id
stringlengths
10
14
query
stringlengths
13.2k
30.2k
answer
stringlengths
12
3.68k
MS2_1shot0
***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 transplantation of adult bone marrow mesenchymal stem cells ( BM-MSCs ) holds promise in the treatment for pulmonary arterial hypertension ( PAH ) , the poor survival and differentiation potential of adult BM-MSCs have limited their therapeutic efficiency . Here , we compared the therapeutic efficacy of human embryonic stem cell-derived MSCs ( hESC-MSCs ) with adult BM-MSCs for the treatment of PAH in an animal model . One week following monocrotaline (MCT)-induced PAH , mice were r and omly assigned to receive phosphate-buffered saline ( MCT group ) ; 3.0 × 106 human BM-derived MSCs ( BM-MSCs group ) or 3.0 × 106 hESC-derived MSCs ( hESC-MSCs group ) via tail vein injection . At 3 weeks posttransplantation , the right ventricular systolic pressure ( RVSP ) , degree of RV hypertrophy , and medial wall thickening of pulmonary arteries were lower= , and pulmonary capillary density was higher in the hESC-MSC group as compared with BM-MSC and MCT groups ( all p < 0.05 ) . At 1 week posttransplantation , the number of engrafted MSCs in the lungs was found significantly higher in the hESC-MSC group than in the BM-MSC group ( all p < 0.01 ) . At 3 weeks posttransplantation , implanted BM-MSCs were undetectable whereas hESC-MSCs were not only engrafted in injured pulmonary arteries but had also undergone endothelial differentiation . In addition , protein profiling of hESC-MSC- and BM-MSC-conditioned medium revealed a differential paracrine capacity . Classification of these factors into bioprocesses revealed that secreted factors from hESC-MSCs were preferentially involved in early embryonic development and tissue differentiation , especially blood vessel morphogenesis . We concluded that improved cell survival and paracrine capacity of hESC-MSCs provide better therapeutic efficacy than BM-MSCs in the treatment for PAH Abstract We investigated the effect of adipose-derived stem cells ( ADSCs ) transplantation effects on structural remodeling and pulmonary artery pressure in monocrotaline (MCT)-induced pulmonary hypertensive rats . In the first experiment , 32 male Sprague-Dawley ( SD ) rats were r and omly divided into four groups ( n = 8/group ) : 3 ADSCs treated groups and normal control ( Ctrl ) . ADSCs were administered through the left jugular vein at 105 , 106 and 107 cells , respectively , and a cell density of 106cells/ml was shown to be optimal . The GFP-tagged ADSCs were identified in the lungs and differentiated into endothelial-like cells . In the second experiment , 96 male SD rats were r and omly divided into three groups ( n = 32/group ) : Ctrl , MCT-induced pulmonary arterial hypertension ( PAH ) , and PAH treated with ADSCs ( ADSCs ) . Two weeks post-MCT administration , the ADSCs group received 1 × 106 ADSCs via the external jugular vein . Compared to PAH rats , mean pulmonary arterial pressure was decreased in rats at 1 , 2 , and 3 weeks after ADSCs-treatment ( 18.63 ± 2.15 mmHg versus 24.53 ± 2.90 mmHg ; 23.07 ± 2.84 mmHg versus 33.18 ± 2.30 mmHg ; 22.98 ± 2.34 mmHg versus 36.38 ± 3.28 mmHg , p < 0.05 ) . Meanwhile , the right heart hypertrophy index ( 36.2 1 ± 4.27 % versus 41.01 ± 1.29 % ; 39.47 ± 4.02 % versus 48.75 ± 2 .13 % ; 41.02 ± 0.9 % versus 50.52 ± 1.49 % , p < 0.05 , respectively ) , ratio of wall/lumen thickness , as well as the wall/lumen area were significantly reduced in PAH rats at these time points following ADSCs-treatment , as compared with untreated PAH rats . In summary , ADSCs may colonize the pulmonary arteries , attenuate pulmonary arterial hypertension and ameliorate pulmonary arterial remodeling The aim of the present study was to investigate the effect of bone marrow mesenchymal stem cell ( BMSC ) transp1antation on lung and heart damage in a rat model of monocrotaline (MCT)-induced pulmonary arterial hypertension ( PAH ) . The animals were r and omly divided into 3 groups : control , PAH and BMSC implantation groups . Structural changes in the pulmonary vascular wall , such as the pulmonary artery lumen area ( VA ) and vascular area ( TAA ) were measured by hematoxylin and eosin ( H&E ) staining , and the hemodynamics were detected by echocardiography . Two weeks post-operation , our results demonstrated that sublingual vein injection of BMSCs significantly attenuated the pulmonary vascular structural and hemodynamic changes caused by pulmonary arterial hypertension . The mechanism may be executed via paracrine effects OBJECTIVE To characterize mortality in persons diagnosed with primary pulmonary hypertension and to investigate factors associated with survival . DESIGN Registry with prospect i ve follow-up . SETTING Thirty-two clinical centers in the United States participating in the Patient Registry for the Characterization of Primary Pulmonary Hypertension supported by the National Heart , Lung , and Blood Institute . PATIENTS Patients ( 194 ) diagnosed at clinical centers between 1 July 1981 and 31 December 1985 and followed through 8 August 1988 . MEASUREMENTS At diagnosis , measurements of hemodynamic variables , pulmonary function , and gas exchange variables were taken in addition to information on demographic variables , medical history , and life-style . Patients were followed for survival at 6-month intervals . MAIN RESULTS The estimated median survival of these patients was 2.8 years ( 95 % Cl , 1.9 to 3.7 years ) . Estimated single-year survival rates were as follows : at 1 year , 68 % ( Cl , 61 % to 75 % ) ; at 3 years , 48 % ( Cl , 41 % to 55 % ) ; and at 5 years , 34 % ( Cl , 24 % to 44 % ) . Variables associated with poor survival included a New York Heart Association ( NYHA ) functional class of III or IV , presence of Raynaud phenomenon , elevated mean right atrial pressure , elevated mean pulmonary artery pressure , decreased cardiac index , and decreased diffusing capacity for carbon monoxide ( DLCO ) . Drug therapy at entry or discharge was not associated with survival duration . CONCLUSIONS Mortality was most closely associated with right ventricular hemodynamic function and can be characterized by means of an equation using three variables : mean pulmonary artery pressure , mean right atrial pressure , and cardiac index . Such an equation , once vali date d prospect ively , could be used as an adjunct in planning treatment strategies and allocating medical re sources BACKGROUND Sildenafil inhibits phosphodiesterase type 5 , an enzyme that metabolizes cyclic guanosine monophosphate , thereby enhancing the cyclic guanosine monophosphate-mediated relaxation and growth inhibition of vascular smooth-muscle cells , including those in the lung . METHODS In this double-blind , placebo-controlled study , we r and omly assigned 278 patients with symptomatic pulmonary arterial hypertension ( either idiopathic or associated with connective-tissue disease or with repaired congenital systemic-to-pulmonary shunts ) to placebo or sildenafil ( 20 , 40 , or 80 mg ) orally three times daily for 12 weeks . The primary end point was the change from baseline to week 12 in the distance walked in six minutes . The change in mean pulmonary-artery pressure and World Health Organization ( WHO ) functional class and the incidence of clinical worsening were also assessed , but the study was not powered to assess mortality . Patients completing the 12-week r and omized study could enter a long-term extension study . RESULTS The distance walked in six minutes increased from baseline in all sildenafil groups ; the mean placebo-corrected treatment effects were 45 m ( + 13.0 percent ) , 46 m ( + 13.3 percent ) , and 50 m ( + 14.7 percent ) for 20 , 40 , and 80 mg of sildenafil , respectively ( P<0.001 for all comparisons ) . All sildenafil doses reduced the mean pulmonary-artery pressure ( P=0.04 , P=0.01 , and P<0.001 , respectively ) , improved the WHO functional class ( P=0.003 , P<0.001 , and P<0.001 , respectively ) , and were associated with side effects such as flushing , dyspepsia , and diarrhea . The incidence of clinical worsening did not differ significantly between the patients treated with sildenafil and those treated with placebo . Among the 222 patients completing one year of treatment with sildenafil monotherapy , the improvement from baseline at one year in the distance walked in six minutes was 51 m. CONCLUSIONS Sildenafil improves exercise capacity , WHO functional class , and hemodynamics in patients with symptomatic pulmonary arterial hypertension BACKGROUND Current therapies for pulmonary arterial hypertension have been adopted on the basis of short-term trials with exercise capacity as the primary end point . We assessed the efficacy of macitentan , a new dual endothelin-receptor antagonist , using a primary end point of morbidity and mortality in a long-term trial . METHODS We r and omly assigned patients with symptomatic pulmonary arterial hypertension to receive placebo once daily , macitentan at a once-daily dose of 3 mg , or macitentan at a once-daily dose of 10 mg . Stable use of oral or inhaled therapy for pulmonary arterial hypertension , other than endothelin-receptor antagonists , was allowed at study entry . The primary end point was the time from the initiation of treatment to the first occurrence of a composite end point of death , atrial septostomy , lung transplantation , initiation of treatment with intravenous or subcutaneous prostanoids , or worsening of pulmonary arterial hypertension . RESULTS A total of 250 patients were r and omly assigned to placebo , 250 to the 3-mg macitentan dose , and 242 to the 10-mg macitentan dose . The primary end point occurred in 46.4 % , 38.0 % , and 31.4 % of the patients in these groups , respectively . The hazard ratio for the 3-mg macitentan dose as compared with placebo was 0.70 ( 97.5 % confidence interval [ CI ] , 0.52 to 0.96 ; P=0.01 ) , and the hazard ratio for the 10-mg macitentan dose as compared with placebo was 0.55 ( 97.5 % CI , 0.39 to 0.76 ; P<0.001 ) . Worsening of pulmonary arterial hypertension was the most frequent primary end-point event . The effect of macitentan on this end point was observed regardless of whether the patient was receiving therapy for pulmonary arterial hypertension at baseline . Adverse events more frequently associated with macitentan than with placebo were headache , nasopharyngitis , and anemia . CONCLUSIONS Macitentan significantly reduced morbidity and mortality among patients with pulmonary arterial hypertension in this event-driven study . ( Funded by Actelion Pharmaceuticals ; SERAPHIN Clinical Trials.gov number , NCT00660179 . ) Our previous studies have shown that bone marrow mesenchymal stem cells ( BMSCs ) can inhibit the progression of pulmonary artery hypertension ( PAH ) in the monocrotaline ( MCT ) model in the short term . The aim of this study was to further investigate the long-term effect of BMSCs on PAH and to explore the mechanism of the protective effect including the pulmonary vascular remodeling and cell differentiation . PAH model was established by subcutaneous injection of 50 mg/kg MCT as previously study . Postoperatively , the animals were r and omly divided into three groups ( n = 10 in each group ) : control , PAH group , and BMSCs implantation group . Six months after injection , immunology and immunohistochemistry analysis indicated the MCT-induced intima-media thickness in muscular arteries was reduced ( P < 0.05 ) ; the area of collagen fibers in lung tissue was lower ( P < 0.05 ) , and the proliferating cell nuclear antigen level in pulmonary artery smooth muscle cells was decreased ( P < 0.05 ) . Immunofluorescence showed that the cells have the ability to differentiate between von Willebr and factor and vascular endothelial growth factor . Six months after int Output:
Conclusions SC therapy is effective for PAH in pre clinical studies . These results may help to st and ardise pre clinical animal studies and provide a theoretical basis for clinical trial design in the future .
MS2_1shot1
***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 Primary pulmonary hypertension is a progressive disease for which no treatment has been shown in a prospect i ve , r and omized trial to improve survival . METHODS We conducted a 12-week prospect i ve , r and omized , multicenter open trial comparing the effects of the continuous intravenous infusion of epoprostenol ( formerly called prostacyclin ) plus conventional therapy with those of conventional therapy alone in 81 patients with severe primary pulmonary hypertension ( New York Heart Association functional class III or IV ) . RESULTS Exercise capacity was improved in the 41 patients treated with epoprostenol ( median distance walked in six minutes , 362 m at 12 weeks vs. 315 m at base line ) , but it decreased in the 40 patients treated with conventional therapy alone ( 204 m at 12 weeks vs. 270 m at base line ; P < 0.002 for the comparison of the treatment groups ) . Indexes of the quality of life were improved only in the epoprostenol group ( P < 0.01 ) . Hemodynamics improved at 12 weeks in the epoprostenol-treated patients . The changes in mean pulmonary-artery pressure for the epoprostenol and control groups were -8 percent and + 3 percent , respectively ( difference in mean change , -6.7 mm Hg ; 95 percent confidence interval , -10.7 to -2.6 mm Hg ; P < 0.002 ) , and the mean changes in pulmonary vascular resistance for the epoprostenol and control groups were -21 percent and + 9 percent , respectively ( difference in mean change , -4.9 mm Hg/liter/min ; 95 percent confidence interval , -7.6 to -2.3 mm Hg/liter/min ; P < 0.001 ) . Eight patients died during the study , all of whom had been r and omly assigned to conventional therapy ( P = 0.003 ) . Serious complications included four episodes of catheter-related sepsis and one thrombotic event . CONCLUSIONS As compared with conventional therapy , the continuous intravenous infusion of epoprostenol produced symptomatic and hemodynamic improvement , as well as improved survival in patients with severe primary pulmonary hypertension BACKGROUND Patients with precapillary pulmonary hypertension ( PH ) exhibit a poor exercise capacity due to an impaired vasodilatory response of their pulmonary arteries . By causing the pulmonary artery to dilate , inhaled nitric oxide ( NO ) may allow an increase in exercise capacity in patients with PH . METHODS AND RESULTS On 2 separate days , 3 days apart , 14 patients with precapillary PH ( 10 primary PH , 4 residual PH after correction of an intracardiac shunt ; age , 40+/-12 years ; mean pulmonary artery pressure , 60+/-23 mm Hg ) performed exercise , with and without inhalation of 20 ppm NO , on a cycle ergometer . The work rate was increased 15 W/min until their symptom-limited maximum , with breath-by-breath gas analysis . Patients were r and omly and blindly selected to inhale NO on either their first or second test . Peak exercise load and anaerobic threshold tended to increase , but not significantly . Peak oxygen consumption ( f1.gif " BORDER="0" > O(2 ) ) and Deltaf1.gif " BORDER="0" > O(2)/DeltaW ratio increased significantly , by 18 % and 22 % , respectively ( peak f1.gif " BORDER="0" > O(2 ) , 13.6+/-3.6 to 16.0+/-4 . 1 mL. kg(-1 ) . min(-1 ) ; Deltaf1.gif " BORDER="0" > O(2)/DeltaW ratio , 5 . 8+/-2.4 to 7.1+/-2.3 mL. kg(-1 ) . min(-1 ) . W(-1 ) ; both P<0.01 ) . Peak f1.gif " BORDER="0" > O(2 ) increased > 10 % in 12 of the 14 patients . However , respiratory quotient at peak exercise decreased from 1 . 22+/-0.15 to 1.09+/-0.15 ( P<0.01 ) . CONCLUSIONS Inhaled NO substantially increases oxygen consumption at the same workload during exercise . This finding supports the possibility of ambulatory NO inhalation therapy in patients with precapillary PH After the approval of bosentan for the treatment of pulmonary arterial hypertension ( PAH ) , European authorities required the introduction of a post-marketing surveillance system ( PMS ) to obtain further data on its safety profile . A novel , prospect i ve , internet-based PMS was design ed , which solicited reports on elevated aminotransferases , medical reasons for bosentan discontinuation and other serious adverse events requiring hospitalisation . Data captured included demographics , PAH aetiology , baseline functional status and concomitant PAH-specific medications . Safety signals captured included death , hospitalisation , serious adverse events , unexpected adverse events and elevated aminotransferases . Within 30 months , 4,994 patients were included , representing 79 % of patients receiving bosentan in Europe . In total , 4,623 patients were naïve to treatment ; of these , 352 had elevated aminotransferases , corresponding to a crude incidence of 7.6 % and an annual rate of 10.1 % . Bosentan was discontinued due to elevated aminotransferases in 150 ( 3.2 % ) bosentan-naïve patients . Safety results were consistent across subgroups and aetiologies . The novel post-marketing surveillance captured targeted safety data ( “ potential safety signals ” ) from the majority of patients and confirmed that the incidence and severity of elevated aminotransferase levels in clinical practice was similar to that reported in clinical trials . These data complement those from r and omised controlled clinical trials and provide important additional information on the safety profile of bosentan Background : Endothelin-1 is considered to be a central pathogenic factor in connective tissue diseases ( CTDs ) such as systemic sclerosis ( SSc ) , leading to vasoconstriction , fibrosis , hypertrophy and inflammation . A frequent complication of CTD is pulmonary arterial hypertension ( PAH ) , which has a major effect on functioning and quality of life , and is associated with a particularly poor prognosis . Objective : To present a subgroup analysis that summarises experiences from the pivotal studies and their open-label extensions with the oral dual endothelin-1 receptor antagonist bosentan in patients with PAH and CTD , mostly SSc and lupus erythematosus . Methods : 66 patients with PAH secondary to CTD , in World Health Organization functional class III or IV , were r and omised to two double-blind , placebo-controlled studies and followed up for 12 and 16 weeks , respectively . The primary end point was change in exercise capacity , assessed using the 6-min walk test . In both studies and their extensions , survival was assessed from start of treatment to death or data cut-off and analysed as Kaplan – Meier estimates . Results : 44 patients with PAH secondary to CTD who were treated with bosentan were stable in 6-min walk distance at the end of the study ( + 19.5 m , 95 % confidence interval ( CI ) −3.2 to 42.2 ) , whereas patients treated with placebo deteriorated ( −2.6 m , 95 % CI −54.0 to 48.7 ) . 64 patients subsequently received bosentan in an open-label long-term extension study . Mean ( st and ard deviation ( SD ) ) exposure to bosentan was 1.6 ( 0.9 ) years , and duration of observation was 1.8 ( 0.8 ) years . 8 ( 16 % ) patients received epoprostenol as add-on treatment and 7 ( 14 % ) after discontinuation of bosentan . Survival in those receiving bosentan was 85.9 % after 1 year and 73.4 % after 2 years . Conclusion : Short-term bosentan treatment in a subgroup of patients with PAH secondary to CTD seems to have a favourable effect compared with placebo . The long-term follow-up of these patients suggests that first-line bosentan , with the subsequent addition of other PAH treatments if required , is safe for long-term treatment and may have a positive effect on outcome Pulmonary hypertension is characterized by progressive elevation of pulmonary artery pressure and vascular resistance , often leading to right ventricular failure and death ( 1 - 3 ) . Continuous intravenous infusion of epoprostenol improves prognosis and symptoms in patients with primary ( idiopathic ) pulmonary hypertension ( 4 - 8 ) . R and omized , controlled clinical trials of epoprostenol for secondary pulmonary hypertension have not been conducted . Pulmonary hypertension frequently complicates the scleroderma spectrum of disease , which includes diffuse scleroderma , limited scleroderma ( the CREST syndrome [ calcinosis cutis , the Raynaud phenomenon , esophageal dysfunction , sclerodactyly , and telangectasia ] ) , and the overlap syndrome . These multisystem diseases are characterized by connective tissue and vascular abnormalities ; vascular lesions are prominent in all affected tissues ( 9 ) . Pulmonary hypertension occurs in up to 33 % of patients with diffuse scleroderma and 10 % to 50 % of those with the CREST syndrome ( 10 , 11 ) , in which it is one of the leading causes of death ( 12 , 13 ) . Pulmonary hypertension in the scleroderma spectrum of disease may be associated with interstitial pulmonary fibrosis or may consist of a direct involvement of small and medium-sized pulmonary arteries and arterioles with smooth-muscle hyperplasia , medial hypertrophy , and intimal proliferation ( 10 , 13 , 14 ) . Principal involvement of the pulmonary vasculature is more common in the CREST syndrome , whereas patients with pulmonary hypertension and diffuse scleroderma more often have interstitial lung disease ( 13 ) . No therapies have been proven effective for pulmonary hypertension secondary to the scleroderma spectrum of disease . Small numbers of patients have responded to captopril ( 15 ) , nifedipine ( 16 - 20 ) , and prazosin . In a short-term study of intravenous epoprostenol in seven patients with scleroderma ( two with diffuse scleroderma and five with limited scleroderma ) , six had a decrease in mean pulmonary artery pressure and pulmonary vascular resistance ( 21 ) . In a small study of pulmonary hypertension secondary to connective tissue disease , long-term infusion therapy with a prostacyclin analogue , iloprost , result ed in improvement in New York Heart Association ( NYHA ) functional class and quality of life but a variable hemodynamic response ( 22 ) . Results from a single-center , uncontrolled study suggest that long-term , continuously infused epoprostenol therapy can produce hemodynamic and symptomatic responses in patients with connective tissue disease who have severe pulmonary hypertension that is refractory to conventional medical therapy ( 23 ) . The rationale for using continuous epoprostenol infusion to treat pulmonary hypertension secondary to the scleroderma spectrum of disease was based on the efficacy of this therapy for primary pulmonary hypertension ( 4 - 8 ) and recognition that scleroderma is a disease characterized by vasospasm and structural changes in the walls of blood vessels . Prostacyclin is a naturally occurring substance produced by vascular endothelium that has vasodilating , antiplatelet aggregation , and cytoprotective effects ( 24 - 33 ) . Endogenous production of prostacyclin is decreased in an animal model of neonatal pulmonary hypertension ( 34 ) and in adult humans with pulmonary hypertension ( 35 ) . Continuous infusion of prostacyclin normalizes plasma markers of endothelial cell injury and platelet aggregation in patients with primary pulmonary hypertension ( 36 ) . Endothelial dysfunction also plays an important role in the vascular manifestations of the scleroderma spectrum of disease ( 37 , 38 ) , including the Raynaud phenomenon and digital ischemia , which cause considerable morbidity . Calcium-channel blockers ( 39 - 45 ) , enalapril ( 46 ) , and intermittent intravenous infusions of prostacyclin ( 47 - 49 ) and iloprost ( 50 - 54 ) improve the Raynaud phenomenon in some patients . Mixed results have been obtained with oral prostacyclin analogues ( 55 , 56 ) , and a recent multicenter trial of oral iloprost showed no benefit ( 57 ) . The effect of long-term , continuously infused epoprostenol on the severity of the Raynaud phenomenon and on digital ulcer counts has not been previously evaluated . Our 12-week multicenter , open-label , r and omized study was design ed to determine whether the beneficial effect of epoprostenol seen in patients with primary pulmonary hypertension could be extended to patients with pulmonary hypertension secondary to the scleroderma spectrum of disease . Our objective was to evaluate the effects of continuous infusion of epoprostenol on exercise capacity in patients with pulmonary hypertension secondary to the scleroderma spectrum of disease . A secondary objective was assessment of the effects of long-term continuous epoprostenol infusion on cardiopulmonary hemodynamics , Borg Dyspnea Score , Dyspnea-Fatigue Rating , NYHA functional class , survival , and safety . Vasospastic manifestations , such as the Raynaud phenomenon and digital ulcerations Output:
There was a trend for endothelin receptor antagonists to reduce mortality ( OR 0.48 ; 95 % CI 0.21 to 1.09 ) , and limited data suggest that endothelin receptor antagonists improve Borg dyspnoea score and cardiopulmonary haemodynamics in symptomatic patients . Hepatic toxicity was not common , and endothelin receptor antagonists were well tolerated in this population . Endothelin receptor antagonists can increase exercise capacity , improve WHO/NYHA functional class , prevent WHO/NYHA functional class deterioration , reduce dyspnoea and improve cardiopulmonary haemodynamic variables in patients with pulmonary arterial hypertension with WHO/NYHA functional class II and III . However , there was only a trend towards endothelin receptor antagonists reducing mortality in patients with pulmonary arterial hypertension . Efficacy data are strongest in those with idiopathic pulmonary hypertension
MS2_1shot2
***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 Although improved epicardial blood flow ( as assessed with either TIMI flow grade s or TIMI frame count ) has been related to reduced mortality after administration of thrombolytic drugs , the relationship of myocardial perfusion ( as assessed on the coronary arteriogram ) to mortality has not been examined . METHODS AND RESULTS A new , simple angiographic method , the TIMI myocardial perfusion ( TMP ) grade , was used to assess the filling and clearance of contrast in the myocardium in 762 patients in the TIMI ( Thrombolysis In Myocardial Infa rct ion ) 10B trial , and its relationship to mortality was examined . TMP grade 0 was defined as no apparent tissue-level perfusion ( no ground-glass appearance of blush or opacification of the myocardium ) in the distribution of the culprit artery ; TMP grade 1 indicates presence of myocardial blush but no clearance from the microvasculature ( blush or a stain was present on the next injection ) ; TMP grade 2 blush clears slowly ( blush is strongly persistent and diminishes minimally or not at all during 3 cardiac cycles of the washout phase ) ; and TMP grade 3 indicates that blush begins to clear during washout ( blush is minimally persistent after 3 cardiac cycles of washout ) . There was a mortality gradient across the TMP grade s , with mortality lowest in those patients with TMP grade 3 ( 2.0 % ) , intermediate in TMP grade 2 ( 4.4 % ) , and highest in TMP grade s 0 and 1 ( 6.0 % ; 3-way P=0.05 ) . Even among patients with TIMI grade 3 flow in the epicardial artery , the TMP grade s allowed further risk stratification of 30-day mortality : 0.73 % for TMP grade 3 ; 2.9 % for TMP grade 2 ; 5.0 % for TMP grade 0 or 1 ( P=0.03 for TMP grade 3 versus grade s 0 , 1 , and 2 ; 3-way P=0.066 ) . TMP grade 3 flow was a multivariate correlate of 30-day mortality ( OR 0.35 , 95 % CI 0.12 to 1.02 , P=0.054 ) in a multivariate model that adjusted for the presence of TIMI 3 flow ( P = NS ) , the corrected TIMI frame count ( OR 1.02 , P=0.06 ) , the presence of an anterior myocardial infa rct ion ( OR 2.3 , P=0.03 ) , pulse rate on admission ( P = NS ) , female sex ( P = NS ) , and age ( OR 1.1 , P<0.001 ) . CONCLUSIONS Impaired perfusion of the myocardium on coronary arteriography by use of the TMP grade is related to a higher risk of mortality after administration of thrombolytic drugs that is independent of flow in the epicardial artery . Patients with both normal epicardial flow ( TIMI grade 3 flow ) and normal tissue level perfusion ( TMP grade 3 ) have an extremely low risk of mortality Background —We hypothesized that preserved microvascular integrity in the area at risk would favorably influence left ventricular ( LV ) remodeling and long-term outcome after acute myocardial infa rct ion . Methods and Results —Before and after successful primary angioplasty ( percutaneous transluminal coronary angioplasty [ PTCA ] ) , 124 patients with acute myocardial infa rct ion underwent intracoronary myocardial contrast echo ( MCE ) . An MCE score index ( MCESI ) was derived by averaging the single-segment score ( 0=not visible , 1=patchy , 2=homogeneous contrast effect ) within the area at risk . An MCESI ≥1 was considered adequate reperfusion . Mean follow-up was 46±32 months . After PTCA , 100 patients showed adequate reperfusion ( no microvascular dysfunction , NoMD ) , whereas 24 did not ( MD ) . MD patients had a higher mean creatine kinase ( 4153±2422 versus 2743±1774 U/L ; P = 0.002 ) and baseline wall-motion score index ( 2.61±0.31 versus 2.25±0.42 ; P < 0.001 ) and a lower baseline ejection fraction ( 33±8 % versus 40±7 % ; P < 0.001 ) . From day 1 on , LV volumes progressively increased in the MD patients ( n=19 ) and were larger than those of NoMD patients ( n=85 ) at 6 months ( end-diastolic volume 170±55 versus 115±29 mL ; P < 0.001 ) . MCESI was the most important independent predictor of LV dilation ( OR 0.61 , 95 % CI 0.52 to 0.71 , P < 0.000001 ) . By Cox analysis , MD represented the only predictor of cardiac death ( OR 0.26 , 95 % CI 0.09 to 0.72 , P = 0.010 ) and combined events ( cardiac death , reinfa rct ion , and heart failure ; OR 0.44 , 95 % CI 0.23 to 0.85 , P = 0.014 ) . MD patients showed worse survival in terms of cardiac death ( P < 0.0001 ) and combined events ( P < 0.0001 ) . Conclusions —In reperfused acute myocardial infa rct ion , MD within the risk area is an important predictor of both LV remodeling and unfavorable long-term outcome Increased neutrophil counts have been associated with an increased risk of adverse clinical events after acute myocardial infa rct ion ( AMI ) . We examined the association of neutrophil counts on admission with degree of microvascular injury and left ventricular functional recovery after primary coronary angioplasty in AMI . We studied 116 patients with a first anterior wall AMI who underwent primary coronary angioplasty within 12 hours of onset . Patients were categorized into 3 groups based on initial neutrophil count : low ( < 5,000/mm(3 ) ) , intermediate ( 5,000 to 10,000/mm(3 ) ) , and high ( > 10,000/mm(3 ) ) . Coronary flow velocity parameters were assessed immediately after reperfusion using a Doppler guidewire . We defined severe microvascular injury as the presence of systolic flow reversal and a diastolic deceleration time < 600 ms . Echocardiographic wall motion was analyzed before revascularization and 4 weeks after revascularization . In patients with a high neutrophil count , systolic flow reversal was more frequently observed , diastolic deceleration time was shorter , and coronary flow reserve was lower . By regression analysis , neutrophil count significantly correlated with diastolic deceleration time ( r = -0.38 , p < 0.0001 ) , coronary flow reserve ( r = -0.33 , p = 0.0004 ) , and score for change in wall motion ( r = -0.36 , p = 0.0004 ) . Multivariate analysis showed that neutrophil count on admission was an independent predictor of severe microvascular injury ( odds ratio 2.94 , p = 0.02 ) . In conclusion , neutrophilia on admission is associated with impaired microvascular reperfusion and poor functional recovery after primary coronary angioplasty Objective : The aim of this pilot study was to determine whether early atorvastatin treatment will reduce left ventricle ( LV ) remodeling , infa rct size , and improve microvascular perfusion . Background : In animal studies , early statin therapy reduces reperfusion injury after a percutaneous coronary intervention ( PCI ) for acute myocardial infa rct ion ( AMI ) . Methods : Forty‐two consecutive patients ( 82 % male , mean age 61.2 ± 9.8 ) who underwent a primary PCI for a first ST‐elevated AMI were r and omized for pretreatment with atorvastatin 80 mg ( n = 20 ) or placebo ( n = 22 ) and continued with the same dosage daily for 1 week . All patients received atorvastatin 80 mg once daily 7 days after primary PCI . The LV function and infa rct size were measured by magnetic resonance imaging within 1 day , at 1 week , and 3 months follow up . The primary endpoint was the end‐systolic volume index ( ESVI ) at 3 months . Secondary endpoints were global LV function measurements , myocardial infa rct size , biochemical cardiac markers , TIMI flow , and ST‐T elevation resolution . Results : ESVI 3 months after AMI was 25.1 mL/m2 in the atorvastatin arm and 25.0 mL/m2 in the placebo arm ( P = 0.74 ) . The differences in change from baseline to 3 months follow up in global LV function and myocardial infa rct size did not differ between both treatment arms . Furthermore , biochemical markers , TIMI flow , and ST‐T elevation resolution did not differ between atorvastatin and placebo arm . Conclusions : In this pilot study , pretreatment with atorvastatin in an acute myocardial infa rct ion does not result in an improved cardiac function , microvascular perfusion , or decreased myocardial infa rct size . © 2012 Wiley Periodicals Primary and secondary prevention with statins reduce major cardiac events in patients with coronary artery disease . The impact of pretreatment with statins prior to percutaneous coronary intervention ( PCI ) is not well established . The objective of this study was to determine if pretreatment with statins prior to PCI reduce myonecrosis and improve clinical outcome . One hundred nineteen consecutive patients with acute coronary syndrome who underwent PCI were identified . We compared the incidence of myonecrosis defined as peak elevation of CK‐MB or CK three time above upper limit of normal within 24 hr and the 6‐month cardiovascular event rate ( death , nonfatal myocardial infa rct ion unrelated to PCI , target vessels revascularization , and unstable angina requiring hospitalization ) among patients who received statins prior to PCI ( n = 63 ) to those who did not ( n = 56 ) . Pretreated patients were more likely to have history of myocardial infa rct ion or revascularization ( 63 % vs. 43 % ; P = 0.015 ) , hyperlipidemia ( 80 % vs. 48 % ; P = 0.001 ) , hypertension ( 83 % vs. 49 % ; P = 0.02 ) , and use of angiotensin‐converting enzyme inhibitor ( 62 % vs. 38 % ; P = 0.008 ) . The rest of baseline characteristics were similar between the two groups , including use of glycoprotein IIb/IIIa inhibitors , number of diseased vessels , and type of lesions . Patients pretreated with statins had a significantly lower incidence of myonecrosis ( 2 % vs. 10 % ; P = 0.04 ) at 24 hr and a significantly lower clinical event ( CE ) rate at 6 months ( 17 % vs. 21 % ; P = 0.015 ) . Of patients not pretreated with statins , 72 % were taking statins at 6 months as compared to 98 % of pretreated patients . After adjusting for all baseline characteristics , use of statins prior to PCI was associated with a marked decrease in risk of all CEs ( OR = 0.2 ; CI = 0.06–0.63 ; P = 0.006 ) . Statin therapy prior to PCI may reduces peri‐PCI myonecrosis and late cardiac events . These results need to be confirmed in large prospect i ve r and omized trials . Catheter Cardiovasc Interv 2004;62:193–197 . © 2004 Wiley‐Liss , OBJECTIVES This study sought to determine the efficacy of high-dose atorvastatin in patients with ST-segment elevation myocardial infa rct ion ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) . BACKGROUND Previous r and omized trials have demonstrated that statin pre-treatment reduced major adverse cardiac events ( MACEs ) in patients with stable angina pectoris and acute coronary syndrome . However , no r and omized studies have been carried out with STEMI patients in a primary PCI setting . METHODS A total 171 patients with STEMI were r and omized to 80-mg atorvastatin ( n = 86 ) or 10-mg atorvastatin ( n = 85 ) arms for pre-treatment before PCI . All patients were prescribed clopidogrel ( 600 mg ) before PCI . After PCI , both groups were treated with atorvastatin ( 10 mg ) . The primary end point was 30-day incidence of MACE including death , nonfatal MI , and target vessel revascularization . Secondary end points included corrected thrombolysis in myocardial infa rct ion frame count , myocardial blush grade , and ST-segment resolution at 90 min after PCI . RESULTS MACE occurred in 5 ( 5.8 % ) and 9 ( 10.6 % ) patients in the 80-mg and 10-mg atorv Output:
This present meta- analysis suggests that statin pretreatment might be effective in improving myocardial perfusion in STEMI patients
MS2_1shot3
***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 We explored the differential effect of cessation interventions ( behavioral support sessions with [ BSS+ ] and without [ BSS ] bupropion ) between hookah and cigarette smokers . METHODS We reanalyzed the data from a major cluster-r and omized controlled trial , ASSIST ( Action to Stop Smoking In Suspected Tuberculosis ) , which consisted of 3 conditions : ( a ) behavioral support sessions ( BSS ) , ( b ) behavioral support sessions plus 7 weeks of bupropion therapy ( BSS+ ) , and ( c ) controls receiving usual care . The trial originally recruited 1,955 adult smokers with suspected tuberculosis from 33 health centers in the Jhang and Sargodha districts of Pakistan between 2010 and 2011 . The primary endpoint was continuous 6-month smoking abstinence , which was determined by carbon monoxide levels . Subgroup-specific relative risks ( RRs ) of smoking abstinence were computed and tested for differential intervention effect using log binomial regression ( generalized linear model ) between 3 subgroups ( cigarette-only : 1,255 ; mixed : 485 ; and hookah-only : 215 ) . RESULTS The test result for homogeneity of intervention effects between the smoking forms was statistically significant ( p-value for BSS+ : .04 and for BSS : .02 ) . Compared to the control , both interventions appeared to be effective among hookah smokers ( RR = 2.5 ; 95 % CI = 1.3 - 4.7 and RR = 2.2 ; 95 % CI = 1.3 - 3.8 , respectively ) but less effective among cigarette smokers ( RR = 6.6 ; 95 % CI = 4.6 - 9.6 and RR = 5.8 ; 95 % CI = 4.0 - 8.5 ) , respectively . CONCLUSIONS The differential intervention effects on hookah and cigarette smokers were seen ( a ) because the behavioral support intervention was design ed primarily for cigarette smokers ; ( b ) because of differences in demographic characteristics , behavioral , and sociocultural determinants ; or ( c ) because of differences in nicotine dependency levels between the 2 groups INTRODUCTION Tobacco use in low- to middle-income countries is a major public health concern for both smokers and those exposed to environmental tobacco smoke ( ETS ) . Egypt has made important strides in controlling tobacco use , but smoking and ETS remain highly prevalent . This r and omized intervention sought to improve the target population 's knowledge regarding the hazards of smoking and ETS and to change attitudes and smoking behaviors within the community and the household . METHODS In this 2005 - 2006 study in Egypt 's Qalyubia governorate , trained professionals visited schools , households , mosques , and health care centers in rural villages r and omly selected for the intervention to discuss the adverse effects of smoking and ETS exposure and ways to reduce one 's ETS exposure . Data collected in interviewer-facilitated surveys before and after the intervention period were analyzed in pairwise comparisons with data from control villages to assess the effectiveness of the intervention in achieving its aims . RESULTS The intervention group showed a greater increase in underst and ing the dangers associated with smoking cigarettes and waterpipes and became more proactive in limiting ETS exposure by asking smokers to stop , avoiding areas with ETS , and enacting smoking bans in the home . However , the intervention had little to no impact on the number of smokers and the amount of tobacco smoked . CONCLUSIONS Results are consistent with previous studies showing that changing smokers ' behavior can be difficult , but community-wide efforts to reduce ETS exposure through smoking bans , education , and empowering people to ask smokers to stop are effective . The method can be generalized to other setting In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias INTRODUCTION Tobacco use remains a major public health problem worldwide . Water-pipe smoking is spreading rapidly and threatening to undermine the successes achieved in tobacco control . METHODS A school-based longitudinal study in the city of Irbid , Jordan , was performed from 2008 to 2010 . All seventh- grade students in 19 r and omly selected schools , out of a total of 60 schools in the city , were enrolled at baseline and surveyed annually . RESULTS Of the 1781 students enrolled at baseline 1,701 ( 95.5 % ) were still in the study at the end of the second year of follow-up ( 869 boys , median age at baseline 13 years ) . Ever and current water-pipe smoking were higher than those of cigarette smoking at baseline ( ever smoking : 25.9 % vs. 17.6 % and current smoking : 13.3 % vs. 5.3 % for water-pipe and cigarette smoking , respectively ; p < .01 for both ) but cigarette smoking caught up by the second year of follow-up ( ever smoking : 46.4 % vs. 44.7 % ; p = .32 and current smoking : 18.9 % vs. 14.9 % ; p < .01 ) . Water pipe-only smokers at baseline were twice as likely to become current cigarette smokers after 2 years compared with never smokers ( relative risk ( RR ) = 2.1 ; 95 % CI = 1.2 , 3.4 ) . A similar pattern was observed for cigarette-only smokers at baseline ( RR = 2.0 ; 95 % CI = 0.9 , 4.8 ) . CONCLUSIONS Prevalence of water-pipe and cigarette smoking increased dramatically over the 2-year follow-up period with similar patterns in boys and girls , although girls had lower prevalence in all categories . Water-pipe smoking at baseline predicted the progress to cigarette smoking in the future and vice versa Background Involving children in research studies requires obtaining parental permission . A school-based intervention to delay/prevent waterpipe use for 7th and 8th grade rs in Qatar was developed , and parental permission requested . Fifty three percent ( 2308/4314 ) of the parents returned permission forms ; of those 19.5 % of the total ( 840/4314 ) granted permission . This paper describes the challenges to obtaining parental permission . No research to date has described such challenges in the Arab world . Methods A r and om sample of 40 schools in Doha , Qatar was selected for inclusion in the original intervention . Permission forms were distributed to parents for approval of their child ’s participation . The permission forms requested that parents indicate their reasons for non-permission if they declined . These were categorized into themes . In order to underst and reasons for non-permission , interviews with parents were conducted . Phone numbers of parents were requested from the school administration ; 12 of the 40 schools ( 30 % ) agreed to provide the contact information . A r and om sample of 28 parents from 12 schools was interviewed to reach data saturation . Thematic analysis was used to analyze their responses . Results Reasons for non-permission documented in both the forms and interviews included : poor timing ; lack of interest ; the child not wanting to participate ; and the child living in a smoke-free environment . Interviews provided information on important topics to include in the consent forms , parents ’ decision-making processes regarding their child ’s participation , and considerations for communicating with parents . Many parents also indicated that this was the first time they had been asked to give an informed consent for their child ’s participation in a study . Conclusions Results indicate that more attention needs to be given to the informed parental consent process . Research ers should consider enhancing both the methods of communicating information as well the specific information provided . Before embarking on recruitment of children for studies , formative research on the parental consent process is suggested Background Among Arab citizens in Israel , cigarette and nargila ( hookah , waterpipe ) smoking is a serious public health problem , particularly among the young adult population . With the dramatic increase of Internet and computer use among Arab college and university students , a Web-based program may provide an easy , accessible tool to reduce smoking rates without heavy re source dem and s required by traditional methods . Objective The purpose of this research was to examine the acceptability and feasibility of a pilot Web-based program that provides tailored feedback to increase smoking knowledge and reduce cigarette and nargila smoking behaviors among Arab college/university students in Israel . Methods A pilot Web-based program was developed , consisting of a self-administered question naire and feedback system on cigarette and nargila smoking . Arab university students were recruited to participate in a mixed- methods study , using both quantitative ( pre-/posttest study design ) and qualitative tools . A posttest was implemented at 1 month following participation in the intervention to assess any changes in smoking knowledge and behaviors . Focus group sessions were implemented to assess acceptability and preferences related to the Web-based program . Results A total of 225 participants —response rate of 63.2 % (225/356)—completed the intervention at baseline and at 1-month post study , and were used for the comparative analysis . Statistically significant reductions in nargila smoking among participants ( P=.001 ) were found . The intervention did not result in reductions in cigarette smoking . However , the tailored Web intervention result ed in statistically significant increases in the intention to quit smoking ( P=.021 ) . No statistically significant increases in knowledge were seen at 1-month post study . Participants expressed high satisfaction with the intervention and 93.8 % ( 211/225 ) of those who completed the intervention at both time intervals reported that they would recommend the program to their friends , indicating excellent acceptability and feasibility of the intervention . This was further emphasized in the focus group sessions . Conclusions A tailored Web-based program may be a promising tool to reduce nargila smoking among Arab university students in Israel . The tailored Web intervention was not successful at significantly reducing cigarette smoking or increasing knowledge . However , the intervention did increase participants ’ intention to quit smoking . Participants considered the Web-based tool to be an interesting , feasible , and highly acceptable strategy . Trial Registration Trial Registration : IS RCT N registry IS RCT N59207794 ; http://www.is rct n.com/IS RCT N59207794 ( Archived by WebCite at http://www.webcitation.org/6VkYOBNOJ ) Objectives : This research was undertaken with the aim of assessing the indoor air quality in popular hospitality venues , as also to evaluate the effectiveness of the nationwide comprehensive public smoking ban . The analysis was split into two halves – baseline study taken up prior to implementation of the said ban on 2nd October 2008 , and the follow-up study after it came into effect . Material s and Methods : Twenty-five venues including five restaurants , fourteen resto-bars , two hookah ( smoking water-pipe ) cafes and four pubs were selected using a mix of r and om , convenience and purpose ful sampling . Particulate matter ( PM2.5 ) measurements at these venues were made using TSI SidePak AM510 Personal Aerosol Monitor . Results : The average PM2.5 level in venues where smoking was permitted prior to implementation of ban was found to be 669.95 μg/m3 in the baseline study . Post ban , the average PM2.5 level in same test venues reduced to 240.8 μg/m3 . The hookah cafes were an exception as the average PM2.5 levels exceeded the permissible limits before as well as post ban . Conclusion : The baseline study showed that the hospitality venues had hazardous levels of PM2.5 particles arising from second-h and smoke prior to smoking ban . These decreased by a maximum of 64 % after the law took effect . A substantial improvement in air quality at these venues post implementation of the smoking ban indicated the effectiveness of the law BACKGROUND Waterpipe use has increased dramatically in the Middle East and other parts of the world . Many users exhibit signs of dependence , including withdrawal and difficulty quitting , but there is no evidence base to guide cessation efforts . METHODS We developed a behavioral cessation program for willing-to-quit waterpipe users , and evaluated its feasibility and efficacy in a pilot , two arm , parallel group , r and omized , open label trial in Aleppo , Syria . Fifty adults who smoked waterpipe ≥3 times per week in the last year , did not smoke cigarettes , and were interested in quitting were r and omized to receive either brief ( 1 in-person session and 3 phone calls ) or intensive ( 3 in-person sessions and 5 phone calls ) behavioral cessation treatment delivered by a trained physician in a clinical setting . The primary efficacy end point of the developed interventions was prolonged abstinence at three months post-quit day , assessed by self-report and exhaled carbon monoxide levels of < 10 ppm . Secondary end points were 7 day point-prevalent abstinence and adherence to treatment . RESULTS Thirty percent of participants were fully adherent to Output:
In conclusion , there is a lack of evidence of effectiveness for most waterpipe interventions .
MS2_1shot4
***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 Cultural sensitivities tend to limit assessment s of sexual dysfunction ( SD ) in Parkinson 's disease ( PD ) . OBJECTIVE To assess the validity and reliability of the Thai translation ( ASEX-Thai ) of the Arizona Sexual Experiences Scale ( ASEX ) . METHOD The validity and reliability of ASEX-Thai were assessed with a r and om sample of 40 PD patients . Back translation and cross-cultural modifications assured content validity . Criterion validity used DSM-IV-TR criteria and receiver operating characteristics ( ROC ) analysis was calculated for cutoff points plus sensitivity and specificity . Internal consistency was assessed with Cronbach 's alpha coefficient . Test-retest reliability was assessed by Pearson 's correlation at baseline and at a 2-month follow-up . RESULT Criterion validity was conducted with a positive correlation between the clinical diagnosis of SD and DSM-IV-TR ( r = 0.601 ; p < 0.001 ) . The ROC analysis differentiated between SD and non-SD patients ( p < 0.001 ) . The cutoff point of ASEX-Thai at ≥16 points effectively screened for SD ( sensitivity 96.2 % , specificity 92.9 % ) . Reliability was documented with the Cronbach 's alpha of all items at baseline and at a 2-month follow-up with values of 0.948 and 0.962 respectively . The Pearson 's correlation also showed highly significant test-retest reliability [ Item 1 ( r = 0.959 , p < 0.001 ) , Item 2 ( r = 0.914 , p < 0.001 ) , Item 3 ( r = 0.944 , p < 0.001 ) , Item 4 ( r = 0.992 , p < 0.001 ) , Item 5 ( r = 0.930 , p < 0.001 ) , and total ASEX-Thai score ( r = 0.883 , p < 0.001 ) ] . CONCLUSION ASEX-Thai is a valid and reliable instrument for the assessment of sexual dysfunction in Thai PD patients Study design : Two r and omized , double-blind , placebo-controlled trials . Objective : To evaluate the efficacy and safety of fampridine sustained-release tablets ( fampridine-SR ) 25 mg twice daily for moderate-to-severe spasticity in patients with chronic spinal cord injury ( SCI ) . Setting : United States and Canada . Methods : Patients with incomplete chronic SCI were r and omized to twice daily fampridine-SR 25 mg or placebo , with a 2-week single-blind placebo run-in , a 2-week titration , 12 weeks of stable dosing , 2 weeks of downward titration and 2 weeks of untreated follow-up . Co- primary end points were the change from baseline , averaged over the double-blind treatment period , for Ashworth score ( bilateral knee flexors and extensors ) and a 7-point Subject Global Impression of treatment ( SGI ; 1 , terrible ; 7 , delighted ) . Secondary end points were : Penn Spasm Frequency Scale ; the motor/sensory score from the International St and ards for Neurological Classification of SCI ; Clinician ’s Global Impression of Change of neurological status ; and the International Index of Erectile Function ( men ) or the Female Sexual Function Index ( women ) . Results : The population s were 212 and 203 patients in the two studies , respectively . Changes from baseline in Ashworth score were −0.15 ( placebo ) and −0.19 ( fampridine-SR ) in the first study , and −0.16 ( placebo ) and −0.28 ( fampridine-SR ) in the second study . The between-treatment difference was not significant for either the Ashworth score or the SGI and , with few exceptions , neither were the secondary end points . Fampridine-SR was generally well tolerated ; treatment-emergent adverse events ( TEAEs ) and serious TEAEs were reported with similar frequency between treatments . Conclusion : Fampridine-SR was well tolerated . No significant differences were observed between treatment groups for the primary end points of Ashworth score and SGI Introduction and hypothesisThe objective of this study was to create a valid , reliable , and responsive sexual function measure in women with pelvic floor disorders ( PFDs ) for both sexually active ( SA ) and inactive ( NSA ) women . Methods Expert review identified concept gaps and generated items evaluated with cognitive interviews . Women underwent Pelvic Organ Prolapse Quantification ( POPQ ) exams and completed the Incontinence Severity Index ( ISI ) , a prolapse question from the Epidemiology of Prolapse and Incontinence Question naire ( ISI scores ) , the Pelvic Floor Distress Inventory-20 ( PFDI-20 ) , and the Female Sexual Function Index ( FSFI ) . Principle components and orthogonal varimax rotation and principle factor analysis with oblique rotation identified item grouping . Cronbach ’s alpha measured internal consistency . Factor correlations evaluated criterion validation . Change scores compared to change scores in other measures evaluated responsiveness among women who underwent surgery . Results A total of 589 women gave baseline data , 200 returned surveys after treatment , and 147 provided test-retest data . For SA women , 3 subscales each in 2 domains ( 21 items ) and for NSA women 2 subscales in each of 2 domains ( 12 items ) emerged with robust psychometric properties . Cronbach ’s alpha ranged from .63 to .91 . For SA women , correlations were in the anticipated direction with PFDI-20 , ISI , and FSFI scores , POPQ , and EPIQ question # 35 ( all p < .05 ) . PFDI-20 , ISI , and FSFI subscale change scores correlated with Pelvic Organ Prolapse/Urinary Incontinence Sexual Question naire International Urogynecological Association-revised ( PISQ-IR ) factor change scores and with mean change scores in women who underwent surgery ( all p < .05 ) . For NSA women , PISQ-IR scores correlated with PFDI-20 , ISI scores , and with EPIQ question # 35 ( all p < .05 ) . No items demonstrated differences between test and retest ( all p ≥ .05 ) , indicating stability over time . Conclusions The PISQ-IR is a valid , reliable , and responsive measure of sexual function OBJECTIVE To identify determinants of sexual adjustment by persons with spinal cord injury ( SCI ) and quality of the relationship compared with persons in the general population . DESIGN Controlled survey . SETTING Postdischarge community setting . PARTICIPANTS A consecutive series of 252 persons admitted to our spinal unit between November 1982 and July 1991 with traumatic SCI were contacted , 85 of whom persons were excluded : 36 were dead , 37 had recovered , 5 could not be located , 4 were younger than 18 years , 2 had language difficulties , and 1 had a psychiatric illness . Of the remaining 167 persons with SCI , 85 had a stable partner relationship , 75 of whom ( 88 % ) completed and returned the question naires ( median age , 33 years ; range 19 to 76 ) . An age- and sex-matched control group was r and omly selected from the general population . Of the 264 respondents , 155 ( 59 % ) had a stable partner relationship . MAIN OUTCOME MEASURES The 80-item question naire addressed experiences concerning sexual functioning , desire , and activity , sexual behavior , satisfaction with sex life , and aspects of the emotional quality of the relationship . RESULTS Sexual activity and satisfaction was lower among persons with SCI compared with the controls ; the emotional quality of the relationship did not differ . The most important correlates for sexual fulfillment in both groups were found to be the use of a varied repertoire of sexual behaviors and the perception that the partner enjoys and is satisfied with the sexual part of the relationship . CONCLUSION Psychosocial rather than physical factors were important for a satisfying sexual life and relationship . A qualitative study should be undertaken to further explore the complexity of sexual adjustment after SCI OBJECTIVE To describe sexual life in women with spinal cord injury . DESIGN Controlled cross-sectional , question naire . PARTICIPANTS AND METHODS Women , 18 - 65 years , treated at spinal cord centres in Sweden , Denmark , Norway , Finl and and Icel and . 545 women ( 57 % ) completed the question naires . The age-matched control group consisted of 507 women . The 104-item Spinal Cord Injury Women Question naire , was design ed to assess different dimensions of sexuality . RESULTS 80 % of the women with spinal cord injury had engaged in sex after the injury . Reasons for not wanting or not having the courage to be intimate and sexual were physical problems , low sexual desire , low self-esteem and feelings of being unattractive . The motivations of both the women with spinal cord injury and controls to engage in sexual activity were intimacy-based rather than primarily sexual . Being in the right mood both before and during sex to become receptive to sexual stimulation was important . CONCLUSION For women who are able to overcome the physical restrictions and mental obstacles due to injury , it is possible to regain an active and positive sexual life together with a partner . Sexual information and counselling should be available both during initial rehabilitation and later when the women have returned to their homes Output:
Several PROMs have been identified to evaluate sexual function in neurologic patients . Strong evidence was found only for the Multiple Sclerosis Intimacy and Sexuality Question naire-15 and Multiple Sclerosis Intimacy and Sexuality Question naire-19 for patients with MS , although evidence was lacking for certain measurement properties as well .
MS2_1shot5
***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 effect on gastric pH and volume of 0 , 6 and 10 ml · kg−1 , of apple juice given 2.5 hours before surgery to children aged five to ten years was investigated in this prospect i ve , r and omized , single-blind study . Gastric contents were aspirated after induction of anaesthesia , and the volume measured . The pH of the gastric aspirate was then assessed using pH paper . Neither gastric volume nor pH immediately following the induction of general anaesthesia were significantly different among the three groups . Gastric volumes after 0 , 6 and 10 ml · kg−1 , of juice averaged ( mean ±SD ) 0.45 ±0.31 , 0.66 ±0.79 and 0.71 ±0.76 ml · kg−1 , respectively ; gastric pH averaged 1.7 ±0.6 , 1.7 ±0.6 and 1.8 ±0.8 , respectively . On the basis of questions asked immediately before induction of anaesthiesia , patients who drank 6 ml · kg−1 of apple juice had decreased thirst and were less irritable and upset before anaesthesia than those who had not ( P < 0.05 ) . It is concluded that drinking large volumes of clear apple juice 2.5 hours before scheduled surgery does not have a measurable effect on gastric volume and pH and may offer benefits such as improved patient comfort . RésuméL’effet sur le volume et le pH gastrique de 0,6 et 10 ml · kg−1 de jus de pomme donné 2.5 heures avant la chirurgie aux enfants âgés de cinq à dix ans a été investigué dans cette étude prospect i ve r and omisée et a simple insu . Le contenu gastrique fut aspiré après induction de l’anesthésie et le volume mesuré . Le pH du sue gastrique aspiré a par la suite été évalué par un papier à pH. Ni le volume gastrique ni son pH n’était significativement différent pour les trois groupes après l’induction de l’anesthesie générale . Le volume gastrique après 0,6 et 10 ml · kg−1 de jus de pomme était en moyenne ( moyenne ±SD ) respectivement 0,45 ±0,31 , 0,66 ±0,79 et 0,71 ±0,76 ml · kg−1 , en moyenne le pH gastrique était de 1,7 ±0,6 , 1,7 ±0,6 et 1,8 ±0,8 . Pour les avoir question né immédiatement avant l’induction de l’anesthésie les patients ayant bu 6 ml · kg−1 de jus de pomme avaient moins soif et étaient moins irritables avant l’anesthésie que ceux qui n’en ont pas eu ( P < 0.05 ) . On conclut que l’ingestion dun large volume de jus de pomme 2.5 heures avant la chirurgie n’a pas d’effet mesurable sur le volume et le pH gastrique et peut offrir des bénéfices tel que l’amélioration du confort du patient The effect of preoperative glucose infusion on preoperative alterations in hepatic glycogen content , the activity of key hepatic glucoregulatory enzymes ( fructose 1,6-diphosphatase [ FDPase ] ) , pyruvate kinase ( PK ) , hormonal developments , and plasma levels of free fatty acids ( FFA ) were investigated in 16 patients undergoing open cholecystectomy . Patients were r and omized to receive ( group G ) or not receive ( group C ) overnight glucose infusion ( 5 mg.kg-1.d-1 ) preoperatively . Infusion of glucose overnight result ed in preoperative elevations of insulin and c-peptide ( P < 0.05 ) and lower plasma levels of FFA , while the same glucose levels were found in both groups , 4.6 mmol/L. During and after surgery , only minor changes in the plasma levels of insulin , c-peptide , catecholamines , glucagon , cortisol , growth hormone , and FFA were found , with minimal differences between groups . The hepatic glycogen content was 65 % higher in group G and a significant reduction was confirmed only in this group of patients during surgery . The higher glycogen content was associated with a higher FDPase activity ratio ( P < 0.05 ) , which remained unchanged during surgery . In contrast , a significant ( P < 0.05 ) increase in the activity of this enzyme was found in group C. The PK activity ratio did not differ between groups and remained unchanged during surgery . The finding of enhanced FDPase activity suggests that the indirect route ( via gluconeogenesis ) represents an important contributor to the increased glycogen formation during glucose infusion . Additionally , surgery in the overnight fasted patient induces enzymatic changes favoring gluconeogenesis . Lastly , preoperative high-dose glucose infusion has only minor effects on the endocrine response , plasma levels of FFA , and glycogen depletion during elective open cholecystectomy The effect of 3 ml·kg-1 of apple juice given 2.6 ± 0.4 hours preoperatively was investigated in 80 healthy children of ages five to ten years in this prospect i ve , r and omized , single blind study . The children who drank apple juice preoperatively had decreased gastric volume , thirst , and hunger ( p < 0.05 ) . The gastric volume in the control group was 0.43 ± 0.46 ml·kg-1 and in the patients who received apple juice the gastric volume was 0.24 ± 0.31 ml·kg-1 . The gastric pH was not significantly different , with the control group ’s gastric pH being 1.7 ± 0.6 and the treated group ’s pH was 2.2 ± 1.2 . Further studies of the effects of different volumes and timing of preoperative clear fluids are indicated in paediatric patients .RésuméNous avons entrepris une étude prospect i ve , r and omisée et à ľaveugle pour déterminer ľeffet de 3 ml · kg-1 de jus de pomme donné 2.6 ± 0.4 h. avant ľopération à 80 enfants agés de 5 à 10 ans . Les enfants qui avaient bu du jus avant ľopération avaient moins f aim et soif et leurs volumes gastriques étaient moindres ( p < 0.05 ) . Le volume gastrique était de 0.43 ± 0.46 ml · kg-1 chez le groupe contrôle , et de 0.24 ± 0.31 ml · kg-1 chez le groupe “ jus de pomm ” . Le pH du liquide se chiffrait à 1.7 ± 0.6 pour les contrôles et à 2.2 ± 1.2 pour les buveurs de jus , écart non significatif . On aura besoin ďautres études pour préciser ľimpact du volume et de ľintervalle ďadministration des liquides clairs chez les enfants Background : Post‐operative insulin resistance and hyperglycaemia are associated with an impaired outcome after surgery . Pre‐operative oral carbohydrate loading ( CHO ) reduces post‐operative insulin resistance with a reduced risk of hyperglycaemia during post‐operative nutrition . Insulin‐resistant diabetic patients have not been given CHO because the effects on pre‐operative glycaemia and gastric emptying are unknown BACKGROUND AND AIMS Preoperative intake of a clear carbohydrate-rich drink reduces insulin resistance after surgery . In this study , we evaluated whether this could be related to increased insulin sensitivity at the onset of surgery . Furthermore , we aim ed to establish the optimal dose-regimen . METHODS Six healthy volunteers underwent hyperinsulinaemic ( 0.8 mU/kg/min ) , normoglycaemic ( 4.5 mmol/l ) clamps and indirect calorimetry on four occasions in a crossover-r and omised order ; after overnight fasting ( CC ) , after a single evening dose ( 800 ml ) of the drink ( LC ) , after a single morning dose ( 400 ml , CL ) and after intake of the drink in the evening and in the morning before the clamp ( LL ) . Data are presented as mean+/-SD . Statistical analysis was performed using the Student 's t-test and ANOVA . RESULTS Insulin sensitivity was higher in CL and LL ( 9.2+/-1.5 and 9.3+/-1.9 mg/kg/min , respectively ) compared to CC and LC ( 6.1+/-1.6 and 6.6+/-1.9 mg/kg/min , P<0.01 vs. CL and LL ) . CONCLUSIONS A carbohydrate-rich drink enhances insulin action 3 h later by approximately 50 % . Enhanced insulin action to normal postpr and ial day-time level at the time of onset of anaesthesia or surgery is likely to , at least partly , explain the effects on postoperative insulin resistance Background Studies showing the improvement of insulin sensitivity by reducing the term of preoperative fasting are mostly done in patients undergoing major operations . More information about the role of shortened preoperative fasting in perioperative metabolism is needed for such elective minor/moderate abdominal procedures as laparoscopic cholecystectomy . We investigated the influence of a carbohydrate-rich drink given 2 h before laparoscopic cholecystectomy on insulin resistance and the metabolic response to trauma . Methods A group of 21 female c and i date s ( 18–65 years old ) for elective laparoscopic cholecystectomy were r and omized to either an 8 h fasting group ( control group : n = 10 ) or to a group receiving 200 ml of a carbohydrate beverage containing 12.5 % ( 25 g , 50 kcal per 100 ml and approximately 285 mOsm ) of maltodextrine 2 h before operation ( CHO group : n = 11 ) . Blood sample s for various biochemical assays were collected both at induction of anesthesia and after the 10th postoperative hour . Insulin resistance was assessed by the HOMA-IR equation ( Insulin ( μU/ml ) × blood glucose (mg/dl)/405 ) . Results There were no postoperative complications . Seventy percent ( 7/10 ) of the controls and 27.3 % ( 3/11 ) of the CHO group experienced at least one episode of vomiting ( RR = 2.42 , 95 % Confidence Interval [ CI ] = 0.88–6.68 ; P = 0.08 ) . Biochemical analysis showed that serum glucose ( P < 0.01 ) , insulin ( P < 0.01 ) , lactate/pyruvate ratio ( P = 0.03 ) , and triglycerides ( P < 0.01 ) for the control group were higher than for the CHO group . The value of HOMA-IR was significantly greater ( P = 0.03 ) in the conventionally fasted patients than in the CHO group . Conclusions Abbreviation of the period of preoperative fasting and administration of a carbohydrate beverage diminishes insulin resistance and the organic response to trauma BACKGROUND Diabetes mellitus is a risk factor for deep sternal wound infection after open heart surgical procedures . We previously showed that elevated postoperative blood glucose levels are a predictor of deep sternal wound infection in diabetic patients . Therefore , we hypothesized that aggressive intravenous pharmacologic control of postoperative blood glucose levels would reduce the incidence of deep sternal wound infection . METHODS In a prospect i ve study of 2,467 consecutive diabetic patients who underwent open heart surgical procedures between 1987 and 1997 , perioperative blood glucose levels were recorded every 1 to 2 hours . Patients were classified into two sequential groups : the control group included 968 patients treated with sliding-scale-guided intermittent subcutaneous insulin injections ( SQI ) ; the study group included 1,499 patients treated with a continuous intravenous insulin infusion in an attempt to maintain a blood glucose level of less than 200 mg/dL. There were no differences between these groups with respect to age , sex , procedure , bypass time , antibiotic prophylaxis , or skin preparation methods . RESULTS Compared with subcutaneous insulin injections , continuous intravenous insulin infusion induced a significant reduction in perioperative blood glucose levels , which led to a significant reduction in the incidence of deep sternal wound infection in the continuous intravenous insulin infusion group ( 0.8 % [ 12 of 1,499 ] ) versus the intermittent subcutaneous insulin injection group ( 2.0 % [ 19 of 968 ] , p = 0.01 by the chi2 test ) . Multivariate logistic regression revealed that continuous intravenous insulin infusion induced a significant decrease in the risk of deep sternal wound infection ( p = 0.005 ; relative risk , 0.34 ) , whereas obesity ( p < 0.03 ; relative risk , 1.06 ) and use of an internal thoracic artery pedicle ( p = 0.1 ; relative risk , 2.0 ) increased the risk of deep sternal wound infection . CONCLUSIONS Use of perioperative continuous intravenous Output:
Preoperative carbohydrate drinks significantly improved insulin resistance and indices of patient comfort following surgery , especially hunger , thirst , malaise , anxiety and nausea . No definite conclusions could be made regarding preservation of muscle mass . Following ingestion of carbohydrate drinks , no adverse events such as apparent or proven aspiration during or after surgery were reported . Administration of oral carbohydrate drinks before surgery is probably safe and may have a positive influence on a wide range of perioperative markers of clinical outcome .
MS2_1shot6
***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 : For patients who survive intracerebral haemorrhage ( ICH ) during treatment with oral anticoagulation ( OAC ) , the balance between the benefits and risks of restarting OAC is unclear . The decision to restart OAC or to start antiplatelet therapy in these patients therefore poses a dilemma for all physicians involved . We assessed the long-term outcome of patients who did or did not restart antithrombotic therapy after OAC-associated ICH . Methods : We conducted a retrospective follow-up study of all patients discharged from our institution after OAC-associated ICH over a 10-year period . Data on the use of OAC or platelet inhibitors and the occurrence of vascular events during follow-up were assessed through question naires and patient files . The primary outcome was recurrent fatal or non-fatal stroke . Secondary outcomes were the occurrence of other haemorrhagic , thrombotic or thromboembolic events . With patients without antithrombotic treatment as reference , we calculated incidence ratios with corresponding 95 % confidence intervals ( CI ) for treatment with OAC and for treatment with antiplatelet therapy . Results : We included 38 patients , of whom 21 ( 55 % ) died during a mean follow-up of 3.5 years . The medication regime changed frequently during follow-up , illustrated by the fact that two thirds of the patients who had resumed OAC within 2 months of ICH terminated this at later points in time . Two recurrent strokes occurred during 35.4 patient-years without antithrombotic medication , 7 during 63.8 patient-years on antiplatelet medication ( incidence ratio 1.9 ; 95 % CI , 0.4 - 9.4 ) , and 3 during 19.5 patient-years on OAC ( incidence ratio 2.7 ; 95 % CI , 0.5 - 16.3 ) . There was only 1 recurrent ICH , which occurred during treatment with OAC . Conclusion : In this observational study , no significant difference in the primary outcome measure was found between the treatment groups , but there was a tendency towards a higher long-term risk of any stroke in patients who resumed OAC or started antiplatelet therapy . However , based on these results it is difficult to draw any concrete conclusions or make any strong recommendations . A r and omized trial to assess the optimal long-term strategy after OAC-related ICH is warranted . Based on the point estimates of our study , such a trial should involve at least 300 patient-years of follow-up BACKGROUND While warfarin-related intracranial hemorrhage ( ICH ) occurs in 0.25%-1.1 % patients per year , little is known about the practice and outcomes of anticoagulant reinitiation . METHODS We studied a cohort of consecutive patients with warfarin-related ICH ( intracerebral or subarachnoid ) admitted to 13 stroke centres in the Registry of the Canadian Stroke Network between July 2003 and March 2008 . We examined patterns of warfarin reinitiation and variables associated with 30-day and 1-year outcomes . RESULTS Among the 284 patients studied ( mean age 74 ± 12 years ) , warfarin was restarted in-hospital in 91 patients ( 32 % ) . Factors associated with restarting warfarin were lower stroke severity ( adjusted odds ratio [ aOR ] 2.07 , 95 % confidence interval [ CI ] ; 1.20 - 3.57 , P = 0.009 ) or presence of valve prosthesis ( aOR 3.07 , 95 % CI ; 1.29 - 7.27 , P = 0.011 ) . Mortality rates were not higher in those who restarted warfarin in-hospital : 31.9 % vs 54.4 % ( 30-day , P < 0.001 ) and 48 % vs 61 % ( 1-year , P = 0.04 ) , and bleeding was not increased . Multivariable predictors of mortality included initial international normalized ratio > 3.0 ( aOR , 3.28 [ 30-day , P < 0.001 ] and 3.32 [ 1-year , P = 0.003 ] ) , greater stroke severity ( aOR , 6.04 [ 30-day ] and 4.22 [ 1-year ] ; both P < 0.001 ) , and intraventricular hemorrhage ( aOR , 2.19 [ 30-day ; P = 0.03 ] and 2.04 [ 1-year ; P = 0.04 ] ) . In selected patients who reinitiated warfarin , there was no increase in 30-day ( aOR , 0.49 ; P = 0.03 ) or 1-year mortality ( aOR , 0.79 ; P = 0.43 ) . CONCLUSIONS In selected patients at high thrombosis risk , reinitiation of warfarin after ICH did not confer increased mortality or bleeding events OBJECT Aneurysmal subarachnoid hemorrhage ( aSAH ) predisposes to delayed neurological deficits , including stroke and cognitive and neuropsychological abnormalities . Heparin is a pleiotropic drug that antagonizes many of the pathophysiological mechanisms implicated in secondary brain injury after aSAH . METHODS The authors performed a retrospective analysis in 86 consecutive patients with Fisher Grade 3 aSAH due to rupture of a supratentorial aneurysm who presented within 36 hours and were treated by surgical clipping within 48 hours of their ictus . Forty-three patients were managed postoperatively with a low-dose intravenous heparin infusion ( Maryl and low-dose intravenous heparin infusion protocol : 8 U/kg/hr progressing over 36 hours to 10 U/kg/hr ) beginning 12 hours after surgery and continuing until Day 14 after the ictus . Forty-three control patients received conventional subcutaneous heparin twice daily as deep vein thrombosis prophylaxis . RESULTS Patients in the 2 groups were balanced in terms of baseline characteristics . In the heparin group , activated partial thromboplastin times were normal to mildly elevated ; no clinical ly significant hemorrhages or instances of heparin-induced thrombocytopenia or deep vein thrombosis were encountered . In the control group , the incidence of clinical vasospasm requiring rescue therapy ( induced hypertension , selective intraarterial verapamil , and angioplasty ) was 20 ( 47 % ) of 43 patients , and 9 ( 21 % ) of 43 patients experienced a delayed infa rct on CT scanning . In the heparin group , the incidence of clinical vasospasm requiring rescue therapy was 9 % ( 4 of 43 , p = 0.0002 ) , and no patient suffered a delayed infa rct ( p = 0.003 ) . CONCLUSIONS In patients with Fisher Grade 3 aSAH whose aneurysm is secured , postprocedure use of a low-dose intravenous heparin infusion may be safe and beneficial Abstract Purpose s : Intracranial haemorrhage ( ICH ) is a rare but potentially devastating complication of oral anticoagulants ( OAC ) . This raises the difficult clinical choice between either permanent cessation of OAC , or continuing OAC and if so , when to restart . To make this choice , one needs to balance the thrombo-embolic risk after cessation of OAC against the risk of recurrent intracranial haemorrhage when OAC are restarted . There are few published data to base this difficult clinical decision on . Methods : We present an observational study of a consecutive series of 108 patients , collected prospect ively and admitted to our department , with an OAC-related intracranial haemorrhage , in whom we assessed the thrombotic event rate and the recurrent intracranial bleeding rate during follow-up . Results : In the 25 patients in whom OAC were reinstituted no new thrombo-embolic events occurred ( 0/506 unprotected patient-days ) . In the group of patients in whom OAC were not restarted ( n = 81 ) , the thrombo-embolic event rate was 8/11590 unprotected patient-days , of which only 2 were cerebrovascular thrombo-embolisms . The overall risk of a thrombo-embolic complication can be estimated to be 0.66 events/1000 patient-days at risk ( 95 % exact confidence limits of 0.3 to 1.3 events/1000 patient-days at risk ) . In three patients the thrombo-embolic event was fatal . We saw recurrent intracranial bleeding in eight patients , 2 of which were fatal . Seven of these occurred before the restarting of the OAC . Conclusions : In OAC-related intracranial haemorrhages , OAC can be stopped safely for a considerable period , with a very low overall thrombotic event rate . The recurrent bleeding risk after restarting OAC is low . Recurrent bleeding mostly occurred before restarting OAC and is probably caused by insufficient or unsustained correction of the initial coagulation deficit . Immediate reversal of anticoagulation provides the patient with the best possible treatment options including surgery . OAC-related intracranial haemorrhages can therefore be actively treated IMPORTANCE Although use of oral anticoagulants ( OACs ) is increasing , there is a substantial lack of data on how to treat OAC-associated intracerebral hemorrhage ( ICH ) . OBJECTIVE To assess the association of anticoagulation reversal and blood pressure ( BP ) with hematoma enlargement and the effects of OAC resumption . DESIGN , SETTING , AND PARTICIPANTS Retrospective cohort study at 19 German tertiary care centers ( 2006 - 2012 ) including 1176 individuals for analysis of long-term functional outcome , 853 for analysis of hematoma enlargement , and 719 for analysis of OAC resumption . EXPOSURES Reversal of anticoagulation during acute phase , systolic BP at 4 hours , and reinitiation of OAC for long-term treatment . MAIN OUTCOMES AND MEASURES Frequency of hematoma enlargement in relation to international normalized ratio ( INR ) and BP . Incidence analysis of ischemic and hemorrhagic events with or without OAC resumption . Factors associated with favorable ( modified Rankin Scale score , 0 - 3 ) vs unfavorable functional outcome . RESULTS Hemorrhage enlargement occurred in 307 of 853 patients ( 36.0 % ) . Reduced rates of hematoma enlargement were associated with reversal of INR levels < 1.3 within 4 hours after admission ( 43/217 [ 19.8 % ] ) vs INR of ≥1.3 ( 264/636 [ 41.5 % ] ; P < .001 ) and systolic BP < 160 mm Hg at 4 hours ( 167/504 [ 33.1 % ] ) vs ≥160 mm Hg ( 98/187 [ 52.4 % ] ; P < .001 ) . The combination of INR reversal < 1.3 within 4 hours and systolic BP of < 160 mm Hg at 4 hours was associated with lower rates of hematoma enlargement ( 35/193 [ 18.1 % ] vs 220/498 [ 44.2 % ] not achieving these values ; OR , 0.28 ; 95 % CI , 0.19 - 0.42 ; P < .001 ) and lower rates of in-hospital mortality ( 26/193 [ 13.5 % ] vs 103/498 [ 20.7 % ] ; OR , 0.60 ; 95 % CI , 0.37 - 0.95 ; P = .03 ) . OAC was resumed in 172 of 719 survivors ( 23.9 % ) . OAC resumption showed fewer ischemic complications ( OAC : 9/172 [ 5.2 % ] vs no OAC : 82/547 [ 15.0 % ] ; P < .001 ) and not significantly different hemorrhagic complications ( OAC : 14/172 [ 8.1 % ] vs no OAC : 36/547 [ 6.6 % ] ; P = .48 ) . Propensity-matched survival analysis in patients with atrial fibrillation who restarted OAC showed a decreased HR of 0.258 ( 95 % CI , 0.125 - 0.534 ; P < .001 ) for long-term mortality . Functional long-term outcome was unfavorable in 786 of 1083 patients ( 72.6 % ) . CONCLUSIONS AND RELEVANCE Among patients with OAC-associated ICH , reversal of INR < 1.3 within 4 hours and systolic BP < 160 mm Hg at 4 hours were associated with lower rates of hematoma enlargement , and resumption of OAC therapy was associated with lower risk of ischemic events . These findings require replication and assessment in prospect i ve studies . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01829581 Output:
Conclusions — In observational studies , reinstitution of anticoagulation after ICH was associated with a lower risk of thromboembolic complications and a similar risk of ICH recurrence .
