants reported overall reductions in substance use over time . Differences between sampling methods for the current and previous study are discussed , as are the limitations of brief interventions with this population . Future research needs to eluci date mechanisms of change and service engagement for highly vulnerable youth OBJECTIVE This research examined the impact of completing a question naire about blood donation on subsequent donation behavior among a large sample of experienced blood donors . DESIGN Participants ( N=4672 ) were r and omly assigned to an experimental condition that received a postal question naire measuring cognitions about donation or a control condition that did not receive a question naire . MAIN OUTCOME MEASURES Number of registration s at blood drives and number of successful blood donations were assessed using objective records both 6 months and 12 months later . RESULTS Findings indicated that , compared to control participants , the mean frequency of number of registration s at blood drives among participants in the experimental group was 8.6 % greater at 6 months ( p<.0.007 ) , and was 6.4 % greater at 12 months ( p<.035 ) . Significant effects were also observed for successful blood donations at 6 months ( p<.001 ) and 12 months ( p<.004 ) . CONCLUSION These findings provide the first evidence that the mere measurement is relevant to promoting consequential health behaviors . Implication s of the research for intervention evaluation are discussed This study examined the effects of cognitive- Output:
The interventions being evaluated consisted of time limited therapeutically based programmes which did not prove more effective than st and ard shelter or drop-in services for most outcomes and in most studies . There were favourable changes from baseline in outcomes for most particpants in therapy interventions and also in st and ard services . The review discussion section included consideration of the relevance of the findings for LMIC setting s. AUTHORS ' CONCLUSIONS Analysis across the included studies found no consistently significant benefit for the ' new ' interventions compared to st and ard services for street-connected children and young people .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Thirty – two patients scheduled for total knee arthroplasty were r and omized to receive an identical epidural blockade initiated 30 min before surgical incision ( N = 16 ) , or at closure of the surgical wound ( N=16 ) . Before induction of general anaesthesia the epidural catheter was tested with bupivacaine 7.5 mg ml‐1 , 2 ml . General anaesthesia was induced with thiopentone , pancuronium or atracurium , and fentanyl 0.1–0.3 mg , and maintained with N2O/O2 and enflurane . The epidural regimen consisted of a bolus of 16 ml of bupivacaine 7.5 mg ml‐1 plus morphine 2 mg , and continuous infusion of bupivacaine 1.25 mg ml‐1 plus morphine 0.05 mg – ml‐1 , 4 mlh‐1 for the first 24 h , and bupivacaine 0.625 mg ml‐1 plus morphine 0.05 mg·ml‐1 , 4 ml . h‐1 , for the next 24 h after operation . Additional morphine 2.5–5 mg was administered i.v . or i.m . for the first 24 h postoperatively , and ketobemidone or morphine 5–10 mg orally or rectally from 24 h to 7 d postoperatively , on request . Paracetamol 1000 mg every 8 h was administered from 48 h to 7 days postoperatively . No significant differences were observed in request for additional opioids , or in pain scores at rest or during mobilisation of the operated limb , during or after cessation of the epidural regimen . These results do not suggest timing of analgesia with a conventional , continuous epidural regimen to be of major clinical importance in patients undergoing total knee arthroplasty This prospect i ve , controlled study compared cold compressive dressings with wool and crepe in the postoperative management of patients undergoing total knee replacement ( TKR ) . Forty TKR patients were assessed for blood loss , pain , swelling , and range of motion . Patients in the cold compression group had less blood loss through suction drainage ( 982 mL versus 768 mL ) . A higher proportion of patients in the treatment group did not require blood transfusion postoperatively . Mean opiate requirements were lower in the cold compression group ( 0.57 versus 0.71 mg/kg/48 hours ) . The cold compression device appeared to reduce blood loss and pain following TKR BACKGROUND We studied whether a small dose of clonidine added to a ropivacaine-fentanyl mixture improves epidural analgesia without provoking side effects typically related to larger amounts of epidural clonidine . METHODS In this r and omized , double-blinded study , patients ( < or = 85 yr , ASA I-III ) underwent total knee arthroplasty ( TKA ) performed under spinal anaesthesia . After the operation , patients received an epidural infusion consisting of ropivacaine 2 mg ml(-1 ) and fentanyl 5 microg ml(-1 ) either without ( Group RF , n=33 ) or with clonidine 2 microg ml(-1 ) ( Group RFC , n=36 ) . The infusion rate was adjusted within the range 3 - 7 ml h(-1 ) . RESULTS Average rate of infusion was slightly smaller in Group RFC than in Group RF ( mean ( sd ) 4.7 ( 0.72 ) vs 5.2 ( 0.8 ) ml h(-1 ) , P=0.004 ) . Compared with the RF group , patients in the RFC group required significantly less rescue pain medication , that is i.m . oxycodone ( median ( 25th , 75th percentile ) 0 ( 0 , 7 ) vs 7 ( 0 , 12 ) mg , P=0.027 ) . Arterial pressure and heart rate were slightly lower in Group RFC throughout the study period ( mean difference between the groups 5 mm Hg ( P<0.002 ) and 3 min(-1 ) ( P=0.12 ) , respectively ) . The groups did not differ statistically with respect to nausea , motor block , and sedation . CONCLUSIONS The small amount of clonidine added to the low-dose ropivacaine-fentanyl mixture reduced the need for opioid rescue pain medication after TKA . Clonidine slightly decreased arterial pressure and heart rate without jeopardizing haemodynamics . Otherwise , the side effect profiles were comparable in both groups 68 consecutive patients who had primary knee arthroplasties because of arthrosis were r and omized to postoperative continuous passive motion ( CPM ) or active physical therapy ( APT ) . Rehabilitation in both groups was initiated on the first postoperative day . The CPM group sustained less postoperative knee swelling with more rapid initial improvement in knee flexion than did the APT group , but there were no differences between the groups in knee flexion at discharge . Postoperative pain rating and hospitalization times were similar in the two groups During a two-year period , eighty-nine patients who were scheduled to have a total knee arthroplasty for the treatment of degenerative osteoarthrosis were r and omly assigned to one of two groups : resurfacing of the patella or retention of the patella . All patients received the same posterior cruciate-sparing prosthesis , and all operations were performed by , or under the direct supervision of , one of us . Three patients died in the early postoperative period . The remaining eighty-six patients ( 118 knees ; fifty-eight that had had resurfacing of the patella and sixty that had not ) formed the study group . They were followed for a mean of thirty months ( range , twenty-four to forty-four months ) . Evaluation was performed with use of the clinical scoring system of The Knee Society , a patient-satisfaction question naire , specific questions regarding patellofemoral symptoms and function , and radiographs . All clinical evaluations were performed by the same research nurse , without the involvement of a physician , in a blinded manner ( neither the nurse nor the patient had knowledge of whether the patella had been resurfaced ) . Preoperatively , the mean Knee Society score , on a scale ranging from 0 to 200 points , was 89.7 points ( range , 33 to 132 points ) ; postoperatively , this score improved to a mean of 172.7 points ( range , 98 to 200 points ) . With the numbers available for study , we could detect no significant difference between the knees that had had patellar resurfacing and those that had not with regard to the over-all score ( p = 0.63 ) , the subscore for pain ( p = 0.56 ) , or the subscore for function ( p = 0.77 ) . We also could detect no difference between the treatment groups , with the numbers available , with regard to patient satisfaction or the responses to questions involving the function of the patellofemoral joint , including the ability to exit from an automobile , to rise from a chair , and to climb stairs . Thirty-two patients had bilateral total knee replacement with resurfacing of the patella in one knee and retention of the patella in the other . These patients expressed no clear preference for either knee . Eight ( 13 per cent ) of the sixty knees that had not had resurfacing were painful anteriorly compared with four ( 7 per cent ) of the fifty-eight that had ; this was not a significant difference ( p = 0.38 ) , with the numbers available . The anterior pain that was noted postoperatively was predominantly of new onset ; it had not been observed preoperatively in three of the four knees that had had resurfacing or in four of the eight that had not . No additional treatment options were offered to the patients who had anterior pain in the knee after resurfacing . However , six ( 10 per cent ) of the sixty knees that had not had resurfacing had it subsequently , because of anterior pain in the knee , after the twelfth postoperative month ( range , fifteen to thirty-nine months ) . The pain decreased in four of these knees . Thus , total knee arthroplasty with retention of the patella yielded clinical results that were comparable with those after total knee arthroplasty with patellar resurfacing , but it was associated with a 10 per cent prevalence of the need for subsequent resurfacing . The prevalence of anterior pain after total knee arthroplasty was not influenced by whether or not the patella had been resurfaced . The postoperative clinical scores , the postoperative development of anterior pain , and the need for subsequent resurfacing were not predicted by the presence of preoperative anterior pain , obesity , or the grade of chondromalacia observed intraoperatively . Because of the short duration of follow-up , these results should be considered preliminary . Additional follow-up is planned Sixty patients undergoing total knee replacement were r and omized to receive either a cold compression dressing ( Cryo/Cuff , Aircast , UK ) or a modified Robert Jones b and age immediately after surgery . The cold compression dressing was used for a minimum of 6 h per day throughout the hospital stay , and the modified Robert Jones b and age remained in place for 48 h from the time of operation . The 2 groups of patients were compared during their hospital stay for blood loss , range of movement , pain scores and need for analgesia . No difference was found between the 2 groups except for less blood loss in the surgical drains in the cold compression group ( P<0.05 ) . Postoperative complications were seen in both groups , but no complication was associated with either the cold compression dressing or the modified Robert Jones b and age . RésuméEtude r and omisée de 60 patients qui , immédiatement après une arthroplastie totale du genou ont eu soit un pansement compressif froid de type “ Cryocuff ” soit un pansement compressif de type Robert Jones . Le pansement froid a été utilisé 6 heures par jour pendant la durée de l'hospitalisation t and is que le pansement compressif de type Robert Jones a été laisse en place pendant 48 heures après l'opération . Aucune différence statistiquement significative n'a pu être mise en évidence entre les deux groupes , à l'exception des pertes sanguines dans le drainage , moins importantes dans le premier groupe de patients . Nous avons eu des complications post opératoires dans les deux groupes mais aucune corrélation n'a pu être établie entre ces complications et le type de b and age appliqué Background : Patient‐controlled epidural analgesia ( PCEA ) has been found to be an effective method for pain relief during labour and after surgery . The goal of this study was to compare the efficacy of bupivacaine – fentanyl PCEA and continuous epidural infusion with the same mixture for treatment of pain after total knee arthroplasty We report the results of a prospect i ve r and omised trial which assessed the role of the posterior cruciate ligament ( PCL ) following total knee replacement ( Genesis I ; Smith and Nephew , Memphis , Tennessee ) . Over a four-year period , 211 patients underwent total knee replacement by the senior author ( TJW ) . They were r and omised at surgery to have the PCL either retained , excised or substituted with a posterior stabilised insert . If it was not possible to retain the ligament due to soft-tissue imbalance , it was released from its tibial insertion until suitable tension was obtained . This created a fourth group , those who were intended preoperatively to have the ligament retained , but in whom it was partially released as a result of findings at the time of surgery . All patients were evaluated using the Knee Society rating system ( adapted from Insall ) . A total of 188 patients ( 212 knees ) was available for follow-up at a mean of 3.5 years after surgery . Preoperatively , there was a varus deformity in 191 knees ( 90 % ) and a valgus deformity in 21 ( 10 % ) . There were no statistical differences in the knee or function scores or the range of movement between the excised , retained and substituted groups . There were , however , significantly worse knee and function scores in the group in whom the PCL was released ( p = 0.002 ) Purpose We previously established that a 5 mg·kg−1 intraoperative dose can reduce the nausea/vomiting associated with tramadol patient-controlled analgesia ( PCA ) . This study was conducted to identify the most appropriate initial dose to improve the quality of tramadol PCA . Methods During general anesthesia , 60 patients undergoing knee arthroplasty were r and omly allocated to receive 1.25 mg·kg−1 ( Group I ) , 2.5 mg·kg−1 ( Group II ) , 3.75 mg·kg−1 ( Group III ) , or 5 mg·kg−1 ( Group IV ) tramadol . The emergence condition was recorded . The titration of additional tramadol 20 mg + metoclopramide 1 mg doses by PCA every five minutes was performed in the postanesthesia care unit ( PACU ) until the visual analogue scale ( VAS ) score was ≤ 3 . An investigator blinded to study group recorded the VAS and side effects every ten minutes . Results In the PACU , significantly more tramadol ( 8.4 ± 3.1vs 4.3 ± 2.1 , 2.5 ± 1.8 , and 0.4 ± 0.3,P < 0.05 ) , and a higher incidence ( 15/15vs 5/15 , 3/15 , and 2/15,P < 0.05 ) of PCA use was observed in Group I compared to Groups II – IV . VAS was significantly higher in Group I than in Groups II – Output:
The evidence from this review supports the use of general anaesthesia combined with a femoral nerve block for surgery and postoperative analgesia , or alternatively spinal anaesthesia with local anaesthetic plus spinal morphine .
MS2_1shot286
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVES Despite the high prevalence of both mental illness and human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome ( AIDS ) in developing countries , there are few data on the association between different forms of mental illness and sexual risk behaviours in re source -poor setting s. The objective of this study was to examine the association between mental illness and HIV risk behaviours in a South African township . STUDY DESIGN A cross-sectional study was performed among 645 individuals living in households selected at r and om . METHODS A self-administered translated question naire investigated sexual risk behaviours [ including sexual partners , condom use , casual sexual contacts , and sex in exchange for money , drugs or a place to stay ( transactional sex ) ] , depression ( measured using the Center for Epidemiological Studies Depression Scale ) , alcohol abuse ( from the Alcohol Use Disorders Identification Test ) , and post-traumatic stress disorder ( based on the Life Event Checklist ) . RESULTS Of the 645 individuals who completed the survey , 33 % reported depression , 17 % reported alcohol abuse , and 15 % reported post-traumatic stress disorder . After adjusting for demographic characteristics , the presence of any of these three conditions was strongly associated with experiences of forced sex [ adjusted odds ratio ( AOR ) 2.53 ; 95 % confidence intervals ( CI ) 1.60 - 4.02 ] , transactional sex ( AOR 2.88 ; 95 % CI 1.29 - 6.48 ) and increased condom use ( AOR 2.07 ; 95 % CI 1.32 - 3.25 ) . CONCLUSIONS These findings emphasize the substantial burden of mental illness in this setting , and its association with forced and transactional sex . The temporal nature of these associations is not always clear from this cross-sectional study , and additional prospect i ve research is required . Public health interventions are needed to address the dual burden of HIV/AIDS and mental illness in this and similar setting Background The 10-item Centre for Epidemiological Studies Depression Scale ( CES-D-10 ) is a depression screening tool that has been used in the South African National Income Dynamics Study ( NIDS ) , a national household panel study . This screening tool has not yet been vali date d in South Africa . This study aim ed to establish the reliability and validity of the CES-D-10 in Zulu , Xhosa and Afrikaans . The CES-D-10 ’s psychometric properties were also compared to the Patient Health Question naire ( PHQ-9 ) , a depression screening tool already vali date d in South Africa . Methods Stratified r and om sample s of Xhosa , Afrikaans and Zulu-speaking participants aged 15 years or older ( N = 944 ) were recruited from Cape Town Metro and Ethekwini districts . Face-to-face interviews included socio-demographic questions , the CES-D-10 , Patient Health Question naire ( PHQ-9 ) , and WHO Disability Assessment Schedule 2.0 ( WHODAS ) . Major depression was determined using the Mini International Neuropsychiatric Interview . All instruments were translated and back-translated to English . Construct validity was examined using exploratory factor analysis with varimax rotation . Receiver Operating Characteristics ( ROC ) curves were used to investigate the CES-D-10 and PHQ-9 ’s criterion validity , and compared using the DeLong method . Results Overall , 6.6 , 18.0 and 6.9 % of the Zulu , Afrikaans and Xhosa sample s were diagnosed with depression , respectively . The CES-D-10 had acceptable internal consistency across sample s ( α = 0.69–0.89 ) , and adequate concurrent validity , when compared to the PHQ-9 and WHODAS . The CES-D-10 area under the Receiver Operator Characteristic curve was good to excellent : 0.81 ( 95 % CI 0.71–0.90 ) for Zulu , 0.93 ( 95 % CI 0.90–0.96 ) for Afrikaans , and 0.94 ( 95 % CI 0.89–0.99 ) for Xhosa . A cut-off of 12 , 11 and 13 for Zulu , Afrikaans and Xhosa , respectively , generated the most balanced sensitivity , specificity and positive predictive value ( Zulu : 71.4 , 72.6 % and 16.1 % ; Afrikaans : 84.6 % , 84.0 % , 53.7 % ; Xhosa : 81.0 % , 95.0 % , 54.8 % ) . These were slightly higher than those generated for the PHQ-9 . The CES-D-10 and PHQ-9 otherwise performed similarly across sample s. Conclusions The CES-D-10 is a valid , reliable screening tool for depression in Zulu , Xhosa and coloured Afrikaans population Background Self-report measures can guide clinical decisions and are useful when evaluating treatment outcomes . However , many clinicians do not use self-report measures systematic ally in their clinical practice . Internet-based question naires could facilitate administration , but the psychometric properties of the online version of an instrument should be explored before implementation . The recommendation from the International Test Commission is to test the psychometric properties of each question naire separately . Objective Our objective was to compare the psychometric properties of paper- and -pencil versions and Internet versions of two question naires measuring depressive symptoms . Methods The 87 participating patients were recruited from primary care and psychiatric care within the public health care system in Sweden . Participants completed the Beck Depression Inventory ( BDI-II ) and the Montgomery-Åsberg Depression Rating Scale — Self-rated ( MADRS-S ) , both on paper and on the Internet . The order was r and omized to control for order effects . Symptom severity in the sample ranged from mild to severe depressive symptoms . Results Psychometric properties of the two administration formats were mostly equivalent . The internal consistency was similar for the Internet and paper versions , and significant correlations were found between the formats for both MADRS-S ( r = .84 ) and the BDI-II ( r = .89 ) . Differences between paper and Internet total scores were not statistically significant for either question naire nor for the MADRS-S question dealing with suicidality ( item 9 ) when analyzed separately . The score on the BDI-II question about suicidality ( item 9 ) was significantly lower when administered via the Internet compared with the paper score , but the difference was small ( effect size , Cohen ’s [ d ] = 0.14 ) . There were significant main effects for order of administration on both question naires and significant interaction effects between format and order . This should not , however , pose a problem in clinical use as long as the administration format is not changed when repeated measurements are made . Conclusions The MADRS-S can be transferred to online use without affecting the psychometric properties in a clinical ly meaningful way . The full BDI-II also seems to retain its properties when transferred ; however , the item measuring suicidality in the Internet version needs further investigation since it was associated with a lower score in this study . The use of online question naires offers clinicians a more practical way of measuring depressive symptoms and has the potential to save re sources Output:
It was also evident that there were negligible differences in the psychometric properties of online versus paper versions of the online screening tools .