MS2_1shot7
***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 Alcohol and nicotine dependence are common in schizophrenia . Varenicline is effective in smoking cessation and has also been shown to decrease alcohol consumption in smokers . The present pilot study assessed the safety and effectiveness of varenicline for treatment of concurrent nicotine and alcohol dependence in schizophrenia . Out patients with schizophrenia or schizoaffective disorder and concurrent alcohol and nicotine dependence were enrolled in this 8-week , double-blind , r and omized , placebo-controlled trial . Alcohol use and smoking were assessed using self-report ( Timeline Follow-Back ) and biological measures . Adverse events were recorded . Changes in the number of st and ard drinks per week and cigarettes per week were compared in the 2 groups . Because of safety concerns or loss to follow-up , of 55 patients enrolled , only 10 started study medication , 5 each on varenicline and placebo . Gastrointestinal adverse effects , such as severe abdominal pain , limited study completion to only 4 subjects . Number of st and ard alcoholic drinks consumed per week decreased by [ mean ( SD ) ] 16.6 ( 20.1 ) in the varenicline group and by 2.4 ( 27.4 ) in the placebo group . Mean ( SD ) number of cigarettes smoked per week decreased by 66 ( 65 ) in the varenicline group and by 47 ( 77 ) in the placebo group . Varenicline treatment of concurrent alcohol and nicotine dependence in schizophrenia may be problematic because of safety concerns limiting recruitment and poor tolerability ( gastrointestinal adverse effects ) limiting retention . There was no increased number of serious neuropsychiatric adverse events in the varenicline group . Based on this small sample , concurrent alcohol and nicotine dependence in schizophrenia may present special obstacles to successful treatment with varenicline BACKGROUND Varenicline is approved as an aid to smoking cessation in adults aged > or = 18 years . OBJECTIVE The goal of this study was to characterize the multiple-dose pharmacokinetics , safety , and tolerability of varenicline in adolescent smokers . METHODS This multicenter , r and omized , double-blind , placebo-controlled , parallel-group study enrolled healthy 12- to 16-year-old smokers ( > or =3 cigarettes daily ) into high-body-weight ( > 55 kg ) and low-body-weight ( < or = 55 kg ) groups . Subjects were r and omized to receive 14 days of treatment with a high dose of varenicline , a low dose of varenicline , or placebo . The varenicline doses in the high-body-weight group were 1 mg BID and 0.5 mg BID ; the varenicline doses in the low-body-weight group were 0.5 mg BID and 0.5 mg once daily . The apparent renal clearance ( CL/F ) and volume of distribution ( V/F ) of varenicline and the effect of body weight on these parameters were estimated using nonlinear mixed-effects modeling . RESULTS The high-body-weight group consisted of 35 subjects ( 65.7 % male ; 77.1 % white ; mean age , 15.2 years ) . The low-body-weight group consisted of 37 subjects ( 37.8 % male ; 48.6 % white ; mean age , 14.3 years ) . The pharmacokinetic parameters of varenicline were dose proportional over the dose range from 0.5 to 2 mg/d . The CL/F for a 70-kg adolescent was 10.4 L/h , comparable to that in a 70-kg adult . The estimated varenicline V/F was decreased in individuals of small body size , thus predicting a varenicline C(max ) approximately 30 % greater in low-body-weight subjects than in high-body-weight subjects . In high-body-weight subjects , steady-state varenicline exposure , as represented by the AUC(0 - 24 ) , was 197.0 ng . h/mL for varenicline 1 mg BID and 95.7 ng . h/mL for varenicline 0.5 mg BID , consistent with values reported previously in adult smokers at the equivalent doses . In low-body-weight subjects , varenicline exposure was 126.3 ng . h/mL for varenicline 0.5 mg BID and 60.1 ng . h/mL for varenicline 0.5 mg once daily , values at the lower end of the range observed previously in adults at doses of 1 mg BID and 0.5 mg BID , respectively . Among high-body-weight subjects , adverse events ( AEs ) were reported by 57.1 % of subjects in both the high- and low-dose varenicline groups and by 14.3 % of subjects in the placebo group ; among low-body-weight subjects , AEs were reported by 64.3 % , 73.3 % , and 12.5 % of subjects in the high-dose varenicline , low-dose varenicline , and placebo groups , respectively . The most common AEs were nausea , headache , vomiting , and dizziness . Psychiatric AEs that were considered treatment related included abnormal dreams in 2 subjects and mild , transient anger in 1 subject . Of the AEs reported by > or = 1 subject in any treatment group , > or = 92 % were mild in intensity . No subject discontinued the study because of an AE . CONCLUSIONS Varenicline steady-state exposure in study subjects weighing > 55 kg was similar to that observed previously in adults . The body-weight effect on varenicline pharmacokinetics , which result ed in higher exposure in individuals of smaller body size ( < or = 55 kg ) , was adequately offset by administration of half the varenicline dose recommended in adults . Varenicline was generally well tolerated during the 14-day treatment period . Clinical Trials Identification Number : NCT00463918 Background — Smoking cessation is a key component of secondary cardiovascular disease prevention . Varenicline , a partial & agr;4&bgr;2 nicotinic acetylcholine receptor agonist , is effective for smoking cessation in healthy smokers , but its efficacy and safety in smokers with cardiovascular disease are unknown . Methods and Results — A multicenter , r and omized , double-blind , placebo-controlled trial compared the efficacy and safety of varenicline with placebo for smoking cessation in 714 smokers with stable cardiovascular disease . Participants received varenicline ( 1 mg twice daily ) or placebo , along with smoking-cessation counseling , for 12 weeks . Follow-up lasted 52 weeks . The primary end point was carbon monoxide – confirmed continuous abstinence rate for weeks 9 through 12 ( last 4 weeks of treatment ) . The continuous abstinence rate was higher for varenicline than placebo during weeks 9 through 12 ( 47.0 % versus 13.9 % ; odds ratio , 6.11 ; 95 % confidence interval [ CI ] , 4.18 to 8.93 ) and weeks 9 through 52 ( 19.2 % versus 7.2 % ; odds ratio , 3.14 ; 95 % CI , 1.93 to 5.11 ) . The varenicline and placebo groups did not differ significantly in cardiovascular mortality ( 0.3 % versus 0.6 % ; difference , −0.3 % ; 95 % CI , −1.3 to 0.7 ) , all-cause mortality ( 0.6 % versus 1.4 % ; difference , −0.8 % ; 95 % CI , −2.3 to 0.6 ) , cardiovascular events ( 7.1 % versus 5.7 % ; difference , 1.4 % ; 95 % CI , −2.3 to 5.0 ) , or serious adverse events ( 6.5 % and 6.0 % ; difference , 0.5 % ; 95 % CI , −3.1 to 4.1 ) . As a result of adverse events , 9.6 % of varenicline and 4.3 % of placebo participants discontinued study drug . Conclusions — Varenicline is effective for smoking cessation in smokers with cardiovascular disease . It was well tolerated and did not increase cardiovascular events or mortality ; however , trial size and duration limit definitive conclusions about safety . Clinical Trial Registration Information— URL : http://www . clinical trials.gov/ct2/show/NCT00282984 . Unique identifier : NCT00282984 BACKGROUND Currently available smoking cessation therapies have limited success rates . Varenicline tartrate is a novel , selective nicotinic receptor partial agonist developed specifically for smoking cessation . This study evaluated the efficacy , tolerability , and safety of 3 varenicline doses for smoking cessation . Bupropion hydrochloride was included as an active control . METHODS A phase 2 , multicenter , r and omized , double-blind , placebo-controlled study of healthy smokers ( 18 - 65 years old ) . Subjects were r and omized to varenicline tartrate , 0.3 mg once daily ( n = 128 ) , 1.0 mg once daily ( n = 128 ) , or 1.0 mg twice daily ( n = 127 ) , for 6 weeks plus placebo for 1 week ; to 150-mg sustained-release bupropion hydrochloride twice daily ( n = 128 ) for 7 weeks ; or to placebo ( n = 127 ) for 7 weeks . RESULTS During the treatment phase , the continuous quit rates for any 4 weeks were significantly higher for varenicline tartrate , 1.0 mg twice daily ( 48.0 % ; P<.001 ) and 1.0 mg once daily ( 37.3 % ; P<.001 ) , than for placebo ( 17.1 % ) . The bupropion rate was 33.3 % ( P = .002 vs placebo ) . The carbon monoxide-confirmed continuous quit rates from week 4 to week 52 were significantly higher in the varenicline tartrate , 1.0 mg twice daily , group compared with the placebo group ( 14.4 % vs 4.9 % ; P = .002 ) . The bupropion rate was 6.3 % ( P = .60 vs placebo ) . Discontinuation owing to treatment-emergent adverse events was 15.9 % for bupropion , 11.2 % to 14.3 % for varenicline , and 9.8 % for placebo . No dose-related increases occurred in adverse events for varenicline . CONCLUSIONS Varenicline tartrate demonstrated both short-term ( 1 mg twice daily and 1 mg once daily ) and long-term efficacy ( 1 mg twice daily ) vs placebo . Varenicline was well tolerated and may provide a novel therapy to aid smoking cessation Objective : The objective of this double-blind , placebo-controlled , r and omized study was to evaluate the efficacy of varenicline ( Chantix ) , a partial agonist at α4β2 neuronal nicotinic acetylcholine receptors used for smoking cessation , in patients with spinocerebellar ataxia ( SCA ) 3 . Methods : Patients with genetically confirmed SCA3 were r and omly assigned to receive either varenicline ( 4 weeks for titration and 4 weeks at a dose of 1 mg twice daily ) or placebo . Outcome measures included changes in the Scale for the Rating and Assessment of Ataxia ( SARA ) scores at endpoint ( 8 weeks ) compared with baseline , a timed 25-foot walk and 9-hole peg test , measurements of mood and anxiety , and adverse events . Results : Twenty patients with SCA3 ( mean age = 51 ± 10.98 years ; mean disease duration = 14 ± 9.82 years ; mean SARA score = 16.13 ± 4.67 ) were enrolled in the study , and data on 18 patients were analyzed in period I. The most common side effect associated with varenicline was nausea . Improvements were noted in the SARA subsections for gait ( p = 0.04 ) , stance ( p = 0.03 ) , rapid alternating movements ( p = 0.003 ) , and timed 25-foot walk ( p = 0.05 ) and Beck Depression Inventory scores ( p = 0.03 ) in patients taking varenicline compared with those taking placebo at endpoint , with a trend toward improvement in the SARA total score ( p = 0.06 ) in the varenicline group . Conclusions : In this controlled study , varenicline significantly improved axial symptoms and rapid alternating movements in patients with SCA3 as measured by SARA subscores and was fairly well tolerated . Classification of evidence : This study provides Class II evidence that varenicline improved the axial functions of gait , stance , and timed 25-foot walk but did not improve appendicular function , except for rapid alternating movements , in adult patients with genetically confirmed SCA3 BACKGROUND The selective nicotinic acetylcholine receptor partial agonist , varenicline tartrate , represents a novel type of therapy for smoking cessation . This study evaluated the efficacy , safety , and tolerability of 4 varenicline dose regimens , 2 with progressive dos Output:
This meta- analysis found no evidence of an increased risk of suicide or attempted suicide , suicidal ideation , depression , or death with varenicline . These findings provide some reassurance for users and prescribers regarding the neuropsychiatric safety of varenicline . There was evidence that varenicline was associated with a higher risk of sleep problems such as insomnia and abnormal dreams .
MS2_1shot8
***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: This study prospect ively evaluated the clinical performance of computer-assisted design and computer-assisted manufacturing (CAD/CAM)-generated In-Ceram Alumina core crowns in Japanese patients for up to 5 years . A total of 101 In-Ceram crowns with aluminium copings fabricated using the GN-I system were placed in Japanese patients . The crowns were evaluated using a California Dental Association ( CDA ) quality assessment system at baseline and at all follow-up examinations . Gingival condition was assessed using plaque and bleeding scores . The survival of anterior and posterior crowns was analysed according to the Kaplan-Meier method . The scores of gingival condition were compared between restored crowns and contralateral teeth using a t-test . During the observation period , six crowns were lost to follow-up . Five crowns were fractured from the copings and removed , and four crowns were removed for other reasons . Chipping within the porcelain was detected in three crowns , which were then polished . The cumulative survival rates after 60 months were 96·9 % for anterior crowns and 87·7 % for posterior ones , and there were no significant differences between anterior and posterior crowns . According to the CDA criteria , most of the crowns were rated as satisfactory during the observation period . There were significant differences in soft tissue conditions between In-Ceram crowns and control teeth at 2- and 5-year examinations . Despite the five fractures from copings , In-Ceram Alumina crowns with copings fabricated using the CAD/CAM ( GN-I system ) for replacing both anterior and posterior teeth showed predictable results during a 5-year observation period Objectives The purpose of this prospect i ve study was to evaluate the clinical outcome of anterior and posterior crowns made of a lithium-disilicate glass – ceramic framework material ( IPS e.max Press , Ivoclar Vivadent ) . Material s and methods A total of 104 single crowns were placed in 41 patients ( mean age , 34 ± 9.6 years ; 15 male , 26 female ) . Eighty-two anterior and 22 posterior crowns were inserted . All teeth received a 1-mm-wide chamfer or rounded shoulder preparation with an occlusal/incisal reduction of 1.5–2.0 mm . The minimum framework thickness was 0.8 mm . Frameworks were laminated by a prototype of a veneering material combined with an experimental glaze . Considering the individual abutment preconditions , the examined crowns were either adhesively luted ( 69.2 % ) or inserted with glass – ionomer cement ( 30.8 % ) . Follow-up appointments were performed 6 months after insertion , then annually . Replacement of a restoration was defined as failure . Results Four patients ( 10 crowns ) were defined as dropouts . For the remaining 94 crowns , the mean observation time was 79.5 months ( range , 34–109.7 months ) . The cumulative survival rate according to Kaplan – Meier was 97.4 % after 5 years and 94.8 % after 8 years . Applying log rank test , it was shown that the location of the crown did not significantly have an impact on the survival rate ( p = 0.74 ) and that the cementation mode did not significantly influence the occurrence of complications ( p = 0.17 ) . Conclusions The application of lithium-disilicate framework material for single crowns seems to be a reliable treatment option . Clinical relevance Crowns made of a lithium-disilicate framework material can be used clinical ly in the anterior and posterior region irrespective of an adhesive or conventional cementation when considering abutment preconditions PURPOSE This study aim ed to prospect ively analyze the outcomes of 304 feldspathic porcelain veneers prepared by the same operator , in 100 patients , that were in situ for up to 16 years . MATERIAL S AND METHODS A total of 304 porcelain veneers on incisors , canines , and premolars in 100 patients completed by one prosthodontist between 1988 and 2003 were sequentially included . Preparations were design ed with chamfer margins , incisal reduction , and palatal overlap . At least 80 % of each preparation was in enamel . Feldspathic porcelain veneers from refractory dies were etched ( hydrofluoric acid ) , silanated , and cemented ( Vision 2 , Mirage Dental Systems ) . Outcomes were expressed as percentages ( success , survival , unknown , dead , repair , failure ) . The results were statistically analyzed using the chi-square test and Kaplan-Meier survival estimation . Statistical significance was set at P < .05 . RESULTS The cumulative survival for veneers was 96 % + /- 1 % at 5 to 6 years , 93 % + /- 2 % at 10 to 11 years , 91 % + /- 3 % at 12 to 13 years , and 73 % + /- 16 % at 15 to 16 years . The marked drop in survival between 13 and 16 years was the result of the death of 1 patient and the low number of veneers in that period . The cumulative survival was greater when different statistical methods were employed . Sixteen veneers in 14 patients failed . Failed veneers were associated with esthetics ( 31 % ) , mechanical complications ( 31 % ) , periodontal support ( 12.5 % ) , loss of retention > 2 ( 12.5 % ) , caries ( 6 % ) , and tooth fracture ( 6 % ) . Statistically significantly fewer veneers survived as the time in situ increased . CONCLUSIONS Feldspathic porcelain veneers , when bonded to enamel substrate , offer a predictable long-term restoration with a low failure rate . The statistical methods used to calculate the cumulative survival can markedly affect the apparent outcome and thus should be clearly defined in outcome studies The aim of this prospect i ve clinical study was to investigate the long-term survival of Procera AllCeram all-ceramic crowns in the anterior and posterior regions . Between 1997 and 2005 , 155 Procera crowns with aluminum oxide cores were placed in 50 patients . Patients were recalled in 2005 for a clinical assessment . Thirty-nine patients with 135 crowns attended the recall examination . Of the 135 total crowns , 103 were located in the posterior region and 32 were located in the anterior region . The cumulative survival rate was 100 % in the anterior region and 98.8 % in the posterior region ( 1 crown fracture ) after 5 and 7 years . Clinical success was achieved irrespective of the tooth position , cement used ( resin composite or glass-ionomer cement ) , or the core design with reduced or conventional margins . Procera AllCeram seems to be a predictable technique for esthetic all-ceramic single crown restorations in the anterior and posterior regions OBJECTIVE Ceramic inlays and onlays are a tooth colored alternative to metallic restorations . Clinical long-term data are scarce though , especially about inlays and onlays having proximal margins in dentin . The present prospect i ve controlled clinical study evaluated the clinical performance of IPS Empress inlays and onlays with cuspal replacements and proximal margins below the cementoenamel junction over eight years . METHODS Ninety six ceramic restorations were placed in 34 patients by six dentists . The restorations were bonded with an enamel/dentin bonding system ( Syntac Classic ) and four different resin composite systems . The restorations were assessed after placement by two calibrated investigators using modified USPHS codes and criteria at the following time periods : baseline , 1,2,4,6 and 8 years . RESULTS Eight of the 96 restorations investigated had to be replaced ( failure rate 8 % ; Kaplan-Meier ) : Six inlays suffered cohesive bulk fractures , two teeth required endodontic treatment . After eight years of clinical service , significant deterioration ( Friedman 2-way ANOVA ; P < 0.05 ) was found for marginal adaptation of the remaining restorations . 98 % of the surviving restorations exhibited marginal deficiencies , independent of the luting composite . CONCLUSIONS IPS Empress inlays and onlays demonstrated to be successful even in large defects . Neither the absence of enamel margins , nor cuspal replacement significantly affected the quality of the restorations Procera AllCeram crowns were prospect ively evaluated clinical ly in both anterior and posterior regions in Japanese . One-hundred and one crowns were fabricated for 57 patients at the Tsurumi University Dental Hospital from August 2001 to October 2002 and evaluated according to the California Dental Association ( CDA ) quality evaluation system at baseline and annually at all follow-up examinations for 5 years . The plaque index ( PI ) and gingival index ( GI ) were recorded , and chipping and fracture were checked at the same time as well . A total of 75 Procera AllCeram crowns were evaluated , and the cumulative survival rate was 90.2 % over the 5-year clinical trial . Six crowns experienced fractures within the veneering porcelain and from aluminium oxide coping , all of which occurred on the premolar and molar regions , and they had to be removed . Small chipping was observed on three crowns . According to the CDA criteria , 98 % of Procera AllCeram crowns were rated as satisfactory , and PI and GI were comparable to those of control teeth during the observation period PURPOSE The aim of this prospect i ve study was to evaluate the clinical efficacy and long-term survival rate of three-unit fixed partial dentures ( FPDs ) made from lithium disilicate-based core ceramic . MATERIAL S AND METHODS Twenty-one three-unit FPDs were placed in 19 patients to replace single lost teeth in the esthetic area , following a study protocol that took clinical , esthetic , and radiologic aspects into consideration . Each case was review ed at 1 week following placement , at 6 months , and then annually for 10 years . Statistical analysis was performed using Kaplan-Meier survival analysis . RESULTS Out of the 19 patients , 14.3 % presented reversible postoperative sensitivity . Recession was observed in 24 % of dental posts , and 7.1 % presented marginal discoloration . Treatment did not increase either Bleeding or Plaque Index scores at prepared teeth ; secondary caries did not appear either . The restorations ' survival rate at the 10-year follow-up was 71.4 % ; six FPDs had fractured and one debonded . CONCLUSIONS Fracture failure rate was 28.6 % after 10 years ; a high percentage corresponded to connector fractures and occurred during the first 5 years . Lithium disilicate glass-ceramic FPDs present a higher risk of fracture than st and ard therapies ( metal-ceramic ) or other more recently developed ceramic material s. The prognosis for survival improves for Class I occlusion and nonparafunctional patients The purpose of this prospect i ve cohort study was to assess the performance of tooth-supported , long-span , zirconia fixed dental prostheses ( FDPs ) . Thirty FDPs with span lengths from 36 to 46 mm ( mean 40·33 mm ) , with 4 - 7 units and with connector dimensions ∼9 mm(2 ) were inserted ( 19 in the posterior region , 11 including anterior teeth ) using glass-ionomer cement . The performance of the FDPs was assessed ( aesthetic evaluation , failures , hypersensitivity/tooth vitality , secondary caries , pocket depth , decementation , and chipping ) at baseline and after 5 years . Cox regression analysis was performed to identify risk factors . There were 16 failures after 5 years . Framework fracture occurred for two FDPs , four FDPs had to be re-cemented , one abutment tooth had to be treated endodontically , one abutment tooth fractured and cohesive failure of the veneer occurred for eight . Four FDPs had to be replaced , so survival was 82 % . The aesthetics were rated as excellent by the patients at baseline and good at the 5-year recall . Cox regression analysis showed that both length [ P = 0·05 , exp(B ) = 1·22 ] and location [ P = 0·019 , exp(B ) = 4·09 ] of the FDP were risk factors for failure . Compared with the previously published 2-year results , the incidence of complications increased dramatically . Additionally , it was shown that long-span FDPs in the molar region are at greater risk of failure than FDPs in the anterior region PURPOSE The aim of the present study was to clinical ly evaluate the effect of two different adhesive/resin composite combinations for luting IPS Empress inlays with a special focus on luting gap wear and marginal adaptation . MATERIAL S AND METHODS In the course of a controlled prospect i ve clinical split-mouth study , 94 IPS Empress restorations were placed in 31 patients . The inlays were luted with EBS Multi + Compolute ( EC ; 3 M ESPE ) or with Syntac + Variolink II low ( SV ; Ivoclar Vivadent ) . At baseline and after 0.5 , 1 , 2 , 4 , and 8 years , the ceramic restorations were examined according to modified USPHS codes and criteria . Thirty-five selected sample s were investigated under an SEM regarding morphological changes ; marginal quality analysis was carried out using a stereo light microscope , and luting composite wear was scanned with a profilometer . RESULTS Eight patients ( including 25 restorations ) missed the recalls ; the recall rate at the last investigation was 72 % . After 96 months of clinical service , seven restorations in five patients ( six Output:
Overall , the 5-year complication rates were low . The most frequent complications were secondary caries , endodontic problems , ceramic fractures , ceramic chipping , and loss of retention . CONCLUSION This systematic review showed that all-ceramic restorations fabricated using the correct clinical protocol have an adequate clinical survival for at least 5 years of clinical service with very low complication rates . Minor ceramic chipping and debonding did not affect the longevity of the restorations . CLINICAL RELEVANCE Long-term clinical performance of all-ceramic restorations manufactured using various ceramic systems provides clinical evidence of complications and long-term management of these restorations . Available evidence indicates the effectiveness of many ceramic systems for numerous clinical applications . Correct planning and a rigorous technical execution protocol increase clinical success . Studies of ceramic prostheses indicate more problems with ceramic failure and debonding
MS2_1shot9
***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 and Purpose — Several prognostic factors have been identified for outcome after stroke . However , there is a need for empirically derived models that can predict outcome and assist in medical management during rehabilitation . To be useful , these models should take into account early changes in recovery and individual patient characteristics . We present such a model and demonstrate its clinical utility . Methods — Data on functional recovery ( Barthel Index ) at 0 , 2 , 4 , 6 , and 12 months after stroke were collected prospect ively for 299 stroke patients at 2 London hospitals . Multilevel models were used to model recovery trajectories , allowing for day-to-day and between-patient variation . The predictive performance of the model was vali date d with an independent cohort of 710 stroke patients . Results — Urinary incontinence , sex , prestroke disability , and dysarthria affected the level of outcome after stroke ; age , dysphasia , and limb deficit also affected the rate of recovery . Applying this to the validation cohort , the average difference between predicted and observed Barthel Index was −0.4 , with 90 % limits of agreement from −7 to 6 . Predicted Barthel Index lay within 3 points of the observed Barthel Index on 49 % of occasions and improved to 69 % when patients ’ recovery histories were taken into account . Conclusions — The model predicts recovery at various stages of rehabilitation in ways that could improve clinical decision making . Predictions can be altered in light of observed recovery . This model is a potentially useful tool for comparing individual patients with average recovery trajectories . Patients at elevated risk could be identified and interventions initiated Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items Although visual neglect is a predictor of poor outcome after stroke , some patients regain independence , whilst others take up considerable rehabilitation re sources . Intensive treatment of visual neglect is available and a knowledge of the predictive features in the recovery of these patients would be helpful in the early selection of patients for treatment . A study was therefore carried out to determine the prognosis of patients presenting with visual neglect at two to three days after stroke . Linear logistic regression showed that the initial degree of paralysis ( measured by the Motricity Index ) , the severity of neglect ( measured by the Visual Neglect Recovery Index ) and the patient 's age were the significant predictors of independence ( Barthel score 20 ) , mild dependence ( Barthel 15 - 19 ) , and moderate/severe dependence ( Barthel 0 - 14 ) in surviving patients at three months and at six months . Regression equations correctly predicted 78 % of outcomes , and had a sensitivity and specificity for " independence " of 84 % and 90 % respectively , and a sensitivity and specificity for " moderate/severe dependence " of 89 % and 80 % . It is suggested that these equations may be useful in selecting comparable groups of patients for r and omised controlled trials of treatment of visual neglect A cohort study tracks two or more groups forward from exposure to outcome . This type of study can be done by going ahead in time from the present ( prospect i ve cohort study ) or , alternatively , by going back in time to comprise the cohorts and following them up to the present ( retrospective cohort study ) . A cohort study is the best way to identify incidence and natural history of a disease , and can be used to examine multiple outcomes after a single exposure . However , this type of study is less useful for examination of rare events or those that take a long time to develop . A cohort study should provide specific definitions of exposures and outcomes : determination of both should be as objective as possible . The control group ( unexposed ) should be similar in all important respects to the exposed , with the exception of not having the exposure . Observational studies , however , rarely achieve such a degree of similarity , so investigators need to measure and control for confounding factors . Reduction of loss to follow-up over time is a challenge , since differential losses to follow-up introduce bias . Variations on the cohort theme include the before-after study and nested case-control study ( within a cohort study ) . Strengths of a cohort study include the ability to calculate incidence rates , relative risks , and 95 % CIs . This format is the preferred way of presenting study results , rather that with p values Background and Purpose — Prediction models for ischemic stroke outcome have the potential to contribute prognostic information in the clinical and /or research setting . The importance of diffusion-weighted magnetic resonance imaging ( DWI ) in the prediction of clinical outcome , however , is unclear . The purpose of this study was to combine acute clinical data and DWI lesion volume for ischemic stroke patients to determine whether DWI improves the prediction of clinical outcome . Methods — Patients ( N=382 ) with baseline DWI data from the Glycine Antagonist In Neuroprotection and citicoline ( 010 and 018 ) trials were used to develop the prediction models by multivariable logistic regression . Data from prospect ively collected patients ( N=266 ) from the Acute Stroke Accurate Prediction Study were used to externally vali date the model equations . The models predicted either full recovery or nursing home – level disability/death , as defined by the National Institutes of Health Stroke Scale , Barthel Index , or modified Rankin Scale . Results — The full-recovery models with DWI lesion volume had areas under the receiver operating characteristic curves ( AUCs ) of 0.799 to 0.821 , and those without DWI lesion volume had AUCs of 0.758 to 0.798 . The nursing home – level disability/death models with DWI had AUCs of 0.832 to 0.882 , and those without DWI Output:
Because of insufficient method ological quality of most prognostic studies , the predictive value of many clinical determinants for outcome of ADL remains unclear .
MS2_1shot10
***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: Visceral leishmaniasis ( VL ) is a deadly vector-borne disease that causes an estimated 500 000 new cases a year . In India , Nepal and Bangladesh , VL is caused by Leishmania donovani , which is transmitted from man to man by the s and fly Phlebotomus argentipes . In 2005 , these three countries signed a memor and um of underst and ing to eliminate VL from the region . Integrated vector management is one of the pillars of this elimination strategy , alongside early case detection and treatment . We review ed the evidence of effectiveness of different vector control methods , to examine the potential role of insecticide treated bednets ( ITNs ) . Indoor residual spraying has shown poor impact for various reasons and resistance to DDT is emerging in Bihar . Environmental management performed poorly compared to insecticide based methods . ITNs could give individual protection but this still needs to be proven in r and omized trials . Given the constraints of indoor residual spraying , it is worthwhile to further explore the use of ITNs , in particular long lasting ITNs , as an additional tool in the VL elimination initiative INTRODUCTION American cutaneous leishmaniasis is endemic in Colombia , where approximately 6.000 new cases are reported every year . Current prevention and control measures are restricted to the diagnosis and treatment of cases . OBJECTIVE To evaluate the efficacy of a multifaceted intervention to prevent the transmission of Leishmania in the endemic focus of Tumaco , on the Pacific Coast of Colombia . MATERIAL S AND METHODS A group-r and omized trial was conducted . Twenty villages were matched according to prevalence of Leishmania infection , number of inhabitants and level of community participation , and then r and omly assigned to intervention or control . The intervention included deltamethrin-impregnated bednets , repellent ( 20 % diethyltoluamide and 0.5 % permethrin ) , modification of s and fly resting sites , and health education . Villages were under surveillance for one year and the use of the intervention measures monitored . The incidence of American cutaneous leishmaniasis and Leishmania infection in the two groups were compared , adherence to the intervention and adverse events were monitored , and the results were adjusted for village intraclass correlation . RESULTS Ten cases of American cutaneous leishmaniasis were confirmed in the intervention and 23 in the control group , OR = 0.42 , 95 % CI 0.14 - 1.26 . The intervention had a greater effect in children < 10 years old , in people living on the periphery of the village and in villages with a prevalence of infection in small children > 1 % . Adverse events associated with the use of the bednets and the repellent were reported in 2 % of the participants and were always mild . CONCLUSION Incident cases of American cutaneous leishmaniasis were reduced by 58 % in the intervention group . However , the small number of cases renders the effect estimate imprecise and precludes us to cl aim a protective effect for the intervention . Specific population s could be the targets of simpler and more cost-effective interventions in the future A large-scale intervention field trial of the effect of Olyset long-lasting insecticide-treated bednets on transmission of cutaneous leishmaniasis was carried out in 2 cities in the Islamic Republic of Iran from October 2003 to July 2005 . We enrolled 8620 individuals in 3000 households in 6 pairs of sectors in each city . Epidemiological and entomological surveys were carried out pre- and post-intervention . In both cities a statistically significant reduction was found in the incidence of new cases in intervention sectors who received bednets compared with control areas . Entomological surveys showed a reduction in numbers of female Phlebotomus sergenti captured indoors in intervention sectors Objective To test the effectiveness of large scale distribution of longlasting nets treated with insecticide in reducing the incidence of visceral leishmaniasis in India and Nepal . Design Paired cluster r and omised controlled trial design ed to detect a 50 % reduction in incidence of Leishmania donovani infection . Setting Villages in Muzaffarpur district in India and Saptari , Sunsari , and Morang districts in Nepal . Participants 13 intervention and 13 control clusters . 12 691 people were included in the analysis of the main outcome ( infection ) , and 19 810 were enrolled for the secondary ( disease ) end point . Intervention Longlasting insecticidal nets ( treated with deltamethrin ) were distributed in the intervention clusters in December 2006 . Main outcome measures Infection was determined by direct agglutination test at 12 and 24 months after the intervention in those who had negative results ( titre < 1:1600 ) at baseline . The effect estimate was computed as the geometric mean of the risk ratios for seroconversion for each cluster pair ( net/no net ) , with its 95 % confidence interval . Formal tests of effect of no intervention were obtained with a paired t test . Results There was no significant difference in the risk of seroconversion over 24 months in intervention ( 5.4 % ; 347/6372 ) compared with control ( 5.5 % ; 345/6319 people ) clusters ( risk ratio 0.90 , 95 % confidence interval 0.49 to 1.65 ) nor in the risk of clinical visceral leishmaniasis ( 0.99 , 0.46 to 1.40 ) . Adjustment for covariates did not alter these conclusions . Conclusions There is no evidence that large scale distribution of longlasting insecticidal nets provides additional protection against visceral leishmaniasis compared with existing control practice in the Indian subcontinent . The observed effect was small and not significant , though the confidence intervals did not exclude a 50 % change in either direction . Trial registration Clinical Trials NCT 2005 - 015374 Abstract Objective : To measure the impact on transmission of leishmaniasis of curtains impregnated with insecticide . Design : Cluster r and omised controlled trial : household interview survey , observational study of people 's behaviour , entomological study with light trap captures of s and flies inside houses . Setting : 14 urban sectors in Trujillo , Venezuela . Participants : 2913 inhabitants of 569houses . Intervention : Sectors were paired according to their 12month cumulative incidence of cutaneous leishmaniasis , one sector in each pair was r and omly allocated to receive polyester curtains impregnated with lambdacyhalothrin ( intervention group ) while the other sector received curtains without insecticide or no curtains ( control groups ) . After 12 months a follow up household survey was conducted . Main outcome measures : Reduction in abundance of s and flies indoors and 12 month incidence of clinical cases of cutaneous leishmaniasis . Results : Transmission of cutaneous leishmaniasis occurred mainly in the domestic setting , with the incidence over 12 months of 4 % . The mean number of s and flies per trap per night was 16.After follow up the 12 month incidence of cutaneous leishmaniasis was 0 % in the intervention group and 8 % in the six pairs in the control group that received unimpregnated curtains ( mean difference 8 , 95 % confidence interval 4.22 to 11.78 ; P=0.001 ) . There were significantly fewer s and flies in the intervention group ( 2 v 15,mean difference 13 s and flies per trap ; 9 to 17 ; P<0.001 ) . Conclusion : Curtains impregnated with insecticide provide a high degree of protection against indoor transmission of cutaneous leishmaniasis Background Bangladesh , India and Nepal are working towards the elimination of visceral leishmaniasis ( VL ) by 2015 . In 2005 the World Health Organization/Training in Tropical Diseases launched an implementation research programme to support integrated vector management for the elimination of VL from Bangladesh , India and Nepal . The programme is conducted in different phases , from proof-of-concept to scaling up intervention . This study was design ed in order to evaluate the efficacy of the three different interventions for VL vector management : indoor residual spraying ( IRS ) ; long-lasting insecticide treated nets ( LLIN ) ; and environmental modification ( EVM ) through plastering of walls with lime or mud . Methods Using a cluster r and omized controlled trial we compared three vector control interventions with a control arm in 96 clusters ( hamlets or neighbourhoods ) in each of the 4 study sites : Bangladesh ( one ) , India ( one ) and Nepal ( two ) . In each site four villages with high reported VL incidences were included . In each village six clusters and in each cluster five households were r and omly selected for s and fly collection on two consecutive nights . Control and intervention clusters were matched with average pre-intervention vector densities . In each site six clusters were r and omly assigned to each of the following interventions : indoor residual spraying ( IRS ) ; long-lasting insecticide treated nets ( LLIN ) ; environmental management ( EVM ) or control . All the houses ( 50 - 100 ) in each intervention cluster underwent the intervention measures . A reduction of intra-domestic s and fly densities measured in the study households by overnight US Centres for Disease Prevention and Control light trap captures ( that is the number of s and flies per trap per night ) was the main outcome measure . Results IRS , and to a lesser extent EVM and LLINs , significantly reduced s and fly densities for at least 5 months in the study households irrespective of type of walls or whether or not people shared their house with cattle . IRS was effective in all sites but LLINs were only effective in Bangladesh and India . Mud plastering did not reduce s and fly density ( Bangladesh study ) ; lime plastering in India and one Nepali site , result ed in a significant reduction of s and fly density but not in the second Nepali site . ConclusionS and fly control can contribute to the regional VL elimination programme ; IRS should be strengthened in India and Nepal but in Bangladesh , where vector control has largely been ab and oned during the last decades , the insecticide treatment of existing bed nets ( coverage above 90 % in VL endemic districts ) could bring about an immediate reduction of vector population s ; operational research to inform policy makers about the efficacious options for VL vector control and programme performance should be strengthened in the three countries The efficacy of insecticide-treated window curtains ( ITCs ) for dengue vector control was evaluated in Thail and in a cluster-r and omized controlled trial . A total of 2,037 houses in 26 clusters was r and omized to receive the intervention or act as control ( no treatment ) . Entomological surveys measured Aedes infestations ( Breteau index , house index , container index , and pupae per person index ) and oviposition indices ( mean numbers of eggs laid in oviposition traps ) immediately before and after intervention , and at 3-month intervals over 12 months . There were no consistent statistically significant differences in entomological indices between intervention and control clusters , although oviposition indices were lower ( P < 0.01 ) in ITC clusters during the wet season . It is possible that the open housing structures in the study reduced the likelihood of mosquitoes making contact with ITCs . ITCs deployed in a region where this house design is common may be unsuitable for dengue vector control Abstract Objectives To measure the impact on the dengue vector population ( Aedes aegypti ) and disease transmission of window curtains and water container covers treated with insecticide . Design Cluster r and omised controlled trial based on entomological surveys and , for Trujillo only , serological survey . In addition , each site had a non-r and omised external control . Setting 18 urban sectors in Veracruz ( Mexico ) and 18 in Trujillo ( Venezuela ) . Participants 4743 inhabitants ( 1095 houses ) in Veracruz and 5306 inhabitants ( 1122 houses ) in Trujillo . Intervention Sectors were paired according to entomological indices , and one sector in each pair was r and omly allocated to receive treatment . In Veracruz , the intervention comprised curtains treated with lambdacyhalothrin and water treatment with pyriproxyfen chips ( an insect growth regulator ) . In Trujillo , the intervention comprised curtains treated with longlasting deltamethrin ( PermaNet ) plus water jar covers of the same material . Follow-up surveys were conducted at intervals , with the final survey after 12 months in Veracruz and nine months in Trujillo . Main outcome measures Reduction in entomological indices , specifically the Breteau and house indices . Results In both study sites , indices at the end of the trial were significantly lower than those at baseline , though with no significant differences between control and intervention arms . The mean Breteau index dropped from 60 % ( intervention clusters ) and 113 % ( control ) to 7 % ( intervention ) and 12 % ( control ) in Veracruz and from 38 % to 11 % ( intervention ) and from 34 % to 17 % ( control ) in Trujillo . The pupae per person and container indices showed similar patterns . In contrast , in nearby communities not in the trial the entomological indices followed the rainfall pattern . The intervention reduced mosquito population s in neighbouring control clusters ( spill-over effect ) ; and houses closer to treated houses were less likely to have infestations than those further away . This created a community effect whereby mosquito numbers were reduced throughout the study site . The observed effects were probably associated with the use of material s treated with insecticide at both sites because in Veracruz , people did not accept and use the pyriproxyfen chips . Conclusion Window curtains and domestic water container covers treated with insecticide can reduce densities of dengue vectors to low levels and potentially affect dengue transmission Background Visceral leishmaniasis ( VL ) control in the Indian subcontinent is currently based on case detection and treatment , and on vector control using indoor residual spraying ( IRS ) . The use of long-lasting insecticidal Output:
There are likely to be considerable collateral benefits of ITN roll out on cutaneous leishmaniasis where this disease is co-endemic with malaria . Nonetheless , it is clear that insecticide-treated material s such as ITNs have the potential to reduce pathogen transmission and morbidity from VBDs where vectors enter houses
MS2_1shot11
***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 small , non-blinded , RCT ( r and omised controlled trial ) had reported that oral antibiotics reduced the incidence of mastitis in lactating women with Staphylococcus aureus ( S. aureus)- colonized cracked nipples . We aim ed to replicate the study with a more rigorous design and adequate sample size . Methods Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic ( flucloxacillin ) could prevent mastitis in lactating women with S. aureus-colonized cracked nipples . We planned to recruit two groups of 133 women with S. aureus-colonized cracked nipples . Results We spent over twelve months su bmi tting applications to five hospital ethics committees and seven funding bodies , before commencing the trial . Recruitment to the trial was very slow and only ten women were r and omized to the trial after twelve months , and therefore the trial was stopped early . Conclusions In retrospect we should have conducted a feasibility study , which would have revealed the low number of women in these Melbourne hospitals ( maternity wards and breastfeeding clinics ) with damaged nipples . The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested Trial design A r and omised , parallel group , pragmatic trial . Setting A large UK maternity hospital . Participants Term infants < 2 weeks old with a mild or moderate degree of tongue-tie , and their mothers who were having difficulties breastfeeding . Objectives To determine if immediate frenotomy was better than st and ard breastfeeding support . Interventions Participants were r and omised to an early frenotomy intervention group or a ‘ st and ard care ’ comparison group . Outcomes Primary outcome was breastfeeding at 5 days , with secondary outcomes of breastfeeding self-efficacy and pain on feeding . Final assessment was at 8 weeks ; 20 also had qualitative interviews . Research ers assessing outcomes , but not participants , were blinded to group assignment . Results 107 infants were r and omised , 55 to the intervention group and 52 to the comparison group . Five-day outcome measures were available for 53 ( 96 % ) of the intervention group and 52 ( 100 % ) of the comparison group , and intention-to-treat analysis showed no difference in the primary outcome —Latch , Audible swallowing , nipple Type , Comfort , Hold score . Frenotomy did improve the tongue-tie and increased maternal breastfeeding self-efficacy . At 5 days , there was a 15.5 % increase in bottle feeding in the comparison group compared with a 7.5 % increase in the intervention group . After the 5-day clinic , 44 of the comparison group had requested a frenotomy ; by 8 weeks only 6 ( 12 % ) were breastfeeding without a frenotomy . At 8 weeks , there were no differences between groups in the breastfeeding measures or in the infant weight . No adverse events were observed . Conclusions Early frenotomy did not result in an objective improvement in breastfeeding but was associated with improved self-efficacy . The majority in the comparison arm opted for the intervention after 5 days BACKGROUND : Ankyloglossia has been associated with a variety of infant-feeding problems . Frenotomy commonly is performed for relief of ankyloglossia , but there has been a lack of convincing data to support this practice . OBJECTIVES : Our primary objective was to determine whether frenotomy for infants with ankyloglossia improved maternal nipple pain and ability to breastfeed . A secondary objective was to determine whether frenotomy improved the length of breastfeeding . METHODS : Over a 12-month period , neonates who had difficulty breastfeeding and significant ankyloglossia were enrolled in this r and omized , single-blinded , controlled trial and assigned to either a frenotomy ( 30 infants ) or a sham procedure ( 28 infants ) . Breastfeeding was assessed by a preintervention and postintervention nipple-pain scale and the Infant Breastfeeding Assessment Tool . The same tools were used at the 2-week follow-up and regularly scheduled follow-ups over a 1-year period . The infants in the sham group were given a frenotomy before or at the 2-week follow-up if it was desired . RESULTS : Both groups demonstrated statistically significantly decreased pain scores after the intervention . The frenotomy group improved significantly more than the sham group ( P < .001 ) . Breastfeeding scores significantly improved in the frenotomy group ( P = .029 ) without a significant change in the control group . All but 1 parent in the sham group elected to have the procedure performed when their infant reached 2 weeks of age , which prevented additional comparisons between the 2 groups . CONCLUSIONS : We demonstrated immediate improvement in nipple-pain and breastfeeding scores , despite a placebo effect on nipple pain . This should provide convincing evidence for those seeking a frenotomy for infants with signficant ankyloglossia BACKGROUND The negative outcomes associated with painful and damaged nipples have been widely documented in the breastfeeding literature . Numerous studies have been conducted evaluating topical preparations to treat nipple pain and damage with equivocal findings . No studies have evaluated the effectiveness of the increasingly popular all- purpose nipple ointment ( APNO ) . The purpose of this trial is to evaluate the effect of the APNO versus lanolin on nipple pain among breastfeeding women with damaged nipples . SUBJECTS AND METHODS A double-blind , r and omized controlled trial was conducted in a large single-site , tertiary-care hospital in Toronto , ON , Canada . Breastfeeding women ( n=151 ) identified as having damage to one or both nipples were r and omized to apply either APNO ( intervention group ) or lanolin ( control group ) to their nipples according to the trial protocol . The primary outcome was nipple pain at 1 week after r and omization measured using the Short Form McGill Pain Question naire . Additional outcomes at 1 week after r and omization and 12 weeks postpartum included nipple yeast symptoms and /or mastitis , rates of breastfeeding duration and exclusivity , and maternal satisfaction with infant feeding method and treatment ointment . RESULTS There were no significant group differences in mean pain scores at 1 week after r and omization . Women in the lanolin group reported significantly greater satisfaction with their infant feeding method and had nonsignificantly higher breastfeeding duration and exclusivity rates at 12 weeks postpartum . CONCLUSION Results suggest that APNO is not superior to lanolin in treating painful , damaged nipples Painful and /or damaged nipples associated with breastfeeding are common and represent a challenge for both the persons experiencing nipple pain and /or trauma and for those providing treatment . However , evidence -based data has been insufficient to demonstrably minimize these common reasons for failure to initiate or continue successful breastfeeding . The aim of this study was to evaluate the efficacy of specific- grade highly purified anhydrous ( HPA ) lanolin versus expressed breastmilk ( EBM ) for the treatment of painful and damaged nipples associated with breastfeeding in a prospect i ve controlled clinical trial evaluating 84 lactating mothers . Nipple trauma and healing rates were rated by the Nipple Trauma Score . Nipple pain intensity was assessed on a visual analog scale . Outcome parameters were in favor of the HPA lanolin group , reaching statistical significance for healing rates , nipple trauma and nipple pain . In our study , we found HPA lanolin more effective than EBM , inducing faster healing of nipple trauma ( absolute risk reduction of 0.43 ) and reducing nipple pain ( absolute risk reduction of 0.61 on day 3 ) . We concluded that HPA lanolin , combined with breastfeeding education , was more effective than EBM , combined with breastfeeding education , in reducing nipple pain and promoting healing of nipple trauma Pre- and perinatal variables commonly found to predict breast-feeding duration were examined to see whether they also predicted breast-feeding problems in the first week postpartum . One hundred and twenty-eight families who prenatally committed to breast-feeding for at least 6 weeks comprised the sample . The families were r and omly assigned to one of two groups : a group in which bottle feedings would be avoided in Weeks 2–6 postpartum and a group in which approximately one bottle per day would be given during the same period . Breastfeeding events most commonly experienced as problems in previous studies were also reported by mothers in this sample . Multiple regression analyses revealed that bottle use in the hospital , lower satisfaction with first breastfeeding , and group assignment were weakly predictive of the Breast-feeding Problem Score at 1 week , R2 = .154 , p = .0004 . The negative effect of hospital bottle use was greater for women in the bottle-restricted group than for women in the planned-bottle group The research undertaken in this study utilized a case-control group nested within a prospect i ve cohort which was followed for the first 3 months postpartum . Mothers with mastitis and their controls were requested to complete a self-report question naire design ed to investigate the association between the potential risk factors , identified from the literature , and lactation mastitis . Logistic regression analyses of the possible risk factors were performed separately for mothers who had not breastfed Obviously and those mothers who had breastfed at least one infant prior to this lactation/nalysis showed blocked duct(s ) and increased levels of stress were the significant pre icors for mastitis in mothers who had breastfed a previous infant and blocked duct(s ) , restriction from a tight bra , attachment difficulties , and nipple pain during a feed were the significant predictors for mastitis in first time breastfeeding mothers AIM This study investigated if a maternally reported , immediate improvement in breastfeeding following division of tongue-tie is due to a placebo effect . METHODS This r and omized controlled trial was conducted at Southampton General Hospital , Southampton , UK , in 2003 - 2004 . Sixty breastfed babies 5 - 115 days old ( mean , 32 days ; median , 23 days ) were r and omized to division ( Group A ) or non-division ( Group B ) . The mother and a trained observer were blinded and assessed breastfeeding before the intervention . Fifty-seven babies were analyzed because blinding failed in three of the babies in Group A. Following the intervention , the mother 's and observer 's views were noted , and then those infants allocated to non-division had their tongue-tie divided . RESULTS Seventy-eight percent ( 21 of 27 ) of mothers in Group A reported an immediate improvement in feeding following the intervention , compared with 47 % ( 14 of 30 ) in Group B ( two-tailed χ(2 ) p<0.02 ; 95 % confidence interval , 6 - 51 % ) . At 1-day follow-up , 90 % ( 54 of 60 ) reported improved feeding following division . At 3-month follow-up , 92 % ( 54 of 59 ) still reported improved feeding , with 51 % ( 30 of 59 ) continuing to breastfeed . CONCLUSIONS There is a real , immediate improvement in breastfeeding , detectable by the mother , which is sustained and does not appear to be due to a placebo effect BACKGROUND Sore nipples are common during lactation and remain the major reason for failing to establish successful breastfeeding . To formulate a peppermint gel and to evaluate its effect on the prevention of nipple crack associated with breast-feeding , a r and omized double-blinded clinical trial comparing the above formulation with modified lanolin and a neutral ointment was carried out . MATERIAL / METHODS Two hundred and sixteen primiparous participants were assigned r and omly to three groups . Each group applied only one of the above three preparations on both breasts for 14 days . Each group consisted of 72 primiparous mothers and was seen for a maximum of four follow-up visits within 14 days and a final visit at week 6 . The rate of nipple and areola crack and pain was evaluated . RESULTS The study groups were comparable in mean age and route of delivery . Nipple crack were less in mothers who received peppermint gel than in those who received lanolin ointment or placebo ( chi(2)=16.8 , df=6 , P=0.01 ) . Relative risk of nipple crack in the lanolin group ( RR : 2.41 , 95%CI : 1.20 - 3.01 ) was higher than in the peppermint group ( RR : 1.85 , 95%CI : 1.64 - 3.10 ) . CONCLUSIONS Prophylactic peppermint gel in breastfeeding lactating women is associated with fewer nipple cracks and is more effective than lanolin and placebo . It could be recommended for preventing of nipple crack along with teaching better breastfeeding technique at the initiation of breastfeeding PURPOSE Ankyloglossia ( " tongue-tie " ) occurs in nearly 5 % of neonates , but its clinical significance relating to breast-feeding difficulties is controversial . We tested the hypothesis that in infants with ankyloglossia referred because of breast-feeding difficulties , frenotomy alleviates the symptoms . METHODS Twenty-five mothers of healthy infants with ankyloglossia were recruited because of sore nipples . Infants were r and omized to either of 2 sequences : ( 1 ) frenotomy , breast-feeding , sham , breast-feeding ( n = 14 ) or ( 2 ) sham , breast-feeding , frenotomy , breast-feeding ( n = 11 ) . The mothers as well as all personnel taking care of the child after each sham or frenotomy procedure were masked as to the study sequence . In every sequence , and after each sham or frenotomy procedure , a st and ardized latch score and pain score were obtained from the mother Output:
We did not pool data for other outcomes due to either heterogeneity in outcome measures or differing interventions .There was no evidence that glycerine gel dressings or breast shells with lanolin significantly improved nipple pain . However , this beneficial effect was not maintained after six to seven days of treatment . There were no group differences in nipple pain perceptions at any assessment between women who applied expressed breast milk and women who applied nothing . Women who applied an " all- purpose nipple ointment " , in comparison to women who applied lanolin , had no improvement in nipple pain after seven days of treatment . There was insufficient evidence that glycerine gel dressings , lanolin with breast shells , lanolin alone , expressed breast milk , or all- purpose nipple ointment improved maternal perceptions of nipple pain . Overall , there was insufficient evidence to recommend any intervention for the treatment of nipple pain . However , one important finding was that regardless of the treatment used , for most women nipple pain reduced to mild levels after approximately seven to 10 days ' postpartum . The provision of anticipatory guidance regarding usual time to pain reduction may be a useful strategy in assisting women to continue to breastfeed and to do so exclusively . There was insufficient evidence that glycerine gel dressings , breast shells with lanolin , lanolin alone , or the all- purpose nipple ointment significantly improved maternal perceptions of nipple pain . The results from these four trials of good method ological quality suggested that applying nothing or just expressed breast milk may be equally or more beneficial in the short-term experience of nipple pain than the application of an ointment such as lanolin .
MS2_1shot12
***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 This r and omized , open-label phase II study compared the efficacy of sunitinib monotherapy with that of single-agent st and ard-of-care ( SOC ) chemotherapy in patients with previously treated advanced triple-negative breast cancer ( TNBC ) . METHODS Patients with advanced TNBC , relapsed after anthracycline- and taxane-based chemotherapy , were r and omized to receive either sunitinib ( 37.5 mg/day ) or the investigator 's choice of SOC therapy . Progression-free survival was the primary endpoint . RESULTS Median progression-free survival was 2.0 months with sunitinib and 2.7 months with SOC chemotherapy ( one-sided P = 0.888 ) . Median overall survival was not prolonged with sunitinib ( 9.4 months ) compared with SOC chemotherapy ( 10.5 months ; one-sided P = 0.839 ) . The objective response rate was 3 % with sunitinib and 7 % with SOC chemotherapy ( one-sided P = 0.962 ) . CONCLUSIONS Sunitinib monotherapy did not improve efficacy compared with SOC chemotherapy in patients with previously treated advanced TNBC , for which identification of effective treatments and therapeutic targets remains an urgent need . TRIAL REGISTRATION NCT00246571 BACKGROUND Bevacizumab and the antimetabolites capecitabine and gemcitabine have been shown to improve outcomes when added to taxanes in patients with metastatic breast cancer . The primary aims of this trial were to determine whether the addition of capecitabine or gemcitabine to neoadjuvant chemotherapy with docetaxel , followed by doxorubicin plus cyclophosphamide , would increase the rates of pathological complete response in the breast in women with operable , human epidermal growth factor receptor 2 (HER2)-negative breast cancer and whether adding bevacizumab to these chemotherapy regimens would increase the rates of pathological complete response . METHODS We r and omly assigned 1206 patients to receive neoadjuvant therapy consisting of docetaxel ( 100 mg per square meter of body-surface area on day 1 ) , docetaxel ( 75 mg per square meter on day 1 ) plus capecitabine ( 825 mg per square meter twice a day on days 1 to 14 ) , or docetaxel ( 75 mg per square meter on day 1 ) plus gemcitabine ( 1000 mg per square meter on days 1 and 8) for four cycles , with all regimens followed by treatment with doxorubicin-cyclophosphamide for four cycles . Patients were also r and omly assigned to receive or not to receive bevacizumab ( 15 mg per kilogram of body weight ) for the first six cycles of chemotherapy . RESULTS The addition of capecitabine or gemcitabine to docetaxel therapy , as compared with docetaxel therapy alone , did not significantly increase the rate of pathological complete response ( 29.7 % and 31.8 % , respectively , vs. 32.7 % ; P=0.69 ) . Both capecitabine and gemcitabine were associated with increased toxic effects -- specifically , the h and -foot syndrome , mucositis , and neutropenia . The addition of bevacizumab significantly increased the rate of pathological complete response ( 28.2 % without bevacizumab vs. 34.5 % with bevacizumab , P=0.02 ) . The effect of bevacizumab on the rate of pathological complete response was not the same in the hormone-receptor-positive and hormone-receptor-negative subgroups . The addition of bevacizumab increased the rates of hypertension , left ventricular systolic dysfunction , the h and -foot syndrome , and mucositis . CONCLUSIONS The addition of bevacizumab to neoadjuvant chemotherapy significantly increased the rate of pathological complete response , which was the primary end point of this study . ( Funded by the National Cancer Institute and others ; Clinical Trials.gov number , NCT00408408 . ) BACKGROUND The addition of bevacizumab to chemotherapy improves progression-free survival in metastatic breast cancer and pathological complete response rates in the neoadjuvant setting . Micrometastases are dependent on angiogenesis , suggesting that patients might benefit from anti-angiogenic strategies in the adjuvant setting . We therefore assessed the addition of bevacizumab to chemotherapy in the adjuvant setting for women with triple-negative breast cancer . METHODS For this open-label , r and omised phase 3 trial we recruited patients with central ly confirmed triple-negative operable primary invasive breast cancer from 360 sites in 37 countries . We r and omly allocated patients aged 18 years or older ( 1:1 with block r and omisation ; stratified by nodal status , chemotherapy [ with an anthracycline , taxane , or both ] , hormone receptor status [ negative vs low ] , and type of surgery ) to receive a minimum of four cycles of chemotherapy either alone or with bevacizumab ( equivalent of 5 mg/kg every week for 1 year ) . The primary endpoint was invasive disease-free survival ( IDFS ) . Efficacy analyses were based on the intention-to-treat population , safety analyses were done on all patients who received at least one dose of study drug , and plasma biomarker analyses were done on all treated patients consenting to biomarker analyses and providing a measurable baseline plasma sample . This trial is registered with Clinical Trials.gov , number NCT00528567 . FINDINGS Between Dec 3 , 2007 , and March 8 , 2010 , we r and omly assigned 1290 patients to receive chemotherapy alone and 1301 to receive bevacizumab plus chemotherapy . Most patients received anthracycline-containing therapy ; 1638 ( 63 % ) of the 2591 patients had node-negative disease . At the time of analysis of IDFS , median follow-up was 31·5 months ( IQR 25·6 - 36·8 ) in the chemotherapy-alone group and 32·0 months ( 27·5 - 36·9 ) in the bevacizumab group . At the time of the primary analysis , IDFS events had been reported in 205 patients ( 16 % ) in the chemotherapy-alone group and in 188 patients ( 14 % ) in the bevacizumab group ( hazard ratio [ HR ] in stratified log-rank analysis 0·87 , 95 % CI 0·72 - 1·07 ; p=0·18 ) . 3-year IDFS was 82·7 % ( 95 % CI 80·5 - 85·0 ) with chemotherapy alone and 83·7 % ( 81·4 - 86·0 ) with bevacizumab and chemotherapy . After 200 deaths , no difference in overall survival was noted between the groups ( HR 0·84 , 95 % CI 0·64 - 1·12 ; p=0·23 ) . Exploratory biomarker assessment suggests that patients with high pre-treatment plasma VEGFR-2 might benefit from the addition of bevacizumab ( Cox interaction test p=0·029 ) . Use of bevacizumab versus chemotherapy alone was associated with increased incidences of grade 3 or worse hypertension ( 154 patients [ 12 % ] vs eight patients [ 1 % ] ) , severe cardiac events occurring at any point during the 18-month safety reporting period ( 19 [ 1 % ] vs two [ < 0·5 % ] ) , and treatment discontinuation ( bevacizumab , chemotherapy , or both ; 256 [ 20 % ] vs 30 [ 2 % ] ) ; we recorded no increase in fatal adverse events with bevacizumab ( four [ < 0·5 % ] vs three [ < 0·5 % ] ) . INTERPRETATION Bevacizumab can not be recommended as adjuvant treatment in unselected patients with triple-negative breast cancer . Further follow-up is needed to assess the potential effect of bevacizumab on overall survival 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 consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists INTRODUCTION A multicenter , open-label phase III study was conducted to test whether sunitinib plus paclitaxel prolongs progression-free survival ( PFS ) compared with bevacizumab plus paclitaxel as first-line treatment for patients with HER2(- ) advanced breast cancer . PATIENTS AND METHODS Patients with HER2(- ) advanced breast cancer who were disease free for ≥ 12 months after adjuvant taxane treatment were r and omized ( 1:1 ; planned enrollment 740 patients ) to receive intravenous ( I.V. ) paclitaxel 90 mg/m(2 ) every week for 3 weeks in 4-week cycles plus either sunitinib 25 to 37.5 mg every day or bevacizumab 10 mg/kg I.V. every 2 weeks . [ corrected ] RESULTS The trial was terminated early because of futility in reaching the primary endpoint as determined by the independent data monitoring committee during an interim futility analysis . At data cutoff , 242 patients had been r and omized to sunitinib-paclitaxel and 243 patients to bevacizumab-paclitaxel . Median PFS was shorter with sunitinib-paclitaxel ( 7.4 vs. 9.2 months ; hazard ratio [ HR ] 1.63 [ 95 % confidence interval ( CI ) , 1.18 - 2.25 ] ; 1-sided P = .999 ) . At a median follow-up of 8.1 months , with 79 % of sunitinib-paclitaxel and 87 % of bevacizumab-paclitaxel patients alive , overall survival analysis favored bevacizumab-paclitaxel ( HR 1.82 [ 95 % CI , 1.16 - 2.86 ] ; 1-sided P = .996 ) . The objective response rate was 32 % in both arms , but median duration of response was shorter with sunitinib-paclitaxel ( 6.3 vs. 14.8 months ) . Bevacizumab-paclitaxel was better tolerated than sunitinib-paclitaxel . This was primarily due to a high frequency of grade 3/4 , treatment-related neutropenia with sunitinib-paclitaxel ( 52 % ) precluding delivery of the prescribed doses of both drugs . CONCLUSION The sunitinib-paclitaxel regimen evaluated in this study was clinical ly inferior to the bevacizumab-paclitaxel regimen and is not a recommended treatment option for patients with advanced breast cancer In February 2008 , the U.S. Food and Drug Administration ( FDA ) granted accelerated approval to bevacizumab ( Avastin ) in combination with paclitaxel as first-line treatment for HER-2 negative metastatic breast cancer . Approval was based on the results of E2100 , a cooperative-group r and omized trial that showed a 5.5-month increase in progression-free survival associated with the addition of bevacizumab to paclitaxel therapy.1,2 Confirmatory studies by Genentech , the manufacturer , however , showed that bevacizumab 's benefits for progression-free survival may be appreciably smaller than those shown in E2100 and have demonstrated convincingly that the addition of bevacizumab to the chemotherapy agents they have tested offers no . . PURPOSE The AVAGAST study showed that adding bevacizumab to chemotherapy in patients with advanced gastric cancer improves progression-free survival and tumor response rate but not overall survival . To examine the hypothesis that angiogenic markers may have predictive value for bevacizumab efficacy in gastric cancer , AVAGAST included a prospect i ve , m and atory biomarker program . PATIENTS AND METHODS Patients with previously untreated , locally advanced or metastatic gastric cancer were r and omly assigned to bevacizumab ( n = 387 ) or placebo ( n = 387 ) in combination with chemotherapy . Blood and tumor tissue sample s were collected at baseline . Prespecified biomarkers included plasma vascular endothelial growth factor-A ( VEGF-A ) , protein expression of neuropilin-1 , and VEGF recept Output:
VEGF-A level is a reasonable c and i date biomarker for bevacizumab in the treatment of breast cancer .
MS2_1shot13
***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 investigated the role of aluminized metal foil ( space blanket , UN 320 ) , used pre-emptively , in post-anaesthetic shivering and patients ' subjective perception of cold after general anaesthesia of short duration . Sixty-eight ASA I and II patients undergoing orthopaedic and plastic surgery on the peripheries were allocated r and omly to two groups : those in group 1 were wrapped ( not less than 60 % of body surface area ) in the space blanket before induction of anaesthesia . In group 2 patients had st and ard surgical draping . In all subjects , anaesthesia was induced with fentanyl and propofol , and maintained with nitrous oxide and enflurane in oxygen , after a laryngeal mask airway was positioned . Patients were asked to grade their perception of cold on a visual analogue scale , before induction and on recovery . Skin ( dorsum of h and ) and core ( nasopharyngeal ) temperatures were recorded at 15-min intervals . Occurrence of shivering and cold scores were recorded by blinded observers . Groups were similar in age and gender ; duration of anaesthesia was also similar ( mean 41.6 ( SEM 4.8 ) vs 47.5 ( 3.3 ) min , respectively ) . The incidences of shivering were 15 % and 63 % in groups 1 and 2 , respectively ( P < 0.001 ) . Cold scores were 2.4 ( 0.4 ) and 5.7 ( 0.5 ) , respectively ( P < 0.001 ) . Skin temperatures increased with increasing duration of anaesthesia in both groups but were greater at 15 , 30 and 45 min in group 1 ( 33.38 ( 0.25 ) vs 31.56 ( 0.31 ) , 34.46 ( 0.25 ) vs 32.45 ( 0.31 ) and 35.22 ( 0.36 ) vs 33.13 ( 0.34 ) , respectively ; P < 0.001 each comparison ) . Core temperature increased slightly in group 1 and decreased in group 2 ( P = 0.11 ) . ( ABSTRACT TRUNCATED AT 250 WORDS Background Keeping abdominal surgery patients warm is common and warming methods are needed in power outages during natural disasters . We aim ed to evaluate the efficacy of low-cost , low-power warming methods for maintaining normothermia in abdominal surgery patients . Methods Patients ( n = 160 ) scheduled for elective abdominal surgery were included in this prospect i ve clinical study . Five warming methods were applied : heated blood transfusion/fluid infusion vs. unheated ; wrapping patients vs. not wrapping ; applying moist dressings , heated or not ; surgical field rinse heated or not ; and applying heating blankets or not . Patients ’ nasopharyngeal and rectal temperatures were recorded to evaluate warming efficacy . Significant differences were found in mean temperatures of warmed patients compared to those not warmed . Results When we compared temperatures of abdominal surgery patient groups receiving three specific warming methods with temperatures of control groups not receiving these methods , significant differences were revealed in temperatures maintained during the surgeries between the warmed groups and controls . Discussion The value of maintaining normothermia in patients undergoing abdominal surgery under general anesthesia is accepted . Three effective economical and practically applicable warming methods are combined body wrapping and heating blanket ; combined body wrapping , heated moist dressings , and heating blanket ; combined body wrapping , heated moist dressings , and warmed surgical rinse fluid , with or without heating blanket . These methods are practically applicable when low-cost method is indeed needed BACKGROUND Mild perioperative hypothermia , which is common during major surgery , may promote surgical-wound infection by triggering thermoregulatory vasoconstriction , which decreases subcutaneous oxygen tension . Reduced levels of oxygen in tissue impair oxidative killing by neutrophils and decrease the strength of the healing wound by reducing the deposition of collagen . Hypothermia also directly impairs immune function . We tested the hypothesis that hypothermia both increases susceptibility to surgical-wound infection and lengthens hospitalization . METHODS Two hundred patients undergoing colorectal surgery were r and omly assigned to routine intraoperative thermal care ( the hypothermia group ) or additional warming ( the normothermia group ) . The patient 's anesthetic care was st and ardized , and they were all given cefam and ole and metronidazole . In a double-blind protocol , their wounds were evaluated daily until discharge from the hospital and in the clinic after two weeks ; wounds containing culture-positive pus were considered infected . The patients ' surgeons remained unaware of the patients ' group assignments . RESULTS The mean ( + /- SD ) final intraoperative core temperature was 34.7 + /- 0.6 degrees C in the hypothermia group and 36.6 + /- 0.5 degrees C in the normothermia group ( P < 0.001 ) Surgical-wound infections were found in 18 of 96 patients assigned to hypothermia ( 19 percent ) but in only 6 of 104 patients assigned to normothermia ( 6 percent , P = 0.009 ) . The sutures were removed one day later in the patients assigned to hypothermia than in those assigned to normothermia ( P = 0.002 ) , and the duration of hospitalization was prolonged by 2.6 days ( approximately 20 percent ) in hypothermia group ( P = 0.01 ) . CONCLUSIONS Hypothermia itself may delay healing and predispose patients to wound infections . Maintaining normothermia intraoperatively is likely to decrease the incidence of infectious complications in patients undergoing colorectal resection and to shorten their hospitalizations Changes in mean body temperature and muscle protein metabolism were studied in elderly patients undergoing large bowel surgery . Two groups were studied : in one , efforts were made to maintain the patients normothermic during and after surgery by warming the fresh gases , the i.v . fluids , by placing warmed cotton padding around the exposed parts of the body and by covering the patients with a metallized plastic sheet in the recovery period . The other group received routine management . Otherwise the anaesthetic technique was comparable . The excretion of the amino acid 3-methylhistidine ( 3-MeH ) , an indicator of muscle protein breakdown , and urea nitrogen loss were measured in the urine collected the day before , and on the 2nd and 4th postoperative days . Prevention of heat loss during and after surgery caused a significant decrease in muscle protein degradation and nitrogen loss UNLABELLED Perioperative hypothermia poses a challenge because of its deleterious effects on patient recovery . The current practice of applying two cotton blankets on patients during surgery is thought to be less ideal than using reflective insulation or forced-air warming . We studied 300 patients who underwent unilateral total knee replacement and were r and omized equally to three groups : ( a ) the two-cotton-blanket group , ( b ) the one-reflective-blanket with one-cotton-blanket group , and ( c ) the forced-air-warming with one-cotton-blanket group . Tympanic temperature readings were taken before surgery in the induction room , on arrival at the recovery room , and at 10-min intervals until discharge from the recovery room . On arrival at the recovery room , the forced-air-warming group had significantly higher temperatures ( adjusted for sex , age , and patient 's induction room temperature ) of 0.577 degrees C + /- 0.079 degrees C ( 95 % confidence interval [ CI ] , 0.427 - 0.726 ; P < 0.001 ) and 0.510 degrees C + /- 0.08 degrees C ( 95 % CI , 0.349 - 0.672 ; P < 0.001 ) more than the reflective-blanket and two-cot-ton-blanket groups , respectively . The forced-air-warming group took a significantly ( P < 0.001 ) shorter time of 18.75 min ( 95 % CI , 13.88 - 23.62 ) to achieve a temperature of 36.5 degrees C in the recovery room as compared with 41.78 min ( 95 % CI , 36.86 - 46.58 ) and 36.43 min ( 95 % CI , 31.23 - 41.62 ) for the reflective-blanket and two-cotton-blanket groups , respectively . The reflective technology was less effective than using two cotton blankets , and the forced-air warming was most efficient in maintaining perioperative normothermia . IMPLICATION S Perioperative hypothermia has deleterious effects on patient recovery . We found in patients having knee surgery that reflective technology was less effective than using two cotton blankets , whereas active surface warming with the forced-air method was most effective in maintaining normothermia Mild intraoperative hypothermia is common . We therefore studied the effects of mild hypothermia on propofol pharmacokinetics , hepatic blood flow , and atracurium duration of action in healthy volunteers . Six young volunteers were studied on two r and omly assigned days , at either 34 degrees C or 37 degrees C. Anesthesia was induced with thiopental , 3 mg/kg , and maintained with 70 % N2 O and 0.6 % isoflurane . Core hypothermia was induced by conductive and convective cooling . On the other study day , normothermia was maintained by a Bair Hugger Registered Trademark ( Augustine Medical , Inc. , Eden Prairie , MN ) forced-air warmer . Propofol , 1 mg/kg lean body mass ( LBM ) , then was given , followed by a 4-h infusion at 5 mg centered dot kg-1 centered dot h-1 . After 2 h , atracurium 0.5 mg/kg was administered as an intravenous bolus . Indocyanine green was administered for estimation of hepatic blood flow . Arterial blood was assayed for propofol and indocyanine green concentration . Pharmacokinetic analysis was performed using NONMEM . Results are reported as means + /- SEM . Propofol blood concentrations averaged approximate equals 28 % more at 34 degrees C than at 37 degrees C ( P < 0.05 ) . Hepatic blood flow decreased 23 % + /- 11 % in normothermic volunteers during the propofol infusion , and 33 % + /- 11 % in hypothermic volunteers ( P = not significant ) . A three-compartment mamillary model fitted the data best . Inclusion of hepatic blood flow change from the prepropofol baseline as a covariate for total body clearance significantly improved the fit . The intercompartmental clearances were decreased in the presence of hypothermia . Core hypothermia prolonged the time to recovery of the first twitch in the train-of-four to 10 % of its control value ( T1 = 10 % ) after atracurium administration by approximate equals 60 % ( P < 0.05 ) , from 44 + /- 4 min to 68 + /- 7 min . In contrast , T1 = 25%-75 % remained unchanged . We conclude that 3 degrees C of core hypothermia increased propofol blood concentrations and prolonged atracurium duration of action . Hepatic blood flow was decreased during propofol administration , and this change was a significant predictor of propofol clearance , indicating that the effect of propofol on hepatic blood flow impairs the clearance of propofol itself . ( Anesth Analg 1995;80:1007 - 14 Background and objective Unintentional hypothermia of a patient is a common adverse effect during surgical procedures . Many strategies can be used to reduce heat loss . The aim of this prospect i ve , r and omised , controlled study was to determine whether the use of the thermal suit ( T-Balance ) could prevent surgical patients from experiencing thermal loss better than conventional measures . Methods We examined a group of consecutive patients undergoing transurethral resection of the prostate under spinal anaesthesia . Forty patients were r and omised to receive the special textile clothing , thermal suit ( group 1 ) or the conventional clothing ( group 2 , control ) . Heated blankets and a forced-air warming device ( Bair-Hugger ) were used when any patient felt cold or body temperature decreased below 35 ° C . Body temperatures were measured via mouth using an infrared thermometer and recorded at given points ( T1–T10 ) during the procedure . Results The mean temperatures were higher ( about 0.5 ° C ) in group 1 than in group 2 at the entrance to the recovery room ( P = 0.03 ) . The mean maximal decrease in temperature was 0.56 ° C in group 1 and 1.31 ° C in group 2 ( P = 0.000 between groups ) . One patient in group 1 and seven patients in group 2 needed warming with a Bair-Hugger , and 15 out of 20 patients in group 2 needed extra blankets during surgery or recovery . Conclusion The use of the thermal suit is a good alternative to conventional measures of warming in reducing heat loss during surgical procedure under regional anaesthesia Hypothermia is one of the common complications in the perioperative period . Currently , normothermia is maintained with forced air warming ( FAW ) or passive heat retention methods . We compared the efficacy of the Mediwrap blanket with FAW in maintaining normothermia during intra-operative period in thoracic surgery in a prospect i ve r and omised controlled trial on 30 patients . Core temperature was measured at 30-min intervals in Output:
There were no clear effects on bleeding , shivering or length of stay in post-anaesthetic care for either comparison . No other adverse effects were reported . There is no clear benefit of extra thermal insulation compared with st and ard care . Forced air warming does seem to maintain core temperature better than extra thermal insulation , by between 0.5 ºC and 1 ºC , but the clinical importance of this difference is unclear
MS2_1shot14
***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 To determine the protective effects of memantine on cognitive function in patients receiving whole-brain radiotherapy ( WBRT ) . METHODS Adult patients with brain metastases received WBRT and were r and omized to receive placebo or memantine ( 20 mg/d ) , within 3 days of initiating radiotherapy for 24 weeks . Serial st and ardized tests of cognitive function were performed . RESULTS Of 554 patients who were accrued , 508 were eligible . Grade 3 or 4 toxicities and study compliance were similar in the 2 arms . There was less decline in delayed recall in the memantine arm at 24 weeks ( P = .059 ) , but the difference was not statistically significant , possibly because there were only 149 analyzable patients at 24 weeks , result ing in only 35 % statistical power . The memantine arm had significantly longer time to cognitive decline ( hazard ratio 0.78 , 95 % confidence interval 0.62 - 0.99 , P = .01 ) ; the probability of cognitive function failure at 24 weeks was 53.8 % in the memantine arm and 64.9 % in the placebo arm . Superior results were seen in the memantine arm for executive function at 8 ( P = .008 ) and 16 weeks ( P = .0041 ) and for processing speed ( P = .0137 ) and delayed recognition ( P = .0149 ) at 24 weeks . CONCLUSIONS Memantine was well tolerated and had a toxicity profile very similar to placebo . Although there was less decline in the primary endpoint of delayed recall at 24 weeks , this lacked statistical significance possibly due to significant patient loss . Overall , patients treated with memantine had better cognitive function over time ; specifically , memantine delayed time to cognitive decline and reduced the rate of decline in memory , executive function , and processing speed in patients receiving WBRT . RTOG 0614 , Clinical Trials.gov number CT00566852 Output:
None of the RCTs with altered WBRT dose-fractionation schemes as compared to st and ard ( 3000 cGy in 10 daily fractions or 2000 cGy in 4 or 5 daily fractions ) found a benefit in terms of overall survival , neurologic function , or symptom control . Radiosurgery boost with WBRT may improve local disease control in selected participants as compared to WBRT alone , although survival remains unchanged for participants with multiple brain metastases . The addition of WBRT to radiosurgery improves local and distant brain control but there is no difference in overall survival . It may be that supportive care alone , without WBRT , is appropriate for some participants , particularly those with advanced disease and poor performance status
MS2_1shot15
***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 clinical and experimental data indicate that volatile anaesthetics may precondition myocardium against ischaemia and infa rct ion . The present clinical trial was design ed to verify the cardioprotective effects of desflurane in patients undergoing elective coronary artery bypass surgery . It was hypothesized that desflurane preconditioning would decrease postoperative release of troponin I and brain natriuretic peptide ( NT-proBNP ) . Besides , we have hypothesized that desflurane preconditioning would preserve the myocardium from the dysfunction following cardioplegic arrest . METHODS Twenty-eight patients were r and omly divided into two groups : Control group ( 14 patients ) and Desflurane group ( 14 patients ) . In Desflurane group ( DS ) patients , preconditioning was elicited after the onset of cardiopulmonary bypass via a 5-min exposure to desflurane ( 2.5 minimum alveolar concentration ) , followed by a 10-min washout before aortic cross-clamping and cardioplegic arrest . The control group ( C ) patients underwent an equivalent period ( 15 min ) of pre-arrest desflurane-free bypass . Haemodynamic measurements were obtained at six different times . The biochemistry markers of cellular damage and myocardial dysfunction ( troponin I , NT-proBNP ) were determined . Left ventricular ( LV ) function was assessed using tissue Doppler imaging ( TDI ) of mitral annulus . Two-factor repeated- measures analysis of variance was used to evaluate differences over time between groups for all parameters determined in plasma sample s and for all TDI-derived variables . RESULTS After surgery , both the troponin I values ( 2.04+/-1.09 ng/ml vs 1.44+/-0.77 ng/ml , p<0.01 after 24h and 1.62+/-0.96 ng/ml vs 1.00+/-0.24 ng/ml , p<0.01 after 72 h respectively ) and those of the NT-proBNP ( 2187+/-282.9 ng/l vs 885.4+/-117.35 ng/l , p<0.01 after 24h and 3097.9+/-226.2 vs 1393.6+/-312.07 ng/l , p<0.01 after 72 h respectively ) were less in the desflurane-treated patients . The values of TDI of mitral annulus were constantly better in desflurane-treated patients . CONCLUSIONS We can conclude that the use of desflurane in these patients provides a pharmacological preconditioning so as to reduce myocardial necrosis and improve the cardiac performance in the postoperative period Background The present study investigated the effects of propofol , desflurane , and sevoflurane on recovery of myocardial function in high-risk coronary surgery patients . High-risk patients were defined as those older than 70 yr with three-vessel disease and an ejection fraction less than 50 % with impaired length-dependent regulation of myocardial function . Methods Coronary surgery patients ( n = 45 ) were r and omly assigned to receive either target-controlled infusion of propofol or inhalational anesthesia with desflurane or sevoflurane . Cardiac function was assessed perioperatively and during 24 h postoperatively using a Swan-Ganz catheter . Perioperatively , a high-fidelity pressure catheter was positioned in the left and right atrium and ventricle . Response to increased cardiac load , obtained by leg elevation , was assessed before and after cardiopulmonary bypass ( CPB ) . Effects on contraction were evaluated by analysis of changes in dP/dtmax . Effects on relaxation were assessed by analysis of the load-dependence of myocardial relaxation . Postoperative levels of cardiac troponin I were followed for 36 h. Results After CPB , cardiac index and dP/dtmax were significantly lower in patients under propofol anesthesia . Post-CPB , leg elevation result ed in a significantly greater decrease in dP/dtmax in the propofol group , whereas the responses in the desflurane and sevoflurane groups were comparable with the responses before CPB . After CPB , load dependence of left ventricular pressure drop was significantly higher in the propofol group than in the desflurane and sevoflurane group . Troponin I levels were significantly higher in the propofol group . Conclusions Sevoflurane and desflurane but not propofol preserved left ventricular function after CPB in high-risk coronary surgery patients with less evidence of myocardial damage postoperatively Background : Two preconditioning stimuli should induce a more consistent overall cell protection . We hypothesized that remote ischemic preconditioning ( RIPC , second preconditioning stimulus ) applied during isoflurane inhalation ( first preconditioning stimulus ) would provide more protection to the myocardium of patients undergoing on-pump coronary artery bypass grafting . Methods : In this placebo-controlled r and omized controlled study , patients in the RIPC group received four 5-min cycles of 300 mmHg cuff inflation/deflation of the leg before aortic cross-clamping . Anesthesia consisted of opioids and propofol for induction and isoflurane for maintenance . The primary outcome was high-sensitivity cardiac troponin T release . Secondary endpoints were plasma levels of N-terminal pro-brain natriuretic peptide , high-sensitivity C-reactive protein , S100 protein , and short- and long-term clinical outcomes . Gene expression profiles were obtained from atrial tissue using microarrays . Results : RIPC ( n = 27 ) did not reduce high-sensitivity cardiac troponin T release when compared with placebo ( n = 28 ) . Likewise , N-terminal pro-brain natriuretic peptide , a marker of myocardial dysfunction ; high-sensitivity C-reactive protein , a marker of perioperative inflammatory response ; and S100 , a marker of cerebral injury , were not different between the groups . The incidence for the perioperative composite endpoint combining new arrhythmias and myocardial infa rct ions was higher in the RIPC group than the placebo group ( 14/27 vs. 6/28 , P = 0.036 ) . However , there was no difference in the 6-month cardiovascular outcome . N-terminal pro-brain natriuretic peptide release correlated with isoflurane-induced transcriptional changes in fatty-acid metabolism ( P = 0.001 ) and DNA-damage signaling ( P < 0.001 ) , but not with RIPC-induced changes in gene expression . Conclusions : RIPC applied during isoflurane inhalation provides no benefit to the myocardium of patients undergoing on-pump coronary artery bypass grafting OBJECTIVE The purpose of this study was to evaluate the effects of volatile anesthesia versus total intravenous anesthesia on cardiac troponin release in off-pump coronary artery bypass grafting ( OPCAB ) . DESIGN The authors performed a multicenter r and omized controlled study to compare cardiac troponin release in patients receiving either volatile anesthetics or total intravenous anesthesia for cardiac surgery on the beating heart , which is an excellent model of human myocardial ischemia . SETTING Three university hospitals . PARTICIPANTS The authors r and omly assigned 57 patients to desflurane ( volatile anesthetic ) and 55 patients to propofol ( intravenous anesthetic ) in addition to an opiate-based anesthesia for OPCAB . INTERVENTIONS The 2 groups of patients received either desflurane ( volatile anesthetic ) or propofol in addition to an opiate-based anesthesia for OPCAB . Peak postoperative troponin I release was measured as a marker of myocardial necrosis . Prolonged hospitalization was considered as a secondary outcome . MEASUREMENTS AND MAIN RESULTS Patient mean age was 69 years , and 82 % were men . There was a significant ( p < 0.001 ) reduction in postoperative median ( 25th-75th percentiles ) peak of troponin I in patients receiving volatile anesthetics , 1.2 ( 0.9 - 1.9 ) ng/dL , compared with patients receiving total intravenous anesthesia , 2.7 ( 2.1 - 4.0 ) ng/dL. This myocardial protection result ed in a reduced ( p = 0.04 ) number ( percentage ) of patients requiring postoperative inotropes , 20 ( 35 % ) versus 31 ( 56 % ) , and a reduced number ( percentage ) of patients su bmi tted to prolonged hospitalization ( > or = 7 days ) , 7 ( 12 % ) versus 20 ( 36 % ) in the 2 groups ( p = 0.005 ) . One patient receiving total intravenous anesthesia died within 30 days of surgery . CONCLUSIONS Myocardial damage measured by cardiac troponin release could be reduced by volatile anesthetics during OPCAB . Because patients underwent cardiac surgery on the beating heart , these results could have implication s for cardiac patients undergoing noncardiac surgery Background The value of postoperative cardiac troponin I ( cTnI ) has been shown to indicate a higher risk of in-hospital death after cardiac surgery . The authors therefore assessed the long-term prognostic value of cTnI in patients undergoing elective coronary artery bypass grafting . Methods Consecutive patients ( n = 202 ) were included and divided into two groups according to the postoperative value of cTnI ( < or ≥ 13 ng/ml ) . In-hospital mortality and nonfatal cardiac events ( delayed extubation > 24 h ; postoperative requirement of inotropic agent ; ventricular and supraventricular arrhythmia ; postoperative myocardial infa rct ion ) were recorded . Survivors were then followed up over a 2-yr period . Data are median and odds ratio ( 95 % confidence interval ) . Results Of all patients , 174 ( 86 % ) had a low cTnI ( 4.1 ng/ml ; range , 1.1–12.6 ) and 28 ( 14 % ) had a high cTnI ( 23.8 ng/ml ; range , 13.4–174.6 ) . In-hospital mortality was not significantly different ( 4 vs. 2 % ) , whereas long-term mortality ( 18 vs. 3 % , P = 0.006 ) and mortality from cardiac cause ( 18 vs. 1 % , P < 0.001 ) was greater in patients with a high cTnI. A high cTnI was a significant factor predicting death ( odds ratio , 7.3 [ 2.0–27.1 ] ) or death from cardiac causes ( odds ratio , 37.4 [ 4.2–334.4 ] ) . Nonfatal cardiac events were also more frequent in the hospital ( 64 vs. 41 % , P = 0.02 ) and within the 2-yr follow-up period ( 39%vs . 16 % , P = 0.03 ) in patients with high cTnI. Conclusion A high postoperative peak of cTnI is associated with increased risk of death , death from cardiac causes , and nonfatal cardiac events within 2 yr after coronary artery bypass grafting BACKGROUND Activation of the kinase cascade ( protein kinase C ( PKC ) , tyrosine kinase ( TK ) , and mitogen-activated protein kinase ( MAPK ) is a key feature of the transduction pathway , elicited by preconditioning signals and mediating their cardioprotective effects . We assessed whether such an activation occurred during cardiac operations and could thus represent a target for cardioprotective strategies . METHODS A total of 20 patients undergoing coronary artery bypass grafting surgery were studied . During the first 10 minutes of cardiopulmonary bypass ( CPB ) , 10 were treated with sevoflurane ( 2.5 minimum alveolar concentration ) , an inhalational anesthetic that mimics preconditioning through a similar activation of the kinase cascade . Ten case-matched patients undergoing 10 minutes of sevoflurane-free CPB served as controls . Right atrial biopsies were taken before and 10 minutes after CPB and were then processed for the measurement of PKC , TK , and p38 MAPK activities by enzyme assay techniques . Troponin I was also monitored over the first 2 postoperative days . RESULTS Compared with pre-CPB values , PKC and p38 MAPK activities ( in nanomoles per milligram of protein per minute and arbitrary units , respectively ) increased significantly and to the same extent in both groups : PKC , from 20.7+/-0.7 to 29.9+/-3.9 in controls ( p = 0.037 ) and from 18.4+/-1.1 to 23.9+/-1.8 in sevoflurane ( p = 0.016 ) ; p38 MAPK , from 88.6+/-8.5 to 312.9+/-66.2 in controls ( p = 0.005 ) and from 114.6+/-14.7 to 213.4+/-51.8 in sevoflurane ( p = 0.045 ) . Conversely , sevoflurane triggered Output:
This is not yet the case for off-pump surgery
MS2_1shot16
***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 Prophylaxis for venous thromboembolism is routinely performed for all patients undergoing bariatric surgery . However , there is disagreement regarding the optimal dosing and duration of anticoagulant therapy . Furthermore , there is little data regarding the incidence of asymptomatic deep venous thrombosis ( DVT ) in this population . Our objective was to conduct a pilot r and omized double blind study to evaluate the pharmacodynamic parameters of 2 different anticoagulation medications ( enoxaparin and fondaparinux ) administered to patients undergoing bariatric surgery . METHODS From July 2010 to August 2013 , 198 consecutive bariatric surgery patients from an academic institution were r and omized in a double blinded manner to receive either 40 mg enoxaparin twice daily or 5 mg fondaparinux sodium once daily . Antifactor Xa activity was measured on all patients in both study arms , 3 hours after the first dose ( on the day of the operation ) , immediately before the second dose ( postoperative day one ) , and 3 hours after the second dose . At the routine 2 week postoperative visit , patients underwent magnetic resonance venography ( MRV ) to detect DVT . The primary outcome was attainment of therapeutic antifactor Xa levels . The secondary outcome was DVT , as detected by MRV . Safety outcomes were perioperative bleeding , perioperative complications , and death . RESULTS Of 198 patients r and omized , 177 underwent MRV and 137 had interpretable antifactor Xa levels . Nearly half of the patients ( 47.4 % ) did not attain target prophylactic antifactor Xa levels . Adequate antifactor Xa levels were more common with fondaparinux ( 74.2 % ) than with enoxaparin ( 32.4 % ) . Antifactor Xa levels were also associated with preoperative D-dimer level . 4 of the 175 patients who underwent MRV developed DVT , 2 in each arm of the study . No major adverse events occurred in either arm . CONCLUSION Fondaparinux was much more likely to produce target prophylactic antifactor Xa levels than enoxaparin . Both regimens appear to be equally effective at reducing the risk of DVT . Further prospect i ve studies are needed to determine the optimal DVT prophylaxis regimen in the bariatric surgical population Background The incidence of venous thromboembolism ( VTE ) after bariatric surgery is uncertain . Methods Using the re sources of the Rochester Epidemiology Project and the Mayo Bariatric Surgery Registry , we identified all residents of Olmsted County , Minnesota , with incident VTE after undergoing bariatric surgery from 1987 through 2005 . Using the date s of bariatric surgery and VTE events , we determined the cumulative incidence of VTE after bariatric surgery by using the Kaplan – Meier estimator . Cox proportional hazards modeling was used to assess patient age , sex , weight , and body mass index as potential predictors of VTE after bariatric surgery . Results We identified 396 residents who underwent 402 bariatric operations . The most common operation was an open Roux-en-Y gastric bypass ( n = 228 ) . Eight patients had VTE that developed within 6 months ( 7 within 1 month ) after surgery ; five events occurred after hospital discharge but within 1 month after bariatric surgery . The cumulative incidence of VTE at 7 , 30 , 90 , and 180 days was 0.3 , 1.9 , 2.1 , and 2.1 % , respectively ( 180-day 95 % confidence interval ( CI ) , 0.7–3.6 % ) . Patient age was a predictor of postoperative VTE ( hazard ratio , 1.89 per 10-year increase in age ; 95 % CI , 1.01–3.55 ; P = 0.05 ) . Conclusions In our population -based study , bariatric surgery had a high risk of VTE , especially for older patients . Because most VTE events occurred after hospital discharge , a r and omized controlled trial of extended outpatient thromboprophylaxis is warranted in patients undergoing open Roux-en-Y gastric bypass for medically complicated obesity Background Obese patients have a higher risk of venous thromboembolism when immobilized due to surgery . The objective of this study was to assess anti-factor Xa activity in adolescent bariatric surgical patients receiving prophylactic enoxaparin . Methods Four morbidly obese adolescents undergoing laparoscopic sleeve gastrectomy were enrolled . Enoxaparin was administered ( 40 mg subcutaneous ( SC ) if BMI ≤50 kg/m2 or 60 mg SC if BMI > 50 kg/m2 ) for prevention of venous thromboembolism every 12 h starting after induction of anesthesia until discharge . Plasma anti-factor Xa activity was assessed over 12 h after the first dose and used as a surrogate marker for enoxaparin levels . Non-compartmental analysis of anti-factor Xa activity levels was performed and compared with previously published studies . Results Patients recruited were 16 to 18 years of age with a mean BMI of 52.6 ± 5.8 kg/m2 ( > 99th BMI percentile ) . Peak anti-factor Xa activity ranged from 0.20 to 0.23 IU/mL in our study population , compared to 0.38 to 0.53 IU/mL in the cited lean comparator groups . Conclusions Our current dosing practice of 40 mg SC for individuals with a BMI ≤50 kg/m2 and 60 mg for individuals with a BMI ≥50 kg/m2 result ed in anti-factor Xa activity that was sufficient for adequate thromboprophylaxis in adolescent bariatric surgical patients . Our data also demonstrates lower drug exposures in the obese when compared to lean patients . Therefore , r and omized controlled efficacy and safety studies are urgently needed to guide the use of low-molecular-weight heparins in the pediatric and adolescent obese population BACKGROUND Venous thromboembolism ( VTE ) after laparoscopic bariatric surgery is a significant cause of morbidity and mortality . The objective of the present study was to study the incidence of symptomatic VTE in extended thromboprophylaxis regimens using dalteparin at an independent hospital in Engl and , United Kingdom . METHODS A prospect i ve data base of all patients undergoing bariatric surgery was retrospectively analyzed . All patients underwent VTE prophylaxis regimen using perioperative and extended postoperative low-molecular-weight heparin ( dalteparin 2500 IU preoperatively , followed by 5000 IU daily postoperatively ) . The treatment period was 1 week for laparoscopic gastric b and ing or 3 weeks for all other procedures . Inferior vena cava filters were used in selected patients with thrombophilia , a history of pulmonary embolism , or > 1 episode of deep vein thrombosis . The endpoint was the incidence of symptomatic VTE . RESULTS A total of 735 patients underwent laparoscopic bariatric surgery , all of whom received dalteparin . The postoperative VTE incidence was 0 % . The 30-day and 90-day all-cause mortality rate was 0 % . A total of 3 adverse bleeding events occurred . CONCLUSION An extended VTE prophylaxis regimen using low-molecular-weight heparin is simple and effective and was associated with a low incidence of bleeding complications BACKGROUND The optimal scheme of thromboprophylaxis in bariatric surgery remains uncertain , because clinical practice is different between countries and r and omized trials are lacking . OBJECTIVES The primary objective of this r and omized multicenter study was to determine the optimal regimen of enoxaparin providing an antifactor Xa peak activity between .3 and .5 IU/mL at equilibrium and to evaluate the course of procoagulant microparticles ( MPs ) . SETTING University hospital . METHODS A total of 164 patients scheduled for gastric bypass were allocated to 3 groups ( A , B , and C ) of enoxaparin treatment ( 4000 , 6000 , or 2 × 4000 IU , respectively ) . Antifactor Xa activity was measured before and 4 hours after each injection from D0 to D2 . Doppler screening of the lower limbs was performed at D1 , D9 , and D30 . Bleeding ( BE ) and thrombotic events ( TE ) were recorded during the first postoperative month . Total MPs were measured at D0 , D9 , and D30 . MPs of leucocyte , platelet , and granulocyte origin were assessed in one third of the patients from each group . The 3 groups were compared by ANOVA . RESULTS A total of 135 patients were analyzed . The equilibrium of antifactor Xa peak levels was obtained 52 hours after the presurgery injection and 12.8 % , 56.4 % , and 27.3 % of the patients reached the target in groups A , B , and C , respectively ( P<.001 ) . No TE was detected . BE occurred in 1 , 2 , and 6 patients in groups A , B , and C , respectively ) . Total MPs remained unchanged over time . While no significant variation was observed in the other groups , platelet GP1 b(+)-MPs increased ( P = .01 ) at D9 in group C , suggesting an incomplete control of anticoagulation leading to cell activation and procoagulant MP release that was confirmed by the higher MP levels measured at D30 ( P = .04 ) . CD66(+)-MPs were also highly elevated at J9 and D30 in group C indicating a granulocyte contribution . CONCLUSIONS This study shows that a single dose of enoxaparin 6000 IU/d allowed most of the patients to reach the target range of antifactor Xa activity without increasing the bleeding risk , with the most likely efficient reduction of procoagulant MPs . ( Surg Obes Relat Dis 2015;0:000 - 000 . ) © 2015 American Society for Metabolic and Bariatric Surgery . All rights reserved 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 Objective : To compare two enoxaparin dosing strategies at achieving prophylactic anti-Xa levels in women with a body mass index ( BMI ) ⩾35 ( kg m−2 ) postcesarean delivery . Study Design : Women with BMI ⩾35 were r and omized to receive prophylactic enoxaparin at a fixed dose of 40 mg daily or weight-based dosing of 0.5 mg kg−1 twice daily . The primary outcome was the proportion of subjects with peak anti-Xa levels in the prophylactic range of 0.2 to 0.6 IU ml−1 . Result : From August 2013 through February 2014 , 84 demographically similar women completed the protocol . In the weight-based group , 88 % ( 37/42 ) of the women reached prophylactic anti-Xa levels versus 14 % ( 6/42 ) in the fixed dose group ( odds ratio 44.4 , 95 % confidence interval 12.44 , 158.48 , P<0.001 ) . No anti-Xa level exceeded 0.48 IU ml−1 . There were no venous thromboembolic or bleeding events requiring reoperation or transfusion in either group . Conclusion : Compared with fixed dosing daily , weight-based dosing twice daily more effectively achieved prophylactic anti-Xa levels without reaching the therapeutic range Background The optimal dose of low molecular weight heparin ( LMWH ) to prevent venous thromboembolism ( VTE ) after bariatric surgery remains controversial . The aim of this multicentre , open-label , pilot study was to evaluate the efficacy and safety of two different doses of the LMWH parnaparin administered to patients undergoing bariatric surgery . Methods Patients were r and omised to receive 4,250 IU/day ( group A ) or 6,400 IU/day ( group B ) of parnaparin s.c . for 7–11 days . Bilateral colour Doppler ultrasound of the lower limb was performed before surgery and at the end of the treatment period . The primary efficacy outcome was a composite of asymptomatic and symptomatic deep vein thrombosis , symptomatic pulmonary embolism and death from any cause during treatment . The primary safety endpoint was major and clinical ly relevant non-major bleeding . Results A total of 258 patients underwent r and omization ; 8 subjects were excluded following the safety analysis . One hundred thirty-one patients [ 106 females ; mean age , 40.3 years ( st and ard deviation ( SD ) ±9.6 ) ; mean body mass index ( BMI ) , 44.6 kg/m2 ( SD ±5.4 ) ] were assigned to group A and 119 patients [ 93 females ; mean age , 41.5 years ( SD ±9.9 ) ; mean BMI , 44.2 kg/m2 ( SD ±5.4 ) ] were assigned to group B. The rate of the primary efficacy outcome was 1.5 % ( two cases ; 95 % confidence interval ( CI ) , 0.2–6.0 % ) in group A as compared with 0.8 % ( one case ; 95 % CI , 0.4–5.3 % Output:
Weight-based and high fixed-dose chemoprophylaxis regimens achieved target anti-Xa concentrations more frequently than st and ard fixed-dose regimens but were not associated with a reduction in VTE . Additionally , high fixed-dose approaches are associated with increased bleeding complications .