MS2_1shot287
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Neuroimaging studies have demonstrated activations in the anterior cingulate cortex ( ACC ) related to the affective component of pain , but not to stimulus intensity . However , it is possible that the low spatial resolution of positron emission tomography , as used in the majority of these studies , obscured areas coding stimulus intensity . We revisited this issue , using a parametric single-trial functional magnetic resonance imaging design , and investigated pain , stimulus intensity , and stimulus awareness ( i.e. , pain unrelated ) responses within the ACC in nine healthy volunteers . Four different stimulus intensities ranging from warm to painful ( 300–600 mJ ) were applied with a thulium yttrium – aluminum granate infrared laser in a r and omized order and rated by the subjects on a five point scale ( P0–P4 ) . Pain-related regions in the ventral posterior ACC showed a response that did not distinguish between innocuous trials ( P0 and P1 ) but showed a positive linear relationship with the blood oxygenation level-dependent contrast signal for painful trials ( P2–P4 ) . Regions in the dorsal anterior ACC along the cingulate sulcus differentiated between P0 ( not perceived ) and P1 but exhibited no additional signal increase with P2 ; these regions are related to stimulus awareness and probably to cognitive processing . Most importantly , we identified a region in the dorsal posterior ACC showing a response that discriminated between nonpainful trials ( P0 and P1 ) ; therefor , this region was simply related to basic sensory processing and not to pain intensity . Stimulus-related activations were all located adjacent to the cingulate motor area , highlighting the strategic link of stimulus processing and response generation in the posterior ACC Although behavioral studies suggest that pain distress may alter the perception of somatic stimulation , neural correlates underlying such alteration remain to be clarified . The present study was aim ed to test the hypothesis that expectation of pain might amplify brain responses to somatosensory stimulation in the anterior cingulate cortex ( ACC ) and the region including parietal operculum and posterior insula ( PO/PI ) , both of which may play roles in regulating pain-dependent behavior . We compared brain responses with and subjective evaluation of physically identical nonpainful warm stimuli between two psychologically different context s : one linked with pain expectation by presenting the nonpainful stimuli r and omly intermixed with painful stimuli and the other without . By applying the event-related functional magnetic resonance imaging technique , brain responses to the stimuli were assessed with respect to signal changes and activated volume , setting regions of interest on activated clusters in ACC and bilateral PO/PI defined by painful stimuli . As a result , the uncertain expectation of painful stimulus enhanced transient brain responses to nonpainful stimulus in ACC and PO/PI . The enhanced responses were revealed as a higher intensity of signal change in ACC and larger volume of activated voxels in PO/PI . Behavioral measurements demonstrated that expectation of painful stimulus amplified perceived unpleasantness of innocuous stimulus . From these findings , it is suggested that ACC and PO/PI are involved in modulation of affective aspect of sensory perception by the uncertain expectation of painful stimulus Abstract Although individual differences in fear and anxiety modulate the pain response and may even cause more suffering than the initiating physical stimulus , little is known about the neural systems mediating this relationship . The present study provided the first examination of the neural correlates of individual differences in the tendency to ( 1 ) feel anxious about the potentially negative implication s of physical sensations , as measured by the anxiety sensitivity index ( ASI ) , and ( 2 ) fear various types of physical pain , as indexed by the fear of pain question naire ( FPQ ) . In separate sessions , participants completed these question naires and experienced alternating blocks of noxious thermal stimulation ( 45–50 ° C ) and neutral thermal stimulation ( 38 ° C ) during the collection of whole‐brain fMRI data . Regression analyses demonstrated that during the experience of pain , ASI scores predicted activation of a medial prefrontal region associated with self‐focused attention , whereas FPQ scores predicted activation of a ventral lateral frontal region associated with response regulation and anterior and posterior cingulate regions associated with monitoring and evaluation of affective responses . These functional relationships can not be wholly explained by generalized anxiety ( indexed by STAI‐T scores ) , which did not significantly correlate with activation of any regions . The present findings may help clarify both the impact of individual differences in emotion on the neural correlates of pain , and the roles in anxiety , fear , and pain processing played by medial and orbitofrontal systems Cortical activity patterns to thermal painful stimuli of two different sizes were examined in normal volunteers using functional magnetic resonance imaging ( fMRI ) . Seven right-h and ed subjects were studied when the painful stimulus applied to the right h and fingers covered either 1,074-mm(2)-area large stimulator or 21-mm(2)-area small stimulator . Stimulus temperatures were adjusted to give rise to equivalent moderately painful ratings . fMRI signal increases and decreases were determined for the contralateral parietal and motor areas . When the overall activity in these regions was compared across subjects , increased fMRI activity was observed over more brain volume with the larger stimulator , whereas decreased fMRI activity was seen in more brain volume for the smaller stimulator . The individual subject and group-averaged activity patterns indicated regional specific differences in increased and decreased fMRI activity . The small stimulator result ed in decreased fMRI responses throughout the upper body representation in both primary somatosensory and motor cortices . In contrast , no decreased fMRI signals were seen in the secondary somatosensory cortex and in the insula . In another seven volunteers , the effects of the size of the thermal painful stimulus on vibrotactile thresholds were examined psychophysically . Painful stimuli were delivered to the fingers and vibrotactile thresholds were measured on the arm just distal to the elbow . Consistent with the fMRI results in the primary somatosensory cortex , painful thermal stimuli using the small stimulator increased vibrotactile thresholds on the forearm , whereas similarly painful stimuli using the large stimulator had no effect on forearm vibrotactile thresholds . These results are discussed in relation to the cortical dynamics for pain perception and in relation to the center-surround organization of cortical neurons Activation studies have shown that in response to evocative visual stimuli , brain activity increases in the visual cortex and limbic areas . However , non-affective characteristics of these images , such as color composition and visual complexity , confound the interpretation of these results . To address this issue , we had subjects rate over 100 images on aversive intensity ( facial mutilation , dead bodies ) and semantic complexity ( number of objects subjects could name ) . From these images , we assembled digitized image sets of non-aversive , mild and strong intensity , balanced on semantic complexity and content ( human faces and figures ) , and adjusted for color composition . A fourth condition consisted of a fixation cross on a blank screen . Thirteen subjects underwent eight positron emission tomography scans using the [ (15)O ] water methodology . Measurement of skin conductance was recorded simultaneously . All picture conditions , relative to the blank screen , activated the amygdalae and bilateral orbitofrontal cortex , while we found activation trends associated with increasing aversive content in the sub-lenticular region . Skin conductance increased during all picture conditions . Relative to the non-aversive pictures , aversive image content caused modulation of occipital and occipital-temporal cortex . These results demonstrated activation of the amygdala to salient , arousing stimuli , and not just aversive stimuli . In addition , they suggest that pictorial complexity , as indexed by our semantic measure , does not account for the modulation of visual cortex by aversive , emotional stimuli Previous functional neuroimaging studies have characterized brain systems mediating associative learning using classical delay conditioning paradigms . In the present study , we used event-related functional magnetic resonance imaging to characterize neuronal responses mediating aversive trace conditioning . During conditioning , neutral auditory tones were paired with an aversive sound [ unconditioned stimulus ( US ) ] . We compared neuronal responses evoked by conditioned ( CS+ ) and nonconditioned ( CS− ) stimuli in which a 50 % pairing of CS+ and the US enabled us to limit our analysis to responses evoked by the CS+ alone . Differential responses ( CS+ vs CS− ) , related to conditioning , were observed in anterior cingulate and anterior insula , regions previously implicated in delay fear conditioning . Differential responses were also observed in the amygdala and hippocampus that were best characterized with a time × stimulus interaction , indicating rapid adaptation of CS+-specific responses in medial temporal lobe . These results are strikingly similar to those obtained with a previous delay conditioning experiment and are in accord with a preferential role for medial temporal lobe structures during the early phase of conditioning . However , an additional activation of anterior hippocampus in the present experiment supports a view that its role in trace conditioning is to maintain a memory trace between the offset of the CS+ and the delayed onset of the US to enable associative learning in trace conditioning Functional neuroimaging studies in humans have shown that nociceptive stimuli elicit activity in a wide network of cortical areas commonly labeled as the " pain matrix " and thought to be preferentially involved in the perception of pain . Despite the fact that this " pain matrix " has been used extensively to build models of where and how nociception is processed in the human brain , convincing experimental evidence demonstrating that this network is specifically related to nociception is lacking . The aim of the present study was to determine whether there is at least a subset of the " pain matrix " that responds uniquely to nociceptive somatosensory stimulation . In a first experiment , we compared the fMRI brain responses elicited by a r and om sequence of brief nociceptive somatosensory , non-nociceptive somatosensory , auditory and visual stimuli , all presented within a similar attentional context . We found that the fMRI responses triggered by nociceptive stimuli can be largely explained by a combination of ( 1 ) multimodal neural activities ( i.e. , activities elicited by all stimuli regardless of sensory modality ) and ( 2 ) somatosensory-specific but not nociceptive-specific neural activities ( i.e. , activities elicited by both nociceptive and non-nociceptive somatosensory stimuli ) . The magnitude of multimodal activities correlated significantly with the perceived saliency of the stimulus . In a second experiment , we compared these multimodal activities to the fMRI responses elicited by auditory stimuli presented using an oddball paradigm . We found that the spatial distribution of the responses elicited by novel non-target and novel target auditory stimuli resembled closely that of the multimodal responses identified in the first experiment . Taken together , these findings suggest that the largest part of the fMRI responses elicited by phasic nociceptive stimuli reflects non nociceptive-specific cognitive processes The amygdala has been implicated in fundamental functions for the survival of the organism , such as fear and pain . In accord with this , several studies have shown increased amygdala activity during fear conditioning and the processing of fear-relevant material in human subjects . In contrast , functional neuroimaging studies of pain have shown a decreased amygdala activity . It has previously been proposed that the observed deactivations of the amygdala in these studies indicate a cognitive strategy to adapt to a distressful but in the experimental setting unavoidable painful event . In this positron emission tomography study , we show that a simple context ual manipulation , immediately preceding a painful stimulation , that increases the anticipated duration of the painful event leads to a decrease in amygdala activity and modulates the autonomic response during the noxious stimulation . On a behavioral level , 7 of the 10 subjects reported that they used coping strategies more intensely in this context . We suggest that the altered activity in the amygdala may be part of a mechanism to attenuate pain-related stress responses in a context that is perceived as being more aversive . The study also showed an increased activity in the rostral part of anterior cingulate cortex in the same context in which the amygdala activity decreased , further supporting the idea that this part of the cingulate cortex is involved in the modulation of emotional and pain networks The allocation of attention modulates negative emotional processing in the amygdala . However , the role of passive exposure time to emotional signals in the modulation of amygdala activity during active task performance has not been examined . In two functional Magnetic Resonance Imaging ( fMRI ) experiments conducted in two different groups of healthy human subjects , we examined activation in the amygdala due to cued anticipation of painful stimuli while subjects performed a simple continuous performance task ( CPT ) with either a fixed or a parametrically varied trial duration . In the first experiment ( N = 16 ) , engagement in the CPT during a task with fixed trial duration produced the expected attenuation of amygdala activation , but close analysis suggested that the attenuation occurred during the period of active engagement in CPT , and that amygdala activity increased proportionately during the remainder of each trial , when subjects were passively exposed to the pain cue . In the second experiment ( N = 12 ) , the duration of each trial was parametrically varied , and we found that amygdala activation was linearly related to the time of passive exposure to the anticipatory cue . We suggest that amygdala activation during negative anticipatory processing depends directly on the passive exposure time to the negative cue Although pathological muscle pain involves a significantly larger population than any other pain condition , the central mechanisms are less explored than those of cutaneous pain . The aims of the study were to establish the pain matrix for muscle pain in the full head volume and , further , to explore the possibility of a functional segregation to nonpainful and painful stimuli within the area of the parasylvian cortex corresponding to the secondary somatosensory area . Additionally , we speculate that a r and omization of nonpainful and painful stimuli may target specific structures related to stimulus salience . We used event-related functional magnetic resonance imaging ( MRI ) and the high sensitivity of the 3-T MRI scanner to study the central processing of acute muscle pain induced by intramuscular electrostimulation . Brief nonpainful and painful stimuli ( 1-ms duration , interst Output:
Results Animal and human data combined to show a core aversion-related network , consisting of similar cortical ( i.e. MCC , PCC , AI , DMPFC , RTG , SMA , VLOFC ; see results section or abbreviation section for full names ) and subcortical ( i.e. Amyg , BNST , DS , Hab , Hipp/Parahipp , Hyp , NAc , NTS , PAG , PBN , raphe , septal nuclei , Thal , LC , midbrain ) regions . In addition , a number of regions appeared to be more involved in pain-related ( e.g. sensory cortex ) or non-pain-related ( e.g. amygdala ) aversive processing . Conclusions This investigation suggests that aversive processing , at the most basic level , relies on similar neural substrates , and that differential responses may be due , in part , to the recruitment of additional structures as well as the spatio-temporal dynamic activity of the network . This network perspective may provide a clearer underst and ing of why components of this circuit appear dysfunctional in some psychiatric and pain-related disorders
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: BACKGROUND Rifapentine is a cyclopentyl-substituted rifamycin whose serum half-life is five times that of rifampin . The US Public Health Service Study 22 compared a once-weekly regimen of isoniazid and rifapentine with twice weekly isoniazid and rifampin in the continuation phase ( the last 4 months ) of treatment for pulmonary tuberculosis in HIV-seropositive and HIV-seronegative patients . This report concerns only the HIV-seropositive part of the trial , which has ended . The HIV-seronegative part will stop follow-up in 2001 . METHODS Adults with culture-positive , drug-susceptible pulmonary tuberculosis who completed 2 months of four-drug ( isoniazid , rifampin , pyrazinamide , ethambutol ) treatment ( induction phase ) were r and omly assigned 900 mg isoniazid and 600 mg rifapentine once weekly , or 900 mg isoniazid and 600 mg rifampin twice weekly . All therapy was directly observed . Statistical analysis used univariate , Kaplan-Meier , and logistic and proportional hazards regression methods . FINDINGS 71 HIV-seropositive patients were enrolled : 61 completed therapy and were assessed for relapse . Five of 30 patients in the once-weekly isoniazid/rifapentine group relapsed , compared with three of 31 patients in the twice-weekly isoniazid/rifampin group ( log rank chi2=0.69 , p=0.41 ) . However , four of five relapses in the once-weekly isoniazid/rifapentine group had monoresistance to rifamycin , compared with none of three in the rifampin group ( p=0.05 ) . Patients who relapsed with rifamycin monoresistance were younger ( median age 29 vs 41 years ) , had lower baseline CD4 cell counts ( median 16 vs 144 microL ) , and were more likely to have extrapulmonary involvement ( 75 % vs 18 % , p=0.03 ) and concomitant therapy with antifungal agents ( 75 % vs 9 % , p=0.006 ) . No rifamycin monoresistant relapse has occurred among 1004 HIV-seronegative patients enrolled to date . INTERPRETATION Relapse with rifamycin monoresistant tuberculosis occurred among HIV-seropositive tuberculosis patients treated with a once-weekly isoniazid/rifapentine continuation-phase regimen . Until more effective regimens have been identified and assessed in clinical trials , HIV-seropositive people with tuberculosis should not be treated with a once-weekly isoniazid/rifapentine regimen BACKGROUND The occurrence of acquired rifamycin resistance despite use of directly observed therapy for tuberculosis is associated with advanced human immunodeficiency virus ( HIV ) disease and highly intermittent administration of antituberculosis drugs . Beyond these associations , the pathogenesis of acquired rifamycin resistance is unknown . METHODS We performed a pharmacokinetic sub study of patients in a trial of treatment with twice-weekly rifabutin and isoniazid . RESULTS A total of 102 ( 60 % ) of 169 patients in the treatment trial participated in the pharmacokinetic sub study , including 7 of 8 patients in whom tuberculosis treatment failure or relapse occurred in association with acquired rifamycin-resistant mycobacteria ( hereafter , " ARR failure or relapse " ) . The median rifabutin area under the concentration-time curve ( AUC(0 - 24 ) ) was lower for patients with than for patients without ARR failure or relapse ( 3.3 vs. 5.2 microg*h/mL ; P = .06 , by the Mann-Whitney exact test ) . In a multivariate analysis adjusted for CD4 + T cell count , the mean rifabutin AUC(0 - 24 ) was significantly lower for patients with ARR failure or relapse than for other patients ( 3.0 microg*h/mL [ 95 % confidence interval { CI } , 1.9 - 4.5 ] vs. 5.2 microg*h/mL [ 95 % CI , 4.6 - 5.8 ] ; P = .02 , by analysis of covariance ) . The median isoniazid AUC(0 - 12 ) was not significantly associated with ARR failure or relapse ( 20.6 vs. 28.0 microg*h/mL ; P = .24 , by the Mann-Whitney exact test ) . However , in a multivariate logistic regression model that adjusted for the rifabutin AUC(0 - 24 ) , a lower isoniazid AUC(0 - 12 ) was associated with ARR failure or relapse ( OR , 10.5 ; 95 % CI , 1.1 - 100 ; P = .04 ) . CONCLUSIONS Lower plasma concentrations of rifabutin and , perhaps , isoniazid were associated with ARR failure or relapse in patients with tuberculosis and HIV infection treated with twice-weekly therapy BACKGROUND It is believed that nonadherence is the proximate cause of multidrug-resistant tuberculosis ( MDR-tuberculosis ) emergence . The level of nonadherence associated with emergence of MDR-tuberculosis is unknown . Performance of a r and omized controlled trial in which some patients are r and omized to nonadherence would be unethical ; therefore , other study design s should be utilized . METHODS We performed hollow fiber studies for both bactericidal and sterilizing effect , with inoculum spiked with 0.5 % rifampin- and isoniazid-resistant isogenic strains in some experiments . St and ard therapy was administered daily for 28 - 56 days , with extents of nonadherence varying between 0 % and 100 % . Sizes of drug-resistant population s were compared using analysis of variance . We also explored the effect of pharmacokinetic variability on MDR-tuberculosis emergence using computer-aided clinical trial simulations of 10 000 Cape Town , South Africa , tuberculosis patients . RESULTS Therapy failure was only encountered at extents of nonadherence ≥60 % . Surprisingly , isoniazid- and rifampin-resistant population s did not achieve ≥1 % proportion in any experiment and did not achieve a higher proportion with nonadherence . However , clinical trial simulations demonstrated that approximately 1 % of tuberculosis patients with perfect adherence would still develop MDR-tuberculosis due to pharmacokinetic variability alone . CONCLUSIONS These data , based on a pre clinical model , demonstrate that nonadherence alone is not a sufficient condition for MDR-tuberculosis emergence BACKGROUND Based on a hollow-fiber system model of tuberculosis , we hypothesize that microbiologic failure and acquired drug resistance are primarily driven by low drug concentrations that result from pharmacokinetic variability . METHODS Clinical and pharmacokinetic data were prospect ively collected from 142 tuberculosis patients in Western Cape , South Africa . Compartmental pharmacokinetic parameters of isoniazid , rifampin , and pyrazinamide were identified for each patient . Patients were then followed for up to 2 years . Classification and regression tree analysis was used to identify and rank clinical predictors of poor long-term outcome such as microbiologic failure or death , or relapse . RESULTS Drug concentrations and pharmacokinetics varied widely between patients . Poor long-term outcomes were encountered in 35 ( 25 % ) patients . The 3 top predictors of poor long-term outcome , by rank of importance , were a pyrazinamide 24-hour area under the concentration-time curve ( AUC ) ≤ 363 mg·h/L , rifampin AUC ≤ 13 mg·h/L , and isoniazid AUC ≤ 52 mg·h/L. Poor outcomes were encountered in 32/78 patients with the AUC of at least 1 drug below the identified threshold vs 3/64 without ( odds ratio = 14.14 ; 95 % confidence interval , 4.08 - 49.08 ) . Low rifampin and isoniazid peak and AUC concentrations preceded all cases of acquired drug resistance . CONCLUSIONS Low drug AUCs are predictive of clinical outcomes in tuberculosis patients Background Development of resistance to antituberculosis drugs during treatment ( i.e. , acquired resistance ) can lead to emergence of resistant strains and consequent poor clinical outcomes . However , it is unknown whether Mycobacterium tuberculosis complex species and lineage affects the likelihood of acquired resistance . Methods We analyzed data from the U.S. National Tuberculosis Surveillance System and National Tuberculosis Genotyping Service for tuberculosis cases during 2004–2011 with assigned species and lineage and both initial and final drug susceptibility test results . We determined univariate associations between species and lineage of Mycobacterium tuberculosis complex bacteria and acquired resistance to isoniazid , rifamycins , fluoroquinolones , and second-line injectables . We used Poisson regression with backward elimination to generate multivariable models for acquired resistance to isoniazid and rifamycins . Results M. bovis was independently associated with acquired resistance to isoniazid ( adjusted prevalence ratio = 8.46 , 95 % CI 2.96–24.14 ) adjusting for HIV status , and with acquired resistance to rifamycins ( adjusted prevalence ratio = 4.53 , 95 % CI 1.29–15.90 ) adjusting for homelessness , HIV status , initial resistance to isoniazid , site of disease , and administration of therapy . East Asian lineage was associated with acquired resistance to fluoroquinolones ( prevalence ratio = 6.10 , 95 % CI 1.56–23.83 ) . Conclusions We found an association between mycobacterial species and lineage and acquired drug resistance using U.S. surveillance data . Prospect i ve clinical studies are needed to determine the clinical significance of these findings , including whether rapid genotyping of isolates at the outset of treatment may benefit patient management OBJECTIVES To determine rates of drug resistance to Mycobacterium tuberculosis and associated risk factors , including HIV infection . DESIGN Prospect i ve cohort study of patients with pulmonary tuberculosis . SETTING The study population comprised 28,522 men working on four goldmines in Westonaria , Gauteng . Health care is provided at a 240-bed mine hospital , Gold Fields West Hospital , and its primary health care facilities . SUBJECTS All 425 patients with culture-positive pulmonary tuberculosis identified in 1995 . OUTCOME MEASURES Tuberculosis drug resistance on enrollment and after 6 months ' treatment . RESULTS There were 292 cases of new tuberculosis , 77 of recurrent disease and 56 prevalent cases in treatment failure . Two hundred and seven patients ( 48.7 % ) were HIV infected . Primary resistance to one or more drugs ( 9 % ) was similar to the 11 % found in a previous study done on goldminers in 1989 . Primary multidrug resistance ( 0.3 % ) was also similar ( 0.8 % ) . Acquired multidrug resistance was 18.1 % : 6.5 % for recurrent disease and 33.9 % in treatment failure cases . Neither HIV infection nor the degree of immunosuppression as assessed by CD4 + lymphocyte counts was associated with drug resistance at the start or end of treatment . New patterns of drug resistance were present in 9 of 52 patients in treatment failure at 6 months , 1 of whom was HIV-infected . CONCLUSION Primary and acquired drug resistance rates are stable in this population and are not affected by the high prevalence of HIV infection RATIONALE The outcome of fully intermittent thrice-weekly antituberculosis treatment of various duration s in HIV-associated tuberculosis is unclear . OBJECTIVES To compare the efficacy of an intermittent 6-month regimen ( Reg6 M : 2EHRZ(3)/4HR(3 ) [ ethambutol , 1,200 mg ; isoniazid , 600 mg ; rifampicin , 450 or 600 mg depending on body weight < 60 or > or = 60 kg ; and pyrazinamide , 1,500 mg for 2 mo ; followed by 4 mo of isoniazid and rifampicin at the same doses ] ) versus a 9-month regimen ( Reg9 M : 2EHRZ(3)/7HR(3 ) ) in HIV/tuberculosis ( TB ) . METHODS HIV-infected patients with newly diagnosed pulmonary or extrapulmonary TB were r and omly assigned to Reg6 M ( n = 167 ) or Reg9 M ( n = 160 ) and monitored by determination of clinical , immunological , and bacteriological parameters for 36 months . Primary outcomes included favorable responses at the end of treatment and recurrences during follow-up , whereas the secondary outcome was death . Intent-to-treat and on-treatment analyses were performed . All patients were antiretroviral treatment-naive during treatment . MEASUREMENTS AND MAIN RESULTS Of the patients , 70 % had culture-positive pulmonary TB ; the median viral load was 155,000 copies/ml and the CD4(+ ) cell count was 160 cells/mm(3 ) . Favorable response to antituberculosis treatment was similar by intent to treat ( Reg Output:
Baseline drug resistance and HIV co-infection were significant risk factors for ADR . There was a trend of positive association with non-adherence which is likely to contribute to the outcome of ADR .