MS2_1shot17
***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 individual kinematic roles of the anterolateral ligament ( ALL ) and the distal iliotibial b and Kaplan fibers in the setting of anterior cruciate ligament ( ACL ) deficiency require further clarification . This will improve underst and ing of their potential contribution to residual anterolateral rotational laxity after ACL reconstruction and may influence selection of an anterolateral extra-articular reconstruction technique , which is currently a matter of debate . Hypothesis/ Purpose : To compare the role of the ALL and the Kaplan fibers in stabilizing the knee against tibial internal rotation , anterior tibial translation , and the pivot shift in ACL-deficient knees . We hypothesized that the Kaplan fibers would provide greater tibial internal rotation restraint than the ALL in ACL-deficient knees and that both structures would provide restraint against internal rotation during a simulated pivot-shift test . Study Design : Controlled laboratory study . Methods : Ten paired fresh-frozen cadaveric knees ( n = 20 ) were used to investigate the effect of sectioning the ALL and the Kaplan fibers in ACL-deficient knees with a 6 degrees of freedom robotic testing system . After ACL sectioning , sectioning was r and omly performed for the ALL and the Kaplan fibers . An established robotic testing protocol was utilized to assess knee kinematics when the specimens were subjected to a 5-N·m internal rotation torque ( 0 ° -90 ° at 15 ° increments ) , a simulated pivot shift with 10-N·m valgus and 5-N·m internal rotation torque ( 15 ° and 30 ° ) , and an 88-N anterior tibial load ( 30 ° and 90 ° ) . Results : Sectioning of the ACL led to significantly increased tibial internal rotation ( from 0 ° to 90 ° ) and anterior tibial translation ( 30 ° and 90 ° ) as compared with the intact state . Significantly increased internal rotation occurred with further sectioning of the ALL ( 15 ° -90 ° ) and Kaplan fibers ( 15 ° , 60 ° -90 ° ) . At higher flexion angles ( 60 ° -90 ° ) , sectioning the Kaplan fibers led to significantly greater internal rotation when compared with ALL sectioning . On simulated pivot-shift testing , ALL sectioning led to significantly increased internal rotation and anterior translation at 15 ° and 30 ° ; sectioning of the Kaplan fibers led to significantly increased tibial internal rotation at 15 ° and 30 ° and anterior translation at 15 ° . No significant difference was found when anterior tibial translation was compared between the ACL/ALL- and ACL/Kaplan fiber – deficient states on simulated pivot-shift testing or isolated anterior tibial load . Conclusion : The ALL and Kaplan fibers restrain internal rotation in the ACL-deficient knee . Sectioning the Kaplan fibers led to greater tibial internal rotation at higher flexion angles ( 60 ° -90 ° ) as compared with ALL sectioning . Additionally , the ALL and Kaplan fibers contribute to restraint of the pivot shift and anterior tibial translation in the ACL-deficient knee . Clinical Relevance : This study reports that the ALL and distal iliotibial b and Kaplan fibers restrain anterior tibial translation , internal rotation , and pivot shift in the ACL-deficient knee . Furthermore , sectioning the Kaplan fibers led to significantly greater tibial internal rotation when compared with ALL sectioning at high flexion angles . These results demonstrate increased rotational knee laxity with combined ACL and anterolateral extra-articular knee injuries and may allow surgeons to optimize the care of patients with this injury pattern Background : Rotational instability of the knee remains an issue after anterior cruciate ligament ( ACL ) reconstruction . Hypothesis/ Purpose : The purpose was to evaluate the subjective and objective outcomes of combined reconstruction of the ACL and anterolateral ligament ( ALL ) of the knee . The hypothesis was that favorable outcomes can be achieved with this surgical procedure compared with isolated anatomic reconstruction of the ACL . Study Design : R and omized controlled trial ; Level of evidence , 2 . Methods : One hundred ten patients with a unilateral ACL injury and high- grade pivot shift were r and omly assigned to undergo either combined ACL and ALL reconstruction ( group A ) or isolated ACL reconstruction ( group B ) . Preoperative and postoperative evaluations of the patients were conducted by obtaining history details , recording physical examination findings , measuring knee laxity using the KT-1000 arthrometer , and using vali date d outcome scores for the knee . P < .05 was considered as the cut-off level of statistical significance . The Fisher exact and Mann-Whitney U tests were used to assess statistical significance . Results : At a mean follow-up of 27 months , 53 and 50 patients in groups A and B , respectively , were available for analysis . No statistically different outcomes were found between the 2 groups except for the KT-1000 arthrometer values . The median KT-1000 arthrometer result for combined ACL and ALL reconstruction was 1.3 mm , while the median result for isolated ACL reconstruction was 1.8 mm ( P < .001 ) . None of the patients ( n = 0 ; 0.0 % ) who underwent combined ACL and ALL reconstruction had anterior translation of greater than 5 mm at maximum pulling strength compared with their normal knees at final follow-up . On the other h and , 3 ( 6.0 % ) patients who underwent isolated ACL reconstruction had anterior translation of more than 5 mm . No serious complications were found in both groups . Conclusion : Combined ACL and ALL reconstruction was found to be effective in improving subjective and objective outcomes . Nevertheless , these findings were not significantly superior to isolated ACL reconstruction except for the instrumented knee laxity testing results . This might indicate that ALL reconstruction should not be performed routinely for patients undergoing ACL reconstruction PURPOSE The purpose of the current paper was to report the surgical technique of combined anatomic anterior cruciate ligament ( ACL ) and anterolateral ligament ( ALL ) reconstruction as well as the short term clinical results after this surgical procedure . MATERIAL AND METHODS The current prospect i ve study included 32 patients ( 5 females and 27 males ) with combined ACL and ALL reconstruction performed between December 2015 and July 2016 . The patients were included in the study taking into consideration the following criteria : chronic ACL lesion , high grade rotational instability ( pivot shift grade II and III ) and participation in high grade pivoting sports . Patient evaluation followed an established clinical and imaging protocol both preoperatively and at 6 and 12 weeks postoperatively . This included clinical knee stability testing ( Lachman test , Pivot shift test ) , Rolimeter differential laxity testing , subjective and objective IKDC scores and Lysholm score and Tegner score . RESULTS Postoperative stability at 6 weeks and 12 weeks as tested with Lachman test ( p=0.02 and 0.01 , respectively ) , pivot shift test ( p=0.03 and 0.01 , respectively ) and the Rolimeter arthrometer ( p=0.008 and 0.006 , respectively ) showed a statistically significant difference as compared to preoperative values . Postoperative scores at 6 weeks and 12 weeks as measured using objective IKDC form ( p=0.008 and 0.006 , respectively ) , subjective IKDC form ( p=0.04 and 0.03 , respectively ) and Lysholm form ( p=0.02 and 0.01 , respectively ) were statistically significant improved as compared to preoperative values . All patients had a negative Lachman test at 6 and 12 weeks postoperatively . One patient had a positive grade I pivot shift test at 6 weeks postoperatively and two patients had a positive grade I pivot shift test at 12 weeks postoperatively . Differential anteroposterior laxity as measured with the Rolimeter arthrometer improved from 7.19±1.96 mm preoperatively to 0.28±0.45 mm and 0.13±0.34 mm , at 6 weeks and 12 weeks postoperatively , respectively . According to the objective IKDC form , 29 patients were normal or nearly normal ( grade A and B ) at 6 weeks postoperatively and 31 patients were normal or nearly normal at 12 weeks postoperatively . Subjective IKDC score improved from 47.72±17.18 preoperatively to 56.52±11.74 and 73.38±14.28 at 6 and 12 weeks postoperatively , respectively . Lysholm score improved from 63.44±23.01 preoperatively to 80.41±11.94 and 90.47±8.22 at 6 and 12 weeks postoperatively , respectively . Improved Tegner activity scores were present at 12 weeks postoperatively as compared with 6 weeks postoperatively , but still lower as compared to pre-traumatic scores . No significant complications were present in the current study group . CONCLUSIONS Combined ACL and ALL reconstruction is an effective surgical procedure , with improved postoperative clinical results and no significant short term complications . Longer follow-up is necessary in order to better evaluate the results of this procedure INTRODUCTION Lateral tenodesis ( LT ) is performed to limit the risk of iterative tear following anterior cruciate ligament ( ACL ) reconstruction in at-risk patients . By adding an extra procedure to isolated ACL graft , LT reconstruction increases operating time and may complicate postoperative course . The objective of the present study was to evaluate the rate of early complications . The study hypothesis was that associating ALL reconstruction to ACL reconstruction does not increase the complications rate found with isolated ACL reconstruction . MATERIAL AND METHODS A prospect i ve multicenter study included 392 patients : 70 % male ; mean age , 29.9 years ; treated by associated ACL and LT reconstruction . All adverse events were inventoried . RESULTS Mean hospital stay was 2 days , with 46 % day-surgery . Walking was resumed at a mean 27 days , with an advantage for patients treated by the hamstring technique . The early postoperative complications rate was 12 % , with 1.7 % specifically implicating LT reconstruction : pain , hematoma , stiffness in flexion and extension , and infection . There was a 5 % rate of surgical revision during the first year , predominantly comprising arthrolysis for extension deficit . The 1-year recurrence rate was 2.8 % . DISCUSSION The complications rate for combined intra- and extra-articular reconstruction was no higher than for isolated intra-articular ACL reconstruction , with no increase in infection or stiffness rates . The rate of complications specific to ALL reconstruction was low , at 1.7 % , and mainly involved fixation error causing lateral soft-tissue impingement . LEVEL OF EVIDENCE IV , prospect i ve multicenter study Output:
LET could lead to worse anterior instability than with ALL reconstruction when these two approaches were combined with single-bundle ACL reconstruction . However , rotational stability and patient-reported outcomes were similar between the techniques
MS2_1shot18
***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 A comprehensive worksite health promotion program design ed to reduce risk factors for cardiovascular disease among 4000 city of Birmingham employees was used to develop and implement a tailored antihypertensive educational intervention . The mean age of the underlying population was 36 years , 89 % were blue-collar or unskilled workers , 50 % were African Americans and 20 % were female . METHODS First , we identified barriers to hypertension control : low literacy , difficulty underst and ing the need for treatment of asymptomatic disease , and wide variability of health beliefs and priorities . We then tailored an educational program , which offered employees health education sessions on a variety of different topics , including heart disease , cancer , sleep disorders and back injury . All program material s focused on lifestyle changes and the need to seek medical care . This program was offered to all hypertensive workers ; 130 chose to enroll , and 81 completed the program . These 81 participants were matched by age , sex , race and baseline BP with nonparticipating hypertensive workers ( controls ) . Changes in SBP and DBP from before to after the educational program were used to evaluate the program . RESULTS Overall , intervention participants had a decrease of 4.5 mm Hg in mean SBP ( different from zero , [ p = 0.03 ] ) . African American participants showed a significant decrease ( 7.4 mm Hg , [ p = 0.004 ] ) , as did unskilled intervention participants ( SBP changes = 7.7 mm Hg , [ p = 0.004 ] ) . Although not statistically significant , controls showed decreases in BP in the same direction . CONCLUSION An educational intervention tailored to the specific health perceptions and working conditions of a low literacy population is feasible , and may have a significant effect on hypertension control A nutrition intervention focused on low-fat eating pattern changes was conducted among low-literacy participants in a Twin Cities Metropolitan area Exp and ed Food and Nutrition Education Program ( EFNEP ) . A total of 134 EFNEP participants who participated in the intervention were compared to 70 comparison participants who received EFNEP nutrition education material s. Associations between changes in outcome variables specific to the intervention were evaluated using mixed-model regression analyses . The principal effects seen for this program were related to changes in eating pattern scales . More modest effects were seen in scales related to attitudes of low-fat eating , and although changes in dietary fat intake as measured by 24-hour dietary interviews suggested a positive intervention effect , this did not approach statistical significance We used a r and omized trial to compare two polio vaccine pamphlets written on a sixth grade level -- the vaccine information statement prepared by the Centers for Disease Control ( CDC ) and an easy-to-read pamphlet we developed (LSU)--for reading ability , comprehension and preference among 610 parents with a broad range of demographic characteristics . Parents at all reading levels and incomes preferred LSU ( 76 % vs. 21 % , P < 0.001 ) . Although readers of LSU achieved significantly higher comprehension ( 65 % vs. 60 % , P < 0.05 ) this difference may not be clinical ly significant . The information items presented with instructional graphics were the only items on which differences in comprehension levels achieved both clinical and statistical significance . Comprehension was lowest for the CDC m and ated information on risks and the National Injury Compensation . Our findings demonstrate that simplifying written immunization material and making it more suitable will increase appeal , but such modification may not raise comprehension to an acceptable level without use of instructional graphics . Health education material s intended for general parent population s , which are written on a sixth grade reading level , may not adequately educate parents or prepare them for a discussion with their physicians CONTEXT Pneumococcal immunization rates for elderly and high-risk patients are only one third to one half the target rate of 60 % established by the US Public Health Service . Limited or marginal literacy , which affects nearly 100 million Americans , especially the elderly , may contribute to these low rates of immunization . OBJECTIVE To determine whether the use of a simple , low-literacy educational tool enhances patient-physician dialogue about pneumococcal vaccination and increases rates of immunization . DESIGN A r and omized controlled trial conducted between May and June of 1998 . SETTING Ambulatory care clinic of a 900-bed public teaching hospital serving a predominantly indigent , low-literate , African American , inner-city population . PARTICIPANTS Of 433 patients who presented for routine primary care , had vaccine indications ( age > or = 65 years or chronic disease ) , and had not been previously vaccinated , 221 were r and omly assigned to the intervention group and 212 to the control group . Of the total patient population ( mean age , 63 years ) , 280 ( 64.7 % ) had less than a high school education , 401 ( 92.6 % ) were African American , and 300 ( 69.3 % ) were female . INTERVENTION One-page , low-literacy ( below fifth- grade level ) educational h and out encouraging patients to " ask your doctor about the pneumonia shot " vs a control group ( 1 -page , low-literacy educational h and out conveying information about nutrition ) . MAIN OUTCOME MEASURES Vaccination rates ( documented by chart audit ) of patients who received pneumococcal vaccination and rates of patients who self-reported having discussed vaccination with their physicians . RESULTS Patients in the intervention group were 4 times more likely to have discussed the pneumococcal vaccine with their physicians than patients in the control group ( 87/221 [ 39.4 % ] vs 21/212 [ 9.9 % ] ; relative risk [ RR ] , 3.97 [ 95 % confidence interval [ CI ] , 2.71 - 5.83 ] ) , and were more than 5 times as likely to have received the pneumococcal vaccine than the control group ( 44/221 [ 19.9 % ] vs 8/212 [ 3.8 % ] ; RR , 5.28 [ 95 % CI , 2.80 - 9.93 ] ) . In a multivariate analysis controlling for race , sex , education , insurance status , age , level of physician training , health status , and vaccine indication , only assignment to the intervention group was statistically significantly related to the probability of being immunized or discussing the issue with their physicians ( P<.001 for both trends ) . CONCLUSIONS A simple , low-literacy educational tool increased pneumococcal vaccination rates and patient-physician discussion s about the vaccine in an elderly , low-literate , indigent , minority population OBJECTIVES This study was undertaken to test the effectiveness of the Stanford Nutrition Action Program , an experimental trial to reduce dietary fat intake among low-literacy , low-income adults . METHODS Twenty-four paired adult education classes ( 351 participants , 85 % women , mean age = 31 years ) were r and omly assigned to receive a newly developed dietary fat curriculum ( the Stanford Nutrition Action Program ) or an existing general nutrition curriculum . Food frequency and nutrition-related data , body mass index , and capillary blood cholesterol were collected at baseline and at two postintervention follow-ups . RESULTS The Stanford Nutrition Action Program classes showed significantly greater net improvements in nutrition knowledge ( + 7.7 ) , attitudes ( /0.2 ) , and self-efficacy ( -0.2 ) than the general nutrition classes ; they also showed significantly greater reductions in the percentage of calories from total ( -2.3 % ) and saturated ( -0.9 % ) fat . There were no significant differences in body mass index or blood cholesterol . All positive intervention effects were maintained for 3 months postintervention . CONCLUSIONS The Stanford Nutrition Action Program curriculum , tailored to the cultural , economic , and learning needs of low-literacy , low-income adults , was significantly more effective in achieving fat-related nutritional changes than the general nutrition curriculum The effect of the readability level of patient drug information material s on patient comprehension of and attitude toward the information was studied . The reading level of 108 out patients at a Veterans Administration hospital who could read English , read type of normal size , and who were not receiving warfarin sodium was measured . Patients then were given , on a r and om basis , a warfarin drug monograph written on either the 5th- or 10th- grade level . To test comprehension , all subjects took a true-false test of recall written at the 5th- grade level . A significant relationship was found between comprehension and reading ability ( p less than 0.001 ) . Patients receiving the 5th- grade level monograph exhibited significantly better comprehension than those receiving the 10th- grade level material ( p less than 0.001 ) . As compared with those getting 10th- grade material , the group receiving the 5th- grade material had a more favorable perception of the level of difficulty , underst and ability , and clarity of the material . The study indicates that comprehension of written patient drug information can be improved by adjusting the readability of informational material s to the reading level of the patients We investigated whether printed or videotaped information is more effective in enhancing colon cancer knowledge . Subjects ( n = 1100 ) were r and omized into three groups : to receive a booklet , view a videotape , or receive no intervention . Subjects receiving the intervention showed increased knowledge compared with control subjects ( booklet = 23 % and videotape = 26 % vs no intervention = 3 % ) . Findings suggest that personalized educational material s are effective in enhancing colon cancer knowledge A r and omized controlled trial was conducted to determine whether an education program specifically design ed for patients with non-insulin-dependent diabetes and limited literacy could improve and sustain glucose and weight control . From a referral clinic , 120 obese ( > 130 per cent of ideal body weight ) diabetic patients who were not taking insulin were recruited . Of these , 55 per cent were female and 49 per cent were black ; the mean age was 53 years . Mean glycosylated hemoglobin ( HbA1 % ) was 10.2 per cent . Each subject was assigned to one of three groups : 1 ) monthly group sessions with videotapes for diabetic persons with low literacy skills ; 2 ) monthly group sessions without videotapes ; or 3 ) no monthly sessions . After seven months , there had been 16 dropouts ( 13 per cent ) . Differences in weight changes between groups were significant ( p<0.05 ) ; group 1 lost a median of 1 kg of weight ( p<0.05 ) compared with a 0.1-kg loss and no change in groups 2 and 3 , respectively . This weight loss was not sustained at 11 months . There was no significant change in HbA1 % . Age , education , and compliance beliefs did not predict outcome . The authors conclude that the patient education programs did not result in sustained glucose or weight control Research suggests that much of the available health education literature requires a level of reading ability that makes it inaccessible to a large proportion of the population in greatest need of health information . The present study tested the value of illustrations and a narrative text style as means of improving the readability of a brochure design ed to provide information on cervical cancer and condyloma . Two versions of the brochure were design ed , one that had only text presented as simple sentences in bullet-type format ( SMOG reading level score of 7.7 ) , and a second version that had somewhat more difficult text formatted in a narrative style ( SMOG grade level score of 8.4 ) together with drawings design ed to complement the text . A r and omized study design was used to test for comprehension , perceived ease of underst and ing , and overall rating of the two brochures . Women selected from one private and three public health primary -care clinics were r and omly assigned to read one of the two brochures . The brochure with illustrations and narrative text was given a significantly higher overall rating than the one with bullet-type text and no illustrations , while no difference was found in perceived ease of reading . Among poor readers , comprehension was significantly greater for women who read the brochure with illustrations and narrative text , with no difference in comprehension of the two brochures for better readers . The results suggest that the use of aids such as illustrations and text style can make health education literature more accessible to high-risk population s , while remaining interesting enough to appeal to individuals at all levels of reading ability The authors explored changes in dietary behavior , nutrition knowledge , and parental support among inner-city , low-income , Hispanic American families . Thirty-eight families were r and omly assigned to receive a 12-week , culture-specific dietary intervention or be in a control group . Results showed that parental support was related to changes in diet , nutrition knowledge , and attendance for both mothers and children . Dietary behavior changes ( e.g. , reduction in dietary fat ) were seen only in the treatment group . Distribution of health-related pamphlets to the control group may have promoted cognitive changes ( e.g. , increased nutrition knowledge ) seen in this low-literacy sample . Further research is needed to document behavioral changes after ethnic-specific interventions and the maintenance of those changes over time BACKGROUND Medication adherence by older adults who are discharged from the emergency department ( ED ) is an essential attribute of effective treatment . Research ers have demonstrated that delivery of well-structured instructions increases the knowledge of discharge regimens and increases adherence among ED population s. OBJECTIVES This study compared the level of medication knowledge of elderly ED patients receiving instruction by one of two teaching methods : the usual preprinted discharge instructions with h and written medication information and individualized computer-generated discharge instructions design ed within a geragogy framework . METHOD The geragogy intervention included large-print , easily readable , specific information ordered within the elderly memory schema . This schema consists of purpose , administration , and emergency information in that order . The Knowledge of Medication Subtest by Horn and Swain ( Output:
: Several interventions have been developed to improve health for people with low literacy .
MS2_1shot19
***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 outcomes of the current practice of liberally or routinely employing episiotomy to prevent perineal tears and pelvic floor relaxation ( control group ) to a policy of restricting episiotomy use to specific fetal and maternal indications ( experimental group ) . DESIGN : A r and omized controlled trial ( RCT ) . SETTING : Three university hospitals in Montreal . SUBJECTS : Seven hundred three low-risk women enrolled at 30 to 34 weeks of gestation were r and omized late in labor to the design ated trial arm , by parity , and followed up to 3 months postpartum . MAIN OUTCOME MEASURES : Antepartum and postpartum information on perineal trauma and pain , pelvic floor symptoms ( urinary incontinence ) , and sexual activity was collected through the use of st and ard question naires ; pelvic floor function was measured by electromyographic ( EMG ) perineometry . RESULTS : Restricting episiotomy use in primiparous women was associated with similar sutured perineal trauma to the liberal or routine approach . Multiparous women in the restricted episiotomy group more often gave birth with an intact perineum ( 31 % compared with 19 % , odds ratio ( OR ) = 1.85 , 95 % confidence interval ( CI ) = 1.09 to 3.16 ) . All but one 3rd/4th-degree perineal tear was associated with median episiotomy ( 46 of 47 in primiparous women and 6 of 6 among multiparous women ) . No difference between trial groups was found in postpartum perineal pain , antepartum and 3-month postpartum EMG perineometry , and urinary and pelvic floor symptoms . CONCLUSIONS : We found no evidence that liberal or routine use of episiotomy prevents perineal trauma or pelvic floor relaxation . Virtually all severe perineal trauma was associated with median episiotomy . Restriction of episiotomy use among multiparous women result ed in significantly more intact perineums and less perineal suturing Background Despite all the evidence corroborating the selective use of episiotomy and although routine use of the procedure is contraindicated , there are no evidence s corroborating if episiotomy is necessary in any circumstance . The present clinical r and omized trial was performed to compare maternal and perinatal outcomes in women su bmi tted to a non-episiotomy protocol versus one of selective episiotomy . Methods An open-labelled , r and omized clinical trial was carried out in a tertiary teaching hospital in Recife , Northeastern Brazil . Women in labor with a full-term live foetus , dilatation of 6 to 8 cm and cephalic presentation ( vertex position ) were included . Exclusion criteria consisted of bleeding disorders and an indication for a caesarean section . After signing the consent form , 241 women were r and omized to a non-episiotomy protocol ( the experimental group ) or to a selective episiotomy group ( the control group ) . No episiotomies were to be performed in the experimental group except under exceptional circumstances . In the control group , selective episiotomies were to be performed in accordance with the healthcare professionals ’ clinical judgement . Maternal and perinatal outcomes were evaluated . Ratio Risk ( RR ) and the 95 % confidence interval ( 95 % CI ) were calculated for our outcomes . Results The analysis include 115 women assigned to a non-episiotomy protocol and 122 to selective episiotomy . There was no difference between the two groups with respect to maternal or perinatal outcomes . The episiotomy rate was similar ( two cases in each group , about 1.7 % ) , as was the duration of the second stage of labor , the frequency of perineal tears , severe perineal trauma , need for perineal suturing and blood loss at delivery . Conclusions A non-episiotomy protocol appears to be safe for mother and child , and highlights the need to investigate whether there is , in fact , any indication for this procedure . Trial registration This trial was registered at Clinical Trials.gov under reference number ( NCT02178111 ) OBJECTIVE To evaluate the prevalence of obstetrical anal sphincter injuries ( OASIS ) , which include third and fourth degree perineal tears in primigravida in routine versus selective mediolateral episiotomy . Secondly , to determine the rate of episiotomy in local setting s. METHODS This r and omized control trial was carried out in the labor ward of a tertiary hospital of the Universiti Kebangsaan Malaysia Medical Center , Kuala Lumpur , Malaysia between May and October 2009 . The trial included 171 primigravida beyond 38 weeks gestation who achieved vaginal delivery , and r and omly assigned to selective and routine episiotomy groups . The type of perineal injuries following childbirth among 171 women were evaluated . RESULTS The overall episiotomy rate from both groups was 76.6 % . The prevalence of third degree perineal tears was 3.7 % in the routine compared with selective mediolateral episiotomy at 1.1 % . There was no occurrence of fourth degree tears in both groups . However , selective mediolateral episiotomy was associated with an increased risk of periurethral and labial injury compared with the routine group ( 4.5 % versus 0 % ) . CONCLUSION Routine mediolateral episiotomy in primigravida is associated with a higher prevalence of obstetrical anal sphincter injuries . As anal sphincter injuries are known to have morbidities , selective mediolateral episiotomy in primigravida is therefore recommended in the implementation of new delivery practice , and in an attempt to reduce our high episiotomy rate OBJECTIVE To evaluate short-term perineal pain among primiparous women after mediolateral episiotomy ( MLE ) and lateral episiotomy ( LE ) . METHODS The prospect i ve r and omized study was conducted in the Czech Republic during 2010 - 2012 . Consecutive primiparous women who gave birth at or after 37 weeks of pregnancy and had indications for an episiotomy were enrolled and r and omly assigned to undergo MLE or LE . Patients were unaware of the episiotomy type performed . The primary outcomes were pain at 24 hours , 72 hours , and 10 days post partum , measured by a visual analog scale , verbal rating scale , interference with activities of daily living , and amount of analgesic use . RESULTS The analysis included 266 women who underwent MLE and 297 women who underwent LE . Complete relief of pain was observed in 6 ( 2.3 % ) of 266 women after 24 hours , 21 ( 8.0 % ) of 264 after 72 hours , and 77 ( 29.1 % ) of 265 after 10 days in the MLE group , and in 11 ( 3.9 % ) of 285 , 23 ( 7.7 % ) of 297 , and 78 ( 26.4 % ) of 295 in the LE group , respectively ( P=0.36 ) . There were no significant differences in overall pain scores from any rating system or in the amount of analgesics used . CONCLUSION Incidence and extent of pain in the first 10 days after LE correspond to those after adequately performed MLE Background . The influence of the restrictive use of episiotomy at perineal tears judged to be imminent on the urethral pressure profile , analmanometric , and other pelvic floor findings is unknown Introduction Episiotomy angle is a crucial factor in causation of obstetric anal sphincter injuries ( OASIS ) , which are the major cause of female bowel incontinence . Sutured episiotomies angled too close to the midline ( < 30 degree ) or too far away from the midline ( > 60 degree ) fail to unload the perineum sufficiently and predispose to OASIS . A 25-degree post-delivery episiotomy suture angle has a 10 % risk of OASIS while 45-degree episiotomy is associated with 0.5 % risk . To account for perineal distension at crowning , a 60-degree episiotomy incision is required to achieve 43–50 degree suture angles . We compared episiotomy suture angles with commonly used Braun-Stadler episiotomy scissors with the new fixed angle EPISCISSORS-60 ® . Methods Ethical approval was obtained . A prospect i ve cluster r and omization design was chosen . Thirty-one patients were required in each group for a 12-degree difference with power at 90 % and 5 % significance . Sutured episiotomy angles and post-delivery linear distance from caudal end of the sutured episiotomy to the anus were measured with protractors and rulers . Two-tailed t-tests were used to compare the two groups . Results Thirty-one nulliparae had episiotomies with EPISCISSORS-60 ® , 32 with Braun-Stadler . Mean age ( 25 versus 24.8 years ) was similar . EPISCISSORS-60 ® episiotomies were angled 12 degrees more laterally away from the anus compared to Braun-Stadler ( 40.6 degrees , 95 % confidence interval [ CI ] ±2 , interquartile range [ IQR ] 35–45 versus 28.3 degrees , 95 % CI ±2 , IQR 25–30 , P<0.0001 ) . The post-delivery linear distance from caudal end of the sutured episiotomy to the anus was 15 mm more with the EPISCISSORS-60 ® compared to Braun-Stadler ( 35 mm , 95 % CI ±2.2 , IQR = 30–39 versus 19.5 ; 95 % CI ±1.3 , IQR = 14.75–22.25 P<0.0001 ) . EPISCISSORS-60 ® episiotomies measured longer ( 47 mm versus 40 mm , P<0.0001 ) . There were no OASIS cases in the EPISCISSORS-60 ® group versus one in the Braun-Stadler group . Conclusion The EPISCISSORS-60 ® sutured episiotomies are much further away from the midline in angular and distance measures , hence at lower OASIS risk OBJECTIVE To evaluate the incidence and extent of vaginal and perineal trauma among primiparous women after mediolateral and lateral episiotomy . METHODS In a prospect i ve r and omized study at University Hospital Pilsen , Czech Republic , 790 consecutive primiparous women were enrolled between April 2010 and April 2012 . Mediolateral episiotomy ( MLE ) followed an angle of at least 60 ° from the midline . Lateral episiotomy ( LE ) started 1 - 2 cm laterally from the midline and was directed toward the ischial tuberosity . A rectal examination was performed before episiotomy repair . RESULTS MLE was performed for 390 women , and LE for 400 . The groups did not differ in maternal or neonatal characteristics . No difference was found in incidence or extent of vaginal and perineal trauma ; or in additional perineal ( 1.8 % vs 1.5 % , P=0.6 ) or vaginal ( 8.5 % vs 10.6 % , P=0.2 ) trauma continuing along the episiotomy incision . The incidence of anal sphincter injury did not differ between MLE and LE ( 1.5 % vs 1.3 % , P=0.7 ) . MLE was associated with shorter repair times ( P<0.05 ) , less suturing material ( P<0.05 ) , and shorter distances from the anus ( P<0.001 ) . CONCLUSION Risk of additional vaginal and perineal trauma , and anal sphincter injury after adequately performed mediolateral episiotomy is relatively low and corresponds to that of lateral episiotomy OBJECTIVE To evaluate whether physicians ' beliefs concerning episiotomy are related to their use of procedures and to differential outcomes in childbirth . DESIGN Post-hoc cohort analysis of physicians and patients involved in a r and omized controlled trial of episiotomy . SETTING Two tertiary care hospitals and one community hospital in Montreal . PARTICIPANTS Of the 703 women at low risk of medical or obstetric problems enrolled in the trial we studied 447 women ( 226 primiparous and 221 multiparous ) attended by 43 physicians . Subjects attended by residents or nurses were excluded . MAIN OUTCOME MEASURES PATIENTS intact perineum v. perineal trauma , length of labour , procedures used ( instrumental delivery , oxytocin augmentation of labour , cesarean section and episiotomy ) , position for birth , rate of and reasons for not assigning women to a study arm , postpartum perineal pain and satisfaction with the birth experience , physicians : beliefs concerning episiotomy . RESULTS Women attended by physicians who viewed episiotomy very unfavorably were more likely than women attended by the other physicians to have an intact perineum ( 23 % v. 11 % to 13 % , p < 0.05 ) and to experience less perineal trauma . The first stage of labour was 2.3 to 3.5 hours shorter for women attended by physicians who viewed episiotomy favourably than for women attended by physicians who viewed episiotomy very unfavorably ( p < 0.05 to < 0.01 ) , and the former physicians were more likely to use oxytocin augmentation of labour . Physicians who viewed episiotomy more favourably failed more often than those who viewed the procedure very unfavourably to assign patients to a study arm late in labour ( odds ratio [ OR ] 1.88 , p < Output:
Subgroup analyses by parity ( primiparae versus multiparae ) and by surgical method ( midline versus mediolateral episiotomy ) did not identify any modifying effects . One trial examined selective episiotomy compared with routine episiotomy in women where an operative vaginal delivery was intended in 175 women , and did not show clear difference on severe perineal trauma between the restrictive and routine use of episiotomy , but the analysis was underpowered . Authors ' conclusions In women where no instrumental delivery is intended , selective episiotomy policies result in fewer women with severe perineal/vaginal trauma . Other findings , both in the short or long term , provide no clear evidence that selective episiotomy policies results in harm to mother or baby . The review thus demonstrates that believing that routine episiotomy reduces perineal/vaginal trauma is not justified by current evidence .
MS2_1shot20
***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 Levosimendan is a calcium-sensitizing drug with inotropic and other properties that may improve outcomes in patients with sepsis . METHODS We conducted a double-blind , r and omized clinical trial to investigate whether levosimendan reduces the severity of organ dysfunction in adults with sepsis . Patients were r and omly assigned to receive a blinded infusion of levosimendan ( at a dose of 0.05 to 0.2 μg per kilogram of body weight per minute ) for 24 hours or placebo in addition to st and ard care . The primary outcome was the mean daily Sequential Organ Failure Assessment ( SOFA ) score in the intensive care unit up to day 28 ( scores for each of five systems range from 0 to 4 , with higher scores indicating more severe dysfunction ; maximum score , 20 ) . Secondary outcomes included 28-day mortality , time to weaning from mechanical ventilation , and adverse events . RESULTS The trial recruited 516 patients ; 259 were assigned to receive levosimendan and 257 to receive placebo . There was no significant difference in the mean ( ±SD ) SOFA score between the levosimendan group and the placebo group ( 6.68±3.96 vs. 6.06±3.89 ; mean difference , 0.61 ; 95 % confidence interval [ CI ] , -0.07 to 1.29 ; P=0.053 ) . Mortality at 28 days was 34.5 % in the levosimendan group and 30.9 % in the placebo group ( absolute difference , 3.6 percentage points ; 95 % CI , -4.5 to 11.7 ; P=0.43 ) . Among patients requiring ventilation at baseline , those in the levosimendan group were less likely than those in the placebo group to be successfully weaned from mechanical ventilation over the period of 28 days ( hazard ratio , 0.77 ; 95 % CI , 0.60 to 0.97 ; P=0.03 ) . More patients in the levosimendan group than in the placebo group had supraventricular tachyarrhythmia ( 3.1 % vs. 0.4 % ; absolute difference , 2.7 percentage points ; 95 % CI , 0.1 to 5.3 ; P=0.04 ) . CONCLUSIONS The addition of levosimendan to st and ard treatment in adults with sepsis was not associated with less severe organ dysfunction or lower mortality . Levosimendan was associated with a lower likelihood of successful weaning from mechanical ventilation and a higher risk of supraventricular tachyarrhythmia . ( Funded by the NIHR Efficacy and Mechanism Evaluation Programme and others ; LeoPARDS Current Controlled Trials number , IS RCT N12776039 . ) Background — We determined the effects of levosimendan , a calcium sensitizer , on left ventricular ( LV ) diastolic function in patients with LV hypertrophy . Methods and Results — In this prospect i ve , r and omized , blinded study , 23 patients received either levosimendan ( 0.1 and 0.2 & mgr;g · kg−1 · min−1 ; n=12 ) or placebo ( n=11 ) after aortic valve replacement for aortic stenosis . The effects on LV performance , dimensions , filling patterns , and isovolumic relaxation time , as well as systemic hemodynamics , were assessed by pulmonary artery thermodilution catheterization and transesophageal 2-dimensional Doppler echocardiography . To circumvent the confounding effects of the levosimendan-induced hemodynamic changes on Doppler echocardiographic indexes of LV early relaxation , heart rate and mean arterial and central venous pressures were kept constant during levosimendan/placebo infusion by atrial pacing , vasopressor , and colloid infusions . In the levosimendan group , dose-dependent increases in cardiac output ( 28 % ; P<0.001 ) and stroke volume ( 26 % ; P<0.001 ) and a decrease in systemic vascular resistance ( −22 % ; P<0.001 ) were observed . There was a trend for an increase in LV ejection fraction ( 12 % ; P=0.058 ) with levosimendan . There were no significant differences in systolic , diastolic arterial , or LV filling pressures or LV end-diastolic area between the 2 groups . Isovolumic relaxation time decreased ( −23 % ; P<0.001 ) , as did the deceleration slope of early diastolic filling ( −45 % ; P<0.01 ) , whereas peak early diastolic filling velocity ( 16 % , P<0.01 ) and peak late diastolic filling velocity ( 15 % ; P<0.001 ) increased after levosimendan compared with placebo . Conclusion — Levosimendan , in addition to its inotropic effects , exerts a direct positive lusitropic effect in patients with LV hypertrophy as it shortens isovolumic relaxation time and improves LV filling Introduction The purpose of the present study was to investigate microcirculatory blood flow in patients with septic shock treated with levosimendan as compared to an active comparator drug ( i.e. dobutamine ) . The primary end point was a difference of ≥ 20 % in the microvascular flow index of small vessels ( MFIs ) among groups . Methods The study was design ed as a prospect i ve , r and omized , double-blind clinical trial and performed in a multidisciplinary intensive care unit . After achieving normovolemia and a mean arterial pressure of at least 65 mmHg , 40 septic shock patients were r and omized to receive either levosimendan 0.2 μg·kg-1·min-1 ( n = 20 ) or an active comparator ( dobutamine 5 μg·kg-1·min-1 ; control ; n = 20 ) for 24 hours . Sublingual microcirculatory blood flow of small and medium vessels was assessed by sidestream dark-field imaging . Microcirculatory variables and data from right heart catheterization were obtained at baseline and 24 hours after r and omization . Baseline and demographic data were compared by means of Mann-Whitney rank sum test or chi-square test , as appropriate . Microvascular and hemodynamic variables were analyzed using the Mann-Whitney rank sum test . Results Microcirculatory flow indices of small and medium vessels increased over time and were significantly higher in the levosimendan group as compared to the control group ( 24 hrs : MFIm 3.0 ( 3.0 ; 3.0 ) vs. 2.9 ( 2.8 ; 3.0 ) ; P = .02 ; MFIs 2.9 ( 2.9 ; 3.0 ) vs. 2.7 ( 2.3 ; 2.8 ) ; P < .001 ) . The relative increase of perfused vessel density vs. baseline was significantly higher in the levosimendan group than in the control group ( dMFIm 10 ( 3 ; 23)% vs. 0 ( -1 ; 9)% ; P = .007 ; dMFIs 47 ( 26 ; 83)% vs. 10 ( -3 ; 27 ) ; P < .001 ) . In addition , the heterogeneity index decreased only in the levosimendan group ( dHI -93 ( -100 ; -84)% vs. 0 ( -78 ; 57)% ; P < .001 ) . There was no statistically significant correlation between systemic and microcirculatory flow variables within each group ( each P > .05 ) . Conclusions Compared to a st and ard dose of 5 μg·kg-1·min-1 of dobutamine , levosimendan at 0.2 μg·kg-1·min-1 improved sublingual microcirculatory blood flow in patients with septic shock , as reflected by changes in microcirculatory flow indices of small and medium vessels . Trial registration NCT00800306 Background We aim ed to investigate the effect of levosimendan on biomarkers of myocardial injury and systemic hemodynamics in patients with septic shock . Material / Methods After achieving normovolemia and a mean arterial pressure of at least 65 mmHg , 38 septic shock patients with low cardiac output ( left ventricular ejective fraction ) , LEVF ≤45 % ) were r and omly divided into two groups : levosimendan dobutamine . Patients in the levosimendan and dobutamine groups were maintained with intravenous infusion of levosimendan ( 0.2 μg/kg/minute ) and dobutamine ( 5 μg/kg/minute ) for 24 hours respectively . During treatment we monitored hemodynamics and LVEF , and measured levels of heart-type fatty acid binding protein ( HFABP ) , troponin I ( TNI ) , and brain natriuretic peptide(BNP ) . In addition , the length of mechanical ventilation , intensive care unit ( ICU ) stay , hospital stay , and 28-day mortality were compared between the two groups . Results The levosimendan group and the dobutamine group were well matched with respect to age ( years , 55.4±1 7.5 versus 50.2±13.6 ) and gender ( males , 68.4 % versus 57.9 % ) . Levosimendan-treated patients had higher stroke volume index ( SVI ) , cardiac index ( CI ) , LVEF , and left ventricular stroke work index ( LVSWI ) , and lower extravascular lung water index ( EVLWI ) compared to dobutamine-treated patients ( p<0.05 ) . HFABP , TNI , and BNP in the levosimendan group were less than in the dobutamine group ( p<0.05 ) . There was no difference in the mechanical ventilation time , length of stay in ICU and hospital , and 28-day mortality between the two groups . Conclusions Compared with dobutamine , levosimendan reduces biomarkers of myocardial injury and improves systemic hemodynamics in patients with septic shock . However , it does not reduce the days on mechanical ventilation , length of stay in ICU and hospital , or 28-day mortality OBJECTIVE To evaluate the effects of levosimendan on hemodynamics and cardiac function in patients with septic shock . METHODS A prospect i ve single-center r and omized controlled trial was conducted . The patients with septic shock admitted to the Department of Critical Care Medicine of the Third Hospital of Hebei Medical University from June 2011 to October 2013 were enrolled . The patients with septic shock received the conventional treatment according to international guidelines for management of severe sepsis and septic shock . Thirty-six patients received the examination of echocardiography and left ventricular ejection fraction (LVEF)≤ 0.45 after fluid resuscitation were enrolled the study , who were divided into two groups according to r and om number table , with 18 cases in each group . After the conventional treatment , the patients in dobutamine group received intravenous injection of 5 μg × kg⁻¹ min⁻¹ dobutamine for 48 hours immediately after fluid resuscitation , and those in levosimendan group received a 24-hour infusion of 5 μg × kg⁻¹ min⁻¹ dobutamine followed by a 24-hour infusion of 0.2 μg × kg⁻¹ × min⁻¹ levosimendan . The hemodynamics and cardiac function were evaluated by pulse indicator continuous cardiac output ( PiCCO ) and ultrasound during treatment . RESULTS Compared with dobutamine group , after the treatment in the levosimendan group , stroke volume index ( SVI ) , cardiac index ( CI ) and left ventricular stroke work index ( LVSWI ) were significantly increased [ SVI ( mL/m² ) : 39.8 ± 5.4 vs. 37.5 ± 4.5 , t=-2.762 , P=0.020 ; CI ( L × min⁻¹ × m⁻² ) : 4.6 ± 0.7 vs. 3.6 ± 0.7 , t=-9.829 , P=0.000 ; LVSWI ( kg ×min⁻ ¹ m⁻² ) : 33.7 ± 2.4 vs. 28.2 ± 1.2 , t=-6.307 , P=0.000 ] , and central venous pressure ( CVP ) , intrathoracic blood volume index ( ITBVI ) and extravascular lung water index ( EVLWI ) were significantly decreased [ CVP ( mmHg , 1 mmHg=0.133 kPa ) : 8.2 ± 0.9 vs. 12.1 ± 0.8 , t=3.928 , P=0.002 ; ITBVI ( mL/m² ) : 820 ± 42 vs. 978 ± 69 , t=9.472 , P=0.000 ; EVLWI ( mL/kg ) : 6.1 ± 1.6 vs. 8.9 ± 1.7 , t=4.467 , P=0.001 ] . Cardiac ultrasound showed that compared with dobutamine group , in the levosimendan group , left ventricular end-systolic volume ( LVESI ) and end-diastolic volume ( LVEDI ) were significantly lowered [ LVESI ( mL/m² ) : 32.7 ± 9.2 vs. 48.2 ± 1 Output:
Blood lactate was significantly reduced in the levosimendan group while there was no difference in MAP , CI , norepinephrine dose and length of ICU stay . Conclusions Findings from this meta- analysis demonstrated that levosimendan treatment may not reduce mortality in patients with septic shock .
MS2_1shot21
***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 This study was design ed to evaluate the impact of a teleassistance system on the metabolic control of type 2 diabetes patients . RESEARCH DESIGN AND METHODS We conducted a 1-year controlled parallel-group trial comparing patients r and omized ( 1 ) to an intervention group , assigned to a teleassistance system using real-time transmission of blood glucose results , with immediate reply when necessary , and telephone consultations , or ( 2 ) to a control group , being regularly followed-up at their healthcare center . Study subjects were type 2 diabetes patients > 30 years of age followed in the primary care setting . RESULTS A total of 328 type 2 diabetes patients were recruited from 35 family practice s in the province of Málaga , Spain . There was a reduction in hemoglobin A1c after 12 months from 7.62 + /- 1.60 % to 7.40 + /- 1.43 % ( P = 0.027 ) in the intervention group and from 7.44 + /- 1.31 % to 7.35 + /- 1.38 % ( P = 0.303 ) in the control group . The difference in the change between groups was not statistically significant . There was also a significant decrease in systolic and diastolic blood pressure , total cholesterol , low-density lipoprotein cholesterol , and body mass index in the intervention group . In the control group , the only significant decline was in low-density lipoprotein cholesterol . CONCLUSIONS A teleassistance system using real-time transmission of blood glucose results with an option to make telephone consultations is feasible in the primary care setting as a support tool for family physicians in their follow-up of type 2 diabetes patients OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with st and ard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A cluster-r and omized clinical trial , the Mobile Diabetes Intervention Study , r and omly assigned 26 primary care practice s to one of three stepped treatment groups or a control group ( usual care ) . A total of 163 patients were enrolled and included in analysis . The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period . Secondary outcomes were changes in patient-reported diabetes symptoms , diabetes distress , depression , and other clinical ( blood pressure ) and laboratory ( lipid ) values . Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support . Patients received automated , real-time educational and behavioral messaging in response to individually analyzed blood glucose values , diabetes medications , and lifestyle behaviors communicated by mobile phone . Providers received quarterly reports summarizing patient ’s glycemic control , diabetes medication management , lifestyle behaviors , and evidence -based treatment options . RESULTS The mean declines in glycated hemoglobin were 1.9 % in the maximal treatment group and 0.7 % in the usual care group , a difference of 1.2 % ( P = 0.001 ) over 12 months . Appreciable differences were not observed between groups for patient-reported diabetes distress , depression , diabetes symptoms , or blood pressure and lipid levels ( all P > 0.05 ) . CONCLUSIONS The combination of behavioral mobile coaching with blood glucose data , lifestyle behaviors , and patient self-management data individually analyzed and presented with evidence -based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year Background There is a strong will and need to find alternative models of health care delivery driven by the ever-increasing burden of chronic diseases . Objective The purpose of this 1-year trial was to study whether a structured mobile phone-based health coaching program , which was supported by a remote monitoring system , could be used to improve the health-related quality of life ( HRQL ) and /or the clinical measures of type 2 diabetes and heart disease patients . Methods A r and omized controlled trial was conducted among type 2 diabetes patients and heart disease patients of the South Karelia Social and Health Care District . Patients were recruited by sending invitations to r and omly selected patients using the electronic health records system . Health coaches called patients every 4 to 6 weeks and patients were encouraged to self-monitor their weight , blood pressure , blood glucose ( diabetics ) , and steps ( heart disease patients ) once per week . The primary outcome was HRQL measured by the Short Form ( 36 ) Health Survey ( SF-36 ) and glycosylated hemoglobin ( HbA1c ) among diabetic patients . The clinical measures assessed were blood pressure , weight , waist circumference , and lipid levels . Results A total of 267 heart patients and 250 diabetes patients started in the trial , of which 246 and 225 patients concluded the end-point assessment s , respectively . Withdrawal from the study was associated with the patients ’ unfamiliarity with mobile phones — of the 41 dropouts , 85 % ( 11/13 ) of the heart disease patients and 88 % ( 14/16 ) of the diabetes patients were familiar with mobile phones , whereas the corresponding percentages were 97.1 % ( 231/238 ) and 98.6 % ( 208/211 ) , respectively , among the rest of the patients ( P=.02 and P=.004 ) . Withdrawal was also associated with heart disease patients ’ comorbidities—40 % ( 8/20 ) of the dropouts had at least one comorbidity , whereas the corresponding percentage was 18.9 % ( 47/249 ) among the rest of the patients ( P=.02 ) . The intervention showed no statistically significant benefits over the current practice with regard to health-related quality of life — heart disease patients : beta=0.730 ( P=.36 ) for the physical component score and beta=-0.608 ( P=.62 ) for the mental component score ; diabetes patients : beta=0.875 ( P=.85 ) for the physical component score and beta=-0.770 ( P=.52 ) for the mental component score . There was a significant difference in waist circumference in the type 2 diabetes group ( beta=-1.711 , P=.01 ) . There were no differences in any other outcome variables . Conclusions A health coaching program supported with telemonitoring did not improve heart disease patients ' or diabetes patients ' quality of life or their clinical condition . There were indications that the intervention had a differential effect on heart patients and diabetes patients . Diabetes patients may be more prone to benefit from this kind of intervention . This should not be neglected when developing new ways for self-management of chronic diseases . Trial Registration Clinical Trials.gov NCT01310491 ; http:// clinical trials.gov/ct2/show/NCT01310491 ( Archived by WebCite at http://www.webcitation.org/6Z8l5FwAM ) BACKGROUND Drawing on previous web-based diabetes management programs based on the Chronic Care Model , we exp and ed an intervention to include care management through mobile phones and a game console web browser . METHODS The pilot intervention enrolled eight diabetes patients from the University of Washington in Seattle into a collaborative care program : connecting them to a care provider specializing in diabetes , providing access to their full electronic medical record , allowing wireless glucose uploads and e-mail with providers , and connecting them to the program 's web services through a game system . To evaluate the study , we conducted qualitative thematic analysis of semistructured interviews . RESULTS Participants expressed frustrations with using the cell phones and the game system in their everyday lives , but liked the wireless system for collaborating with a provider on uploaded glucoses and receiving automatic feedback on their blood sugar trends . A majority of participants also expressed that their participation in the trial increased their health awareness . DISCUSSION Mobile communication technologies showed promise within a web-based collaborative care program for type 2 diabetes . Future intervention design should focus on integrating easy-to-use applications within mobile technologies already familiar to patients and ensure the system allows for sufficient collaboration with a care provider Objective Few interventions have combined life-style and psychosocial approaches in the context of Type 2 diabetes management . The purpose of this study was to determine the effect of a multicomponent behavioral intervention on weight , glycemic control , renal function , and depressive symptoms in a sample of overweight/obese adults with Type 2 diabetes and marked depressive symptoms . Methods A sample of 111 adults with Type 2 diabetes were r and omly assigned to a 1-year intervention ( n = 57 ) or usual care ( n = 54 ) in a parallel groups design . Primary outcomes included weight , glycosylated hemoglobin , and Beck Depression Inventory II score . Estimated glomerular filtration rate served as a secondary outcome . All measures were assessed at baseline and 6 and 12 months after r and omization by assessors blind to r and omization . Latent growth modeling was used to examine intervention effects on each outcome . Results The intervention result ed in decreased weight ( mean [ M ] = 0.322 kg , st and ard error [ SE ] = 0.124 kg , p = .010 ) and glycosylated hemoglobin ( M = 0.066 % , SE = 0.028 % , p = .017 ) , and Beck Depression Inventory II scores ( M = 1.009 , SE = 0.226 , p < .001 ) , and improved estimated glomerular filtration rate ( M = 0.742 ml·min−1·1.73 m−2 , SE = 0.318 ml·min−1·1.73 m−2 , p = .020 ) each month during the first 6 months relative to usual care . Conclusions Multicomponent behavioral interventions targeting weight loss and depressive symptoms as well as diet and physical activity are efficacious in the management of Type 2 diabetes . Trial Registration : This study is registered at Clinical trials.gov ID : NCT01739205 Aim To explain the subadditive efficacy typically observed with initial combination treatments for type 2 diabetes . Methods Individual subject data from 1186 patients with type 2 diabetes [ mean glycated haemoglobin ( HbA1c ) = 8.8 % ] treated with metformin , canagliflozin or canagliflozin + metformin were used . The baseline HbA1c versus ΔHbA1c relationships for monotherapy arms were determined using analysis of covariance and then used to predict efficacy in the combination arms by modelling how applying one treatment lowers the ‘ effective baseline HbA1c ’ for a second treatment . The model was further tested using data from several published combination studies . Results The mean ΔHbA1c levels were −1.25 , −1.33 , −1.37 , −1.77 and −1.81 % with metformin , canagliflozin 100 mg , canagliflozin 300 mg , canagliflozin 100 mg/metformin and canagliflozin 300 mg/metformin , respectively . Using the monotherapy results , the predicted efficacy for the canagliflozin/metformin arms was within 10 % of the observed values using the new model , whereas assuming simple additivity overpredicted efficacy in the combination arms by nearly 50 % . For 10 other published initial combination studies , predictions from the new model [ mean ( st and ard error ) predicted ΔHbA1c = 1.67 % ( 0.14 ) ] were much more consistent with observed values [ ΔHbA1c = 1.72 % ( 0.12 ) ] than predictions based on assuming additivity [ predicted ΔHbA1c = 2.19 % ( 0.21 ) ] . Conclusions The less‐than‐additive efficacy commonly seen with initial combination treatments for type 2 diabetes can be largely explained by the impact of baseline HbA1c on the efficacy of individual treatments . Novel formulas have been developed for predicting the efficacy of combination treatments based on the efficacy of individual treatments and the baseline HbA1c of the target patients Abstract Background : Overseeing proper insulin initiation and titration remains a challenging task in diabetes care . Recent advances in mobile technology have enabled new models of collaborative care between patients and healthcare providers ( HCPs ) . We hypothesized that the adoption of such technology could help individuals starting basal insulin achieve better glycemic control compared with st and ard clinical practice . Material s and Methods : This was a 12 ± 2-week r and omized controlled study with 40 individuals with type 2 diabetes who were starting basal insulin due to poor glycemic control . The control group ( n = 20 ) received st and ard face-to-face care and phone follow-up as needed in a tertiary center , whereas the intervention group ( n = 20 ) received care through the cloud-based diabetes management program where regular communications about glycemic control and insulin doses were conducted via patient self-tracking tools , shared decision-making interfaces , secure text messages , and virtual visits ( audio , video , and shared screen control ) instead of office visits . Results : By intention-to-treat analysis , the intervention group achieved a greater hemoglobin A1c decline compared with the control group ( 3.2 ± 1.5 % vs. 2.0 % ± 2.0 % ; P = 0.048 ) . The Diabetes Treatment Satisfaction Question naire showed a significant improvement in the intervention group compared with the control group ( an increase of 10.1 ± 11.7 vs. 2.1 ± 6.5 points ; P = 0.01 ) Output:
No effects of mHealth app interventions were found on blood pressure , serum lipids , or weight . Smartphone apps offered moderate benefits for T2DM self-management .
MS2_1shot22
***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 ers are increasingly investigating the potential for ordinal tasks such as ranking and discrete choice experiments to estimate QALY health state values . However , the assumptions of r and om utility theory , which underpin the statistical models used to provide these estimates , have received insufficient attention . In particular , the assumptions made about the decisions between living states and the death state are not satisfied , at least for some people . Estimated values are likely to be incorrectly anchored with respect to death ( zero ) in such circumstances . Methods Data from the Investigating Choice Experiments for the preferences of older people CAPability instrument ( ICECAP ) valuation exercise were analysed . The values ( previously anchored to the worst possible state ) were rescaled using an ordinal model proposed previously to estimate QALY-like values . Bootstrapping was conducted to vary artificially the proportion of people who conformed to the conventional r and om utility model underpinning the analyses . Results Only 26 % of respondents conformed unequivocally to the assumptions of conventional r and om utility theory . At least 14 % of respondents unequivocally violated the assumptions . Varying the relative proportions of conforming respondents in sensitivity analyses led to large changes in the estimated QALY values , particularly for lower-valued states . As a result these values could be either positive ( considered to be better than death ) or negative ( considered to be worse than death ) . Conclusion Use of a statistical model such as conditional ( multinomial ) regression to anchor quality of life values from ordinal data to death is inappropriate in the presence of respondents who do not conform to the assumptions of conventional r and om utility theory . This is clearest when estimating values for that group of respondents observed in valuation sample s who refuse to consider any living state to be worse than death : in such circumstances the model can not be estimated . Only a valuation task requiring respondents to make choices in which both length and quality of life vary can produce estimates that properly reflect the preferences of all respondents BACKGROUND Selecting elderly persons who need geriatric interventions and making accurate treatment decisions are recurring challenges in geriatrics . Chronological age , although often used , does not seem to be the best selection criterion . Instead , the concept of frailty , which indicates several concurrent losses in re sources , can be used . METHODS The predictive values of chronological age and frailty were investigated in a large community sample of persons aged 65 years and older , r and omly drawn from the register of six municipalities in the northern regions of the Netherl and s ( 45 % of the original addressees ) . The participants ' generative capacity to sustain well-being ( i.e. , self-management abilities ) was used as the main outcome measure . RESULTS When using chronological age instead of frailty , both too many and too few persons were selected . Furthermore , frailty related more strongly ( with beta values ranging from -.25 to -.39 ) to a decline in the participants ' self-management abilities than did chronological age ( with beta values ranging from -.06 to -.14 ) . Chronological age added very little to the explained variances of all outcomes once frailty was included . CONCLUSIONS Using frailty as the criterion to select older persons at risk for interventions may be better than selecting persons based only on their chronological age Proximal femoral fractures in elderly patients are a serious problem in the aging society . Recently , surgical indications have changed due to advancements in medical technology . The purpose of this study was to investigate the outcome of elderly patients with displaced proximal hip fractures according to our positive criteria for surgical treatment . Exclusion criteria included ( 1 ) terminal-stage malignancy ; ( 2 ) a combination of an inability to walk , a severe mental disorder , and caregiver refusal of surgery ; and ( 3 ) nonapproval of the anesthesiologist for surgery . The study group comprised 666 elderly patients . They were categorized into surgically and nonsurgically treated groups , and their treatment outcomes were retrospectively analyzed . The majority of patients were treated surgically ( 97.0 % vs 3.0 % ) . One-year survival rate was higher among surgically treated patients ( 82.2%-91.8 % ) than non-surgically treated patients ( 55 % ) . The major cause of death in nonsurgically treated patients was deterioration of comorbidities ( 66.7 % ) , whereas this was the cause of death in 18.9 % of surgically treated patients . One-year survival rates were worse in both groups with a lower American Society of Anesthesiologists grade . The 1-year survival rate of our patients suggests that our surgical criteria offer a reasonable outcome in surgically and nonsurgically treated patients . American Society of Anesthesiologists grade and preexisting comorbidities were strongly correlated with patient outcome We report a prospect i ve clinical trial of 150 cases for the treatment of unstable intertrochanteric fracture of the neck of the femur . Three methods were tested in our series -- skeletal traction with a tibial pin , medial displacement osteotomy and valgus osteotomy -- with 50 patients in each group . Our results showed no significant difference between those treated with the Dimon and Hughston osteotomy and those treated by the Sarmiento osteotomy . Conservative treatment of skeletal traction for unstable fracture was found to be well tolerated by the Chinese patient . A low mortality and morbidity rate was found in this series with an overall infection rate of 4 per cent Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument All elderly patients with extracapsular hip fractures seen in hospitals in Newcastle upon Tyne over a 12-month period were studied and followed up for six months . At one of the hospitals , patients were r and omised to treatment by AO dynamic hip-screw or by traction . Complications specific to the two treatments were low , and general complications , six-month mortality and prevalence of pain , leg swelling and unhealed sores , showed no difference between the two modes of treatment . Operative treatment gave better anatomical results and a shorter hospital stay , but significantly more of the patients treated by traction showed loss of independence six months after injury INTRODUCTION Mortality after hip fracture remains high in spite of the progress of medicine . Due to the trend toward longer life , the problem of hip fracture is getting more significant . The aim of this study is to determine the effects of surgical treatment in patients with high risk of hip fracture on mortality reduction . METHODS In the retrospective- prospect i ve study , 66 patients aged 65 - 92 with a hip fracture and a high cardiac risk have been analyzed . The risk estimation was based on the Lee index . The patients with three or more risk factors were considered high-risk . The first group consisted of surgically treated patients with a hip fracture and at high cardiac risk , and in the second group were conservatively treated patients with a hip fracture and high cardiac risk . RESULTS In the group of conservatively treated patients , 75 % were women and in operatively treated group 67.6 % . Patient in both group are similar in relation to the participation of risk factor . A difference has been noticed in terms of renal insufficiency ( RI ) . There was 18.8 % conservatively treated patient with RI and 2.9 % in operatively treated group . CONCLUSION Patients with hip fracture and at high cardiac risk have lower mortality when treated surgically The outcome of patients with a displaced intracapsular femoral neck fracture treated non-operatively was assessed at 1 year and compared with patients managed operatively over the same time period . Data were collected prospect ively for 102 consecutive patients . 80 patients underwent hemiarthroplasty and 22 were managed non-operatively . Patients were managed non-operatively if they were felt to have an unacceptably high risk of death within the perioperative period despite medical optimisation . Non-operative management entailed active early mobilisation without bed rest or traction . Patients managed non-operatively had a greater 30-day mortality compared with operatively managed patients . Deaths were due to pre-existing medical conditions or events , which had occurred at the time of hip fracture . No patient in the non-operative treatment group developed pneumonia , pressure sores or thrombo-embolic events . Patients treated non-operatively , who survived 30 days after fracture , had a mortality rate over the following year comparable with those who had undergone surgery . At 1 year , all non-operatively managed patients were able to transfer without pain and 6 of the 11 surviving patients were able to mobilise with walking aids . At 1 year , the majority of surviving non-operatively managed patients were living in their own homes . Surgical intervention is the treatment of choice for the majority of elderly patients with a displaced intracapsular femoral neck fracture . However , in patients with life-threatening medical co-morbidity , non-operative treatment with early mobilisation can yield acceptable results Output:
A significantly higher 30-day and 1-year mortality was revealed in nonoperatively treated hip fracture patients . No data were found examining (HR)QOL and costs .
MS2_1shot23
***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 OBJECTIVE To evaluate the influence of a high-fat meal on the pharmacokinetics and pharmacodynamics of the novel atypical antipsychotic drug ziprasidone . DESIGN Open , r and omized , three-way crossover study . SETTING University-based research facility . SUBJECTS Eight healthy male volunteers . INTERVENTIONS Ziprasidone 20 mg was administered under fasting conditions ( treatment A ) , and directly after ( treatment B ) and 2 hours after ( treatment C ) a st and ard high-fat breakfast . MEASUREMENTS AND MAIN RESULTS Serial blood sample s were obtained over 36 hours . Three objective psychometric tests were employed to evaluate daytime vigilance at baseline and 2 hours after each dose . Ziprasidone had a significant effect on area under the curve ( AUC0-infinity ) , maximum serum concentration , and half-life ( analysis of variance all p<0.05 ) , with the mean AUC0-infinity being significantly greater ( 627.2 + /- 206.4 vs 371.0 + /- 126.5 ng x hr/ml , ANOVA with Bonferroni 's criteria p<0.016 ) and half-life significantly shorter ( 4.7 + /- 0.8 vs 6.6 + /- 1.3 hrs , ANOVA with Bonferroni 's criteria p<0.016 ) after treatment B compared with treatment A. Although similar trends were observed after treatment C compared with treatment A , the differences did not reach statistical significance when Bonferroni 's correction criteria were applied ( p>0.016 ) . CONCLUSION These data suggest an increase in systemic exposure to the highly lipophilic compound ziprasidone when taken after fatty foods , possibly due to improved drug dissolution and solubilization . The drug 's longer half-life under fasting conditions may reflect dissolution-limited absorption , although this could not be directly assessed . Despite postpr and ial increases in ziprasidone AUC0-infinity and maximum concentration , daytime vigilance was not affected OBJECTIVE This prospect i ve , naturalistic study investigated the factors influencing physicians ' choice of antipsychotic drug therapy in the treatment of patients with schizophrenia . METHOD 108 in- and out patients treated at the Department of Psychiatry of the Medical University Innsbruck who started treatment with a new generation antipsychotic ( except clozapine ) were included . The following factors were investigated : sociodemographic and illness-related variables , pretreatment , the reasons for change of treatment ( lack of efficacy , side effects , non-compliance ) , side effects of pretreatment and body-mass-index ( BMI ) . RESULTS Sociodemographic and most illness-related variables did not have an influence on the physicians ' choice of medication . Risperidone was more frequently prescribed in patients with severe positive symptoms than amisulpride or quetiapine . Rigidity , orthostatic dizziness and gynecomastia during pretreatment were frequently associated with starting patients on ziprasidone . In patients with diminished sexual desire ziprasidone was preferred over olanzapine . Amisulpride was used more commonly than olanzapine if patients had experienced weight gain during pretreatment . Moreover , patients who were prescribed amisulpride had a significantly higher BMI in comparison to patients who were prescribed olanzapine . The reasons for current change of treatment , as well as the drug history ( total number of antipsychotic drugs prescribed during the course of the illness ) did not have an influence on the physicians ' choice of antipsychotic . CONCLUSION In summary , the data suggest that side effects have a larger influence on the choice of antipsychotic than demographic or illness-related variables , except the severity of positive symptoms There is limited information on the pharmacokinetics of ziprasidone ( ZIP ) in naturalistic clinical setting s. The objective of this study was to investigate the concentrations of ZIP and its active metabolite S-methyl-dihydroziprasidone ( SMDZ ) , and the dose-normalized concentrations , using routine therapeutic drug monitoring ( TDM ) data . A high-performance liquid chromatographic method for determining serum concentrations of these substances for routine clinical use was established at the TDM Laboratory in Linköping , Sweden . This analytical service was available to all physicians in Sweden . Between January 2001 and December 2004 , 545 analyses , representing sample s from 370 patients , were performed . The median daily ZIP dose was 120 mg ( range 20 -320 mg ) . In all , 121 steady-state trough specimens with essential clinical information were included in the pharmacokinetic evaluation . The median ( 25th to 75th percentile ) serum concentration of ZIP was 125 nmol/L ( 82 - 188 nmol/L ) . The SMDZ : ZIP ratio decreased with increasing serum concentration of ZIP . The median ( 25th to 75th percentile ) dose-normalized concentrations ( nmol L−1 mg−1 d−1 ) for ZIP and SMDZ were 1.13 ( 0.74 - 1.77 ) and 0.62 ( 0.45 - 0.86 ) , respectively , with SMDZ : ZIP ratio of 0.57 ( 0.42 - 0.79 ) . The overall coefficients of variation for dose-normalized serum concentrations of ZIP , SMDZ , and SMDZ : ZIP ratio were 62 % , 56 % , and 57 % , respectively ( n = 121 ) . Smoking women had lower normalized ZIP concentrations than nonsmoking women . Twenty-eight patients with repeated eligible TDM analyses were studied for intraindividual variance over time . In summary , great interindividual and intraindividual differences in ZIP concentrations were observed . TDM of ZIP maybe used for individual dose adjustments and monitoring medication adherence Abstract A double-blind , placebo-controlled , multicenter study , was performed to evaluate the efficacy and safety of ziprasidone in 139 patients with an acute exacerbation of schizophrenia or schizoaffective disorder . Patients were r and omized to receive ziprasidone 40 mg/day , 120 mg/day or placebo for 28 days . Ziprasidone 120 mg/day was significantly more effective than placebo in improving the BPRS total , CGI-S , BPRS depression cluster and BPRS anergia cluster scores ( all P < 0.05 ) . Similarly , the percentages of patients classified as responders on the BPRS ( ≥30 % reduction ) and the CGI improvement ( score ≤2 ) were significantly greater with ziprasidone 120 mg/day compared with placebo ( P < 0.05 ) . The number of patients who experienced an adverse event was similar in all three treatment groups , and discontinuation due to adverse events was rare ( five of 91 ziprasidone-treated patients ) . The most frequently reported adverse events , that were more common in either ziprasidone group than in the placebo group , were dyspepsia , constipation , nausea and abdominal pain . There was a notably low incidence extrapyramidal side-effects ( including akathisia ) and postural hypotension and no pattern of laboratory abnormalities or apparent weight gain . Ziprasidone-treated patients were not clinical ly different from placebo-treated patients on the Simpson-Angus Rating scale , Barnes Akathisia scale and AIMS assessment s. These results indicate that ziprasidone 120 mg/day is effective in the treatment of the positive , negative and affective symptoms of schizophrenia and schizoaffective disorder with a very low side-effect burden BACKGROUND Second-generation antipsychotic drugs were introduced over a decade ago for the treatment of schizophrenia ; however , their purported clinical effectiveness compared with first-generation antipsychotic drugs is still debated . We aim ed to compare the effectiveness of second-generation antipsychotic drugs with that of a low dose of haloperidol , in first-episode schizophrenia . METHODS We did an open r and omised controlled trial of haloperidol versus second-generation antipsychotic drugs in 50 sites , in 14 countries . Eligible patients were aged 18 - 40 years , and met diagnostic criteria for schizophrenia , schizophreniform disorder , or schizoaffective disorder . 498 patients were r and omly assigned by a web-based online system to haloperidol ( 1 - 4 mg per day ; n=103 ) , amisulpride ( 200 - 800 mg per day ; n=104 ) , olanzapine ( 5 - 20 mg per day ; n=105 ) , quetiapine ( 200 - 750 mg per day ; n=104 ) , or ziprasidone ( 40 - 160 mg per day ; n=82 ) ; follow-up was at 1 year . The primary outcome measure was all-cause treatment discontinuation . Patients and their treating physicians were not blinded to the assigned treatment . Analysis was by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N68736636 . FINDINGS The number of patients who discontinued treatment for any cause within 12 months was 63 ( Kaplan-Meier estimate 72 % ) for haloperidol , 32 ( 40 % ) for amisulpride , 30 ( 33 % ) for olanzapine , 51 ( 53 % ) for quetiapine , and 31 ( 45 % ) for ziprasidone . Comparisons with haloperidol showed lower risks for any-cause discontinuation with amisulpride ( hazard ratio [ HR ] 0.37 , [ 95 % CI 0.24 - 0.57 ] ) , olanzapine ( HR 0.28 [ 0.18 - 0.43 ] ) , quetiapine ( HR 0.52 [ 0.35 - 0.76 ] ) , and ziprasidone ( HR 0.51 [ 0.32 - 0.81 ] ) . However , symptom reductions were virtually the same in all the groups , at around 60 % . INTERPRETATION This pragmatic trial suggests that clinical ly meaningful antipsychotic treatment of first-episode of schizophrenia is achievable , for at least 1 year . However , we can not conclude that second-generation drugs are more efficacious than is haloperidol , since discontinuation rates are not necessarily consistent with symptomatic improvement INTRODUCTION Head-to-head comparisons of antipsychotics have predominantly included patients with chronic conditions . The aim of the present study was to compare the efficacy and tolerability of ziprasidone and olanzapine in patients with recent-onset schizophrenia . METHODS The study was an 8-week , double-blind , parallel-group , r and omized , controlled multicenter trial ( NCT00145444 ) . Seventy-six patients with schizophreniform disorder , schizophrenia or schizoaffective disorder ( diagnosis < 5 y ) , and a maximum lifetime antipsychotic treatment < 16 weeks participated in the study . Efficacy of ziprasidone ( 80 - 160 mg/d ) and olanzapine 10 - 20 mg was measured using the Positive and Negative Syndrome Scale ( PANSS ) , the Clinical Global Impression ( CGI ) Scale , the Calgary Depression Scale for Schizophrenia ( CDSS ) , and the Heinrich Quality of Life Scale ( HQLS ) ; tolerability assessment s included laboratory assessment s , body weight , and electroencephalogram . RESULTS Olanzapine ( n = 34 ) and ziprasidone ( n = 39 ) showed equal efficacy as measured by the PANSS , CDSS , CGI , and HQLS . However , mean weight gain was significantly higher in the olanzapine group ( 6.8 vs 0.1 kg , P < .001 ) . Ziprasidone was associated with decreasing levels of triglycerides , cholesterol , and transaminases , while these parameters increased in the olanzapine group ( all P values < .05 ) . There were no significant differences in fasting glucose and prolactin levels or in cardiac or sexual side effects . Patients on ziprasidone used biperiden for extrapyramidal side effects more frequently ( P < .05 ) . DISCUSSION The results of this study indicate that ziprasidone and olanzapine have comparable therapeutic efficacy but differ in their side effect profile . However , there is a risk of a type II error with this sample size . Clinical ly significant weight gain and laboratory abnormalities appear early after initiating treatment and are more prominent with olanzapine , while more patients on ziprasidone received anticholinergic drugs to treat extrapyramidal symptoms BACKGROUND In the treatment of schizophrenia , changing antipsychotics is common when one treatment is suboptimally effective , but the relative effectiveness of drugs used in this strategy is unknown . This r and omized , double-blind study compared olanzapine , quetiapine , risperidone , and ziprasidone in patients who had just discontinued a different atypical antipsychotic . METHOD Subjects with schizophrenia ( N=444 ) who had discontinued the atypical antipsych Output:
Ziprasidone exposure was increased when the medication was administered with food , irrespective of fat content . The findings from this meta- analysis and review suggest that ziprasidone 120 - 160 mg/d is a less effective treatment for psychotic disorders compared with olanzapine and risperidone , but that the low levels of hyperprolactinemia and weight gain/metabolic adverse events associated with ziprasidone may make it a useful option in patients in whom antipsychotics are poorly tolerated for these reasons
MS2_1shot24
***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 a prospect i ve , blinded study to assess and compare the values of preoperative contrast venography and magnetic resonance venography in the detection of deep venous thrombosis in the thigh and pelvis of forty-five consecutive patients who had a displaced acetabular fracture . The magnetic resonance venography and contrast venography were performed an average of seven days ( range , one to twenty-nine days ) after the injury . Twenty-four asymptomatic thrombi were identified with magnetic resonance venography in fifteen ( 33 percent ) of the patients . Four of the thrombi were in the superficial femoral vein , nine were in the common femoral vein , one was in the external iliac vein , seven were in the internal iliac vein , and three were in the common iliac vein . Ten ( 42 percent ) of the twenty-four thrombi were confirmed with contrast venography ; nine of them were located in the thigh . The remaining fourteen thrombi ( 58 percent ) that had been noted on magnetic resonance venography could not be seen with contrast venography because they were located either in the deep pelvic veins or in the uninjured extremity . The thrombi in the internal iliac vein were identified only with magnetic resonance venography . Twelve of the fifteen patients who had thrombi had a filter placed in the inferior vena cava preoperatively . In eight of these patients , the filter was placed because of the findings of magnetic resonance venography alone . Magnetic resonance venography result ed in a change in the therapeutic management of ten ( 22 per cent ) of the forty-five patients . There were no pulmonary emboli . We concluded that magnetic resonance venography is superior to contrast venography for the preoperative evaluation of proximal deep venous thrombosis in patients who have an acetabular fracture . Magnetic resonance venography is non-invasive , does not require the use of contrast medium , images the proximal aspects of both lower extremities simultaneously , and , most importantly , allows for the identification of deep venous thrombosis in the pelvis Magnetic resonance venography is a recently developed , noninvasive means of visualizing the proximal veins of the lower extremity and pelvis . Magnetic resonance venography is compared with st and ard contrast venography in the diagnosis of proximal deep vein thrombosis after total joint arthroplasty . Two hundred seven extremities were evaluated in a blinded study 5 to 7 days after surgery . St and ard contrast venography identified 11 proximal deep vein thromboses . Initial interpretations of the magnetic resonance venographies by staff radiologists identified 5 of the proximal vein thromboses ( sensitivity 45 % ) . Two patients with negative st and ard contrast venographies were identified as positive ( specificity 99 % ) . A retrospective review of all magnetic resonance venographies by a dedicated magnetic resonance angiographer identified 10 of 11 deep vein thromboses seen on st and ard contrast venography ( sensitivity 91 % ) . Both false negatives were identified as positives . St and ard contrast venography remains the gold st and ard for identifying proximal vein thromboses . Emerging magnetic resonance imaging techniques have created a potential alternative modality by which to identify deep vein thrombosis . The present study suggests that st and ard contrast venography continues to be the most accurate modality currently available . Although magnetic resonance venography seems to be accurate , its interpretation requires experience . As costs diminish and experience increases , magnetic resonance venography will have increased importance in the clinical recognition of deep vein thrombosis This is a prospect i ve comparative study of magnetic resonance imaging ( MRI ) of the deep veins versus contrast venography in consecutive patients treated for various injuries to their lower extremities , showing no clinical symptoms of deep vein thrombosis . The majority of examinations referred to in this study were performed according to the following methodology : First , the patient was subjected to MRI . Subsequently , within a 24-h interval , he/she was subjected to contrast venography . The acquired results were compared in a blinded manner . The diagnostic indices for MRI were calculated on the assumption that the results of contrast venography were sure to give an accurate indication of either presence or absence of thrombosis . Thirty-six patients were included in the study , of which 27 ( 15 males ) completed it . The overall incidence of distal deep venous thrombosis ( DVT ) was 22 % ( 6/27 ) . One patient showed extension of a crural thrombus into the popliteal vein . MRI did not detect any of the thrombi . This lack of result was ascribed to failure to fully demonstrate all segments of the crural veins . However , MRI did show three proximal thrombi in the superficial femoral vein , which were not shown by the venograms . Thus , both the sensitivity and specificity of MRI were 0 % , so MRI proved to be of no value in the diagnosis of asymptomatic deep venous thrombosis in this study RATIONALE AND OBJECTIVES The authors performed this study to compare magnetic resonance ( MR ) venography and conventional venography in the diagnosis of deep venous thrombosis ( DVT ) in the calf after sonography . MATERIAL S AND METHODS Sonography was performed in 595 patients who were suspected of having lower-extremity DVT . Patients with positive above-knee duplex sonograms , allergy to iodinated contrast material , renal insufficiency , or cardiac pacemakers and patients who were obese were excluded . The remaining 73 patients were asked to undergo MR venography and conventional venography . All studies were to be performed within 48 hours of the clinical diagnosis and according to st and ard clinical practice . Images were interpreted by radiologists who were blinded to the results of other modalities . Two separate analyses were performed : one in which conventional venography was used as the st and ard of reference , and one in which the presence of at least two positive studies for thrombus was considered diagnostic . RESULTS Although 36 patients agreed to participate in the study , only 14 underwent MR venography and conventional venography within 48 hours of the clinical diagnosis . With use of any two positive studies for confirmation , acute DVT was diagnosed in three patients . Conventional venography depicted two of the three cases , whereas sonography and MR venography each depicted all three . The findings were concordant in only five of the 14 patients . CONCLUSION Moderate discrepancy among modalities was demonstrated . This suggests radiologists should undertake comparisons among these three modalities for the detection of calf DVT . In patients with a high clinical suspicion , a second modality may be useful if the initial study is negative The aims of this study were to optimize image quality for indirect CT venography ( sequential versus spiral ) , and to evaluate different image reconstruction parameters for patients with suspected deep venous thrombosis ( DVT ) . Fifty-one patients ( 26/25 with/without DVT ) were prospect ively evaluated for pulmonary embolism ( PE ) with st and ard multidetector-row computed tomography ( MDCT ) protocol s. Retrospective image reconstruction was done with different slice thicknesses and reconstruction increments in sequential and spiral modes . All reconstructions were read for depiction of DVT and to evaluate best reconstruction parameters in comparison with the thinnest reconstruction ( “ gold st and ard ” ) . Image noise and venous enhancement were measured as objective criteria for image quality . Subjective image quality was rated on a four-point scale . Effective dose was estimated for all reconstructions . In sequential 10/50 reconstruction DVT was completely detected in 13/26 cases , partially in 10/26 cases and was not detected at all in 3/26 cases , and 15/26 , 9/26 and 2/26 cases for the 10/20 reconstruction , respectively . DVT was completely detected in all spiral reconstructions . Image noise ranged between 14.8 - 29.1 HU . Median image quality was 2 . Estimated effective dose ranged between 2.3 mSv and 11.8 mSv . Gaps in sequential protocol s may lead to false negative results . Therefore , spiral scanning protocol s for complete depiction of DVT are m and atory Despite considerable recent advances in diagnostic techniques for lower-limb deep venous thrombosis ( DVT ) , current methods have disadvantages . Ultrasonography , the most accurate noninvasive test , is widely available and cheap . As such , it has largely replaced venography as the test of first choice for symptomatic DVT . In a recent meta- analysis , the sensitivity of ultrasonography was 89 % overall for symptomatic DVT and 97 % for above-knee thrombosis ( 1 ) . Large outcome studies have shown that patients may be safely left untreated after a negative result on ultrasonography if they have a low clinical risk score , a low d-dimer level , or a negative result on repeated ultrasonography at 1 week ( 2 - 4 ) . However , these strategies may be complex and still require 3 % to 34 % of out patients and most in patients to undergo repeated ultrasonography at 1 week ( 2 - 4 ) . In practice , retesting after 1 week is inconvenient , and physicians often rely on a single test or request immediate venography ( 5 ) . Other problems with ultrasonography include poor sensitivity for asymptomatic disease , difficulties in diagnosing DVT recurrence , and limited visualization in the pelvis ( 1 , 6 , 7 ) . Impedance plethysmography is also commonly used ; however , it has a lower diagnostic accuracy than ultrasonography and has similar weaknesses in the setting of recurrent thrombosis , asymptomatic DVT , and DVT below the knee or in the pelvis ( 1 , 4 , 6 ) . Computed tomography and magnetic resonance imaging techniques can visualize DVT above the knee and in the pelvis but in general are unsuccessful below the knee ( 8 - 10 ) . The ability of these techniques to diagnose DVT recurrence and asymptomatic disease has not been tested . Venography is the reference st and ard diagnostic test , but it has in large part been replaced by noninvasive tests . In clinical practice , it is the most reliable test for the diagnosis of asymptomatic thrombosis and thrombosis isolated within the calf or pelvis . However , imaging in the pelvis is inadequate in up to 24 % of normal studies , and the proximal extent of thrombosis is frequently not delineated in patients with above-knee DVT ( 11 ) . Underfilling of vessels and vessels overlying one another also create problems with venography below the knee . Studies have shown that interobserver variability for venography is high ( 10 % to 16 % ) , especially below the knee ( = 0.46 to 0.73 below the knee and 0.46 to 0.84 above the knee ) ( 12 , 13 ) . In addition , a high proportion of studies are nondiagnostic for possible DVT recurrence ( 1 , 6 ) . A noninvasive test is needed that accurately diagnoses above-knee DVT and thrombus below the knee , in the pelvis , and in asymptomatic limbs . Unlike most imaging techniques , which identify thrombus as filling defects , magnetic resonance direct thrombus imaging ( MRDTI ) visualizes thrombus against a suppressed background ( 14 ) . In an unblinded comparison with venography , we previously showed that MRDTI precisely visualizes acute deep venous thrombus ( 14 , 15 ) . In the current study , we sought to assess prospect ively whether MRDTI is a reliable diagnostic test for suspected acute symptomatic DVT . Methods The ethics committee at our institution granted approval for the study , and all participants gave written informed consent . With the exceptions of pregnant women , patients with known contrast allergy , and those with renal failure , all patients with DVT suspected on the basis of lower limb symptoms are investigated by using venography at our institution . Participants were recruited after routine venography was done between May 1998 and September 1999 . During this time , 338 consecutive patients underwent routine contrast venography . Consecutive patients with positive venograms were selected , along with one quarter of those with negative venograms , according to a predetermined r and om sequence . This protocol was chosen to equalize the numbers of positive and negative cases and was based on a 6-month audit of venograms in our institution that found that 22 % of venograms were positive . Clinical diagnostic criteria were not used , and the decision to request investigation for suspected DVT had been made by the attending clinician ; however , patients who did not have leg symptoms were not recruited . Other exclusion criteria were failed or inconclusive venography , failed or inconclusive MRDTI , contraindications to MRI , and claustrophobia ( Figure 1 ) . Individual venous segments that were nondiagnostic at venography were also excluded from analysis . Figure 1 . Outline of the study . Magnetic resonance direct thrombus imaging was performed on all patients recruited within 48 hours of venography . The scans were interpreted by an experienced radiologist ( review er A ) and by a nonradiologist ( review er B ) trained to read MRDTI scans . For venograms and MRDTI scans , the review ers noted the presence or absence of DVT ; the diagnostic classification of DVT , divided into isolated calf DVT , femoropopliteal DVT , and ileofemoral DVT ; and the presence of thrombus in the calf , femoropopliteal , and iliac venous segments . Venograms were obtained and initially reported by the radiologists on duty . This initial report was used to make recruitment decisions ; if the results were discordant with those of MRDTI , ultrasonography was also performed . However , ultrasonography was not used in the calculations of the accuracy of MRDTI . After completion of the study , venograms were interpreted by an independent radiologist , and these results were used as the gold st and ard against which MRDTI was compared . Results of MRDTI and venography were reported without Output:
MRI has equivalent sensitivity and specificity to ultrasound for diagnosis of DVT , but has been evaluated in many fewer studies , using a variety of different techniques
MS2_1shot25
***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 —Extracorporeal circulation induces a systemic inflammatory response , which may adversely affect organ function . One manifestation of this response is increased fibrinolysis . Antifibrinolytic drugs such as aprotinin and & egr;-aminocaproic acid have been effective in reducing fibrinolysis and blood loss after extracorporeal circulation ; however , the effects of antifibrinolytic drugs on proinflammatory and anti-inflammatory mediators are not known . This study examined the effects of aprotinin and & egr;-aminocaproic acid on plasma levels of proinflammatory [ interleukin-6 ( IL-6 ) ] and anti-inflammatory [ interleukin-10 ( IL-10 ) ] cytokines during and after extracorporeal circulation . Methods and Results —Seventy-two patients undergoing coronary artery bypass grafting with extracorporeal circulation were r and omly assigned in a double-blind study to receive high-dose aprotinin , & egr;-aminocaproic acid , or saline placebo . Plasma levels of IL-6 and IL-10 were measured at 5 time points before , during , and after extracorporeal circulation . In all 3 groups , both IL-6 and IL-10 rose significantly after institution of extracorporeal circulation and remained elevated through the first postoperative day . Compared with saline , aprotinin significantly reduced IL-10 ( P = 0.02 ) and peak IL-6 ( P = 0.02 ) after extracorporeal circulation . In contrast , none of the reductions in IL-6 and IL-10 by & egr;-aminocaproic acid achieved statistical significance . Both aprotinin and & egr;-aminocaproic acid decreased blood loss compared with saline , but there was no significant difference in the number of patients receiving blood products among the treatment groups . Conclusions —These data suggest that aprotinin and & egr;-aminocaproic acid differ in their effects on the inflammatory response to extracorporeal circulation . Aprotinin but not & egr;-aminocaproic acid appears to attenuate the rise in the proinflammatory and anti-inflammatory cytokines IL-6 and IL-10 . Further studies will be required to determine if these cytokine alterations translate to changes in clinical outcomes OBJECTIVES To examine pump-prime aprotinin action on coagulation and fibrinolysis in patients undergoing primary coronary revascularization . DESIGN A prospect i ve r and omized study . SETTING A university hospital . PARTICIPANTS Forty-three patients were r and omly assigned to either group A , 21 patients treated with 2 x 10(6 ) kallikrein inhibitor units ( KIU ) of aprotinin in the cardiopulmonary bypass ( CPB ) prime , or group B , 22 patients , untreated . INTERVENTIONS Patients , scheduled for elective coronary surgery , were treated with 2 x 10(6 ) KIU of aprotinin in the CPB prime . Markers of coagulation and fibrinolysis were evaluated . MEASUREMENTS AND MAIN RESULTS Surgical times , number of reopenings , and allogeneic blood requirements were collected for each patient . Blood sample s were obtained before and after surgery for assessing coagulation ( prothrombin time [ PT ] , activated partial thromboplastin time [ aPTT ] , ethanol test , factor VII , antithrombin III [ AT III ] , thrombin-antithrombin III complex [ TAT ] , fragment 1.2 of prothrombin [ F1.2 ] ) and fibrinolysis ( fibrin degradation products [ FOP ] , plasmin-antiplasmin complexes [ PAP ] , D-dimers ) markers variations . In group A surgical times were faster , there were fewer reopenings ( 0 v 3 ) , and fewer blood transfusions ( 1 patient v 4 patients ) . The two groups did not differ for PT , aPTT , and fibrinogen measurements . Postoperative FDP ( measurable in more patients of group B at the end of the operation ) , PAP , and D-dimers postoperatory levels ( less increased in aprotinin group ) show the antifibrinolytic properties of the drug . Regarding the coagulation markers , factor VII decreased , whereas TAT and F1.2 increased , all to a lesser extent in the aprotinin group compared with the untreated patients , at the end of operation . CONCLUSION Pump-prime aprotinin minimized , even if not completely inhibited , the activation of coagulation and fibrinolysis during CPB , possibly ensuring a less complicated and safer postoperative recovery . It seemed to allow the maintenance of a correct balance of hemostatic systems , avoiding the risk of thrombotic phenomena The serine proteinase inhibitor aprotinin significantly reduces postoperative blood loss in patients requiring cardiac surgery using cardiopulmonary bypass . This study compared two low‐dose regimens with administration of high‐dose aprotinin and a control protocol to determine whether the dose of aprotinin could be greatly decreased but still maintain efficacy after primary cardiac surgery . Some 100 patients were r and omly assigned to one of four groups : control group ( 0·9 per cent saline placebo , n = 25 ) ; high‐dose group ( aprotinin 2 × 106 kallikrein inactivator ( KI ) units intravenous patient bolus and 0·5 × 106 KI units h−1 plus 2 × 106 KI units into pump prime , n = 25 ) ; prime group ( aprotinin 2 × 106 KI units added to the pump prime , n = 24 ) ; and patient group ( aprotinin 106 KI units intravenous patient bolus plus 106 KI units added to the pump prime , n = 26 ) . Only patients from the high‐dose and patient groups had reduced intraoperative blood loss , but patients from all three aprotinin‐treated groups demonstrated a significant decrease in median postoperative blood loss compared with the control group ( high‐dose 350 ml , prime 420 ml , patient 340 ml versus control 780 ml ; P < 0·001 ) . There was an even greater reduction in measured median postoperative haemoglobin loss within the chest drains in the treated compared with the control patients ( high‐dose 15 g , prime 24 g , patient 14 g versus control 47 g ; P < 0·001 ) . These decreases were statistically the same for all the treated groups ; it is possible to lower the dose of aprotinin to approximately one‐third of the currently recommended dosage and still obtain significantly reduced postoperative blood loss in primary cardiac surgery To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Background Patients on cardiopulmonary bypass ( CPB ) have an increased susceptibility to postoperative bleeding . Previous reports using desmopressin acetate ( DDAVP ) for the prevention of postoperative bleeding have given contradictory results , whereas the protease inhibitor aprotinin has been shown to reduce blood loss after this type of surgery . This r and omized study was performed to assess the efficacy of DDAVP versus aprotinin in the prevention of bleeding after CPB . Methods and Results One hundred nine of 122 eligible patients were r and omized to four different groups : Group A ( n=28 ) received aprotinin starting with a bolus of 2 × 106 KIU followed by a continuous infusion of 0.5 × 106 KIU/h until the end of surgery ; group B ( n=25 ) received of DDAVP 0.3 μ/kg IV on completion of CPB ; group C ( n=28 ) received two doses of DDAVP , the first as in group B and an additional dose 6 hours after surgery ; group D ( n=28 ) received no treatment . There was a marked reduction of postoperative blood loss either at 12 hours ( P<.01 ) or 72 hours ( P<.02 ) in the aprotinin group compared with all other groups , whereas no significant effect was observed in either of the two DDAVP regimens . A significant reduction in the amount of blood used was observed only in the aprotinin group ( P<.01 ) . Of the plasma fibrinolytic components assayed , there was a significant reduction of the fibrin degradation product generation in the aprotinin group ( P<.001 ) , whereas a significant systemic hyperfibrinolysis was observed in both DDAVP-treated groups and the control group . No side effects related to the study drugs were observed in any patient . Conclusions Aprotinin inhibited fibrinolysis ; this correlated with a significant reduction of postoperative blood loss and need for blood replacement after CPB . Neither one nor two doses of DDAVP had a beneficial effect . Aprotinin offers better alternative than DDAVP in the prevention of bleeding after CPB BACKGROUND Aprotinin therapy is now widely used during cardiac surgery . This study examined the clinical and economic effectiveness of high-dose or low-dose aprotinin in comparison to placebo . METHODS In a double blind , r and omized study , three groups of 50 patients received high-dose aprotinin costing AUS$614 per patient ( AUS$ = Australian dollars ) , low-dose aprotinin costing AUS$220 per patient or placebo . Re source use influenced by aprotinin therapy was measured . RESULTS Both doses were effective in reducing chest drainage and postoperative transfusion requirements , high-dose being more effective than low-dose . Both doses reduced the rate of reoperations for hemostasis . A base case of statistically significant differences associated with the high-dose and low-dose aprotinin showed cost savings of AUS$77 and AUS$348 per patient , respectively . If the demonstrated less significant reductions in operating room and ward stay are included , these savings become AUS$463 and AUS$715 , respectively . Alternately , if cross-matches are replaced by group- and -hold and cell savers are not used , the savings per patient would be AUS$196 and AUS$467 , respectively . CONCLUSIONS While high-dose aprotinin is clinical ly more effective than low-dose aprotinin , low-dose therapy demonstrates greater cost savings The effectiveness and mechanism of aprotinin reduced bleeding after cardiopulmonary bypass surgery was studied in a double blind r and omised study of 106 patients undergoing valve replacement surgery . Aprotinin therapy was associated with significant reduction in perioperative bleeding and postoperative blood transfusion requirements . Although initially tissue plasminogen activator ( t-PA ) activity was lower in the aprotinin than placebo group , as surgery proceeded this difference was reversed due to less plasminogen activator inhibitor-1 release in the aprotinin group . This indicates that aprotinin-mediated suppression of fibrinolysis as demonstrated by reduced D-dimer concentration was not related to t-PA . Furthermore , similar perioperative reduction of plasminogen levels in aprotinin and placebo groups indicated a similar degree of conversion of plasminogen to plasmin . However , less plasmin bound with alpha 2-antiplasmin in the plasma in the aprotinin group as it was already complexed with aprotinin where it remained protected from the natural inhibitor on the intact fibrin surface . The reduced fibrinolytic activity of the aprotinin group was thus brought about by the complexing of aprotinin with the plasmin which was bound to the fibrin surface Sixty consecutive patients undergoing elective open-heart surgery were prospect ively enrolled in a study to compare the efficacy of 3 different antifibrinolytic drugs to reduce postoperative bleeding and to reduce homologous blood requirements in combination with blood-saving techniques and restrictive indications for blood transfusion . The patients were r and omized to 1 of 4 intraoperative treatment regimens : 1 ) control ( no antifibrinolytic therapy ) ; 2 ) epsilon-aminocaproic acid ( 10 g IV at induction of anesthesia , followed by infusion of 2 g/h for 5 hours ) ; 3 ) tranexamic acid ( 10 mg/kg IV within 30 minutes after induction of anesthesia , followed by infusion of 1 mg/kg per hour for 10 hours ) ; or 4 ) high-dose aprotinin ( 2 million KIU IV at induction Output:
Conclusions This study demonstrates that investigators evaluating aprotinin were not adequately citing previous research , result ing in a large number of RCTs being conducted to address efficacy questions that prior trials had already definitively answered .
MS2_1shot26
***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 This study was design ed to determine whether increasing the dose of doxorubicin in or adding paclitaxel to a st and ard adjuvant chemotherapy regimen for breast cancer patients would prolong time to recurrence and survival . PATIENTS AND METHODS After surgical treatment , 3,121 women with operable breast cancer and involved lymph nodes were r and omly assigned to receive a combination of cyclophosphamide ( C ) , 600 mg/m(2 ) , with one of three doses of doxorubicin ( A ) , 60 , 75 , or 90 mg/m(2 ) , for four cycles followed by either no further therapy or four cycles of paclitaxel at 175 mg/m(2 ) . Tamoxifen was given to 94 % of patients with hormone receptor-positive tumors . RESULTS There was no evidence of a doxorubicin dose effect . At 5 years , disease-free survival was 69 % , 66 % , and 67 % for patients r and omly assigned to 60 , 75 , and 90 mg/m(2 ) , respectively . The hazard reductions from adding paclitaxel to CA were 17 % for recurrence ( adjusted Wald chi(2 ) P = .0023 ; unadjusted Wilcoxon P = .0011 ) and 18 % for death ( adjusted P = .0064 ; unadjusted P = .0098 ) . At 5 years , the disease-free survival ( + /- SE ) was 65 % ( + /- 1 ) and 70 % ( + /- 1 ) , and overall survival was 77 % ( + /- 1 ) and 80 % ( + /- 1 ) after CA alone or CA plus paclitaxel , respectively . The effects of adding paclitaxel were not significantly different in subsets defined by the protocol , but in an unplanned subset analysis , the hazard ratio of CA plus paclitaxel versus CA alone was 0.72 ( 95 % confidence interval , 0.59 to 0.86 ) for those with estrogen receptor-negative tumors and only 0.91 ( 95 % confidence interval , 0.78 to 1.07 ) for patients with estrogen receptor-positive tumors , almost all of whom received adjuvant tamoxifen . The additional toxicity from adding four cycles of paclitaxel was generally modest . CONCLUSION The addition of four cycles of paclitaxel after the completion of a st and ard course of CA improves the disease-free and overall survival of patients with early breast cancer BACKGROUND The purpose was to compare disease-free survival ( DFS ) between epirubicin-based chemoendocrine therapy and tamoxifen alone in one to three node-positive ( N1 - 3 ) , estrogen-receptor-positive ( ER+ ) , postmenopausal early breast cancer ( EBC ) patients . PATIENTS AND METHODS We analyzed , retrospectively , 457 patients r and omized in FASG 02 and 07 trials who received : tamoxifen alone ( 30 mg/day , 3 years ) ; or FEC50 ( fluorouracil 500 mg/m2 , epirubicin 50 mg/m2 , cyclophosphamide 500 mg/m2 , six cycles every 21 days ) plus tamoxifen started concurrently . Radiotherapy was delivered after the third cycle in FASG 02 trial , and after the sixth in FASG 07 trial . RESULTS The 9-year DFS rates were 72 % with tamoxifen and 84 % with FEC50-tamoxifen ( P = 0.008 ) . The multivariate analysis showed that pathological tumor size > 2 cm was an independent prognostic factor ( P = 0.002 ) , and treatment effects remained significantly in favor of chemoendocrine therapy ( P = 0.0008 ) . The 9-year overall survival rates were 78 % and 86 % , respectively ( P = 0.11 ) . In the multivariate model , there was a trend in favor of chemoendocrine therapy ( P = 0.07 ) . CONCLUSION The addition of FEC50 adjuvant chemotherapy to tamoxifen significantly improves long-term DFS in N1 - 3 , ER+ and postmenopausal women . Chemoendocrine therapy seems to be more effective than tamoxifen in terms of long-term survival BACKGROUND Amplification of the human epidermal growth factor receptor type 2 ( HER2 , also called HER2/neu ) gene and overexpression of its product in breast-cancer cells may be associated with responsiveness to anthracycline-containing chemotherapy regimens . METHODS In the r and omized , controlled Mammary.5 trial , we studied 639 formalin-fixed paraffin-embedded specimens obtained from 710 premenopausal women with node-positive breast cancer who had received either cyclophosphamide , epirubicin , and fluorouracil ( CEF ) or cyclophosphamide , methotrexate , and fluorouracil ( CMF ) as adjuvant chemotherapy . HER2 amplification or overexpression was evaluated with the use of fluorescence in situ hybridization , immunohistochemical analysis , and polymerase-chain-reaction analysis . RESULTS Amplification of HER2 was associated with a poor prognosis regardless of the type of treatment . In patients whose tumors showed amplification of HER2 , CEF was superior to CMF when assessed on the basis of relapse-free survival ( hazard ratio , 0.52 ; 95 percent confidence interval , 0.34 to 0.80 ; P=0.003 ) and overall survival ( hazard ratio , 0.65 ; 95 percent confidence interval , 0.42 to 1.02 ; P=0.06 ) . For women whose tumors lacked amplification of HER2 , CEF did not improve relapse-free survival ( hazard ratio for relapse , 0.91 ; 95 percent confidence interval , 0.71 to 1.18 ; P=0.49 ) or overall survival ( hazard ratio for death , 1.06 ; 95 percent confidence interval , 0.83 to 1.44 ; P=0.68 ) . The adjusted hazard ratio for the interaction between treatment and HER2 amplification was 1.96 for relapse-free survival ( 95 percent confidence interval , 1.15 to 3.36 ; P=0.01 ) and 2.04 for overall survival ( 95 percent confidence interval , 1.14 to 3.65 ; P=0.02 ) . CONCLUSIONS Amplification of HER2 in breast-cancer cells is associated with clinical responsiveness to anthracycline-containing chemotherapy . ( cancer.gov number , NCI-V90 - 0027 . ) PURPOSE To determine the influence of the epirubicin dose in operable node-positive breast cancer patients with factors of poor prognosis . PATIENTS AND METHODS Between April 1990 and July 1993 , 565 operable breast cancer patients with either more than three positive nodes or between one and three positive nodes with Scarff Bloom Richardson grade > or = 2 and hormone receptor negativity were r and omized after surgery to receive either fluorouracil 500 mg/m(2 ) , epirubicin 50 mg/m(2 ) , and cyclophosphamide 500 mg/m(2 ) every 21 days for six cycles ( FEC 50 ) or the same regimen except with epirubicin dose of 100 mg/m(2 ) ( FEC 100 ) . Postmenopausal patients received tamoxifen 30 mg/d for 3 years at the beginning of chemotherapy . Radiotherapy was delivered at the end of chemotherapy in both groups . RESULTS The median follow-up was 67 months . The 5-year disease-free survival ( DFS ) was 54.8 % with FEC 50 and 66.3 % with FEC 100 ( P = .03 ) . The 5-year overall survival ( OS ) was 65.3 % and 77.4 % , respectively ( P = .007 ) . The mean relative dose-intensity was similar in the two groups ( 90.3 % and 86.1 % , respectively ) . Neutropenia and anemia were significantly more frequent in FEC 100 ( P < 10(-3 ) ) , as were nausea-vomiting ( P = .008 ) and stomatitis and alopecia ( P < 10(-3 ) ) . Nine cases of grade 3 infection occurred only with FEC 100 , and no toxic deaths occurred . Three cases of acute cardiac toxicity were observed ( FEC50 = 1 , FEC100 = 2 ) and 10 patients ( FEC50 = 6 , FEC100 = 4 ) presented delayed cardiac dysfunctions . Two cases of secondary leukemia were observed ( acute lymphatic leukemia with FEC 50 and acute myelogenous leukemia with FEC 100 ) . CONCLUSION After 5 years of follow-up , the increased epirubicin dose led to a significant benefit in terms of DFS and OS , with a high survival rate among patients with poor-prognosis breast cancer No data are available on the role of HER2 overexpression in predicting the efficacy of dose-dense anthracycline-containing adjuvant chemotherapy in breast cancer patients . We retrospectively evaluated this role in patients enrolled in a phase III study comparing st and ard FEC21 ( 5-fluorouracil , epirubicin , and cyclophosphamide , administered every 3 weeks ) vs dose-dense FEC14 ( the same regimen repeated every 2 weeks ) . HER2 status was determined for 731 of 1214 patients . Statistical analyses were performed to test for interaction between treatment and HER2 status with respect to event-free survival ( EFS ) and overall survival ( OS ) ; EFS and OS were compared within each HER2 subgroup and within each treatment arm . Median follow-up was 6.7 years . Among FEC21-treated patients , both EFS ( HR=2.07 ; 95 % CI 1.27–3.38 ) and OS ( HR=2.47 ; 95 % CI 1.34–4.57 ) were significantly worse in HER2 + patients than in HER2 − patients . Among FEC14-treated patients , differences in either EFS ( HR=1.21 ; 95 % CI 0.65–2.24 ) or OS ( HR=1.85 ; 95 % CI 0.88–3.89 ) between HER2 + and HER2 − patients were not statistically significant . Interaction analysis suggested that the use of dose-dense FEC14 might remove the negative prognostic effect of HER2 overexpression on EFS and OS . Our data suggest a potential role of HER-2 overexpression in predicting the efficacy of dose-dense epirubicin-containing chemotherapy and the need to confirm this hypothesis in future prospect i ve studies BACKGROUND Overexpression of the erbB-2 protein by breast cancer cells has been suggested to be a predictor of response to doxorubicin . A retrospective study was design ed to test this hypothesis . METHODS In National Surgical Adjuvant Breast and Bowel Project protocol B-11 , patients with axillary lymph node-positive , hormone receptor-negative breast cancer were r and omly assigned to receive either L-phenylalanine mustard plus 5-fluorouracil ( PF ) or a combination of L-phenylalanine mustard , 5-fluorouracil , and doxorubicin ( PAF ) . Tumor cell expression of erbB-2 was determined by immunohistochemistry for 638 of 682 eligible patients . Statistical analyses were performed to test for interaction between treatment and erbB-2 status ( positive versus negative ) with respect to disease-free survival ( DFS ) , survival , recurrence-free survival ( RFS ) , and distant disease-free survival ( DDFS ) . Reported P values are two-sided . RESULTS Overexpression of erbB-2 ( i.e. , positive immunohistochemical staining ) was observed in 239 ( 37.5 % ) of the 638 tumors studied . Overexpression was associated with tumor size ( P=.02 ) , lack of estrogen receptors ( P=.008 ) , and the number of positive lymph nodes ( P=.0001 ) . After a mean time on study of 13.5 years , the clinical benefit from doxorubicin ( PAF versus PF ) was statistically significant for patients with erbB-2-positive tumors -- DFS : relative risk of failure (RR)=0.60 ( 95 % confidence interval [CI]=0.44 - 0.83 ) , P=.001 ; survival : RR=0.66 ( 95 % CI=0.47 - 0.92 ) , P = .01 ; RFS : RR=0.58 ( 95 % CI=0.42 - 0.82 ) , P=.002 ; DDFS : RR=0.61 ( 95 % CI=0.44 - 0.85 ) , P=.003 . However , it was not significant for patients with erbB-2-negative tumors-DFS : RR=0.96 ( 95 % Output:
The published data suggest that nonanthracycline alternatives are less toxic than anthracycline-containing regimens and equally , if not more , efficacious .
MS2_1shot27
***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 BACKGROUND Interleukin 12 ( IL-12 ) , a cytokine that promotes generation of helper T cells subtype 1 , is increased in multiple sclerosis . Albuterol sulfate , a β2-adrenergic agonist , reduces IL-12 expression , so we tested the effect of albuterol as an add-on treatment to glatiramer acetate therapy . OBJECTIVES To investigate the clinical and immunologic effects of albuterol treatment as an add-on therapy in patients starting glatiramer acetate treatment . DESIGN Single-center double-masked clinical trial . SETTING Academic research . Patients Subjects with relapsing-remitting multiple sclerosis . MAIN OUTCOME MEASURES In this single-center double-masked clinical trial , subjects with relapsing-remitting multiple sclerosis were r and omized to receive a subcutaneous injection of glatiramer acetate ( 20 mg ) plus an oral dose of placebo daily for 2 years or a subcutaneous injection of glatiramer acetate ( 20 mg ) plus an oral dose of albuterol daily for 2 years . The primary clinical efficacy measurement was the change in Multiple Sclerosis Functional Composite at 2 years , and the primary immunologic end point was the change in expression of IL-13 and interferon γ at each study time point . The classification level of evidence from this trial is C for each question , as this is the first class II clinical trial addressing the efficacy of glatiramer acetate plus albuterol . RESULTS Forty-four subjects were r and omized to receive glatiramer acetate plus albuterol or glatiramer acetate plus placebo , and 39 subjects contributed to the analysis . Improvement in the Multiple Sclerosis Functional Composite was observed in the glatiramer acetate plus albuterol group at the 6-month ( P = .005 ) and 12-month ( P = .04 ) time points but not at the 24-month time point . A delay in the time to first relapse was also observed in the glatiramer acetate plus albuterol group ( P = .03 ) . Immunologically , IL-13 and interferon-γ production decreased in both treatment groups , and a treatment effect on IL-13 production was observed at the 12-month time point ( P < .05 ) . Adverse events were generally mild , and only 3 moderate or severe events were considered related to the treatment . CONCLUSION Treatment with glatiramer acetate plus albuterol is well tolerated and improves clinical outcomes in patients with multiple sclerosis . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00039988 A double‐blind , r and omized , controlled study was undertaken to determine whether combined use of interferon β‐1a ( IFN ) 30μg intramuscularly weekly and glatiramer acetate ( GA ) 20 mg daily is more efficacious than either agent alone in relapsing – remitting multiple sclerosis OBJECTIVE To study changes in brain volume measured monthly in patients treated for relapsing multiple sclerosis due to loss of tissue and the appearance of inflammation . DESIGN AND PATIENTS The results from T2/fluid-attenuated inversion recovery axial images from 13 consecutive monthly 3-T brain magnetic resonance imaging tests conducted on 74 patients diagnosed with relapsing multiple sclerosis in the BECOME study were used to calculate whole brain volumes using automated software analysis tools . The patients had been r and omized to receive treatment with interferon beta-1b or glatiramer acetate . Ongoing inflammation was studied by counting the number of combined active lesions and measuring the volume of gadolinium enhancement . A mixed-effects model was used to analyze brain volumes over time . RESULTS There was a significant decrease in brain volume over time but there was no difference in its rate of change by age , sex , frequency of ongoing inflammation , multiple sclerosis type , or r and omized treatment assignment . The mean rate of brain volume change per month from multivariable models was -1.1 cm(3 ) ( 95 % CI , -1.5 to -0.6 ) and during times of magnetic resonance imaging activity , it increased transiently by an average of 1.2 cm(3)/lesion ( 95 % CI , 0.7 to 1.7 ) and 7.1 cm(3)/1 cm(3 ) of gadolinium volume . In a model with both measures , combined active lesions were independent predictors of brain volume but gadolinium volume was not . CONCLUSION Two major changes in brain volume occur in patients with relapsing multiple sclerosis , a steady decrease likely due to tissue loss with overlapping transient increases due to the appearance of inflammation Objective : To measure the effects of disease-modifying drugs ( DMDs ) on the development of cortical lesions ( CL ) and cortical atrophy in patients with relapsing – remitting multiple sclerosis ( RRMS ) . Methods : RRMS patients ( n = 165 ) were r and omized to subcutaneous ( sc ) interferon ( IFN ) beta-1a ( 44 mcg three times weekly ) , intramuscular ( i m ) IFN beta-1a ( 30 mcg weekly ) or glatiramer acetate ( GA ; 20 mg daily ) . The reference population comprised 50 untreated patients . Clinical and MRI examinations were performed at baseline , 12 months and 24 months . Results : One hundred and forty-one treated patients completed the study . After 12 months , 37/50 ( 74 % ) of untreated patients developed ≥1 new CL ( mean 1.6 ) , compared with 30/47 ( 64 % ) of i m IFN beta-1a-treated patients ( mean 1.2 , p = 0.021 ) , 24/48 ( 50 % ) of GA-treated patients ( mean 0.8 , p = 0.001 ) and 12/46 ( 26 % ) of sc IFN beta-1a-treated patients ( mean 0.4 , p < 0.001 ) . After 24 months , ≥1 new CL was observed in 41/50 ( 82 % ) of untreated ( mean 3.0 ) , 34/47 ( 72 % ) of i m IFN beta-1a-treated ( mean 1.6 , p < 0.001 ) , 30/48 ( 62 % ) of GA-treated ( mean 1.3 , p < 0.001 ) and 24/46 ( 52 % ) of sc IFN beta-1a-treated patients ( mean 0.8 , p < 0.001 ) . Mean grey matter fraction decrease in DMD-treated patients at 24 months ranged from 0.7 to 0.8 versus 1.0 in untreated patients ( p = 0.023 ) . Conclusions : Disease-modifying drugs significantly decreased new CL development and cortical atrophy progression compared with untreated patients , with faster and more pronounced effects seen with sc IFN beta-1a than with i m IFN beta-1a or GA Evidence of a significant improvement of IFNB-1b in clinical severity in the older population with RRMS has not been established so far . The aim of this exploratory post hoc analysis of the 250 mcg IFNB-1b group of the BEYOND study is to compare the efficacy and safety of older versus younger patients using a cut-off at the age of 50 and at the age of 40 , respectively . There was no difference between age groups in adjusted relapse risk ( age 50 cut-off : P = 0.482 , age 40 cut-off : P = 0.073 ) nor in adjusted time to confirmed EDSS progression ( age 50 cut-off : P = 0.096 , age 40 cut-off : P = 0.189 ) . There were no significant differences between patients < 50 and ≥50 years in the adjusted annualized relapse rate ( P = 0.285 ) , whereas relapse rate was higher in the < 40 as compared to the ≥40 group ( P = 0.024 ) . The proportion of patients with confirmed disability progression was not significantly different for the 50 cutoff ( P = 0.148 ) , whereas significantly fewer < 40 than ≥40 patients had disability progression ( P = 0.047 ) . Only minor differences in adverse event frequencies between the age groups for the two cut-offs were seen . These results indicate that IFNB-1b is as efficacious and safe in patients ≥50 years as < 50 years of age To evaluate the safety , tolerability , and efficacy of glatiramer acetate ( GA ) 40 mg compared to a 20 mg dose Switching treatment may be beneficial in patients with relapsing – remitting multiple sclerosis ( RRMS ) who respond inadequately to first‐line immunomodulatory therapy . The objective of this study was to evaluate clinical outcomes after switching treatment in such patients . This prospect i ve longitudinal observational study included 114 patients with RRMS who failed first‐line monotherapy and were switched treatments after 3 years . Every 3 months , patients underwent a full neurological examination . Outcome was compared between the 3‐year Before Switch and After Switch treatment periods . The primary outcome measure was the annualized relapse rate ; secondary outcome measures were the proportion of relapse‐free patients and the median change in Exp and ed Disability Status Scale ( EDSS ) . Patients were switched either from low‐dose to high‐dose interferon‐β ( IFNβ ; n = 31 ) , from IFNβ to glatiramer acetate ( GA ; n = 52 ) or mitoxantrone ( n = 13 ) , or from GA to IFNβ ( n = 16 ) . In 3 years after switching , annualized relapse rates fell by 57–78 % according to the group . The proportion of relapse‐free patients varied from 56 % to 81 % . Least improved was observed in patients switching between INFβ preparations . Median EDSS scores remained stable in all groups except the GA to IFNβ switchers . In conclusion , patients who fail first‐line immunomodulatory therapy generally benefit from switching to another class of immunomodulatory therapy BACKGROUND Interferon beta-1a and glatiramer acetate are commonly prescribed for relapsing-remitting multiple sclerosis ( RRMS ) , but no published r and omised trials have directly compared these two drugs . Our aim in the REGARD ( REbif vs Glatiramer Acetate in Relapsing MS Disease ) study was to compare interferon beta-1a with glatiramer acetate in patients with RRMS . METHODS In this multicentre , r and omised , comparative , parallel-group , open-label study , patients with RRMS diagnosed with the McDonald criteria who had had at least one relapse within the previous 12 months were r and omised to receive 44 mug subcutaneous interferon beta-1a three times per week or 20 mg subcutaneous glatiramer acetate once per day for 96 weeks to assess the time to first relapse . A sub population of 460 patients ( 230 from each group ) also had serial MRI scans to assess T2-weighted and gadolinium-enhancing lesion number and volume . Treatments were assigned by a computer-generated r and omisation list that was stratified by centre . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00078338 . FINDINGS Between February and December , 2004 , 764 patients were r and omly assigned : 386 to interferon beta-1a and 378 to glatiramer acetate . After 96 weeks , there was no significant difference between groups in time to first relapse ( hazard ratio 0.94 , 95 % CI 0.74 to 1.21 ; p=0.64 ) . Relapse rates were lower than expected : 258 patients ( 126 in the interferon beta-1a group and 132 in the glatiramer acetate group ) had one or more relapses ( the expected number was 460 ) . For secondary outcomes , there were no significant differences for the number and change in volume of T2 active lesions or for the change in the volume of gadolinium-enhancing lesions , although patients treated with interferon beta-1a had significantly fewer gadolinium-enhancing lesions ( 0.24 vs 0.41 lesions per patient per scan , 95 % CI -0.4 to 0.1 ; p=0.0002 ) . Safety and tolerability profiles were consistent with the known profiles for both compounds . The overall number and severity of adverse events were similar between Output:
The effects of IFNs-beta and GA in the treatment of people with RRMS , including clinical ( e.g. people with relapse , risk to progression ) and MRI ( Gd-enhancing lesions ) measures , seem to be similar or to show only small differences . When MRI lesion load accrual is considered , the effect of the two treatments differs , in that IFNs-beta were found to limit the increase in lesion burden as compared with GA . Evidence was insufficient for a comparison of the effects of the two treatments on patient-reported outcomes , such as quality -of-life measures
MS2_1shot28
***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: Of 57 individuals diagnosed with Alzheimer 's disease ( AD ) in a phase III study , 13 ( 23 % ) had amyloid-β ( Aβ ) levels on postmortem histopathology that did not explain the dementia . Based on postmortem histopathology , a wide range of different non-AD conditions was identified , including frontotemporal dementia , hippocampal sclerosis , and dementia with Lewy bodies . Of the histopathologically Aβ negative scored cases ante-mortem Florbetaben PET scans were classified as negative for Aβ in 11 patients based on visual analysis and in all 12 quantifiable cases based on composite st and ardized uptake value ratios . Thus , florbetaben PET can assist physicians in the differential diagnosis of neurodegenerative disorders by reliably excluding Aβ pathology BACKGROUND Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination , Wechsler Adult Intelligence Scale-Revised , Wechsler Memory Scale-Revised , Dementia Rating Scale , Free and Cued Selective Reminding Test , and Auditory Verbal Learning Test . Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer 's Disease and Related Disorders Association criteria , respectively . RESULTS The primary distinction between control subjects and subjects with MCI was in the area of memory , while other cognitive functions were comparable . However , when the subjects with MCI were compared with the patients with very mild AD , memory performance was similar , but patients with AD were more impaired in other cognitive domains as well . Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD . CONCLUSIONS Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD . They appear to constitute a clinical entity that can be characterized for treatment interventions Evaluation of brain β‐amyloid by positron emission tomography ( PET ) imaging can assist in the diagnosis of Alzheimer disease ( AD ) and other dementias Objective : To investigate the 10-year risk of dementia in subjects with mild cognitive impairment ( MCI ) ages 40 to 85 years . Methods : We selected subjects from a memory clinic if they met one of the following definitions of MCI : cognitive complaints ( n = 181 ) , aging-associated cognitive decline ( AACD ) ( n = 163 ) , mild functional impairment ( n = 86 ) , or amnestic MCI ( n = 64 ) . Subjects were reassessed after 2 , 5 , and 10 years . The risk of dementia was calculated with Kaplan-Meier statistics . Analyses were conducted in the entire sample and in subgroups of subjects aged 40 to 54 years , 55 to 69 years , and 70 to 85 years . Results : The 10-year risk of dementia was 0.27 ( 95 % CI 0.20 to 0.34 ) in subjects with cognitive complaints , 0.28 ( 95 % CI 0.21 to 0.35 ) in subjects with AACD , 0.44 ( 95 % CI 0.32 to 0.56 ) in subjects with mild functional impairment , and 0.48 ( 95 % CI 0.35 to 0.61 ) in subjects with amnestic MCI . Ninety-one percent of the demented subjects had probable AD . The risk of dementia increased with increasing age for all MCI definitions ( p < 0.001 ) . Depending on the MCI definition used , the risk for dementia ranged from 0 to 0.06 in subjects aged 40 to 54 years , from 0.37 to 0.52 in subjects aged 55 to 69 years , and from 0.77 to 1.0 in subjects aged 70 to 85 years . Conclusions : The majority of subjects with MCI do not progress to dementia at the long term . Age strongly influences the dementia risk . MCI often represents the predementia stage of a neurodegenerative disorder in elderly subjects but rarely in younger subjects CONTEXT Small single-center studies have shown that cerebrospinal fluid ( CSF ) biomarkers may be useful to identify incipient Alzheimer disease ( AD ) in patients with mild cognitive impairment ( MCI ) , but large-scale multicenter studies have not been conducted . OBJECTIVE To determine the diagnostic accuracy of CSF beta-amyloid(1 - 42 ) ( Abeta42 ) , total tau protein ( T-tau ) , and tau phosphorylated at position threonine 181 ( P-tau ) for predicting incipient AD in patients with MCI . DESIGN , SETTING , AND PARTICIPANTS The study had 2 parts : a cross-sectional study involving patients with AD and controls to identify cut points , followed by a prospect i ve cohort study involving patients with MCI , conducted 1990 - 2007 . A total of 750 individuals with MCI , 529 with AD , and 304 controls were recruited by 12 centers in Europe and the United States . Individuals with MCI were followed up for at least 2 years or until symptoms had progressed to clinical dementia . MAIN OUTCOME MEASURES Sensitivity , specificity , positive and negative likelihood ratios ( LRs ) of CSF Abeta42 , T-tau , and P-tau for identifying incipient AD . RESULTS During follow-up , 271 participants with MCI were diagnosed with AD and 59 with other dementias . The Abeta42 assay in particular had considerable intersite variability . Patients who developed AD had lower median Abeta42 ( 356 ; range , 96 - 1075 ng/L ) and higher P-tau ( 81 ; range , 15 - 183 ng/L ) and T-tau ( 582 ; range , 83 - 2174 ng/L ) levels than MCI patients who did not develop AD during follow-up ( 579 ; range , 121 - 1420 ng/L for Abeta42 ; 53 ; range , 15 - 163 ng/L for P-tau ; and 294 ; range , 31 - 2483 ng/L for T-tau , P < .001 ) . The area under the receiver operating characteristic curve was 0.78 ( 95 % confidence interval [ CI ] , 0.75 - 0.82 ) for Abeta42 , 0.76 ( 95 % CI , 0.72 - 0.80 ) for P-tau , and 0.79 ( 95 % CI , 0.76 - 0.83 ) for T-tau . Cut-offs with sensitivity set to 85 % were defined in the AD and control groups and tested in the MCI group , where the combination of Abeta42/P-tau ratio and T-tau identified incipient AD with a sensitivity of 83 % ( 95 % CI , 78%-88 % ) , specificity 72 % ( 95 % CI , 68%-76 % ) , positive LR , 3.0 ( 95 % CI , 2.5 - 3.4 ) , and negative LR , 0.24 ( 95 % CI , 0.21 - 0.28 ) . The positive predictive value was 62 % and the negative predictive value was 88 % . CONCLUSIONS This multicenter study found that CSF Abeta42 , T-tau , and P-tau identify incipient AD with good accuracy , but less accurately than reported from single-center studies . Intersite assay variability highlights a need for st and ardization of analytical techniques and clinical procedures Background We assessed the clinical utility of β-amyloid ( Aβ ) imaging with 18F-florbetaben ( FBB ) in mild cognitive impairment ( MCI ) by evaluating its prognostic accuracy for progression to Alzheimer 's disease ( AD ) , comparing semiquantitative with visual scan assessment , and exploring the relationships among Aβ , hippocampal volume ( HV ) and memory over time . Methods 45 MCI underwent FBB positron emission tomography , MRI and neuropsychological assessment at baseline and 2 years and clinical follow-up at 4 years . Positive FBB ( FBB+ ) , defined by a cortical to cerebellar cortex st and ardised uptake value ratio ( SUVR ) ≥1.45 , was compared with visual assessment by five readers . Amnestic MCI ( aMCI ) was defined by a composite episodic memory ( EM ) Z-score of < −1.5 . Results At baseline , 24 ( 53 % ) MCI were FBB+ . Majority reads agreed with SUVR classification ( κ 0.96 ) . In 2 years , 18 ( 75 % ) FBB+ progressed to AD compared with 2 ( 9.5 % ) FBB− , yielding a predictive accuracy of 83 % ( 95 % CI 61 % to 94 % ) . Four FBB− developed non-AD dementia . Predictive accuracies of HV ( 58 % ( 95 % CI 42 % to 73 % ) ) and aMCI status ( 73 % ( 95 % CI 58 % to 81 % ) ) were lower . Combinations did not improve accuracy . By 4 years , 21 ( 87.5 % ) FBB+ had AD whereas 5 ( 24 % ) FBB− had non-AD dementia yielding a predictive accuracy of 94 % ( 95 % CI 74 % to 99 % ) . While the strong baseline association between FBB SUVR and EM declined over 2 years , the association between EM and HV became stronger . FBB SUVR increased 2.2%/year in FBB+ with no change in FBB−. Conclusions 18F-florbetaben Aβ imaging facilitates accurate detection of prodromal AD . As neurodegeneration progresses , and in contrast with the early stages of the disease , hippocampal atrophy and not Aβ , seems to drive memory decline . Trial registration number NCT01138111 Assessment of disease biomarkers , particularly the in vivo assessment of amyloid-β ( Aβ ) burden with positron emission tomography ( PET ) , is gradually becoming central to the diagnosis of mild cognitive impairment ( MCI ) due to Alzheimer 's disease ( AD ) . However , the incorporation of biomarker evidence to the diagnostic process is currently restricted mainly to research setting s. The identification of memory measures that are associated with Aβ is of clinical relevance as this may enhance the confidence in making a diagnosis of MCI due to AD in clinical setting s. Forty one persons with amnestic MCI underwent Aβ imaging with (18)F-Florbetaben PET , magnetic resonance imaging , and a comprehensive neuropsychological assessment . All measures of episodic memory were significantly correlated with Aβ burden , but regression analyses revealed a strong and selective association between story recall and Aβ over and beyond the effects of age , education , global cognition , hippocampal volume , or other memory tests . Analyses of sensitivity and specificity of memory measures to detect high versus low Aβ scans suggested that word-list recall performed better when high sensitivity was preferred , whereas story recall performed better when high specificity was preferred . In conclusion , a measure of story recall may increase the confidence in making a diagnosis of MCI due to AD in clinical setting A retrospective clinico-pathological study of a consecutive autopsy series of 1050 elderly demented individuals ( mean age 83.4 + /- 6.0 years ; MMSE < 20 ) was performed . Clinical diagnoses were probable or possible Alzheimer disease ( 62.9 % ) , nonspecific degenerative dementia ( 10.4 % ) , vascular dementia ( 10 % ) , Parkinson disease with dementia ( 9.5 % ) , 1.5 % mixed dementia , and 5.7 % other disorders . At autopsy , 86 % revealed Alzheimer-related pathology , but only 42.8 % showed " pure " Alzheimer disease , with additional cerebrovascular lesions in 22.6 % and Lewy body pathology in 10.8 % , while among 660 cases of clinical ly suspected Alzheimer disease , Alzheimer pathology was seen in 93 % , only 44.7 % in " pure " form , and additional vascular lesions and Lewy bodies in 27.7 and 10 % , respectively . The non-Alzheimer cases included Huntington and Creutzfeldt-Jakob disease , frontotemporal dementias , and others . These and other recent data indicate that in patients with the clinical diagnosis of Alzheimer disease its combination with cerebro Output:
Although we were able to calculate one estimation of DTA in , especially , the prediction of progression from MCI to ADD at four years follow-up , the small number of participants implies imprecision of sensitivity and specificity estimates .
MS2_1shot29
***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: Of 22 r and omized trials of rehabilitation with exercise after myocardial infa rct ion ( MI ) , one trial had results that achieved conventional statistical significance . To determine whether or not these studies , in the aggregate , show a significant benefit of rehabilitation after myocardial infa rct ion , we performed an overview of all r and omized trials , involving 4,554 patients ; we evaluated total and cardiovascular mortality , sudden death , and fatal and nonfatal reinfa rct ion . For each endpoint , we calculated an odds ratio ( OR ) and 95 % confidence interval ( 95 % CI ) for the trials combined . After an average of 3 years of follow-up , the ORs were significantly lower in the rehabilitation than in the comparison group : specifically , total mortality ( OR = 0.80 [ 0.66 , 0.96 ] ) , cardiovascular mortality ( OR = 0.78 [ 0.63 , 0.96 ] ) , and fatal reinfa rct ion ( OR = 0.75 [ 0.59 , 0.95 ] ) . The OR for sudden death was significantly lower in the rehabilitation than in the comparison group at 1 year ( OR = 0.63 [ 0.41 , 0.97 ] ) . The data were compatible with a benefit at 2 ( OR = 0.76 [ 0.54 , 1.06 ] ) and 3 years ( OR = 0.92 [ 0.69 , 1.23 ] ) , but these findings were not statistically significant . For nonfatal reinfa rct ion , there were no significant differences between the two groups after 1 ( OR = 1.09 [ 0.76 , 1.57 ] ) , 2 ( OR = 1.10 [ 0.82 , 1.47 ] ) , or 3 years ( OR = 1.09 [ 0.88 , 1.34 ] ) of follow-up . The observed 20 % reduction in overall mortality reflects a decreased risk of cardiovascular mortality and fatal reinfa rct ion throughout at least 3 years and a reduction in sudden death during the 1st year after infa rct ion and possibly for 2 - 3 years . With respect to the independent effects of the physical exercise component of cardiac rehabilitation , the relatively small number of " exercise only " trials , combined with the possibility that they may have had a formal or informal nonexercise component precludes the possibility of reaching any definitive conclusion . To do so would require a r and omized trial of sufficient size to distinguish between no effect and the most plausible effect based on the results of this overview BACKGROUND Recent clinical trials have shown that modification of plasma lipoprotein concentrations can favorably alter progression of coronary atherosclerosis , but no data exist on the effects of a comprehensive program of risk reduction involving both changes in lifestyle and medications . This study tested the hypothesis that intensive multiple risk factor reduction over 4 years would significantly reduce the rate of progression of atherosclerosis in the coronary arteries of men and women compared with subjects r and omly assigned to the usual care of their physician . METHODS AND RESULTS Three hundred men ( n = 259 ) and women ( n = 41 ) ( mean age , 56 + /- 7.4 years ) with angiographically defined coronary atherosclerosis were r and omly assigned to usual care ( n = 155 ) or multifactor risk reduction ( n = 145 ) . Patients assigned to risk reduction were provided individualized programs involving a low-fat and -cholesterol diet , exercise , weight loss , smoking cessation , and medications to favorably alter lipoprotein profiles . Computer-assisted quantitative coronary arteriography was performed at baseline and after 4 years . The main angiographic outcome was the rate of change in the minimal diameter of diseased segments . All subjects underwent medical and risk factor evaluations at baseline and yearly for 4 years , and reasons for all hospitalizations and deaths were documented . Of the 300 subjects r and omized , 274 ( 91.3 % ) completed a follow-up arteriogram , and 246 ( 82 % ) had comparative measurements of segments with visible disease at baseline and follow-up . Intensive risk reduction result ed in highly significant improvements in various risk factors , including low-density lipoprotein cholesterol and apolipoprotein B ( both , 22 % ) , high-density lipoprotein cholesterol ( + 12 % ) , plasma triglycerides ( -20 % ) , body weight ( -4 % ) , exercise capacity ( + 20 % ) , and intake of dietary fat ( -24 % ) and cholesterol ( -40 % ) compared with relatively small changes in the usual-care group . No change was observed in lipoprotein(a ) in either group . The risk-reduction group showed a rate of narrowing of diseased coronary artery segments that was 47 % less than that for subjects in the usual-care group ( change in minimal diameter , -0.024 + /- 0.066 mm/y versus -0.045 + /- 0.073 mm/y ; P < .02 , two-tailed ) . Three deaths occurred in each group . There were 25 hospitalizations in the risk-reduction group initiated by clinical cardiac events compared with 44 in the usual-care group ( rate ratio , 0.61 ; P = .05 ; 95 % confidence interval , 0.4 to 0.9 ) . CONCLUSIONS Intensive multifactor risk reduction conducted over 4 years favorably altered the rate of luminal narrowing in coronary arteries of men and women with coronary artery disease and decreased hospitalizations for clinical cardiac events Background Significant regression of coronary and femoral atherosclerotic lesions has been documented by angiographic studies using aggressive lipid-lowering treatment . This study tested the applicability and effects of intensive physical exercise and low-fat diet on coronary morphology and myocardial perfusion in nonselected patients with stable angina pectoris . Methods and Results Patients were recruited after routine coronary angiography for stable angina pectoris ; they were r and omized to an intervention group ( n = 56 ) and a control group on “ usual care ” ( n = 57 ) . Treatment comprised intensive physical exercise in group training sessions ( minimum , 2 hr/wk ) , daily home exercise periods ( 20 min/d ) , and low-fat , low-cholesterol diet ( American Heart Association recommendation , phase 3 ) . No lipid-lowering agents were prescribed . After 12 months of participation , repeat coronary angiography was performed ; relative and minimal diameter reductions of coronary lesions were measured by digital image processing . Change in myocardial perfusion was assessed by 201TI scintigraphy . In patients participating in the intervention group , body weight decreased by 5 % ( p<0.001 ) , total cholesterol by 10 % ( p<0.001 ) , and triglycerides by 24 % ( p<0.001 ) ; high density lipoproteins increased by 3 % ( p = NS ) . Physical work capacity improved by 23 % ( p<0.0001 ) , and myocardial oxygen consumption , as estimated from maximal rate-pressure product , by 10 % , ( p<0.05 ) . Stress-induced myocardial ischemia decreased concurrently , indicating improvement of myocardial perfusion . Based on minimal lesion diameter , progression of coronary lesions was noted in nine patients ( 23 % ) , no change in 18 patients ( 45 % ) , and regression in 13 patients ( 32 % ) . In the control group , metabolic and hemodynamic variables remained essentially unchanged , whereas progression of coronary lesions was noted in 25 patients ( 48 % ) , no change in 18 patients ( 35 % ) , and regression in nine patients ( 17 % ) . These changes were significantly different from the intervention group ( p<0.05 ) . Conclusions In patients participating in regular physical exercise and low-fat diet , coronary artery disease progresses at a slower pace compared with a control group on usual care Background —Whether cardiac rehabilitation ( CR ) is effective in patients older than 75 years , who have been excluded from most trials , remains unclear . We enrolled patients 46 to 86 years old in a r and omized trial and assessed the effects of 2 months of post-myocardial infa rct ion ( MI ) CR on total work capacity ( TWC , in kilograms per meter ) and health-related quality of life ( HRQL ) . Methods and Results —Of 773 screened patients , 270 without cardiac failure , dementia , disability , or contraindications to exercise were r and omized to outpatient , hospital-based CR ( Hosp-CR ) , home-based CR ( Home-CR ) , or no CR within 3 predefined age groups ( middle-aged , 45 to 65 years ; old , 66 to 75 years ; and very old , > 75 years ) of 90 patients each . TWC and HRQL were determined with cycle ergometry and Sickness Impact Profile at baseline , after CR , and 6 and 12 months later . Within each age group , TWC improved with Hosp-CR and Home-CR and was unchanged with no CR . The improvement was similar in middle-aged and old persons but smaller , although still significant , in very old patients . TWC reverted toward baseline by 12 months with Hosp-CR but not with Home-CR . HRQL improved in middle-aged and old CR and control patients but only with CR in very old patients . Complications were similar across treatment and age groups . Costs were lower for Home-CR than for Hosp-CR . Conclusions —Post-MI Hosp-CR and Home-CR are similarly effective in the short term and improve TWC and HRQL in each age group . However , with lower costs and more prolonged positive effects , Home-CR may be the treatment of choice in low-risk older patients BACKGROUND Increases in life stress have been linked to poor prognosis , after myocardial infa rct ion ( MI ) . Previous research suggested that a programme of monthly screening for psychological distress , combined with supportive and educational home nursing interventions for distressed patients , may improve post-MI survival among men . Our study assessed this approach for both men and women . We aim ed to find out whether the programme would reduce 1-year cardiac mortality for women and men . METHODS We carried out a r and omised , controlled trial of 1376 post-MI patients ( 903 men , 473 women ) assigned to the intervention programme ( n = 692 ) or usual care ( n = 684 ) for 1 year . All patients completed a baseline interview that included assessment of depression and anxiety . Survivors were also interviewed at 1 year . FINDINGS The programme had no overall survival impact . Preplanned analyses showed higher cardiac ( 9.4 vs 5.0 % , p = 0.064 ) and all-cause mortality ( 10.3 vs 5.4 % , p = 0.051 ) among women in the intervention group . There was no evidence of either benefit or harm among men ( cardiac mortality 2.4 vs 2.5 % , p = 0.94 ; all-cause mortality 3.1 vs 3.1 % , p = 0.93 ) . The programme 's impact on depression and anxiety among survivors was small . INTERPRETATION Our results do not warrant the routine implementation of programmes that involve psychological-distress screening and home nursing intervention for patients recovering from MI . The poorer overall outcome for women , and the possible harmful impact of the intervention on women , underline the need for further research and the inclusion of adequate numbers of women in future post-MI trials Abstract Objective : To evaluate the effects of secondary prevention clinics run by nurses in general practice on the health of patients with coronary heart disease . Design : R and omised controlled trial of clinics over one year with assessment by self completed postal question naires and audit of medical records at the start and end of the trial . Setting : R and om sample of 19 general practice s in northeast Scotl and . Subjects : 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease who did not have terminal illness or dementia and were not housebound . Intervention : Clinic staff promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures : Health status measured by the SF-36 question naire , chest pain by the angina type specification , and anxiety and depression by the hospital anxiety and depression scale . Use of health services before and during the study . Results : There were significant improvements in six of eight health status domains ( all functioning scales , pain , and general health ) among patients attending the clinic . Role limitations attributed to physical problems improved most ( adjusted difference 8.52 , 95 % confidence interval 4.16 to 12.9 ) . Fewer patients reported worsening chest pain ( odds ratio 0.59 , 95 % confidence interval 0.37 to 0.94 ) . There were no significant effects on anxiety or depression . Fewer intervention group patients required hospital admissions ( 0.64 , 0.48 to 0.86 ) , but general practitioner consultation rates did not alter . Conclusions : Within their first year secondary prevention clinics improved patients ' health and reduced hospital admissions . Key messages Nurse led clinics in general practice were used to promote secondary prevention to patients with coronary heart disease Within the first year the health of patients invited to the clinics improved Most benefit was in functional status , but chest pain improved too There was no effects on anxiety or depression There were significant reductions in hospital admissions in the first The Women ’s Lifestyle Heart Trial was a small ( N=28 ) r and omized controlled trial to evaluate the effects of a comprehensive lifestyle self-management program ( very low-fat vegetarian Output:
Since exercise training confers substantial physiologic and clinical benefits and activity levels are inversely proportional to cardiovascular mortality ( 9 ) , it is not surprising that trials of exercise programs found positive effects on survival .