MS2_1shot289
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Purpose : To establish the effect of a 6-week programme of cycle ergometry training on exercise tolerance , balance , activities of daily living ( ADL ) and quality of life in individuals with Parkinson ’s disease ( PD ) . Method : Twenty-three subjects were recruited from the Parkinson ’s data base of the neurology service in a large urban teaching hospital . Quasi-experimental study of interrupted time-series design was conducted with subjects acting as their own control . Assessment s were carried out at baseline , week 7 following the control phase , and week 14 following the intervention phase . Intervention consisted of 30-min cycle ergometry training once weekly . Outcome measures included Six Minute Walk Test , Physiological Cost Index , Berg Balance Scale , Timed Up and Go Test ( TUAG ) , ADL and mobility sections of the Unified Parkinson ’s disease Rating Scale ( UPDRS ) and the Parkinson ’s disease question naire ( PDQ ) . Results : Statistically significant improvements were noted for the Berg Balance Scale ( p = 0.003 ) , TUAG ( p = 0.019 ) and ADL ( p = 0.006 ) and mobility ( p = 0.021 ) sections of the UPDRS . A trend towards improvement was found for exercise tolerance . No significant effect on quality of life was found . Conclusion : A 6-week programme of cycle ergometry training did not significantly influence exercise tolerance in this sample , but improved balance , functional abililty and PD-related disability were noted . Implication s for Rehabilitation Individuals with Parkinson ’s disease demonstrate lower levels of exercise tolerance than healthy controls . Individuals with Parkinson ’s disease could participate in 30 min of cycle ergometry training , with no rest periods required . Cycle ergometry training has a positive effect on balance , function and PD-related disability Background People with idiopathic Parkinson ’s disease ( PD ) frequently have low activity levels , poor mobility and reduced quality of life . Although increased physical activity may improve mobility , balance and wellbeing , adherence to exercises and activity programs over the longer term can be challenging , particularly for older people with progressive neurological conditions such as PD . Physical activities that are engaging and enjoyable , such as dancing , might enhance adherence over the long term . The objective of this study was to evaluate the feasibility of a r and omized controlled trial of Irish set dancing compared with routine physiotherapy for people with mild to moderately severe PD . Methods Twenty-four people with idiopathic PD referred for movement rehabilitation were r and omized to receive st and ard physiotherapy exercises or Irish set dancing classes once per week plus a weekly home program for 6 months ( 12 in each group ) . The feasibility and safety of the proposed RCT protocol was the main focus of this evaluation . The primary outcome was motor disability measured by the motor component of the UPDRS , which was assessed prior to and after therapy by trained assessors blinded to group assignment . The Timed Up and Go , the Berg Balance Scale and the modified Freezing of Gait Question naire were secondary measures . Quality of life of the people with PD was evaluated using the PDQ-39 . Results Both the Irish set dancing and physiotherapy exercise program were shown to be feasible and safe . There were no differences between groups in the rate of adverse events such as falls , serious injuries , death or rates of admission to hospital . The physiotherapists who provided usual care remained blind to group allocation , with no change in their st and ard clinical practice . Compliance and adherence to both the exercise and dance programs were very high and attrition rates were low over the 6 months of therapy . Although improvements were made in both groups , the dance group showed superior results to st and ard physiotherapy in relation to freezing of gait , balance and motor disability . Conclusions Irish dancing and physiotherapy were both safe and feasible in this sample from Venice , with good adherence over a comparatively long time period of 6 months . A larger multi-centre trial is now warranted to establish whether Irish set dancing is more effective than routine physiotherapy for enhancing mobility , balance and quality of life in people living with idiopathic PD.Trial registration EudraCT number 2012 - 005769 - AIM To investigate the effects of an aerobic training in subjects with Parkinson 's disease ( PD ) as compared to a medical Chinese exercise ( Qigong ) . METHODS DESIGN r and omized controlled trial with a cross over design . SETTING PD out- patients referred to a Neurorehabilitation facility for the management of motor disability . SUBJECTS 26 PD patients in Hoehn and Yahr stage II to III under stable medication were r and omly allocated to either Group AT1+QG2 ( receiving 20 aerobic training sessions followed by 20 ' ' Qigong ' ' group sessions with 2 month interval between the interventions ) , or Group QG1+AT2 ( performing the same treatments with an inverted sequence ) . MAIN OUTCOME MEASURES clinical effects of treatment were sought through the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , Brown 's Disability Scale ( B'DS ) , six-Minute Walking Test ( 6MWT ) , Borg scale for breathlessness , Beck Depression Inventory ( BDI ) and Parkinson 's Disease Question naire-39 items ( PDQ-39 ) . A spirometry test and maximum cardiopulmonary exercise test ( CPET ) were also performed to determine the pulmonary function , the metabolic and cardio-respiratory requests at rest and under exercise . All measures were taken immediately before and at the completion of each treatment phase . RESULTS The statistical analysis focusing on the evolution of motor disability and quality of life revealed a significant interaction effect between group and time for the 6MWT ( time x group effect : F : 5.4 P=0.002 ) and the Borg scale ( time x group effect : F : 4.2 P=0.009 ) . Post hoc analysis showed a significant increase in 6MWT and a larger decrease in Borg score after aerobic training within each subgroup , whereas no significant changes were observed during Qigong . No significant changes over time were detected through the analysis of UPDRS , B'DS , BDI and PDQ-39 scores . The analysis of cardiorespiratory parameters showed significant interaction effects between group and time for the Double Productpeak ( time x group effect : F : 7.7 P=0.0003 ) , the VO(2peak ) ( time x group effect : F : 4.8 P=0.007 ) , and the VO(2)/kg ratio ( time x group effect : F : 4.3 P=0.009 ) , owing to their decrease after aerobic training to an extent that was never observed after Qigong treatment . CONCLUSIONS Aerobic training exerts a significant impact on the ability of moderately disabled PD patients to cope with exercise , although it does not improve their self-sufficiency and quality of life BACKGROUND Depression is a major health problem for community-dwelling elderly adults . Since limited re sources are available to decrease the high prevalence of depressive symptoms among the elderly adults , improved support for them can be provided if we can determine which intervention is superior in ridding depressive symptoms . OBJECTIVE To compare the effectiveness of the physical fitness exercise program and the cognitive behavior therapy program on primary ( depressive symptoms ) and secondary outcomes ( 6-min walk distance , quality of life , and social support ) for community-dwelling elderly adults with depressive symptoms . DESIGN AND SETTING S A prospect i ve r and omized control trial was conducted in three communities in northern Taiwan . PARTICIPANTS The elderly adults in the three communities were invited to participate by mail , phone calls , and posters . There were a total of 57 participants who had depressive symptoms and all without impaired cognition that participated in this trial . None of the participants withdrew during the 9 months of follow-up for this study . METHODS Fifty-seven participants were r and omly assigned to one of the three groups : the physical fitness exercise program group , the cognitive behavior therapy ( CBT ) group , or the control group . The primary ( Geriatric Depression Scale-15 , GDS-15 ) , and secondary outcomes ( 6-min walk distance , SF-36 , and Inventory of Socially Supportive Behaviors scales , ISSB ) were collected immediately ( T2 ) , at 3 months ( T3 ) , and at 6 months after the interventions ( T4 ) . RESULTS After the interventions , the CBT group participants demonstrated significantly lower symptoms of depression ( p=0.009 ) at T2 and perceived more social support from those around them ( p<0.001 , < 0.001 and = 0.004 , respectively ) at three time-point comparisons than the control group . Moreover , after intervention , participants in the physical fitness exercise program group had decreased GDS-15 scores at three time-point comparisons ( p=0.003 , 0.012 and 0.037 , respectively ) , had a substantially greater 6-min walk distance ( p=0.023 ) , a better quality of life ( p<0.001 ) , and a better perceived social support at T2 ( p<0.001 ) . CONCLUSIONS Immediately after a 12-week intervention , there were significant decreases in depressive symptoms and more perceived social support amongst those in the CBT group . When considering the effectiveness in the decrease of depressive symptoms longer term , the increase in the 6-min walk distance and raising the patients ' quality of life , physical fitness exercise program may be a better intervention for elderly adults with depressive symptoms Background . Novel rehabilitation strategies have demonstrated potential benefits for motor and non-motor symptoms of Parkinson 's disease ( PD ) . Objective . To compare the effects of Lee Silverman Voice Therapy BIG ( LSVT BIG therapy ) versus a general exercise program ( combined treadmill plus seated trunk and limb exercises ) on motor and non-motor symptoms of PD . Methods . Eleven patients with early-mid stage PD participated in the prospect i ve , double-blinded , r and omized clinical trial . Both groups received 16 one-hour supervised training sessions over 4 weeks . Outcome measures included the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , Beck Depression Inventory ( BDI ) , Beck Anxiety Inventory ( BAI ) and Modified Fatigue Impact Scale ( MFIS ) . Five patients performed general exercise and six patients performed LSVT BIG therapy . Post-intervention evaluations were conducted at weeks 4 , 12 and 24 . Results . The combined cohort made improvements at all follow-up evaluations with statistical significance for UPDRS total and motor , BDI , and MFIS ( P < 0.05 ) . Conclusion . This study demonstrated positive effects of general exercise and LSVT BIG therapy on motor and non-motor symptoms of patients with PD . Our results suggest that general exercise may be as effective as LSVT BIG therapy on symptoms of PD for patients not able to readily access outpatient LSVT BIG therapy Introduction The health benefits of exercise are well established . However , the relationship between exercise volume and intensity and health benefits remains unclear , particularly the benefits of low-volume and intensity exercise . Purpose The primary purpose of this investigation was , therefore , to examine the dose – response relationship between exercise volume and intensity with derived health benefits including volumes and intensity of activity well below international recommendations . Methods Generally healthy , active participants ( n = 72 ; age = 44 ± 13 years ) were assigned r and omly to control ( n = 10 ) or one of five 13-week exercise programs : ( 1 ) 10-min brisk walking 1 × /week ( n = 10 ) , ( 2 ) 10-min brisk walking 3 × /week ( n = 10 ) , ( 3 ) 30-min brisk walking 3 × /week ( n = 18 ) , ( 4 ) 60-min brisk walking 3 × /week ( n = 10 ) , and ( 5 ) 30-min running 3 × /week ( n = 14 ) , in addition to their regular physical activity . Health measures evaluated pre- and post-training including blood pressure , body composition , fasting lipids and glucose , and maximal aerobic power ( VO2max ) . Results Health improvements were observed among programs at least 30 min in duration , including body composition and VO2max : 30-min walking 28.8–34.5 mL kg−1 min−1 , 60-min walking 25.1–28.9 mL kg−1 min−1 , and 30-min running 32.4–36.4 mL kg−1 min−1 . The greater intensity running program also demonstrated improvements in triglycerides . Conclusion In healthy active individuals , a physical activity program of at least 30 min in duration for three sessions/per week is associated with consistent improvements in health status Background . Postural instability ( PI ) is a disabling sign of Parkinson ’s disease ( PD ) not easily amenable to treatment with medication . Objective . To evaluate the effects of balance training on PI in patients with PD . Methods . A total of 64 patients with PI were r and omly assigned to the experimental group ( n = 33 ) for balance training or to the control group ( n = 31 ) for general physical exercises . Each patient received 21 treatment sessions of 50 minutes each . Patients were evaluated by a blinded rater before and after treatment as well as 1 month posttreatment using the Berg Balance Scale ( BBS ) , Activities-Specific Balance Confidence Scale ( ABC ) , postural transfer test , self-destabilization of the center of foot pressure test , number of falls , Unified Parkinson ’s Disease Rating Scale ( UPDRS ) , modified Hoehn and Yahr ( H&Y ) Staging Scale , and Geriatric Depression Scale ( GDS ) . Results .At the end of treatment , the experimental group showed significant improvements in all outcome measures , except for the UPDRS and the H&Y scale . Improvement was maintained at the 1-month follow-up in all outcome measures except for the GDS . No significant Output:
Results of this review show empirical evidence to support the efficacy of physical activity for the population with Parkinson 's disease . Aerobic training exercise significantly improved the participants ' scores on the Unified Parkinson 's Disease Rating Scale , the Beck Depression Inventory , and the Quality of Life of the patients . Qigong improved scores in UPDRS-III and decreased incidences of multiple non-motor symptoms and depression . Furthermore , a balance-training program , such as Tai Chi , can improve postural stability and Quality of Life . CONCLUSIONS Physical activity may assuage the degeneration of motor skills and depression as well as increase the Quality of Life of Parkinson 's disease patients , with aerobic training producing the best results . These findings suggest that physical activity , notably aerobic training , could be a good exercise strategy for patients with Parkinson 's disease
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: OBJECTIVE To assess height growth over 10 years in children treated for obesity . DESIGN Longitudinal , prospect i ve follow-up of a series of r and omized , controlled weight control trials . SETTING Specialized pediatric weight control clinic . PARTICIPANTS One hundred fifty-eight 6- to 12-year-old obese children who were followed up for 10 years after treatment . INTERVENTIONS Family-based behavioral weight control . MEASUREMENTS /MAIN RESULTS At entry the height percentiles of the obese children were significantly higher ( 71.6 percentile ) than same-sex parent ( 52.0 percentile ) or midparent ( 51.5 percentile ) height ( an estimate of parental contribution to height ) . After an average growth of 22.7 cm , children were 2.2 cm taller than their same-sex parent and decreased to an average height percentile of 57.8 . Multiple regression analysis showed that child sex , age , baseline height and percent overweight , midparent height , and height change of the child from baseline to 5 years accounted for 94 % of the variance in growth . Child percent overweight change made no contribution to predicting height change . Comparison between children obese and nonobese at 10 years showed no differences in growth . CONCLUSIONS Moderate energy restriction with dietary guidance by overweight children did not negatively influence long-term growth CONTEXT The prevalence of overweight and obesity in children and adolescents is increasing rapidly . In this population , behavioral therapy alone has had limited success in providing meaningful , sustained weight reduction , and pharmacological treatment has not been extensively studied . OBJECTIVE To determine the efficacy and safety of orlistat in weight management of adolescents . DESIGN , SETTING , AND PATIENTS Multicenter , 54-week ( August 2000-October 2002 ) , r and omized , double-blind study of 539 obese adolescents ( aged 12 - 16 years ; body mass index [ BMI ] > or=2 units above the 95th percentile ) at 32 centers in the United States and Canada . INTERVENTIONS A 120-mg dose of orlistat ( n = 357 ) or placebo ( n = 182 ) 3 times daily for 1 year , plus a mildly hypocaloric diet ( 30 % fat calories ) , exercise , and behavioral therapy . MAIN OUTCOME MEASURES Change in BMI ; secondary measures included changes in waist and hip circumference , weight loss , lipid measurements , and glucose and insulin responses to oral glucose challenge . RESULTS There was a decrease in BMI in both treatment groups up to week 12 , thereafter stabilizing with orlistat but increasing beyond baseline with placebo . At the end of the study , BMI had decreased by 0.55 with orlistat but increased by 0.31 with placebo ( P = .001 ) . Compared with 15.7 % of the placebo group , 26.5 % of participants taking orlistat had a 5 % or higher decrease in BMI ( P = .005 ) ; 4.5 % and 13.3 % , respectively , had a 10 % or higher decrease in BMI ( P = .002 ) . At study end , weight had increased 0.53 kg with orlistat and 3.14 kg with placebo ( P<.001 ) . Dual-energy x-ray absorptiometry showed that this difference was explained by changes in fat mass . Waist circumference decreased in the orlistat group but increased in the placebo group ( -1.33 cm vs + 0.12 cm ; P<.05 ) . Generally mild to moderate gastrointestinal tract adverse events occurred in 9 % to 50 % of the orlistat group and in 1 % to 13 % of the placebo group . CONCLUSIONS In combination with diet , exercise , and behavioral modification , orlistat statistically significantly improved weight management in obese adolescents compared with placebo . The use of orlistat for 1 year in this adolescent population did not raise major safety issues although gastrointestinal adverse events were more common in the orlistat group BACKGROUND The prevalence of overweight and obesity in children and adolescents is increasing in both the United States and Mexico . OBJECTIVE The goal of this article was to assess the efficacy and safety of sibutramine in obese Mexican adolescents . METHODS This was a 6-month , r and omized , double-blind , placebo-controlled , prospect i ve clinical trial of sibutramine QD . Male and female patients aged 14 to 18 years with sex-specific body mass index ( BMI ) for age and sex > 85th percentile were eligible . The primary end points for the trial were the baseline versus end point absolute values for body weight , BMI , and percentage of the initial BMI ( % BMI ) ; secondary end points were waist circumference and percentage of the initial waist circumference ( % waist ) . These were measured at days -15 , 0 , 30 , 60 , 90 , 120 , 150 , and 180 of the study . Quality of life was assessed at the study start and end using the 36-Item Short-Form Health Survey ( SF-36 ) question naire . Blood pressure and heart rate were assessed , and adverse events ( AEs ) were recorded . Both groups received individually tailored diet and exercise programs . RESULTS Forty-six patients ( age range , 14 - 18 years ) with a BMI > 95th percentile for age were included ( sibutramine group , n = 23 [ 14 females , 9 males ] ; placebo group , n = 23 [ 12 females , 11 males ] ) . Twenty-one patients in the sibutramine group and 19 patients in the placebo group completed the 6-month trial . Using the intent-to-treat data , weight ( mean [ SD ] ) in the sibutramine group changed from 92.5 ( 14.6 ) kg to 85.7 ( 14.4 ) kg , for a net weight loss of 7.3 kg ( 95 % CI 4.6 - 9.9 ) , a waist circumference loss of 8.0 cm ( 95 % CI , 4.7 - 11.3 ) , and a % BMI loss of 9.2 % ( 95 % CI , 6.9 - 11.6 ) . In the placebo group , weight changed from 98.9 ( 22.7 ) kg to 94.6 ( 22.5 ) kg , a weight loss of 4.3 kg ( 95 % CI , 1.7 - 6.9 ) , a waist circumference loss of 3.8 cm ( 95 % CI , 0.7 - 7.0 ) , and a % BMI loss of 5.2 % ( 95 % CI , 2.4 - 7.9 ) ( P < 0.05 for all intragroup comparisons ; P > 0.05 for the intergroup comparisons ) . Mean ( SD ) scores on the SF-36 scale in the sibutramine group changed from 78.0 ( 13.3 ) at baseline to 84.8 ( 7.4 ) at study end ( P < 0.05 ) ; the respective values in the placebo group were 82.8 ( 10.3 ) and 87.3 ( 7.6 ) ( P < 0.05 ) . At base-line , systolic blood pressure ( SBP ) was 116.7 ( 5.9 ) mm Hg in the sibutramine group and 118.3 ( 7.6 ) mm Hg in the placebo group ; at end point , the respective SBPs were 112.4 ( 9.6 ) mm Hg and 112.6 ( 6.5 ) mm Hg . At baseline , diastolic blood pressure ( DBP ) was 78.9 ( 4.5 ) mm Hg in the sibutramine group and 79.5 ( 5.2 ) mm Hg in the placebo group ; at end point , the respective DBPs were 73.5 ( 6.3 ) mm Hg and 76.6 ( 6.2 ) mm Hg . At baseline , heart rate was 76.3 ( 6.4 ) beats/min in the sibutramine group and 81.1 ( 9.5 ) beats/min in the placebo group ; at end point , the respective findings were 79.8 ( 8.8 ) beats/min and 77.6 ( 8.6 ) beats/min ( P > 0.05 for all preceding intergroup comparisons ) . One patient in the sibutramine group had increased blood pressure ( at month 3 ) and 3 had increased heart rate ( at months 1 , 2 , and 4 ) ; 2 patients receiving placebo had increased blood pressure ( month 3 ) and 2 had increased heart rate ( at months 1 and 3 ) . These changes disappeared in 1 week and did not require treatment or trial suspension . Additionally , in the sibutramine group , 3 patients experienced 4 mild AEs : headache , dry mouth , headache with nausea , and headache with weakness and paleness ( P > 0.05 ) . In the placebo group , 3 patients experienced 4 mild AEs : 2 cases of headache , as well as 1 case of headache with somnolence and 1 case of headache with dry mouth ( P > 0.05 ) . CONCLUSION Sibutramine 10 mg QD in addition to diet and exercise was effective and generally well tolerated in this population of obese Mexican adolescents OBJECTIVE To determine whether regular aerobic exercise improves symptoms of sleep-disordered breathing in overweight children , as has been shown in adults . RESEARCH METHODS AND PROCEDURES Healthy but overweight ( BMI > or = 85th percentile ) 7- to 11-year-old children were recruited from public schools for a r and omized controlled trial of exercise effects on diabetes risk . One hundred children ( 53 % black , 41 % male ) were r and omly assigned to a control group ( n = 27 ) , a low-dose exercise group ( n = 36 ) , or a high-dose exercise group ( n = 37 ) . Exercise groups underwent a 13 + /- 1.5 week after-school program that provided 20 or 40 minutes per day of aerobic exercise ( average heart rate = 164 beats per minute ) . Group changes were compared on BMI z-score and four Pediatric Sleep Question naire scales : Snoring , Sleepiness , Behavior , and a summary scale , Sleep-Related Breathing Disorders . Analyses were adjusted for age . RESULTS Both the high-dose and low-dose exercise groups improved more than the control group on the Snoring scale . The high-dose exercise group improved more than the low-dose exercise and control groups on the summary scale . No group differences were found for changes on Sleepiness , Behavior , or BMI z-score . At baseline , 25 % screened positive for sleep-disordered breathing ; half improved to a negative screen after intervention . DISCUSSION Regular vigorous exercise can improve snoring , a symptom of sleep-disordered breathing , in overweight children . Aerobic exercise programs may be valuable for prevention and treatment of sleep-disordered breathing in overweight children Aims : To evaluate effects of a low energy diet , with or without strength training , on blood lipid profile in obese children . Methods : Eighty two obese children were enrolled into a six week dietary programme , and were r and omly allocated to a training group or a non-training group . The training group underwent regular exercise sessions with emphasis on strength training . Results : Height increased significantly , with a non-significant reduction in body mass index . Fat free mass increased significantly in the training group . Serum total cholesterol was significantly reduced in both groups . The LDL : HDL ratio significantly decreased in the training group . Conclusion : Results support the potentially beneficial effects of both diet and physical training . Further and longer term evaluation of such programmes is required OBJECTIVE To evaluate the efficacy of orlistat to enhance weight loss in obese adolescents . METHODS The study was a 6-month r and omized , double-blind , placebo-controlled trial to compare the effects of orlistat ( 120 mg orally 3 times a day ) and placebo on reduction of body mass index ( BMI ) . Forty adolescents between 14 and 18 years of age with a mean BMI of 40 kg/m2 entered the protocol between December 2002 and February 2003 . Study subjects stayed overnight in the General Clinical Research Center , during which dietary records were review ed and lifestyle recommendations were given . The study participants received either orlistat ( 120 mg orally 3 times a day ) or placebo and were assessed monthly for 6 months . At 0 , 3 , and 6 months , fasting laboratory tests were performed . The primary end point was the change in BMI from baseline to 6 months . Secondary outcomes included changes in weight , lean body mass , and results of blood chemistry studies . RESULTS No statistically significant difference was noted between the 2 study groups for decrease in BMI from baseline to 6 months ( P = 0.39 ) . The decrease in BMI within the orlistat group ( -1.3 + /- 1.6 kg/m2 ; P = 0.04 ) and within the placebo group ( -0.8 + /- 3.0 kg/m2 ; P = 0.02 ) , however , was statistically significant . Laboratory measurements did not differ between the 2 groups . In comparison with the placebo group , the orlistat group had increased adverse events , primarily gastrointestinal symptoms and findings . CONCLUSION In this study of obese adolescents , orlistat did not significantly reduce BMI in comparison with placebo at 6 months Background . Obesity has become the Output:
More limited evidence suggests that these improvements can be maintained over the 12 months after the end of treatments and that there are few harms with behavioral interventions . Potential adverse effects were greater than for behavioral interventions alone and varied in severity . Despite important gaps , available research supports at least short-term benefits of comprehensive medium- to high-intensity behavioral interventions in obese children and adolescents
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Although r and omised trials are important for evidence -based medicine , little is known about their overall characteristics . We assessed the epidemiology and reporting of method ological details for all 519 PubMed -indexed r and omised trials published in December , 2000 ( 383 [ 74 % ] parallel-group , 116 [ 22 % ] crossover ) . 482 ( 93 % ) were published in specialty journals . A median of 80 participants ( 10th-90th percentile 25 - 369 ) were recruited for parallel-group trials . 309 ( 60 % ) were blinded . Power calculation , primary outcomes , r and om sequence generation , allocation concealment , and h and ling of attrition were each adequately described in less than half of publications . The small sample sizes are worrying , and poor reporting of method ological characteristics will prevent reliable quality assessment of many published trials When reading a clinical research article , the clinician must judge if the reported findings and conclusions are valid before applying them to patient care . This concern is legitimate given the wide range of study validity in the clinical literature . In this article , the authors present many validity markers that signify the quality of the information reported from a study , such as authors hip , bias , confounding , statistics , r and omization , controls , blinding , and the logical framework of scientific investigations The statistical adequacy of all papers published in the period 1976 - 80 describing clinical trials of five non-steroidal anti-inflammatory and two analgesic drugs introduced into the UK market in 1978 and 1979 has been assessed using a checklist of simple criteria . Most trials were reported to be r and omised and double-blind . Trial design s were less satisfactory in other important respects ; the sample size of most trials was inadequate to demonstrate superiority of the new drug compared with an active control therapy . The period of treatment assessment was short in view of the likelihood of prolonged prescription of drugs in these classes . It is suggested that licensing authorities should dem and higher st and ards of clinical trial evidence offered in support of new drugs Recent empirical evidence supports the importance of adequate r and omization in controlled trials . Trials with inadequate allocation concealment have been associated with larger treatment effects compared with trials in which authors reported adequate allocation concealment . While that provides empirical evidence of bias being interjected into trials , trial investigators rarely document the sensitive details of subverting the intended purpose of r and omization . This article relates anonymous accounts run the gamut from simple to intricate operations , from transillumination of envelopes to search ing for code in the office files of the principal investigator . They indicate that deciphering is something more frequent than a rate occurrence . These accounts prompt some method ological recommendations to help prevent deciphering . R and omized controlled trials appear to annoy human nature -- if properly conducted , indeed they should In the r and omized , placebo-controlled , physician-blinded Canadian cooperative trial of cyclophosphamide and plasma exchange , neither active treatment regimens ( group I : IV cyclophosphamide and prednisone ; group II : weekly plasma exchange , oral cyclophosphamide , and prednisone ) were superior to placebo ( group III : sham plasma exchange and placebo medications ) using the blinded , evaluating neurologists ' assessment s of disease course ( primary analysis ) . All patients were examined by both a blinded and an unblinded neurologist at each assessment in this trial . We compared the blinded and unblinded neurologists ' judgment of treatment response and analyzed the clinical behavior of patients who correctly guessed their treatment . The unblinded ( but not the blinded ) neurologists ' scores demonstrated an apparent treatment benefit at 6 , 12 , and 24 months for the group II patients ( not group I or placebo ; p < 0.05 , two-tailed ) . There were no significant differences in the time to treatment failure or in the proportions of patients improved , stable , or worse between the group II and group III patients who correctly guessed their treatment assignments and those who did not . Physician blinding prevented an erroneous conclusion about treatment efficacy ( false positive , type 1 error ) A system has been constructed to evaluate the design , implementation , and analysis of r and omized control trials ( RCT ) . The degree of quadruple blinding ( the r and omization process , the physicians and patients as to therapy , and the physicians as to ongoing results ) is considered to be the most important aspect of any trial . The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies . Description of the patient and treatment material s and the measurement of various controls of quality have less weight . An index of quality of a RCT is proposed with its pros and cons . If published papers were to approximate these principles , there would be a marked improvement in the quality of r and omized control trials . Finally , a reasonable st and ard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials BACKGROUND The interpretation of the results of r and omized controlled trials ( RCTs ) has traditionally emphasized statistical significance rather than clinical importance . Our aim was to assess the quality of reporting of factors related to clinical importance in a sample of published RCTs . METHODS A r and om sample of 27 ( of a total of 266 ) RCTs published in 5 major medical journals over a 1-year period were review ed by 4 independent review ers for factors considered important in the interpretation of the clinical importance of study results : identification of a clearly defined primary outcome , reporting of the expected difference between groups used in the calculation of sample size ( the delta value ) and whether it was based on the minimal clinical ly important difference of the intervention , the statistical significance of the results , presentation of pertinent confidence intervals , and the authors ' interpretation of the clinical importance of the results . RESULTS Twenty-two of 27 ( 81 % ) articles explicitly reported a single primary outcome . Of the 20 articles that included a sample size calculation , 18 ( 90 % ) reported a delta value . Two of the 18 ( 11 % ) articles explicitly stated that the delta value was chosen to reflect the minimal clinical ly important difference of the intervention . For the primary outcomes , confidence intervals surrounding the point estimates of the efficacy of the interventions were reported in 11 of 27 ( 41 % ) studies . The study results were interpreted from the perspective of clinical importance in 20 of 27 ( 74 % ) of the articles . Of these 20 reports , 5 ( 25 % ) provided justification for their clinical interpretation of the results . INTERPRETATION Authors of RCTs published in major general medical and internal medicine journals do not consistently provide their own interpretation of the clinical importance of their results , and they often do not provide sufficient information to allow readers to make their own interpretation BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences Systematic Review Series Series Editors : Cynthia Mulrow , MD , MSc Deborah Cook , MD , MSc The last article in this series outlined methods with which to search the literature for studies on the clinical question that generates a systematic review [ 1 ] . Herein , we discuss the subsequent steps of selecting and appraising studies for a review . Both of these steps involve important judgments that can influence the results of a review . In selecting studies , review ers judge the relevance of the studies to the review question . In appraising studies , review ers judge numerous features of design and analysis . Some of these judgments are easy to make ; others are more difficult and prone to error . To be confident in their decisions , review ers should use methods that are reliable ( the results do not change if the procedure is repeated ) , impartial ( not influenced by the study results ) , and explicit ( unambiguous ) [ 2 ] . These strategies for selection and appraisal are sensible , and they distinguish most systematic review s from most narrative review s. However , evidence to support the importance of some of the methods we suggest is either scant or conflicting ; readers are referred to the original research on these approaches for more details . Selecting Studies for Systematic Review s If review ers perform a comprehensive search of the literature using the methods described previously in this series [ 1 ] , they will probably have assembled a large sample of articles . This sample will include most ( ideally , all ) studies that are relevant to the review question ( that is , the sensitivity of the search will be high ) . Inevitably , because such a wide net is cast , articles not pertinent to the clinical question will be retrieved ( that is , the specificity of the search will be modest ) . Thus , the review ers ' next task is to sort through all of the potentially relevant articles and select those that will be included in the review . To do so , review ers adopt several of the tactics listed in Table 1 and Table 2 for planning and executing the selection process ( in effect , improving the specificity of the search ) ; these tactics are described below . Table 1 . Planning Study Selection Table 2 . Strategies for Selecting and Appraising Studies Begin with a Well-Built Clinical Question Review ers should ensure that the question for review includes the four elements of a well-built clinical question [ 3 , 4 ] : the patients of interest , the main interventions under investigation , the comparison interventions , and the clinical outcomes of interest . By including these four elements , review ers can better focus the selection process . Choose Selection Criteria That Fit the Clinical Question Consider a systematic review of the effectiveness of a drug treatment ( for example , a proton-pump inhibitor ) for patients with a particular disorder ( such as esophageal reflux ) . Review ers need to decide whether to include studies of patients with any symptoms of reflux , only those with classic symptoms , or only those in whom definitive diagnostic tests have confirmed the presence of reflux . In addition , review ers might choose to include studies of patients with different comorbid conditions ; patients from different demographic or geographic or cultural background s ; or patients from different health systems , such as inpatient or community population s. Similarly , review ers should use selection criteria that reflect the main and comparison interventions of interest . In our esophageal reflux example , review ers would need to decide whether to include studies of a particular drug or studies of all agents in that drug 's class and whether to include studies of any dose and regimen or only studies with a specific regimen . For the comparison interventions , the review ers would decide whether to include studies that compare the experimental drug with alternate treatments ( such as antacids or histamine-2-receptor antagonists ) , with placebo , or with both . For the clinical outcomes , review ers have analogous tasks of defining the outcomes and translating them into criteria . In our example , the review ers would start by listing each clinical outcome ( for example , whether the outcome was endoscopic or clinical and whether it focused on cure or persistence ) and then decide whether to include studies that reported any outcome or only those with certain clinical ly important outcomes ( such as improvement in symptoms at 1 year ) . After thoroughly considering each element of the review question , review ers compile a set of explicit selection criteria . When these criteria are not explicit , the results of the review are more prone to error [ 5 , 6 ] . Reporting the selection criteria used in a review is extremely important to readers because the criteria indicate the relevance of the review to the readers ' clinical practice . Specify the Types of Study Design To Be Included After creating selection criteria that appropriately reflect the review question , review ers should consider which study design s to include . Ideally , review ers choose study design s that are most likely to produce valid results . For example , to answer questions about therapy or harm , review ers may want to include r and omized trials [ 7 ] because they provide more accurate estimates of benefit or harm than do cohort studies , casecontrol studies , and case series [ 8 ] . In reality , however , r and omized trials may not be conducted to address questions of harm [ 9 ] . Therefore , review ers need to consider which study design s are likely to be available to answer their question ; this information may necessitate modification of originally conceptualized selection criteria to incorporate observational ( nonexperimental ) studies . Specify Criteria Related to Type and Form of Publication Review ers also need to consider issues related to type and form of publication . Ideally , all of the relevant studies would be published as peer- review ed journal articles . However , some completed studies may be published only as abstract s , in non-peer- review ed form , or not at all . Review ers decide whether to include these incompletely reported studies when planning their literature search . By including all articles in various stages of publication and subjecting them to rigorous critical appraisal , review ers minimize the threat of publication bias ( the preferential reporting of studies with positive results ) [ 10 - 12 ] , which could generate misleading review s. Other studies may be reported more than once . To avoid over-representing duplicate studies in the review , investigators should plan to look for and exclude duplicate publications [ 13 ] . Finally , because studies may be published in different language s and because excluding studies published in different language s may bias the results of review s [ 14 , 15 ] , articles should be included , as appropriate Output:
The field test of the new instrument showed good criterion validity . Participants found it useful in translating evidence from RCTs to practice . Conclusion A new instrument for the critical appraisal of RCTs of NPs was developed and tested . The instrument is distinct from other available assessment instruments for RCTs of NPs in its systematic development and validation .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: PURPOSE To compare outcome following in vitro fertilization-embryo transfer ( IVF-ET ) using controlled ovarian hyperstimulation ( COH ) regimens using either the gonadotropin-releasing hormone ( GnRH ) agonist leuprolide acetate vs the GnRH antagonist ganirelix . METHODS Women needing IVF for conception were r and omly assigned to 300 IU of gonadotropins with ganirelix used in the follicular phase when a follicle with a 14 mm average diameter was attained vs a regimen using leuprolide acetate from the mid-luteal phase of the previous cycle . RESULTS There were no differences found in clinical , ongoing , delivered pregnancy rates or implantation rates between groups . CONCLUSIONS The use of GnRH antagonists do not seem to reduce IVF outcome compared to using GnRH agonists in COH regimens OBJECTIVE To compare the efficacy of the long GnRH agonist and the fixed GnRH antagonist protocol s in IVF poor responders . STUDY DESIGN This was a r and omized controlled trial performed in the Iakentro IVF centre , Thessaloniki , from January 2007 to December 2011 , concerning women characterised as poor responders after having 0 - 4 oocytes retrieved at a previous IVF cycle . They were assigned at r and om , using sealed envelopes , to either a long GnRH agonist protocol ( group I ) or a GnRH antagonist protocol ( group II ) . RESULTS Overall 364 women fulfilled the inclusion criteria and were allocated to the two groups : finally 330 participated in our trial . Of these , 162 were treated with the long GnRH agonist protocol ( group I ) , and 168 with the fixed GnRH antagonist protocol ( group II ) . Numbers of embryos transferred and implantation rates were similar between the two groups ( P = NS ) . The overall cancellation rate was higher in the antagonist group compared to the agonist group , but the difference was not significant ( 22.15 % vs. 15.2 % , P = NS ) . Although clinical pregnancy rates per transfer cycle were not different between the two groups ( 42.3 % vs. 33.1 % , P = NS ) , the clinical pregnancy rate per cycle initiated was significantly higher in the agonist compared to the antagonist group ( 35.8 % vs. 25.6 % , P=0.03 ) . CONCLUSIONS Although long GnRH agonist and fixed GnRH antagonist protocol s seem to have comparable pregnancy rates per transfer in poor responders undergoing IVF , the higher cancellation rate observed in the antagonist group suggests the long GnRH agonist protocol as the first choice for ovarian stimulation in these patients Objective To study if luteal E2 pre-treatment before GnRH antagonist protocol improves IVF/ICSI outcomes compared with st and ard long GnRH agonist protocol . Design A prospect i ve , r and omized and controlled study . Setting ART center of a state public hospitalPatient(s)Two hundred twenty infertile women underwent IVF/ICSI treatments . Intervention(s ) Participants received oral Estradiol Valerate 4 mg/day preceding the IVF cycle from day 21 until day 2 of next cycle before GnRH antagonist protocol ( E2 pre-treatment group n = 109 ) or received st and ard long GnRH agonist protocol as control group ( n = 111).Main outcome measure(s)Number of oocytes collected , MII oocytes , fertilization , implantation , live birth and early pregnancy rate , and hormone profiles . Result (s)E2 pre-treatment exerted a significant suppressive effect on FSH but not LH secretion compared with basal FSH and LH levels . In E2 pre-treatment group serum LH level was significantly higher during COH and serum P was also significantly higher on the day of HCG injection compared with control group . Five patients from E2 pre-treatment group had elevated LH at all time ( ≥10 IU/L ) and also a concomitantly high P ( > 1 ng/mL ) . Two of the five women achieved pregnancy but had early pregnancy loss . Overall , IVF/ICSI outcomes such as implantation , clinical pregnancy and live birth rates were similar between E2 pre-treatment and control groups . Conclusion (s)Luteal E2 pre-treatment before GnRH antagonist protocol significantly increases serum LH level and incidence rate of premature LH but no significant effect is observed on implantation , clinical pregnancy , live birth and early pregnancy loss rates compared with long GnRH agonist protocol . However , more studies in large numbers of cycles are needed to confirm that increased serum LH level by E2 pre-treatment during COH has no negative effect on the IVF/ICSI outcomes OBJECTIVE To evaluate whether the incidence of luteinizing hormone ( LH ) rise is reduced by using a flexible compared with a fixed day-6 protocol of GnRH antagonist administration . DESIGN R and omized controlled trial . SETTING Tertiary university hospital . PATIENT(S ) Patients undergoing in vitro fertilization ( n = 146 ) . INTERVENTION(S ) Ovarian stimulation was performed using recombinant FSH and GnRH antagonists . GnRH antagonist cetrorelix ( 0.25 mg/d ) was started either on day 6 of stimulation ( fixed group ) or when LH was > 10 IU/L , and /or a follicle with mean diameter > 12 mm was present , and /or serum E(2 ) was > 150 pg/mL. Patient monitoring was initiated on day 3 of stimulation . MAIN OUTCOME MEASURE(S ) Incidence of LH rise . RESULT ( S ) No statistically significant difference was observed between the flexible and fixed groups regarding the incidence of LH rise , which was lower in the flexible group ( 11.0 % vs. 15.1 % , difference -4.1 % , 95 % confidence interval -15.4 % to + 7.1 % ) . No LH surges were observed in any of the patients studied . CONCLUSION ( S ) Flexible antagonist administration from day 3 onward does not appear to reduce the incidence of LH rises compared with fixed antagonist administration on day 6 of stimulation Purpose To evaluate the results of gonadotropin-releasing hormone agonist ( GnRHa ) and gonadotropin-releasing hormone antagonist ( GnRHant ) use in two demographically matched groups of normoresponder in-vitro fertilisation or intracytoplasmic sperm injection ( IVF/ICSI ) patients in a prospect i ve study . Methods We r and omised 93 patients undergoing IVF/ICSI between May 2005 and August 2006 . Patients with IVF indications were included except for those with polycystic ovary syndrome or azoospermia , women older than 38 years and those with follicle-stimulating hormone ( FSH ) ≥10 IU/ml . Patients were stimulated with st and ard 225 IU recombinant FSH . In Group I ( n=45 ) a daily dose of GnRHant cetrorelix acetate 0.25 mg was administered when follicles reached a diameter of ≥14 mm . Group II ( n=48 ) patients were desensitised with the GnRHa , leuprolide acetate , in a long protocol . Human chorionic gonadotropin ( hCG ) was administered when at least three follicles of 18 mm in diameter were observed . Oocyte retrieval was scheduled 36 hours following hCG administration and embryos were transferred on day 3 after oocyte retrieval . Results The two groups were homogenous for age , infertility duration , basal FSH and serum oestradiol ( E2 ) ( P=0.537 , P=0.911 , P=0.103 and P=0.733 , respectively ) . In Group II ( the GnRHa group ) more antral follicles ( P<0.001 ) , a longer induction duration ( P=0.017 ) and higher peak E2 levels ( P<0.001 ) were observed . No differences were observed in the number of oocytes retrieved ( P=0.749 ) , embryos achieved and transferred ( P=0.677 ) , or fertilisation rates ( P=0.839 ) between the two groups . There was no statistically significant difference between groups in clinical pregnancy rates , cycle cancellation and ovarian hyperstimulation ( P=0.437 , P=0.109 and P=0.415 , respectively ) . Conclusion GnRHant and GnRHa provide comparable results in normoresponder patients , while GnRHant allows a greater flexibility in their treatment BACKGROUND The specific role of LH in folliculogenesis and oocyte maturation is unclear . GnRH antagonists , when administered in the late follicular phase , induce a sharp decrease in serum LH which may be detrimental for IVF outcome . This study was performed to evaluate whether the replacement of GnRH agonist ( triptorelin ) by a GnRH antagonist ( ganirelix ; NV Organon ) in oocyte donation cycles has any impact on pregnancy and implantation rates . METHODS A total of 148 donor IVF cycles was r and omly assigned to use either a GnRH antagonist daily administered from the 8th day of stimulation ( group I ) or a GnRH agonist long protocol ( group II ) for the ovarian stimulation of their donors . The primary endpoints were the pregnancy and the implantation rates . RESULTS The clinical pregnancy rate per transfer ( 39.72 % , 29/73 versus 41.33 % , 31/75 ) based on transvaginal scan findings at 7 weeks of gestation , the implantation rate ( 23.9 versus 25.4 % ) and the first trimester abortion rate ( 10.34 versus 12.90 % ) were similar in the two groups . CONCLUSION In oocyte donation cycles the replacement of GnRH agonist by a GnRH antagonist appears to have no impact on the pregnancy and implantation rates when its administration starts on day 8 of stimulation Objective To evaluate the effectiveness of GnRH antagonist multiple dose protocol applied during early and late follicular phase ( MDP-EL ) in comparison with st and ard GnRH agonist luteal long protocol ( LP ) in each non-obese and obese polycystic ovary syndrome ( PCOS ) women undergoing IVF . Methods Two hundred eleven infertile women with PCOS were recruited and r and omized to undergo either GnRH antagonist MDP-EL ( antagonist group ) or st and ard GnRH agonist luteal LP ( agonist group ) . IVF cycle outcomes were compared between the two groups . Results Total dose and days of recombinant human follicle stimulating hormone ( rhFSH ) administered were significantly fewer in the antagonist group than in the agonist group . Incidence of severe ovarian hyperstimulation syndrome was significantly lower in the antagonist group . However , IVF and pregnancy outcomes were similar in the two groups . When all subjects were divided into non-obese and obese subgroups , in non-obese PCOS subgroup , IVF and pregnancy outcomes were comparable in the antagonist and agonist groups but total dose and days of rhFSH were also significantly fewer in the antagonist group . Similar findings were also observed in obese PCOS subgroup . Conclusion GnRH antagonist MDP-EL is at least as effective as GnRH agonist LP and may be a more patient-friendly alternative in controlled ovarian stimulation for PCOS patients undergoing IVF , independent of body mass index OBJECTIVE To compare the effects of oral contraceptive ( OC ) pill pretreatment in recombinant FSH/GnRH-antagonist versus recombinant FSH/GnRH-agonist stimulation in in vitro fertilization ( IVF ) patients , and to evaluate optimization of retrieval day . DESIGN Prospect i ve , r and omized , multicenter study . SETTING Private practice and university centers . PATIENT(S ) Eighty patients undergoing IVF who met the appropriate inclusion criteria . INTERVENTION(S ) Four study centers recruited 80 patients . The OC regimen began on cycle days 2 to 4 and was discontinued on a Sunday after 14 to 28 days . The recombinant FSH regimen was begun on the following Friday . The GnRH-agonist group was treated with a long protocol ; the GnRH-antagonist was initiated when the lead follicle reached 12 to 14 mm . When two follicles had reached 16 to 18 mm , hCG was administered . MAIN OUTCOME MEASURE(S ) The primary outcome measures were the number of cumulus-oocyte complexes , day of the week for oocyte retrieval , and total dose and days of stimulation of recombinant FSH . Secondary efficacy variables included pregnancy and implantation rate ; serum E(2 ) levels on stimulation day 1 ; serum E(2 ) , P , and LH levels on the day of hCG administration ; follicle size on day 6 and day of hCG administration ; the total days of GnRH-analogue treatment ; total days on OC ; total days from end of OC to oocyte retrieval ; and the cycle cancellation rate . RESULT ( S ) Patient outcomes were similar for the days of stimulation , total dose of gonadotropin used , two-pr Output:
WIDER IMPLICATION S In a general IVF population , GnRH antagonists are associated with lower ongoing pregnancy rates when compared to long protocol agonists , but also with lower OHSS rates . Thus st and ard use of the long GnRH agonist treatment is perhaps still the approach of choice for prevention of premature luteinization . In couples with PCOS and poor responders , GnRH antagonists do not seem to compromise ongoing pregnancy rates and are associated with less OHSS and therefore could be considered as st and ard treatment
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: To study the antiepileptic effects of rTMS in patients with refractory epilepsy and malformations of cortical development in a r and omized , double‐blind , sham‐controlled trial Repetitive transcranial magnetic stimulation ( rTMS ) is an emerging non-pharmacological approach to treating many brain-based disorders . rTMS uses electromagnetic coils to stimulate areas of the brain non-invasively . Deep transcranial magnetic stimulation ( dTMS ) with the Brainsway H1-coil system specifically is a type of rTMS indicated for treating patients with major depressive disorder ( MDD ) who are resistant to medication . The unique H1-coil design of this device is able to stimulate neuronal pathways that lie deeper in the targeted brain areas than those reached by conventional rTMS coils . dTMS is considered to be low-risk and well tolerated , making it a viable treatment option for people who have not responded to medication or psychotherapy trials for their depression . R and omized , sham-control studies have demonstrated that dTMS produces significantly greater improvement in depressive symptoms than sham dTMS treatment in patients with major depression that has not responded to antidepressant medication . In this paper , we will review the methodology for treating major depression with dTMS using an H1-coil We evaluated the effect of low-frequency repetitive transcranial magnetic stimulation ( rTMS ) on seizure frequency in adult patients with medically intractable extratemporal lobe epilepsy ( ETLE ) . Seven patients with medically intractable ETLE received low-frequency rTMS at 0.9 Hz , basically two sets of 15 min stimulation per day for five days in a week , with the stimulus intensity of 90 % of resting motor threshold ( RMT ) . The number of seizures during two weeks before and after the stimulation of one week was compared . Furthermore , RMT and active motor threshold ( AMT ) were measured before and after rTMS for each daily session . After low-frequency rTMS of one week , the frequency of all seizure types , complex partial seizures ( CPSs ) and simple partial seizures was reduced by 19.1 , 35.9 and 7.4 % , respectively . The patients with smaller difference between RMT and AMT before rTMS had higher reduction rate of CPSs . A favorable tendency of seizure reduction , though not statistically significant , during two weeks after low-frequency rTMS was demonstrated in medically intractable ETLE patients . As far as CPSs are concerned , smaller decrease of motor threshold by voluntary muscle contraction was associated with better response to rTMS PURPOSE To evaluate the number of seizures and interictal epileptiform discharges ( IEDs ) in patients with focal neocortical epilepsy before , during and after rTMS . METHODS Twelve patients ( seven men and five women , mean age 29.3+/-15.8 years ) were studied . An open-label study with baseline ( 4 weeks ) , intervention ( 2 weeks ) and follow-up ( 8 weeks ) periods was carried out . Repetitive transcranial magnetic stimulation ( rTMS ) with 900 pulses , intensity of 120 % motor resting threshold and 0.5Hz frequency was used . A 120 channel EEG was recorded ; an electrical source analysis of IEDs with Variable Resolution Electromagnetic Tomography ( VARETA ) was performed . The number of seizures per week and IEDs per minute were measured and compared in the three periods . RESULTS During the basal period the mean seizure frequency was 2.25 per week ; in the intervention period it decreased to 0.66 per week ( F=2.825 ; p=0.0036 ) which corresponds to a 71 % reduction . In the follow-up period the mean frequency was 1.14 seizures per week , that is , a 50 % reduction in the number of seizures . In the visual EEG analysis , the baseline IED frequency was 11.9+/-8.3events/min ; it decreased to 9.3+/-7.9 during 2 weeks of rTMS with a further reduction to 8.2+/-6.6 in the follow-up period . These differences however were not significant ( p=0.190 ) . CONCLUSION We conclude that 2 weeks of rTMS at 0.5Hz with a figure-of-eight coil placed over the epileptic focus , determined with VARETA , decreases the number of seizures in patients with focal epilepsy , without reduction in IEDs PURPOSE To assess the effectiveness of slow repetitive transcranial magnetic stimulation ( rTMS ) as an adjunctive treatment for drug-resistant epilepsy . METHODS Forty-three patients with drug-resistant epilepsy from eight Italian Centers underwent a r and omized , double-blind , sham-controlled , crossover study on the clinical and EEG effects of slow rTMS . The stimulus frequency was 0.3 Hz . One thous and stimuli per day were given at the resting motor threshold intensity for 5 consecutive days , with a round coil at the vertex . RESULTS " Active " rTMS was no better than placebo for seizure reduction . However , it decreased interictal EEG epileptiform abnormalities significantly ( p < 0.05 ) in one-third of the patients , which supports a detectable biologic effect . No correlation linked the rTMS effects on seizure frequency to syndrome or anatomic classification , seizure type , EEG changes , or resting motor threshold ( an index of motor cortex excitability ) . CONCLUSIONS Although the antiepileptic action was not significant ( p > 0.05 ) , the individual EEG reactivity to " active " rTMS may be encouraging for the development of more-powerful , noninvasive neuromodulatory strategies OBJECTIVE To evaluate the antiepileptic effect of low-frequency rTMS ( repetitive transcranial magnetic stimulation ) in the patients with intractable epilepsy . METHODS We enrolled 35 patients with localization-related epilepsy who had experienced at least one complex partial seizure or a secondarily generalized seizure per week on a constant antiepileptic drug regimen over an 8-week period . rTMS was administered using a Rapid(2 ) magnetic stimulator with an air-cooled coil at 0.5Hz for 5 consecutive days at 100 % of rMT ( resting motor threshold ) . Patients were divided into a focal stimulation group with a localized epileptic focus , or a non-focal stimulation group with a non-localized or multifocal epileptic focus . These two groups were then r and omly subdivided into four subgroups depending on the total number of stimulations administered , i.e. , 3000 pulse and 1500 pulse subgroups . Weekly seizure frequencies were determined for 8 weeks before and after rTMS . To compare the number of interictal spikes before and after rTMS , EEG was recorded twice before ( 1st day ) and after rTMS ( 5th day ) . RESULTS Mean weekly seizure frequency was non-significantly decreased after rTMS ( 8.4 - ->6.8/week , -13.9 % ) . Longer stimulation subgroups ( 3000 pulses , -23.0 % ) tended to have fewer seizures than shorter stimulation subgroups ( 1500 pulses , -3.0 % ) , without statistical significance . TMS stimulation site and structural brain lesions did not influence seizure outcome . However , interictal spikes significantly decreased ( -54.9 % , P=0.012 ) after rTMS and they totally disappeared in 6 patients ( 17.1 % , 6/35 ) . CONCLUSIONS Low-frequency rTMS reduced interictal spikes , but its effect on seizure outcome was not significant . Focal stimulation for a longer duration tended to further reduce seizure frequency . SIGNIFICANCE These findings may help clinicians to further investigate the therapeutic potential of the rTMS for patients with intractable epilepsy Publisher Summary Based on the findings that the effects of repetitive transcranial magnetic stimulation ( rTMS ) last beyond the period of stimulation itself , therapeutical antiepileptic potential of low-frequency rTMS was hypothesized . This chapter presents an interim analysis of an ongoing placebo-controlled trial . The results are discussed on the bases of the existing rTMS literature regarding the treatment of epilepsies in humans . The results presented in this chapter are interim analyses of the first crossover placebo-controlled investigation on the antiepileptic efficacy of low-frequency rTMS . Although a significant difference to placebo could not be demonstrated in this patient group , the data seem to be in line with the results of the first open pilot study on nine patients who showed reduction in seizure frequency within a similar range over a 4-week period . The results were supplemented by a case report on a patient with focal dysplasia by another group : biweekly treatment with 100 stimuli at 0.5 Hz and 95 % motor threshold intensity using an unfocal coil placed over the area of dysplasia reduced seizure frequency by 70 % over a 4-weeks period of treatment PURPOSE This study was design ed to evaluate the therapeutic effect of low-frequency repetitive transcranial magnetic stimulation ( rTMS ) on patients with refractory partial epilepsy . METHODS Sixty-four patients with refractory focal epilepsy were screened and 60 patients were r and omly divided into two groups by stimulation intensity : 90 % ( group 1 ) or 20 % ( group 2 ) of resting motor threshold ( rMT ) . Seizure frequency and interictal EEG epileptic discharges were compared between the baseline and follow-up periods . KEY FINDINGS Seizures significantly decreased following 2-weeks high intensity ( 90 % rMT ) rTMS treatment compared with baseline level ( p < 0.05 ) . rTMS also decreased interictal epilepsy discharges and improved the scales of Symptom Checklist-90 significantly ( p < 0.05 ) . Seizures and spikes in the follow-up period in the patients who received low intensity ( 20 % rMT ) rTMS did not show any difference compared with baseline data ( p > 0.05 , respectively ) . SIGNIFICANCE Low-frequency high intensity rTMS ( 90 % rMT ) delivered into the epileptogenic zone had a significant antiepileptic effect on patients with refractory partial seizures . rTMS treatment can also reduce the interictal epileptic discharge frequency and improve the psychological condition of these patients Rapid-rate transcranial magnetic stimulation ( rTMS ) allows for the noninvasive examination of the cerebral cortex . Recent studies have begun to investigate whether rTMS may be therapeutic for the treatment of depression . In the present study , the authors report on the safety and efficacy of rTMS in treating 50 patients with refractory depression . Overall , there were 21 responders ( 42 % ) . Interestingly , 56 % of the young patients responded , but only 23 % of the elderly patients responded to rTMS . Overall , rTMS was well tolerated in all patients . Specifically , no patient developed a new onset of seizures during rTMS . The authors discuss the extant literature on rTMS for the treatment of depression along with future areas of research Objective To perform a controlled trial of transcranial magnetic stimulation ( TMS ) . Methods Twenty-four patients with localization-related epilepsy were r and omized to blinded active or placebo stimulation . Weekly seizure frequency was compared for 8 weeks before and after 1 week of 1-Hz TMS for 15 minutes twice daily . Results When the 8-week baseline and post-stimulation periods were compared , active patients had a mean seizure frequency reduction of 0.045 ± 0.13 and sham-stimulated control subjects −0.004 ± 0.20 . Over 2 weeks , actively treated patients had a mean reduction in weekly seizure frequency of 0.16 ± 0.18 and sham-stimulated control subjects 0.01 ± 0.24 . Neither difference was significant . Conclusion The effect of TMS on seizure frequency was mild and short lived Seventeen refractory partial epilepsy patients were enrolled in an open-label study to evaluate the antiepileptic effect of low-frequency repetitive transcranial magnetic stimulation ( rTMS ) . Seven of the patients had not obtained seizure-free status after epileptogenic focus resection surgery before they were enrolled in the study . All patients were treated with low-frequency rTMS which included 3 sessions per day ( 0.5 Hz , 90 % RMT and 500 pulses each session ) and lasted for 2 weeks . Seizure frequency , seizure days and epileptic discharges in the EEG obtained before , during and after stimulation were compared . The psychological conditions of all individual patients were evaluated with Symptom Checklist-90 ( SCL-90 ) before and after rTMS treatment . Mean seizure frequencies per week significantly decreased in the following 4-week rTMS treatment period compared with the pretreatment period ( 14.09 vs. 5.63 , p < 0.05 , mean reduction of 60.02 % in seizure frequency ) . Mean seizure days per week during the treatment period and the post-treatment period were lower than that of the pretreatment period ( 5.18 vs. 2.99 p < 0.05 , mean reduction of 42.5 % in seizure days ) . Mean epileptic discharges in the EEG decreased significantly during the treatment period compared to that of the pre-treatment period ( 78.60 vs. 66.09 , p < 0.05 , mean reduction of 15. Output:
Significance Real-world evidence suggests that low-frequency rTMS using a figure-8 coil may be an effective therapy for the treatment of drug-resistant epilepsy in pediatric patients .
MS2_1shot294
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: CONTEXT Pelvic floor electrical stimulation ( PFES ) has been shown to be effective for stress incontinence . However , its role in a multicomponent behavioral training program has not been defined . OBJECTIVE To determine if PFES increases efficacy of behavioral training for community-dwelling women with stress incontinence . DESIGN AND SETTING Prospect i ve r and omized controlled trial conducted from October 1 , 1995 , through May 1 , 2001 , at a university-based outpatient continence clinic in the United States . PATIENTS Volunteer sample of 200 ambulatory , nondemented , community-dwelling women aged 40 to 78 years with stress or mixed incontinence with stress as the predominant pattern ; stratified by race , type of incontinence ( stress only vs mixed ) , and severity ( frequency of episodes ) . INTERVENTIONS Patients were r and omly assigned to 8 weeks ( 4 visits ) of behavioral training , 8 weeks ( 4 visits ) of the behavioral training plus home PFES , or 8 weeks of self-administered behavioral treatment using a self-help booklet ( control condition ) . MAIN OUTCOME MEASURES Primary outcome was percentage reduction in the number of incontinent episodes as documented in bladder diaries . Secondary outcomes were patient satisfaction and changes in quality of life . RESULTS Intention-to-treat analysis showed that incontinence was reduced a mean of 68.6 % with behavioral training , 71.9 % with behavioral training plus PFES , and 52.5 % with the self-help booklet ( P = .005 ) . In comparison with the self-help booklet , behavioral training ( P = .02 ) and behavioral training plus PFES ( P = .002 ) were significantly more effective , but they were not significantly different from each other ( P = .60 ) . The PFES group had significantly better patient self-perception of outcome ( P<.001 ) and satisfaction with progress ( P = .02 ) . Significant improvements were seen across all 3 groups on the Incontinence Impact Question naire but with no between-group differences . CONCLUSIONS Treatment with PFES did not increase effectiveness of a comprehensive behavioral program for women with stress incontinence . A self-help booklet reduced incontinence and improved quality of life but not as much as the clinic-based programs In a prospect i ve r and omized study the efficiacy of physical therapy in female stress incontinence could be verified . The greatest success rate was achieved by medical gymnastics , whereas the perineal electrical stimulation should be used as supporting measure like a biofeedback mechanism because of its low effective intensity . Despite of the good therapeutic success ( 51.5 % ) with lasting effects no objective criteria to the use of physical therapy in female stress incontinence were found Purpose This study assessed the benefit of adding behavioural modification to darifenacin treatment for overactive bladder ( OAB ) . Material s and methods The ABLE trial was a r and omised , open-label , parallel-group , multicentre study of 12 weeks of darifenacin treatment [ with voluntary up-titration from 7.5 mg once daily ( qd ) to 15 mg qd at week 2 ] alone or in combination with a Behavioural Modification Programme ( BMP ) for men and women with dry or wet OAB . Efficacy was assessed as the change in the number ( per day ) of micturitions ( primary variable ) , urge urinary incontinence ( UUI ) episodes , urgency episodes , pads used and nocturnal voids . Health-related quality of life ( HRQoL ) was also evaluated . Tolerability and safety assessment s included adverse events and the number of discontinuations . Results Of 592 patients screened , 395 were r and omised , 190 to darifenacin alone and 205 to darifenacin + BMP . At baseline , the majority of subjects were dry ( mean 2.8 and three UUI episodes per day in the darifenacin and darifenacin + BMP groups respectively ) . At study end , darifenacin alone and darifenacin + BMP both produced significant reductions from baseline in median numbers of micturitions , UUI episodes , urgency episodes and nocturnal voids ( all p < 0.05 ) , but not in the number of pads used . HRQoL also improved . There were no significant differences between treatment groups in efficacy or HRQoL variables . Conclusions Darifenacin treatment provides a degree of normalisation of micturition variables and improvement in HRQoL that can not be further enhanced by behavioural therapy of the type used in this study . Whether behavioural modification would add benefit over darifenacin treatment in patients with more pronounced incontinence problems remains to be determined The objectives of this paper were to assess the quality of life of community-living women with urinary incontinence according to age , symptom group , amount of leakage , and duration , by use of the Sickness Impact Profile ( SIP ) . Thirty-six women aged between 40 and 60 years and 40 women aged 70 years or more were r and omly selected from the clients attending an incontinence clinic and interviewed using the SIP question naire . Urge and stress incontinence subgroups were defined by means of a symptom question naire . Total , psychosocial , and physical dysfunctions were moderate ( 8 % , 7 % , and 8 % respectively ) in general , but major differences were found when age and symptom groups were analysed . Urge symptoms were associated with more impairment than symptoms of stress incontinence . The elderly women with symptoms of stress incontinence were relatively little affected , while their younger counterparts were severely affected , especially in the categories of emotional behavior and recreation and pastimes . We conclude that urinary incontinence in women adversely affects quality of life to a significant degree ; the extent depends on the nature of incontinence and the age of the person The purpose of this study was to explore changes in psychological distress associated with behavioral treatment and drug treatment for urge incontinence in community-dwelling older women . Participants were 197 ambulatory , nondemented women ( aged 55 years or older ) with persistent urge urinary incontinence . Participants were patients in a r and omized clinical trial comparing biofeedback-assisted behavioral treatment , drug treatment with oxybutynin chloride , and a placebo-control condition . Psychological distress was measured before and after treatment using the Hopkins Symptom Checklist ( SCL-90-R ) . Multivariate and univariate analyses of variance showed that the two treatment groups and the control group had similar significant improvements on the nine subscales and the global severity index . Analysis of individual SCL-90-R subscale scores revealed trends suggesting that behavioral treatment tended to produce the largest improvements . The reductions of distress were not correlated consistently with reduction of incontinence . The results of this study showed that psychological distress was significantly reduced after treatment , regardless of the type of treatment ABSTRACT Objective To determine the efficacy of stress urinary incontinence treatments adding pelvic floor muscle training to vaginal electrical stimulation . Methods Forty-eight women with stress urinary incontinence were r and omized into 2 groups : 24 underwent isolated vaginal electrical stimulation , and 24 vaginal electrical stimulation plus pelvic floor muscle training . History , physical examination , voiding diary , perineum strength test , and urodynamic study were assessed . Comparisons were made for adherence to treatment , muscle strength improvement , urinary symptoms , and degree of satisfaction immediately , 12 and 96 months after treatment . Results Patients ' degree of satisfaction on vaginal electrical stimulation , and on vaginal electrical stimulation plus pelvic floor muscle training immediately , 12 and 96 months post treatment , were , respectively : 88.2 % versus 88.9 % 64.7 % versus 61.1 % and 42.9 % versus 28.6 % ( p>0.05 ) . Conclusion Vaginal electrical stimulation associated to pelvic floor muscle training did not show better results than vaginal electrical stimulation alone Introduction and hypothesisThe aim of the study was to determine whether successful incontinence pessary fitting or pessary size can be predicted by specific POPQ measurements in women without advanced pelvic organ prolapse . Methods