MS2_1shot30
***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 Although data from studies in animals demonstrated beneficial effects of whole-body vibration ( WBV ) therapy on bone , clinical trials in postmenopausal women showed conflicting results . OBJECTIVE To determine whether WBV improves bone density and structure . DESIGN A 12-month , single-center , superiority , r and omized , controlled trial with 3 parallel groups . ( Clinical Trials.gov registration number : NCT00420940 ) SETTING Toronto General Hospital , Ontario , Canada . PARTICIPANTS 202 healthy postmenopausal women with bone mineral density ( BMD ) T-scores between -1.0 and -2.5 who were not receiving prescription bone medications . INTERVENTION Participants were r and omly assigned to 1 of 3 groups ( 1:1:1 ratio ) by using a block-r and omization scheme and sealed envelopes . They were asked to st and on a low-magnitude ( 0.3 g ) 90-Hz or 30-Hz WBV platform for 20 minutes daily or to serve as control participants ; all participants received calcium and vitamin D. MEASUREMENTS Bone outcome assessors , who were blinded to group assignment , determined trabecular volumetric BMD and other measurements of the distal tibia and distal radius with high-resolution peripheral quantitative computed tomography and areal BMD with dual-energy x-ray absorptiometry at baseline and at 12 months . RESULTS 12 months of WBV therapy had no significant effect on any bone outcomes compared with no WBV therapy . For the primary outcome of tibial trabecular volumetric BMD , mean change from baseline was 0.4 mg/cm(3 ) ( 95 % CI , -0.4 to 1.2 mg/cm(3 ) ) in the 90-Hz WBV group , -0.1 mg/cm(3 ) ( CI , -1.0 to 0.8 mg/cm(3 ) ) in the 30-Hz WBV group , and -0.2 mg/cm(3 ) ( CI , -1.1 to 0.6 mg/cm(3 ) ) in the control group ( P = 0.55 ) . Changes in areal BMD at the femoral neck , total hip , and lumbar spine were also similar among the groups . Overall , low-magnitude WBV at both 90 and 30 Hz was well-tolerated . LIMITATIONS Adherence to WBV ranged from 65 % to 79 % . Double-blinding was not possible . CONCLUSION Whole-body vibration therapy at 0.3 g and 90 or 30 Hz for 12 months did not alter BMD or bone structure in postmenopausal women who received calcium and vitamin D supplementation BACKGROUND whole-body vibration training may improve neuromuscular function , falls risk and bone density , but previous studies have had conflicting findings . OBJECTIVE this study aim ed to evaluate the influence of vertical vibration ( VV ) and side-alternating vibration ( SV ) on musculoskeletal health in older people at risk of falls . DESIGN single-blind , r and omised , controlled trial comparing vibration training to sham vibration ( Sham ) in addition to usual care . PARTICIPANTS participants were 61 older people ( 37 women and 24 men ) , aged 80.2 + 6.5 years , referred to an outpatient falls prevention service . METHODS participants were r and omly assigned to VV , SV or Sham in addition to the usual falls prevention programme . Participants were requested to attend three vibration sessions per week for 12 weeks , with sessions increasing to six , 1 min bouts of vibration . Falls risk factors and neuromuscular tests were assessed , and blood sample s collected for determination of bone turnover , at baseline and following the intervention . RESULTS chair st and time , timed-up- and -go time , fear of falling , NEADL index and postural sway with eyes open improved in the Sham group . There were significantly greater gains in leg power in the VV than in the Sham group and in bone formation in SV and VV compared with the Sham group . Conversely , body sway improved less in the VV than in the Sham group . Changes in falls risk factors did not differ between the groups . CONCLUSIONS whole-body vibration increased leg power and bone formation , but it did not provide any additional benefits to balance or fall risk factors beyond a falls prevention programme in older people at risk of falls OBJECTIVE To test whether training on a high-frequency ( 28Hz ) vibrating platform improves muscle power and bone characteristics in postmenopausal women . DESIGN R and omized controlled trial with 6-month follow-up . SETTING Outpatient clinic in a general hospital in Italy . PARTICIPANTS Twenty-nine postmenopausal women ( intervention group , n=14 ; matched controls , n=15 ) . INTERVENTION Participants stood on a ground-based oscillating platform for three 2-minute sessions for a total of 6 minutes per training session , twice weekly for 6 months . The controls did not receive any training . Both groups were evaluated at baseline and after 6 months . MAIN OUTCOME MEASURES Muscle power , calculated from ground reaction forces produced by l and ing after jumping as high as possible on a forceplate , cortical bone density , and biomarkers of bone turnover . RESULTS Over 6 months , muscle power improved by about 5 % in women who received the intervention , and it remained unchanged in controls ( P=.004 ) . Muscle force remained stable in both the intervention and control groups . No significant changes were observed in bone characteristics . CONCLUSION Reflex muscular contractions induced by vibration training improve muscle power in postmenopausal women Background Whole-body vibration ( WBV ) is a new type of exercise that has been increasingly tested for the ability to prevent bone fractures and osteoporosis in frail people . There are two currently marketed vibrating plates : a ) the whole plate oscillates up and down ; b ) reciprocating vertical displacements on the left and right side of a fulcrum , increasing the lateral accelerations . A few studies have shown recently the effectiveness of the up- and -down plate for increasing Bone Mineral Density ( BMD ) and balance ; but the effectiveness of the reciprocating plate technique remains mainly unknown . The aim was to compare the effects of WBV using a reciprocating platform at frequencies lower than 20 Hz and a walking-based exercise programme on BMD and balance in post-menopausal women . Methods Twenty-eight physically untrained post-menopausal women were assigned at r and om to a WBV group or a Walking group . Both experimental programmes consisted of 3 sessions per week for 8 months . Each vibratory session included 6 bouts of 1 min ( 12.6 Hz in frequency and 3 cm in amplitude with 60 ° of knee flexion ) with 1 min rest between bouts . Each walking session was 55 minutes of walking and 5 minutes of stretching . Hip and lumbar BMD ( g·cm-2 ) were measured using dual-energy X-ray absorptiometry and balance was assessed by the blind flamingo test . ANOVA for repeated measurements was adjusted by baseline data , weight and age . Results After 8 months , BMD at the femoral neck in the WBV group was increased by 4.3 % ( P = 0.011 ) compared to the Walking group . In contrast , the BMD at the lumbar spine was unaltered in both groups . Balance was improved in the WBV group ( 29 % ) but not in the Walking group . Conclusion The 8-month course of vibratory exercise using a reciprocating plate is feasible and is more effective than walking to improve two major determinants of bone fractures : hip BMD and balance Purpose . To examine the effects of two doses of low-frequency ( 12 Hz ) , low-magnitude ( 0.3 g ) , whole body vibration on markers of bone formation and resorption in postmenopausal women . Methods . Women were recruited and r and omized into a sham vibration control group , one time per week vibration group ( 1 × /week ) , or three times per week vibration group ( 3 × /week ) . Vibration exposure consisted of 20 minutes of intermittent vibration for the 1 × /week and 3 × /week groups , and sham vibration ( < 0.1 g ) for the control group for eight weeks . Double-blinded primary outcome measures were urine markers of bone resorption : N-telopeptide X normalised to creatinine ( NTx/Cr ) and bone formation : bone-specific alkaline phosphatase ( ALP ) . Results . Forty-six women ( 59.8 ± 6.2 years , median 7.3 years since menopause ) were enrolled . NTx/Cr was significantly reduced ( 34.6 % ) in the 3 × /wk vibration group but not in the 1 × /wk vibration group compared with sham control ( P < .01 ) group . No effect of time or group allocation was observed on the bone formation marker ALP ( P = .27 ) . Conclusion . We have shown for the first time that low-frequency , low-magnitude vibration 3 × /week for eight weeks in postmenopausal women results in a significant reduction in NTx/Cr , a marker of bone resorption , when compared with sham vibration exposure OBJECTIVES We aim ed to clarify whether a short-term whole body vibration training has a beneficial effect on bone mass and structure in elderly men and women . DESIGN R and omised controlled trial . METHODS A total of 49 non-institutionalised elderly ( 20 men and 29 women ) volunteered to participate in the study . Participants who met the inclusion criteria were r and omly assigned to one of the study groups ( whole body vibration or control ) . A total of 24 elderly trained squat positioned on a vibration platform 3 times per week for 11 weeks . Bone-related variables were assessed by dual-energy X-ray absorptiometry and peripheral quantitative computed tomography . Two-way repeated measures one-way analysis of variance ( group by time ) was used to determine the effects of the intervention on the bone-related variables and also to determinate the changes within group throughout the intervention period . Analysis of covariance was used to test the differences between groups for bone-related variables in pre- and post-training assessment s and in the percentage of change between groups . All analysis were carried out including age , height , subtotal lean mass and daily calcium intake as covariates . RESULTS 11 weeks of whole body vibration training led to no changes in none of the bone mineral content and bone mineral density parameters measured by dual-energy X-ray absorptiometry through the skeleton . At the tibia , total , trabecular and cortical volumetric bone mineral density decreased significantly in the whole body vibration group ( all P<0.05 ) . CONCLUSIONS A short-term whole body vibration therapy is not enough to cause any changes on bone mineral content or bone mineral density and it only produces a slight variation on bone structure among elderly people Background and aims : Exercise may enhance the effect of alendronate on bone mineral density ( BMD ) and reduce chronic back pain in elderly women with osteoporosis . The aim of this study was to determine whether whole-body vibration exercise would enhance the effect of alendronate on lumbar BMD and bone turnover , and reduce chronic back pain in post-menopausal women with osteoporosis . Methods : Fifty post-menopausal women with osteoporosis , 55–88 years of age , were r and omly divided into two groups of 25 patients each : one taking alendronate ( 5 mg daily , ALN ) and one taking alendronate plus exercise ( ALN+EX ) . Exercise consisted of whole-body vibration using a Galileo machine ( Novotec , Pforzheim , Germany ) , at an intensity of 20 Hz , frequency once a week , and duration of exercise 4 minutes . The study lasted 12 months . Lumbar BMD was measured by dual energy X-ray absorptiometry ( Hologic QDR 1500W ) . Urinary cross-linked N-terminal telopeptides of type I collagen ( NTX ) and serum alkaline phos-phatase ( ALP ) levels were measured by enzyme-linked immunosorbent assay and st and ard laboratory techniques , respectively . Chronic back pain was evaluated by face scale score at baseline and every 6 months . Results : There were no significant differences in baseline characteristics , including age , body mass index , years since menopause , lumbar BMD , urinary NTX and serum ALP levels , or face scale score between the two groups . The increase in lumbar BMD and the reduction in urinary NTX and serum ALP levels were similar in the ALN and ALN+EX groups . However , the reduction in chronic back pain was greater in the ALN+EX group than in the ALN group . Conclusions : The results of this study suggest that whole-body vibration exercise using a Galileo machine appears to be useful in reducing chronic back pain , probably by relaxing the back muscles in post-menopausal osteoporotic women treated with alendronate Nonpharmacologic approaches to preserve or increase bone mineral density ( BMD ) include whole-body vibration ( WBV ) , but its efficacy in elderly persons is not clear . Therefore , we conducted the Vibration to Improve Bone in Elderly Subjects ( VIBES ) trial , a r and omized , placebo-controlled trial of 10 minutes of daily WBV ( 0.3 g at 37 Hz ) in seniors recruited from 16 independent living communities . The primary outcomes were volumetric BMD of the hip and spine measured by quantitative computed tomography ( QCT ) and biochemical markers of bone turnover . We r and omized 174 men and women ( 89 active , 85 placebo ) with T-scores -1 Output:
Most review s including children and adolescents with compromised bone mass showed an improvement of BMD at lower limbs , lumbar spine , and whole body . In conclusion , WBV interventions seem to help children and adolescents with compromised bone mass to increase their BMD , but these improvements are limited in postmenopausal women and there is insufficient evidence for young adults .
MS2_1shot31
***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 conducted a clinical trial to assess adoptive transfer of T cells genetically modified to express an anti-CD19 chimeric Ag receptor ( CAR ) . Our clinical protocol consisted of chemotherapy followed by an infusion of anti-CD19-CAR-transduced T cells and a course of IL-2 . Six of the 8 patients treated on our protocol obtained remissions of their advanced , progressive B-cell malignancies . Four of the 8 patients treated on the protocol had long-term depletion of normal polyclonal CD19(+ ) B-lineage cells . Cells containing the anti-CD19 CAR gene were detected in the blood of all patients . Four of the 8 treated patients had prominent elevations in serum levels of the inflammatory cytokines IFNγ and TNF . The severity of acute toxicities experienced by the patients correlated with serum IFNγ and TNF levels . The infused anti-CD19-CAR-transduced T cells were a possible source of these inflammatory cytokines because we demonstrated peripheral blood T cells that produced TNF and IFNγ ex vivo in a CD19-specific manner after anti-CD19-CAR-transduced T-cell infusions . Anti-CD19-CAR-transduced T cells have great promise to improve the treatment of B-cell malignancies because of a potent ability to eradicate CD19(+ ) cells in vivo ; however , reversible cytokine-associated toxicities occurred after CAR-transduced T-cell infusions BACKGROUND Chimeric antigen receptor ( CAR ) modified T cells targeting CD19 have shown activity in case series of patients with acute and chronic lymphocytic leukaemia and B-cell lymphomas , but feasibility , toxicity , and response rates of consecutively enrolled patients treated with a consistent regimen and assessed on an intention-to-treat basis have not been reported . We aim ed to define feasibility , toxicity , maximum tolerated dose , response rate , and biological correlates of response in children and young adults with refractory B-cell malignancies treated with CD19-CAR T cells . METHODS This phase 1 , dose-escalation trial consecutively enrolled children and young adults ( aged 1 - 30 years ) with relapsed or refractory acute lymphoblastic leukaemia or non-Hodgkin lymphoma . Autologous T cells were engineered via an 11-day manufacturing process to express a CD19-CAR incorporating an anti-CD19 single-chain variable fragment plus TCR zeta and CD28 signalling domains . All patients received fludarabine and cyclophosphamide before a single infusion of CD19-CAR T cells . Using a st and ard 3 + 3 design to establish the maximum tolerated dose , patients received either 1 × 10(6 ) CAR-transduced T cells per kg ( dose 1 ) , 3 × 10(6 ) CAR-transduced T cells per kg ( dose 2 ) , or the entire CAR T-cell product if sufficient numbers of cells to meet the assigned dose were not generated . After the dose-escalation phase , an expansion cohort was treated at the maximum tolerated dose . The trial is registered with Clinical Trials.gov , number NCT01593696 . FINDINGS Between July 2 , 2012 , and June 20 , 2014 , 21 patients ( including eight who had previously undergone allogeneic haematopoietic stem-cell transplantation ) were enrolled and infused with CD19-CAR T cells . 19 received the prescribed dose of CD19-CAR T cells , whereas the assigned dose concentration could not be generated for two patients ( 90 % feasible ) . All patients enrolled were assessed for response . The maximum tolerated dose was defined as 1 × 10(6 ) CD19-CAR T cells per kg . All toxicities were fully reversible , with the most severe being grade 4 cytokine release syndrome that occurred in three ( 14 % ) of 21 patients ( 95 % CI 3·0 - 36·3 ) . The most common non-haematological grade 3 adverse events were fever ( nine [ 43 % ] of 21 patients ) , hypokalaemia ( nine [ 43 % ] of 21 patients ) , fever and neutropenia ( eight [ 38 % ] of 21 patients ) , and cytokine release syndrome ( three [ 14 % ) of 21 patients ) . INTERPRETATION CD19-CAR T cell therapy is feasible , safe , and mediates potent anti-leukaemic activity in children and young adults with chemotherapy-resistant B-precursor acute lymphoblastic leukaemia . All toxicities were reversible and prolonged B-cell aplasia did not occur . FUNDING National Institutes of Health Intramural funds and St Baldrick 's Foundation BACKGROUND Relapsed acute lymphoblastic leukemia ( ALL ) is difficult to treat despite the availability of aggressive therapies . Chimeric antigen receptor-modified T cells targeting CD19 may overcome many limitations of conventional therapies and induce remission in patients with refractory disease . METHODS We infused autologous T cells transduced with a CD19-directed chimeric antigen receptor ( CTL019 ) lentiviral vector in patients with relapsed or refractory ALL at doses of 0.76 × 10(6 ) to 20.6 × 10(6 ) CTL019 cells per kilogram of body weight . Patients were monitored for a response , toxic effects , and the expansion and persistence of circulating CTL019 T cells . RESULTS A total of 30 children and adults received CTL019 . Complete remission was achieved in 27 patients ( 90 % ) , including 2 patients with blinatumomab-refractory disease and 15 who had undergone stem-cell transplantation . CTL019 cells proliferated in vivo and were detectable in the blood , bone marrow , and cerebrospinal fluid of patients who had a response . Sustained remission was achieved with a 6-month event-free survival rate of 67 % ( 95 % confidence interval [ CI ] , 51 to 88 ) and an overall survival rate of 78 % ( 95 % CI , 65 to 95 ) . At 6 months , the probability that a patient would have persistence of CTL019 was 68 % ( 95 % CI , 50 to 92 ) and the probability that a patient would have relapse-free B-cell aplasia was 73 % ( 95 % CI , 57 to 94 ) . All the patients had the cytokine-release syndrome . Severe cytokine-release syndrome , which developed in 27 % of the patients , was associated with a higher disease burden before infusion and was effectively treated with the anti-interleukin-6 receptor antibody tocilizumab . CONCLUSIONS Chimeric antigen receptor-modified T-cell therapy against CD19 was effective in treating relapsed and refractory ALL . CTL019 was associated with a high remission rate , even among patients for whom stem-cell transplantation had failed , and durable remissions up to 24 months were observed . ( Funded by Novartis and others ; CART19 Clinical Trials.gov numbers , NCT01626495 and NCT01029366 . ) Adoptively transferred gene-modified T cells exp and in vivo , eliminate leukemic cells , and form functional memory cells in patients . Go CAR-Ts in the Fast Lane As members of the body ’s police force , cells of the immune system vigilantly pursue bad actors that harm healthy tissues , such as infection or cancer , and then try to deter dangerous activity . Research ers have long sought to harness the power of the immune system to fight cancers such as leukemia ; however , targeting functional immune T cells to the tumor and maintaining these cells in patients remains challenging . Now , Kalos et al. have genetically modified T cells to express a chimeric antigen receptor ( CAR ) to yield so-called CAR T cells that specifically target chronic lymphocytic leukemia ( CLL ) ( a B cell cancer ) . The design er T cells not only exp and ed , persisted , and attacked tumor cells after transfer into patients ; they also mediated cancer remission . Innocent byst and ers were also targeted , as reflected by decreased numbers of B cells and plasma cells and the development of hypogammaglobulinemia . The CAR T cells used in this study expressed an antigen receptor that consists of antibody binding domains that bind in a restricted manner to the CD19 protein ( which is found solely on normal B cells and plasma cells ) attached to both a T cell – specific costimulatory domain and a T cell – specific intracellular signaling domain . The result ing chimeric receptor could activate T cells in response to CD19 in the absence of major histocompatibility complex restriction , allowing for much broader cellular targeting than is obtained with normal T cells . After transfer into three CLL patients , these CAR T cells exp and ed > 1000-fold , persisted for more than 6 months , and eradicated CLL cells . Some of these CAR T cells persisted with a memory phenotype , which would allow them to respond more quickly and on a larger scale with a second exposure to CLL cells . Indeed , two of the three CLL patients who underwent the CAR T cell treatment had complete remission of their leukemia . Although this is early in the clinical study , these results highlight the potential for CAR-modified T cells to bring cancer therapy up to speed . Tumor immunotherapy with T lymphocytes , which can recognize and destroy malignant cells , has been limited by the ability to isolate and exp and T cells restricted to tumor-associated antigens . Chimeric antigen receptors ( CARs ) composed of antibody binding domains connected to domains that activate T cells could overcome tolerance by allowing T cells to respond to cell surface antigens ; however , to date , lymphocytes engineered to express CARs have demonstrated minimal in vivo expansion and antitumor effects in clinical trials . We report that CAR T cells that target CD19 and contain a costimulatory domain from CD137 and the T cell receptor ζ chain have potent non – cross-resistant clinical activity after infusion in three of three patients treated with advanced chronic lymphocytic leukemia ( CLL ) . The engineered T cells exp and ed > 1000-fold in vivo , trafficked to bone marrow , and continued to express functional CARs at high levels for at least 6 months . Evidence for on-target toxicity included B cell aplasia as well as decreased numbers of plasma cells and hypogammaglobulinemia . On average , each infused CAR-expressing T cell was calculated to eradicate at least 1000 CLL cells . Furthermore , a CD19-specific immune response was demonstrated in the blood and bone marrow , accompanied by complete remission , in two of three patients . Moreover , a portion of these cells persisted as memory CAR+ T cells and retained anti-CD19 effector functionality , indicating the potential of this major histocompatibility complex – independent approach for the effective treatment of B cell malignancies Five adults with chemotherapy-refractory B-ALL were induced into molecular remissions after treatment with CD19 CAR-targeted T cells . CARving a Niche for Cancer Immunotherapy Acute lymphoblastic leukemia ( ALL ) is a cancer of the white blood cells that fend off infection . It ’s most common in children but — as with many diseases that primarily affect children — has a much worse prognosis when it affects adults . Adults with relapsed disease have a very low chance of survival , and new therapies are desperately needed . Now , Brentjens et al. test T cells engineered to target CD19 , which is expressed on both healthy B lymphocytes and B-ALL cells , in five chemotherapy-refractory adult B-ALL patients . Here , the authors treat patients with the patients ’ own T cells altered to express not only CD19 but also a fusion of the costimulatory molecule CD28 with CD3ζ chain — so-called “ second-generation chimeric antigen receptor ( CAR ) T cells . ” All patients treated with these cells achieved tumor eradication and complete remission . These CAR T cells were well tolerated , although there was substantial cytokine release in some patients that correlated to tumor burden . These patients were treated with steroid therapy . Long-term follow-up in four of these patients was not possible because the CAR T cell therapy allowed these patients to be eligible for subsequent hematopoietic stem cell transplant ( HSCT ) , which result ed in restored hematopoiesis . The remaining patient experienced a relapse of CD19 + cells that coincided with the lack of persistence of the CAR T cells from circulation . These data suggest that subsequent transfusions should be considered for patients unable to undergo HSCT . Adults with relapsed B cell acute lymphoblastic leukemia ( B-ALL ) have a dismal prognosis . Only those patients able to achieve a second remission with no minimal residual disease ( MRD ) have a hope for long-term survival in the context of a subsequent allogeneic hematopoietic stem cell transplantation ( allo-HSCT ) . We have treated five relapsed B-ALL subjects with autologous T cells expressing a CD19-specific CD28/CD3ζ second-generation dual-signaling chimeric antigen receptor ( CAR ) termed 19 - 28z . All patients with persistent morphological disease or MRD+ disease upon T cell infusion demonstrated rapid tumor eradication and achieved MRD− complete remissions as assessed by deep sequencing polymerase chain reaction . Therapy was well tolerated , although significant cytokine elevations , specifically observed in those patients with morphologic evidence of disease at the time of treatment , required lymphotoxic steroid therapy to ameliorate cytokine Output:
Conclusion : Lymphodepletion regimen may play a crucial role in predicting the prognosis of patients with hematological malignancies . Lymphodepletion patients had better progression-free survival than those who did not
MS2_1shot32
***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: Tobacco use is the single most important preventable cause of death in military personnel . The purpose of this r and omized clinical trial was to evaluate the effectiveness of two behavioral interventions when added to nicotine-replacement therapy on smoking cessation . The sample of 512 included 52 % active duty military , 29 % family , 11 % retirees , and 8 % Department of Defense civilians . There was a main effect of compliance at the end of the program ( EOP ) ; 69 % of those who attended 75 % of the classes were abstinent from tobacco ; regression analysis found the more intensive program to be twice as effective at EOP and at 3 months , an outcome not continued at 6 months . The longer , more intensive V and erbilt University Medical Center program was significantly more effective at helping the civilian portion of the population ( 85 % versus 60 % in the American Cancer Society program ) but not the active duty participants Residential treatment for substance use disorders ( SUD ) provides opportunity for smoking intervention . A r and omized controlled trial compared : ( 1 ) motivational interviewing ( MI ) to brief advice ( BA ) , ( 2 ) in one session or with two booster sessions , for 165 alcoholics in SUD treatment . All received nicotine replacement ( NRT ) . MI and BA produced equivalent confirmed abstinence , averaging 10 % at 1 month , and 2 % at 3 , 6 and 12 months . However , patients with more drug use pretreatment ( > 22 days in 6 months ) given BA had more abstinence at 12 months ( 7 % ) than patients in MI or with less drug use ( all 0 % ) . Boosters produced 16 - 31 % fewer cigarettes per day after BA than MI . Substance use was unaffected by treatment condition or smoking cessation . Motivation to quit was higher after BA than MI . Thus , BA plus NRT may be a cost-effective way to reduce smoking for alcoholics with comorbid substance use who are not seeking smoking cessation Background There is no more effective intervention for secondary prevention of coronary heart disease than smoking cessation . Yet , evidence about the (cost-)effectiveness of smoking cessation treatment methods for cardiac in patients that also suit nursing practice is scarce . This protocol describes the design of a study on the (cost-)effectiveness of two intensive smoking cessation interventions for hospitalised cardiac patients as well as first results on the inclusion rates and the characteristics of the study population . Methods / design An experimental study design is used in eight cardiac wards of hospitals throughout the Netherl and s to assess the (cost-)effectiveness of two intensive smoking cessation counselling methods both combined with nicotine replacement therapy . R and omization is conducted at the ward level ( cross-over ) . Baseline and follow-up measurements after six and 12 months are obtained . Upon admission to the cardiac ward , nurses assess patients ’ smoking behaviour , ensure a quit advice and subsequently refer patients for either telephone counselling or face-to-face counselling . The counselling interventions have a comparable structure and content but differ in provider and delivery method , and in duration . Both counselling interventions are compared with a control group receiving no additional treatment beyond the usual care . Between December 2009 and June 2011 , 245 cardiac patients who smoked prior to hospitalisation were included in the usual care group , 223 in the telephone counselling group and 157 in the face-to-face counselling group . Patients are predominantly male and have a mean age of 57 years . Acute coronary syndrome is the most frequently reported admission diagnosis . The ultimate goal of the study is to assess the effects of the interventions on smoking abstinence and their cost-effectiveness . Telephone counselling is expected to be more (cost-)effective in highly motivated patients and patients with high SES , whereas face-to-face counselling is expected to be more (cost-)effective in less motivated patients and patients with low SES . Discussion This study examines two intensive smoking cessation interventions for cardiac patients using a multi-centre trial with eight cardiac wards . Although not all eligible patients could be included and the distribution of patients is skewed in the different groups , the results will be able to provide valuable insight into effects and costs of counselling interventions varying in delivery mode and intensity , also concerning subgroups . Trial registration Dutch Trial Register Subjects ( N = 139 ) were assigned to intensive behavioral or to low-contact smoking treatment and to 2-mg nicotine gum or to placebo gum in a 2 X 2 factorial design . The 2-mg gum produced higher abstinence rates than did the placebo . Subjects receiving the low-contact condition plus the 2-mg nicotine gum had excellent abstinence rates at both 26 weeks ( 56 % abstainers ) and 52 weeks ( 50 % abstainers ) . Smokers who scored at the median on a measure of physical dependence to nicotine were more likely to benefit by nicotine gum treatment than subjects who scored either higher or lower , but this relation was nonsignificant . The results of this study are compared with an earlier nonblind trial OBJECTIVE To compare the efficacy of Mindfulness-Based Addiction Treatment ( MBAT ) to a Cognitive Behavioral Treatment ( CBT ) that matched MBAT on treatment contact time , and a Usual Care ( UC ) condition that comprised brief individual counseling . METHOD Participants ( N = 412 ) were 48.2 % African American , 41.5 % non-Latino White , 5.4 % Latino , and 4.9 % other , and 57.6 % reported a total annual household income < $ 30,000 . The majority of participants were female ( 54.9 % ) . Mean cigarettes per day was 19.9 ( SD = 10.1 ) . Following the baseline visit , participants were r and omized to UC ( n = 103 ) , CBT ( n = 155 ) , or MBAT ( n = 154 ) . All participants were given self-help material s and nicotine patch therapy . CBT and MBAT groups received 8 2-hr in-person group counseling sessions . UC participants received 4 brief individual counseling sessions . Biochemically verified smoking abstinence was assessed 4 and 26 weeks after the quit date . RESULTS Logistic r and om effects model analyses over time indicated no overall significant treatment effects ( completers only : F(2 , 236 ) = 0.29 , p = .749 ; intent-to-treat : F(2 , 401 ) = 0.9 , p = .407 ) . Among participants classified as smoking at the last treatment session , analyses examining the recovery of abstinence revealed a significant overall treatment effect , F(2 , 103 ) = 4.41 , p = .015 ( MBAT vs. CBT : OR = 4.94 , 95 % CI : 1.47 to 16.59 , p = .010 , Effect Size = .88 ; MBAT vs. UC : OR = 4.18 , 95 % CI : 1.04 to 16.75 , p = .043 , Effect Size = .79 ) . CONCLUSION Although there were no overall significant effects of treatment on abstinence , MBAT may be more effective than CBT or UC in promoting recovery from lapses . ( PsycINFO Data base OBJECTIVES To investigate the effects on serum lipids , plasma fibrinogen , plasma insulin , plasma C-peptide and blood glucose , of smoking cessation after 4 months . To develop a group-based smoking intervention programme in primary health care . SETTING Twenty health centres in primary health care in southern Sweden . SUBJECTS Four hundred habitual smokers ( > 10 cigarettes per day-1 , > 10 years ) , recruited by advertisement in local papers . INTERVENTION The smokers were r and omized , after stratification for age and sex , to one intervention group ( n = 200 ) and one control group ( n = 200 ) . The intervention group was offered supportive group sessions and free nicotine supplementation ( patches , chewing gum ) . MAIN OUTCOME MEASURES All participants were investigated at the start and after 4 months ( medical history , physical examination , laboratory evaluation ) . Blood sample s were drawn for determination of glucose , insulin and C-peptide , both in the fasting state and during an oral glucose tolerance test ( OGTT ) , and for measurement of lipoproteins , fibrinogen , nicotine and cotinine . RESULTS In the intervention group 98 of the subjects ( 48 % ) had quit smoking after 4 months . They were compared with the 156 subjects in the control group ( 91 % ) who were still daily smokers during the whole period . There were no significant differences in any variable between the two ( total ) experimental groups at baseline . Plasma nicotine and cotinine decreased ( P < 0.001 ) in the intervention group following smoking cessation , and weight increased by 2.7 kg . In the intervention group HDL-cholesterol increased by 11 % ( P < 0.001 ) , whereas HbA1c increased by 2 % ( P < 0.05 ) only in the control group . No changes occurred in levels of glucose , insulin , C-peptide and fibrinogen . CONCLUSION The smoking cessation programme had a success rate of almost 50 % over 4 months . Smoking cessation was associated with a marked increase in HDL-cholesterol levels but did not affect glucose tolerance . A concomitant weight increase may have blunted any independent beneficial effect of smoking cessation on glucose metabolism ABSTRACT Background : Tobacco use is higher among homeless individuals than the general population . Homeless individuals are also more likely to have symptoms of depression . Depression symptoms may add to the burden of homelessness by increasing psychological distress and serve as a barrier to quitting smoking . Objectives : The primary goal of this study is to assess the impact of depression symptoms on psychological distress in homeless smokers . The effect of depression symptoms on abstinence and the effect of Motivational Interviewing ( MI ) on cessation among smokers is also explored . Methods : Homeless smokers ( N = 430 ) enrolled in a smoking cessation study were r and omized to Motivational Interviewing ( MI ) or st and ard care ( SC ) . Participants received nicotine replacement therapy and were followed for 26 weeks . Participants were categorized into a depression symptoms ( DS ) group or control group using the Patient Health Question naire-9 . Between group differences of perceived stress , hopelessness , confidence , craving and abstinence were assessed at weeks 8 and 26 . The interaction between depression symptoms ( levels : DS and control ) and the intervention ( levels : MI and SC ) was also assessed . Results : Homeless smokers in the DS group reported higher levels of hopelessness , perceived stress , and craving . There was no effect of DS status on abstinence at week 8 or week 26 . There was no significant interaction between depression symptoms ( DS vs. Control ) and the intervention ( MI vs. SC ) . Conclusion : Despite reporting greater psychological distress , homeless smokers with depression symptoms in this sample had abstinence levels similar to the control group . Future research should explore protective factors among depressed smokers INTRODUCTION Identifying successful smoking treatment interventions and methods of delivery is critical given the smoking rates among HIV-positive population s and the medical implication s of smoking in this population . This study compared the efficacy of 3 smoking cessation interventions provided in HIV clinical treatment setting s. METHODS Following a baseline assessment , 209 HIV-positive smokers were r and omly assigned to 1 of 3 conditions in a parallel group design . Treatment conditions were individual counseling plus nicotine replacement treatment ( NRT ) , a computer-based Internet smoking treatment plus NRT , and self-help plus NRT . Smoking status was determined at follow-up assessment s completed at 12 , 24 , 36 , and 52 weeks following treatment initiation . RESULTS Cessation rates ranged from 15 % to 29 % ; however , no statistically significant differences in abstinence were found among the treatment conditions over time . Those employed , those who reported a greater desire to quit , or those with lower mood disturbance scores were more likely to achieve abstinence ( p < .01 ) . The number of cigarettes participants reported smoking in the 24hr prior to each assessment significantly declined over time ( p < .001 ) . CONCLUSIONS Although we found no differences in abstinence rates across groups , the results indicate that integration of smoking cessation interventions is feasible in HIV clinical treatment setting s , and cessation results are promising . The overall abstinence rates we report are comparable to those found in similar treatment studies across multiple population s. Further research is warranted AIM The study aim ed to test simultaneously our underst and ing of the effects of bupropion sustained-release ( SR ) treatment on putative mediators and our underst and ing of determinants of post-quit abstinence , including withdrawal distress , cigarette craving , positive affect and subjective reactions to cigarettes smoked during a lapse . The specificity of bupropion SR effects was also tested in exploratory analyses . DESIGN Data from a r and omized , placebo-controlled clinical trial of bupropion SR were su bmi tted to mediation analyses . SETTING Center for Tobacco Research and Intervention , Madison , WI , USA . PARTICIPANTS A total of 403 adult , daily smokers without contraindications to bupropion SR use . INTERVENTION Participants Output:
Findings demonstrated a benefit of behavioural support in addition to pharmacotherapy . There is high-certainty evidence that providing behavioural support in person or via telephone for people using pharmacotherapy to stop smoking increases quit rates . Subgroup analysis suggests that the incremental benefit from more support is similar over a range of levels of baseline support .
MS2_1shot33
***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: This study investigated the C. albicans adhesion to cold- and heat-polymerized soft lining material s that were initially incubated in two different artificial body fluids , namely saliva and nasal secretion , and examined the surface roughness the material s ( cold and heat polymerized soft liner ) tested in vitro . Cold ( Visco Gel ) and heat-polymerized ( Molloplast B ) soft liner specimens ( N=32 , n=8 per group ) ( 10x10x1.5 mm ) were r and omly produced to express the relationship between surface roughness and contamination , and influence of body fluids , and incubated in 1.5 ml contaminated solutions for 2 h. After fixation , all of material s were evaluated under optical microscope ( x400 ) and SEM . Surface roughness measurements were examined with profilometre for each material . Data were analyzed using two-way ANOVA , Tukey 's HSD and Dunnett T3 tests ( alpha=0.05 ) . Material type ( p<0.05 ) and contamination media ( p<0.05 ) showed a significant influence on the C. albicans adherence . The surface roughness of cold polymerized soft liner ( Visco Gel ) was significantly higher than heat-polymerized soft liner ( Molloplast B ) ( p<0.05 ) OBJECTIVE This study evaluated . the effect of mouthrinses and tissue conditioner on the clinical findings and microbial flora of 60 patients with Newton 's type II denture stomatitis ( N2DS ) BACKGROUND : Denture stomatitis is a common problem in complete denture wearers . MATERIAL S AND METHODS Sixty patients with N2DS were included in this study and divided into three groups . Two groups of patients were instructed to rinse their mouth with the design ated mouthrinses DioxiDent and Corsodyl twice daily for 1 min and to soak their dentures overnight in these solutions for 15 days . For the third group , tissue conditioner was placed in each of 20 patients ' existing maxillary dentures . Patients were evaluated both clinical ly and microbiologically at baseline and after 15 days . Palatal swabs and smears were taken from each patient before and after treatment and these sample s were examined mycologically . The difference between C and ida colonisation before and after treatment and the differences between pre-treatment and post-treatment clinical findings were assessed . RESULTS DioxiDent and Corsodyl showed an improvement in palatal inflammation and a decrease in C and ida colonisation compared to Visco-gel . CONCLUSIONS The effectiveness of topical chlorine dioxide and chlorhexidine gluconate in the management of N2DS was demonstrated As poor denture hygiene is related to C and ida colonisation , disinfectant solutions have been proposed as an effective method of preventing denture stomatitis . This study assessed the efficacy of denture cleansers on C and ida albicans and C and ida glabrata adherence on denture liners . Another aim was to correlate material s ’ surface roughness ( Ra ) to C and ida adherence . Specimens of three denture liners ( soft and hard polymethyl methacrylate (PMMA)-based and soft silicone-based ) were prepared and had their Ra measured . Specimens were r and omly divided to adherence assays with C. albicans or C. glabrata . After contamination with the fungi , specimens were treated with an enzymatic cleanser solution , a cleanser solution or a 0.5 % NaOCl solution by soaking for 3 , 15 or 10 min , respectively . Control group specimens were soaked in distilled water for 15 min . Number of remaining C and ida cells after treatment was determined by light microscopy ( ×400 ) . Analysis of variance ( α = 0.05 ) showed that Ra of the silicone-based liner was lower than that of the PMMA-based liners ( p < 0.05 ) . The overall results showed high C. glabrata adherence ( p < 0.001 ) , while the lowest levels of remaining C and ida cells were found for the treatment with 0.5 % NaOCl ( p = 0.0019 ) . No difference among denture cleansers and control was found ( p = 0.19 ) . There was no correlation between Ra and C. albicans or C. glabrata adherence in all material s tested . The only treatment able to reduce both C and ida species adherence on all material s tested was 0.5 % NaOCl solution Polymer-gel material s used as short-term denture soft linings are blended with plasticizers to lower the glass transition temperature ( Tg ) . A lower Tg allows for greater polymer chain mobility , thus producing a more flexible material . The present work evaluated the loss of plasticizers due to leaching both in vivo and in vitro . Two commercial denture soft-lining material s ( A and B ) were tested . These were both poly(ethyl methacrylate ) polymers , blended with alcohol and phthalate esters . A clinical study was conducted in which patients wore , sequentially , dentures bearing ( on separate occasions ) each of the two soft-polymer lining material s. The two material s A and B were r and omly assigned for each of ten patients and were worn for 14 and 30 days , respectively . With one exception , patients wore dentures with both lining material s , for a total of 19 clinical evaluations . The plasticizer loss occurring during the clinical trial was determined by GC analysis from the initial and terminal day sampling of plasticizer content of the soft polymer-gel material s. The results of this analysis were compared with results obtained from an in vitro leachability study by use of sink conditions in water at 37 ° C for the same two commercial soft polymers conducted over the same time periods of 14 and 30 days . The results indicated that a higher loss of plasticizer occurred in vivo , compared with the in vitro tests for 17 of the 19 clinical evaluations . The average plasticizer lost in vivo from material A at 14 days was 122 ± 58 mg/g , and for material B at 30 days it was 33 ± 27 mg/g . This can be compared with the in vitro loss that was 13.41 ± 1.11 mg/g for material A at 14 days , and 8.47 ± 0.73 mg/g for material B at 30 days . It is not known how much of the plasticizer lost from the denture soft lining in the in vivo trial was ingested by the patient . Patients were caution ed against soaking the denture in any liquid ; however , it is not known how much was lost due to cleaning of the denture by the patients BACKGROUND Soft denture lining- material s are more susceptible to microbial adhesion than hard denture base acrylic resin . Poor oral hygiene and C and ida albicans infection are common among elderly denture wearers as these patients usually have difficulty in keeping them clean . PURPOSE To evaluate the influence of the oral hygiene methods on the formation of a biofilm over a soft denture-lining material . MATERIAL AND METHODS Twenty volunteers were r and omly separated into two groups : G1 and G2 . Ten volunteers performed daily hygiene of the prostheses with a soft toothbrush and toothpaste . The G2 performed a treatment identical to G1 but also immersed the prostheses in sodium hypochlorite 0.5 % for 20 min , once a week . Quantification of the mean score values of biofilm formation at different times were statistically analysed using analysis of variance and Tukey 's test ( alpha = 0.05 ) . RESULTS G1 ( 0.65 + /- 0.52 ) showed the lowest mean score values of biofilm formation . There was statistical difference between G1 and G2 . The highest mean score values were found at 6 weeks ( 1.3 + /- 1.08 ) and were statistically different from other times . CONCLUSION The oral hygiene methods had a significant effect in the formation of the biofilm over a soft denture-lining material This study evaluated the long-term efficacy of denture cleansers against C and ida spp . biofilm recolonization on liner surface . Specimens were fabricated of a poly(methyl methacrylate)-based denture liner and had their surface roughness evaluated at baseline and after cleansing treatments . C. albicans or C. glabrata biofilms were formed on liner surface for 48 h , and then the specimens were r and omly assigned to one of cleaning treatments : two alkaline peroxides ( soaking for 3 or 15 min ) , 0.5 % sodium hypochlorite ( 10 min ) or distilled water ( control ; 15 min ) . After the treatments , the specimens were sonicated to disrupt the biofilm , and residual cells were counted ( cell/mL ) . Long-term effectiveness of the cleaning processes was determined by su bmi tting a set of cleaned specimens to biofilm growth conditions for 48 h followed by estimation of cell counts . The topography of specimens after cleaning treatments was analyzed by SEM . Data were analyzed by ANOVA and Tukey 's test ( α ; = 0.05 ) . Results of cell count estimation showed significant differences in cleanliness among the treatments ( p < 0.001 ) , and it could be observed by SEM . However , no significant difference ( p > 0.05 ) was observed among the C and ida species regarding the recolonization condition . Alkaline denture cleansers showed similar cleaning performance and both differed from the control ( p < 0.001 ) . Sodium hypochlorite was the only treatment that removed biofilm efficiently , since no viable cells were found after its use . In conclusion , alkaline peroxide denture cleansers were not effective in removing C and ida spp . biofilm from denture liner surfaces and preventing biofilm recolonization PURPOSE The aim of this study was to evaluate if the use of a varnish on a tissue conditioner would affect biofilm adhesion . BACKGROUND After the surgery has been performed , before the delivery of a complete denture , it is often necessary to use material s such as tissue conditioners on the surgical wound . However , these material s present deficient physico-mechanical properties , which allow biofilm development . METHODS Forty elderly volunteers wearing complete maxillary dentures were selected . They were r and omly allocated into two groups ( n = 20 ) , G1 and G2 . In both groups , a silicone-based tissue conditioner was placed in a recess created at the base of the denture , according to the manufacturer 's guidelines . In group G1 , a varnish was applied to the tissue conditioner , while in group G2 , no treatment was applied . All volunteers performed daily hygiene of the prosthesis with a soft toothbrush , and toothpaste . Quantification of the mean score values of biofilm formed at different time points ( baseline , 1 week and 3 weeks ) was statistically analysed using anova ( alpha = 0.05 ) . RESULTS Group G2 ( 1.6 + /- 1.2 ) showed the lowest mean score values of biofilm formation and there was a statistical difference between the groups ( p = 0.03 ) . The highest mean score values were found after 3 weeks ( 2.7 + /- 1.4 ) and were statistically different from the other time points studied ( baseline and 1 week ) . CONCLUSION The use of a varnish had a detrimental effect on the tissue conditioner studied , allowing higher biofilm formation Output:
RESULTS The incorporation of nystatin ( in general , 500 000 units ) into tissue conditioners to prevent the onset of the disease and immersion in sodium hypochlorite for disinfection were the methods most often described in this systematic review , and both methods were able to prevent or inhibit C and ida colonization , depending on their concentrations . The 0.5 % sodium hypochlorite concentration can disinfect tissue conditioners and denture liners . Microwave irradiation has also been described an alternative method of disinfection . The literature suggests that the use of 0.5 % sodium hypochlorite can help disinfect denture liners and tissue conditioners . The incorporation of nystatin in those material s is also able to treat or prevent oral c and idiasis .
MS2_1shot34
***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 whether observed differences in dementia rates between black and white older people living in the community could be explained by measures of socioeconomic status ( income , financial adequacy , education , and literacy ) and health related factors . Design Prospect i ve cohort study . Setting General community from two clinic sites in the United States ( Pittsburgh , Pennsylvania and Memphis , Tennessee ) . Participants 2457 older people ( mean age 73.6 years ; 1019 ( 41.5 % ) black ; 1233 ( 50.2 % ) women ) , dementia-free at baseline , in the Health , Aging , and Body Composition study . Main outcome measure Dementia was determined over 12 years ( ending January 2011 ) by prescribed dementia drugs , hospital records , and decline in global cognitive scores . The influence of socioeconomic status and health related factors on dementia rates was examined in a series of Cox proportional hazard models in which these variables were added sequentially in covariate blocks . Results Over follow-up , 449 ( 18.3 % ) participants developed dementia . Black participants were more likely than white participants to develop dementia ( 211 ( 20.7 % ) v 238 ( 16.6 % ) , P<0.001 ; unadjusted hazard ratio 1.44 , 95 % confidence interval 1.20 to 1.74 ) . The hazard ratio lessened somewhat after adjustment for demographics , apolipoprotein E e4 , comorbidities , and lifestyle factors ( 1.37 , 1.12 to 1.67 ) but was greatly reduced and no longer statistically significant when socioeconomic status was added ( 1.09 , 0.87 to 1.37 ) . Conclusion These findings suggest that differences in the burden of risk factors , especially socioeconomic status , may contribute to the higher rates of dementia seen among black compared with white older people . Strategies aim ed at reducing these disparities may favorably affect the incidence of dementia Background and Purpose — Although aspirin is effective in prevention of stroke , fewer studies have examined the impact of aspirin on stroke morbidity . Methods — The Women ’s Health Study is a completed r and omized , placebo-controlled trial design ed to test the effect of low-dose aspirin and vitamin E in the primary prevention of cardiovascular disease and cancer , which enrolled 39 876 women . We used multinomial logistic regression to evaluate the relationship between r and omized aspirin assignment and functional outcomes from stroke . Possible functional outcomes were neither stroke nor transient ischemic attack ( TIA ) , modified Rankin scale ( mRS ) score 0 to 1 , 2 to 3 , and 4 to 6 . Results — After a mean of 9.9 years of follow-up , 460 confirmed strokes ( 366 ischemic , 90 hemorrhagic , and 4 unknown type ) and 405 confirmed TIAs occurred . With regard to total and ischemic stroke , women who were r and omized to aspirin had a nonsignificant decrease in risk of any outcome compared to women not r and omized to aspirin . This decrease in risk only reached statistical significance for those experiencing TIA compared to participants without stroke or TIA ( odds ratio=0.77 ; 95 % confidence interval , 0.63–0.94 ) . For hemorrhagic stroke , a nonsignificant increase in the risk of achieving an mRS score 2 to 3 or 4 to 6 compared with no stroke or TIA was observed for the women r and omized to aspirin compared to those r and omized to placebo . Conclusions — Results from this large r and omized clinical trial provide evidence that 100 mg of aspirin every other day may reduce the risk of ischemic cerebral vascular events but does not have differential effects on functional outcomes from stroke Objective To determine whether low dose aspirin protects women aged 65 or more against cognitive decline . Design Cohort study within both arms of the women 's health study , a r and omised , double blind , placebo controlled trial of low dose aspirin for the primary prevention of cardiovascular disease and cancer , 1992 - 5 . Setting Women 's health study , 1998 - 2004 . Participants 6377 women aged 65 or more . Interventions Low dose aspirin ( 100 mg on alternate days ) or placebo for a mean of 9.6 years . Main outcome measures Women had three cognitive assessment s at two year intervals by telephone . The battery to assess cognition included five tests measuring general cognition , verbal memory , and category fluency . The primary prespecified outcome was a global score , averaging performance across all tests . The key secondary outcome was a verbal memory score , averaging performance on four measures of verbal memory . Results At the initial assessment ( mean 5.6 years after r and omisation ) cognitive performance in the aspirin group was similar to that of the placebo group ( mean difference in global score −0.01 , 95 % confidence interval −0.04 to 0.02 ) . Mean decline in the global score from the first to the final cognitive assessment was also similar in the aspirin compared with placebo groups ( mean difference 0.01 , −0.02 to 0.04 ) . The risk of substantial decline ( in the worst 10th centile of decline ) was also comparable between the groups ( relative risk 0.92 , 0.77 to 1.10 ) . Findings were similar for verbal memory ; however , a 20 % lower risk was observed for decline in category fluency with aspirin ( relative risk 0.80 , 0.67 to 0.97 ) . Conclusion Long term use of low dose aspirin does not provide overall benefits for cognition among generally healthy women aged 65 or more Background Amnestic mild cognitive impairment represents , in many cases , the earliest clinical phases of Alzheimer disease . Anti-inflammatory agents have epidemiologic support as drugs potentially beneficial in Alzheimer disease . In vivo studies have shown that Triflusal and its active metabolite 2-hydroxy-4-trifluoromethyl-benzoic acid have potent anti-inflammatory actions in the central nervous system . Methods We conducted a r and omized , double-blind , placebo-controlled trial of Triflusal in patients with amnestic mild cognitive impairment . Subjects were r and omly assigned to receive 900 mg of Triflusal or placebo for 18 months . The primary outcome was a change in Cognitive subscale of the Alzheimer Disease Assessment Scale ; conversion to dementia was a secondary outcome . Results A slow rate of recruitment forced a premature cessation of the study . Two hundred and fifty-seven subjects were enrolled and followed-up for an average of 13 months . The significance level was not reached for the primary outcome even though a trend in favor of Triflusal was observed . However , there was a significant difference in the probability of progression to dementia of Alzheimer 's type with a lower risk in the Triflusal compared with the placebo group ( hazard ratio , 2.10 ; 95 % confidence interval , 1.10 - 4.01 ; P=0.024 ) . Conclusions In this study , Triflusal therapy was associated with a significant lower rate of conversion to dementia that is likely to be clinical ly relevant . Because the trial was prematurely halted , these results should be interpreted with caution and require further confirmation BACKGROUND Selective inhibition of cyclooxygenase-2 ( COX-2 ) may be associated with an increased risk of thrombotic events , but only limited long-term data have been available for analysis . We report on the cardiovascular outcomes associated with the use of the selective COX-2 inhibitor rofecoxib in a long-term , multicenter , r and omized , placebo-controlled , double-blind trial design ed to determine the effect of three years of treatment with rofecoxib on the risk of recurrent neoplastic polyps of the large bowel in patients with a history of colorectal adenomas . METHODS A total of 2586 patients with a history of colorectal adenomas underwent r and omization : 1287 were assigned to receive 25 mg of rofecoxib daily , and 1299 to receive placebo . All investigator-reported serious adverse events that represented potential thrombotic cardiovascular events were adjudicated in a blinded fashion by an external committee . RESULTS A total of 46 patients in the rofecoxib group had a confirmed thrombotic event during 3059 patient-years of follow-up ( 1.50 events per 100 patient-years ) , as compared with 26 patients in the placebo group during 3327 patient-years of follow-up ( 0.78 event per 100 patient-years ) ; the corresponding relative risk was 1.92 ( 95 percent confidence interval , 1.19 to 3.11 ; P=0.008 ) . The increased relative risk became apparent after 18 months of treatment ; during the first 18 months , the event rates were similar in the two groups . The results primarily reflect a greater number of myocardial infa rct ions and ischemic cerebrovascular events in the rofecoxib group . There was earlier separation ( at approximately five months ) between groups in the incidence of nonadjudicated investigator-reported congestive heart failure , pulmonary edema , or cardiac failure ( hazard ratio for the comparison of the rofecoxib group with the placebo group , 4.61 ; 95 percent confidence interval , 1.50 to 18.83 ) . Overall and cardiovascular mortality was similar in the two groups . CONCLUSIONS Among patients with a history of colorectal adenomas , the use of rofecoxib was associated with an increased cardiovascular risk Objective To determine the effects of low dose aspirin on cognitive function in middle aged to elderly men and women at moderately increased cardiovascular risk . Design R and omised double blind placebo controlled trial . Setting Central Scotl and . Participants 3350 men and women aged over 50 participating in the aspirin for asymptomatic atherosclerosis trial . Intervention Low dose aspirin ( 100 mg daily ) or placebo for five years . Main outcome measures Tests of memory , executive function , non-verbal reasoning , mental flexibility , and information processing five years after r and omisation , with scores used to create a summary cognitive score ( general factor ) . Results At baseline , mean vocabulary scores ( an indicator of previous cognitive ability ) were similar in the aspirin ( 30.9 , SD 4.7 ) and placebo ( 31.1 , SD 4.7 ) groups . In the primary intention to treat analysis , there was no significant difference at follow-up between the groups in the proportion achieving over the median general factor cognitive score ( 32.7 % and 34.8 % respectively , odds ratio 0.91 , 95 % confidence interval 0.79 to 1.05 , P=0.20 ) or in mean scores on the individual cognitive tests . There were also no significant differences in change in cognitive ability over the five years in a subset of 504 who underwent detailed cognitive testing at baseline . Conclusion Low dose aspirin does not affect cognitive function in middle aged to elderly people at increased cardiovascular risk . Trial registration IS RCT N 66587262 Inflammatory mechanisms have been implicated in Alzheimer 's disease ( AD ) and might be mediated via the COX-2 enzyme . Previous studies with the selective COX-2 inhibitors , rofecoxib and celecoxib , have shown that they do not alter the progression of AD . We conducted a double-blind study to investigate whether rofecoxib could delay a diagnosis of AD in patients with mild cognitive impairment ( MCI ) , a group with an expected annual AD diagnosis rate of 10–15 % . MCI patients ⩾65 years were r and omized to rofecoxib 25 mg ( N=725 ) or placebo ( N=732 ) daily for up to 4 years . The primary end point was the percentage of patients with a clinical diagnosis of AD . The estimated annual AD diagnosis rate was lower than the anticipated 10–15 % : 6.4 % in the rofecoxib group vs 4.5 % in the placebo group ( rofecoxib : placebo hazard ratio=1.46 ( 95 % CI : 1.09 , 1.94 ) , p=0.011 ) . Analyses of secondary end points , including measures of cognition ( eg the cognitive subscale of the AD Assessment Scale ( ADAS-Cog ) ) and global function ( eg the Clinical Dementia Rating ( CDR ) ) , did not demonstrate differences between treatment groups . There was also no consistent evidence that rofecoxib differed from placebo in post hoc analyses comparing ADAS-Cog and CDR-sum of boxes scores in overlapping subgroups of patients who had Mini Mental State Exam scores of 24–26 in the present MCI study and in a previous AD treatment study with a similar design . The results from this MCI study did not support the hypothesis that rofecoxib would delay a diagnosis of AD . In conjunction with the lack of effects observed in previous AD studies , the findings suggest that inhibition of COX-2 is not a useful therapeutic approach in AD BACKGROUND Selective cyclooxygenase-2 ( COX-2 ) inhibitors have come under scrutiny because of reports suggesting an increased cardiovascular risk associated with their use . Experimental research suggesting that these drugs may contribute to a prothrombotic state provides support for this concern . METHODS We review ed all potentially serious cardiovascular events among 2035 patients with a history of col Output:
There is no evidence to support the use of low-dose aspirin or other NSAIDs of any class ( celecoxib , rofecoxib or naproxen ) for the prevention of dementia , but there was evidence of harm .
MS2_1shot35
***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: Serum biochemical liver tests ( LTs ) ( ALT , AST , GGT ) and platelet counts are often used to screen for chronic liver disease . Population ‐based data on abnormal LTs in Mediterranean areas are lacking . The prevalence and etiology of abnormal LTs were assessed from 2002 to 2003 in a 1 in 5 systematic r and om sample of the general population who were 12 years of age or older in Cittanova , a southern Italian town with 10,600 inhabitants . LTs , indices of metabolism , and markers of HBV and HCV infection were assayed and alcohol intake was recorded in the selected population . In virus‐free individuals with abnormal LTs , LTs were retested , and upper abdominal echography and tests for other causes of liver damage were undertaken . Among the 1,645 individuals screened , the prevalence of anti‐HCV was 6.5 % ; the prevalence was particularly high in individuals over 50 years of age . The corresponding prevalence for HBsAg was 0.8 % . The overall prevalence of individuals with abnormal LTs was 12.7 % ( 95 % CI : 11.1‐14.3 ) . The probable cause of abnormal LTs was excessive alcohol in 45.6 % , HCV in 18.6 % , HBV in 1 % , alcohol plus HCV and /or HBV in 8.8 % , and rare diseases in 2 % . In 24 % of individuals with abnormal LTs , the probable cause was nonalcoholic fatty liver disease ( NAFLD ) ; in this subgroup , increased body weight , hypercholesterolemia , and hyperglycemia were common , and 63.3 % of them had a bright liver at echography . In conclusion , in southern Italy , a Mediterranean area where dietary habits are different from those in industrialized areas , one eighth of the general population has abnormal LTs suggestive of possible liver damage ; NAFLD appears to be emerging as a potentially important etiology of this presumed liver injury . ( HEPATOLOGY 2005;41:1151–1159 . BACKGROUND & AIMS Elevated serum alanine aminotransferase ( ALT ) and gamma-glutamyltransferase ( GGT ) activities are markers of liver injury , but may also be associated with other diseases and death . In a prospect i ve , national , population -based sample , we examined whether elevated ALT and GGT were associated with increased risk of all-cause and disease-specific mortality . METHODS Death certificate-based 12-year mortality was analyzed among 14,950 adult participants in the third US National Health and Nutrition Examination Survey , 1988 - 1994 , who were negative for markers of viral hepatitis B and C. Abnormal ALT was defined as > 30 U/L in men or > 19 U/L in women , and abnormal GGT as > 51 U/L in men or > 33 U/L in women . RESULTS Cumulative mortality was 13.9 % from all causes , including 4.2 % from cardiovascular disease , 4.2 % from neoplasms , 0.44 % from diabetes , and 0.13 % from liver disease . In multivariate-adjusted analyses , elevated ALT was not associated with all-cause mortality ( hazard ratio [ HR ] , 1.2 ; 95 % confidence interval [ CI ] , 0.88 - 1.6 ) . ALT elevation was associated with deaths from liver disease ( HR , 8.2 ; 95 % CI , 2.1 - 31.9 ) , but not from cardiovascular disease ( HR , 0.90 ; 95 % CI , 0.56 - 1.4 ) , neoplasms ( HR , 1.0 ; 95 % CI , 0.65 - 1.5 ) , or diabetes ( HR , 2.4 ; 95 % CI , 0.65 - 9.1 ) . All-cause mortality increased with elevated GGT ( HR , 1.5 ; 95 % CI , 1.2 - 1.8 ) , as did mortality from liver disease ( HR , 13.0 ; 95 % CI , 2.4 - 71.5 ) , neoplasms ( HR , 1.5 ; 95 % CI , 1.01 - 2.2 ) , and diabetes ( HR , 3.3 ; 95 % CI , 1.4 - 7.6 ) , but not from cardiovascular disease ( HR , 1.3 ; 95 % CI , 0.80 - 2.0 ) . CONCLUSIONS In the US population , elevated GGT was associated with mortality from all causes , liver disease , cancer , and diabetes , while ALT was associated only with liver disease mortality Abstract Objective To examine the relation between the normal range of serum aminotransferase concentration and mortality from liver disease . Design Prospect i ve cohort study . Setting Korea Medical Insurance Corporation study with eight years ' follow up . Participants 94 533 men and 47 522 women aged 35 - 59 years . Main outcome measure Mortality from liver diseases according to death certificate . Results There was a positive association between the aminotransferase concentration , even within normal range ( 35 - 40 IU/l ) , and mortality from liver disease . Compared with the concentration < 20 IU/l , the adjusted relative risks for an aspartate aminotransferase concentration of 20 - 29 IU/l and 30 - 39 IU/l were 2.5 ( 95 % confidence interval 2.0 to 3.0 ) and 8.0 ( 6.6 to 9.8 ) in men and 3.3 ( 1.7 to 6.4 ) and 18.2 ( 8.1 to 40.4 ) in women , respectively , The corresponding risks for alanine aminotransferase were 2.9 ( 2.4 to 3.5 ) and 9.5 ( 7.9 to 11.5 ) in men and 3.8 ( 1.9 to 7.7 ) and 6.6 ( 1.5 to 25.6 ) in women , respectively . According to receiver operating characteristic curves the best cut-off values for the prediction of liver disease in men were 31 IU/l for aspartate aminotransferase and 30 IU/l for alanine aminotransferase . Conclusion People with slightly increased aminotransferase activity , but still within the normal range , should be closely observed and further investigated for liver diseases Background Although serum γ-glutamyltransferase ( GGT ) predicted cardiovascular diseases ( CVD ) in prospect i ve studies and may be useful in risk assessment , prediction in older adults was weaker in several studies . Methods We performed a nested case-control study with 5 - 12-year follow-up in 137 CVD deaths and 249 controls ( frequency-matched on age , sex , and examination year , age range 26 - 85 years ) . Results An age interaction of serum GGT and CVD mortality ( P value for interaction = 0.02 ) was observed . After adjusting for known CVD risk factors , compared with the lowest tertile , odds ratios ( 95 % confidence intervals ) in participants less than 70 years ( half the participants ) were : middle tertile : 2.17 ( 0.68 - 6.97 ) , top tertile up to GGT less than 50 U/I : 3.54 ( 1.07 - 11.7 ) , and GGT ≥ 50 U/l : 4.69 ( 1.16 - 18.9 ) . In participants aged more than or equal to 70 years , GGT was not related to CVD . Well-known demographic and health behavior associations with serum GGT were observed only in controls among participants aged less than 70 years . Conclusion Our findings suggest that serum GGT within its normal range can predict CVD mortality in those aged less than 70 years , but may have limited usefulness for risk assessment in older adults . Eur J Cardiovasc Prev Rehabil 16:16 - 20 © 2009 The European Society of Background — There is evidence from recent studies that γ-glutamyltransferase ( GGT ) is likely to be associated with cardiovascular disease ( CVD ) . However , few studies to date with sufficient sample size and follow-up investigated the association of GGT with CVD mortality . Methods and Results — The relation of GGT to the risk of death from CVD was examined in a cohort of 163 944 Austrian adults that was monitored for up to 17 years . To evaluate GGT as an independent predictor , Cox proportional hazards models were calculated , which adjusted for established risk factors . In both men and women , high GGT was significantly ( P<0.001 ) associated with total mortality from CVD , showing a clear dose-response relationship . Adjusted hazard ratios ( 95 % CI ) per log GGT increase were 1.66 ( 1.40 to 1.98 ) in men and 1.64 ( 1.36 to 1.97 ) in women . In men , subgroup analyses showed that high GGT was positively associated with incident fatal events of chronic forms of coronary heart disease ( P=0.009 ) , congestive heart failure ( P<0.001 ) , and hemorrhagic ( P=0.01 ) and ischemic stroke ( P<0.001 ) . No significant associations were observed for acute myocardial infa rct ion ( P=0.16 ) . In women , hazard ratios suggested associations in all subgroups ; however , for hemorrhagic and ischemic stroke they were not statistically significant ( P=0.09 and P=0.07 , respectively ) . In addition , subgroup analyses stratified by age revealed a stronger relationship of GGT in younger participants . Hazard ratios for total CVD were 2.03 ( 1.53 to 2.69 ) in men and 2.60 ( 1.53 to 4.42 ) in women younger than 60 years . Conclusions — This study demonstrates in a large , prospect ively observed cohort that GGT is independently associated with cardiovascular mortality Context Current upper limits ( 500 nkat/L [ 30 U/L ] for women , 667 nkat/L [ 40 U/L ] for men ) for serum alanine aminotransferase ( ALT ) level were defined in population s that included persons with nonalcoholic fatty liver disease ( NAFLD ) and persons with hepatitis C virus ( HCV ) infection . Contribution This study redefined ALT limits in blood donors at low risk for NAFLD and without hepatitis B or C ( 317 nkat/L [ 19 U/L ] in women , 500 nkat/L [ 30 U/L ] in men ) . When applied to 209 anti-HCV-positive donors , the new thresholds had 76.3 % sensitivity and 88.5 % specificity in identifying patients with hepatitis C viremia compared with 55 % and 97.4 % for old thresholds . Implication s Laboratories should consider revising the upper limits of normal for ALT to improve the sensitivity of this test in identifying sub clinical liver disease . The Editors Serum alanine aminotransferase ( ALT ) concentration is the most commonly used variable for assessment of liver disease ( 1 , 2 ) . However , particularly in the case of chronic hepatitis C virus ( HCV ) infection , ALT measurement often fails to identify patients with minimal to mild necroinflammatory activity ( 3 - 7 ) . Current upper limits of normal for ALT level were set , on average , at 667 nkat/L ( 40 U/L ) ( range , 500 to 833 nkat/L [ 30 to 50 U/L ] ) in studies conducted over the past 10 years ( 1 , 3 - 5 , 7 , 8) . Such thresholds , however , were mostly computed in the 1980s , when ALT testing was introduced as a surrogate marker for the screening of non-A , non-B hepatitis among blood donors and before anti-HCV testing and restrictive behavioral criteria for donor selection were implemented . Furthermore , so-called reference population s were likely to include many persons with nonalcoholic fatty liver disease , now recognized as the most prevalent cause of chronic liver disease in developed countries ( 8 - 10 ) . Current reference ranges for ALT level probably underestimate the frequency of chronic liver disease . Because dietary and behavioral risks for liver disease are widespread in many countries , a critical revision of ALT limits would require the definition of healthy ranges rather than a generic up date of normal ranges . Thus far , several factors have hampered this task . For example , to obtain solid data , many clinical , biochemical , and behavioral variables potentially related to liver disease must be investigated , requiring screening of large numbers of persons . Furthermore , repeated blood donors , who currently represent the vast majority of blood-donation c and i date s , can not be included in the sampling frame , because they have been selected on the basis of ALT activity during the past two decades . We report the results of a 4-year study of first-time blood-donation c and i date s. To up date the definitions of healthy ranges for serum ALT level , we identified a population at low risk for sub clinical liver disease by exploring factors related to enzyme activity in both healthy persons and those with mild abnormalities on liver tests . Next , we tested the sensitivity Output:
The ALT-mortality association was inconsistent and seems particularly susceptible to age after synthesizing the previous prospect i ve studies . In terms of the age , ALT activity was more valuable in predicting mortality in the older population ; extremely low ALT levels indicated a higher all-cause , CV-related , and cancer-related mortality . ALT activity may therefore be a useful biomarker when predicting the long-term survival of elderly patients
MS2_1shot36
***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 Programmed death-1 ( PD-1 ) , an inhibitory receptor expressed on activated T cells , may suppress antitumor immunity . This phase I study sought to determine the safety and tolerability of anti-PD-1 blockade in patients with treatment-refractory solid tumors and to preliminarily assess antitumor activity , pharmacodynamics , and immunologic correlates . PATIENTS AND METHODS Thirty-nine patients with advanced metastatic melanoma , colorectal cancer ( CRC ) , castrate-resistant prostate cancer , non-small-cell lung cancer ( NSCLC ) , or renal cell carcinoma ( RCC ) received a single intravenous infusion of anti-PD-1 ( MDX-1106 ) in dose-escalating six-patient cohorts at 0.3 , 1 , 3 , or 10 mg/kg , followed by a 15-patient expansion cohort at 10 mg/kg . Patients with evidence of clinical benefit at 3 months were eligible for repeated therapy . RESULTS Anti-PD-1 was well tolerated : one serious adverse event , inflammatory colitis , was observed in a patient with melanoma who received five doses at 1 mg/kg . One durable complete response ( CRC ) and two partial responses ( PRs ; melanoma , RCC ) were seen . Two additional patients ( melanoma , NSCLC ) had significant lesional tumor regressions not meeting PR criteria . The serum half-life of anti-PD-1 was 12 to 20 days . However , pharmacodynamics indicated a sustained mean occupancy of > 70 % of PD-1 molecules on circulating T cells > or = 2 months following infusion , regardless of dose . In nine patients examined , tumor cell surface B7-H1 expression appeared to correlate with the likelihood of response to treatment . CONCLUSION Blocking the PD-1 immune checkpoint with intermittent antibody dosing is well tolerated and associated with evidence of antitumor activity . Exploration of alternative dosing regimens and combinatorial therapies with vaccines , targeted therapies , and /or other checkpoint inhibitors is warranted BACKGROUND Treatments for small-cell lung cancer ( SCLC ) after failure of platinum-based chemotherapy are limited . We assessed safety and activity of nivolumab and nivolumab plus ipilimumab in patients with SCLC who progressed after one or more previous regimens . METHODS The SCLC cohort of this phase 1/2 multicentre , multi-arm , open-label trial was conducted at 23 sites ( academic centres and hospitals ) in six countries . Eligible patients were 18 years of age or older , had limited-stage or extensive-stage SCLC , and had disease progression after at least one previous platinum-containing regimen . Patients received nivolumab ( 3 mg/kg bodyweight intravenously ) every 2 weeks ( given until disease progression or unacceptable toxicity ) , or nivolumab plus ipilimumab ( 1 mg/kg plus 1 mg/kg , 1 mg/kg plus 3 mg/kg , or 3 mg/kg plus 1 mg/kg , intravenously ) every 3 weeks for four cycles , followed by nivolumab 3 mg/kg every 2 weeks . Patients were either assigned to nivolumab monotherapy or assessed in a dose-escalating safety phase for the nivolumab/ipilimumab combination beginning at nivolumab 1 mg/kg plus ipilimumab 1 mg/kg . Depending on tolerability , patients were then assigned to nivolumab 1 mg/kg plus ipilimumab 3 mg/kg or nivolumab 3 mg/kg plus ipilimumab 1 mg/kg . The primary endpoint was objective response by investigator assessment . All analyses included patients who were enrolled at least 90 days before data base lock . This trial is ongoing ; here , we report an interim analysis of the SCLC cohort . This study is registered with Clinical Trials.gov , number NCT01928394 . FINDINGS Between Nov 18 , 2013 , and July 28 , 2015 , 216 patients were enrolled and treated ( 98 with nivolumab 3 mg/kg , three with nivolumab 1 mg/kg plus ipilimumab 1 mg/kg , 61 with nivolumab 1 mg/kg plus ipilimumab 3 mg/kg , and 54 with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg ) . At data base lock on Nov 6 , 2015 , median follow-up for patients continuing in the study ( including those who had died or discontinued treatment ) was 198·5 days ( IQR 163·0 - 464·0 ) for nivolumab 3 mg/kg , 302 days ( IQR not calculable ) for nivolumab 1 mg/kg plus ipilimumab 1 mg/kg , 361·0 days ( 273·0 - 470·0 ) for nivolumab 1 mg/kg plus ipilimumab 3 mg/kg , and 260·5 days ( 248·0 - 288·0 ) for nivolumab 3 mg/kg plus ipilimumab 1 mg/kg . An objective response was achieved in ten ( 10 % ) of 98 patients receiving nivolumab 3 mg/kg , one ( 33 % ) of three patients receiving nivolumab 1 mg/kg plus ipilimumab 1 mg/kg , 14 ( 23 % ) of 61 receiving nivolumab 1 mg/kg plus ipilimumab 3 mg/kg , and ten ( 19 % ) of 54 receiving nivolumab 3 mg/kg plus ipilimumab 1 mg/kg . Grade 3 or 4 treatment-related adverse events occurred in 13 ( 13 % ) patients in the nivolumab 3 mg/kg cohort , 18 ( 30 % ) in the nivolumab 1 mg/kg plus ipilimumab 3 mg/kg cohort , and ten ( 19 % ) in the nivolumab 3 mg/kg plus ipilimumab 1 mg/kg cohort ; the most commonly reported grade 3 or 4 treatment-related adverse events were increased lipase ( none vs 5 [ 8 % ] vs none ) and diarrhoea ( none vs 3 [ 5 % ] vs 1 [ 2 % ] ) . No patients in the nivolumab 1 mg/kg plus ipilimumab 1 mg/kg cohort had a grade 3 or 4 treatment-related adverse event . Six ( 6 % ) patients in the nivolumab 3 mg/kg group , seven ( 11 % ) in the nivolumab 1 mg/kg plus ipilimumab 3 mg/kg group , and four ( 7 % ) in the nivolumab 3 mg/kg plus ipilimumab 1 mg/kg group discontinued treatment due to treatment-related adverse events . Two patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg died from treatment-related adverse events ( myasthenia gravis and worsening of renal failure ) , and one patient who received nivolumab 3 mg/kg plus ipilimumab 1 mg/kg died from treatment-related pneumonitis . INTERPRETATION Nivolumab monotherapy and nivolumab plus ipilimumab showed antitumour activity with durable responses and manageable safety profiles in previously treated patients with SCLC . These data suggest a potential new treatment approach for a population of patients with limited treatment options and support the evaluation of nivolumab and nivolumab plus ipilimumab in phase 3 r and omised controlled trials in SCLC . FUNDING Bristol-Myers Squibb BACKGROUND Blockade of programmed death 1 ( PD-1 ) , an inhibitory receptor expressed by T cells , can overcome immune resistance . We assessed the antitumor activity and safety of BMS-936558 , an antibody that specifically blocks PD-1 . METHODS We enrolled patients with advanced melanoma , non-small-cell lung cancer , castration-resistant prostate cancer , or renal-cell or colorectal cancer to receive anti-PD-1 antibody at a dose of 0.1 to 10.0 mg per kilogram of body weight every 2 weeks . Response was assessed after each 8-week treatment cycle . Patients received up to 12 cycles until disease progression or a complete response occurred . RESULTS A total of 296 patients received treatment through February 24 , 2012 . Grade 3 or 4 drug-related adverse events occurred in 14 % of patients ; there were three deaths from pulmonary toxicity . No maximum tolerated dose was defined . Adverse events consistent with immune-related causes were observed . Among 236 patients in whom response could be evaluated , objective responses ( complete or partial responses ) were observed in those with non-small-cell lung cancer , melanoma , or renal-cell cancer . Cumulative response rates ( all doses ) were 18 % among patients with non-small-cell lung cancer ( 14 of 76 patients ) , 28 % among patients with melanoma ( 26 of 94 patients ) , and 27 % among patients with renal-cell cancer ( 9 of 33 patients ) . Responses were durable ; 20 of 31 responses lasted 1 year or more in patients with 1 year or more of follow-up . To assess the role of intratumoral PD-1 lig and ( PD-L1 ) expression in the modulation of the PD-1-PD-L1 pathway , immunohistochemical analysis was performed on pretreatment tumor specimens obtained from 42 patients . Of 17 patients with PD-L1-negative tumors , none had an objective response ; 9 of 25 patients ( 36 % ) with PD-L1-positive tumors had an objective response ( P=0.006 ) . CONCLUSIONS Anti-PD-1 antibody produced objective responses in approximately one in four to one in five patients with non-small-cell lung cancer , melanoma , or renal-cell cancer ; the adverse-event profile does not appear to preclude its use . Preliminary data suggest a relationship between PD-L1 expression on tumor cells and objective response . ( Funded by Bristol-Myers Squibb and others ; Clinical Trials.gov number , NCT00730639 . ) PURPOSE Immune checkpoint inhibition has been demonstrated to be an effective anticancer strategy . Several lines of evidence support the study of immunotherapy in triple-negative breast cancer ( TNBC ) . We assessed the safety and antitumor activity of the programmed cell death protein 1 ( PD-1 ) inhibitor pembrolizumab in patients with advanced TNBC . METHODS KEYNOTE-012 ( Clinical Trials.gov identifier : NCT01848834 ) was a multicenter , nonr and omized phase Ib trial of single-agent pembrolizumab given intravenously at 10 mg/kg every 2 weeks to patients with advanced PD-L1-positive ( expression in stroma or ≥ 1 % of tumor cells by immunohistochemistry ) TNBC , gastric cancer , urothelial cancer , and head and neck cancer . This report focuses on the TNBC cohort . RESULTS Among 111 patients with TNBC whose tumor sample s were screened for PD-L1 expression , 58.6 % had PD-L1-positive tumors . Thirty-two women ( median age , 50.5 years ; range , 29 to 72 years ) were enrolled and assessed for safety and antitumor activity . The median number of doses administered was five ( range , 1 to 36 doses ) . Common toxicities were mild and similar to those observed in other tumor cohorts ( eg , arthralgia , fatigue , myalgia , and nausea ) , and included five ( 15.6 % ) patients with grade ≥ 3 toxicity and one treatment-related death . Among the 27 patients who were evaluable for antitumor activity , the overall response rate was 18.5 % , the median time to response was 17.9 weeks ( range , 7.3 to 32.4 weeks ) , and the median duration of response was not yet reached ( range , 15.0 to ≥ 47.3 weeks ) . CONCLUSION This phase Ib study describes preliminary evidence of clinical activity and a potentially acceptable safety profile of pembrolizumab given every 2 weeks to patients with heavily pretreated , advanced TNBC . A single-agent phase II study examining a 200-mg dose given once every 3 weeks ( Clinical Trials.gov identifier : NCT02447003 ) is ongoing BACKGROUND Expression of PD-L1 has been shown to be upregulated in some patients with gastric cancer . As part of the phase 1b KEYNOTE-012 study , we aim ed to assess the safety and activity of the anti-PD-1 antibody pembrolizumab in patients with PD-L1-positive recurrent or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction . METHODS This study was a multicentre , open-label , phase 1b trial done at 13 cancer research centres in the USA , Israel , Japan , South Korea , and Taiwan . We enrolled patients with PD-L1-positive recurrent or metastatic adenocarcinoma of the stomach or gastro-o Output:
Conclusions and Relevance Our study provides more precise data on the incidence of endocrine dysfunctions among patients receiving ICI regimens . Patients on combination therapy are at increased risk of thyroid dysfunction and hypophysitis
MS2_1shot37
***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 There has been little rigorous economic analysis of the relationship between asthma and improved housing . AIM To evaluate the cost-effectiveness of installing ventilation systems , and central heating if necessary , in homes of children with ' moderate ' or ' severe ' asthma . DESIGN AND SETTING An incremental cost-effectiveness analysis alongside a pragmatic r and omised controlled trial of a tailored package of housing modifications design ed to improve ventilation and household heating in homes within Wrexham County Borough , Wales , UK . METHOD A total of 177 children aged between 5 and 14 years , identified from general practice registers , were studied . Parents reported on the quality of life of their children over a 12-month period . General practice s reported on health-service re sources used by those children , and their asthma-related prescriptions , over the same period . RESULTS The tailored package shifted 17 % of children in the intervention group from ' severe ' to ' moderate ' asthma , compared with a 3 % shift in the control group . The mean cost of these modifications was £ 1718 per child treated or £ 12300 per child shifted from ' severe ' to ' moderate ' . Healthcare costs over 12 months following r and omisation did not differ significantly between intervention and control groups . Bootstrapping gave an incremental cost-effectiveness ratio ( ICER ) of £ 234 per point improvement on the 100-point PedsQL ™ asthma-specific scale , with 95 % confidence interval ( CI ) = £ 140 to £ 590 . The ICER fell to £ 165 ( 95 % CI = £ 84 to £ 424 ) for children with ' severe ' asthma . CONCLUSION This novel and pragmatic trial , with integrated economic evaluation , reported that tailored improvement of the housing of children with moderate to severe asthma is likely to be a cost-effective use of public re sources . This is a rare example of evidence for collaboration between local government and the NHS Evaluating cost effectiveness of interventions for aging in place is essential for adoption in service setting s. We present the cost effectiveness of Advancing Better Living for Elders ( ABLE ) , previously shown in a r and omized trial to reduce functional difficulties and mortality in 319 community-dwelling elders . ABLE involved occupational and physical therapy sessions and home modifications to address client-identified functional difficulties , performance goals , and home safety . Incremental cost-effectiveness ratio ( ICER ) , expressed as additional cost to bring about one additional year of life , was calculated . Two models were then developed to account for potential cost differences in implementing ABLE . Probabilistic sensitivity analyses were conducted to account for variations in model parameters . By two years , there were 30 deaths ( 9 : ABLE ; 21 : control ) . Additional costs for 1 additional year of life was $ 13,179 for Model 1 and $ 14,800 for Model 2 . Investment in ABLE may be worthwhile depending on society 's willingness to pay Aims To assess the cost-effectiveness of installing thermostatic mixer valves ( TMVs ) in reducing risks of bath water scalds and estimate the costs of avoiding bath water scalds . Methods The evaluation was undertaken from the perspective of the UK public sector , and conducted in conjunction with a r and omised control trial of TMVs installed in social housing in Glasgow . Installation costs were borne by the social housing organisation , while support material s were provided by the UK NHS . Effectiveness was represented by the number of families with at-risk bath water temperatures pre- and post-installation , and the number of bath scalds avoided as a result of installation . Differences in the number of families with at-risk temperatures between groups were derived from the RCT . Cost-effectiveness was assessed and a series of one-way sensitivity analyses were conducted . Results Unit costs associated with installation were calculated to be £ 13.68 , while costs associated with treating bath water scalds ranged from £ 25 226 to £ 71 902 . The cost of an avoided bath water scald ranged from net savings to public purse of £ 1887 to £ 75 520 and at baseline produced a net saving of £ 3 229 008 ; that is , £ 1.41 saved for every £ 1 spent . Conclusion It is very likely that installing TMVs as st and ard in social housing in new buildings and major refurbishments accompanied by educational information represents value for money . Trial registration number IS RCT N:21179067 BACKGROUND In 2001 , 486 deaths and 17,300 injuries occurred in domestic fires in the UK . Domestic fires represent a significant cost to the UK economy , with the value of property loss alone estimated at pounds 375 million in 1999 . In 2001 in the US , there were 383 500 home fires , result ing in 3110 deaths , 15,200 injuries and dollar 5.5 billion in direct property damage . METHODS A cluster RCT was conducted to determine whether a smoke alarm give-away program , directed to an inner-city UK population , is effective and cost-effective in reducing the risk of fire-related deaths/injuries . Forty areas were r and omized to the give-away or control group . The number of injuries/deaths and the number of fires in each ward were collected prospect ively . Cost-effectiveness analysis was undertaken to relate the number of deaths/injuries to re source use ( damage , fire service , healthcare and give-away costs ) . Analytical methods were used which reflected the characteristics of the trial data including the cluster design of the trial and a large number of zero costs and effects . RESULTS The mean cost for a household in a give-away ward , including the cost of the program , was pounds 12.76 , compared to pounds 10.74 for the control ward . The total mean number of deaths and injuries was greater in the intervention wards then the control wards , 6.45 and 5.17 . When an injury/death avoided is valued at pounds 1000 , a smoke alarm give-away has a probability of being cost effective of 0.15 . CONCLUSIONS A smoke alarm give-away program , as administered in the trial , is unlikely to represent a cost-effective use of re sources Background : Housing is an important environmental influence on population health , and there is growing evidence of health effects from indoor environment characteristics such as low indoor temperatures . However , there is relatively little research , and thus little firm guidance , on the cost-effectiveness of public policies to retrospectively improve the st and ards of houses . The purpose of this study was to value the health , energy and environmental benefits of retrofitting insulation , through assessing a number of forms of possible benefit : a reduced number of visits to GPs , hospitalisations , days off school , days off work , energy savings and CO2 savings . Methods : All these metrics are used in a cluster r and omised trial — the “ Housing , Insulation and Health Study ” —of retrofitting insulation in 1350 houses , in which at least one person had symptoms of respiratory disease , in predominantly low-income communities in New Zeal and . Results : Valuing the health gains , and energy and CO2 emissions savings , suggests that total benefits in “ present value ” ( discounted ) terms are one and a half to two times the magnitude of the cost of retrofitting insulation . Conclusion : This study points to the need to consider as wide a range of benefits as possible , including health and environmental benefits , when assessing the value for money of an intervention to improve housing quality . From an environmental , energy and health perspective , the value for money of improving housing quality by retrofitting insulation is compelling Background Despite much success in reducing the burden of malaria in Vietnam , pockets of malaria persist and eliminating them remains an important development goal . In central Vietnam , insecticide-treated hammocks have recently been introduced to help counter the disease in the highly forested , mountainous areas , where other measures have so far been unsuccessful . This study assesses the cost-effectiveness of using long-lasting insecticide-treated hammocks in this area . Methods and Findings This cost-effectiveness study was run alongside a r and omized control trial testing the efficacy of the long-lasting insecticide-treated hammocks . Data were collected through an exit survey , a household survey , expenditure records and key informant interviews . The study estimates that under normal ( non-trial ) conditions the total net societal cost per malaria episode averted in using long-lasting insecticide-treated hammocks in this area was 126 USD . Cost per hammock , including insecticidal netting , sewing , transport , and distribution was found to be approximately 11.76 USD per hammock . Average savings per episode averted were estimated to be $ 14.60 USD for the health system and 14.37 USD for households ( including both direct and indirect cost savings ) . The study estimates that the annual financial outlay required of government to implement this type of programme to be 3.40 USD per person covered per year . Conclusion The study finds that the use of a hammock intervention could represent good value for money to help prevent malaria in more remote areas , where traditional control measures such as insecticide-treated bednets and indoor residual spraying are insufficient or inappropriate to control malaria . However , the life span of the hammock – the number of years over which it effectively deters mosquitoes – has a significant impact on the cost-effectiveness of the intervention and study results should be interpreted in light of the evidence on effectiveness gathered in the years to come OBJECTIVES To model the incremental cost-utility of seven interventions reported as effective for preventing falls in older adults . DESIGN Mathematical epidemiological model populated by data based on direct clinical experience and a critical review of the literature . SETTING Model represents population level interventions . PARTICIPANTS No human subjects were involved in the study . MEASUREMENS : The last Cochrane data base review and meta-analyses of r and omized controlled trials categorized effective fall-prevention interventions into seven groups : medical management ( withdrawal ) of psychotropics , group tai chi , vitamin D supplementation , muscle and balance exercises , home modifications , multifactorial individualized programs for all elderly people , and multifactorial individualized treatments for high-risk frail elderly people . Fall-related hip fracture incidence was obtained from the literature . Salary figures for health professionals were based on Bureau of Labor Statistics data . Using an integrated healthcare system perspective , healthcare costs were estimated based on practice and studies on falls in older adults . Base case incremental cost utility ratios were calculated , and probabilistic sensitivity analyses were conducted . RESULTS Medical management of psychotropics and group tai chi were the least-costly , most-effective options , but they were also the least studied . Excluding these interventions , the least-expensive , most-effective options are vitamin D supplementation and home modifications . Vitamin D supplementation costs less than home modifications , but home modifications cost only $ 14,794/ quality -adjusted life year ( QALY ) gained more than vitamin D. In probabilistic sensitivity analyses excluding management of psychotropics and tai chi , home modification is most likely to have the highest economic benefit when QALYs are valued at $ 50,000 or $ 100,000 . CONCLUSION Of single interventions studied , management of psychotropics and tai chi reduces costs the most . Of more-studied interventions , home modifications provide the best value . These results must be interpreted in the context of the multifactorial nature of falls Objective To determine whether insulating existing houses increases indoor temperatures and improves occupants ' health and wellbeing . Design Community based , cluster , single blinded r and omised study . Setting Seven low income communities in New Zeal and . Participants 1350 households containing 4407 participants . Intervention Installation of a st and ard retrofit insulation package . Main outcome measures Indoor temperature and relative humidity , energy consumption , self reported health , wheezing , days off school and work , visits to general practitioners , and admissions to hospital . Results Insulation was associated with a small increase in bedroom temperatures during the winter ( 0.5 � C ) and decreased relative humidity ( −2.3 % ) , despite energy consumption in insulated houses being 81 % of that in uninsulated houses . Bedroom temperatures were below 10 � C for 1.7 fewer hours each day in insulated homes than in uninsulated ones . These changes were associated with reduced odds in the insulated homes of fair or poor self rated health ( adjusted odds ratio 0.50 , 95 % confidence interval 0.38 to 0.68 ) , self reports of wheezing in the past three months ( 0.57 , 0.47 to 0.70 ) , self reports of children taking a day off school ( 0.49 , 0.31 to 0.80 ) , and self reports of adults taking a day off work ( 0.62 , 0.46 to 0.83 ) . Visits to general practitioners were less often reported by occupants of insulated homes ( 0.73 , 0.62 to 0.87 ) . Hospital admissions for respiratory conditions were also reduced ( 0.53 , 0.22 to 1.29 ) , but this reduction was not statistically significant ( P=0.16 ) . Conclusion Insulating existing houses led to a significantly warmer , drier indoor environment and result ed in improved self rated health , self reported wheezing , days off school and work , and visits to general practitioners as well as a trend for fewer hospital admissions for respiratory conditions Background Insecticide-treated bed nets ( ITN ) reduce malaria morbidity and mortality consistently in Africa , but their benefits have been less consistent in Asia . This study ’s objective was to evaluate the malaria protective efficacy of village-wide usage of ITN in Western Myanmar and estimate the cost-effectiveness of ITN compared with extending early diagnosis and treatment services . Methods A cluster-r and omized controlled trial was conducted in Rakhine State to assess the efficacy of ITNs in preventing malaria and anaemia in children and their secondary effects Output:
There was fairly consistent evidence for the cost-effectiveness/favorable cost-benefit of removing indoor lead to prevent lead poisoning and sequelae , and retrofitting insulation to prevent lung disease . But the value of assessing and improving home safety and providing smoke alarms to prevent injuries was more mixed and the economic evidence was inconclusive or insufficient for : home ventilation to prevent lung disease , installing heaters to prevent lung disease and regulating tap water temperatures to prevent scalding . Conclusions This systematic review provides up date d evidence that several housing improvement interventions ( such as removing indoor lead and retrofitting insulation ) and also the provision of insecticide-treated bednets are cost-effective interventions .
MS2_1shot38
***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 UK clinical guidance advises against continuing trastuzumab ( T ) beyond disease progression ( PD ) in the absence of brain metastases in patients with HER-2 positive ( + ve ) advanced breast cancer .We have retrospectively evaluated the outcome of patients with HER-2+ve locally advanced ( LA ) or metastatic breast cancer ( MBC ) who continued T beyond PD , treated in our unit . Methods : All HER-2+ve patients on our prospect ively maintained data base with LA or MBC who received T beyond PD after adjuvant or one line of T for advanced disease were assessed for response and outcome . From the timepoint of T continuation beyond PD , we calculated the overall disease control rate , time to progression ( TTP ) , and overall survival ( OS ) . Results : One hundred and fourteen patients with HER-2+ve LA or MBC treated with T beyond PD were identified . The main site of disease was visceral_in 84 ( 74 % ) patients . Seventy-six ( 66 % ) had one line of chemotherapy before continuation of T beyond PD and 21 ( 19 % ) had two or more . Post-progression , 66 ( 58 % ) received T combined with chemotherapy . Of the 93 ( 82 % ) patients with documented clinical or radiological response evaluation , 67 ( 59 % ) were considered as having stable disease or better . The median TTP was 24 weeks ( 95 % CI : 21–28 ) and the median OS was 19 months ( 95 % CI : 12–24 ) . Conclusion : Our results from an unselected group of patients provide additional evidence that continuation of T beyond PD is of clinical benefit Background Combining trastuzumab and chemotherapy is st and ard in her2/neu overexpressing advanced breast cancer . It is not established however , whether trastuzumab treatment should continue after the failure of one earlier combination . In this trial , we report our experience with continued treatment beyond disease progression . Methods Fifty-four patients , median age 46 years , range 25–73 years , were included . We analysed for time to tumour progression ( TTP ) for first , second and beyond second line treatment , response rates and overall survival . Results Median time of observation was 24 months , range 7–51 . Response rates for first line treatment were 7.4 % complete remission ( CR ) , 35.2 % partial remissions ( PR ) , 42.6 % stable disease > 6 months ( SD ) and 14.8 % of patients experienced disease progression despite treatment ( PD ) . Corresponding numbers for second line were 3.7 % CR , 22.2 % PR , 42.6 % SD and 31.5 % PD ; numbers for treatment beyond second line ( 60 therapies , 33 pts 3rd line , 18 pts 4th line , 6 pts 5th line , 2 pts 6th line and 1 patient 7th line ) were 1.7 % CR , 28.3 % PR , 28.3 % SD and 41.6 % PD respectively . Median TTP was 6 months ( m ) in the first line setting , and also 6 m for second line and beyond second line . An asymptomatic drop of left ventricular ejection fraction below 50 % was observed in one patient . No case of symptomatic congestive heart failure was observed . Conclusion The data presented clearly strengthen evidence that patients do profit from continued trastuzumab treatment . The fact that TTP did not decrease significantly from first line to beyond second line treatment is especially noteworthy . Still , r and omized trials are warranted HER2 overexpression is associated with poor breast cancer prognosis and is the target for the humanized monoclonal antibody trastuzumab . This novel agent , when administered until disease progression in combination with chemotherapy , extends the survival of women with HER2-positive metastatic breast cancer ( MBC ) . However , the optimal duration of trastuzumab therapy remains to be confirmed . We conducted a retrospective case review study of women with HER2-positive MBC who continued to receive trastuzumab beyond disease progression . Objectives were to assess whether treatment beyond disease progression shows any evidence of efficacy and to evaluate the feasibility of this approach . One hundred five patients ( median age , 47 years ; range , 24 - 77 years ) were identified in 13 centers . Women had received < /=6 chemotherapy regimens ( median , 1 ) before trastuzumab therapy . Median survival from first trastuzumab dose was 29 months . The overall response rate to trastuzumab alone or with a taxane as the first regimen was 39 % ; a further 30 % of patients had stable disease as the best response . These rates were 36 % and 38 % after a second regimen of trastuzumab alone or with paclitaxel or vinorelbine was administered . Some patients responded to both the first and second regimens ; others responded to the second regimen after the first had failed . Twenty-two patients experienced cardiac events , of whom 18 received > /=1 more trastuzumab regimen . Trastuzumab treatment beyond progression appears to be of value , producing responses and clinical benefit , and is well tolerated without significant cardiac toxicity . The feasibility of this approach warrants examination in prospect i ve trials Purpose Lapatinib is a small molecule , dual tyrosine kinase inhibitor of epidermal growth factor receptor ( EGFR ) and human epidermal growth factor receptor type 2 ( HER2 ) . Initial results of a phase III trial demonstrated that lapatinib plus capecitabine is superior to capecitabine alone in women with HER2-positive advanced breast cancer that progressed following prior therapy including trastuzumab . Up date d efficacy and initial biomarker results from this trial are reported . Methods Women with HER2-positive , locally advanced or metastatic breast cancer previously treated with anthracycline- , taxane- , and trastuzumab-containing regimens were r and omized to lapatinib 1,250 mg/day continuously plus capecitabine 2,000 mg/m2 days 1–14 of a 21-day cycle or capecitabine 2,500 mg/m2 on the same schedule . The primary endpoint was time to progression ( TTP ) as determined by an independent review panel . Relationship between progression-free survival ( PFS ) and tumor HER2 expression and serum levels of HER2 extracellular domain ( ECD ) were assessed . Results 399 women were r and omized . The addition of lapatinib prolonged TTP with a hazard ratio ( HR ) of 0.57 ( 95 % CI , 0.43–0.77 ; P < 0.001 ) and provided a trend toward improved overall survival ( HR : 0.78 , 95 % CI : 0.55–1.12 , P = 0.177 ) , and fewer cases with CNS involvement at first progression ( 4 vs. 13 , P = 0.045 ) . Baseline serum HER2 ECD did not predict for benefit from lapatinib . Conclusion The addition of lapatinib to capecitabine provides superior efficacy for women with HER2-positive , advanced breast cancer progressing after treatment with anthracycline- , taxane- , and trastuzumab-based therapy . Biomarker studies could not identify a subgroup of patients who failed to benefit from the addition of lapatinib to capecitabine BACKGROUND Patients with HER2-positive breast cancer whose disease has become resistant to the anti-HER2 monoclonal antibody trastuzumab can benefit from lapatinib , a dual epidermal growth factor receptor/HER2 tyrosine kinase ( TK ) inhibitor . Before the availability of this compound , trastuzumab was often continued beyond disease progression , usually in addition to further chemotherapy , an approach which was not based on r and omized studies . We sought to retrospectively compare the clinical outcomes of patients who , upon progression during an initial trastuzumab-based regimen , stopped or continued trastuzumab in addition to further chemotherapy . PATIENTS AND METHODS From the clinical records of 407 patients with HER2-positive advanced breast cancer , we identified 279 patients progressing during an initial trastuzumab-based treatment . Of these patients , 83 continued trastuzumab in addition to chemotherapy , and 112 received chemotherapy alone . RESULTS We found no difference in response rate ( 28 % vs. 30 % ; P = .5 ) , median time to second tumor progression ( 8.4 months vs. 7 months ; P = .24 ) , or median postprogression survival ( 20.6 months and 15.4 months ; P = .29 ) according to whether patients continued or stopped trastuzumab . At multivariate analysis , continuation of trastuzumab was associated with a statistically insignificant trend toward reduced risk of second progression ( hazard ratio , 0.753 ; P = .08 ) . CONCLUSION Patients with HER2-positive advanced breast cancer developing tumor progression during an initial trastuzumab-based regimen did not seem to benefit significantly from the continuation of trastuzumab in addition to chemotherapy . For these patients , there is evidence from a large r and omized trial that effective HER2 targeting can be accomplished by inhibiting the HER2 TK activity with lapatinib PURPOSE To evaluate the efficacy and safety of weekly paclitaxel and trastuzumab in patients with HER2-positive metastatic breast cancer , with trastuzumab administered beyond disease progression . PATIENTS AND METHODS Twenty-six women with metastatic breast cancer , that was HER2-positive as determined by immunohistochemistry , were treated with weekly paclitaxel 70 or 90 mg/m2 and trastuzumab ( 4 mg/kg initial dose followed by 2 mg/kg weekly ) . RESULTS The median duration of treatment was 28 ( 8 - 72 ) weeks for paclitaxel and 59 ( 14 - 150 ) weeks for trastuzumab . Two ( 8 % ) patients experienced complete and 14 ( 54 % ) partial responses , for an overall response rate of 62 % . The median time to disease progression was 11 ( 2.89 - 36 ) months and median survival 34 + months . Grade 3/4 adverse events were alopecia ( 46 % ) , neurotoxicity ( 15 % ) , leukopenia ( 12 % ) and neutropenia ( 12 % ) . Infusion-related reactions were mild to moderate . No symptomatic cardiac toxicity was observed . No patient discontinued trastuzumab due to toxicity . CONCLUSION Prolonged administration of weekly paclitaxel and trastuzumab is effective and well-tolerated in women with HER2-positive metastatic breast cancer BACKGROUND Continuation of trastuzumab plus capecitabine ( XH ) showed a significantly improved overall response rate and time to progression compared with capecitabine ( X ) alone in women with HER2-positive breast cancer progressing during trastuzumab treatment . Here , we report the final analysis on overall survival . PATIENTS AND METHODS Patients with HER2-positive , advanced breast cancer who progressed during treatment with trastuzumab with or without 1st-line metastatic chemotherapy were prospect ively r and omised to X ( 2500mg/m(2 ) on days 1 - 14 , q3w ) or XH ( 6 (8)mg/kg , q3w ) . Overall survival was a pre-specified secondary end-point . RESULTS Median follow-up at June 2010 was 20.7months . Fifty nine of 74 and 60 of 77 patients died in the X and XH arm , respectively . Median overall survival was 20.6 and 24.9months with X and XH , respectively ( HR=0.94 [ 0.65 - 1.35 ] ; p=0.73 ) . Performance status and metastatic site were independent prognosticators for overall survival . No difference between treatment arms was observed for patients who achieved clinical response or clinical benefit , respectively . Patients who continued/restarted anti-HER2 treatment ( trastuzumab or lapatinib ) after 2nd progression ( N=52 ) had a post-progression survival of 18.8 compared with 13.3months for those who did not receive 3rd line treatment with anti-HER2 agents ( N=88 ) ( HR 0.63 ; p=0.02 ) . CONCLUSIONS Final overall survival analysis of the GBG-26 study did not demonstrate a significant survival benefit for treatment beyond progression with trastuzumab . However , in a post-hoc analysis , patients receiving anti-HER2 treatment as 3rd line therapy showed a better post-progression survival than those not receiving this targeted treatment BACKGROUND Trastuzumab emtansine ( T-DM1 ) is an antibody-drug conjugate incorporating the human epidermal growth factor receptor 2 (HER2)-targeted antitumor properties of trastuzumab with the cytotoxic activity of the microtubule-inhibitory agent DM1 . The antibody and the cytotoxic agent are conjugated by means of a stable linker . METHODS We r and omly assigned patients with HER2-positive advanced breast cancer , who had previously been treated with trastuzumab and a taxane , to T-DM1 or lapatinib plus capecitabine . The primary end points were progression-free survival ( as assessed by independent review ) , overall survival , and safety . Secondary end points included progression-free survival ( Output:
This pooled analysis confirms that continuing T beyond the first progression continues to be 1 of the effective and preferred choices in HER2 + MBC , failing a ( T-based ) first-line regimen
MS2_1shot39
***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 aim of this study was to compare the upper GI mucosal effects of i.v . parecoxib sodium with i.v . ketorolac tromethamine and placebo in healthy elderly subjects . METHODS : This was a two-center , double-blind , r and omized , placebo-controlled study . Healthy subjects aged 65–75 yr who were shown at baseline endoscopy to have no gastric or duodenal lesions received either parecoxib sodium 40 mg b.i.d . for 7 days , ketorolac 15 mg q.i.d . for 5 days , or placebo for 7 days . Endoscopy was repeated at the end of dosing . Measures of upper GI effects were : 1 ) ulceration , 2 ) incidence of an ulcer and /or any erosions , and 3 ) incidence of an ulcer and /or ≥11 erosions in the stomach , duodenum , or both . RESULTS : No gastric or duodenal ulcers occurred in any subjects receiving parecoxib sodium ( n = 29 ) or placebo ( n = 32 ) . In contrast , seven ( 23 % ) of the 31 ketorolac subjects had at least one ulcer ; five ( 16 % ) had gastric ulcers , and two ( 6 % ) had duodenal ulcers ( p < 0.05 vs parecoxib sodium and placebo for gastroduodenal ulcers and for gastric ulcers ) . A total of 28 ( 90 % ) ketorolac subjects had an ulcer or at least one erosion in the stomach , compared with incidences of four ( 14 % ) and two ( 6 % ) for parecoxib sodium and placebo , respectively . Incidences of duodenal ulcers/erosions were 45 % ( n = 14 ) for ketorolac , 10 % ( n = 3 ) for parecoxib sodium , and none for placebo . The differences between ketorolac and both other treatment groups were statistically significant for both stomach and duodenum . No parecoxib sodium or placebo subjects had an ulcer or ≥11 erosions in the stomach , compared with eight ( 26 % ) ketorolac subjects ( p < 0.05 vs both parecoxib sodium and placebo ) . No subject in any group had ≥11 duodenal erosions . CONCLUSIONS : These results indicate that multiple dose administration of parecoxib sodium is safe and well tolerated in healthy elderly subjects , with a decreased risk of gastroduodenal mucosal injury compared with ketorolac Background : The gastrointestinal safety of the novel injectable cyclooxygenase-2 selective inhibitor , parecoxib sodium , was compared with the nonselective nonsteroidal anti-inflammatory drug , ketorolac , and placebo in healthy subjects . Study : In a multicenter , r and omized , double-blind , placebo-controlled design , 123 adults with endoscopically-confirmed normal upper gastrointestinal mucosae received parecoxib sodium 40 mg twice daily ( 7 days ) ; placebo ( 2 days ) followed by ketorolac 30 mg 4 times daily ( 5 days ) ; or placebo ( 7 days ) ( each group n = 41 ) . Posttreatment endoscopy scores were analyzed at 3 levels of severity : ulcers ( scores of 7 ) , ≥11 erosions/ulcers ( scores of 5–7 ) , and any erosions/ulcers ( scores of 3–7 ) . Results : No subjects treated with parecoxib sodium or placebo developed gastroduodenal ulcers or ≥11 erosions/ulcers . Parecoxib sodium was comparable to placebo with respect to the combined incidence of erosions/ulcers ( 12 % vs. 7 % , P = 0.419 ) . In contrast , in the ketorolac group , 11 ( 28 % ) subjects developed ulcers , 19 ( 48 % ) subjects developed ≥11 gastroduodenal erosions/ulcers , and the rate of combined ulcers/erosions was 85 % ( P < 0.001 vs. placebo and parecoxib sodium ) . Conclusions : Parecoxib sodium 40 mg twice daily for 7 days has a gastrointestinal safety profile superior to ketorolac 30 mg 4 times daily for 5 days , and comparable to placebo Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size BACKGROUND : This multicenter , multiple-dose , r and omized , double-blind , parallel-group study compared the analgesic efficacy and safety of two dosing regimens of parecoxib sodium ( parecoxib ) versus placebo after total hip arthroplasty . METHODS : On study Day 1 , 490 patients received a postoperative initial loading dose of IV parecoxib 40 mg , followed by a re-dose of parecoxib 20 mg in 484 of 490 patients . Subsequently , 479 r and omized patients received double-blind treatment with parecoxib 20 mg bid ( n = 159 ) , parecoxib 20 mg qd ( n = 159 ) followed by placebo , or placebo ( n = 161 ) on Day 2 . RESULTS : Patients treated with parecoxib 20 mg bid reported significantly lower summed pain intensity over 24 h ( SPI-24 ) scores and improved patients ’ global evaluation of study medication ( PGESM ) ratings compared with placebo-treated patients on Days 2 to 5 ( P < 0.05 ) . For patients treated with parecoxib 20 mg qd , SPI-24 scores were significantly lower on Days 3 and 4 ( P < 0.05 ) , and PGESM ratings significantly improved on Day 5 compared with placebo . The incidence of adverse events was similar in all treatment groups with the exception of fever , vomiting and impaired concentration , which were significantly more common in the placebo group compared with one or other of the parecoxib treatment groups ( P < 0.05 ) . CONCLUSION : Multiple-day administration of parecoxib 20 mg once or twice daily is effective and generally well tolerated after total hip arthroplasty & NA ; There is uncertainty over whether the patient group in which acute pain studies are conducted ( pain model ) has any influence on the estimate of analgesic efficacy . Data from four recently up date d systematic review s of aspirin 600/650 mg , paracetamol 600/650 mg , paracetamol 1000 mg and ibuprofen 400 mg were used to investigate the influence of pain model . Area under the pain relief versus time curve equivalent to at least 50 % maximum pain relief over 6 h was used as the outcome measure . Event rates with treatment and placebo , and relative benefit ( RB ) and number needed to treat ( NNT ) were used as outputs from the meta‐analyses . The event rate with placebo was systematic ally statistically lower for dental than postsurgical pain for all four treatments . Event rates with analgesics , RB and NNT were infrequently different between the pain models . Systematic difference in the estimate of analgesic efficacy between dental and postsurgical pain models remains unproven , and , on balance , no major difference is likely Background : Valdecoxib and its intravenous prodrug parecoxib are reported to increase thromboembolic risk after coronary artery bypass grafting . The authors conducted a r and omized trial to examine their safety and analgesic efficacy in patients recovering from major noncardiac surgical procedures . Methods : The trial was r and omized and double-blind , with 10 days of treatment and 30 days of follow-up . Patients ( n = 1,062 ) received either parenteral parecoxib for 3 days and oral valdecoxib for the rest of the treatment period or placebo medications throughout . The frequency of predefined adjudicated postr and omization adverse events , including cardiovascular thromboembolism , renal dysfunction , gastroduodenal ulceration , and wound-healing complications , was assessed in each group . Secondary efficacy endpoints included patients ' pain ratings , opioid analgesic consumption ( recorded as morphine equivalents ) , and reports of opioid-related adverse effects . Results : Predefined adjudicated adverse events had similar frequencies among patients who received parecoxib and valdecoxib ( 2.7 % ) and placebo patients ( 3.2 % ) ( P = 0.58 ) , including cardiovascular thromboembolic events ( 1.0 % in each group ; P = 1.0 ) . Placebo patients consumed more morphine equivalents ( 66.2 ± 92.4 mg ) than did patients receiving parecoxib and valdecoxib ( 43.2 ± 65.7 mg ) ( P < 0.001 ) . Placebo patients had higher mean pain ratings on each of study days 2–10 ( P < 0.01 ) and reported more opioid-related symptom distress on days 2–6 ( P < 0.01 ) . Conclusions : Parecoxib and valdecoxib are useful adjuncts to opioids for the treatment of postoperative pain in noncardiac surgical patients . Further study will be required to determine the safety profile of parecoxib and valdecoxib administered to patients with known atherosclerotic disease after noncardiac surgery BACKGROUND This multicentre , double-blind , placebo-controlled study compared the opioid-sparing effectiveness and clinical safety of parecoxib sodium over 48 h , in 195 postoperative patients after routine total knee replacement surgery . METHODS Elective total primary knee arthroplasty was performed under spinal anaesthesia , with a single dose of spinal bupivacaine 10 - 20 mg , and intraoperative sedation with midazolam 0.5 - 1.0 mg i.v . , or propofol < 6 mg kg(-1)h(-1 ) . Patients were r and omized to receive either parecoxib sodium 20 mg twice daily ( bd ) i.v . ( n=65 ) , parecoxib sodium 40 mg bd i.v . ( n=67 ) , or placebo ( n=63 ) at the completion of surgery , and after 12 , 24 , and 36 h. Morphine ( 1 - 2 mg ) was taken by patient-controlled analgesia or by bolus doses after 30 min . RESULTS Patients receiving parecoxib sodium 20 mg bd and 40 mg bd consumed 15.6 % and 27.8 % less morphine at 24 h than patients taking placebo ( both P<0.05 ) . Both doses of parecoxib sodium administered with morphine provided significantly greater pain relief than morphine alone from 6 h ( P<0.05 ) . A global evaluation of study medication demonstrated a greater level of satisfaction among patients taking parecoxib sodium than those taking placebo . Parecoxib sodium administered in combination with morphine was well tolerated . However , a reduction in opioid-type side-effects was not demonstrated in the parecoxib sodium groups . CONCLUSION Parecoxib sodium provides opioid-sparing analgesic effects in postoperative patients Background Clinical trials suggest that cyclo-oxygenase-2 specific inhibitors ( coxibs ) are an effective treatment for acute postoperative pain . The aims of this systematic review were to examine the evidence for oral valdecoxib and injected parecoxib , and quantify efficacy and adverse Output:
Adverse events were generally mild to moderate , rarely led to withdrawal , and did not differ in frequency between groups . A single dose of parecoxib 20 mg or 40 mg provided effective analgesia for 50 to 60 % of those treated compared to about 15 % with placebo , and was well tolerated . Duration of analgesia was longer , and significantly fewer participants required rescue medication over 24 hours with the higher dose
MS2_1shot40
***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 Alternative dosing schedules of temozolomide may improve survival in patients with newly diagnosed glioblastoma ( GBM ) by increasing the therapeutic index , overcoming common mechanisms of temozolomide resistance , or both . The goal of this r and omized phase II study was to evaluate two different temozolomide regimens in the adjuvant treatment of newly diagnosed GBM . PATIENTS AND METHODS Adult patients with newly diagnosed GBM were r and omly assigned to receive st and ard radiotherapy with concurrent daily temozolomide followed by six adjuvant cycles of either dose-dense ( 150 mg/m(2 ) days 1 to 7 and 15 to 21 ) or metronomic ( 50 mg/m(2 ) continuous daily ) temozolomide . Maintenance doses of 13-cis-retinoic acid were then administered until tumor progression . The primary end point was overall survival ( OS ) at 1 year . Tumor tissue was assayed to determine O(6)-methylguanine-DNA methyltransferase ( MGMT ) promoter methylation status . RESULTS Eighty-five eligible patients were enrolled ; 42 were r and omly assigned to dose-dense and 43 to metronomic temozolomide . The 1-year survival rate was 80 % for the dose-dense arm and 69 % for the metronomic arm ; median OS was 17.1 months ( 95 % CI , 14.0 to 28.1 months ) and 15.1 months ( 95 % CI , 12.3 to 18.9 months ) , respectively . The most common toxicities were myelosuppression ( leukopenia , neutropenia , and thrombocytopenia ) and elevated liver enzymes . Pseudoprogression was observed in 37 % of assessable patients and may have had an impact on estimates of progression-free survival ( 6.6 months in the dose-dense arm and 5.0 months in the metronomic arm ) . CONCLUSION Both dose-dense and metronomic temozolomide regimens were well tolerated with modest toxicity . The dose-dense regimen appears promising , with 1-year survival of 80 % PURPOSE Approximately 50 % of glioblastomas ( GBMs ) are characterized by overexpression of the epidermal growth factor receptor ( EGFR ) and EGFR gene amplification . In approximately 25 % of instances , constitutively activated EGFR mutants are present . These observations make EGFR-inhibiting drugs a logical approach for trials in recurrent GBM . PATIENTS AND METHODS In a r and omized , controlled , phase II trial , 110 patients with progressive GBM after prior radiotherapy were r and omly assigned to either erlotinib or a control arm that received treatment with either temozolomide or carmustine ( BCNU ) . The primary end point was 6-month progression-free survival ( PFS ) . Tumor specimens obtained at first surgery were investigated for EGFR expression ; EGFRvIII mutants ; EGFR amplification ; EGFR mutations in exons 18 , 19 , and 21 ; and pAkt . These results were correlated with outcome . Pharmacokinetic analysis was part of the study . RESULTS ; Treatment was well tolerated in general ; skin toxicity was the most frequent adverse effect of erlotinib . The 6-month PFS rate in the erlotinib arm was 11.4 % ( 95 % CI , 4.6 % to 21.5 % ) , and it was 24 % in the control arm . Of all explored biomarkers , only low pAkt expression appeared to be of borderline significance to an improved outcome . None of the eight patients who had tumors with EGFRvIII mutant presence and PTEN expression had 6-month PFS . The use of enzyme-inducing anticonvulsants significantly increased erlotinib clearance , but pharmacokinetic findings were not related to outcome . CONCLUSION Erlotinib has insufficient single-agent activity in unselected GBM . No clear biomarker associated with improved outcome to erlotinib was identified BACKGROUND In this r and omized phase III study , the effectiveness as well as the side-effects of intraarterial [ i.a . ] ( 17 patients ) versus intravenous [ i.v . ] ( 16 patients ) ACNU [ Nimustine ] administration in newly diagnosed glioblastoma , were compared . PATIENTS AND METHODS All patients undenwent extensive surgical resection , and both groups were homogeneous for the other known risk factors . Thirty-three patients with glioblastoma were treated with ACNU at the dose of 80 - 100 mg/m2 . Treatment was repeated every 5 - 8 weeks for a minimum of 2 and maximum of 14 cycles . Total survival time ( TST ) and to time to progression were chosen as outcome variables . RESULTS AND CONCLUSION No significant differences in systemic and hematological toxicity between the i.a . and iv . ACNU administration routes were detected . In both groups , tolerance of the procedure was excellent . Analysis of the main outcome measured showed no significant differences between i.a . and i.v . ACNU administration : time to progression was 6 months for i.a . ACNU and 4 months for i.v . ACNU and total survival time was 17 months for i.a . ACNU and 20 months for i.v . ACNU . In spite of ACNU dose incrementation , obtained through i.a . route administration , and subsequent higher concentration in the tumor bed , no improvement could be achieved in effectiveness Using MRI techniques , we show here that normalization of tumor vessels in recurrent glioblastoma patients by daily administration of AZD2171-an oral tyrosine kinase inhibitor of VEGF receptors-has rapid onset , is prolonged but reversible , and has the significant clinical benefit of alleviating edema . Reversal of normalization began by 28 days , though some features persisted for as long as four months . Basic FGF , SDF1alpha , and viable circulating endothelial cells ( CECs ) increased when tumors escaped treatment , and circulating progenitor cells ( CPCs ) increased when tumors progressed after drug interruption . Our study provides insight into different mechanisms of action of this class of drugs in recurrent glioblastoma patients and suggests that the timing of combination therapy may be critical for optimizing activity against this tumor Summary Purpose Because raised matrix metalloprotease ( MMP ) levels are associated with glioma invasion and angiogenesis , we tested the efficacy of marimastat ( MT ) an orally active drug that can reduce MMP levels , in patients with gliomas . Patients and Methods A total of 162 patients with intracranial glioblastoma multiforme or gliosarcomas who had undergone surgery and radiotherapy participated in this multicenter , double-blind , placebo-controlled , parallel group study conducted at 20 institutions . Seventy-nine patients ( 57 male , 22 female , median age 58 years ) were r and omized to receive placebo ( PB ) , and 83 patients ( 51 male , 32 female , median age 57 years ) were r and omized to receive MT , 10 mg orally twice daily , until tumor progression . Results This intention-to-treat efficacy analysis showed no statistically significant difference between MT and PB groups with respect to survival ( P=0.38 , log rank test ) . The median survival time from protocol initiation was 37.9 weeks for the PB group and 42.9 weeks for the MT group , with a hazard ratio of 1.16 ( 95 % CI 0.83 to 1.60 ) . There were no statistically significant differences in quality of life between the PB and MT groups , as assessed by the FACT-BR question naire . Musculoskeletal toxicities led to dose modification or withdrawal in 20 % of MT-treated and 1.2 % of PB-treated patients . Conclusion MT does not improve survival in patients with glioblastoma or gliosarcoma following surgery and radiotherapy . Therefore , single-agent MT appears unwarranted ; however , MT in combination with cytotoxic chemotherapy may be warranted , as suggested by observations in our study and other studies PURPOSE This phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma ( WHO grade 4 ) . PATIENTS AND METHODS Patients were r and omly assigned 2:1 to receive 6-week cycles of enzastaurin 500 mg/d ( 1,125-mg loading dose , day 1 ) or lomustine ( 100 to 130 mg/m(2 ) , day 1 ) . Assuming a 45 % improvement in progression-free survival ( PFS ) , 397 patients were required to provide 80 % power to achieve statistical significance at a one-sided level of .025 . RESULTS Enrollment was terminated at 266 patients ( enzastaurin , n = 174 ; lomustine , n = 92 ) after a planned interim analysis for futility . Patient characteristics were balanced between arms . Median PFS ( 1.5 v 1.6 months ; hazard ratio [ HR ] = 1.28 ; 95 % CI , 0.97 to 1.70 ) , overall survival ( 6.6 v 7.1 months ; HR = 1.20 ; 95 % CI , 0.88 to 1.65 ) , and 6-month PFS rate ( P = .13 ) did not differ significantly between enzastaurin and lomustine , respectively . Stable disease occurred in 38.5 % and 35.9 % of patients and objective response occurred in 2.9 % and 4.3 % of patients , respectively . Time to deterioration of physical and functional well-being and symptoms did not differ between arms ( HR = 1.12 ; P = .54 ) . Four patients discontinued enzastaurin because of drug-related serious adverse events ( AEs ) . Eleven patients treated with enzastaurin died on study ( four because of AEs ; one was drug-related ) . All four deaths that occurred in patients receiving lomustine were disease-related . Grade 3 to 4 hematologic toxicities were significantly higher with lomustine ( 46 events ) than with enzastaurin ( one event ; P < or = .001 ) . CONCLUSION Enzastaurin was well tolerated and had a better hematologic toxicity profile but did not have superior efficacy compared with lomustine in patients with recurrent glioblastoma CONTEXT The relative merits of various study design s and their placement in hierarchies of evidence are often discussed . However , there is limited knowledge about the relative citation impact of articles using various study design s. OBJECTIVE To determine whether the type of study design affects the rate of citation in subsequent articles . DESIGN AND SETTING We measured the citation impact of articles using various study design s -- including meta-analyses , r and omized controlled trials , cohort studies , case-control studies , case reports , non systematic review s , and decision analysis or cost-effectiveness analysis --published in 1991 and in 2001 for a sample of 2646 articles . MAIN OUTCOME MEASURE The citation count through the end of the second year after the year of publication and the total received citations . RESULTS Meta-analyses received more citations than any other study design both in 1991 ( P<.05 for all comparisons ) and in 2001 ( P<.001 for all comparisons ) and both in the first 2 years and in the longer term . More than 10 citations in the first 2 years were received by 32.4 % of meta-analyses published in 1991 and 43.6 % of meta-analyses published in 2001 . R and omized controlled trials did not differ significantly from epidemiological studies and non systematic review articles in 1991 but clearly became the second-cited study design in 2001 . Epidemiological studies , non systematic review articles , and decision and cost-effectiveness analyses had relatively similar impact ; case reports received negligible citations . Meta-analyses were cited significantly more often than all other design s after adjusting for year of publication , high journal impact factor , and country of origin . When limited to studies addressing treatment effects , meta-analyses received more citations than r and omized trials . CONCLUSION Overall , the citation impact of various study design s is commensurate with most proposed hierarchies of evidence PURPOSE To evaluate single-agent activity of bevacizumab in patients with recurrent glioblastoma . PATIENTS AND METHODS Patients with recurrent glioblastoma were treated with bevacizumab 10 mg/kg every 2 weeks . After tumor progression , patients were immediately treated with bevacizumab in combination with irinotecan 340 mg/m(2 ) or 125 mg/m(2 ) every 2 weeks , depending on use of enzyme-inducing antiepileptic drugs . Complete patient evaluations were repeated every 4 weeks . RESULTS Forty-eight heavily pretreated patients were accrued to this study . Thromboembolic events ( 12.5 % ) , hypertension ( 12.5 % ) , hypophosphatemia ( 6 % ) , and thrombocytopenia ( 6 % ) were the most common drug-associated adverse events . Six patients ( 12.5 % ) were removed from study for drug-associated toxicity ( five thromboembolic events , one bowel perforation ) . Thirty-four patients ( Output:
In general , annual citation rate appeared to gradually increase during the first 2 - 3 years after publication before reaching high levels . However , areas such as quality of life , side effects , and end-of-life care were underrepresented .
MS2_1shot41
***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 Underst and ing the correlates of dietary intake is necessary in order to effectively promote healthy dietary behavior among children and adolescents . A literature review was conducted on the correlates of the following categories of dietary intake in children and adolescents : Fruit , Juice and Vegetable Consumption , Fat in Diet , Total Energy Intake , Sugar Snacking , Sweetened Beverage Consumption , Dietary Fiber , Other Healthy Dietary Consumption , and Other Less Healthy Dietary Consumption in children and adolescents . Methods Cross-sectional and prospect i ve studies were identified from PubMed , PsycINFO and PsycArticles by using a combination of search terms . Quantitative research examining determinants of dietary intake among children and adolescents aged 3–18 years were included . The selection and review process yielded information on country , study design , population , instrument used for measuring intake , and quality of research study . Results Seventy-seven articles were included . Many potential correlates have been studied among children and adolescents . However , for many hypothesized correlates substantial evidence is lacking due to a dearth of research . The correlates best supported by the literature are : perceived modeling , dietary intentions , norms , liking and preferences . Perceived modeling and dietary intentions have the most consistent and positive associations with eating behavior . Norms , liking , and preferences were also consistently and positively related to eating behavior in children and adolescents . Availability , knowledge , outcome expectations , self-efficacy and social support did not show consistent relationships across dietary outcomes . Conclusion This review examined the correlates of various dietary intake ; Fruit , Juice and Vegetable Consumption , Fat in Diet , Total Energy Intake , Sugar Snacking , Sweetened Beverage Consumption , Dietary Fiber , Other Healthy Dietary Consumption , and Other Less Healthy Dietary Consumption in cross-sectional and prospect i ve studies for children and adolescents . The correlates most consistently supported by evidence were perceived modeling , dietary intentions , norms , liking and preferences . More prospect i ve studies on the psychosocial determinants of eating behavior using broader theoretical perspectives should be examined in future research OBJECTIVE To evaluate the feasibility , acceptability , and efficacy of an after-school team sports program for reducing weight gain in low-income overweight children . DESIGN Six-month , 2-arm , parallel-group , pilot r and omized controlled trial . SETTING Low-income , racial/ethnic minority community . PARTICIPANTS Twenty-one children in grade s 4 and 5 with a body mass index at or above the 85th percentile . INTERVENTIONS The treatment intervention consisted of an after-school soccer program . The " active placebo " control intervention consisted of an after-school health education program . MAIN OUTCOME MEASURES Implementation , acceptability , body mass index , physical activity measured using accelerometers , reported television and other screen time , self-esteem , depressive symptoms , and weight concerns . RESULTS All 21 children completed the study . Compared with children receiving health education , children in the soccer group had significant decreases in body mass index z scores at 3 and 6 months and significant increases in total daily , moderate , and vigorous physical activity at 3 months . CONCLUSION An after-school team soccer program for overweight children can be a feasible , acceptable , and efficacious intervention for weight control BACKGROUND Policies to require afterschool programs ( ASPs , 3 PM to 6 PM ) to provide children a minimum of 30 minutes of moderate-to-vigorous physical activity ( MVPA ) exist . With few low-cost , easy-to-use measures of MVPA available to the general public , ASP providers are limited in their ability to track progress toward achieving this policy- goal . Pedometers may fill this gap , yet there are no step-count guidelines for ASPs linked to 30 minutes of MVPA . METHODS Steps and accelerometer estimates of MVPA were collected concurrently over multiple days on 245 children ( 8.2 years , 48 % boys , BMI -percentile 68.2 ) attending 3 community-based ASPs . R and om intercept logit models and receiver operating characteristic ( ROC ) analyses were used to identify a threshold of steps that corresponded with attaining 30 minutes of MVPA . RESULTS Children accumulated an average of 2876 steps ( st and ard error [ SE ] 79 ) and 16.1 minutes ( SE0.5 ) of MVPA over 111 minutes ( SE1.3 ) during the ASP . A threshold of 4600 steps provided high specificity ( 0.967 ) and adequate sensitivity ( 0.646 ) for discriminating children who achieved the 30 minutes of MVPA ; 93 % of the children were correctly classified . The total area under the curve was 0.919 . Children accumulating 4600 steps were 25times more likely to accumulate 30 minutes of MVPA . CONCLUSIONS This step threshold will provide ASP leaders with an objective , low-cost , easy-to-use tool to monitor progress toward policy-related goals PURPOSE This intervention compares the effectiveness of daily step count targets with time-based prescription for increasing the health-related physical activity of low-active adolescent girls . METHODS We assigned participants ( N = 85 , mean age 15.8 + /- 0.8 yr ) depending on school attended to a control ( CON ) , pedometer ( PED ) , or minutes ( MIN ) group . The intervention groups were involved in a 12-wk physical activity self-monitoring and educative program . The only difference between the intervention groups was that the PED group set daily step count targets whereas the MIN group set daily time-based goals for physical activity involvement . Pre- , mid- , and postintervention changes in physical activity ( 4-d blinded step count and 3-d physical activity recall ) and body mass index ( BMI ) were assessed using a series of 3 ( group assignment ) x 3 ( time ) ANOVA . Where significant interactions were found , separate follow-up simple main effects tests were used . RESULTS At postintervention , only the PED group had significantly increased their total activity as measured by a 4-d step count , when compared with the control ( P = 0.03 , ES = 0.13 ) . The group , time , and interaction effects for 4-d step count were significant , indicating that although both the participants in the PED and the MIN groups significantly increased their step count across the 12-wk intervention ( P = 0.00 - 0.01 ) , the participants in the PED group had a greater increase at the midintervention time point ( P = 0.04 , ES = 0.10 ) . No pre- , mid- , or postintervention changes were reported in any group for BMI ( F = 1.18 , P = 0.32 ) . CONCLUSION The use of pedometers and daily step count targets with low-active adolescent girls may result in short-term ( 6 wk ) enhanced physical activity related outcomes when compared with traditional time-based physical activity prescriptions . However , both interventions appear to result in similar improvements in physical activity when duration of the observation is extended to 12 wk PURPOSE This study evaluated the effects of a classroom-based physical activity program on children 's in-school physical activity levels and on-task behavior during academic instruction . METHODS Physical activity of 243 students was assessed during school hours . Intervention-group students ( N = 135 ) received a classroom-based program ( i.e. , Energizers ) . The control group ( N = 108 ) did not receive Energizers . On-task behavior during academic instruction time was observed for 62 third- grade ( N = 37 ) and fourth- grade students ( N = 25 ) before and after Energizers activities . An independent groups t-test compared in-school physical activity levels between intervention and control classes . A multiple-baseline across-classrooms design was used to evaluate the effectiveness of the Energizers on on-task behavior . Additionally , a two-way ( time [ pre- vs postobservation ] x period [ baseline vs intervention ] ) repeated- measures analysis of variance compared on-task behavior between observation periods . Magnitudes of mean differences were evaluated with Cohen 's delta ( ES ) . RESULTS Students in the intervention group took significantly ( P < 0.05 ) more in-school steps ( 5587 + /- 1633 ) than control-group students ( 4805 + /- 1543 ) , and the size of this difference was moderate ( ES = 0.49 ) . The intervention was effective in improving on-task behavior ; after the Energizers were systematic ally implemented , on-task behavior systematic ally improved . The improvement in on-task behavior of 8 % between the pre-Energizers and post-Energizers observations was statistically significant ( P < 0.017 ) , and the difference was moderate ( ES = 0.60 ) . Likewise , the least on-task students improved on-task behavior by 20 % after Energizers activities . This improvement was statistically significant ( P < 0.001 ) and meaningful ( ES = 2.20 ) . CONCLUSION A classroom-based physical activity program was effective for increasing daily in-school physical activity and improving on-task behavior during academic instruction BACKGROUND Policies now recommend afterschool programs ( ASP , 3 - 6 pm ) provide children a minimum amount of physical activity daily . We examined the extent to which children attending ASPs meet existing national and state-level policies that specify expected levels of physical activity ( PA ) . METHODS Accelerometer-derived physical activity ( light and moderate-to-vigorous , MVPA ) of 253 children ( 5 - 13 years ) was compared to policies that recommend varying amounts of PA children should achieve during an ASP . RESULTS The proportion of children achieving a policy ranged from 0.0 % ( California 60 min MVPA and North Carolina 20 % of daily program time devoted to MVPA ) , 1.2 % ( California 30 min MVPA ) , to 48.2 % ( National Afterschool Association 30 min light plus MVPA ) . R and om effects logistic models indicated boys ( odds ratio [ OR ] range 2.0 to 6.27 ) and children from a minority background ( Black/Hispanic , OR range 1.87 to 3.98 ) were more likely to achieve a recommended level of physical activity , in comparison to girls and White children . Neither age nor BMI were related to achieving a policy . CONCLUSIONS The PA of children attending ASP falls below policy recommended levels ; however , these policies were developed in absence of data on expected PA levels during ASPs . Thus , concerted effort towards building a stronger ASP evidence -base for policy refinement is required BACKGROUND Substantial differences exist in how and where physical education ( PE ) is conducted in elementary schools throughout the United States . Few effectiveness studies of large-scale interventions to improve PE have been reported . DESIGN Multicenter r and omized trial . SETTING / PARTICIPANTS The Child and Adolescent Trial for Cardiovascular Health ( CATCH ) was implemented in PE classes in 96 schools ( 56 intervention , 40 control ) in four study centers : California , Louisiana , Minnesota , and Texas . INTERVENTION The 2.5-year PE intervention consisted of professional development sessions , curricula , and follow-up consultations . MAIN OUTCOME MEASURES Intervention effects on student physical activity and lesson context in PE were examined by teacher type ( PE specialists and classroom teachers ) and lesson location ( indoors and outdoors ) . RESULTS Differential effects by teacher type and lesson location were evidence d for both physical activity and lesson context . Observations of 2016 lessons showed that intervention schools provided more moderate-to-vigorous physical activity ( p=0.002 ) and vigorous physical activity ( p=0.02 ) than controls . Classroom teachers improved physical activity relatively more than PE specialists , but PE specialists still provided longer lessons and more physical activity . Classroom teachers increased lesson length ( p=0.02 ) and time for physical fitness ( p=0.03 ) . CONCLUSIONS The intervention improved PE of both specialists ' and classroom teachers ' lessons . States and districts should ensure that the most qualified staff teaches PE . Interventions need to be tailored to meet local needs and conditions , including teacher type and location of lessons PURPOSE School physical education ( PE ) is highly recommended as a means of promoting physical activity , and r and omized studies of health-related PE interventions in middle schools have not been reported . We developed , implemented , and assessed an intervention to increase physical activity during middle-school PE classes . METHODS Twenty-four middle schools ( approximately 25,000 students , 45 % nonwhite ) in Southern California participated in a r and omized trial . Schools were assigned to intervention ( N = 12 ) or control ( N = 12 ) conditions , and school was the unit of analysis . A major component of the intervention was a 2-yr PE program , which consisted of curricular material s , staff development , and on-site follow-up . Control schools continued usual programs . Student activity and lesson context were observed in 1849 PE lessons using a vali date d instrument during baseline and intervention years 1 and 2 . RESULTS The intervention significantly ( P = 0.02 ) improved student moderate to vigorous physical activity ( MVPA ) in PE , by approximately 3 min per lesson . Effects were cumulative ; by year 2 intervention schools increased MVPA by 18 % . Effect sizes were greater for boys ( d = 0.98 ; large ) than girls ( d = 0.68 ; medium ) . CONCLUSIONS A st and ardized program increased MVPA in middle schools without requiring an increase in frequency or duration of PE lessons . Program components were well received by teachers and have the potential for generalization to other schools . Additional strategies may be needed for girls OBJECTIVES This study evaluated a health-related physical education program for fourth- and fifth- grade students design ed to increase physical activity during physical education classes and outside of school . METHODS Seven Output:
These elements were distilled into 5 primary categories and conceptually referred to as the 5 Ms : mission-clearly defined policy/st and ards for PAaN ; motivate-providing choices , developmentally appropriate activities , feedback , and encouragement ; manage-structuring and managing the environment for safety , routines , and discipline ; monitor-ongoing evaluation of PAaN ; and maximize-incorporating all former Ms. CONCLUSIONS The application of this training framework should lead to improved implementation and eventual achievement of policy goals for PAaN in ASPs .
MS2_1shot42
***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 evaluate the use of a computerised support system for decision making for implementing evidence based clinical guidelines for the management of asthma and angina in adults in primary care . Design : A before and after pragmatic cluster r and omised controlled trial utilising a two by two incomplete block design . Setting : 60 general practice s in north east Engl and . Participants : General practitioners and practice nurses in the study practice s and their patients aged 18 or over with angina or asthma . Main outcome measures : Adherence to the guidelines , based on review of case notes and patient reported generic and condition specific outcome measures . Results : The computerised decision support system had no significant effect on consultation rates , process of care measures ( including prescribing ) , or any patient reported outcomes for either condition . Levels of use of the software were low . Conclusions : No effect was found of computerised evidence based guidelines on the management of asthma or angina in adults in primary care . This was probably due to low levels of use of the software , despite the system being optimised as far as was technically possible . Even if the technical problems of producing a system that fully supports the management of chronic disease were solved , there remains the challenge of integrating the systems into clinical encounters where busy practitioners manage patients with complex , multiple conditions Objective . We evaluated the effectiveness of a continuing medical education program , Physician Asthma Care Education , in improving pediatricians ’ asthma therapeutic and communication skills and patients ’ health care utilization for asthma . Methods . We conducted a r and omized trial in 10 regions in the United States . Primary care providers were recruited and r and omly assigned by site to receive the program provided by local faculty . The program included 2 interactive seminar sessions ( 2.5 hours each ) that review ed national asthma guidelines , communication skills , and key educational messages . Format included short lectures , case discussion s , and a video modeling communication techniques . We collected information on parent perceptions of physicians ’ communication , the child ’s asthma symptoms , and patients ’ asthma health care utilization . We used multivariate regression models to determine differences between control and intervention groups . Results . A total of 101 primary care providers and a r and om sample of 870 of their asthma patients participated . After 1 year , we completed follow-up telephone interviews with the parents of 731 of the 870 patients . Compared to control subjects , parents reported that physicians in the intervention group were more likely to inquire about patients ’ concerns about asthma , encourage patients to be physically active , and set goals for successful treatment . Patients of physicians that attended the program had a greater decrease in days limited by asthma symptoms ( 8.5 vs 15.6 days ) , as well as decreased emergency department asthma visits ( 0.30 vs 0.55 visits per year ) . Conclusions . The Physician Asthma Care Education program was used in a range of locations and was effective in improving parent-reported provider communication skills , the number of days affected by asthma symptoms , and asthma health care use . Patients with more frequent asthma symptoms and higher health care utilization at baseline were more likely to benefit from their physician ’s participation in the program OBJECTIVE : Asthma continues to be 1 of the most common chronic diseases of childhood and affects ∼6 million US children . Although National Asthma Education Prevention Program guidelines exist and are widely accepted , previous studies have demonstrated poor clinician adherence across a variety of population s. We sought to determine if clinical decision support ( CDS ) embedded in an electronic health record ( EHR ) would improve clinician adherence to national asthma guidelines in the primary care setting . METHODS : We conducted a prospect i ve cluster-r and omized trial in 12 primary care sites over a 1-year period . Practice s were stratified for analysis according to whether the site was urban or suburban . Children aged 0 to 18 years with persistent asthma were identified by International Classification of Diseases , Ninth Revision codes for asthma . The 6 intervention- practice sites had CDS alerts imbedded in the EHR . Outcomes of interest were the proportion of children with at least 1 prescription for controller medication , an up-to- date asthma care plan , and the performance of office-based spirometry . RESULTS : Increases in the number of prescriptions for controller medications , over time , was 6 % greater ( P = .006 ) and 3 % greater for spirometry ( P = .04 ) in the intervention urban practice s. Filing an up-to- date asthma care plan improved 14 % ( P = .03 ) and spirometry improved 6 % ( P = .003 ) in the suburban practice s with the intervention . CONCLUSION : In our study , using a cluster-r and omized trial design , CDS in the EHR , at the point of care , improved clinician compliance with National Asthma Education Prevention Program guidelines OBJECTIVES This study was conducted to assess the impact of an interactive seminar based on self-regulation theory on 1 ) the treatment practice s and communications and education behavior of physicians , 2 ) the health status and medical care utilization of their pediatric patients with asthma , and 3 ) the satisfaction with care of the subjects ' parents . METHODS A total of 74 general practice pediatricians were assigned to either a program or a control group in a r and omized controlled study . Data were collected from physicians at baseline , and 69 ( 93 % ) provided follow-up data 5 months after the program . Data were also collected from 637 of their patients at baseline , and in a 22-month window after the intervention , 472 ( 74 % ) of this number provided follow-up data . RESULTS After the seminar , physicians in the program group were more likely than were control group physicians to address patients ' fears about medicines , review written instructions , provide a sequence of educational messages , write down how to adjust the medicines at home when symptoms change , and report that they spent less time with their patients . Parents of the children treated by program physicians were significantly more likely than were control group parents to report that the physician had been reassuring , described as a goal that the child be fully active , and gave information to relieve specific worries . After a visit with the physician , these parents were also more likely to report that they knew how to make management decisions at home . After the intervention compared to controls , patients of physicians in the program group were more likely to have received a prescription for inhaled antiinflammatory medicine and to have been asked by the physician to demonstrate how to use a metered-dose inhaler . After the intervention , children seen by program physicians made significantly fewer nonemergency office visits and visits for follow-up of an episode of symptoms ; however , there were no differences in emergency department visits and hospitalizations . Among children who were placed on inhaled corticosteroids during this study , however , children treated by physicians who had received education had significantly fewer symptoms and fewer follow-up office visits , nonemergency physician office visits , emergency department visits , and hospitalizations . CONCLUSIONS The interactive seminar based on theories of self-regulation led to patient-physician encounters that were of shorter duration , had significant impact on the prescribing and communications behavior of physicians , led to more favorable patient responses to physicians ' actions , and led to reductions in health care utilization Abstract Objectives : To evaluate the effectiveness of an asthma re source centre in improving treatment and quality of life for asthmatic patients Design : Community based r and omised controlled trial Setting : 41 general practice s in Greenwich with a practice nurse Subjects : All registered patients aged 15 - 50 years Intervention : Nurse specialists in asthma who educated and supported practice nurses , who in turn educated patients in the management of asthma according to the British Thoracic Society 's guidelines Main outcome measures : Quality of life of asthmatic patients , attendance at accident and emergency departments , admissions to local hospitals , and steroid prescribing by general practitioners Results : Of 24 400 patients r and omly selected and surveyed in 1993 , 12 238 replied ; 1621 were asthmatic of whom 1291 were sent a repeat question naire in 1996 and 780 replied . Of 24 400 patients newly surveyed in 1996 , 10 783 ( 1616 asthmatic ) replied . No evidence was found for an improvement in asthma related quality of life among newly surveyed patients in intervention practice s compared with control practice s. Neither was there evidence of an improvement in other measures of the quality of asthma care . Weak evidence was found for an improvement in quality of life in intervention practice s among asthmatics registered with study practice s in 1993 and followed up in 1996 . Neither attendances at accident and emergency departments nor admissions for asthma showed any tendency to diverge in intervention and control practice s over the study period . Steroid prescribing rates rose steadily during the study period . The average annual increase in steroid prescribing was 3 % per year higher in intervention than control practice s ( 95 % confidence interval −1 % to 6 % , P=0.10 ) Conclusions : This model of service delivery is not effective in improving the outcome of asthma in the community . Further development is required if cost effective management of asthma is to be OBJECTIVE To test a quality improvement intervention , a learning collaborative based on the Institute for Healthcare Improvement 's Breakthrough Series methodology , specifically intended to improve care and outcomes for patients with childhood asthma . DESIGN R and omized trial in primary care practice s. SETTING Practice s in greater Boston , Mass , and greater Detroit , Mich. PARTICIPANTS Forty-three practice s , with 13 878 pediatric patients with asthma , r and omized to intervention and control groups . Intervention Participation in a learning collaborative project based on the Breakthrough Series methodology of continuous quality improvement . MAIN OUTCOME MEASURES Change from baseline in the proportion of children with persistent asthma who received appropriate medication therapy for asthma , and in the proportion of children whose parent received a written management plan for their child 's asthma , as determined by telephone interviews with parents of 631 children . RESULTS After adjusting for state , practice size , child age , sex , and within- practice clustering , no overall effect of the intervention was found . CONCLUSIONS This method ologically rigorous assessment of a widely used quality improvement technique did not demonstrate a significant effect on processes or outcomes of care for children with asthma . Potential deficiencies in program implementation , project duration , sample selection , and data sources preclude making the general inference that this type of improvement program is ineffective . Additional rigorous studies should be undertaken under more optimal setting s to assess the efficacy of this method for improving care Objective . To evaluate effects on the process and outcomes of care brought about by use of a h and held , computer-based system that implements the American Academy of Pediatrics guideline on office management of asthma exacerbations . Design . A before – after trial with r and omly selected , office-based Connecticut pediatricians . In both the control and intervention phases , physicians collected data from 10 patient encounters for acute asthma exacerbations . During the intervention phase , the computer provided for structured encounter documentation and offered recommendations based on the guideline of the American Academy of Pediatrics . Patients were contacted by telephone 7 to 14 days after the visit to assess outcomes . Results . Nine study -physicians enrolled 91 patients in the control phase and 74 in the intervention phase . Follow-up information was available for 93 % of encounters . Use of the intervention was associated with increased mean frequency/visit of : 1 ) measurements of peak expiratory flow rate ( 2.18 vs 1.57 ) and oxygen saturation ( 1.12 vs .42 ) , and 2 ) administration of nebulized β2-agonists ( 1.25 vs .71 ) . Visits in the intervention phase lasted longer and fees were higher ( $ 145.61 vs $ 103.11 ) . There were no significant differences in immediate disposition or subsequent emergency department visits , hospitalizations , missed school , or caretaker 's missed work during the 7 days post visit . Conclusion . Use of h and held computers that provide guideline -based decision support was associated with increased physician adherence to guideline recommendations ; however , visits were prolonged , fees were higher , and no improvement could be demonstrated with regard to the observed intermediate-term patient outcomes . Guideline implementers ( and users ) should be cautious about putting unvali date d recommendations into practice OBJECTIVE : Outpatient asthma management remains suboptimal . We previously reported significant improvements in asthma guideline adherence and outcomes in children by using quality -improvement processes and community health workers . We hypothesized that a larger project could achieve comparable outcome improvements with streamlined quality -improvement processes and decreased technical assistance . METHODS : Seventeen clinics treating 12 000 children with asthma were evaluated through interviews of a subset of patients with persistent or high-risk asthma ( n = 761 ) at baseline and at 12 and 21 months and chart review s r and omly selected from all patients with asthma at baseline and 12 and 24 months ( n = 2040 ) . Multidisciplinary teams developed data -driven continuous quality -improvement activities . Asthma coordinators provided patient education and were active team members . RESULTS : Study children were predominantly Hispanic ( 77 % ) and black ( 11 % ) ; 60 % were enrolled in Medicaid , and 9 % were uninsured . Comparing results between baseline and the 21-month follow-up , significantly fewer families reported emergency-department visits ( 29.6 % vs 9.3 % ) , hospitalizations ( 10.9 % vs 3.4 % ) , frequent daytime symptoms ( 44.0 % vs 11.7 % ) , and missed school days ( 28.7 % vs 13.6 % ) ; significantly more reported confidence in asthma management ( 70.6 % vs 95.5 % ) ; and quality -of-life scores increased significantly for both children Output:
Moderate evidence supports the use of decision support and clinical pharmacy interventions to increase provision of patient self-education/asthma action plans . Moderate evidence supports use of decision support tools to reduce emergency department visits , and low- grade evidence suggests there is no benefit for this outcome with organizational change , education only , and quality improvement/pay-for-performance . : Decision support tools , feedback and audit , and clinical pharmacy support were most likely to improve provider adherence to asthma guidelines , as measured through health care process outcomes .
MS2_1shot43
***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 The purpose of this study was to directly and prospect ively compare the capability of dynamic O(2)-enhanced MRI and quantitatively assessed thin-section MDCT to assess smokers ' COPD in a large prospect i ve cohort . MATERIAL S AND METHODS The GOLD criteria for smokers were used to classify 187 smokers into four clinical stage groups as follows : smokers without COPD ( n=56 ) and with mild ( n=54 ) , moderate ( n=52 ) and severe or very severe COPD ( n=24 ) . All smokers underwent dynamic O(2)-enhanced MRI , MDCT and pulmonary function tests . Mean relative enhancement ratio and mean wash-in time on MRI and CT-based functional lung volume ( CT-based FLV ) as well as the ratio of airway wall area to total airway area on MDCT were computationally calculated . Then , all indexes were significantly correlated with functional parameters . To determine the efficacy of all indexes for clinical stage classification , the indexes for the four clinical groups were statistically compared by using Tukey 's honestly significant difference multiple comparison test . RESULTS All indexes had significant correlations with functional parameters ( p<0.0001 ) . All indexes except CT-based FLV in all groups had significant differences each other ( p<0.05 ) . CONCLUSIONS Dynamic O(2)-enhanced MRI for assessment of COPD in smokers is potentially as efficacious as quantitatively assessed thin-section MDCT Computed Tomography ( CT ) has been proved to be the most accurate imaging modality to diagnose emphysema in vivo . Our study was aim ed at comparing different CT methods for pulmonary emphysema quantification in patients with severe chronic obstructive pulmonary disease ( COPD ) . Forty-six consecutive in patients affected with COPD underwent high resolution CT ( H RCT ) . Three scans were acquired at 3 preselected anatomic levels at both full inspiration and expiration . Three different observers were asked to subjectively evaluate , under blind conditions , the extent alone and both the severity and the extent of emphysema on the 6 scans . H RCT findings were also analyzed quantitatively by measuring the mean CT number in Hounsfield Units ( HU ) and the % of lung area with CT numbers < -900 HU ( pixel index ) . Quantitative CT data were compared with reference values obtained in 7 normal nonsmokers . The CT visual score of emphysema exhibited medium-high interobserver reproducibility with correlation coefficients ranging from 0.80 to 0.96 and a good correlation with pulmonary function tests , particularly relative to the assessment of the extent of emphysema alone as expressed by one observer . CT quantification demonstrated an excellent correlation with functional indices of expiratory airflow , lung volumes and diffusion coefficients ( p < 0.001 ) . The expiratory measurements were better than the inspiratory ones while the analysis of both CT number and pixel index gave comparable results . Only the CT expiratory quantitative data allowed to differentiate the patients affected with COPD from the controls . In conclusion , the severity of emphysema as expressed by CT correctly reflects the functional impairment of patients with severe COPD . ( ABSTRACT TRUNCATED AT 250 WORDS Output:
Conclusions CT measurements of emphysema or peripheral airways are significantly related to airflow obstruction in COPD patients . CT provides a morphological method to investigate airway obstruction in COPD .Key Points• Computed tomography is widely performed in patients with chronic obstructive pulmonary disease ( COPD ) • CT provides quantitative morphological methods to investigate airflow obstruction in COPD • CT measurements correlate significantly with the degree of airflow obstruction in COPD • Expiratory CT measurements correlate more strongly with airflow obstruction than inspiratory CT• Low-dose CT decreases the radiation dose for diagnosis and quantitative emphysema
MS2_1shot44
***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 psychometric properties of the Italian version of the Hospital Anxiety and Depression Scale and its utility as a screening instrument for anxiety and depression in a non-psychiatric setting were evaluated . The question naire was administered twice to 197 breast cancer patients r and omised in a phase III adjuvant clinical trial : before the start of chemotherapy and at the first follow-up visit . The presence of psychiatric disorders was evaluated at the follow-up visit using the Structured Clinical Interview for DSM-III-R in 132 patients . Factor analyses identified two strictly correlated factors . Crohnbach 's alpha for the anxiety and depression scales ranged between 0.80 and 0.85 . At follow-up , 50 patients ( 38 % ) were assigned a current DSM-III-R diagnosis , in most cases adjustment disorders ( 24 % ) or major depressive disorder ( 10 % ) . Receiver operating characteristics ( ROC ) analysis was used to test the discriminant validity for both anxiety and depressive disorders . The comparison of the areas under the curve ( AUC ) between the two scales did not show any difference in identifying either anxiety ( P=0.855 ) or depressive disorders ( P=0.357 ) . The 14-item total scale showed a high internal consistency ( alpha=0.89 and 0.88 ) and a high discriminating power for all the psychiatric disorders ( AUC=0.89 ; 95 % CI=0.83–0.94 ) . The cut-off point that maximised sensitivity ( 84 % ) and specificity ( 79 % ) was 10 . These results suggest that the total score is a valid measure of emotional distress , so that the Italian version of HADS can be used as a screening question naire for psychiatric disorders . The use of the two subscales as a ' case identifier ' or as an outcome measure should be considered with caution The Hospital Anxiety and Depression ( HAD ) scale , a self-report question naire , was tested as a method of identifying mood disorder among patients with operable breast cancer during the year after diagnosis . In a cohort of 91 patients anxiety and depression were assessed preoperatively , and at 3 and 12 months post-operatively , using a st and ardised psychiatric interview and diagnostic rating criteria . The patients also completed the HAD scale at each assessment . Fifty out of 91 ( 55 % ) patients were full or borderline cases of depression and /or anxiety at one or more assessment points . Using a receiver operator characteristic curve analysis , the optimum threshold for the preoperative HAD scale total score to identify psychiatric disorder either preoperatively or at 3 and 12 months post-operatively was 11 . With this threshold 70 % of both full and borderline cases occurring at any of the assessment points were correctly identified . The false-positive rate was 12 % . This approach was particularly sensitive to full cases , correctly identifying 90 % of them . The potential for the preoperative HAD scale total score to identify mood disorder in the year after diagnosis was influenced by age . Among women aged less than 50 years , a preoperative HAD scale total score > or = 11 provided a highly sensitive indicator of mood disorder ( full and borderline cases ) at any time in the year after diagnosis ( sensitivity = 90 % ) . The false-positive rate was 40 % . Among women older than 50 who experienced a mood disorder , only 57 % were correctly identified by a HAD scale total score of > or = 11 ( sensitivity = 57 % ) . However , the false-positive rate among older women was low ( 3 % ) . This simple preoperative screening approach can be used to identify patients who have or are at high risk of developing severe mood disorder in the year after diagnosis . The HAD scale is also sensitive to the detection of borderline mood disorder in patients under the age of 50 . It is a specific screening tool among patients over 50 , but is not sensitive to the detection of borderline mood disorder in this age group BACKGROUND This study aim ed to determine the prevalence of psychiatric morbidity and distress among 189 consecutively recruited cancer patients upon admission to surgical oncology wards , and to investigate the recognition of distressed patients by medical staff . PATIENTS AND METHODS Assessment consisted of a diagnostic psychiatric interview ( SCID , DSM-IV ) , patient-reported distress using a st and ardised question naire ( Hospital Anxiety and Depression Scale ) , and physicians ' and nurses ' estimates of patients ' distress . Twenty-eight per cent of patients were assigned a psychiatric diagnosis , with adjustment disorder predominating . RESULTS Surgeons accurately recognised marked distress in 77 % of patients with a psychiatric disorder and nurses did so in 75 % . Because of low specificity , the positive predictive value was only 39 % in surgeons and 40 % in nurses . However , recognition of distress translated into referral to the psychosocial liaison service for only a minor proportion of distressed patients . CONCLUSIONS Since a remarkable proportion of distressed patients remained unrecognised by the medical staff , only systematic screening of patients upon admission allows timely support to those who are most in need Prediction of delayed psychiatric disorders in breast cancer patients by using a screening procedure was investigated . Two question naires , the Psychological Distress Inventory and the Hospital Anxiety and Depression Scale , were administered before and during chemotherapy , and at the first follow-up visit . A psychiatric diagnosis was assigned to 50 of the 132 patients ( 38 % ) evaluated at follow-up . Including a set of clinical and demographic variables in a logistic regression , increasing age ( P=0.001 ) and psychiatric history ( P<0.001 ) were associated with psychiatric morbidity at follow-up . The accuracy of the two question naires in predicting delayed psychiatric disorders increased from the evaluation before chemotherapy to the evaluation during chemotherapy . The most accurate prediction was observed for the concurrent evaluation at follow-up . The accuracy of three predictive models developed for each evaluation point by including age , psychiatric history and psychological distress measured with each of the two question naires was not significantly better than that observed using only the question naires ' scores as predictors PURPOSE Distress has been recognized as the sixth vital sign in cancer care and several guidelines recommend routine screening . Despite this , screening for distress is rarely conducted and infrequently evaluated . METHODS A program of routine online screening for distress was implemented for new patients with breast and lung cancer . Patients were r and omly assigned to one of three conditions : ( 1 ) minimal screening : the distress thermometer ( DT ) only plus usual care ; ( 2 ) full screening : DT , problem checklist , Psychological Screen for Cancer part C measuring anxiety and depression , a personalized report summarizing concerns and the report on the medical file ; or ( 3 ) triage : full screening plus optional personalized phone triage with referral to re sources . Patients in all conditions received an information packet and were reassessed 3 months later with the full screening battery . RESULTS Five hundred eighty-five patients with breast cancer and 549 patients with lung cancer were assessed at baseline ( 89 % of all patients ) , and 75.5 % retained for follow-up . High prevalence of baseline distress was found across patients . Twenty percent fewer patients with lung cancer in triage continued to have high distress at follow-up compared to those in the other two groups , and patients with breast cancer in the full screening and triage conditions showed lower distress at follow-up than those in minimal screening . The best predictor of decreased anxiety and depression in full screening and triage conditions was receiving a referral to psychosocial services . CONCLUSION Routine online screening is feasible in a large cancer center and may help to reduce future distress levels , particularly when coupled with uptake of appropriate re sources The aim of this prospect i ve study was to identify the psychiatric morbidity associated with the diagnosis and treatment of early breast cancer . At each of five time points , 269 women were interviewed using a shortened version of the Present State Examination ( PSE ) and 266 completed self- assessment question naires , the Hospital and Anxiety Depression Scale ( HADS ) and the Rotterdam Symptom Checklist ( RSCL ) . This paper compares the ability of the question naires to detect psychiatric morbidity with that of the PSE . The majority of women who experienced anxiety and /or depression did so within 3 months of their initial surgery . The clinical interview identified anxiety disorder in 132 of 266 women ( 49.6 % ) and depressive illness in 99/266 ( 37.2 % ) during the first 3 months . Using the recommended threshold of > or = 11 for caseness , the sensitivities for both tests were very low at 24.2 % ( HADS anxiety ) and 14.1 % ( HADS depression ) and 30.6 % ( RSCL psychological distress scale ) . Lowering the threshold value to > or = 7 on the HADS improved the sensitivity to 72 % for the anxiety subscale , but it remained low at 37.4 % for the depression subscale . A threshold of > or = 7 for the RSCL scale raised sensitivity to 66.7 % . Lowering the threshold values raised the sensitivity of both the instruments but decreased their specificity : the lower the threshold , the greater the number of women who were identified as false positives which would increase the work load for clinic staff if used as a screening tool . Given that the HADS was inadequate in discriminating for depressive illness , it was not surprising that its use as a unitary scale with a threshold value as low as 12 result ed in a sensitivity of only 42.7 % . In the light of these findings , we question the use of both the HADS and the RSCL as suitable research or screening instruments for detection of psychological morbidity in early breast cancer Two hundred fifteen r and omly accessed cancer patients who were new admissions to three collaborating cancer centers were examined for the presence of formal psychiatric disorder . Each patient was assessed in a common protocol via a psychiatric interview and st and ardized psychological tests . The American Psychiatric Association 's DSM-III diagnostic system was used in making the diagnoses . Results indicated that 47 % of the patients received a DSM-III diagnosis , with 44 % being diagnosed as manifesting a clinical syndrome and 3 % with personality disorders . Approximately 68 % of the psychiatric diagnoses consisted of adjustment disorders , with 13 % representing major affective disorders ( depression ) . The remaining diagnoses were split among organic mental disorders ( 8 % ) , personality disorders ( 7 % ) , and anxiety disorders ( 4 % ) . Approximately 85 % of those patients with a positive psychiatric condition were experiencing a disorder with depression or anxiety as the central symptom . The large majority of conditions were judged to represent highly treatable disorders Output:
Conclusions The HADS anxiety subscale performed worse than the total and the depression subscales for both indicators . Diagnostic accuracy varied widely by threshold but was consistently superior for depression screening than for screening of any mental disorder
MS2_1shot45
***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 use of systemic prophylactic antibiotics in third molar surgery is still a controversial issue . A double-blind study has been conducted with 75 selected patients r and omized into two groups . After exclusions , 68 patients requiring removal of 133 bone impacted m and ibular third molars remained . Surgery was carried out under general anesthesia and a St and ard operative technique used . Postoperative raorbidity was assessed by recording trismus , swelling , pain , and the incidence of infection . In the group given an antibiotic 15.1 % of patients and 7.8 % of sockets became infected ; in the control group the incidence was 14.3 % and 8.7 % , respectively . Difficult extraction s were more likely to give rise to postoperative infection , but neither the state of eruption nor the occurrence of previous pericoronitis appeared to predispose to dry socket . Trismus and swelling were associated with increased difficulty of extraction , but increased pain did not usually occur unless a socket became infected , Differences of overall morbidity between the groups were slight and not statistically significant . The main conclusion from the study is that the use of prophylactic antibiotics in third molar surgery is unnecessary unless specific systemic factors are present Treatment of osteitis after surgical removal of the third molar of the m and ible is still a clinical problem . A total of 140 patients undergoing operations for removal of an impacted third molar of the m and ible , were included in a double-blind study . Placebo or antibiotics - azidocillin , erythromycin , clindamycin and doxycycline - were given to the patients preoperatively and for the following 7 days . The concentrations in serum , alveolar serum and m and ibular bone were measured and the postoperative courses - pain , trismus , swelling and wound-healing - were recorded . No correlation was obtained between the antibiotic concentration and the postoperative complaints , except in the azidocillin group on day 2 , in which fewer complaints were noticed in patients with high concentrations of the drug at the time of operations . The 80 patients in the antibiotic groups responded significantly better with respect to wound-healing than the 60 patients in the placebo groups . Only 15 operations lasted more than 15 min and the three of them which subsequently result ed in alveolitis were in the placebo groups . Antibiotics significantly reduced pain on day 7 postoperatively . In general , no statistically significant differences in trismus and swelling could be demonstrated between the patient groups . However , there was a significant difference between the placebo and doxycycline groups with respect to swelling ( day 2 postoperative , P < 0.01 ; day 5 postoperative , P < 0.05 ) . Thus systemically administered antibiotics offered only slight advantages in routine operations of impacted third m and ibular molars , but could decrease the rate of infections after traumatic operations A prospect i ve r and omized crossover , within-patient , controlled study was performed in 26 healthy patients to test the effect of the prophylactic local use of gauze drain impregnated with chlortetracycline ( Aureomycin 3 % , Lederle ) ointment on postoperative alveolitis formation after surgical removal of 52 bilaterally impacted m and ibular third molars . The teeth were removed on two separate occasions ; on one side drain was inserted in the socket , and on the other side no drain treatment was used for control . The influence on postoperative pain , swelling , and mouth opening ability was investigated . The results indicated a statistically significant reduction ( P = 0.02 ) in the incidence of postoperative inflammatory complications , defined as postoperative alveolitis , from 35 % in the no-drain group to 4 % in the drain group . No statistically significant difference was found between the two treatment methods with regard to pain and mouth opening reduction . There was a significant difference between the drain and no-drain treatment with regard to swelling on the 1st postoperative day in favor of the no-drain method . It is concluded that insertion of a chlortetracycline-impregnated drain may be an effective method for reducing postoperative alveolitis formation but has no beneficial effect on pain , swelling , and mouth opening reduction after impacted m and ibular third-molar surgery PURPOSE This study evaluated the influence of antibiotic prophylaxis on postoperative complications after inferior third molar removal in young patients . PATIENTS AND METHODS We extracted 59 m and ibular third molars from 59 patients with a mean age of 15 years ( range , 12 - 19 years ) . The patients were included in the study when radiographs at the time of surgery showed that only the crown of the tooth germ was formed . Patients were r and omized into 2 groups , the test group and the control group . The test group received 2-g amoxicillin tablets 1 hour before surgery , and the control group received no antibiotic therapy . The test group included 32 patients , 20 of whom were female and 12 were male ; the mean age was 15 years . The control group included 27 patients , 12 of whom were female and 15 were male ; the mean age was 15 years . Postoperative complications such as pain , swelling , wound infection , and fever were recorded by use of a question naire completed by the patient for the week after the extraction . Suture removal and question naire evaluation were performed by a surgeon who did not know the preoperative regimen . RESULTS The mean operating time was 34 minutes in the control group and 31 minutes in the test group . This difference was not significant . In the test group there was a statistically significant reduction of postoperative pain in the 7 days after the extraction , and the patients had a consistent minor consumption of analgesics . Swelling was always present in the control and test groups in the postoperative week , but in the test group it was a minor sequela and was absent in 2 patients . Wound infection was a sequela reported in 4 patients in the control group and in 1 patient in the test group ; this difference was statistically significant ( P < .01 ) . Fever was present in 2 patients in the control group and in 1 patient in the test group ; this difference was not statistically significant . CONCLUSIONS A statistically significant difference was found between patients receiving preoperative amoxicillin and the control group in the incidence of postoperative pain , fever , and wound infection . Another important finding was the statistically minor consumption of analgesics in the test group in the postoperative week AIM To test the efficacy of two dosing regimens of antimicrobial prophylaxis during the removal of impacted lower third molars . DESIGN Double blind , prospect i ve , placebo-controlled trial . SETTING Teaching hospital , India . SUBJECTS 151 patients aged 19 - 36 having impacted lower third molars removed . METHODS R and om allocation into three groups : placebo ( n= 34 ) , metronidazole 1 g orally , 1 hour preoperatively ( n= 44 ) , or metronidazole 400 mg orally eight hourly for 5 days postoperatively ( n= 47 ) . Patients were recalled on the sixth postoperative day for assessment of pain scores on the second and sixth days , swelling , differences in mouth opening between preoperative and the sixth postoperative day , and the state of the wound . RESULTS There were no significant differences in the outcome between the three groups ( P= 0.09 ) . CONCLUSION Antimicrobial prophylaxis does not seem to reduce morbidity after removal of lower third molars PURPOSE We sought to compare recovery for clinical and health-related quality of life ( HRQOL ) outcomes after third molar surgery in patients treated with or without intravenous antibiotics at surgery . PATIENTS AND METHODS Fifty-six patients at least 18 years of age and with all 4 third molars below the occlusal plane , treated at 3 clinical centers , were given intravenous antibiotics just before third molar surgery . Clinical and HRQOL outcomes of these patients were compared with those of a nonconcurrent control group ( n = 60 patients ) who did not receive antibiotics . The control group was selected using the same criteria and treated under the same surgical protocol as the antibiotic group . Differences between the groups were assessed with Cochran-Mantel-Haenszel row mean score statistics . RESULTS The incidence of delayed clinical recovery defined as a postsurgery visit with treatment was higher in the control group compared with the antibiotic group . In the antibiotic group , 4 % had 1 postsurgery visit with treatment ; no patient had 2 visits . In the control group without antibiotics , 28 % had at least 1 postsurgery visit with treatment ( P < .0001 ) and 13 % had at least 2 postsurgery visits with treatment . No statistically significant differences in HRQOL outcomes were found between the 2 groups . CONCLUSIONS Administration of intravenous antibiotics before third molar surgery may improve clinical recovery in healthy adult patients with all 4 third molars below the occlusal plane , a presenting characteristic that has been suggested as a risk factor for delayed recovery . The findings from this exploratory trial indicate that evaluation of the effectiveness of systemic antibiotic administration with third molar surgery in a r and omized , multi-intervention , explanatory clinical trial is warranted A double blind trial , was design ed , in which 118 patients undergoing the removal of impacted wisdom teeth were r and omly divided into the following groups ; 41 patients received Metronidazole , 39 patients received Arnica Montana , 38 patients received the placebo . Metronidazole was more effective in pain control than Arnica ( p less than 0.001 ) and placebo ( p less than 0.01 ) . It prevented swelling better than Arnica ( p less than 0.01 ) and placebo ( p less than 0.05 ) and was more effective in promoting healing than Arnica ( p less than 0.01 ) and placebo ( p greater than 0.02 ) . Arnica Montana appeared to give rise to greater pain than placebo ( p less than 0.05 ) and caused more swelling than the placebo ( p less than 0.01 ) The effect of a single preoperative dose of metronidazole in the prevention of alveolitis sicca dolorosa ( ASD ) after surgical removal of one impacted , non-infected m and ibular third molar was investigated . A patient sample of 270 were given either 1000 mg of metronidazole or placebo at least 30 min before surgery . The preoperative recordings included gender , age , tooth to be removed , experience of surgeon , time of test medication , and duration of surgery . No difference was found between the metronidazole and placebo groups in the occurrence of ASD . The duration of surgery and the experience of the operating surgeons had no effect on the occurrence of ASD . The present study failed to demonstrate any preventive effect of a single dose of metronidazole on the development of ASD PURPOSE We evaluated the need for prophylactic postoperative oral antibiotic treatment in the removal of asymptomatic third molars . MATERIAL S AND METHODS In a prospect i ve study of more than 30 months , a total of 528 impacted lower third molars were surgically removed in 288 patients . All patients were referred to our department by a dentist or a general practitioner . No patient showed any sign of pain , inflammation , or swelling at the time of removal . Three groups were established . In the first group , antibiotic treatment with amoxicillin/clavulanic acid as an oral medication was carried out for 5 days postoperatively . In the second group , we used clindamycin . In the third group , the patients received no antibiotic treatment . Clinical and radiologic factors were recorded for each case , and the rationale for assigning the patients to the groups was strictly r and om . The surgical technique was the same in all cases , and the follow-up period was 4 weeks . Parameters that were evaluated were pain , differences in mouth opening , infection , the occurrence of dry socket , and adverse postoperative side effects . RESULTS We could not find any significant difference between the 3 groups regarding the evaluated parameters , but in 69.6 % of the patients with dry socket , the teeth were partially erupted , which showed a significant difference . CONCLUSIONS The results of our study show that specific postoperative oral prophylactic antibiotic treatment after the removal of lower third molars does not contribute to a better wound healing , less pain , or increased mouth opening and could not prevent the cases of inflammatory problems after surgery , respectively , and therefore is not recommended for routine use Background The aim of this study was to assess the efficacy of a single prophylactic dose of amoxicillin and /or dexamethasone in preventing postoperative complications ( PC ) after a surgical removal of a single m and ibular third molar ( M3 ) . Methods This study is a r and omized , placebo controlled clinical trial . Four groups were included : Group 1 ( G1 ) included a prophylactic dose of 2 g of amoxicillin and 8 mg of dexamethasone ; Group 2 ( G2 ) included a prophylactic dose of 2 g of amoxicillin and 8 mg of placebo ; Group 3 ( G3 ) included a prophylactic dose of 8 mg of dexamethasone and 2 g of placebo and ; Group 4 ( G4 ) placebo . Results Fifty patients were included . It was observed one case of alveolar infection ( 2 % ) and two of alveolar osteitis ( 4 % ) result ing in three PC ( 6 % ) . No statistical differences were observed between therapeutic groups for development of PC , trismus , pain and edema . The use of antibiotics showed an absolute risk reduction ( ARR ) for PC development of 3.52 % and the number needed to treat ( NNT ) Output:
A single oral dose of 2 g of amoxicillin before lower third molar osteotomy surgical extraction significantly decreased the incidence of SSI . A single dose of 0.8 g of penicillin V before lower third molar osteotomy surgical extraction significantly decreased the incidence of alveolar osteitis
MS2_1shot46
***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 After 40 years of experience with anterior cervical operations , whether to fuse is still controversial . This study seeks to answer this question . METHODS In this prospect i ve r and omized study , we operated on 91 patients with single-level cervical root compression using three different methods : 1 ) discectomy without fusion , 2 ) fusion with autologous bone graft , and 3 ) fusion with autologous bone graft plus plating . RESULTS After 4 years of follow-up , the radiological results indicated that complete bony union was achieved in almost all cases . A slight kyphosis developed in 62.5 % of the patients who had undergone discectomy , 40 % of the patients who had undergone fusion , and 44 % of the patients who had undergone fusion plus plating ( not significant ) . The clinical outcomes were good for 76 % of the patients who had undergone discectomy , 82 % who had undergone fusion , and 73 % who had undergone fusion plus plating . The outcomes were poor in 0 , 4 , and 4 % , respectively ( not significant ) . CONCLUSION According to this study , satisfactory results can be achieved by performing simple discectomy to treat single-level cervical root compressive disease OBJECT The authors have previously reported that the results of using cadaveric fibula and locking plate ( CF/LP ) fusion following anterior cervical discectomy ( ACD ) for cervical spondylotic radiculopathy and myelopathy are superior to those obtained using autologous iliac crest ( AIC ) grafts in the short term . The long-term results of using this construct are important in substantiating this improvement . The authors report on 246 consecutive patients ( 54 % smokers ) who underwent ACD with CF/LP fusion ( 175 with allogeneic bone matrix [ ABM ] ) and compare them with 111 consecutive patients in whom AIC fusions ( 49 % smokers ) were performed by the same surgeons . METHODS The study is a retrospective nonr and omized analysis , and chi-square statistics were used . Bone densitometric studies of AIC grafts and CF grafts were performed . A paired t-test was used for statistical analysis of the results . Disease in the group of patients undergoing CF/LP fusion included soft-disc herniation with radiculopathy in 14 , soft-disc hemiation with myelopathy in seven , cervical spondylotic radiculopathy in 144 , cervical spondylotic myelopathy in 75 , AIC graft collapse pseudarthrosis in five , and ACD with no fusion collapse/kyphosis in one . Operations consisted of single-level CF/LP fusion in 142 patients and multilevel CF/LP fusion in 104 . Perioperative complications in the CF/LP group included three cases of transient hoarseness . There were no transfusions , infections , neurological injuries , or deaths . The mean hospital length of stay was 1.2 days ( 28 % outpatient and 66 % 23-hour stay ) . The mean follow-up period was 60 months ( range 12 - 94 months ) . Ten patients were lost to follow up after 1 year . Long-term complications included one traumatic plate fracture and one symptomatic pseudarthrosis with plate fracture . At 1 year and beyond , in 245 ( 99.6 % ) of 246 patients radiographically documented fusion with no motion at the fused level on flexion-extension films was demonstrated . There was no kyphosis , no symptomatic screw plate backout , and no CF/LP graft collapse ( 100 % in the ABM group ) . In the 111 consecutive patients with AIC fusions , however , there was a 17 % graft-related complication rate . There were significantly fewer graft-related complications in the CF/LP group ( p < 0.001 ) . There was no difference in neurological outcome for any of the groups . In the groups undergoing single-level ACD there was a significantly greater chance of complete relief of neck pain CF/LP fusion compared with those undergoing AIC fusion ( p < 0.02 ) . There was a significantly greater chance of AIC collapse with the passage of time compared with CF graft ( p < 0.02 ) . Time until return to work was shorter for the CF/LP group by 5 to 6 weeks ( p < 0.02 ) . There was a higher rate of radiographically documented pseudarthrosis in the AIC group ( p < 0.006 ) . The mean bone densitometry for the CF/LP group was 0.7 g/cm2 , significantly greater than that of the AIC group , which was 0.2 g/cm2 ( paired t-test p < 0.001 ) . CONCLUSIONS When fusion is necessary following ACD , the results of CF/LP fusion are significantly superior in the first 5 years after surgery compared with those for AIC fusions . It remains to be determined if demineralized ABM has a significant effect in enhancing fusion OBJECT The authors compare clinical outcome and fusion rates after iliac crest autograft (ICAG)- and rectangular titanium cage (RTC)-augmented fusion in patients undergoing anterior cervical discectomy ( ACD ) . METHODS One hundred consecutive patients with 127 levels of cervical disc disease refractory to conservative treatment were r and omized into one of the two treatment groups ( ICAG/RTC fusion ) . The visual analog scale was used by the patient to rate overall pain and head , neck , arm , and donor site pain separately . Myelopathy was documented according to Japanese Orthopaedic Association and Nurick grading systems . Outcome was analyzed using Odom criteria , the 36-Item Short Form ( SF-36 ) , and Patient Satisfaction Index scales . Fusion rates were assessed on st and ard and flexion-extension radiographs . Follow-up data of at least 12 months ' duration were available for 95 patients . More residual overall pain after 12 months was documented in patients who underwent ICAG fusion ( 3.3 + /- 2.5 [ ICAG ] and 2.2 + /- 2.4 [ RTC ] ; p < 0.05 ) . Although arm and head pain were minimal in both groups , neck pain proved to be the predominant symptom ( 2.7 + /- 2.5 [ ICAG ] and 1.9 + /- 2.1 [ RTC ] ) , which resolved in only 67 and 48 % of RTC- and ICAG-treated patients , respectively ( p < 0.05 ) . Myelopathy improved comparably in both groups . Regardless of increased pain in ICAG-treated patients , PSI and SF-36 scores were not significantly different between groups ( only four [ 8 % ] of 47 ICAG-treated patients and five [ 10 % ] of 48 RTC-treated patients were unsatisfied ) . Good to excellent functional recovery according to Odom criteria was observed in 75 and 79 % of ICAG- and RTC-treated patients , respectively . Fusion rates were 81 and 74 % , respectively ( p = 0.51 ) . CONCLUSIONS Fusion rates and clinical outcome at 12 months after ACD were comparable between patients who underwent ICAG and RTC fusion . The use of rectangular cages , however , avoids donor site morbidity and reduces overall pain and , thus , seems to be an advantageous treatment alternative Study Design . This study analyzed the fusion results of an allograft-demineralized bone matrix composite versus autograft in a prospect i ve series of patients undergoing surgery for cervical disc disease . Objectives . To determine the fusion rates of allograft-demineralized bone matrix composite in anterior cervical fusion as compared with the gold st and ard autograft . Summary of Background Data . For the anterior cervical fusion , the use of freeze-dried allograft is well documented in the literature , citing its effectiveness and inferior fusion rates . The use of demineralized bone matrix in conjunction with freeze-dried allograft in anterior cervical fusion has not been reported . Methods . This study was done in a prospect i ve fashion in two medical centers . One group received autograft from the anterior iliac crest , whereas others received freeze-dried allograft augmented with demineralized bone matrix ( Grafton , Osteotech , inc , Shrewsbury , New Jersey ) . For the autograft group , the st and ard Smith-Robinson grafting technique was used . For the allograft composite group , demineralized bone matrix was pasted onto the freeze-dried allograft and into the disc space before graft insertion . The autograft group consisted of 38 patients with age ranging 26–71 years ( mean , 46.1 years ) and follow-up periods of 12–33 months ( mean , 18.4 months ) . There were 19 onelevel , 17 two-level , and two three-level fusions , Similarly , the allograft group consisted of 39 patients with age ranging 28–80 years ( mean , 48.0 years ) with follow-up period of 12–31 months ( mean , 17.5 months ) . There were 19 one-level , 16 two-level , and four three level fusions . Clinical and radiographic follow-up evaluations were completed at 3-month intervals . Radio graphs taken 12 months after surgery were analyzed blindly . Results . Pseudarthrosis developed in 46.2 % of patients ( 33.3 % of levels ) in the allograft-demineralized bone matrix group compared with 26.3 % ( 22 % of levels ) in the autograft group ( p = 0.11 for patients , p = 0.23 for levels ) . For patients undergoing two-level fusions , 37.5 % of allograft-demineralized bone matrix failed compared with 23.5 % of of autografts , for singlelevel fusions , 47.4 % of allograft patients developed a pseudarthrosis compared with 26.3 % in the autograft group . Graft collapse of ≥ 3 mm was noted in 11 % of the autograft group versus 19 % in the allograft-demineralized bone matrix group ( p = 0.32 ) . Graft collapse of ≥ 2 mm occurred in 24.4 % of autograft patients compared with 39.7 % of the allograft-demineralized bone matrix group ( p = 0.09 ) . Smokers had an increased rate of pseudarthrosis ( 47.1 % ) compared with nonsmokers ( 27.9 % , p = 0.13 ) . Conclusions . The study revealed that the allograft-demineralized bone matrix construct gives a higher rate of graft collapse and pseudarthrosis when compared with autograft in a prospect i ve series , although the differences were not statistically significant , The pseudar-throsis rate in the series may be high because of the large percentage of smokers and radiographic evaluation techniques . For the purpose of solid radiographic fusion , the use of autograft is recommended in anterior cervical surgery until other acceptable osteoinductive material s are developed Anterior cervical discectomy and interbody grafting provide excellent results in treating cervical radiculopathy . This prospect i ve study compares the results of the technique obtaining autogenous bone from the cervical vertebrae for grafting to the modified Smith-Robinson technique using autogenous iliac crest graft . Seven levels in six patients were fused using the vertebral body autograft technique and 43 levels in 40 patients using the st and ard technique . All patients had radiculopathy and neck pain . Statistically significant differences in fusion rate ( 4/7 vertebral body autograft ; 40/43 modified Smith-Robinson ) ( p = 0.029 ) , disc height maintenance ( p = 0.001 ) , and neck pain improvement ( p = 0.05 ) occurred between the techniques . We do not recommend vertebral body autograft over the modified Smith-Robinson technique for anterior cervical fusion following discectomy Abstract This study evaluated whether addition of a cervical spine locking plate ( CSLP ) in two-level disc fusions improved the postoperative stability and reduced the time to healing . Radiostereometric analysis was used to obtain precise recordings of the three-dimensional motion between the fused vertebrae . Eighteen consecutive patients were operated on with excision of two adjacent cervical discs and anterior horseshoe grafting with autologous bone ( Smith Robinson technique ) . Nine patients were r and omized to stabilization with autologous bone grafting and CSLP plate fixation and nine patients to grafting without fixation . Clinical symptoms in terms of pain in the neck and the arm were analysed preoperatively and after 1 year using a visual analogue scale ( VAS ) . The patients operated without a plate displayed increased rotations around the transverse axis , corresponding to the development of a kyphosis [ mean value no plate/plate 14.4 ° /0.8 ° ( repeated measure ANOVA : P < 0.01 ) ] . The mean compression was 3.2 mm larger in patients operated without a plate ( repeated measure ANOVA : P < 0.01 ) . Patients operated without a plate had more arm pain at the 1-year follow up ( P < 0.05 , Mann-Whitney U test ) . The VAS score for neck pain did not differ significantly between the two groups . Plate fixation could not be demonstrated to increase the healing rate , promote more rapid fusion or influence the frequency of graft complications Study Design . In this study , 43 patients scheduled for a single-level cervical Cloward procedure for disc disease were r and omized prospect ively to fusion with autograft , allograft , or xenograft . Objective . To outline any differences in fusion over time in terms of final mobility and clinical outcome between the three bone grafts . Summary of Background Data . Fusion is used to relieve pain from a spinal segment . The bovine xenograft gives a fibr Output:
Few studies reported on pain , therefore , at best , there was very low quality evidence of little or no difference in pain relief between the different techniques . When the working mechanism for pain relief and functional improvement is fusion of the motion segment , there is low quality evidence that iliac crest autograft appears to be the better technique . When ignoring fusion rates and looking at complication rates , a cage has a weak evidence base over iliac crest autograft , but not over discectomy alone .