In a multicenter study , women with stress urinary incontinence ( SUI ) and POPQ stage ≤2 were r and omized to three treatment arms : ( 1 ) incontinence pessary , ( 2 ) behavioral therapy , or ( 3 ) both . This study evaluates incontinence pessary size , POPQ measures , and successful fitting in the 266 women assigned to treatment arms 1 and 3 . Results Two hundred thirty-five women ( 92 % ) were successfully fitted with an incontinence ring ( n = 122 ) or dish ( n = 113 ) . Hysterectomy , genital hiatus ( GH ) , and GH/total vaginal length ( TVL ) ratios did not predict unsuccessful fitting ( p > 0.05 ) . However , mean TVL was greater in women successfully fitted ( 9.6 vs. 8.8 cm , p < 0.01 ) . Final pessary diameter was not predicted by TVL , point D , or point C ( p > 0.05 ) . Conclusions The vast majority of women with SUI can be successfully fitted with an incontinence pessary , but specific POPQ measures were not helpful in determining incontinence pessary size A r and omized controlled trial was carried out to evaluate the extent to which a program of reinforced pelvic floor muscle exercises ( PFME ) reduces urinary incontinence 1 year after delivery . Two hundred and thirty women who were incontinent 3 months postpartum were r and omized to either a control group doing st and ard postnatal pelvic floor muscle exercises ( n=117 ) or to an intervention group ( n=113 ) who saw a physiotherapist for instruction at approximately 3 , 4 , 6 and 9 months postpartum . Results collected 12 months after delivery included prevalence and frequency of incontinence and PFME , sexual satisfaction , perineometry measurements and pad tests . Twenty-six ( 22 % ) of the control group and 59 ( 52 % ) of the intervention group withdrew before the final assessment . The prevalence of incontinence was significantly less in the intervention group than in the control group ( 50 % versus 76%,P=0.0003 ) , and this group also did significantly more PFME . There were no significant differences between the groups as regards sexual satisfaction , perineometry measurements or pad test results Objective : To evaluate a new pattern of electrical of electrical stimulation as a treatment for stress incontinence . Design : A r and omized , double-blind , controlled trial . Setting : The study took place on three clinical sites . Subjects : Patients ( n= 27 ) with urodynamically proven stress incontinence recruited via consultant referral . Interventions : Patients were r and omly allocated to one of two groups : the new pattern of stimulation or sham stimulation . Main outcome measures : Patients were assessed pre , mid and post treatment using : perineometry , digital assessment and pad testing . The following were only used pre and post treatment : seven-day frequency/ volume chart , SF-36 , the Incontinence Impact Question naire and the Urogenital Distress Inventory . Results : No significant between-group differences were highlighted except when quality of life was assessed with the Urogenital Distress Inventory ( p= 0.01 ) . A significant reduction in scores was observed in the stimulation group ( p= 0.03 ) However , improvements were seen in both the strength and endurance characteristics of the pelvic floor musculature , although these changes were not translated into a reduction in symptoms . Conclusion : Although promising , the improvement in pelvic floor function did not result in a reduction in symptoms in all patients . Further research is required to investigate the effects of the new stimulation in combination with pelvic floor exercises and to compare the new stimulation pattern with existing forms of electrical stimulation PURPOSE We tested whether individualized drug therapy enhanced with behavioral training would result in better outcomes than individualized drug therapy alone . MATERIAL S AND METHODS Participants were community dwelling women with urge predominant incontinence . Using a r and omized clinical trial design women were r and omized to 8 weeks ( 4 visits ) of drug therapy alone ( 32 ) or drug therapy plus behavioral training ( 32 ) . Drug therapy was individually titrated , extended release oxybutynin with proactive management of side effects . Behavioral training included pelvic floor muscle training and urge suppression techniques . The primary outcome measure was reduction in frequency of incontinence episodes on bladder diary at 8 weeks ( with followup at 6 and 12 months ) . Secondary outcomes included patient satisfaction , global perception of improvement , Urogenital Distress Inventory and Incontinence Impact Question naire . RESULTS In intent to treat analysis frequency of incontinence was reduced a mean of 88.5 % in the drug alone group and 78.3 % in the combined therapy group ( p = 0.16 ) . Outcomes were not significantly different between the groups in the analysis of completers ( 91.5 % vs 86.2 % , p = 0.34 ) , or in either analysis at 6 or 12 months . The groups also did not differ significantly on secondary outcomes at any point . Participants in the drug alone group tended to be taking higher doses of oxybutynin at 8 weeks but the final dose did not differ significantly between the groups . Based on a conditional power calculation the trial was stopped early for futility . CONCLUSIONS When drug therapy is implemented with frequent individualized dose titration , daily bladder diaries and careful management of side effects , initiating concurrent behavioral training does not enhance outcomes for urge incontinence in women OBJECTIVES We previously reported high rates of urinary incontinence among gynecologic cancer survivors and aim ed to evaluate the effectiveness of a simple intervention for Output:
This systematic review found insufficient evidence to state whether or not there were additional effects by adding PFMT to other active treatments when compared with the same active treatment alone for urinary incontinence ( SUI , UUI or MUI ) in women . Also , none of the included trials reported data on adverse events associated with the PFMT regimen , thereby making it very difficult to evaluate the safety of PFMT
MS2_1shot295
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: The role of folic acid ( 5mg/day ) in combination with oral hygiene measures ( group II ) vis-a-vis oral hygiene measures alone ( group I ) in prevention of phenytoin-induced gingival overgrowth was investigated in a one-year follow-up study on sixty , 8 - 13-year-old epileptic children receiving phenytoin . The allocation of the children to the two groups was done alternately . In these children , at baseline , plaque ( Silness & Löe ) , gingivitis ( Löe & Silness ) and probing depths of gingival sulcus were recorded . These parameters were re-evaluated at 3-monthly intervals when gingival overgrowth was also recorded ( Modified Harris & Ewalt Index ) . It was seen that , after a period of one year , gingival overgrowth occurred in 60 and 50 percent children of groups I & II respectively and its development , too , was delayed in group II . More cases ( 93 percent ) in group II exhibited minimal overgrowth as against 78 percent in group I. The study concluded that systemic folic acid prescribed along with phenytoin delays the onset and reduces the incidence and severity of gingival overgrowth induced by phenytoin Summary Fifty-four out- patients with epilepsy who had been taking phenytoin for more than one year were examined for gingival hyperplasia . Approximately 76 % of patients showed either mild or no gingival hyperplasia . Lesion severity was then compared statistically to phenytoin dosage and drug concentrations as well as to other clinical and laboratory parameters . There was a tendency for gingival hypertrophy to be associated with both increasing dosage of phenytoin per unit of body weight and the duration of phenytoin administration . All patients followed had a statistically significant progressive trend to increasing gingival hyperplasia with higher total and free phenytoin concentration BACKGROUND More than 30 percent of patients with epilepsy have inadequate control of seizures with drug therapy , but why this happens and whether it can be predicted are unknown . We studied the response to antiepileptic drugs in patients with newly diagnosed epilepsy to identify factors associated with subsequent poor control of seizures . METHODS We prospect ively studied 525 patients ( age , 9 to 93 years ) who were given a diagnosis , treated , and followed up at a single center between 1984 and 1997 . Epilepsy was classified as idiopathic ( with a presumed genetic basis ) , symptomatic ( result ing from a structural abnormality ) , or cryptogenic ( result ing from an unknown underlying cause ) . Patients were considered to be seizure-free if they had not had any seizures for at least one year . RESULTS Among the 525 patients , 333 ( 63 percent ) remained seizure-free during antiepileptic-drug treatment or after treatment was stopped . The prevalence of persistent seizures was higher in patients with symptomatic or cryptogenic epilepsy than in those with idiopathic epilepsy ( 40 percent vs. 26 percent , P=0.004 ) and in patients who had had more than 20 seizures before starting treatment than in those who had had fewer ( 51 percent vs. 29 percent , P<0.001 ) . The seizure-free rate was similar in patients who were treated with a single established drug ( 67 percent ) and patients who were treated with a single new drug ( 69 percent ) . Among 470 previously untreated patients , 222 ( 47 percent ) became seizure-free during treatment with their first antiepileptic drug and 67 ( 14 percent ) became seizure-free during treatment with a second or third drug . In 12 patients ( 3 percent ) epilepsy was controlled by treatment with two drugs . Among patients who had no response to the first drug , the percentage who subsequently became seizure-free was smaller ( 11 percent ) when treatment failure was due to lack of efficacy than when it was due to intolerable side effects ( 41 percent ) or an idiosyncratic reaction ( 55 percent ) . CONCLUSIONS Patients who have many seizures before therapy or who have an inadequate response to initial treatment with antiepileptic drugs are likely to have refractory epilepsy Output:
Although several studies examined the effects of PHT on oral health , none have studied those of the newer generation of AEDs .
MS2_1shot296
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Treatment with heparin or streptokinase was allocated r and omly to 30 patients with life-threatening pulmonary embolism verified by angiography . Treatment was given for 72 hours and pulmonary angiography was repeated . There was significantly greater ( P < 0·001 ) evidence of thrombolysis in those patients treated with streptokinase compared with those treated with heparin . The reduction of systolic and mean pulmonary arterial pressures was also significantly greater ( P < 0·05 and P < 0·02 respectively ) in the streptokinase group . Seven patients failed to complete 72 hours of the trial treatment : five successfully underwent pulmonary embolectomy . Six of these “ failures ” had initial pulmonary angiographic scores of 24 or more and systemic systolic blood pressure recordings of 100 mm Hg or less . Patients with these features should probably be considered for pulmonary embolectomy as the initial treatment . A febrile reaction commonly occurred in the streptokinase group ; otherwise side effects were no more common than in the heparin group Dissolution of pulmonary emboli with heparin and urokinase is ascribed , respectively , to anticoagulation and fibrinolysis . Since truly independent assessment of these effects in man is lacking , we administered each drug alone . Fibrinogen and plasminogen plasma levels and the resolution of pulmonary emboli were measured in three r and omized groups of 10 patients each : groups A and C infused with small repeated doses of urokinase and a large single dose of urokinase , respectively , and group B who received heparin . After 6 h of treatment , fibrinogen fell in all the groups , while , after 12 h , remained equally reduced in groups A and B and declined further in group C. Plasminogen behaved similarly . Up to 60 h , statistical analysis showed that these effects were related to timing and amounts of urokinase and heparin infusion . These observations suggest that heparin may induce a lytic state . As to signs of pulmonary emboli resolution , no differences between groups were found in lung perfusion and gas exchange recovery at any time ( from 1 day to 1 year ) and in pulmonary artery pressure reduction at 1 week . The greater angiographic and scintigraphic recovery observed with urokinase , versus heparin alone , after 1 day of treatment in the Urokinase Pulmonary Embolism Trial may be ascribed to a synergistic effect with urokinase of heparin administered during the diagnostic work-out . The indications of heparin and urokinase should be evaluated in the light of these results BACKGROUND The role of echocardiographic right ventricular ( RV ) dysfunction in predicting clinical outcome in clinical ly stable patients with pulmonary embolism ( PE ) is undefined . In this study , we assessed the prevalence and clinical outcome of normotensive patients with RV dysfunction among a broad spectrum of PE patients . METHODS AND RESULTS This prospect i ve clinical outcome study included cohort of 209 consecutive patients ( age , 65+/-15 years ) with documented PE . Acute RV dysfunction was diagnosed in the presence of > /=1 of the following : RV dilatation ( without hypertrophy ) , paradox septal systolic motion , and Doppler evidence of pulmonary hypertension . Four groups were identified : 28 patients presenting with shock or cardiac arrest ( 13 % ) , 19 hypotensive patients without shock ( 9 % ) , 65 normotensive patients with echocardiographic RV dysfunction ( 31 % ) , and 97 normotensive patients without RV dysfunction ( 47 % ) . Among normotensive patients with RV dysfunction , 6 ( 10 % ) developed PE-related shock after admission : 3 of these patients died , and 3 were successfully treated with thrombolytic agents . In comparison , none of the 97 normotensive patients without RV dysfunction developed shock or died as a result of PE . CONCLUSIONS A significant proportion ( 31 % ) of normotensive patients with acute PE presents with RV dysfunction ; these patients with latent hemodynamic impairment have a 10 % rate of PE-related shock and 5 % in-hospital mortality and may require aggressive therapeutic strategies . Conversely , normotensive patients without echocardiographic RV dysfunction have a benign short-term prognosis . Thus , early detection of echocardiographic RV dysfunction is of major importance in the risk stratification of normotensive patients with acute PE BACKGROUND The effect of alteplase versus heparin in pulmonary embolism has not been studied extensively with serial pulmonary angiograms . OBJECTIVES The aim of this r and omized , open trial was to evaluate the efficacy and safety of alteplase followed by heparin , versus heparin alone , in 36 patients with angiographically documented pulmonary embolism . METHODS Twenty patients were allocated r and omly to a 2-h infusion of alteplase ( 10 mg bolus , then 90 mg over 2 h ) followed by heparin ; the other 16 patients were given intravenous heparin at a continuous infusion rate of 1,750 IU/h . RESULTS The vascular obstruction , assessed by the Miller index at pulmonary angiography , decreased significantly in alteplase-treated patients ( p less than 0.01 ) from a baseline of 28.3 + /- 2.9 to a value of 24.8 + /- 5.2 2 h after the start of infusion ; in the heparin group there was no change ( from 25.3 + /- 5.3 to 25.2 + /- 5.4 ) . Mean pulmonary artery pressure decreased significantly from a baseline of 30.2 + /- 7.8 mm Hg to 21.4 + /- 6.7 in the alteplase group and increased in the heparin group ( from 22.3 + /- 10.5 to 24.8 + /- 11.2 mm Hg ) . For a subset of patients , lung scans were performed at baseline and on days 7 and 30 . There were no differences between the two groups in the follow-up lung scans , but there were significant decreases from the baseline values . Bleeding occurred in 14 of 20 alteplase-treated patients and in 6 of 16 in the heparin group ( p = NS ) . There were three major bleeding episodes in the alteplase group and two in the heparin group . Two patients died after fibrinolysis ( one of acute renal failure after cardiac tamponade and one of cardiac arrest after cerebral hemorrhage ) and one patient in the heparin group died of recurrent pulmonary embolism . CONCLUSIONS Alteplase result ed in a greater and faster improvement of the angiographic and hemodynamic variables compared with heparin . However , the high frequency of bleeding observed with alteplase in this trial suggests that patients should be carefully selected before thrombolytic therapy is given BACKGROUND Pulmonary embolism is a potentially fatal disorder . Information about the outcome of clinical ly recognized pulmonary embolism is sparse , particularly given that new treatments for more seriously ill patients are now available . METHODS We prospect ively followed 399 patients with pulmonary embolism diagnosed by lung scanning and pulmonary angiography , who were enrolled in a multicenter diagnostic trial . We review ed all hospitalizations , all new investigations of pulmonary embolism , and all deaths among the patients within one year of diagnosis . RESULTS Of the 399 patients , 375 ( 94 percent ) received treatment for pulmonary embolism , usually conventional anticoagulation . Only 10 patients ( 2.5 percent ) died of pulmonary embolism ; 9 of them had clinical ly suspected recurrent pulmonary embolism . Clinical ly apparent pulmonary embolism recurred in 33 patients ( 8.3 percent ) , of whom 45 percent died during follow-up . Ninety-five patients with pulmonary embolism ( 23.8 percent ) died within one year . The conditions associated with these deaths were cancer ( relative risk , 3.8 ; 95 percent confidence interval , 2.3 to 6.4 ) , left-sided congestive heart failure ( relative risk , 2.7 ; 95 percent confidence interval , 1.5 to 4.6 ) , and chronic lung disease ( relative risk , 2.2 ; 95 percent confidence interval , 1.2 to 4.0 ) . The most frequent causes of death in patients with pulmonary embolism were cancer ( in 34.7 percent ) , infection ( 22.1 percent ) , and cardiac disease ( 16.8 percent ) . CONCLUSIONS When properly diagnosed and treated , clinical ly apparent pulmonary embolism was an uncommon cause of death , and it recurred in only a small minority of patients . Most deaths were due to underlying diseases . Patients with pulmonary embolism who had cancer , congestive heart failure , or chronic lung disease had a higher risk of dying within one year than did other patients with pulmonary embolism STUDY OBJECTIVES To assess the potential benefit of thrombolysis in patients with massive pulmonary embolism ( PE ) with stable hemodynamics and right ventricular dysfunction . DESIGN Retrospective , cohort study . SETTING University-based , tertiary referral medical center . PATIENTS One hundred fifty-three consecutive patients with massive PE from January 1992 to December 1997 treated with heparin or thrombolysis . MEASUREMENTS AND RESULTS Massive PE was confirmed by perfusion lung scan or pulmonary angiography . Right ventricular dysfunction was assessed by echocardiography ( right ventricular/left ventricular [ RV/LV ] diastolic diameter ratio > 0.6 ) in all patients . In order to study a homogeneous population , 64 patients treated with thrombolysis ( group 1 ) were matched on baseline RV/LV diameter ratio to 64 patients treated with heparin ( group 2 ) . Perfusion lung scan was repeated at day 7 to day 10 . Mean relative improvement in perfusion lung scans was higher in group 1 than group 2 ( 54 % vs 42 % , respectively ) . PE recurrences were the same in both groups ( 4.7 % ; n = 3 ) . There were no bleeding complications and no deaths in group 2 . Conversely , in group 1 , 15.6 % ( n = 10 ) of patients suffered from bleeding ( 4.7 % ; n = 3 with intracranial bleeding ) and 6.25 % ( n = 4 ) of them died . CONCLUSIONS The results of this monocenter registry do not support the indication for thrombolysis in patients suffering from massive PE with stable hemodynamics and right ventricular dysfunction . Appropriate therapy in such patients still remains unknown . Further prospect i ve r and omized trials should be performed To test the efficacy of thrombolytic therapy in massive pulmonary embolism , we conducted a prospect i ve r and omized controlled trial . Eight patients were r and omized to receive either 1,500,000 IU of streptokinase in 1 hour through a peripheral vein followed by heparin or heparin alone . All patients had major risk factors for deep vein thrombosis ( DVT ) and were considered to have high clinical suspicion for pulmonary embolism ( PE ) . At baseline all patients had a similar degree of systemic arterial hypotension , pulmonary arterial hypertension , and right ventricular dysfunction . The time of onset of cardiogenic shock in both groups was comparable ( 2.25 ±0.5 hours in the streptokinase group and 1.75 ±0.96 hours in the heparin group ) . The four patients who were r and omized to streptokinase improved in the first hour after treatment , survived , and in 2 years of follow-up are without pulmonary arterial hypertension . All four patients treated with heparin alone died from 1 to 3 hours after arrival at the emergency room ( p=0.02 ) . Post-thrombolytic therapy the diagnosis of PE was sustained in the streptokinase group by high probability V/Q lung scans and proven DVT . A necropsy study performed in three patients in the heparin group showed massive pulmonary embolism and right ventricular myocardial infa rct ion , without significant coronary arterial obstruction . The results indicate that thrombolytic therapy reduces the mortality rate of massive acute pulmonary embolism Experiments in animals have demonstrated that recombinant tissue plasminogen activator ( rt-PA ) produces continuing thrombolysis after it is cleared from the circulation and that thrombolysis is both increased and accelerated , and bleeding is reduced when rt-PA is administered over a short period . In previous studies in patients with thrombotic disease , rt-PA has been shown to be an effective thrombolytic agent when administered by continuous infusion over a period between 90 minutes and 8 hours . To determine whether a short course regimen of rt-PA can achieve thrombolysis , a double-blind r and omized trial has been conducted in which patients with objective ly established acute symptomatic pulmonary embolism who were receiving heparin were allocated to either a 2-minute infusion of rt-PA at a dose of 0.6 mg/kg ( 33 patients ) or saline placebo ( 25 patients ) . Perfusion lung scanning was used to assess the change in pulmonary perfusion at 24 hours and seven days post- study drug administration . Thirty-four percent of the rt-PA patients had a greater than 50 percent resolution in the perfusion defect at 24 hours compared to 12 percent of placebo Output:
Because 30 % to 50 % of patients with PE present with echocardiographic evidence of RV dysfunction , the administration of a thrombolytic treatment toallof them would have significant implication s. The arguments for thrombolysis in such patients are essentially the following:(1)RVdysfunctionisastrong prognostic factor in patients with acute PE ; ( 2 ) the ability of thrombolytic agents to improve pulmonary reperfusion and enhanceRVfunction should translate into clinical benefit ; and ( 3 ) results of several studies have suggestedabeneficialeffectof thrombolysis in patients with acute PE and RV dysfunction .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Objective To determine the effectiveness of the provision of whole food to enhance completion of treatment for tuberculosis . Design Parallel group r and omised controlled trial . Setting Three primary care clinics in Dili , Timor-Leste . Participants 270 adults aged ≥18 with previously untreated newly diagnosed pulmonary tuberculosis . Main outcome measures Completion of treatment ( including cure ) . Secondary outcomes included adherence to treatment , weight gain , and clearance of sputum smears . Outcomes were assessed remotely , blinded to allocation status . Interventions Participants started st and ard tuberculosis treatment and were r and omly assigned to intervention ( nutritious , culturally appropriate daily meal ( weeks 1 - 8 ) and food package ( weeks 9 - 32 ) ( n=137 ) or control ( nutritional advice , n=133 ) groups . R and omisation sequence was computer generated with allocation concealment by sequentially numbered , opaque , sealed envelopes . Results Most patients with tuberculosis were poor , malnourished men living close to the clinics ; 265/270 ( 98 % ) contributed to the analysis . The intervention had no significant beneficial or harmful impact on the outcome of treatment ( 76 % v 78 % completion , P=0.7 ) or adherence ( 93 % for both groups , P=0.7 ) but did lead to improved weight gain at the end of treatment ( 10.1 % v 7.5 % improvement , P=0.04 ) . Itch was more common in the intervention group ( 21 % v 9 % , P<0.01 ) . In a subgroup analysis of patients with positive results on sputum smears , there were clinical ly important improvements in one month sputum clearance ( 85 % v 67 % , P=0.13 ) and completion of treatment ( 78 % v 68 % , P=0.3 ) . Conclusion Provision of food did not improve outcomes with tuberculosis treatment in these patients in Timor-Leste . Further studies in different setting s and measuring different outcomes are required . Trial registration Clinical Trials NCT0019256 BACKGROUND Drug users are at increased risk for latent tuberculosis infection ( LTBI ) and also at increased risk for noncompletion of medication regimens for treatment of LTBI or tuberculosis disease . Directly observed therapy ( DOT ) provided by outreach workers , the use of incentives , or both have been suggested as a means to increase adherence . OBJECTIVE To compare the independent and combined effects of monetary incentives and outreach worker provision of DOT for LTBI treatment in a sample of active drug users . METHODS The research design was a r and omized controlled trial in a community outreach program setting . Participants consisted of a volunteer sample of 163 active injection drug and crack cocaine users placed on twice weekly DOT . Condition 1 of the interventions consisted of provision of DOT by an outreach worker at a location chosen by the participant ( active outreach ) and a $ 5 per visit incentive . Condition 2 was comprised of active outreach with no monetary incentive , and Condition 3 , provision of DOT at the study community site and a $ 5 per visit incentive . The main outcome measures were percentage of medication taken as prescribed and completion of medication regimen . RESULTS The percentage of prescribed medication taken was higher for those who received incentives , either with ( 71 % ) or without ( 68 % ) active outreach , compared to those who received active outreach alone ( 13 % ) . Only 4 % of participants assigned to Condition 2 completed treatment , compared to 53 % of Condition 1 participants , and 60 % of Condition 3 participants . CONCLUSIONS Monetary incentives were clearly superior to active outreach . Active outreach in combination with monetary incentives did not increase adherence over incentives alone SETTING Few studies have examined strategies for optimizing adherence to latent tuberculosis infection ( LTBI ) treatment programs in homeless population s. OBJECTIVES 1 ) To compare the effectiveness of an intervention program employing nurse case management and incentives ( NCMI ) vs. a control program with st and ard care and incentives on completion of LTBI treatment ; and 2 ) to compare the impact of the two programs on tuberculosis ( TB ) knowledge among participants . DESIGN A prospect i ve , two-group site-r and omized design conducted among 520 homeless adults residing in the Skid Row region of Los Angeles from 1998 to 2003 , assessing completion rates of a 6-month isoniazid ( INH ) treatment program and change in TB knowledge . RESULTS Using intent-to-treat analysis , 62 % of participants in the intervention program , compared with 39 % of controls , completed the full 6-month course of LTBI treatment with INH . Logistic regression modeling revealed that intervention participants had three times greater odds of completing INH treatment than controls . TB knowledge improved in both programs , but the increase was greater among the intervention participants ( P < 0.001 ) . CONCLUSIONS Nurse case management combined with education , incentives , and tracking dramatically improves both adherence to LTBI treatment and TB knowledge in homeless persons compared to a st and ard approach of outreach and incentives OBJECTIVES To test 2 interventions to improve adherence to isoniazid preventive therapy for tuberculosis in homeless adults . We compared ( 1 ) biweekly directly observed preventive therapy using a $ 5 monetary incentive and ( 2 ) biweekly directly observed preventive therapy using a peer health adviser , with ( 3 ) usual care at the tuberculosis clinic . METHODS R and omized controlled trial in tuberculosis-infected homeless adults . Outcomes were completion of 6 months of isoniazid treatment and number of months of isoniazid dispensed . RESULTS A total of 118 subjects were r and omized to the 3 arms of the study . Completion in the monetary incentive arm was significantly better than in the peer health adviser arm ( P = .01 ) and the usual care arm ( P = .04 ) , by log-rank test . Overall , 19 subjects ( 44 % ) in the monetary incentive arm completed preventive therapy compared with 7 ( 19 % ) in the peer health adviser arm ( P = .02 ) and 10 ( 26 % ) in the usual care arm ( P = .11 ) . The median number of months of isoniazid dispensed was 5 in the monetary incentive arm vs 2 months in the peer health adviser arm ( P = .005 ) and 2 months in the usual care arm ( P = .04 ) . In multivariate analysis , independent predictors of completion were being in the monetary incentive arm ( odds ratio , 2.57 ; 95 % CI , 1.11 - 5.94 ) and residence in a hotel or other stable housing at entry into the study vs residence on the street or in a shelter at entry ( odds ratio , 2.33 ; 95 % CI , 1.00 - 5.47 ) . CONCLUSIONS A $ 5 biweekly cash incentive improved adherence to tuberculosis preventive therapy compared with a peer intervention or usual care . Living in a hotel or apartment at the start of treatment also predicted the completion of therapy Background : The efficacy of a nurse case-managed intervention was evaluated in sub sample s of participants with one of the following characteristics : female gender , African American ethnicity , recruited from a homeless shelter , a history of military service , lifetime injection drug use , daily alcohol and drug use , poor physical health , and a history of poor mental health . Objective : To determine whether a vali date d nurse case-managed intervention with incentives and tracking would improve adherence to latent tuberculosis infection treatment in sub sample s of homeless persons with characteristics previously identified in the literature as predictive of nonadherence . Methods : A prospect i ve 2-group site-r and omized design was conducted with 520 homeless adults residing in 12 homeless shelters and residential recovery sites in the Skid Row region of Los Angeles from 1998 to 2003 . Results : Daily drug users , participants with a history of injection drug use , daily alcohol users , and persons who were not of African American race or ethnicity had particularly poor completion rates , even in the nurse case-managed intervention program ( 48 % , 55 % , 54 % , and 50 % , respectively ) . However , the intervention achieved a 91 % completion rate for homeless shelter residents and significantly improved latent tuberculosis infection treatment adherence in 9 of 12 subgroups tested ( odds ratios = 2.51 - 10.41 ) , including daily alcohol and drug users , when potential confounders were controlled using logistic regression analysis . Discussion : Nurse case management with incentives appears to be a good foundation for increasing adherence to 6-month isoniazid treatment in a variety of homeless subgroups and , in particular , for sheltered homeless population s. However , additional social-structural and environmental strategies are needed to address those at greatest risk of nonadherence The design , logic , and results of a two-year health education study directed at i m proving rates of patient adherence to antituberculosis medical regimens are presented . An incentive scheme to reward positive health behaviors plus targeted educational coun seling sessions was implemented in a r and omized clinical controlled trial . The 205 subjects who participated in the study are categorized according to patients with active tuberculosis ( n = 88 ) or preventive patients with no evidence of active disease ( n = 117 ) . Patients in each of these groups were r and omly assigned to a special intervention ( SI ) group or a usual care ( UC ) control group and were followed monthly throughout their treatment program . While SI patients with active tuberculosis demonstrated higher levels of ap pointment-keeping behavior and mean percent of medication taken compared to UC patients , no statistically significant differences between the two groups were found . Pre ventive therapy patients assigned to the SI group , however , were significantly more likely than UC patients to remain in care during their 12-month regimen ( 64 % vs 47 % ; p = .003 ) . Furthermore , SI patients had significantly higher levels of adherence to their medical regimen compared to UC patients ( 68 % vs 38 % ; p < .001 ) . These results demonstrate the positive effects of a structured health education program on the i m provement of continuity of care and adherence behavior among patients with tuberculosis . This study was funded by the Centers for Disease Control through contract # 200 - 85 - 0835 . The assistance of the Project Clerk , Sook Hee Treadwell , the Project Health Educators , Magda Fischer , Jennifer Adams , Nancy Murray , Fred Dominguez , and the clinic staff and patients who participated in this project are gratefully acknowledged . 1 . US Department of Health and Human Services , Public Health Service : The 1990 Health Objectives for the Nation : A Midcourse Review . Office of Disease Prevention and Health Promotion , 1986 . 2 . Centers for Disease Control . Tuberculosis — Provisional data —United States , 1986 . MMWR 36 : 254 - 255 , 1987 . 3 . Centers for Disease Control . Tuberculosis . Final Data —United States , 1986 . MMWR 36 : 817 - 820 , 1988 . 4 . County of Los Angeles , Department of Health Services , Public Health Programs : Communicable Disease Morbidity Report , County of Los Angeles , 1986 . 5 . Kopanoff DE , Snider DE , Johnson M : Recurrent tuberculosis : Why do patients develop disease again ? A United States Public Health Service Cooperative Survey . Am J Public Health 78 : 30 - 33 , 1988 . 6 . American Thoracic Society : Treatment of tuberculosis and tuberculosis infection in adults and children . Am Rev Respir Dis 134 : 355 - 363 , 1986 . 7 . Haynes RB : Introduction , in RB Haynes , DW Taylor , DL Sackett . ( eds ) : Compliance in Health Care . Baltimore , Johns Hopkins University Press , 1979 , pp 1 - 7 . 8 . Sackett DL , Haynes RB , editor : Compliance with Therapeutic Regimens . Baltimore , Johns Hopkins University Press , 1976 . 9 . Haynes RB , Taylor DW , Sackett DL , ed : Compliance in Health Care . Baltimore , Johns Hopkins University Press , 1979 . 10 . Meichenbaum D , Turk DC : Facilitating Treatment Adherence : A Practitioner 's Guidebook . Plenum Press , New York , 1987 . 11 . Addington WW : Patient compliance : The most serious remaining problem in the control of tuberculosis in the United States . Chest 76 (supp):741 - 743 , 1979 . 12 . Report of the Committee : A Strategic Plan for the Elimination of Tuberculosis in the United States . US Department of Health and Human Services , Centers for Disease Control , May 1988 . 13 . Comstock GW : New data on preventive treatment with isoniazid . Annals of Internal Medicine 98:663 - 665 , 1983 . 14 . Cross FS , Long MW , Banner AS , Snider DE Jr : Rifampin-isoniazid therapy of alcoholics and nonalcoholic tuberculosis patients in a U.S. Public Health Service cooperative trial . Am Rev Respir Dis 122:349 - 353 , 1980 . 15 . Snider DE Jr , . Improving Patient Compliance in Tuberculosis Treatment Output:
Material incentives may also be more effective than motivational education at improving return for tuberculin skin test results ( low quality evidence ) , but may be no more effective than peer counselling , or structured education at improving continuation or completion of prophylaxis ( low quality evidence ) . There is limited evidence to support the use of material incentives to improve return rates for tuberculosis diagnostic test results and adherence to antituberculosis preventive therapy .
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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: Pancreatic cancer is the fifth most common cause of cancer death in the western world and the prognosis for unresectable disease remains poor . Recent advances in conventional chemotherapy and the development of novel ‘ molecular ’ treatment strategies with different toxicity profiles warrant investigation as combination treatment strategies . This r and omised study in pancreatic cancer compares marimastat ( orally administered matrix metalloproteinase inhibitor ) in combination with gemcitabine to gemcitabine alone . Two hundred and thirty-nine patients with unresectable pancreatic cancer were r and omised to receive gemcitabine ( 1000 mg m−2 ) in combination with either marimastat or placebo . The primary end-point was survival . Objective tumour response and duration of response , time to treatment failure and disease progression , quality of life and safety were also assessed . There was no significant difference in survival between gemcitabine and marimastat and gemcitabine and placebo ( P=0.95 log-rank test ) . Median survival times were 165.5 and 164 days and 1-year survival was 18 % and 17 % respectively . There were no significant differences in overall response rates ( 11 and 16 % respectively ) , progression-free survival ( P=0.68 log-rank test ) or time to treatment failure ( P=0.70 log-rank test ) between the treatment arms . The gemcitabine and marimastat combination was well tolerated with only 2.5 % of patients withdrawn due to presumed marimastat toxicity . Grade 3 or 4 musculoskeletal toxicities were reported in only 4 % of the marimastat treated patients , although 59 % of marimastat treated patients reported some musculoskeletal events . The results of this study provide no evidence to support a combination of marimastat with gemcitabine in patients with advanced pancreatic cancer . The combination of marimastat with gemcitabine was well tolerated . Further studies of marimastat as a maintenance treatment following a response or stable disease on gemcitabine may be justified Gemcitabine is a key drug for the treatment of pancreatic cancer ; however , with its limitation in clinical benefits , the development of another potent therapeutic is necessary . Vascular endothelial growth factor receptor 2 is an essential target for tumor angiogenesis , and we have conducted a phase I clinical trial using gemcitabine and vascular endothelial growth factor receptor 2 peptide ( elpamotide ) . Based on the promising results of this phase I trial , a multicenter , r and omized , placebo‐controlled , double‐blind phase II/III clinical trial has been carried out for pancreatic cancer . The eligibility criteria included locally advanced or metastatic pancreatic cancer . Patients were assigned to either the Active group ( elpamotide + gemcitabine ) or Placebo group ( placebo + gemcitabine ) in a 2:1 ratio by the dynamic allocation method . The primary endpoint was overall survival . The Harrington – Fleming test was applied to the statistical analysis in this study to evaluate the time‐lagged effect of immunotherapy appropriately . A total of 153 patients ( Active group , n = 100 ; Placebo group , n = 53 ) were included in the analysis . No statistically significant differences were found between the two groups in the prolongation of overall survival ( Harrington – Fleming P‐value , 0.918 ; log – rank P‐value , 0.897 ; hazard ratio , 0.87 , 95 % confidence interval [ CI ] , 0.486–1.557 ) . Median survival time was 8.36 months ( 95 % CI , 7.46–10.18 ) for the Active group and 8.54 months ( 95 % CI , 7.33–10.84 ) for the Placebo group . The toxicity observed in both groups was manageable . Combination therapy of elpamotide with gemcitabine was well tolerated . Despite the lack of benefit in overall survival , subgroup analysis suggested that the patients who experienced severe injection site reaction , such as ulceration and erosion , might have better survival BACKGROUND To investigate whether addition of cetuximab to st and ard adjuvant chemotherapy with gemcitabine improves outcome in pancreatic cancer , specifically whether the rate of disease-free survival ( DFS ) at 18 months ( primary end point ) exceeds the previously reported 35 % of gemcitabine alone . PATIENTS AND METHODS Prospect i ve , open-label , multicenter , nonr and omized phase II study in 76 patients with R0- or R1-resected ductal adenocarcinoma of the pancreas included between October 2006 and November 2008 . Gemcitabine and cetuximab were administered for 24 weeks . Secondary end points included overall survival ( OS ) and toxic effect . RESULTS Seventy-three patients received cetuximab . Median DFS was 10.0 [ 95 % confidence interval ( CI ) 8.9 - 13.6 ] months and the DFS rate at month 18 of 27.1 % ( 16.7%-37.6 % ) was inferior to 35 % . Median OS was 22.4 ( 18.2 - 27.9 ) months . Subgroup analyses revealed a nonsignificant increase in DFS for patients with versus without skin toxic effect ≥ grade 2 ( median 14.7 versus 8.3 months , P = 0.073 ) and wild-type versus mutated K-Ras ( median 11.5 versus 9.3 months , P = 0.57 ) . Grade 3/4 toxic effects included neutropenia ( 11.0 % ) , thrombopenia ( 7 % ) , skin toxic effect ( 7 % ) and allergic reactions ( 7 % ) . CONCLUSION Addition of cetuximab to adjuvant gemcitabine does not seem to improve DFS or OS of unstratified pancreatic cancer patients . Trends for improved DFS in patients with wild-type K-Ras and skin toxic effect remain to be confirmed PURPOSE To evaluate , in a phase 2 study , the safety and efficacy of induction gemcitabine , oxaliplatin , and cetuximab followed by selective capecitabine-based chemoradiation in patients with borderline resectable or unresectable locally advanced pancreatic cancer ( BRPC or LAPC , respectively ) . METHODS AND MATERIAL S Patients received gemcitabine and oxaliplatin chemotherapy repeated every 14 days for 6 cycles , combined with weekly cetuximab . Patients were then restaged ; " downstaged " patients with resectable disease underwent attempted resection . Remaining patients were treated with chemoradiation consisting of intensity modulated radiation therapy ( 54 Gy ) and concurrent capecitabine ; patients with borderline resectable disease or better at restaging underwent attempted resection . RESULTS A total of 39 patients were enrolled , of whom 37 were evaluable . Protocol treatment was generally well tolerated . Median follow-up for all patients was 11.9 months . Overall , 29.7 % of patients underwent R0 surgical resection ( 69.2 % of patients with BRPC ; 8.3 % of patients with LAPC ) . Overall 6-month progression-free survival ( PFS ) was 62 % , and median PFS was 10.4 months . Median overall survival ( OS ) was 11.8 months . In patients with LAPC , median OS was 9.3 months ; in patients with BRPC , median OS was 24.1 months . In the group of patients who underwent R0 resection ( all of which were R0 resections ) , median survival had not yet been reached at the time of analysis . CONCLUSIONS This regimen was well tolerated in patients with BRPC or LAPC , and almost one-third of patients underwent R0 resection . Although OS for the entire cohort was comparable to that in historical controls , PFS and OS in patients with BRPC and /or who underwent R0 resection was markedly improved Purpose Considering promising results in phase II studies , a r and omized phase III trial was design ed to assess the efficacy of adding bevacizumab to first-line cisplatin plus etoposide for treatment of extensive-disease ( ED ) small-cell lung cancer ( SCLC ) . Patients and Methods Treatment-naive patients with ED-SCLC were r and omly assigned to receive either cisplatin plus etoposide ( arm A ) or the same regimen with bevacizumab ( arm B ) for a maximum of six courses . In the absence of progression , patients in arm B continued bevacizumab alone until disease progression or for a maximum of 18 courses . The primary end point was overall survival ( OS ) . Results Two hundred four patients were r and omly assigned and considered in intent-to-treat analyses ( 103 patients in arm A and 101 patients in arm B ) . At a median follow-up of 34.9 months in arm A and arm B , median OS times were 8.9 and 9.8 months , and 1-year survival rates were 25 % and 37 % ( hazard ratio , 0.78 ; 95 % CI , 0.58 to 1.06 ; P = .113 ) , respectively . A statistically significant effect of bevacizumab on OS in patients who received maintenance was seen ( hazard ratio , 0.60 ; 95 % CI , 0.40 to 0.91 ; P = .011 ) . Median progression-free survival times were 5.7 and 6.7 months in arm A and arm B , respectively ( P = .030 ) . Regarding hematologic toxicity , no statistically significant differences were observed ; for nonhematologic toxicity , only hypertension was more frequent in arm B ( grade 3 or 4 , 1.0 % v 6.3 % in arms A v B , respectively ; P = .057 ) . Conclusion The addition of bevacizumab to cisplatin and etoposide in the first-line treatment of ED-SCLC had an acceptable toxicity profile and led to a statistically significant improvement in progression-free survival , which , however , did not translate into a statistically significant increase in OS . Further research with novel antiangiogenic agents , particularly in the maintenance setting , is warranted Background : We aim ed to identify molecular epidermal growth factor receptor ( EGFR ) tissue biomarkers in pancreatic cancer ( PC ) patients treated with the anti-EGFR agent erlotinib within the phase 3 r and omised AIO-PK0104 study . Methods : AIO-PK0104 was a multicenter trial comparing gemcitabine/erlotinib followed by capecitabine with capecitabine/erlotinib followed by gemcitabine in advanced PC ; primary study end point was the time-to-treatment failure after first- and second-line therapy ( TTF2 ) . Translational analyses were performed for KRAS exon 2 mutations , EGFR expression , PTEN expression , the EGFR intron 1 and exon 13 R497 K polymorphism ( PM ) . Biomarker data were correlated with TTF , overall survival ( OS ) and skin rash . Results : Archival tumour tissue was available from 208 ( 74 % ) of the r and omised patients . The KRAS mutations were found in 70 % ( 121 out of 173 ) of patients and exclusively occurred in codon 12 . The EGFR overexpression was detected in 89 out of 181 patients ( 49 % ) by immunohistochemistry ( IHC ) , and 77 out of 166 patients ( 46 % ) had an EGFR gene amplification by fluorescence in-situ hybridisation ( FISH ) ; 30 out of 171 patients ( 18 % ) had a loss of PTEN expression , which was associated with an inferior TTF1 ( first-line therapy ; HR 0.61 , P=0.02 ) and TTF2 ( HR 0.66 , P=0.04 ) . The KRAS wild-type status was associated with improved OS ( HR 1.68 , P=0.005 ) ; no significant OS correlation was found for EGFR – IHC ( HR 0.96 ) , EGFR – FISH ( HR 1.22 ) , PTEN – IHC ( HR 0.77 ) , intron 1 ( HR 0.91 ) or exon 13 R497 K PM ( HR 0.83 ) . None of the six biomarkers correlated with the occurrence of skin rash . Conclusion : The KRAS wild-type was associated with an improved OS in erlotinib-treated PC patients in this phase 3 study ; it remains to be defined whether this association is prognostic or predictive BACKGROUND Axitinib is a potent , selective inhibitor of vascular endothelial growth factor ( VEGF ) receptors 1 , 2 , and 3 . A r and omised phase 2 trial of gemcitabine with or without axitinib in advanced pancreatic cancer suggested increased overall survival in axitinib-treated patients . On the basis of these results , we aim ed to assess the effect of treatment with gemcitabine plus axitinib on overall survival in a phase 3 trial . METHODS In this double-blind , placebo-controlled , phase 3 study , eligible patients had metastatic or locally advanced pancreatic adenocarcinoma , no uncontrolled hypertension or venous thrombosis , and Eastern Cooperative Oncology Group performance status 0 or 1 . Patients , stratified by disease extent ( metastatic vs locally advanced ) , were r and omly assigned ( 1:1 ) to receive gemcitabine 1000 mg/m(2 ) intravenously Output:
In terms of safety , gemcitabine plus anti-angiogenesis therapy did not increase the rate of grade 3 - 4 common adverse effects except for hypertension . Conclusions : Although gemcitabine plus anti-angiogenesis therapy might prolong the progression-free survival in locally advanced or metastatic pancreatic cancer , these successful results did not translate into a significant improvement in the overall survival or change in the clinical guidelines
MS2_1shot299