MS2_1shot47
***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 compare the efficacy and safety of nifedipine and ritodrine in preventing preterm labor , and to evaluate maternal side effects and neonatal outcome . STUDY DESIGN Non-blind , r and omized controlled trial RESULTS A r and omized trial of 102 pregnant women with gestational ages under 34 weeks , including 24 with twin pregnancies and 45 on betasympathicomimetic drugs , who had regular uterine contractions with either observed cervical changes or preterm rupture of membranes . After stratification women were r and omly assigned to receive either ritodrine intravenously or nifedipine orally . Fifty-five women were r and omized to the nifedipine group and 47 to the ritodrine group . As expected , both groups were comparable in terms of several entry variables , including mean gestational age , ruptured membranes , treatment with tocolytic drugs , cervical examination , contraction frequency , age , and twin gestation . Delivery of women in the nifedipine group was delayed for 48 h , 7 days , and until 34 weeks gestation in 33 ( 60 % ) , 26 ( 47 % ) and 21(38 % ) cases , respectively , compared with 31 ( 66 % ) , 21(45 % ) and 11(23 % ) women in the ritodrine group ( no significant difference ) . Maternal side effects were significantly less common in the nifedipine group than in the ritodrine group , however after 7 days of therapy there was no difference between the two groups . Neonatal outcome was similar in the two groups , with four neonatal deaths in the nifedipine and five in the ritodrine group . CONCLUSIONS Nifedipine seems to be as effective as ritodrine in the treatment of preterm labor and is associated with less frequent side effects OBJECTIVE The objective was to compare the effectiveness , efficacy , and safety of atosiban and nifedipine in preventing or delaying premature labor . DESIGN An interventional , r and omized , controlled trial of 63 women experiencing preterm labor varying from 24 to 35 completed weeks of gestation . The women were r and omized to receive either atosiban intravenously ( group I , n=31 ) , or nifedipine orally ( group II , n=32 ) . RESULTS There were no significant differences in effectiveness and efficacy of tocolysis between the two groups . Women with a history of preterm labor responded significantly better to atosiban than those with no such history . Those at 28 weeks or less responded significantly better to nifedipine , while those at more than 28 weeks ' gestation showed an equal response in the two groups . Nifedipine achieved uterine quiescence in a significantly shorter time than atosiban . The maternal side effects were higher with nifedipine . Neonatal complications were comparable in both groups . CONCLUSIONS Both drugs are equally effective and efficacious in acute tocolysis . Subgrouping of patients according to gestational age and history of preterm labor may be applied in selecting the line of treatment . The maternal side effects were higher with nifedipine OBJECTIVE To perform a comparison between atosiban ( oxytocin antagonist ) and nifedipin ( calcium channel blocker ) for acute treatment of preterm labor and their maternal safety . METHODS A r and omized controlled trial study was performed on 80 pregnant women with preterm labor , between 26 and 34 weeks of pregnancy , in Akbar Abadi Teaching Hospital in Tehran , Iran . 40 women ( the atosiban group ) were compared with another 40 women ( the nifedipin group ) for the drugs ' efficacy in delaying delivery for more than 48 h in order to undergo steroid therapy , and for more than 7 days or more , and also to assess their maternal safety . The duration between the drugs ' administration and delivery were compared . The statistical analysis was performed using the Statistical Package for Social Science ( SPSS ) . RESULTS There was no statistically significant difference between the two groups in the treatment of preterm labor . Atosiban was effective in 82.5 % of cases , and nifedipin in 75 % of the cases ( p=1.000 ) , for delaying delivery for 48 h. Atosiban was effective in 75 % of the cases , and nifedipin in 65 % of the cases , for delaying delivery for more than 7 days . The maternal side effects in the atosiban group were 17.5 % , and in the nifedipin group they were 40 % , which had a statistically significant difference ( p=0.027 ) . The duration between treatment and delivery was 29.03+/-16.12 days in the atosiban group and 22.85+/-13.9 days in the nifedipin group with no statistically significant difference ( p=0.79 ) . CONCLUSION Atosiban is an effective and safe drug for the acute treatment of preterm labor with minimal side effects , and it can be an option in the treatment of preterm labor , especially in patients with heart disease and multi-fetal pregnancies The purpose of this study was to describe the course of preterm labor in patients receiving a st and ard intravenous infusion of the oxytocin antagonist atosiban . An open-labeled , non-r and omized study was conducted at 4 sites . Successful tocolysis was defined as delay of delivery larger than 48 hours from starting atosiban and no need for an alternate tocolytic . Atosiban was administered by continuous intravenous infusion at a rate of 300 micrograms per minute until uterine contractions were absent for 6 hours , or up to a maximum infusion time of 12 hours . Sixty-two patients of between 20 and 36 weeks ' gestation were enrolled over 6 months . One had rupture of membranes and was excluded . Successful tocolysis was noted in 43 of 61 ( 70.5 % ) . Four delivered spontaneously within 48 hours and 14 ( 23.0 % ) required an alternate tocolytic agent . The chance of successful tocolysis was related to the degree of cervical dilation at the start of therapy . Cessation of uterine contractions was noted in 38 patients ( 62.3 % ) . A decrease in uterine contraction frequency of 50 % or more was noted in 50 of 61 patients ( 82.0 % ) . Four patients reported side effects ( nausea , vomiting , headache , dysguesia , chest pain ) , but in no case did side effects require discontinuation of the medication . Intravenous administration of atosiban is associated with a delay in delivery comparable to that seen with other tocolytics . If this effect is confirmed in planned placebo-controlled trials , its favorable side effect profile may give it a place in the armamentarium A phase IV multinational , multicentre study has been design ed -- the Tractocile Efficacy Assessment Survey in Europe ( TREASURE ) . The aim is to assess atosiban in the clinical setting , which is associated with fewer restrictions than in phase III trials . Atosiban is to be compared with ' usual care ' in women eligible for treatment , and will also be evaluated as deferred or immediate treatment in women who have not yet fulfilled the diagnostic criteria for pre-term labour . Exploring the use of atosiban beyond the normal indications may allow the identification of additional sub population s of women who will benefit from early treatment . TREASURE will offer data on new diagnostic tools , investigate respiratory distress syndrome according to severity and record the use of antenatal steroids . It is hoped that additional information concerning the subtle differences in clinical practice will broaden our underst and ing of how to manage pre-term labour and offer the chance to revise treatment guidelines Abstract Objective : To compare the efficacy of atosiban with usual management of threatened preterm labor . Methods : In this prospect i ve , open-label , r and omized controlled trial , women admitted to the hospital in threatened preterm labor ( between 24 and 34 weeks ' gestation ) were r and omized to receive atosiban or usual care ( β-agonists , calcium channel blockers , magnesium sulphate , or any other tocolytic , alone or in combination , and /or bed rest ) . Results : In women r and omized to receive atosiban ( n=295 ) or usual care ( n=290 ) , significantly more women receiving atosiban remained undelivered at 48 h with no alternative tocolytic compared with usual care ( 77.6 % vs. 56.6 % ; P<0.001 ) . The proportion of women remaining undelivered after 48 h was comparable between the treatment groups . However , more women in the atosiban group required no additional tocolytics ( 85.1 % vs. 62.8 % ; P<0.001 ) . Maternal and fetal safety was significantly superior with atosiban . Neonatal safety was comparable . Conclusions : These findings support the use of atosiban to delay preterm birth and are consistent with previously conducted , r and omized , controlled trials . Atosiban was associated with fewer maternal and fetal adverse events compared with other tocolytics , and presented no safety concerns for either the mother or the unborn baby Objective To compare the effects of four methods of analysis on the results of r and omised controlled trials that recruit women with multiple pregnancies and measure outcomes on their babies OBJECTIVE Our aims were to develop a risk assessment system for the prediction of spontaneous preterm delivery using clinical information available at 23 to 24 weeks ' gestation and to determine the predictive value of such a system . STUDY DESIGN A total of 2929 women were evaluated between 23 and 24 weeks ' gestation at 10 centers . Demographic factors , socioeconomic status , home and work environment , drug and alcohol use , and medical history were evaluated . Information regarding symptoms , cultures , and treatments in the current pregnancy were ascertained . Anthropomorphic and cervical examinations were performed . Univariate analysis and multivariate logistic regression were performed in a r and om selection , constituting 85 % of the study population . The derived risk assessment system was applied to the remaining 15 % of the population to evaluate its validity . RESULTS A total of 10.4 % of women were delivered of preterm infants . The multivariate models for spontaneous preterm delivery were highly associated with spontaneous preterm delivery ( p < 0.0001 ) . A low body mass index ( < 19.8 ) and increasing Bishop scores were significantly associated with spontaneous preterm delivery in nulliparous and multiparous women . Black race , poor social environment , and work during pregnancy were associated with increased risk for nulliparous women . Prior obstetric outcome overshadowed socioeconomic risk factors in multiparous women with a twofold increase in the odds of spontaneous preterm delivery for each prior spontaneous preterm delivery . Current pregnancy symptoms , including vaginal bleeding , symptomatic contractions within 2 weeks , and acute or chronic lung disease were variably associated with spontaneous preterm delivery in nulliparous and multiparous women . When the system was applied to the remainder of the population , women defined to be at high risk for spontaneous preterm delivery ( > or = 20 % risk ) carried a 3.8-fold ( nulliparous women ) and 3.3-fold ( multiparous women ) higher risk of spontaneous preterm delivery than those predicted to be at low risk . However , the risk assessment system identified a minority of women who had spontaneous preterm deliveries . The sensitivities were 24.2 % and 18.2 % and positive predictive values were 28.6 % and 33.3 % , respectively , for nulliparous and multiparous women . CONCLUSIONS Although it is possible to develop a grade d risk assessment system that includes factors that are highly associated with spontaneous preterm delivery in nulliparous and multiparous women , such a system does not identify most women who subsequently have a spontaneous preterm delivery . This system has investigational value as the basis for evaluating new technologies design ed to identify at-risk sub population OBJECTIVES This study was design ed to evaluate the efficacy and safety of the oxytocin receptor antagonist atosiban in the treatment of preterm labor . STUDY DESIGN A multicenter , double-blind , placebo-controlled trial with tocolytic rescue was design ed . Five hundred thirty-one patients were r and omized to receive , and 501 received , either intravenous atosiban ( n = 246 ) or placebo ( n = 255 ) , followed by subcutaneous maintenance with the assigned agent . St and ard tocolytics as rescue tocolysis were permitted after 1 hour of either placebo or atosiban if preterm labor continued . The primary end point was the time from the start of study drug to delivery or therapeutic failure . Secondary end points were the proportion of patients who remained undelivered and did not receive an alternate tocolytic at 24 hours , 48 hours , and 7 days . RESULTS No significant difference was found in the time from start of treatment to delivery or therapeutic failure between atosiban and placebo ( median , 25.6 days vs 21.0 days , respectively ; P = .6 ) . The percentages of patients remaining undelivered and not requiring an alternate tocolytic at 24 hours , 48 hours , and 7 days were significantly higher in the atosiban group than in the control group ( all P < or = .008 ) . A significant treatment-by-gestational age interaction existed for the 48-hour and 7-day end points . Atosiban was consistently superior to placebo at a gestational age of > or = 28 weeks . Fourteen atosiban-treated patients and 5 placebo-treated patients were r and omized at < 24 weeks ; the incidence of fetal-infant death Output:
This review failed to demonstrate the superiority of atosiban over betamimetics or placebo in terms of tocolytic efficacy or infant outcomes . A recent Cochrane review suggests that calcium channel blockers ( mainly nifedipine ) are associated with better neonatal outcome and fewer maternal side-effects than betamimetics .
MS2_1shot48
***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 profile of brain structural abnormalities in schizophrenia is still not fully understood , despite decades of research using brain scans . To vali date a prospect i ve meta- analysis approach to analyzing multicenter neuroimaging data , we analyzed brain MRI scans from 2028 schizophrenia patients and 2540 healthy controls , assessed with st and ardized methods at 15 centers worldwide . We identified subcortical brain volumes that differentiated patients from controls , and ranked them according to their effect sizes . Compared with healthy controls , patients with schizophrenia had smaller hippocampus ( Cohen ’s d=−0.46 ) , amygdala ( d=−0.31 ) , thalamus ( d=−0.31 ) , accumbens ( d=−0.25 ) and intracranial volumes ( d=−0.12 ) , as well as larger pallidum ( d=0.21 ) and lateral ventricle volumes ( d=0.37 ) . Putamen and pallidum volume augmentations were positively associated with duration of illness and hippocampal deficits scaled with the proportion of unmedicated patients . Worldwide cooperative analyses of brain imaging data support a profile of subcortical abnormalities in schizophrenia , which is consistent with that based on traditional meta-analytic approaches . This first ENIGMA Schizophrenia Working Group study vali date s that collaborative data analyses can readily be used across brain phenotypes and disorders and encourages analysis and data sharing efforts to further our underst and ing of severe mental illness In this work , we address an important but unexplored topic , namely the neural correlates of hate . In a block- design fMRI study , we scanned 17 normal human subjects while they viewed the face of a person they hated and also faces of acquaintances for whom they had neutral feelings . A hate score was obtained for the object of hate for each subject and this was used as a covariate in a between-subject r and om effects analysis . Viewing a hated face result ed in increased activity in the medial frontal gyrus , right putamen , bilaterally in premotor cortex , in the frontal pole and bilaterally in the medial insula . We also found three areas where activation correlated linearly with the declared level of hatred , the right insula , right premotor cortex and the right fronto-medial gyrus . One area of deactivation was found in the right superior frontal gyrus . The study thus shows that there is a unique pattern of activity in the brain in the context of hate . Though distinct from the pattern of activity that correlates with romantic love , this pattern nevertheless shares two areas with the latter , namely the putamen and the insula BACKGROUND Reduced amygdala volume has been implicated in the development of severe and persistent aggression and the development of psychopathic personality . With longitudinal data , the current study examined whether male subjects with lower amygdala volume have a history of aggression and psychopathic features dating back to childhood and are at increased risk for engaging in future aggression/violence . METHODS Participants were selected from a longitudinal study of 503 male subjects initially recruited when they were in the first grade in 1986 - 1987 . At age 26 , a sub sample of 56 men with varying histories of violence was recruited for a neuroimaging sub study . Automated segmentation was used to index individual differences in amygdala volume . Analyses examined the association between amygdala volume and levels of aggression and psychopathic features of participants measured in childhood and adolescence . Analyses also examined whether amygdala volume was associated with violence and psychopathic traits assessed at a 3-year follow-up . RESULTS Men with lower amygdala volume exhibited higher levels of aggression and psychopathic features from childhood to adulthood . Lower amygdala volume was also associated with aggression , violence , and psychopathic traits at a 3-year follow-up , even after controlling for earlier levels of these features . All effects remained after accounting for several potential confounds . CONCLUSIONS This represents the first prospect i ve study to demonstrate that men with lower amygdala volume have a longst and ing history of aggression and psychopathic features and are at increased risk for committing future violence . Studies should further examine whether specific amygdala abnormalities might be a useful biomarker for severe and persistent aggression This study aim ed to identify the incidence and clinical correlates of aggression and violence in first episode psychosis . We prospect ively recruited subjects with a first episode of DSM-psychosis presenting from a geographically defined catchment area to a secondary referral psychiatric service over a four-year period ( n = 157 ) . We used the Modified Overt Aggression Scale to retrospectively assess aggression ( a hostile or destructive mental attitude , including verbal aggression , physical aggression and /or violence ) and violence ( the exercise of physical force ) , blind to diagnosis . One in three patients with psychosis was aggressive at the time of presentation . One patient in 14 engaged in violence that caused , or was likely to cause , injury to other people . Aggression was independently associated with drug misuse ( odds ratio ( OR ) 2.80 , 95 % confidence interval 1.12 - 6.99 ) and involuntary admission status ( OR = 3.62 , 95 % CI 1.45 - 9.01 ) . Violence in the week prior to presentation was associated with drug misuse ( OR = 2.75 , CI 1.04 - 7.24 ) and involuntary admission status ( OR = 3.21 , CI 1.21 - 8.50 ) . Violence in the week following presentation was associated with poor insight ( OR 2.97 , CI 1.03 - 8.56 ) and pre-contact violence ( OR 3,82 , CI 1.34 - 10.88 ) . In patients with schizophrenia , violence in the week following presentation was associated with drug misuse ( OR = 7.81 , CI 1.33 - 45.95 ) and high psychopathology scores ( OR = 20.59 , CI 1.66 - 254.96 ) . Overall , despite a high rate of verbal aggression , physical violence towards other people is uncommon in individuals presenting with first episode psychosis OBJECTIVE Aggression , suicidality and involuntary treatment constitute severe clinical problems in first-episode psychosis ( FEP ) . Although there are studies on prevalence and clinical predictors of these conditions , little is known on the influence of psychopathology and neuropsychological dysfunction . METHOD 152 FEP in patients were prospect ively assessed using the Brief Psychiatric Rating Scale ( BPRS ) and a neuropsychological examination covering the domains ' processing speed ' , ' concentration and attention ' , ' executive function ' , ' working memory ' , ' verbal memory ' , ' verbal comprehension ' , ' logical reasoning ' , ' global cognition ' , and ' general intelligence ' . Clinical data were collected retrospectively in a structured file audit trial . RESULTS Patients were aged 24.5±4.9years , and 112 ( 74 % ) were male . At admission , 13 ( 9 % ) patients presented with severe aggression , and 28 ( 18 % ) with severe suicidality . 31 patients ( 20 % ) received involuntary treatment . In multivariate analyses , aggression was predicted by BPRS-Excited Component ( BPRS-EC ; p=.001 ) , suicidality was predicted by BPRS-EC ( p=.013 ) and general intelligence ( p=.016 ) , and predictors for involuntary treatment were BPRS-EC ( p=.001 ) and neuropsychological dysfunction in the domain ' concentration and attention ' ( p=.016 ) . CONCLUSION Psychopathology and neuropsychological functioning independently predict dangerous behavior in FEP patients . Some correlations with neuropsychology ( e.g. , of aggression with concentration/attention ) are absent in multivariate analyses and may thus constitute a proxy of psychopathological features . In addition to clinical data , BPRS-EC can be used as a predictor of dangerous behavior . Patients with severe aggression and suicidality show different patterns of neuropsychological dysfunction , indicating that suicidality should not be conceptualized as subtype of aggressive behavior OBJECTIVE Agitation , aggression , and violence are increased in psychotic disorders . Additionally , an earlier age at onset may be associated with aggressive behavior . However , the relationship of age at onset , an agitated-aggressive syndrome as measured with the Positive And Negative Syndrome Scale for Schizophrenia - Excited Component ( PANSS-EC ) , and its potential correlates in first-episode psychosis ( FEP ) has not been studied . METHOD This study assessed the association between age at onset , an agitated-aggressive syndrome , and its potential correlates in a prospect i ve sample of 52 FEP patients with early-onset and adult-onset followed up for 12months . RESULTS Twenty-six patients conformed to the criteria of early-onset psychosis . Early age at onset was associated with antisocial personality disorder ( p=0.004 ; φc=0.39 ) , a history of legal involvement ( p=0.005 ; φc=0.39 ) , and higher rates of lifetime substance use disorder ( SUD ; p=0.002 ; φc=0.42 ) . Early-onset patients had significantly higher PANSS-EC scores over the course of observation ( F(1,44.4)=5.39 ; p=0.025 ; d=0.656 ) , but no significant group differences emerged for the remaining PANSS subscores . PANSS-EC scores were correlated positively with antisocial personality disorder and forensic history at 6weeks , 3months , 6months , and 12months , and with lifetime substance use disorder at 3months and 6months . CONCLUSIONS Patients with early onset psychosis may have increased levels of agitation/aggressiveness , and , more likely , antisocial personality disorder , forensic history , and lifetime substance use disorder . These variables were linked to suicidality , aggressiveness , and involuntary treatment Output:
Qualitative analyses showed lower volumes of WB , prefrontal regions , temporal lobe , hippocampus , thalamus and cerebellum , and higher volumes of lateral ventricles , amygdala , and putamen in violent vs. non-violent people with schizophrenia . Conclusions : We review ed evidence for differences in brain volume correlates of aggression in persons with schizophrenia . Our results point toward a reduced whole brain volume in violent as opposed to non-violent persons with schizophrenia .
MS2_1shot49
***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 This study sought to evaluate whether remote ischemic post-conditioning ( RIPC ) could reduce enzymatic infa rct size in patients with anterior ST-segment elevation myocardial infa rct ion undergoing primary percutaneous coronary intervention ( pPCI ) . BACKGROUND Myocardial reperfusion injury may attenuate the benefit of pPCI . In animal models , RIPC mitigates myocardial reperfusion injury . METHODS One hundred patients with anterior ST-segment elevation myocardial infa rct ion and occluded left anterior descending artery were r and omized to pPCI + RIPC ( n = 50 ) or conventional pPCI ( n = 50 ) . RIPC consisted of 3 cycles of 5 min/5 min ischemia/reperfusion by cuff inflation/deflation of the lower limb . The primary endpoint was infa rct size assessed by the area under the curve of creatinine kinase-myocardial b and release ( CK-MB ) . Secondary endpoints included the following : infa rct size assessed by cardiac magnetic resonance delayed enhancement volume ; T2-weighted edema volume ; ST-segment resolution > 50 % ; TIMI ( Thrombolysis In Myocardial Infa rct ion ) frame count ; and myocardial blush grading . RESULTS Four patients ( 2 RIPC , 2 controls ) were excluded due to missing sample s of CK-MB . A total of 96 patients were analyzed ; median area under the curve CK-MB was 8,814 ( interquartile range [ IQR ] : 5,567 to 11,325 ) arbitrary units in the RIPC group and 10,065 ( IQR : 7,465 to 14,004 ) arbitrary units in control subjects ( relative reduction : 20 % , 95 % confidence interval : 0.2 % to 28.7 % ; p = 0.043 ) . Seventy-seven patients underwent a cardiac magnetic resonance scan 3 to 5 days after r and omization , and 66 patients repeated a second scan after 4 months . T2-weighted edema volume was 37 ± 16 cc in RIPC patients and 47 ± 22 cc in control subjects ( p = 0.049 ) . ST-segment resolution > 50 % was 66 % in RIPC and 37 % in control subjects ( p = 0.015 ) . We observed no significant differences in TIMI frame count , myocardial blush grading , and delayed enhancement volume . CONCLUSIONS In patients with anterior ST-segment elevation myocardial infa rct ion , RIPC at the time of pPCI reduced enzymatic infa rct size and was also associated with an improvement of T2-weighted edema volume and ST-segment resolution > 50 % . ( Remote Postconditioning in Patients With Acute Myocardial Infa rct ion Treated by Primary Percutaneous Coronary Intervention [ PCI ] [ RemPostCon ] ; NCT00865722 ) BACKGROUND Remote ischaemic preconditioning attenuates cardiac injury at elective surgery and angioplasty . We tested the hypothesis that remote ischaemic conditioning during evolving ST-elevation myocardial infa rct ion , and done before primary percutaneous coronary intervention , increases myocardial salvage . METHODS 333 consecutive adult patients with a suspected first acute myocardial infa rct ion were r and omly assigned in a 1:1 ratio by computerised block r and omisation to receive primary percutaneous coronary intervention with ( n=166 patients ) versus without ( n=167 ) remote conditioning ( intermittent arm ischaemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff ) . Allocation was concealed with opaque sealed envelopes . Patients received remote conditioning during transport to hospital , and primary percutaneous coronary intervention in hospital . The primary endpoint was myocardial salvage index at 30 days after primary percutaneous coronary intervention , measured by myocardial perfusion imaging as the proportion of the area at risk salvaged by treatment ; analysis was per protocol . This study is registered with Clinical Trials.gov , number NCT00435266 . FINDINGS 82 patients were excluded on arrival at hospital because they did not meet inclusion criteria , 32 were lost to follow-up , and 77 did not complete the follow-up with data for salvage index . Median salvage index was 0.75 ( IQR 0.50 - 0.93 , n=73 ) in the remote conditioning group versus 0.55 ( 0.35 - 0.88 , n=69 ) in the control group , with median difference of 0.10 ( 95 % CI 0.01 - 0.22 ; p=0.0333 ) ; mean salvage index was 0.69 ( SD 0.27 ) versus 0.57 ( 0.26 ) , with mean difference of 0.12 ( 95 % CI 0.01 - 0.21 ; p=0.0333 ) . Major adverse coronary events were death ( n=3 per group ) , reinfa rct ion ( n=1 per group ) , and heart failure ( n=3 per group ) . INTERPRETATION Remote ischaemic conditioning before hospital admission increases myocardial salvage , and has a favourable safety profile . Our findings merit a larger trial to establish the effect of remote conditioning on clinical outcomes . FUNDING Fondation Leducq Background — In animal models , brief periods of ischemia performed just at the time of reperfusion can reduce infa rct size , a phenomenon called postconditioning . In this prospect i ve , r and omized , controlled , multicenter study , we investigated whether postconditioning may protect the human heart during coronary angioplasty for acute myocardial infa rct ion . Methods and Results — Thirty patients , su bmi tted to coronary angioplasty for ongoing acute myocardial infa rct ion , contributed to the study . Patients were r and omly assigned to either a control or a postconditioning group . After reperfusion by direct stenting , control subjects underwent no further intervention , whereas postconditioning was performed within 1 minute of reflow by 4 episodes of 1-minute inflation and 1-minute deflation of the angioplasty balloon . Infa rct size was assessed by measuring total creatine kinase release over 72 hours . Area at risk and collateral blood flow were estimated on left ventricular and coronary angiograms . No adverse events occurred in the postconditioning group . Determinants of infa rct size , including ischemia time , size of the area at risk , and collateral flow , were comparable between the 2 groups . Area under the curve of creatine kinase release was significantly reduced in the postconditioning compared with the control group , averaging 208 984±26 576 compared with 326 095±48 779 ( arbitrary units ) in control subjects , ie , a 36 % reduction in infa rct size . Blush grade , a marker of myocardial reperfusion , was significantly increased in postconditioned compared with control subjects : 2.44±0.17 versus 1.95±0.27 , respectively ( P<0.05 ) . Conclusions — This study suggests that postconditioning by coronary angioplasty protects the human heart during acute myocardial infa rct ion Remote ischemic conditioning ( RIC ) is known to improve microcirculation in various setting s , but little is known about the impact of the amount of ischemic tissue mass or the limb itself . Since ischemia and subsequent necrosis of flaps is one of the most dreaded complications in reconstructive surgery , adjuvant methods to improve microcirculation are desirable . We therefore performed a r and omized trial to compare the effect of arm versus leg ischemia for RIC of the cutaneous microcirculation of the antero-lateral thigh . Forty healthy volunteers were r and omized to undergo 5 min of ischemia of either the upper or lower extremity , followed by 10 min of reperfusion . Ischemia was induced by a surgical tourniquet applied to the proximal limb , which was inflated to 250 mmHg for the upper and 300 mgHg for the lower extremity . This cycle was repeated a total of three times . Cutaneous microcirculation was assessed by combined laser doppler spectrophotometry on the antero-lateral aspect of the thigh to measure cutaneous blood flow ( BF ) , relative hemoglobin content ( rHb ) , and oxygen saturation ( StO2 ) . Baseline measurements were performed for 10 min , after which the ischemia/reperfusion cycles were begun . Measurements were performed continuously and were afterwards pooled to obtain a mean value per minute . Both groups showed significant increases in all three measured parameters of cutaneous microcirculation after three cycles of ischemia/reperfusion when compared to baseline ( BF : 95.1 % ( P < 0.001 ) and 27.9 % ( P = 0.002 ) ; rHb : 9.4 % ( P < 0.001 ) and 5.9 % ( P < 0.001 ) , StO2 : 8.4 % ( P = 0.045 ) and 9.4 % ( P < 0.001 ) . When comparing both groups , BF was significantly higher in the arm group ( P = 0.019 after 11 min . , P = 0.009 after 45 min ) . In conclusions , both ischemic conditioning of the upper and lower extremity is able to improve cutaneous BF on the ALT donor site . However , RIC of the upper extremity seems to be a superior trigger for improvement of cutaneous BF BACKGROUND Contrast medium-induced acute kidney injury ( CI-AKI ) is a cardiovascular complication after myocardial infa rct ion treated with emergency percutaneous coronary intervention . The aim of this r and omized , sham-controlled trial was to evaluate the impact of remote ischemic preconditioning ( RIPC ) on CI-AKI in patients with ST-elevation myocardial infa rct ion who received emergency primary percutaneous coronary intervention . METHODS AND RESULTS Patients with a suspected ST-elevation myocardial infa rct ion were r and omly assigned at a 1:1 ratio to receive percutaneous coronary intervention either with ( n=63 ) or without ( n=62 ) RIPC ( intermittent arm ischemia through three cycles of 5min of inflation and 5min of deflation of a blood pressure cuff ) . A total of 47 RIPC patients and 47 control patients met all study criteria . The primary endpoint was the incidence of CI-AKI , which was defined as an increase in serum creatinine > 0.5mg/dL or > 25 % over the baseline value 48 - 72h after administration of contrast medium . The incidence of CI-AKI was 10 % ( n=5 ) in the RIPC group and 36 % ( n=17 ) in the control group ( p=0.003 ) . The odds ratio of CI-AKI in patients who received RIPC was 0.18 ( 95 % confidence interval : 0.05 - 0.64 ; p=0.008 ) . CONCLUSIONS In patients with ST-elevation myocardial infa rct ion , RIPC before percutaneous coronary intervention reduced the incidence of CI-AKI Background The aim of this study was to evaluate the role of remote ischemic postconditioning ( RIPC ) of the upper arm on protection from cardiac ischemia-reperfusion injury following primary percutaneous coronary intervention ( PCI ) in patients with acute ST-segment elevation myocardial infa rct ion ( STEMI ) . Material / Methods Eighty patients with STEMI were r and omized into two groups : primary PCI ( N=44 ) and primary PCI+RIPC ( N=36 ) . RIPC consisted of four cycles of 5 minutes of occlusion and five minutes of reperfusion by cuff inflation and deflation of the upper arm , commencing within one minute of the first PCI balloon dilatation . Peripheral venous blood sample s were collected before PCI and at 0.5 , 8 , 24 , 48 , and 72 hours after PCI . Levels of creatine kinase-MB ( CK-MB ) , serum creatinine ( Cr ) , nitric oxide ( NO ) , and stromal cell-derived factor-1α ( SDF-1α ) were measured . The rates of acute kidney injury ( AKI ) and the estimated glomerular filtration rate ( eGFR ) were calculated . Results Patients in the primary PCI+RIPC group , compared with the primary PCI group , had significantly lower peak CK-MB concentrations ( P<0.01 ) , a significantly increased left ventricular ejection fraction ( LVEF ) ( P=0.01 ) , a significantly lower rate of AKI ( P<0.01 ) a significantly increased eGFR ( P<0.01 ) , and decreased area under the curve ( AUC ) of CK-MB , NO and SDF-1α . Conclusions RIPC of the upper arm following primary PCI in patients with acute STEMI might provide cardiac and renal protection from ischemia-reperfusion injury via the actions of SDF-1α , and NO Importance Ischemic postconditioning of the heart during primary percutaneous coronary intervention ( PCI ) induced by repetitive interruptions of blood flow to the ischemic myocardial region immediately after reopening of the infa rct -related artery may limit myocardial damage . Objective To determine whether Output:
Conclusion RIC was associated with lower myocardial edema levels , myocardial salvage index and incidence of MACCE , while non-significant beneficial effect on infa rct size , TIMI flow grade III or LVEF . These findings suggest that RIC is a promising adjunctive treatment to PCI for the prevention of reperfusion injury in STEMI patients
MS2_1shot50
***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 A prospect i ve , open-label phase II study was conducted to determine whether donepezil , a US Food and Drug Administration-approved reversible acetylcholinesterase inhibitor used to treat mild to moderate Alzheimer 's type dementia , improved cognitive functioning , mood , and quality of life ( QOL ) in irradiated brain tumor patients . PATIENTS AND METHODS Thirty-four patients received donepezil 5 mg/d for 6 weeks , then 10 mg/d for 18 weeks , followed by a washout period of 6 weeks off drug . Outcomes were assessed at baseline , 12 , 24 ( end of treatment ) , and 30 weeks ( end of wash-out ) . All tests were administered by a trained research nurse . RESULTS Of 35 patients who initiated the study , 24 patients ( mean age , 45 years ) remained on study for 24 weeks and completed all outcome assessment s. All 24 patients had a primary brain tumor , mostly low- grade glioma . Scores significantly improved between baseline ( pretreatment ) and week 24 on measures of attention/concentration , verbal memory , and figural memory and a trend for verbal fluency ( all P < .05 ) . Confused mood also improved from baseline to 24 weeks ( P = .004 ) , with a trend for fatigue and anger ( all P < .05 ) . Health-related QOL improved significantly from baseline to 24 weeks , particularly , for brain specific concerns with a trend for improvement in emotional and social functioning ( all P < .05 ) . CONCLUSION Cognitive functioning , mood , and health-related QOL were significantly improved following a 24-week course of the acetylcholinesterase inhibitor donepezil . Toxicities were minimal . We are planning a double blinded , placebo-controlled , phase III trial of donepezil to confirm these favorable results From 1990 to 1994 , patients with newly diagnosed malignant gliomas were enrolled and r and omized between hyperfractionated radiation ( HFX ) of 72.0 Gy in 60 fractions given twice daily and 60.0 Gy in 30 fractions given once daily . All patients received 80 mg/m2 of 1,3 bis(2 chloroethyl)-1 nitrosourea on days 1–3 q8 weeks for 1 year . Patients were stratified by age , KPS , and histology . The primary endpoint was overall survival ( OS ) , with secondary endpoints including progression-free survival ( PFS ) and toxicity . Out of the 712 patients accrued , 694 ( 97.5 % ) were analyzable cases ( 350 HFX , 344 st and ard arm ) . There was no significant difference between the arms on overall acute or late treatment-related toxicity . No statistically significant effect for HFX , as compared to st and ard therapy , was found on either OS , with a median survival time ( MST ) of 11.3 versus 13.1 months ( p = 0.20 ) or PFS , with a median PFS time of 5.7 versus 6.9 months ( p = 0.18 ) . The treatment effect on OS remained insignificant based on the multivariate analysis ( hazard ratio 1.16 ; p = 0.0682 ) . When OS was analyzed by histology subgroup there was also no significant difference between the two arms for patients with glioblastoma multiforme ( MST : 10.3 vs. 11.2 months ; p = 0.34 ) , anaplastic astrocytoma ( MST : 69.8 vs. 50.0 months ; p = 0.91 ) or anaplastic oligodendroglioma ( MST : 92.1 vs. 66.5 months ; p = 0.33 ) . Though this trial provided many invaluable secondary analyses , there was no trend or indication of a benefit to HFX radiation to 72.0 Gy in any subset of malignant glioma patients Background Outcome of low- grade glioma ( LGG , WHO grade II ) is highly variable reflecting molecular heterogeneity of the disease . We compared two different single modality treatment strategies : st and ard radiotherapy ( RT ) versus primary temozolomide ( TMZ ) chemotherapy with the aim of tailoring treatment and identifying predictive molecular factors . Methods 477 patients ( 2005 – 2012 , median FU 48 months ) with a low- grade glioma ( astrocytoma , oligoastrocytoma , oligodendroglioma , WHO grade II ) with at least one high-risk feature ( age > 40 years , progressive disease , tumor > 5 cm or crossing the midline , neurological symptoms ( e.g. focal or mental deficits , increased intracranial pressure or intractable seizures ) ) were , after stratification by chromosome 1p-status , r and omized to either conformal RT ( 50.4 Gy/28 fractions ) or dose-dense TMZ ( 75 mg/m2 daily × 21 days , q28 days , max . 12 cycles ) . R and om treatment allocation was performed online using a minimization technique . A planned analysis was performed after 246 progression events . All analyses are intent to treat . Primary clinical endpoint was progression-free survival ( PFS ) , correlative analyses included molecular markers ( 1p/19q co-deletion , MGMT methylation status , IDH1 + 2 mutations ) . The trial has been registered at the European Trials Registry ( EudraCT 2004 - 002714 - 11 ) and at Clinical Trials.gov ( NCT00182819 ) . Findings Four hundred seventy-seven patients were r and omized . Severe hematological toxicity occurred in 14 % of TMZ-treated patients , infections in 3 % of TMZ-treated patients , and 1 % of RT-treated patients . Moderate to severe fatigue was recorded in 3 % of patients in the RT group and 7 % in the TMZ group . At a median follow-up of 48 months ( IQR:31–56 ) , median PFS was 39 months ( IQR:16–46 ) in the TMZ arm and 46 months ( IQR:19–48 ) in the RT group ( hazard ratio 1.16 , 95 % CI , 0.9–1.5 ; p=0.22 ) . Median OS has not been reached . Exploratory analyses identified treatment-dependent variation in outcome of molecular LGG subgroups ( n=318 ) . Interpretation There was no significant difference in outcome of the overall patient population treated with either radiotherapy alone or TMZ chemotherapy alone . Further data maturation is needed for overall survival analyses and evaluation of the full predictive impact of the molecular subtypes for individualized treatment choices . Funding Merck & Co , Swiss-Bridge Award 2011 , Swiss Cancer League We characterized health-related quality of life ( HRQoL ) , cognitive , and functional status in newly diagnosed glioblastoma ( GBM ) patients receiving Tumor treating fields ( TTFields ) with temozolomide ( TMZ ) versus TMZ alone in a planned interim analysis of a r and omized phase III trial [ NCT00916409 ] , which showed significant improvement in progression-free and overall survival with TTFields/TMZ . After radiotherapy with concomitant TMZ , newly diagnosed GBM patients were r and omized ( 2:1 ) to TTFields/TMZ ( n = 210 ) or TMZ ( n = 105 ) . Interim analysis was performed in 315 patients with ≥18 months of follow-up . HRQoL , a secondary endpoint , was evaluated in per- protocol patient population and expressed as change from baseline ( CFB ) at 3 , 6 , and 9 months for each subscale in the EORTC QLQ-C30/BN20 . Karnofsky performance scores ( KPS ) and Mini-Mental State Examination scores ( MMSE ) were assessed . CFB in HRQoL was balanced in treatment groups at the 12-month time point . Initially , HRQoL improved in patients treated with TTFields/TMZ ( CFB3 : 24 % and CFB6 : 13 % ) versus TMZ ( CFB3 : −7 % and CFB6 : −17 % ) , though this difference was no longer evident at the 9-month point . General scales , including physical and social functioning , showed no difference at 9 and 12 months . TTFields/TMZ group reported higher concerns of “ itchy skin ” . KPS over 12 months was just below 90 in both groups . Cognitive status ( MMSE ) was stable over time . HRQoL , KPS , and MMSE were balanced in both groups over time . There was no preliminary evidence that HRQoL , cognitive , and functional status is adversely affected by the continuous use of TTFields BACKGROUND Temozolomide chemotherapy versus radiotherapy in patients with a high-risk low- grade glioma has been shown to have no significant effect on progression-free survival . If these treatments have a different effect on health-related quality of life ( HRQOL ) , it might affect the choice of therapy . We postulated that temozolomide compromises HRQOL and global cognitive functioning to a lesser extent than does radiotherapy . METHODS We did a prospect i ve , phase 3 , r and omised controlled trial at 78 medical centres and large hospitals in 19 countries . We enrolled adult patients ( aged ≥18 years ) with histologically confirmed diffuse ( WHO grade II ) astrocytoma , oligodendroglioma , or mixed oligoastrocytoma , with a WHO performance status of 2 or lower , without previous chemotherapy or radiotherapy , who needed active treatment other than surgery . We r and omly assigned eligible patients ( 1:1 ) using a minimisation technique , stratified by WHO performance status ( 0 - 1 vs 2 ) , age ( < 40 years vs ≥40 years ) , presence of contrast enhancement on MRI , chromosome 1p status ( deleted vs non-deleted vs indeterminate ) , and the treating medical centre , to receive either radiotherapy ( 50·4 Gy in 28 fractions of 1·8 Gy for 5 days per week up to 6·5 weeks ) or temozolomide chemotherapy ( 75 mg/m2 daily , for 21 of 28 days [ one cycle ] for 12 cycles ) . The primary endpoint was progression-free survival ( results published separately ) ; here , we report the results for two key secondary endpoints : HRQOL ( assessed using the European Organisation for Research and Treatment of Cancer 's [ EORTC ] QLQ-C30 [ version 3 ] and the EORTC Brain Cancer Module [ QLQ-BN20 ] ) and global cognitive functioning ( assessed using the Mini-Mental State Examination [ MMSE ] ) . We did analyses on the intention-to-treat population . This study is closed and is registered at EudraCT , number 2004 - 002714 - 11 , and at Clinical Trials.gov , number NCT00182819 . FINDINGS Between Dec 6 , 2005 , and Dec 21 , 2012 , we r and omly assigned 477 eligible patients to either radiotherapy ( n=240 ) or temozolomide chemotherapy ( n=237 ) . The difference in HRQOL between the two treatment groups was not significant during the 36 months ' follow-up ( mean between group difference [ averaged over all timepoints ] 0·06 , 95 % CI -4·64 to 4·75 , p=0·98 ) . At baseline , 32 ( 13 % ) of 239 patients who received radiotherapy and 32 ( 14 % ) of 236 patients who received temozolomide chemotherapy had impaired cognitive function , according to the MMSE scores . After r and omisation , five ( 8 % ) of 63 patients who received radiotherapy and three ( 6 % ) of 54 patients who received temozolomide chemotherapy and who could be followed up for 36 months had impaired cognitive function , according to the MMSE scores . No significant difference was recorded between the groups for the change in MMSE scores during the 36 months of follow-up . INTERPRETATION The effect of temozolomide chemotherapy or radiotherapy on HRQOL or global cognitive functioning did not differ in patients with low- grade glioma . These results do not support the choice of temozolomide alone over radiotherapy alone in patients with high-risk low- grade glioma . FUNDING Merck Sharp & Dohme-Merck & Co , National Cancer Institute , Swiss Cancer League , National Institute for Health Research , Cancer Research UK , Canadian Cancer Society Research Institute , National Health and Medical Research Council , European Organisation for Research and Treatment of Cancer Cancer Research Fund Background The addition of bevacizumab to temozolomide-based chemoradiotherapy ( TMZ/RT → TMZ ) did not prolong overall survival ( OS ) in patients with newly diagnosed glioblastoma in phase III trials . Elderly and frail patients are underrepresented in clinical trials , but early reports suggested preferential benefit in this population . Patients and methods ARTE was a 2 : 1 r and omized , multi-center , open-label , non-comparative phase II trial of hypofractionated RT ( 40 Gy in 15 fractions ) with bevacizumab ( 10 mg/kg × 14 days ) ( arm A , N = 50 ) or without bevacizumab ( arm Output:
Radiotherapy for gliomas with a good prognosis may increase the risk of neurocognitive side effects in the long term ; however the magnitude of the risk is uncertain .