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: To investigate the frequency and risk factors of major depressive disorder ( MDD ) after mild to moderate traumatic brain injury ( TBI ) , 69 TBI and 52 general trauma ( GT ) patients were prospect ively recruited and studied at 3-months postinjury . There was a nonsignificant difference in the proportion of MDD patients in the TBI and GT groups . Therefore , a composite MDD group ( TBI and GT patients ) was compared to patients who were nondepressed . Female gender was related to MDD , but no other risk factors were identified . MDD was associated with disability ( Glasgow Outcome Scale , Community Integration Question naire ) and cognitive impairment . MDD was comorbid with posttraumatic stress disorder . Implication s for postacute management of mild to moderate TBI are discussed OBJECTIVE To conduct a prospect i ve study of the occurrence of psychological disorders and comorbidities after spinal cord injury ( SCI ) , determine psychotropic medication usage , and establish predictors of psychological disorders after transition to the community . DESIGN Longitudinal design with multiple measures . SETTING Assessment occurred in SCI units and the community . PARTICIPANTS Adults with SCI ( N=88 ) admitted over a period of 32 months into 3 SCI units . INTERVENTIONS Participants completed inpatient rehabilitation for an acute SCI . Longitudinal assessment occurred up to 6 months postdischarge . MAIN OUTCOME MEASURES Measures were chosen that had a theoretical and clinical foundation for contributing to recovery after SCI . The Mini International Neuropsychiatric Interview , a structured diagnostic psychiatric interview , was conducted to determine the presence of psychological disorders . Medical measures included severity of secondary conditions or complications . Psychological measures included measures of anxiety and depressive mood , resilience , pain catastrophization , self-efficacy , and cognitive capacity . RESULTS Rates of psychological disorders of 17 % to 25 % were substantially higher than rates found in the Australian community . The occurrence of psychological disorder comorbidities was also very high . Anxiety was significantly elevated in those with a psychological disorder . Psychotropic medications were prescribed to more than 36 % of the sample , with most being antidepressants . Factors predictive of psychological disorders included years of education , premorbid psychiatric/psychological treatment , cognitive impairment , secondary complications , resilience , and anxiety . CONCLUSIONS SCI can have a substantial negative impact on mental health that does not change up to 6 months postdischarge . Findings suggest a substantial minority experience increased psychosocial distress after the injury and after transitioning into the community . Additional re sources should be invested in improving the mental health of adults with SCI Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process . One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the cl aim ant . The aim of this study was to empower injured cl aim ants in order to facilitate recovery . Methods Participants were recruited by three Dutch cl aims settlement offices . The participants had all been injured in a traffic crash and were involved in a compensation process . The study design was a r and omized controlled trial . An intervention website was developed with ( 1 ) information about the compensation process , and ( 2 ) an evidence -based , therapist-assisted problem-solving course . The control website contained a few links to already existing websites . Outcome measures were empowerment , self-efficacy , health status ( including depression , anxiety , and somatic symptoms ) , perceived fairness , ability to work , cl aims knowledge and extent of burden . The outcomes were self-reported through online question naires and were measured four times : at baseline , and at 3 , 6 , and 12 months . Results In total , 176 participants completed the baseline question naire after which they were r and omized into either the intervention group ( n = 88 ) or the control group ( n = 88 ) . During the study , 35 participants ( 20 % ) dropped out . The intervention website was used by 55 participants ( 63 % ) . The health outcomes of the intervention group were no different to those of the control group . However , the intervention group considered the received compensation to be fairer ( P < 0.01 ) . The subgroup analysis of intervention users versus nonusers did not reveal significant results . The intervention website was evaluated positively . Conclusions Although the web-based intervention was not used enough to improve the health of injured cl aim ants in compensation processes , it increased the perceived fairness of the compensation amount . Trial registration Netherl and s Trial Register OBJECTIVE To compare differences in functional outcomes between urban and rural patients with traumatic brain injury ( TBI ) . DESIGN A longitudinal , prospect i ve , multicentre study of a 2-year cohort from the Brain Injury Rehabilitation Program ( BIRP ) for New South Wales , with follow-up at 18 months after injury . PARTICIPANTS 198 patients ( 147 urban , 51 rural ) with severe TBI from the 11 participating rehabilitation units . MAIN OUTCOME MEASURES Demographic and injury details collected prospect ively using a st and ardised question naire , and measures from five vali date d instruments ( Disability Rating Scale , Mayo-Portl and Adaptability Inventory , Sydney Psychosocial Reintegration Scale , Medical Outcomes Study Short Form and the General Health Question naire--28-item version ) administered at follow-up to document functional , psychosocial , emotional and vocational outcomes . RESULTS Demographic details , injury severity , lengths of stay in intensive and acute care wards were similar for both rural and urban groups . There were no significant group differences in functional outcomes , including return to work , at follow-up . CONCLUSIONS Our findings contrast with previous research that has reported poorer outcomes after TBI for rural residents , and suggest that the integrated network of inpatient , outpatient and outreach services provided throughout NSW through the BIRP provides effective rehabilitation for people with severe TBI regardless of where they live & NA ; Psychological distress is a feature of chronic whiplash‐associated disorders , but little is known of psychological changes from soon after injury to either recovery or symptom persistence . This study prospect ively measured psychological distress ( General Health Question naire 28 , GHQ‐28 ) , fear of movement/re‐injury ( TAMPA Scale of Kinesphobia , TSK ) , acute post‐traumatic stress ( Impact of Events Scale , IES ) and general health and well being ( Short Form 36 , SF‐36 ) in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . All whiplash groups demonstrated psychological distress ( GHQ‐28 , SF‐36 ) to some extent at 1 month post‐injury . Scores of the recovered group and those with persistent mild symptoms returned to levels regarded as normal by 2 months post‐injury , parallelling a decrease in reported pain and disability . Scores on both these tests remained above threshold levels in those with ongoing moderate/severe symptoms . The moderate/severe and mild groups showed elevated TSK scores at 1 month post‐injury . TSK scores decreased by 2 months in the group with residual mild symptoms and by 6 months in those with persistent moderate/severe symptoms . Elevated IES scores , indicative of a moderate post‐traumatic stress reaction , were unique to the group with moderate/severe symptoms . The results of this study demonstrated that all those experiencing whiplash injury display initial psychological distress that decreased in those whose symptoms subside . Whiplash participants who reported persistent moderate/severe symptoms at 6 months continue to be psychologically distressed and are also characterised by a moderate post‐traumatic stress reaction Abstract Dysregulations of the hypothalamus – pituitary – adrenal ( HPA ) axis have been discussed as a physiological substrate of chronic pain and fatigue . The aim of the study was to investigate possible dysregulations of the HPA axis in chronic whiplash‐associated disorder ( WAD ) . In 20 patients with chronic WAD and 20 healthy controls , awakening cortisol responses as well as a short circadian free cortisol profile were assessed before and after administration of 0.5 mg dexamethasone . In comparison to the controls , chronic WAD patients had attenuated cortisol responses to awakening , normal cortisol levels during the day , and showed enhanced and prolonged suppression of cortisol after the administration of 0.5 mg dexamethasone . Dysregulations of the HPA axis in terms of reduced reactivity and enhanced negative feedback suppression exist in chronic WAD . The observed endocrine abnormalities could serve as a systemic mechanism of symptoms experienced by chronic WAD patients The question as to whether mild traumatic brain injury ( mTBI ) results in persisting sequelae over and above those experienced by individuals sustaining general trauma remains controversial . This prospect i ve study aim ed to document outcomes 1 week and 3 months post-injury following mTBI assessed in the emergency department ( ED ) of a major adult trauma center . One hundred and twenty-three patients presenting with uncomplicated mTBI and 100 matched trauma controls completed measures of post-concussive symptoms and cognitive performance ( Immediate Post-Concussion Assessment and Cognitive Testing battery ; ImPACT ) and pre-injury health-related quality of life ( SF-36 ) in the ED . These measures together with measures of psychiatric status ( the Mini-International Neuropsychiatric Interview [ MINI ] ) pre- and post-injury , the Hospital Anxiety and Depression Scale , Visual Analogue Scale for Pain , Functional Assessment Question naire , and PTSD Checklist-Specific , were re-administered at follow-up . Participants with mTBI showed significantly more severe post-concussive symptoms in the ED and at 1 week post-injury . They performed more poorly than controls on the Visual Memory subtest of the ImPACT at 1 week and 3 months post-injury . Both the mTBI and control groups recovered well physically , and most were employed 3 months post-injury . There were no significant group differences in psychiatric function . However , the group with mild TBI was more likely to report ongoing memory and concentration problems in daily activities . Further investigation of factors associated with these ongoing problems is warranted OBJECTIVE To conduct a descriptive study investigating the effect of access to motor vehicle accident ( MVA ) compensation on recovery outcomes at 24 months after injury . DESIGN AND SETTING Longitudinal cohort study conducted in two Level 1 trauma hospitals in Victoria , Australia . Participants were 391 r and omly selected injury patients with moderate-to-severe injuries . Compensable and non-compensable patients were compared at 24 months after injury on a number of health outcomes . MAIN OUTCOME MEASURES Health outcomes at 24 months , including anxiety and depression severity , quality of life and disability . RESULTS Medical records identified two groups of compensation patients : MVA-compensable and non-compensable patients . After controlling for baseline variables , the MVA-compensable patients , at 24 months , had higher levels of post-traumatic stress disorder , anxiety and depression , and were less likely to have returned to their pre-injury number of work hours . However , some patients in the non-compensable group had accessed other forms of compensation ( eg , private health care or compensation for victims of crime ) . When these were removed from the non-compensable group , the differences between MVA-compensable and non-compensable groups all but disappeared . CONCLUSION Our findings do not Output: Increased psychological distress remains elevated in SCI , mTBI and WAD for at least 3 years post-MVC . Input: When a r and omized trial ( NMSG 4/90 ) comparing treatment with melphalan/prednisone to melphalan/prednisone + interferon α‐2b in newly diagnosed multiple myeloma was inititated in 1990 , a quality ‐of‐life assessment was integrated into the study . We used the question naire ( QLQ‐C30 ) developed by the European Organization of Research and Treatment of Cancer ( EORTC ) Study Group on Quality of Life . The QLQ‐C30 incorporates five functional scales , three symptom scales , a global health and quality ‐of‐life scale and some single symptom measures . The question naire was completed prior to treatment and after 1 , 6 , 12 , 24 , 36 and 48 months . 524 ( 90.2 % ) of 581 patients enrolled in the NMSG 4/90 completed the first question naire , and 484 ( 83.3 % ) completed all question naires given to them . All but one of the scales met the minimum criteria of reliability ( Cronbach ’s alpha ≥0.70 ) . Validity was shown by ( 1 ) the ability of the scales to discriminate clearly between patients differing in clinical status as defined by pre‐treatment W.H.O. performance index and Durie & Salmon stage , and ( 2 ) the sensitivity to changes in objective disease status ( response and relapse ) . This is the first report of the measurement of health‐related quality of life in a prospect i ve clinical trial in multiple myeloma . The results demonstrate that the QLQ‐C30 is a reliable and valid instrument for the measurement of quality of life in these patients . The data will be used for a cost – utility analysis of the results of the NMSG 4/90 trial Measurement of health-related quality of life was integrated into a r and omized trial ( NMSG 4/90 ) comparing melphalan/prednisone to melphalan/prednisone + interferon alpha-2b in newly diagnosed multiple myeloma . One of the aims of the study was to assess the prognostic significance of quality -of-life scores , using the EORTC QLQ-C30 question naire . Univariate analysis showed a highly significant association with survival from the start of therapy for physical functioning as well as role and cognitive functioning , global quality of life , fatigue and pain . In multivariate analysis , physical functioning and W.H.O. performance status were independent prognostic factors ( P values = 0.001 for both ) when analysed in a Cox regression model with the somatic variables beta-2 microglobulin , skeletal disease and age . The best prediction for survival from the start of therapy was obtained by combining the beta-2 microglobulin and physical functioning scores in a variable consisting of three risk factor levels with an estimated median survival of 17 , 29 and 49 months , respectively . At a 12 months l and mark analysis , the relative risk for patients with physical functioning score 0 - 20 v 80 - 100 was 5.63 ( 99 % CI 2.76 - 11.49 ) , whereas the relative risk for patients without an objective response to chemotherapy compared to those with at least a minor response was 2.32 ( 99 % CI 1.44 - 3.74 ) . Quality -of-life assessment may be an independent and valuable addition to the known prognostic factors in multiple myeloma Patients who undergo hematopoietic SCT ( HSCT ) often experience physical and psychological problems , even long after treatment has been completed . This study was performed to evaluate the effects of a 12-week outpatient physical exercise ( PE ) program , incorporating aerobic and strength exercises , as compared with a usual care control condition on patients ’ physical performance and psychosocial well-being . Patients who had completed HSCT up to 6 months earlier were r and omly assigned to a supervised PE program ( n=64 ) or a usual care control group ( n=67 ) . Primary outcomes were quantified physical performance and self-reported physical functioning . Secondary outcomes were body composition measurement , quantified walking activity and patient-reported outcomes ( physical activity , fatigue and health-related quality of life ) . Assessment s were at baseline , immediately after program completion and at 3-month follow-up . Significant intervention effects were observed at both posttreatment and follow-up on physical performance measures . No other outcomes yielded statistically significant group differences . PE should be considered in the management of HSCT recipients to improve physical performance after discharge from the hospital . Further research is needed to determine how the program can be enhanced so that improved physical performance also translates into improved physical and psychosocial functioning in daily life Few studies have evaluated long-term health-related quality of life ( HRQL ) in patients during auto-SCT . This prospect i ve study examined HRQL in 96 eligible patients before , during and up to 3 years after auto-SCT . The aim of the study was to make a comprehensive assessment of the frequency and severity of different symptoms in patients undergoing auto-SCT . The European Organization for Treatment and Research of Cancer Quality of Life Question naire ( EORTC QLQ C-30 ) was administered 13 times . The second week during treatment was the period when patients had the lowest HRQL regarding both total quality of life and function and symptom scales . The patients recovered quickly and just two months after transplantation the baseline values were restored . Three years after transplantation most of the items in the question naire had stabilized , except role function and dyspnea , which had improved . There were significant differences between multiple myeloma ( MM ) and lymphoma patients ’ physical function , quality of life , fatigue and pain during week 2 . At the 3-year follow-up , lymphoma patients indicated a better HRQL than MM patients . The quick recovery of patients after transplantation suggests that treatment is well tolerated ; however , the supportive care could be improved at week 2 , especially for the lymphoma patients AIM The aim of this study was to compare the effect of two methods of rehabilitation after stem cell transplantation on health and quality of life . BACKGROUND Stem cell transplantation is routinely used in the treatment of haematological malignancy . However , it is an intensive treatment often associated with deterioration in wellbeing and the need for prolonged recovery . METHODS During a 14-month data collection period ( August 2005 to October 2006 ) , patients who had had a stem cell transplant ( n = 58 ) were r and omly allocated to either a healthcare professional-led rehabilitation programme or a self-managed rehabilitation programme . The primary outcome measure , physical functioning as measured by the 36-item Short Form Health Survey , was recorded at baseline and 6 months after r and omization . Secondary health and quality of life measures included the seven other dimensions of the 36-item Short Form Health Survey , General Health Question naire , Graham and Longman Quality of Life Scale and a Shuttle Walk Test . FINDINGS There was no difference in change in Short Form 36 physical functioning scores between the two groups at follow-up ( mean difference 0.19 points , 95 % confidence interval 10.77 - 11.16 ) . No evidence of a difference between the two modes of rehabilitation was observed for any of the trial outcomes . CONCLUSION One approach for providing a flexible service may be for staff and individual patients to work together , selecting from a series of specified options a programme with the appropriate content and duration to meet that individual 's needs PURPOSE To investigate the effect of recombinant human erythropoietin ( epoetin beta ) on anemia , transfusion need , and quality of life ( QOL ) in severely anemic patients with low- grade non-Hodgkin 's lymphoma ( NHL ) , chronic lymphocytic leukemia ( CLL ) , or multiple myeloma ( MM ) . PATIENTS AND METHODS Transfusion-dependent patients with NHL ( n = 106 ) , CLL ( n = 126 ) , or MM ( n = 117 ) and a low serum erythropoietin concentration were r and omized to receive epoetin beta 150 IU/kg or placebo subcutaneously three times a week for 16 weeks . Primary efficacy criteria were transfusion-free and transfusion- and severe anemia-free survival ( hemoglobin [ Hb ] > 8.5 g/dL ) between weeks 5 to 16 . Response was defined as an increase in Hb > or = 2 g/dL with elimination of transfusion need . QOL was assessed by the Functional Assessment of Cancer Therapy scale . RESULTS Transfusion-free ( P = .0012 ) survival and transfusion- and severe anemia-free survival ( P = .0001 ) were significantly greater in the epoetin beta group versus placebo ( Wald chi(2 ) test ) , giving a relative risk reduction of 43 % and 51 % , respectively . The response rate was 67 % and 27 % in the epoetin beta versus the placebo group , respectively ( P < .0001 ) . After 12 and 16 weeks of treatment , QOL significantly improved in the epoetin beta group compared with placebo ( P < .05 ) ; this improvement correlated with an increase in Hb concentration ( > or = 2 g/dL ) . A target Hb that could be generally recommended could not be identified . CONCLUSION Many severely anemic and transfusion-dependent patients with advanced MM , NHL , and CLL and a low performance status benefited from epoetin therapy , with elimination of severe anemia and transfusion need , and improvement in QOL Health‐related quality of life ( HRQL ) was prospect ively measured during the phase III APEX trial of bortezomib versus dexamethasone in relapsed multiple myeloma patients . The European Organisation for Research and Treatment of Cancer ( EORTC ) Quality of Life Question naire – Core ( QLQ‐C30 ) and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity ( NTX ) side‐effects question naires were administered at baseline and every 6 weeks up to 42 weeks . Patients receiving bortezomib ( 1·3 mg/m2 , days 1 , 4 , 8 and 11 for eight 3‐week cycles , then days 1 , 8 , 15 and 22 for three 5‐week cycles ; n = 296 ) demonstrated significantly better mean Global Health Status over the study versus patients receiving dexamethasone ( 40 mg/d , days 1–4 , 9–12 , and 17–20 for four 5‐week cycles , then days 1–4 only for five 4‐week cycles ; n = 302 ) , plus significantly better physical health , role , cognitive , and emotional functioning scores , lower dyspnoea and sleep symptom scores , and better NTX question naire score , using multiple imputation to account for missing data . Results were similar using available‐ data analyses . Sensitivity analyses suggested that improved HRQL with bortezomib is at least partially explained by improved survival . These results show that bortezomib was associated with significantly better multidimensional HRQL compared with dexamethasone , consistent with the better clinical outcomes seen with bortezomib OBJECTIVES Without clear guidelines , clinicians and health care providers are often uncertain how to interpret ( quality of life ) QOL scores . To facilitate the interpretation , QOL scores of multiple myeloma patients at diagnosis were compared with the scores of a reference population , and the clinical significance of QOL score differences and of changes in scores over time was assessed . METHODS Data from two prospect i ve Nordic Myeloma Study Group trials ( 221 patients < 60 yr treated with high dose chemotherapy , and 203 patients > 60 yr treated with melphalan and prednisone ) were analysed . The EORTC QLQ-C30 question naire was used . The results were compared with the scores of an age- and gender-adjusted Norwegian reference population ( n = 3000 ) , using a regressional approach . The magnitude of the observed differences and of score changes during follow-up was estimated as effect size [ score difference ( SD ) ] and according to a subjective rating system as small , moderate or large . RESULTS At diagnosis , the most distressing problems were pain and fatigue , reduced physical functioning , limitations in role functioning and reduced overall QOL . These differences from the reference population were statistically significant ( P < 0.001 ) , and large or moderate according to the rating systems . After the start of treatment , small to moderate improvement in mean QOL scores were observed for most domains . CONCLUSION Comparison with a reference population eases the interpretation of QOL scores and prevents overestimation of symptoms and underestimation of subjective treatment response . The agreement between the two methods to evaluate the meaning of differences and changes in QOL scores was good Purpose To report the experience of using the SEIQoL-DW for the measurement of quality of life with patients with advanced COPD and consider its feasibility , acceptability and appropriateness for a Phase III r and omised controlled trial ( RCT ) . Methods The SEIQoL-DW was administered according to its instructions within a Phase II RCT 3–5 times per patient , across 13 patients and the process audio-recorded . Quantitative and qualitative criteria were used to assess feasibility , acceptability and appropriateness . Qualitative analysis of the transcripts and fieldwork notes was conducted using Framework Analysis . Results The SEIQoL-DW steps ( of identifying five quality of life cues , rating their functioning and importance ) were completed at 48/51 interviews . However , some respondents were overwhelmed by the scripted introduction , experienced difficulty with cue identification , and focused only on certain types of cues ( Step 1 ) ; some had difficulty interpreting and rating the concept of Step 2 ; and some had difficulty interpreting ‘ importance ’ and manipulating the SEIQoL-DW disc ( Step 3 ) . Conclusions Patients with advanced COPD were able to complete the SEIQoL-DW but analysis of its administration identified practical and conceptual concerns which question the validity of the Output:
The EORTC-QLQ-C30 and MY24 have undergone the most comprehensive psychometric validation . Reliable , valid and responsive tools exist for this purpose , but may miss issues important to patients .