MS2_1shot51
***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 Olaparib is a poly(ADP-ribose ) polymerase inhibitor and cediranib is an anti-angiogenic agent with activity against VEGF receptor ( VEGFR ) 1 , VEGFR2 , and VEGFR3 . Both oral agents have antitumour activity in women with recurrent ovarian cancer , and their combination was active and had manageable toxicities in a phase 1 trial . We investigated whether this combination could improve progression-free survival ( PFS ) compared with olaparib monotherapy in women with recurrent platinum-sensitive ovarian cancer . METHODS In our r and omised , open-label , phase 2 study , we recruited women ( aged ≥18 years ) who had measurable platinum-sensitive , relapsed , high- grade serous or endometrioid ovarian , fallopian tube , or primary peritoneal cancer , or those with deleterious germline BRCA1/2 mutations from nine participating US academic medical centres . We r and omly allocated participants ( 1:1 ) according to permuted blocks , stratified by germline BRCA status and previous anti-angiogenic therapy , to receive olaparib capsules 400 mg twice daily or the combination at the recommended phase 2 dose of cediranib 30 mg daily and olaparib capsules 200 mg twice daily . The primary endpoint was progression-free survival analysed in the intention-to-treat population . The phase 2 trial is no longer accruing patients . An interim analysis was conducted in November , 2013 , after 50 % of expected events had occurred and efficacy results were unmasked . The primary analysis was performed on March 31 , 2014 , after 47 events ( 66 % of those expected ) . The trial is registered with Clinical Trials.gov , number NCT01116648 . FINDINGS Between Oct 26 , 2011 , and June 3 , 2013 , we r and omly allocated 46 women to receive olaparib alone and 44 to receive the combination of olaparib and cediranib . Median PFS was 17·7 months ( 95 % CI 14·7-not reached ) for the women treated with cediranib plus olaparib compared with 9·0 months ( 95 % CI 5·7 - 16·5 ) for those treated with olaparib monotherapy ( hazard ratio 0·42 , 95 % CI 0·23 - 0·76 ; p=0·005 ) . Grade 3 and 4 adverse events were more common with combination therapy than with monotherapy , including fatigue ( 12 patients in the cediranib plus olaparib group vs five patients in the olaparib monotherapy group ) , diarrhoea ( ten vs none ) , and hypertension ( 18 vs none ) . INTERPRETATION Cediranib plus olaparib seems to improve PFS in women with recurrent platinum-sensitive high- grade serous or endometrioid ovarian cancer , and warrants study in a phase 3 trial . The side-effect profile suggests such investigations should include assessment s of quality of life and patient-reported outcomes to underst and the effects of a continuing oral regimen with that of intermittent chemotherapy . FUNDING American Recovery and Reinvestment Act grant from the National Institutes of Health ( NIH ) ( 3 U01 CA062490 - 16S2 ) ; Intramural Program of the Center for Cancer Research ; and the Division of Cancer Treatment and Diagnosis , National Cancer Institute , NIH BACKGROUND Olaparib ( AZD2281 ) is an oral poly(adenosine diphosphate [ADP]-ribose ) polymerase inhibitor that has shown antitumor activity in patients with high- grade serous ovarian cancer with or without BRCA1 or BRCA2 germline mutations . METHODS We conducted a r and omized , double-blind , placebo-controlled , phase 2 study to evaluate maintenance treatment with olaparib in patients with platinum-sensitive , relapsed , high- grade serous ovarian cancer who had received two or more platinum-based regimens and had had a partial or complete response to their most recent platinum-based regimen . Patients were r and omly assigned to receive olaparib , at a dose of 400 mg twice daily , or placebo . The primary end point was progression-free survival according to the Response Evaluation Criteria in Solid Tumors guidelines . RESULTS Of 265 patients who underwent r and omization , 136 were assigned to the olaparib group and 129 to the placebo group . Progression-free survival was significantly longer with olaparib than with placebo ( median , 8.4 months vs. 4.8 months from r and omization on completion of chemotherapy ; hazard ratio for progression or death , 0.35 ; 95 % confidence interval [ CI ] , 0.25 to 0.49 ; P<0.001 ) . Subgroup analyses of progression-free survival showed that , regardless of subgroup , patients in the olaparib group had a lower risk of progression . Adverse events more commonly reported in the olaparib group than in the placebo group ( by more than 10 % of patients ) were nausea ( 68 % vs. 35 % ) , fatigue ( 49 % vs. 38 % ) , vomiting ( 32 % vs. 14 % ) , and anemia ( 17 % vs. 5 % ) ; the majority of adverse events were grade 1 or 2 . An interim analysis of overall survival ( 38 % maturity , meaning that 38 % of the patients had died ) showed no significant difference between groups ( hazard ratio with olaparib , 0.94 ; 95 % CI , 0.63 to 1.39 ; P=0.75 ) . CONCLUSIONS Olaparib as maintenance treatment significantly improved progression-free survival among patients with platinum-sensitive , relapsed , high- grade serous ovarian cancer . Interim analysis showed no overall survival benefit . The toxicity profile of olaparib in this population was consistent with that in previous studies . ( Funded by AstraZeneca ; Clinical Trials.gov number , NCT00753545 . ) BACKGROUND The inhibition of poly(adenosine diphosphate [ADP]-ribose ) polymerase ( PARP ) is a potential synthetic lethal therapeutic strategy for the treatment of cancers with specific DNA-repair defects , including those arising in carriers of a BRCA1 or BRCA2 mutation . We conducted a clinical evaluation in humans of olaparib ( AZD2281 ) , a novel , potent , orally active PARP inhibitor . METHODS This was a phase 1 trial that included the analysis of pharmacokinetic and pharmacodynamic characteristics of olaparib . Selection was aim ed at having a study population enriched in carriers of a BRCA1 or BRCA2 mutation . RESULTS We enrolled and treated 60 patients ; 22 were carriers of a BRCA1 or BRCA2 mutation and 1 had a strong family history of BRCA-associated cancer but declined to undergo mutational testing . The olaparib dose and schedule were increased from 10 mg daily for 2 of every 3 weeks to 600 mg twice daily continuously . Reversible dose-limiting toxicity was seen in one of eight patients receiving 400 mg twice daily ( grade 3 mood alteration and fatigue ) and two of five patients receiving 600 mg twice daily ( grade 4 thrombocytopenia and grade 3 somnolence ) . This led us to enroll another cohort , consisting only of carriers of a BRCA1 or BRCA2 mutation , to receive olaparib at a dose of 200 mg twice daily . Other adverse effects included mild gastrointestinal symptoms . There was no obvious increase in adverse effects seen in the mutation carriers . Pharmacokinetic data indicated rapid absorption and elimination ; pharmacodynamic studies confirmed PARP inhibition in surrogate sample s ( of peripheral-blood mononuclear cells and plucked eyebrow-hair follicles ) and tumor tissue . Objective antitumor activity was reported only in mutation carriers , all of whom had ovarian , breast , or prostate cancer and had received multiple treatment regimens . CONCLUSIONS Olaparib has few of the adverse effects of conventional chemotherapy , inhibits PARP , and has antitumor activity in cancer associated with the BRCA1 or BRCA2 mutation . ( Clinical Trials.gov number , NCT00516373 . Purpose : Veliparib , a PARP inhibitor , demonstrated clinical activity in combination with oral cyclophosphamide in patients with BRCA-mutant solid tumors in a phase I trial . To define the relative contribution of PARP inhibition to the observed clinical activity , we conducted a r and omized phase II trial to determine the response rate of veliparib in combination with cyclophosphamide compared with cyclophosphamide alone in patients with pretreated BRCA-mutant ovarian cancer or in patients with pretreated primary peritoneal , fallopian tube , or high- grade serous ovarian cancers ( HGSOC ) . Experimental Design : Adult patients were r and omized to receive cyclophosphamide alone ( 50 mg orally once daily ) or with veliparib ( 60 mg orally once daily ) in 21-day cycles . Crossover to the combination was allowed at disease progression . Results : Seventy-five patients were enrolled and 72 were evaluable for response ; 38 received cyclophosphamide alone and 37 the combination as their initial treatment regimen . Treatment was well tolerated . One complete response was observed in each arm , with three partial responses ( PR ) in the combination arm and six PRs in the cyclophosphamide alone arm . Genetic sequence and expression analyses were performed for 211 genes involved in DNA repair ; none of the detected genetic alterations were significantly associated with treatment benefit . Conclusion : This is the first trial that evaluated single-agent , low-dose cyclophosphamide in HGSOC , peritoneal , fallopian tube , and BRCA-mutant ovarian cancers . It was well tolerated and clinical activity was observed ; the addition of veliparib at 60 mg daily did not improve either the response rate or the median progression-free survival . Clin Cancer Res ; 21(7 ) ; 1574–82 . © 2015 AACR 5003 Background : Olaparib ( AZD2281 ) is an oral PARP inhibitor that has shown antitumor activity in patients ( pts ) with high- grade serous ovarian cancer ( SOC ) with and without BRCA1 or BRCA2 mutations . This r and omized , double-blind , multicenter , placebo-controlled Phase II study evaluated maintenance treatment with olaparib in pts with high- grade PSR SOC ( clinical trials.gov ; NCT00753545 ) . METHODS Pts with PSR SOC who had received ≥2 previous platinum regimens and were in a maintained partial or complete response following their last platinum-containing regimen were r and omized to oral olaparib 400 mg bid or placebo . The primary endpoint was progression-free survival ( PFS ) by RECIST . Secondary endpoints included time to progression ( TTP ) by CA-125 ( GCIG criteria ) or RECIST , overall survival ( OS ) and safety . RESULTS 265 pts were r and omized ( 136 to olaparib and 129 to placebo ) . Demographics and baseline characteristics were generally well balanced . At data cut-off there were 153 ( 58 % ) progression events . PFS by RECIST was significantly longer in the olaparib than the placebo group ( HR , 0.35 ; 95 % CI 0.25 - 0.49 ; P<0.00001 ; median 8.4 vs 4.8 months ) . TTP by CA-125 or RECIST was also significantly longer in the olaparib than the placebo group ( HR , 0.35 ; 95 % CI 0.25 - 0.47 ; P<0.00001 ; median 8.3 vs 3.7 months ) . At data cut-off OS data were too immature for analysis . 68 ( 50 % ) and 21 ( 16 % ) remain on olaparib or placebo , respectively . AEs more commonly reported on olaparib than placebo ( by > 10 % ) were nausea ( 68 % vs 35 % ) , fatigue ( 49 % vs 38 % ) , vomiting ( 32 % vs 14 % ) and anemia ( 17 % vs 5 % ) ; the majority of AEs were CTCAE grade 1 or 2 . The most frequently reported CTCAE grade ≥3 events were fatigue ( 9 pts ) and anemia ( 7 pts ) for olaparib , and abdominal pain and fatigue ( 4 pts each ) for placebo . 3 ( 2.2 % ) pts on olaparib and 1 ( 0.8 % ) on placebo had AEs that led to treatment discontinuation . 31 pts ( 23 % ) in the olaparib group and 9 ( 7 % ) in the placebo group had both dose reductions and interruptions . CONCLUSIONS In pts with PSR SOC , maintenance treatment with olaparib 400 mg bid provided a significant improvement in PFS . Olaparib was well tolerated , and Output:
PARP inhibitors appear to improve PFS in women with recurrent platinum-sensitive disease . Ongoing studies are likely to provide more information about whether the improvement in PFS leads to any change in OS in this subgroup of women with EOC . More research is needed to determine whether PARP inhibitors have any role to play in platinum-resistant disease
MS2_1shot52
***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: UNLABELLED This study determined the changes of calcium concentration in a medium containing teeth/biofilm exposed to Coffea canephora extract ( CCE ) . Enamel fragments were r and omly fixed into two 24-well polystyrene plates containing BHI . Pooled human saliva was added to form biofilm on fragments . Specimens were divided into treatment groups ( G , n = 8 per group ) and treated with 50 μl daily for 1 min per week , as follows : G1 , 20 % CCE ; G2 , Milli-Q water ( negative control ) ; G3 , antibiotic ( positive control ) . Six fragments represented the blank control ( G4 ) . The calcium content was observed at baseline , 4 and 7 days of treatment by atomic-absorption spectrophotometry . Cross-sectional hardness of enamel was a demineralization indicator . Calcium increased in the medium after 4 and 7 days of treatment in G1 ( 3·80 ± 1·3 mg l(-1 ) and 4·93 ± 2·1 mg l(-1 ) , respectively ) and G3 ( 4th day = 5·7 ± 1·8 mg l(-1 ) ; 7th day = 6·7 ± 3·5 mg l(-1 ) ) ( P > 0·05 ) . Calcium from G2 decreased after 7 days , which was different from G3 ( P < 0·05 ) . The lower calcium content , at the end of the experiment , was represented by G4 , 2·16 ± 0·2 mg l(-1 ) . The increase in calcium after treatment with CCE is probably due to its antibacterial effect , which caused the bacterial lysis and consequent release of calcium in the medium . SIGNIFICANCE AND IMPACT OF THE STUDY This study revealed an inhibitory action of Coffea canephora against dental biofilm . This coffee species caused bacterial lysis and consequent release of calcium into the medium . Furthermore , the advantage of coffee as an antibacterial beverage is that it is consumed in a concentrated form ( 6 - 10 % ) as opposed to various medicinal infusions that have shown such effect in vitro and are usually consumed at 1 - 2 % . Therefore , a light roasted C. canephora aqueous extract can be considered as a potential anticariogenic substance In the present work , we studied the effect of the hydro-alcoholic extract ( HAE ) from Punica granatum ( pomegranate ) fruits on dental plaque microorganisms . The study was conducted on 60 healthy patients ( 33 females and 27 males , with age ranging from 9 to 25 years ) using fixed orthodontic appliances , and r and omly distributed into 3 groups of 20 patients each . The first group ( control ) used distilled water , while the second and third groups used chlorhexidine ( st and ard ) and HAE as mouth-rinses , respectively . The dental plaque material was collected from each patient , before and after a 1-min mouth-rinse with 15 ml of either distilled water , chlorhexidine or HAE . In both dental plaque collection s , the material was removed from patients without oral hygiene , for 24 h ( no tooth brushing ) . Dental plaque sample s were diluted in phosphate buffered saline ( PBS ) plated on Mueller-Hinton agar , and incubated for 48 h , at 37 ° C . Results , expressed as the number of colony forming units per milliliter ( CFU/mL ) , show that the HAE was very effective against dental plaque microorganisms , decreasing the CFU/ml by 84 % ( CFU X105 , before mouth-rinse : 154.0 ±41.18 ; after mouth-rinse : 25.4 ±7.76 ) . While similar values were observed with chlorhexidine , used as st and ard and positive control ( 79 % inhibition ) , only an 11 % inhibition of CFU/ml was demonstrated in the distilled water group , negative control ( CFUX 105 , before mouth-rinse : chlorhexidine , 208.7 ±58.81 and distilled water , 81.1 ±10.12 ; after mouth-rinse : chlorhexidine , 44.0 ±15.85 and distilled water , 71.9 ±8.68 ) . The HAE presented also an antibacterial activity against selected microorganisms , and may be a possible alternative for the treatment of dental plaque bacteria OBJECTIVES The present study focused on isolation , characterization and evaluation of purified compounds from Morus alba against Streptococcus mutans biofilm formation . METHODS The effect of crude extract from M. alba leaves was evaluated against oral pathogens , chiefly S. mutans . MICs were determined by the microdilution method . The compound was purified by employing silica gel chromatography and critically analysed with GC-MS , NMR and IR spectroscopy . The S. mutans traits of adherence and biofilm formation were assessed at sub-MIC concentrations of the crude extract and purified compound . Both water-soluble and alkali-soluble polysaccharide were estimated to determine the effect of the purified compound on the extracellular polysaccharide secretion of S. mutans . Its effect on biofilm architecture was also investigated with the help of confocal microscopy . RESULTS The purified compound of M. alba showed an 8-fold greater reduction of MIC against S. mutans than the crude extract ( MICs , 15.6 and 125 mg/L , respectively ) . The extract strongly inhibited biofilm formation of S. mutans at its active accumulation and plateau phases . The purified compound led to a 22 % greater reduction in alkali-soluble polysaccharide than in water-soluble polysaccharide . The purified compound was found to be 1-deoxynojirimycin ( DNJ ) . Confocal microscopy revealed that DNJ distorts the biofilm architecture of S. mutans . CONCLUSIONS The whole study reflects a prospect i ve role of DNJ as a therapeutic agent by controlling the overgrowth and biofilm formation of S. mutans This double-blind , r and omized control trial sought to evaluate the clinical effects of 3 mouthrinses against salivary mutans streptococci ( MS ) . Ninety high-caries risk volunteers were r and omly assigned to 3 groups , each group using a selected mouthrinse BID for 30 days . Subjects in Group 1 rinsed with 10 ml of 50 % Acacia nilotica , Group 2 subjects rinsed with 10 ml of 0.2 % chlorhexidine ( active control ) , and subjects in Group 3 rinsed with saline water ( passive control ) . Unstimulated saliva sample s were collected at baseline , 30 , and 60 days . MS were cultured on mitis salivarius bacitracin agar , and colony counts were obtained . The margin of error was fixed at 5 % . ANOVA and post hoc least significant difference tests were performed . There were significant decreases in the MS colony count in the A. nilotica and chlorhexidine groups at 30 days ( 85 % and 83 % , respectively ) and at 60 days ( 65 % and 63 % , respectively ) ( P < 0.0001 ) . The antibacterial action of A. nilotica against MS was similar to that of chlorhexidine Aim : To determine the anti-carious effect of coffee in humans . Coffee represents one of the most consumed products by the population . Material s and Methods : A r and om sample of 1000 individuals , of both sexes , who consumed only coffee as a beverage and who visited the Out-Patient Department of KLE Society 's Institute of Dental Sciences , with a dental complaint and no history of any major illness , were considered as subjects . The patients ' histories with regard to the coffee intake , such as , period of consumption , frequency of consumption , whether taken with milk or wihout milk , with sugar or without sugar , and the br and make , was noted . History of the type of diet , consumption of sweets , periodicity of brushing , and whether they had undergone fluoride applications were also noted . A thous and patients who consumed beverages other than coffee were taken as the control . Results : The results showed that coffee most consumed was roasted coffee , and the frequency on an average was about three cups per day , for an average period of 35 years . The Decayed/Missing/Filled Surface ( DMFS ) scores varied from 2.9 , in subjects who drank black coffee , to 5.5 in subjects who consumed coffee together with sweeteners and creaming agents . The DMFS score was 3.4 in subjects who consumed coffee together with milk but no sugar . The DMFS score of the control subjects was 4 , indicating that coffee if consumed alone had anticaries action , but in the presence of additives the antibacterial and anticaries action was totally minimized . Conclusion : Thus coffee can help in prevention of dental caries if consumed without additives Output:
The data of 14 reports disclosed enhanced antiadhesive and antibiofilm activity by the plant extracts obtained from Vitis vinifera , Pinus spp . , Overall , a positive correlation was revealed between herb-based therapies and elimination rates of all types of multispecies oral biofilms . In that context , integrating or even replacing conventional dental therapy protocol s with herbal-inspired treatments can allow effective antimicrobial control of oral biofilms and thus , dental diseases
MS2_1shot53
***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 . Birth asphyxia represents a serious problem worldwide , result ing in ∼1 million deaths and an equal number of serious sequelae annually . It is therefore important to develop new and better ways to treat asphyxia . Resuscitation after birth asphyxia traditionally has been carried out with 100 % oxygen , and most guidelines and textbooks recommend this ; however , the scientific background for this has never been established . On the contrary , theoretic considerations indicate that resuscitation with high oxygen concentrations could have detrimental effects . We have performed a series of animal studies as well as one pilot study indicating that resuscitation can be performed with room air just as efficiently as with 100 % oxygen . To test this more thoroughly , we organized a multicenter study and hypothesized that room air is superior to 100 % oxygen when asphyxiated newborn infants are resuscitated . Methodology . In a prospect i ve , international , controlled multicenter study including 11 centers from six countries , asphyxiated newborn infants with birth weight > 999 g were allocated to resuscitation with either room air or 100 % oxygen . The study was not blinded , and the patients were allocated to one of the two treatment groups according to date of birth . Those born on even date s were resuscitated with room air and those born on odd date s with 100 % oxygen . Informed consent was not obtained until after the initial resuscitation , an arrangement in agreement with the new proposal of the US Food and Drug Administration 's rules governing investigational drugs and medical devices to permit clinical research on emergency care without the consent of subjects . The protocol was approved by the ethical committees at each participating center . Entry criterion was apnea or gasping with heart rate < 80 beats per minute at birth necessitating resuscitation . Exclusion criteria were birth weight < 1000 g , lethal anomalies , hydrops , cyanotic congenital heart defects , and stillbirths . Primary outcome measures were death within 1 week and /or presence of hypoxic – ischemic encephalopathy , grade II or III , according to a modification of Sarnat and Sarnat . Secondary outcome measures were Apgar score at 5 minutes , heart rate at 90 seconds , time to first breath , time to first cry , duration of resuscitation , arterial blood gases and acid base status at 10 and 30 minutes of age , and abnormal neurologic examination at 4 weeks . The existing routines for resuscitation in each participating unit were followed , and the ventilation techniques described by the American Heart Association were used as guidelines aim ing at a frequency of manual ventilation of 40 to 60 breaths per minute . Results . Forms for 703 enrolled infants from 11 centers were received by the steering committee . All 94 patients from one of the centers were excluded because of violation of the inclusion criteria in 86 of these . Therefore , the final number of infants enrolled in the study was 609 ( from 10 centers ) , with 288 in the room air group and 321 in the oxygen group . Median ( 5 to 95 percentile ) gestational ages were 38 ( 32.0 to 42.0 ) and 38 ( 31.1 to 41.5 ) weeks ( NS ) , and birth weights were 2600 ( 1320 to 4078 ) g and 2560 ( 1303 to 3900 ) g ( NS ) in the room air and oxygen groups , respectively . There were 46 % girls in the room air and 41 % in the oxygen group ( NS ) . Mortality in the first 7 days of life was 12.2 % and 15.0 % in the room air and oxygen groups , respectively ; adjusted odds ratio ( OR ) = 0.82 with 95 % confidence intervals ( CI ) = 0.50–1.35 . Neonatal mortality was 13.9 % and 19.0 % ; adjusted OR = 0.72 with 95 % CI = 0.45–1.15 . Death within 7 days of life and /or moderate or severe hypoxic – ischemic encephalopathy ( primary outcome measure ) was seen in 21.2 % in the room air group and in 23.7 % in the oxygen group ; OR = 0.94 with 95 % CI = 0.63–1.40 . Heart rates did not differ between the two groups at any time point and were ( mean ± SD ) 90 ± 31 versus 93 ± 33 beats per minute at 1 minute and 110 ± 27 versus 113 ± 30 beats per minute at 90 seconds in the room air and oxygen groups , respectively . Apgar scores at 1 minute ( median and 5 to 95 percentiles ) were significantly higher in the room air group ( 5 [ 1 to 6.7 ] ) than in the oxygen group ( 4 [ 1 to 7 ] ) ; however , at 5 minutes there were no significant differences , with 8 ( 4 to 9 ) versus 7 ( 3 to 9 ) . There were significantly more infants with very low 1-minute Apgar scores ( < 4 ) in the oxygen group ( 44.4 % ) than in the room air group ( 32.3 % ) . There also were significantly more infants with 5-minute Apgar score < 7 in the oxygen group ( 31.8 % ) than in the room air group ( 24.8 % ) . There were no differences in acid base status or Sao 2during the observation period between the two groups . Mean ( SD ) Pao 2 was 31 ( 17 ) versus 30 ( 22 ) mm Hg in cord blood in the room air and oxygen groups , respectively ( NS ) . At 10 minutes Pao 2 was 76 ( 32 ) versus 87 ( 49 ) mm Hg ( NS ) , and at 30 minutes , the values were 74 ( 29 ) versus 89 ( 42 ) mm Hg in the room air and oxygen groups , respectively . Median ( 95 % CI ) time to first breath was 1.1 ( 1.0–1.2 ) minutes in the room air group versus 1.5 ( 1.4 to 1.6 ) minutes in the oxygen group . Time to the first cry also was in mean 0.4 minute shorter in the room air group compared with the oxygen group . In the room air group , there were 25.7 % so-called resuscitation failures ( bradycardia and /or central cyanosis after 90 seconds ) that were switched to 100 % oxygen after 90 seconds . The percentage of resuscitation failures in the oxygen group was 29.8 % . Conclusions . This study with patients enrolled primarily from developing countries indicates that asphyxiated newborn infants can be resuscitated with room air as efficiently as with pure oxygen . In fact , time to first breath and first cry was significantly shorter in room air- versus oxygen-resuscitated infants . Resuscitation with 100 % oxygen may depress ventilation and therefore delay the first breath . More studies are needed confirming these results before resuscitation guidelines are changed ABSTRACT : To test the hypothesis that room air is superior to 100 % oxygen when asphyxiated newborns are resuscitated , 84 neonates ( birth weight > 999 g ) with heart rate < 80 and /or apnea at birth were allocated to be resuscitated with either room air ( n = 42 ) or 100 % oxygen ( n = 42 ) . Serial , unblinded observations of heart rates at 1 , 3 , 5 , and 10 min and Apgar scores at 1 min revealed no significant differences between the two groups . At 5 min , median ( 25th and 75th percentile ) Apgar scores were higher in the room air than in the oxygen group [ 8 ( 7–9 ) versus 7 ( 6–8 ) , p = 0.03 ] . After the initial resuscitation , arterial partial pressure of oxygen , pH , and base excess were comparable in the two groups . Assisted ventilation was necessary for 2.4 ( 1.5–3.4 ) min in the room air group and 3.0 ( 2.0–4.0 ) min in the oxygen group ( p = 0.14 ) . The median time to first breath was 1.5 ( 1.0–2.0 ) min in both the room air and oxygen groups ( p = 0.59 ) , and the time to first cry was 3.0 ( 2.0–4.0 ) min and 3.5 ( 2.5–5.5 ) min in the room air and oxygen groups , respectively ( p = 0.19 ) . Three neonates in the room air group and four in the oxygen group died in the neonatal period . At 28 d , 72 of the 77 surviving neonates were available for follow-up ( 36 in each group ) , and none had any neurologic sequelae . This preliminary study did not provide conclusive evidence that room air is superior to 100 % oxygen in the resuscitation of asphyxiated newborns , although it indicated that room air is as effective as 100 % oxygen . Additional trials with increased numbers of patients are necessary before deciding whether room air or oxygen should be used in clinical practice BACKGROUND Traditional fluid resuscitation strategy in the actively hemorrhaging trauma patient emphasizes maintenance of a normal systolic blood pressure ( SBP ) . One human trial has demonstrated improved survival when fluid resuscitation is restricted , whereas numerous laboratory studies have reported improved survival when resuscitation is directed to a lower than normal pressure . We hypothesized that fluid resuscitation titrated to a lower than normal SBP during the period of active hemorrhage would improve survival in trauma patients presenting to the hospital in hemorrhagic shock . METHODS Patients presenting in hemorrhagic shock were r and omized to one of two fluid resuscitation protocol s : target SBP > 100 mm Hg ( conventional ) or target SBP of 70 mm Hg ( low ) . Fluid therapy was titrated to this endpoint until definitive hemostasis was achieved . In-hospital mortality , injury severity , and probability of survival were determined for each patient . RESULTS One hundred ten patients were enrolled over 20 months , 55 in each group . The study cohort had a mean age of 31 years , and consisted of 79 % male patients and 51 % penetrating trauma victims . There was a significant difference in SBP observed during the study period ( 114 mm Hg vs. 100 mm Hg , p < 0.001 ) . Injury Severity Score ( 19.65 + /- 11.8 vs. 23.64 + /- 13.8 , p = 0.11 ) and the duration of active hemorrhage ( 2.97 + /- 1.75 hours vs. 2.57 + /- 1.46 hours , p = 0.20 ) were not different between groups . Overall survival was 92.7 % , with four deaths in each group . CONCLUSION Titration of initial fluid therapy to a lower than normal SBP during active hemorrhage did not affect mortality in this study . Reasons for the decreased overall mortality and the lack of differentiation between groups likely include improvements in diagnostic and therapeutic technology , the heterogeneous nature of human traumatic injuries , and the imprecision of SBP as a marker for tissue oxygen delivery BACKGROUND Cardiac arrest with widespread cerebral ischemia frequently leads to severe neurologic impairment . We studied whether mild systemic hypothermia increases the rate of neurologic recovery after resuscitation from cardiac arrest due to ventricular fibrillation . METHODS In this multicenter trial with blinded assessment of the outcome , patients who had been resuscitated after cardiac arrest due to ventricular fibrillation were r and omly assigned to undergo therapeutic hypothermia ( target temperature , 32 degrees C to 34 degrees C , measured in the bladder ) over a period of 24 hours or to receive st and ard treatment with normothermia . The primary end point was a favorable neurologic outcome within six months after cardiac arrest ; secondary end points were mortality within six months and the rate of complications within seven days . RESULTS Seventy-five of the 136 patients in the hypothermia group for whom data were available ( 55 percent ) had a favorable neurologic outcome ( cerebral-performance category , 1 [ good recovery ] or 2 [ moderate disability ] ) , as compared with 54 of 137 ( 39 percent ) in the normothermia group ( risk ratio , 1.40 ; 95 percent confidence interval , 1.08 to 1.81 ) . Mortality at six months was 41 percent in the hypothermia group ( 56 of 137 patients died ) , as compared with 55 percent in the normothermia group ( 76 of 138 patients ; risk ratio , 0.74 ; 95 percent confidence interval , 0.58 to 0.95 ) . The complication rate did not differ significantly between the two groups . CONCLUSIONS In patients who have been successfully resuscitated after cardiac arrest due to ventricular fibrillation , therapeutic mild hypothermia increased the rate of a favorable neurologic outcome and reduced mortality BACKGROUND Fluid resuscitation may be detrimental when given before bleeding is controlled in patients with trauma . The purpose of this study was to determine the effects of delaying fluid resuscitation until the time of operative intervention in hypotensive patients with penetrating injuries to the torso . METHODS We conducted a prospect i ve trial comparing immediate and delayed fluid resuscitation in 598 adults with penetrating torso injuries who presented with a pre-hospital systolic blood pressure of < or = 90 mm Hg . The study setting was a city with a single Output:
We did not find strong or consistent evidence that quasi-r and omization is associated with selection bias more often than true r and omization . High risk of bias judgements for quasi-r and omized emergency studies should therefore not be assumed in systematic review s. Clinical heterogeneity across trials within review s , coupled with limited availability of relevant trial accrual data , meant it was not possible to adequately explore the possibility that true r and omization might result in slower trial recruitment rates , or the recruitment of less representative population
MS2_1shot54
***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 This study aim ed to investigate the effects of oral hygiene care by oral professionals on periodontal health in type 2 diabetes mellitus patients . Material s and Methods Diabetic participants were recruited at a university hospital and matched at a 1:1 ratio by age and gender , and r and omly allocated into intervention ( 40 people ) and control groups ( 35 people ) . Tooth brushing instruction , oral health education , and supra-gingival scaling were implemented in all patients at baseline . This program was repeatedly conducted in intervention patients every month for 6 months , and twice at baseline and the sixth month in the control . Oral health was measured by decayed , missing , and filled teeth ( DMFT ) , plaque index , calculus index , bleeding index , patient hygiene performance ( PHP ) index , tooth mobility , Russel 's periodontal index , and community periodontal index ( CPI ) . Diabetes-related factors , oral and general health behaviors , and sociodemographic factors were interviewed as other confounding factors . An analysis of covariance ( ANCOVA ) was used with SPSS for Windows 14.0 . Results At baseline , there were no significant differences between the two groups in average of periodontal health ( calculus index , bleeding index , Russel 's periodontal index , CPI , and tooth mobility ) , diabetes-related factors ( fasting blood glucose , postpr and ial blood glucose , and HbA1c ) , and in distribution of sociodemographic factors and health behaviors . In intervention group , plaque index , dental calculus index , bleeding index , and PHP index were reduced fairly and steadily from the baseline . There were significant differences in plaque index , dental calculus index , bleeding index , PHP index , and Russel 's periodontal index between the two groups at sixth month after adjusted for baseline status . Conclusion Intensive oral hygiene care can persistently improve oral inflammation status and could slow periodontal deterioration A controlled cross-sectional study with the aim of study ing oral health in patients with type 2 diabetes was carried out in a health care district in Sweden . The study included 102 r and omly sample d diabetic patients and 102 age- and gender-matched non-diabetic subjects from the same geographical area , treated at the same Public Dental Service clinics . Oral conditions were measured at clinical and X-ray examinations . Diabetes-related variables were extracted from medical records . Diabetic patients suffered from xerostomia ( dry mouth ) to a significantly higher degree than non-diabetic controls did ( 53.5 vs. 28.4 % ; P=0.0003 ) . Sites with advanced periodontitis were more frequent in the diabetic group ( P=0.006 ) as were initial caries lesions ( P=0.02 ) . Diabetic subjects showed a greater need of periodontal treatment ( P=0.05 ) , caries prevention ( P=0.002 ) and prosthetic corrections ( P=0.004 ) . Diabetes duration or metabolic control of the disease was not related to periodontal status . However , patients with longer duration of diabetes had more manifest caries lesions ( P=0.05 ) as had those on insulin treatment when compared with patients on oral/diet or combined treatment ( P=0.0001 ) . The conclusion is that individuals with type 2 diabetes in some oral conditions exhibited poorer health . Close collaboration between the patient , the primary health care and oral health professionals could be a way of improving the diabetic patient 's general and oral health Abstract Objective : To examine the value of glycated haemoglobin ( HbA1c ) concentration , a marker of blood glucose concentration , as a predictor of death from cardiovascular and all causes in men . Design : Prospect i ve population study . Setting : Norfolk cohort of European Prospect i ve Investigation into Cancer and Nutrition ( EPIC-Norfolk ) . Subjects : 4662 men aged 45 - 79 years who had had glycated haemoglobin measured at the baseline survey in 1995 - 7 who were followed up to December 1999 . Main outcome measures : Mortality from all causes , cardiovascular disease , ischaemic heart disease , and other causes . Results : Men with known diabetes had increased mortality from all causes , cardiovascular disease , and ischaemic disease ( relative risks 2.2 , 3.3 , and 4.2 , respectively , P < 0.001 independent of age and other risk factors ) compared with men without known diabetes . The increased risk of death among men with diabetes was largely explained by HbA1c concentration . HbA1c was continuously related to subsequent all cause , cardiovascular , and ischaemic heart disease mortality through the whole population distribution , with lowest rates in those with HbA1c concentrations below 5 % . An increase of 1 % in HbA1c was associated with a 28 % ( P<0.002 ) increase in risk of death independent of age , blood pressure , serum cholesterol , body mass index , and cigarette smoking habit ; this effect remained ( relative risk 1.46 , P=0.05 adjusted for age and risk factors ) after men with known diabetes , a HbA1c concentration ≥7 % , or history of myocardial infa rct ion or stroke were excluded . 18 % of the population excess mortality risk associated with a HbA1c concentration ≥5 % occurred in men with diabetes , but 82 % occurred in men with concentrations of 5%-6.9 % ( the majority of the population ) . Conclusions : Glycated haemoglobin concentration seems to explain most of the excess mortality risk of diabetes in men and to be a continuous risk factor through the whole population distribution . Preventive efforts need to consider not just those with established diabetes but whether it is possible to reduce the population distribution of HbA1c through behavioural means Despite long-st and ing critiques of the conduct of underpowered clinical trials , the practice not only remains widespread , but also has garnered increasing support . Patients and healthy volunteers continue to participate in research that may be of limited clinical value , and authors recently have offered 2 related arguments to support the validity and value of underpowered clinical trials : that meta- analysis may " save " small studies by providing a means to combine the results with those of other similar studies to enable estimates of an intervention 's efficacy , and that although small studies may not provide a good basis for testing hypotheses , they may provide valuable estimates of treatment effects using confidence intervals . In this article , we examine these arguments in light of the distinctive moral issues associated with the conduct of underpowered trials , the disclosures that are owed to potential participants in underpowered trials so they may make autonomous enrollment decisions , and the circumstances in which the prospect s for future meta-analyses may justify individually underpowered trials . We conclude that underpowered trials are ethical in only 2 situations : small trials of interventions for rare diseases in which investigators document explicit plans for including their results with those of similar trials in a prospect i ve meta- analysis , and early-phase trials in the development of drugs or devices , provided they are adequately powered for defined purpose s other than r and omized treatment comparisons . In both cases , investigators must inform prospect i ve subjects that their participation may only indirectly contribute to future health care benefits Measurement of glycohemoglobin ( GHb ) is widely used in patients with diabetes mellitus as a monitor of long-term glycemic control (1)(2)(3 ) . In addition , prospect i ve r and omized clinical trials , most notably the Diabetes Control and Complications Trial ( DCCT ) and the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) , have demonstrated that GHb is a measure of the risk for the development of diabetes complications (4)(5 ) . GHb is therefore an integral component of the management of patients with diabetes . GHb comprises several different hemoglobin-glucose adducts , including hemoglobin A1a ( HbA1a ) , HbA1b , and HbA1c . More than 30 different methods are commercially available to measure GHb . Together these factors have led to considerable variation in reference intervals and results reported by different laboratories . When the DCCT was published in 1993 , the lack of st and ardization of GHb methods produced very wide variability among methods , with values ranging from 4.0 % to 8.1 % on the same blood sample ( 6 ) . In the United States , the NGSP ( previously known as the National Glycohemoglobin St and ardization Program ) has reduced interlaboratory variation ( 7 ) . Using a st and ardization process based on the DCCT reference method , the NGSP has promoted a dramatic improvement in comparability of GHb values among laboratories ( 3 ) . Data from the 2003 GH2 survey from the College of American Pathologists indicated that ≥98 % of participating laboratories use NGSP-certified methods and report results as HbA1c or HbA1c equivalents ( 3 ) . Analogous st and ardization programs in Sweden and Japan (8)(9 ) , established to harmonize GHb results , have also reduced variability among GHb results . More recently , the IFCC Working Group on HbA1c St and ardization prepared primary reference material s of pure HbA1c and HbA0 and developed a reference method for HbA1c ( 10 ) . They defined HbA1c as the stable adduct of glucose to the N-terminal valine of the β-chain of hemoglobin . In the reference method , hemoglobin is cleaved Background Periodontitis is a common , chronic inflammatory disease caused by gram-negative bacteria leading to destruction of tissues supporting the teeth . Epidemiological studies have consistently shown increased frequency , extent and severity of periodontitis among diabetic adults . More recently , some controlled clinical trials have also suggested that periodontal treatment could improve glycaemic control in diabetic patients . However current evidence does not provide sufficient information on which to confidently base any clinical recommendations . The main objective of this clinical trial is to assess whether periodontal treatment could lead to a decrease in glycated haemoglobin levels in metabolically unbalanced diabetic patients suffering from chronic periodontitis . Methods The DIAPERIO trial is an open-label , 13-week follow-up , r and omized , controlled trial . The total target sample size is planned at 150 participants , with a balanced ( 1:1 ) treatment allocation ( immediate treatment vs delayed treatment ) . Periodontal treatment will include full mouth non-surgical scaling and root planing , systemic antibiotherapy , local antiseptics ( chlorhexidine 0.12 % ) and oral health instructions . The primary outcome will be the difference in change of HbA1c between the two groups after the 13-weeks ' follow-up . Secondary outcomes will be the difference in change of fructosamine levels and quality of life between the two groups . Discussion The DIAPERIO trial will provide insight into the question of whether periodontal treatment could lead to an improvement in glycaemic control in metabolically unbalanced diabetic patients suffering from periodontitis . The results of this trial will help to provide evidence -based recommendations for clinicians and a draft framework for design ing national health policies . Trial registration Current Controlled Trials IS RCT Periodontal disease is a common infection-induced inflammatory disease among individuals suffering from diabetes mellitus . The purpose of this study was to assess the effects of treatment of periodontal disease on the level of metabolic control of diabetes . A total of 113 Native Americans ( 81 females and 32 males ) suffering from periodontal disease and non-insulin dependent diabetes mellitus ( NIDDM ) were r and omized into 5 treatment groups . Periodontal treatment included ultrasonic scaling and curettage combined with one of the following antimicrobial regimens : 1 ) topical water and systemic doxycycline , 100 mg for 2 weeks ; 2 ) topical 0.12 % chlorhexidine ( CHX ) and systemic doxycycline , 100 mg for 2 weeks ; 3 ) topical povidone-iodine and systemic doxycycline , 100 mg for 2 weeks ; 4 ) topical 0.12 % CHX and placebo ; and 5 ) topical water and placebo ( control group ) . Assessment s were performed prior to and at 3 and 6 months after treatment and included probing depth ( PD ) , clinical attachment level ( CAL ) , detection of Porphyromonas gingivalis in subgingival plaque and determination of serum glucose and glycated hemoglobin ( HbA1c ) . After treatment all study groups showed clinical and microbial improvement . The doxycycline-treated groups showed the greatest reduction in probing depth and subgingival Porphyromonas gingivalis compared to the control group . In addition , all 3 groups receiving systemic doxycycline showed , at 3 months , significant reductions ( P < or = 0.04 ) in mean HbA1c reaching nearly 10 % from the pretreatment value . Effective treatment of periodontal infection and reduction of periodontal inflammation is associated with a reduction in level of glycated hemoglobin . Control of periodontal infections should thus be an important part of the overall management of diabetes mellitus patients BACKGROUND Periodontitis is a major cause of tooth loss among adults . Several studies have shown a possible systemic impact of periodontal infection , including poor glycemic control in patients with diabetes . Recently , photodynamic therapy ( PDT ) was used to successfully treat periodontal infection . PDT provides a broad spectrum antimicrobial efficacy with no local or systemic side effects . The objective of this study was to examine the effect of the adjunctive use of PDT on periodontal status and glycemic control of patients with diabetes and periodontitis . METHODS Forty-five patients with type 2 diabetes and moderate to severe chronic periodont Output:
There is some evidence of improvement in metabolic control in people with diabetes , after treating periodontal disease .
MS2_1shot55
***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: Tamoxifen is associated with a reduced risk of coronary heart disease ( CHD ) . However , there are few reports on long-term effects . Using data from a large Swedish r and omized trial of 5 and 2 years of adjuvant tamoxifen in women with early breast cancer , we here present results on morbidity and mortality from cardiac diseases during treatment and long-term after treatment . A total of 4,150 patients were breast cancer recurrence-free after 2 years . Data from the Swedish National Hospital Discharge Registry combined with information from the Swedish Cause of Death Registry were used to define events of disease . Hazard ratios were estimated using Cox regression . Patients assigned to 5 years in comparison with 2 years of postoperative tamoxifen experienced a reduced incidence of CHD [ hazard ratio ( HR ) , 0.83 ; 95 % CI 0.70–1.00 ] , especially apparent during the active treatment period ( HR 0.65 ; 95 % CI 0.43–1.00 ) . The mortality from CHD was significantly reduced ( HR 0.72 ; 95 % CI 0.53–0.97 ) . During the active treatment , the morbidity of other heart diseases was also significantly reduced ( HR 0.40 ; 95 % CI 0.25–0.64 ) but not after treatment stopped ( HR 1.06 ; 95 % CI 0.87–1.30 ) . Similar results were seen for both heart failure and atrial fibrillation/flutter . As compared to 2 years of therapy , 5 years of postoperative tamoxifen therapy prevents CHD as well as other heart diseases . The risk reduction is most apparent during the active treatment period , and later tends to diminish Abstract Objective : To determine any cardiac or vascular morbidity associated with long term treatment with tamoxifen given after mastectomy for primary breast cancer . Design : Cohort study using linkage between data base of a r and omised trial and statistics of Scottish hospital in patients to identify episodes of cardiac and vascular morbidity . Setting : NHS hospitals in Scotl and . Subjects : 1312 women who had undergone mastectomy for breast cancer and who were r and omised either to a treatment group to receive adjuvant tamoxifen or to a control group to be given tamoxifen only on first relapse of disease . Maximum duration of tamoxifen treatment was 14 years . Total woman years of follow up were 9943 . Main outcome measures : R and omised and observational comparisons of risk ( expressed as hazard ratios ) of myocardial infa rct ion , other cardiac event , cerebrovascular disease , or thromboembolic event according to treatment allocated and between non-users , former users , and current users of tamoxifen . Results : Use of tamoxifen was associated with lower rates of myocardial infa rct ion . Hazard ratio for women in control group was 1.92 ( 95 % confidence interval 0.99 to 3.73 ) compared with women allocated to adjuvant treatment . The association was stronger for current use : hazard ratio for non-users was 3.49 ( 1.52 to 8.03 ) compared with current users . Current users of tamoxifen , however , had higher rates of thromboembolic events : hazard ratio for non-users was 0.40 ( 0.18 to 0.90 ) compared with current users . Conclusions : Our results provide further evidence that tamoxifen reduces the risk of myocardial infa rct ion . Thromboembolic events should be carefully monitored in trials of tamoxifen , particularly those of prophylactic treatment , in which tamoxifen is given to healthy women www.thelancet.com/oncology Vol 17 July 2016 e275 Postmenopausal women with hormone-receptor-positive early breast cancer could benefit by extending adjuvant therapy with aromatase inhibitors from 5 years to 10 years , a new double-blind , phase 3 , placebo-controlled trial study suggests . Paul Goss ( Massachusetts General Hospital Cancer Centre , MA , USA ) and colleagues ’ study enrolled postmenopausal women with primary breast cancer who had received 4·5 - 6·0 years of adjuvant therapy with an aromatase inhibitor , most of whom had previously been treated with tamoxifen and who were disease-free at the time of enrolment . 1918 patients were r and omly assigned to receive 25 mg letrozole or placebo daily for a further 5 years . At a median follow-up of 6·3 years , 67 ( 7 % ) of 959 patients in the letrozole group had disease recurrence or contralaleral breast cancer compared with 98 ( 10 % ) of 959 patients in the placebo group . 5-year disease-free survival ( the primary endpoint ) was 95 % ( 95 % CI 93–96 ) in the letrozole group and 91 % ( 89–93 ) in the placebo group , ( 0·66 hazard ratio [ 95 % CI 0·48–0·91 ] ; p=0·01 ) . 5-year overall survival was similar between groups : 93 % ( 95 % CI 92–95 ) with letrozole and 94 % ( 92–95 ) with placebo ( HR 0·97 , 95 % CI 0·73–1·28 ; p=0·83 ) . Except for bone-related toxic eff ects , which occurred more frequently in the letrozole group compared with the placebo group , the toxic eff ects were similar . Commenting on the study , Miguel Martin ( Hospital General Universitario Gregorio Maranon , Madrid , Spain ) , said that “ this [ study ] is very relevant clinical ly , is practice changing , and should be discussed with our patients as a new option , taking into consideration the pros ( reduction of contralateral breast cancers and local-regional and distant metastases ) and the cons ( lack of survival benefi t and negative bone eff ects of letrozole ) of the therapy . ” He continued , “ Avoiding a contralateral breast cancer , regardless of the lack of benefit on survival , is a goal by itself . ” Goss told The Lancet Oncology , “ We are conducting deeper analyses to determine which patients should or should not continue [ alignment therapy ] . We have reduced recurrences or occurrences by 34 % which is clinical ly very significant . ” However , he concluded , “ Extending a therapy clinical ly for 5 years is important and my opinion is that ... a sober judgment by properly appointed guideline committees is needed ” before such changes are instituted Introduction Extended adjuvant endocrine therapy for breast cancer with aromatase inhibitors may potentially alter the lipid profile of postmenopausal patients and thus increase the risk of developing cardiovascular disease . In this study , a sub protocol of the ATENA ( Adjuvant post-Tamoxifen Exemestane versus Nothing Applied ) trial , we compared the effect of the steroidal aromatase inactivator exemestane on the lipid profile of postmenopausal patients with operable breast cancer , in the adjuvant setting , with that of observation alone after completion of 5 to 7 years of primary treatment with tamoxifen . Methods In this open-label , r and omized , parallel-group study , 411 postmenopausal patients with operable breast cancer , who had been treated with tamoxifen for 5 to 7 years , were r and omized to either 5 additional years of exemestane ( 25 mg/day ; n = 211 ) or observation only ( n = 200 ) . Assessment s of total cholesterol ( TC ) , high-density lipoprotein ( HDL ) , low-density lipoprotein ( LDL ) , and total serum triglycerides ( TRG ) were performed at baseline and then during each follow-up visit , performed at either 6 or 12 months , according to the center 's clinical practice , until completing 24 months in the study . Results TC and LDL levels increased significantly across time for both arms ; TC increase was more pronounced for the observation arm , and that was sustained up to 24 months . HDL levels decreased significantly across time for the exemestane arm , whereas no significant change was detected across time for the observation arm . Triglyceride levels decreased significantly across time on both arms , with no difference detected in changes from baseline between the exemestane and the observation arms . Conclusions Exemestane lacks the beneficial effect of tamoxifen on lipids ; however , sequential adjuvant treatment with exemestane in postmenopausal breast cancer patients after cessation of 5 to 7 years of tamoxifen does not appear to alter the lipid profile significantly compared with that of an observational arm . Trial Registration Clinical Trials.gov ID : NCT00810706 PURPOSE This study analyzes the long-term results and causes of death in elderly women with node-positive breast cancer who participated in a double-blind adjuvant trial that compared tamoxifen with placebo to determine the benefit of 2 years of treatment . PATIENTS AND METHODS One hundred eighty-one women 65 to 84 years old were given 20 mg of tamoxifen or placebo daily for 2 years after stratification by estrogen receptor status , tumor size , and degree of lymph node involvement . Approximately 30 % of patients were older than 70 years and 20 % were older than 75 years . Eighty-five percent were estrogen receptor-positive . Median follow-up was 10 years . RESULTS Among the 168 eligible patients , there have been 98 recurrences ( 59 placebo v 39 tamoxifen ) , with reduced distant and bone-only first sites in patients treated with tamoxifen . Median time to failure was 4.4 years for placebo versus 7.4 years for tamoxifen ( log-rank P = .001 ) . A similar number of new nonbreast cancers occurred in each arm ( seven placebo v six tamoxifen ) , but a reduced number of opposite-breast cancers ( five placebo v one tamoxifen ) was noted . Overall , there were 102 deaths ( 57 placebo v 45 tamoxifen ) . Median survivals were 8.0 years with placebo and 8.5 years with tamoxifen ( log-rank P = .063 ) ; 50 % of the tamoxifen patients and 33 % of the placebo patients are still alive . Sixty-one percent of the deaths were reported to have been caused by breast cancer recurrence , 4 % by other cancers , and 22 % by the sequelae of non-cancer-related illness , with equal distributions for cardiovascular and cerebrovascular disease . There was no increase in the number of endometrial or other types of cancer , or thrombotic or orthopedic complications in this older group . CONCLUSION Tamoxifen currently is the treatment of choice for elderly women with breast cancer . It extends the time to treatment failure by 3 years and reduces the number of recurrences , deaths , distant and bone-only first recurrences , and second breast cancers BACKGROUND Adjuvant tamoxifen therapy for breast cancer has been given for a period of several years . Cardiovascular diseases increased in incidence rapidly in women older than 60 years . Favorable changes in cardiovascular risk factors have been seen with 2 years of tamoxifen therapy , and lower rates of myocardial infa rct ion and of hospitalization for heart disease have been observed in tamoxifen-treated women . PURPOSE We sought to evaluate changes in risk factors for cardiovascular diseases in postmenopausal women after therapy with tamoxifen for 5 years . METHODS Five years after their initial entry in a 2-year r and omized , placebo-controlled toxicity study , we re-examined 62 of the original 140 disease-free , axillary node-negative postmenopausal breast cancer patients . These 62 patients were women available for study because they had not suffered major illness and had continued on either the tamoxifen or no-tamoxifen regimen to which they had been originally r and omly assigned for the entire 5 years . Patient and control blood sample s were analyzed for total cholesterol , low-density lipoprotein ( LDL ) cholesterol , high-density lipoprotein ( HDL ) cholesterol and subfractions , triglycerides , apolipoprotein AI , apolipoprotein B , lipoprotein(a ) , fibrinogen , glucose , and platelets . RESULTS At base line for all measurements except atherogenic lipoprotein [ lipoprotein(a ) ] , the 30 long-term tamoxifen recipients and the 32 long-term no-tamoxifen recipients were not significantly different . After 5 years , levels of total serum cholesterol ( P < .001 ) , LDL cholesterol ( P < .001 ) , and lipoprotein(a ) ( P = .001 ) were significantly lower , and apolipoprotein AI levels were significantly higher ( P < .001 ) in the tamoxifen-treated group compared with the no-tamoxifen group . Apolipoprotein B levels increased to a greater extent in the no-tamoxifen than in the tamoxifen group ( P < .001 ) . After 5 years , fibrinogen level decrease and triglyceride level increases in the tamoxifen group compared with the no-tamoxifen group were of borderline statistical significance and HDL cholesterol levels were not different in the two groups . CONCLUSION Favorable changes in lipid , lipoprotein , and fibrinogen levels seen early in tamoxifen therapy in postmenopausal women persist with treatment of 5 years . IMPLICATION S The types and magnitude of changes in cardiovascular risk factors seen here with tamoxifen are similar to a certain extent with those seen with estrogen supplements . Further risk-factor and ethnic-group data are needed to estimate the magnitude of expected benefits of tamoxifen treatment on incidence of heart disease PURPO Output:
Conclusions The increased risk of cardiovascular events with AIs relative to tamoxifen is likely the result of cardioprotective effects of the latter .
MS2_1shot56
***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 and safety of a low molecular weight heparin ( LMWH ) given as a single predialysis bolus injection was compared to st and ard heparin ( SH ) administered with a continuous infusion in a r and omized , 6 month , open follow-up study in 70 patients undergoing hemodialysis . No major bleeding or adverse events were encountered during a total of 4,000 dialysis procedures ( 2,000 with LMWH ) . Clot formation in the extracorporeal circuit was minimal and comparable between the groups at 4 , 13 , and 26 weeks after the start of the study . No accumulation of LMWH anticoagulant activity was noted . It is concluded that the use of LMWH is a safe , effective , and less complex alternative to SH STUDY OBJECTIVE To evaluate the relationship between impaired renal function and antifactor Xa activity in patients receiving dalteparin . DESIGN Open-label prospect i ve study . SETTING Inpatient and outpatient units of a large teaching hospital . SUBJECTS Eleven patients with renal impairment and 11 control subjects with normal renal function . INTERVENTION Subjects were administered dalteparin at a dosage of approximately 100 U/kg subcutaneously every 12 hours . MEASUREMENTS AND MAIN RESULTS Peak steady-state antifactor Xa levels were compared between the groups . Mean + /- SD levels were similar for patients with and without renal impairment : 0.47 + /- 0.25 and 0.55 + /- 0.20 U/ml , respectively . A test of equivalency showed statistical significance ( p=0.0001 ) . CONCLUSION No meaningful difference in peak antifactor Xa activity was found between patients with renal impairment and control subjects . To the extent that peak antifactor Xa levels can be used as markers for adjusting doses of dalteparin , these data suggest that such adjustments are not necessary for patients with renal impairment who are not receiving dialysis BACKGROUND Use of low-molecular-weight heparins is avoided in patients with renal insufficiency because of concerns about an excessive anticoagulant effect and increased bleeding risk . To challenge this premise , we evaluated if deep vein thrombosis ( DVT ) prophylaxis with dalteparin sodium confers an excessive anticoagulant effect in critically ill patients with severe renal insufficiency . METHODS We conducted a multicenter , single-arm clinical trial of DVT prophylaxis with dalteparin sodium , 5000 IU once daily in critically ill patients with a creatinine clearance lower than 30 mL/min ( to convert to milliliters per second , multiply by 0.0167 ) . Bioaccumulation was defined by a trough anti-Xa level higher than 0.40 IU/mL , measured twice weekly . The pharmacodynamic properties of dalteparin were assessed by serial anti-Xa levels measured on days 3 , 10 , and 17 . RESULTS We enrolled 156 patients with a mean ( SD ) creatinine clearance of 18.9 ( 6.5 ) mL/min ; 18 were excluded because they died or were discharged before testing ( n = 3 ) or had prevalent DVT ( n = 15 ) . Of 138 patients included , the median ( interquartile range [ IQR ] ) duration of dalteparin exposure was 7 ( 4 - 12 ) days . In 120 patients who had at least 1 trough anti-Xa level ( 427 total measurements ) , no patient had bioaccumulation ( 0 % ; 95 % confidence interval [ CI ] : 0%-3.0 % ) ; the median ( IQR ) trough anti-Xa level was undetectable ( < 0.10 IU/mL [ < 0.10 to < 0.10 IU/mL ] ) . Based on serial measurements , peak anti-Xa levels were 0.29 to 0.34 IU/mL and trough levels were lower than 0.06 IU/mL. Deep vein thrombosis occurred in 7 of 138 patients ( 5.1 % ; 95 % CI , 2.5%-10.1 % ) ; major bleeding occurred in 10 patients ( 7.2 % ; 95 % CI , 4.0%-12.8 % ) , all with trough anti-Xa levels of 0.18 IU/mL or lower . CONCLUSION In critically ill patients with severe renal insufficiency , DVT prophylaxis with dalteparin sodium , 5000 IU once daily , is not associated with an excessive anticoagulant effect due to drug bioaccumulation and is unlikely to contribute to bleeding . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00138099 BACKGROUND Enoxaparin dosage for obese patients and patients with renal impairment remains controversial . OBJECTIVE To compare anti-factor Xa activity ( anti-Xa ) among obese and renal impairment patients to patients with healthy weight and adequate renal function . DESIGN Open , prospect i ve , nonr and omized clinical trial . SETTING A major community teaching hospital . PATIENTS A total of 233 patients with prescription of enoxaparin . INTERVENTIONS Enoxaparin 1.5 mg/kg once daily or 1 mg/kg twice daily except those on dialysis , who received 75 % of the dose . MEASUREMENTS Anti-Xa was measured 4 h post-injection on day 2 or 3 . RESULTS Mean ( 95 % confidence interval ( 95 % CI ) ) anti-Xa was equal to 1.14 IU/mL ( 1.07 - 1.21 ) and 1.14 IU/mL ( 1.08 - 1.20 ) among patients who received one ( n=92 ) and two injections ( n=122 ) per day , respectively . Anti-Xa increases with body mass index ( BMI ) ( 0.01 IU/mL for each kg/m2 ; 95 % CI : 0.002 - 0.017 ) , but the increase is insufficient to reach supratherapeutic anti-Xa . Anti-Xa decreases with higher creatinine clearance ( CrCl ) ( -0.003 IU/mL for each mL/min ; 95 % CI : -0.006 to -0.001 ) . On the twice-daily regimen , this is sufficient to reach supratherapeutic anti-Xa . The odd ratio ( OR ) ( 95 % CI ) of having a nontherapeutic anti-Xa is equal to 2.28 ( 1.25 - 4.16 ) when enoxaparin is administered twice daily and to 3.03 ( 1.16 - 7.86 ) among severe renal impairment patients ( < or = 30 mL/min ) . CONCLUSIONS Based on Anti-Xa , no dosage adjustments are required in obese patients . In renally impaired patients , adjustments may be necessary when enoxaparin is administered twice daily Enoxaparin is a low molecular weight heparin ( LMWH ) that has been shown to be effective in deep vein thrombosis , pulmonary embolism , and unstable angina . Because renal function plays an important role in the clearance of LMWH , the authors sought to investigate the effect of renal function on enoxaparin . This prospect i ve multiple-dose study evaluated 18 patients with varying degrees of renal function initiated on enoxaparin 1 mg/kg subcutaneously every 12 hours . Peak blood levels of anti-Xa concentrations were obtained 4 + /- 0.5 hours postdose after receiving at least three doses of enoxaparin . The median antifactor Xa levels were higher in patients with creatinine clearance ( CLCr ) < or = 30 mL/min compared to CLCr > or = 31 mL/min ( 1.34 IU/mL vs. 0.91 IU/mL , respectively , p < 0.05 ) . A linear correlation was established between creatinine clearance and anti-Xa concentrations ( p < 0.0005 ) . On the basis of the data , the authors believe that a dose adjustment is necessary in patients receiving repeated doses of enoxaparin with CLCr < or = 30 mL/min Abstract Objectives : Too few very elderly patients with an age-related renal impairment are included in clinical trials . We conducted a study in order to evaluate the safety profile of tinzaparin , a low molecular weight heparin ( LMWH ) , given at a curative dose ( 175 IU/kg once daily ) in very elderly patients treated for up to 30 days . Setting : An 800-bed geriatric hospital . Design : A 1-year prescribing study . Patients : Consecutive in- patients older than age 70 , whose creatinine clearance was above 20 ml/min , and requiring full anticoagulation with LMWH were included . Measurements : Safety parameters ( major bleeding/heparin-induced thrombocytopenia/death ) were recorded . Plasma anti-Xa activity levels were regularly measured throughout the treatment period . Results : Two-hundred in- patients , mean age 85.2 ± 6.9 years ( 70 to 102 ) , mean creatinine clearance 51.2 ± 22.9 ml/min , were given tinzaparin . Six patients died during the treatment period : only one could be related to the anticoagulation treatment . Three major bleeding episodes ( 1.5 % ) were reported . Antithrombotic drug interactions likely contributed to the bleeding event in two of them . Heparin-induced thrombocytopenia was confirmed in two patients ( 1 % ) . No correlation was found between anti-Xa activity and creatinine clearance or age . Conclusions : Tinzaparin can be used safely at a curative dose in very elderly patients as long as ( i ) the accurate bodyweight-adjusted dose is given ; ( ii ) platelet counts and anti-Xa levels are regularly monitored and ; ( iii ) the interaction with other antithrombotic drugs is correctly managed Low-molecular-weight heparins ( LMWHs ) accumulate in patients with impaired renal function . As this accumulation depends on heparin chain length and subsequent reticulo-endothelial/renal elimination , LMWHs might have different pharmacodynamic profiles . The primary objective was to examine if any accumulation effect of two LMWHs , enoxaparin and tinzaparin , occurred after repeated administration of a prophylactic dose over eight days in elderly patients ( age > 75 years ) with creatinine clearance between 20 and 50 ml/min and body weight < 65Kg . Patients were openly r and omized to two groups ( enoxaparin 4,000 IU or tinzaparin 4,500 IU once daily ) . Anti-Xa was measured on day 1 and day 8 . Blood sample s were taken at 0 , 2 , 4 , 5 , 6 , 9 , 12 , 16 and 24 hours . The primary end point was the accumulation factor calculated as a ratio between the maximal anti-Xa activity on day 1 and day 8 . Fifty-five patients were included ( mean age 87.9 + /- 5.5 ) . The creatinine clearance was 34.7 + /- 11.4 ml/min ; the body weight was 52.3 + /- 8.6 kg . The accumulation factor defined was not significant for tinzaparin ( 1.05 , p = 0.29 ) while it was significantly enhanced for enoxaparin ( 1.22 , p < 0.0001 ) . In this pharmacodynamic study performed in elderly patients with impaired renal function , a statistically significant accumulation effect was observed after eight days of prophylactic treatment with enoxaparin but not with tinzaparin , which are two LMWHs with different chain lengths . Trials based on clinical end points should be conducted to evaluate the clinical relevance of these observations Background The safety and optimal use of prophylactic treatment with low-molecular-weight heparins in elderly patients with impaired renal function remain undefined . Methods The primary aim of this study was to analyse , in ‘ real life ’ , the influence of renal function , as assessed by Creatinine clearance ( CLcr ) , on the level of anti-Xa activity in medical hospitalised elderly patients receiving prophylactic dosages of enoxaparin . Consecutive hospitalised acutely ill medical patients aged ≥75 years receiving daily dosages of enoxaparin 4000IU for up to 10 days were prospect ively enrolled in two centres . Peak anti-Xa activity was measured at the beginning and during the course of therapy . Results One hundred and twenty-five patients ( 31 men , 94 women ) , mean age 87.5 ± 6.3 years , mean bodyweight 56.4±11.9 kg and mean CLcr 39.8 ± 16.1 mL/min , were enrolled in the study . The mean maximum anti-Xa activity ( day 1 to day 10 ) [ anti-Xamaxl – l0 ] was 0.64 ± 0.23 IU/mL ( range 0.24–1.50 IU/mL ) . Weak negative correlations were found between CLcr and anti-Xamax and between bodyweight and anti-Xamax . Mean anti-Xamax was slightly but significantly higher in patients with CLcr of 20–30 mL/min compared with patients with CLcr of 31–40,41–50 or 51–80 mL/min ( 0.72 versus 0.61 , 0.61 and 0.60 IU/ m Output:
Results For dalteparin and tinzaparin , no accumulation was observed . Enoxaparin , on the other h and , did lead to accumulation in patients with renal insufficiency , although not in patients undergoing renal replacement therapy . Bemiparin and certoparin also did show accumulation . Conclusions In this systematic review , we show that prophylactic dosages of tinzaparin and dalteparin are likely to be safe in patients with renal insufficiency and do not need dose reduction based on the absence of accumulation . However , prophylactic dosages of enoxaparin , bemiparin , and certoparin did show accumulation in patients with a creatinine clearance ( CrCl ) below 30 ml/min , and therefore , dose reduction is required . The differences in occurrence of accumulation seem to depend on the mean molecular weight of LMWHs
MS2_1shot57
***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: Delay in follow-up after an abnormal mammogram is associated with advanced disease stage , poorer survival , and increased anxiety . Despite the implementation of many patient navigator programs across the country , there are few published , peer- review ed studies documenting its effectiveness . We tested the effectiveness of a patient navigator in improving timeliness to diagnosis , decreasing anxiety , and increasing satisfaction in urban minority women after an abnormal mammogram . Women with suspicious mammograms were r and omly assigned to usual care ( N = 50 ) or usual care plus intervention with a patient navigator ( N = 55 ) . There were no demographic differences between the two groups . Women in the intervention group had shorter times to diagnostic resolution ( mean 25.0 vs. 42.7 days ; p = .001 ) , with 22 % of women in the control group without a final diagnosis at 60 days vs. 6 % in the intervention group . The intervention group also had lower mean anxiety scores ( decrease of 8.0 in intervention vs. increase of 5.8 in control ; p < .001 ) , and higher mean satisfaction scores ( 4.3 vs. 2.9 ; p < .001 ) . Patient navigation is an effective strategy to improve timely diagnostic resolution , significantly decrease anxiety , and increase patient satisfaction among urban minority women with abnormal mammograms Background We carried out this study to examine the health-related quality of life ( HRQOL ) of patients with advanced colorectal cancer treated with the oral fluoropyrimidine S-1 plus irinotecan ( CPT-11 ) . Methods HRQOL was assessed at baseline ( pretreatment ) and at 5-week intervals during treatment , using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR38 question naires . The HRQOL data for 12 preselected scales and 21 courses of treatment were then analyzed longitudinally . Results Thirty-seven patients completed the baseline and post-treatment HRQOL assessment s. Statistically significant differences between the baseline and post-treatment HRQOL scores were observed for the global QOL , social function , and pain scales ( all QLQ-C30 ) , as well as the body image , future perspective , gastrointestinal tract symptoms , weight loss , and chemotherapy side effects scales ( all QLQ-CR38 ) ; favorable post-treatment results were observed for all the scales except for body image and chemotherapy side effects , for which post-treatment deteriorations were observed . The changes in body image , future perspective , weight loss , and chemotherapy side effects were each greater than ten points and seemed clinical ly significant . Conclusion Combined treatment with S-1 plus CPT-11 result ed in an acceptable deterioration in HRQOL functioning and symptoms , compared with baseline levels OBJECTIVES This study investigated whether acculturation was associated with the receipt of clinical breast examinations and mammograms among Colombian , Ecuadorian , Dominican , and Puerto Rican women aged 18 to 74 years in New York City in 1992 . METHODS A bilingual , targeted , r and om-digit-dialed telephone survey was conducted among 908 Hispanic women from a population -based quota sample . Outcome measures included ever and recent use of clinical breast examinations and mammograms . Multivariate logistic regression models were used to assess the effect of acculturation on screening use . RESULTS When demographic , socioeconomic , and health system characteristics and cancer attitudes and beliefs were controlled for , women who were more acculturated had significantly higher odds of ever and recently receiving a clinical breast examination ( P < or = .01 ) and of ever ( P < or = .01 ) and recently ( P < or = .05 ) receiving a mammogram than did less acculturated women . For all screening measures , there was a linear increase in the adjusted probability of being screened as a function of acculturation . CONCLUSIONS Neighborhood and health system interventions to increase screening among Hispanic women should target the less acculturated BACKGROUND Case-control studies and a voluntary-based follow-up study have suggested that repeated screening with faecal-occult-blood ( FOB ) tests can lead to a reduction in mortality from colorectal cancer ( CRC ) . The aim of this r and omised study was to compare mortality rates after FOB tests every 2 years during a 10-year period with those of unscreened similar controls . METHODS 140,000 people aged 45 - 75 years lived in Funen , Denmark , in August , 1985 , and were considered for inclusion in our study . Before r and omisation we excluded individuals who had CRC or precursor adenomas and those who had taken part in a previous pilot study . R and omisation of 137,485 people in blocks of 14 allocated three per 14 to the screening group ( 30,967 ) , three per 14 to the control group ( 30,966 ) , and eight not to be enrolled in the study ( 75,552 ) . Controls were not told about the study and continued to use health-care facilities as normal . Hemoccult-II blood tests ( with dietary restrictions but without rehydration ) were sent to screening-group participants . Only those participants who completed the first screening round were invited for further screening -- five rounds of screening during a 10-year period . Participants with positive tests were asked to attend to full examination and were offered colonoscopy whenever possible . The primary endpoint was death from CRC . FINDINGS Of the 30,967 screening-group participants , 20,672 ( 67 % ) completed the first screening round and were invited for further screening ; more than 90 % accepted repeated screenings . During the 10-year study , 481 people in the screening group had a diagnosis of CRC , compared with 483 unscreened controls . There were 205 deaths attributable to CRC in the screening group , compared with 249 deaths in controls . CRC mortality , including deaths attributable to complications from CRC treatment , was significantly lower in the screening group than in controls ( mortality ratio 0.82 [ 95 % CI 0.68 - 0.99 ] ) p = 0.03 ) . INTERPRETATION Our findings indicate that biennial screening by FOB tests can reduce CRC mortality . This study is being continued to improve its statistical power and to assess the effect of the removal of more precursor adenomas in the screening-group participants than in controls on CRC incidence Cancer and its treatment are known to cause malnutrition in significant numbers of patients . Although a variety of contributory factors have been identified it is clear that the aetiology of malnutrition is complex and multifactorial . Taste aberrations are believed to be amongst the causative factors and to contribute to the development of food avoidance/aversion in affected patients . The study described investigates the incidence of food avoidance in a r and om sample of 72 patients undergoing cancer chemotherapy . The results show that 59 ( 82 % ) had avoided one or more foods since the instigation of treatment . The foods most commonly affected were coffee , tea , citrus fruit , chocolate and red meat . Changes were noted in the consumption of both sweet and salty foods . In terms of food avoidance no apparent relationships were demonstrated between its incidence and either the type of disease or the drugs used in therapy . In men , the pattern of avoidance showed no differences between the younger ( up to 49 years ) and older ( 50 years and older ) patients ; marked differences were observed between younger and older women . Although the foods avoided in general have little nutritional implication their omission may affect the quality of the patient 's life . Food avoidance per se may , however , affect nutritional status ; suggestions for overcoming its effects are made . The results of this study , obtained by subjective assessment of food acceptability , highlight the individual anture of food avoidance in affected patients and suggest that each must be individually assessed if appropriate nutritional advice is to be given Output:
Two broad findings emerged : ( 1 ) disgust appears to be promoting aversion to ( and avoidance of ) CRC screening , and ( 2 ) several known elicitors of disgust are widely apparent in CRC context s. CONCLUSIONS Disgust likely represents a key emotional substrate for avoidance among CRC patients , caregivers , and health professionals . Exposure therapies and mindfulness training may be well suited to treating disgust-generated avoidance .
MS2_1shot58
***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 propranolol and growth hormone ( GH ) have additive effects to combat burn-induced catabolism . SUMMARY BACKGROUND DATA Both GH and propranolol have been attributed anabolic properties after severe trauma and burn . It is conceivable that the two in combination would have additive effects . METHODS Fifty-six children with more than 40 % TBSA burns were r and omized to one of four anabolic regimens : untreated control , GH treatment , propranolol treatment , or combination GH plus propranolol therapy . Clinical treatment was identical for all groups . Resting energy expenditure was determined by indirect calorimetry and skeletal muscle protein kinetics were measured using stable amino acid isotope infusions before and after each anabolic regimen . RESULTS There were no differences in age , sex , or burn size between groups . Tachycardia and energy expenditure were decreased during propranolol treatment ( < .05 ) . The net balance of muscle protein synthesis and breakdown was improved during propranolol and GH plus propranolol treatment ( < .05 ) . There was no significant benefit of GH alone . No additive effect of combination therapy was seen . CONCLUSIONS Propranolol is a strongly anabolic drug during the early , hypercatabolic period after burn . No synergistic effect between propranolol and GH was identified BACKGROUND The catecholamine-mediated hypermetabolic response to severe burns causes increased energy expenditure and muscle-protein catabolism . We hypothesized that blockade of beta-adrenergic stimulation with propranolol would decrease resting energy expenditure and muscle catabolism in patients with severe burns . METHODS Twenty-five children with acute and severe burns ( more than 40 percent of total body-surface area ) were studied in a r and omized trial . Thirteen received oral propranolol for at least two weeks , and 12 served as untreated controls . The dose of propranolol was adjusted to decrease the resting heart rate by 20 percent from each patient 's base-line value . Resting energy expenditure and skeletal-muscle protein kinetics were measured before and after two weeks of beta-blockade ( or no therapy , in controls ) . Body composition was measured serially throughout hospitalization . RESULTS Patients in the control group and the propranolol group were similar with respect to age , weight , percentage of total body-surface area burned , percentage of body-surface area with third-degree burns , and length of time from injury to metabolic study . Beta-blockade decreased the heart rates and resting energy expenditure in the propranolol group , both as compared with the base-line values ( P<0.001 and P=0.01 , respectively ) and as compared with the values in the control group ( P=0.03 and P=0.001 , respectively ) . The net muscle-protein balance increased by 82 percent over base-line values in the propranolol group ( P=0.002 ) , whereas it decreased by 27 percent in the control group ( P not significant ) . The fat-free mass , as measured by whole-body potassium scanning , did not change substantially in the propranolol group , whereas it decreased by a mean ( + /-SE ) of 9+/-2 percent in the control group ( P=0.003 ) . CONCLUSIONS In children with burns , treatment with propranolol during hospitalization attenuates hypermetabolism and reverses muscle-protein catabolism Studies in children with burn injuries have demonstrated that propranolol improves metabolism and reduces muscle protein wasting . However , safety and efficacy in adults are less well established than in children . The purpose of this study was to determine safety of propranolol use in adult patients with burn injuries . Medical records were review ed for burn-injured adults receiving propranolol . Patients between 18 and 65 years old and with ≥20 % TBSA burn were included . Fifty-four patients met the criteria with mean age of 37 years and mean burn size of 38 % TBSA . Propranolol dosages ranged from 0.1 to 3.8 mg/kg/day , with an average maximum dosage of 0.61 mg/kg/day . Mean heart rate decreased by 25 % during 4 weeks . Seventy-two percent of patients experienced at least one episode of hypotension and 15 % experienced bradycardia . Propranolol doses were most frequently held for low blood pressure ; 32 % of patients had at least one dose held for hypotension . This retrospective analysis suggests that modest dosing of propranolol results in frequent episodes of hypotension or bradycardia . Our data suggest that adults do not tolerate the higher doses reported in a pediatric population . Despite potential beneficial anti-catabolic effects of propranolol , burn care providers must recognize potential iatrogenic hemodynamic effects of this intervention . Our data support the need for prospect i ve multicenter studies to delineate the safety and efficacy of propranolol in adult burn-injured patients Burn patients have the highest metabolic rate among critically ill or injured patients . Because propranolol decreases energy expenditure and muscle protein catabolism , in this study , we hypothesized that propranolol would improve healing process and decrease wound-healing time . This study was a double-blind r and omized clinical trial ; a total of 79 burn patients who referred to this center from January 2006 to January 2007 fulfilled the inclusion criteria . Thirty-seven patients were r and omly placed in propranolol group and 42 in control group . The propranolol group received propranolol orally with the dose of 1 mg/kg/d and maximum dose of 1.98 mg/kg/d given in six divided doses . This dose was adjusted to decrease the resting heart rate by 20 % from each patient ’s baseline value . The control group received placebo . The most common cause of burn in both groups was flame followed by flash . Patients with superficial burns in the propranolol group needed less time to heal for acceptable wound healing in superficial burns ( 16.13 ± 7.40 days vs 21.52 ± 7.94 days ; P = .004 ) . We also found that patients with deep burn injury needed less time to be ready for skin graft ( 28.23 ± 8.43 days vs 33.46 ± 9.17 days ; P = .007 ) when compared to that of the control group . The use of propranolol decreased the size of the burn wound that finally needed skin graft . Patients in the propranolol group with an average burn size of 31.42 % TBSA finally needed 13.75 % of TBSA skin graft compared with that of control patients with an average burn size of 33.61 % TBSA who needed 18.72 % of TBSA skin graft , and patients in the control group with an average burn size of 33.61 % TBSA finally needed 18.72 % of TBSA skin graft ( P = .006 ) . Patients in the propranolol group had a shorter hospital stay period than the control group ( 30.95 ± 8.44 days vs 24.41 ± 8.11 days ; P = .05 ) . Administration of propranolol , improved burn wound healing , and decreased healing time and hospital stay period . The use of propranolol decreased the surface area of wounds that needed to be skin grafted BACKGROUND Propranolol , a nonselective beta1 - 2 antagonist , attenuates hypermetabolism and catabolism in severely burned patients . However , recent data suggest that propranolol impairs immune function and enhances inflammation . The purpose of the present study was to determine the effect of propranolol administration on infection , sepsis , and inflammation in severely burned pediatric patients . PATIENTS A prospect i ve , intent-to-treat study was performed ; patient demographics ( age , gender , burn size , and mortality ) ; infectious episodes ( colony count greater then 10 ) ; and sepsis ( guidelines by the society of critical care medicine ) were determined . Hypermetabolic response was determined by resting energy expenditure ( REE ) , and the inflammatory response was determined by measuring serum cytokine expression . RESULTS Two hundred forty-five patients ( 143 controls , 102 propranolol ) were included into the study . There were no differences between the control and propranolol groups for age , gender distribution , burn size , third degree burn , and length of stay . Mortality was 6 % in the control group and 5 % in the propranolol group . Propranolol significantly decreased REE and predicted REE during acute hospital stay . Forty-three patients developed infections in the control group ( 30 % ) , whereas 21 developed infections in the propranolol group ( 21 % ) . The incidence of sepsis was 10 % for controls and 7 % for propranolol . Analysis of the cytokine expression profile in 20 patients in each group revealed that propranolol significantly decreased serum tumor necrosis factor and interleukin-1beta compared with controls ( p < 0.05 ) . CONCLUSION Propranolol treatment attenuates hypermetabolism and does not cause increased incidence of infection and sepsis Background Main contributors to adverse outcomes in severely burned pediatric patients are profound and complex metabolic changes in response to the initial injury . It is currently unknown how long these conditions persist beyond the acute phase post-injury . The aim of the present study was to examine the persistence of abnormalities of various clinical parameters commonly utilized to assess the degree hypermetabolic and inflammatory alterations in severely burned children for up to three years post-burn to identify patient specific therapeutic needs and interventions . Methodology /Principal Findings Patients : Nine-hundred seventy-seven severely burned pediatric patients with burns over 30 % of the total body surface admitted to our institution between 1998 and 2008 were enrolled in this study and compared to a cohort non-burned , non-injured children . Demographics and clinical outcomes , hypermetabolism , body composition , organ function , inflammatory and acute phase responses were determined at admission and subsequent regular intervals for up to 36 months post-burn . Statistical analysis was performed using One-way ANOVA , Student 's t-test with Bonferroni correction where appropriate with significance accepted at p<0.05 . Resting energy expenditure , body composition , metabolic markers , cardiac and organ function clearly demonstrated that burn caused profound alterations for up to three years post-burn demonstrating marked and prolonged hypermetabolism , p<0.05 . Along with increased hypermetabolism , significant elevation of cortisol , catecholamines , cytokines , and acute phase proteins indicate that burn patients are in a hyperinflammatory state for up to three years post-burn p<0.05 . Conclusions Severe burn injury leads to a much more profound and prolonged hypermetabolic and hyperinflammatory response than previously shown . Given the tremendous adverse events associated with the hypermetabolic and hyperinflamamtory responses , we now identified treatment needs for severely burned patients for a much more prolonged time BACKGROUND There is no direct evidence that beta-blockers improve mortality in burn victims . Beta-blockers attenuate hypermetabolic states in burned children , and perioperative use in elective adult cases has beneficial effects , which suggests that beta-blockers may also improve burn outcomes . However , beta-blockers decrease cardiac output and may decrease oxygen delivery , and theoretically may increase mortality . What is the effect of beta-blockers on healing time and mortality in burn patients ? METHODS This was a retrospective cohort study . We identified three cohorts of adult burn patients between 1996 and 2001 : all who were on beta-blockers ( BB ) before their injury ( PMH BB ) ; all who were initiated on BB during their hospitalization for management of hypertension or tachyarrhythmia ( HOSP BB ) ; and control , who were never treated with beta-blockers . For each patient in the PMH BB and HOSP BB groups , two patients were placed in the control cohort by matching age and total body surface area burn . Premorbid conditions such as diabetes , hypertension , cardiac disease , renal insufficiency , and diuretic and calcium channel blocker use were analyzed . Multivariate regression models were used to identify independent modifiers . RESULTS There were 21 PMH BB , 22 HOSP BB , and 86 control patients . All PMH BB patients remained on their BB regimen in the hospital . HOSP BB patients were initiated on beta-blockers at a mean of 8.8 days postinjury . There were no differences in age ( mean , 58 + /- 17 years ) , total body surface area burned ( mean , 14 + /- 12 % ) , or mechanism of injury among the cohorts . The mortality rate was 5 % for the PMH BB cohort , 27 % for the HOSP BB cohort , and 13 % for controls . The mean healing times were 51 + /- 29 days for PMH BB patients , 79 + /- 54 days for HOSP BB patients , and 60 + /- 39 for controls . In multivariate analyses , PMH BB was associated with a significant decrease in fatal outcome and healing time ( p < or = 0.05 compared with control ) . CONCLUSION Beta-blockers have the potential to improve adult burn outcomes . Postinjury treatment should be studied in a r and omized , clinical trial OBJECTIVE To determine if the cardi Output:
Occurrence of adverse events was not significantly different between the treated patients the and controls . Limited evidence suggests beneficial effects of propranolol after burn injury , and its use seems safe .
MS2_1shot59
***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 : An inadequate response to initial empirical treatment of community acquired pneumonia ( CAP ) represents a challenge for clinicians and requires early identification and intervention . A study was undertaken to quantify the incidence of failure of empirical treatment in CAP , to identify risk factors for treatment failure , and to determine the implication s of treatment failure on the outcome . Methods : A prospect i ve multicentre cohort study was performed in 1424 hospitalised patients from 15 hospitals . Early treatment failure ( < 72 hours ) , late treatment failure , and in-hospital mortality were recorded . Results : Treatment failure occurred in 215 patients ( 15.1 % ) : 134 early failure ( 62.3 % ) and 81 late failure ( 37.7 % ) . The causes were infectious in 86 patients ( 40 % ) , non-infectious in 34 ( 15.8 % ) , and undetermined in 95 . The independent risk factors associated with treatment failure in a stepwise logistic regression analysis were liver disease , pneumonia risk class , leucopenia , multilobar CAP , pleural effusion , and radiological signs of cavitation . Independent factors associated with a lower risk of treatment failure were influenza vaccination , initial treatment with fluoroquinolones , and chronic obstructive pulmonary disease ( COPD ) . Mortality was significantly higher in patients with treatment failure ( 25 % v 2 % ) . Failure of empirical treatment increased the mortality of CAP 11-fold after adjustment for risk class . Conclusions : Although these findings need to be confirmed by r and omised studies , they suggest possible interventions to decrease mortality due to CAP BACKGROUND Clinical trials yielded conflicting data about the benefit of adding systemic corticosteroids for treatment of community-acquired pneumonia . We assessed whether short-term corticosteroid treatment reduces time to clinical stability in patients admitted to hospital for community-acquired pneumonia . METHODS In this double-blind , multicentre , r and omised , placebo-controlled trial , we recruited patients aged 18 years or older with community-acquired pneumonia from seven tertiary care hospitals in Switzerl and within 24 h of presentation . Patients were r and omly assigned ( 1:1 ratio ) to receive either prednisone 50 mg daily for 7 days or placebo . The computer-generated r and omisation was done with variable block sizes of four to six and stratified by study centre . The primary endpoint was time to clinical stability defined as time ( days ) until stable vital signs for at least 24 h , and analysed by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00973154 . FINDINGS From Dec 1 , 2009 , to May 21 , 2014 , of 2911 patients assessed for eligibility , 785 patients were r and omly assigned to either the prednisone group ( n=392 ) or the placebo group ( n=393 ) . Median time to clinical stability was shorter in the prednisone group ( 3·0 days , IQR 2·5 - 3·4 ) than in the placebo group ( 4·4 days , 4·0 - 5·0 ; hazard ratio [ HR ] 1·33 , 95 % CI 1·15 - 1·50 , p<0·0001 ) . Pneumonia-associated complications until day 30 did not differ between groups ( 11 [ 3 % ] in the prednisone group and 22 [ 6 % ] in the placebo group ; odds ratio [ OR ] 0·49 [ 95 % CI 0·23 - 1·02 ] ; p=0·056 ) . The prednisone group had a higher incidence of in-hospital hyperglycaemia needing insulin treatment ( 76 [ 19 % ] vs 43 [ 11 % ] ; OR 1·96 , 95 % CI 1·31 - 2·93 , p=0·0010 ) . Other adverse events compatible with corticosteroid use were rare and similar in both groups . INTERPRETATION Prednisone treatment for 7 days in patients with community-acquired pneumonia admitted to hospital shortens time to clinical stability without an increase in complications . This finding is relevant from a patient perspective and an important determinant of hospital costs and efficiency . FUNDING Swiss National Science Foundation , Viollier AG , Nora van Meeuwen Haefliger Stiftung , Julia und Gottfried Bangerter-Rhyner Stiftung Objectives It has been suggested that statins have an effect on the modulation of the cytokine cascade and on the outcome of patients with community-acquired pneumonia ( CAP ) . The aim of this prospect i ve , r and omised , double-blind , placebo-controlled trial was to determine whether statin therapy given to hospitalised patients with CAP improves clinical outcomes and reduces the concentration of inflammatory cytokines . Setting A tertiary teaching hospital in Barcelona , Spain . Participants Thirty-four patients were r and omly assigned and included in an intention-to-treat analysis ( 19 to the simvastatin group and 15 to the placebo group ) . Intervention Patients were r and omly assigned to receive 20 mg of simvastatin or placebo administered in the first 24 h of hospital admission and once daily thereafter for 4 days . Outcome Primary end point was the time from hospital admission to clinical stability . The secondary end points were serum concentrations of inflammatory cytokines and partial pressure of arterial oxygen/fractional inspired oxygen ( PaO2/FiO2 ) at 48 h after treatment administration . Results The trial was stopped because enrolment was much slower than originally anticipated . The baseline characteristics of the patients and cytokine concentrations at the time of enrolment were similar in the two groups . No significant differences in the time from hospital admission to clinical stability were found between study groups ( median 3 days , IQR 2–5 vs 3 days , IQR 2–5 ; p=0.47 ) . No significant differences in PaO2/FiO2 ( p=0.37 ) , C reactive protein ( p=0.23 ) , tumour necrosis factor-α ( p=0.58 ) , interleukin 6 ( IL-6 ; p=0.64 ) , and IL-10 ( p=0.61 ) levels at 48 h of hospitalisation were found between simvastatin and placebo groups . Similarly , transaminase and total creatine kinase levels were similar between study groups at 48 h of hospitalisation ( p=0.19 , 0.08 and 0.53 , respectively ) . Conclusions Our results suggest that the use of simvastatin , 20 mg once daily for 4 days , since hospital admission did not reduce the time to clinical stability and the levels of inflammatory cytokines in hospitalised patients with CAP . Trial registration number IS RCT N91327214 Background : In the assessment of severity in community acquired pneumonia ( CAP ) , the modified British Thoracic Society ( mBTS ) rule identifies patients with severe pneumonia but not patients who might be suitable for home management . A multicentre study was conducted to derive and vali date a practical severity assessment model for stratifying adults hospitalised with CAP into different management groups . Methods : Data from three prospect i ve studies of CAP conducted in the UK , New Zeal and , and the Netherl and s were combined . A derivation cohort comprising 80 % of the data was used to develop the model . Prognostic variables were identified using multiple logistic regression with 30 day mortality as the outcome measure . The final model was tested against the validation cohort . Results : 1068 patients were studied ( mean age 64 years , 51.5 % male , 30 day mortality 9 % ) . Age ⩾65 years ( OR 3.5 , 95 % CI 1.6 to 8.0 ) and albumin < 30 g/dl ( OR 4.7 , 95 % CI 2.5 to 8.7 ) were independently associated with mortality over and above the mBTS rule ( OR 5.2 , 95 % CI 2.7 to 10 ) . A six point score , one point for each of Confusion , Urea > 7 mmol/l , Respiratory rate ⩾30/min , low systolic(<90 mm Hg ) or diastolic ( ⩽60 mm Hg ) Blood pressure ) , age ⩾65 years ( CURB-65 score ) based on information available at initial hospital assessment , enabled patients to be stratified according to increasing risk of mortality : score 0 , 0.7 % ; score 1 , 3.2 % ; score 2 , 3 % ; score 3 , 17 % ; score 4 , 41.5 % and score 5 , 57 % . The validation cohort confirmed a similar pattern . Conclusions : A simple six point score based on confusion , urea , respiratory rate , blood pressure , and age can be used to stratify patients with CAP into different management groups Background Community-acquired pneumonia ( CAP ) is generally considered a major cause of morbidity and mortality in the elderly . However , population -based data are very limited and its overall burden is unclear . This study assessed incidence and mortality from CAP among Spanish community-dwelling elderly . Methods Prospect i ve cohort study that included 11,240 individuals aged 65 years or older , who were followed from January 2002 until April 2005 . Primary endpoints were all-cause CAP ( hospitalised and outpatient ) and 30-day mortality after the diagnosis . All cases were radiographically proved and vali date d by checking clinical records . Results Incidence rate of overall CAP was 14 cases per 1,000 person-year ( 95 % confidence interval : 12.7 to 15.3 ) . Incidence increased dramatically by age ( 9.9 in people 65–74 years vs 29.4 in people 85 years or older ) , and it was almost double in men than in women ( 19.3 vs 10.1 ) . Hospitalisation rate was 75.1 % , with a mean length-stay of 10.4 days . Overall 30-days case-fatality rate was 13 % ( 15 % in hospitalised and 2 % in outpatient cases ) . Conclusion CAP remains as a major health problem in older adults . Incidence rates in this study are comparable with rates described in Northern Europe and America , but they largely doubled prior rates reported in other Southern European regions Objective To determine differences in aetiologies , initial antimicrobial treatment choices and outcomes in patients with nursing-home-acquired pneumonia ( NHAP ) compared with patients with community-acquired pneumonia ( CAP ) , which is a controversial issue . Methods Data from the prospect i ve multicentre Competence Network for Community-acquired pneumonia ( CAPNETZ ) data base were analysed for hospitalised patients aged ≥65 years with CAP or NHAP . Potential differences in baseline characteristics , comorbidities , physical examination findings , severity at presentation , initial laboratory investigations , blood gases , microbial investigations , aetiologies , antimicrobial treatment and outcomes were determined between the two groups . Results Patients with NHAP presented with more severe pneumonia as assessed by CRB-65 ( confusion , respiratory rate , blood pressure , 65 years and older ) score than patients with CAP but received the same frequency of mechanical ventilation and less antimicrobial combination treatment . There were no clinical ly relevant differences in aetiology , with Streptococcus pneumoniae the most important pathogen in both groups , and potential multidrug-resistant pathogens were very rare ( < 5 % ) . Only Staphylococcus aureus was more frequent in the NHAP group ( n=12 , 2.3 % of the total population , 3.1 % of those with microbial sampling compared with 0.7 % and 0.8 % in the CAP group , respectively ) . Short-term and long-term mortality in the NHAP group was higher than in the CAP group for patients aged ≥65 years ( 26.6 % vs 7.2 % and 43.8 % vs 14.6 % , respectively ) . However , there was no association between excess mortality and potential multidrug-resistant pathogens . Conclusions Excess mortality in patients with NHAP can not be attributed to a different microbial pattern but appears to result from increased comorbidities , and consequently , pneumonia is frequently considered and managed as a terminal event Background Age-related alterations in the clinical characteristics and performance of severity scoring systems for community-acquired pneumonia ( CAP ) are unknown . Methods Consecutive patients with CAP presenting to the emergency department were prospect ively studied . Patients were classified as younger adults ( age 18–64 years ) , elderly ( age 65–84 years ) and very old subjects ( age ≥85 years ) . Clinical characteristics , complications , outcomes and validity of the pneumonia severity index ( PSI ) and CURB-65 categories were compared across these three age categories . Results Analysis involved 348 ( 35.3 % ) younger adult patients , 438 ( 44.3 % ) elderly patients and 201 ( 20.0 % ) very old patients . Compared with younger adults , elderly and very old patients had a higher burden of comorbidities and a higher incidence of CAP-related complications . The 30-day mortality rate was 5.2 % in younger adults , 7.1 % in elderly patients and 9.5 % in very old patients . The area under the ROC curve ( AUCs ) for PSI were 0.87 ( 95 % CI 0.77 to 0.97 ) , 0.85 ( 95 % CI 0.803 to 0.897 ) and 0.69 ( 95 % CI 0.597 to 0.787 ) and Output:
Pneumococcal and influenza vaccination comprise one of the most important preventive approaches for CAP in the elderly
MS2_1shot60
***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 reliability of the road test performed by stroke patients . DESIGN Prospect i ve study of a 6-month predriving evaluation . SETTING Driving safety center in Belgium . PARTICIPANTS Thirty patients with sequelae of stroke . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Results of driving performance as judged by 2 assessors from the Center for Determination of Fitness to Drive and Car Adaptations ( CARA ) , in a car fitted with a video camera . A third assessor also evaluated all the video recordings . Interrater reliability was evaluated by comparing results from real-life performance and video recording , as judged by the CARA assessors and video judgments between CARA assessors and the third assessor . RESULTS Most subitems of the road test showed more than 80 % scoring agreement between the various evaluations . Intraclass correlation coefficients ( ICCs ) of the items varied from -.08 to 1.0 . The ICC of the overall performance was.62 when real-life scores were compared with video evaluations and .80 in video versus video comparison . CONCLUSION The reliability of assessing overall performance of stroke patients in the road test is moderately high and better when assessed using the same evidence . Yet , the reliability of some items needs further attention Background : Neurologically impaired persons seem to benefit from driving-training programs , but there is no convincing evidence to support this notion . The authors therefore investigated the effect of simulator-based training on driving after stroke . Methods : Eighty-three first-ever subacute stroke patients entered a 5-week 15-hour training program in which they were r and omly allocated to either an experimental ( simulator-based training ) or control ( driving-related cognitive tasks ) group . Performance in off-road evaluations and an on-road test were used to assess the driving ability of subjects pre- and post-training . Outcome of an official predriving assessment administered 6 to 9 months poststroke was also considered . Results : Both groups significantly improved in a visual and many neuropsychological evaluations and in the on-road test after training . There were no significant differences between both groups in improvements from pre- to post-training except in the “ road sign recognition test ” in which the experimental subjects improved more . Significant improvements in the three-class decision ( “ fit to drive , ” “ temporarily unfit to drive , ” and “ unfit to drive ” ) were found in favor of the experimental group post-training . Academic qualification and overall disability together determined subjects that benefited most from the simulator-based driving training . Significantly more experimental subjects ( 73 % ) than control subjects ( 42 % ) passed the follow-up official predriving assessment and were legally allowed to resume driving . Conclusions : Simulator-based driving training improved driving ability , especially for well educated and less disabled stroke patients . However , the findings of the study may have been modified as a result of the large number of dropouts and the possibility of some neurologic recovery unrelated to training This paper compares the predictive value of the cognitive test battery developed at the Stroke Research Unit , City Hospital , Nottingham with existing assessment procedures . Subjects were referred from 3 stroke units ( Mansfield , Nottingham and Lincoln ) . Those who had been driving in the three months before the stroke , a minimum of 10 weeks previously , and had a full driving licence were considered . After a road test in a dual controlled , automatic vehicle on a set route around public roads , subjects were grade d by the instructor into pass or fail groups . Subjects were then r and omly allocated into two groups , one of which was tested on the stroke drivers screening assessment . In this group scores from the three tasks were used to predict the likelihood of passing a road test . Details of the tests were sent to the subjects doctors with recommendations as to the fitness to drive . The control group was just instructed to request the advice of their general practitioner . After six months subjects were contacted to ascertain the decisions on fitness to drive . The two types of assessment , cognitive and st and ard procedure were compared to determine which assessment method agreed most closely with the performance on the road tests . The results indicate that the stroke drivers screening assessment correctly predicted road performance significantly better than the st and ard procedure and that this was not due to chance A representation and interpretation of the area under a receiver operating characteristic ( ROC ) curve obtained by the " rating " method , or by mathematical predictions based on patient characteristics , is presented . It is shown that in such a setting the area represents the probability that a r and omly chosen diseased subject is ( correctly ) rated or ranked with greater suspicion than a r and omly chosen non-diseased subject . Moreover , this probability of a correct ranking is the same quantity that is estimated by the already well-studied nonparametric Wilcoxon statistic . These two relationships are exploited to ( a ) provide rapid closed-form expressions for the approximate magnitude of the sampling variability , i.e. , st and ard error that one uses to accompany the area under a smoothed ROC curve , ( b ) guide in determining the size of the sample required to provide a sufficiently reliable estimate of this area , and ( c ) determine how large sample sizes should be to ensure that one can statistically detect differences in the accuracy of diagnostic techniques BACKGROUND As the number of older adult drivers increases , distinguishing safe from unsafe older adult drivers will become an increasing public health concern . We report on the medical and functional factors associated with vehicle crashes in a cohort of Alabama drivers , 55 years old and older . METHODS This prospect i ve study involved 174 older adults , on whom demographic , medical , functional , and physical performance data were collected in 1991 . Subjects were then followed through 1996 for incident vehicle crashes . RESULTS Sixty-one subjects experienced between one and four police-reported vehicle crashes during the study period . Following adjustment for age , race , days driven per week , and gender , Cox proportional-hazards models showed the following variables to be associated with crash involvement : reported difficulty with yardwork or light housework ( relative risk [ RR ] = 2.1 ; 95 % confidence interval [ CI ] 1.1 , 4.0 ; p = .02 ) , or opening ajar ( RR = 3 . 1 ; 95 % CI 1.4 , 6.7 ; p = .004 ) ; at least one crash before 1991 ( RR = 2.1 ; 95 % CI 1.2 , 3.7 ; p = .008 ) ; using hypnotic medication ( RR = 2.9 ; 95 % CI 1.3 , 6.6 ; p = .01 ) ; self-reported stroke or transient ischemic attack ( RR = 2.7 ; 95 % CI 1.1 , 6.6 ; p = .03 ) ; scoring within the depressed range on the Geriatric Depression Scale ( RR = 2.5 ; 95 % CI 1.1 , 6.0 ; p = .03 ) , and failing the useful field-of-view test ( RR = 1.9 ; 95 % CI 1.0 , 3.5 ; p = .05 ) . CONCLUSIONS Variables related to function , medication use , affect , neurological disease , and visuocognitive skills were associated with vehicle crash involvement in this cohort . Our findings suggest that multifactorial assessment s are warranted to identify at-risk older drivers OBJECTIVES We sought to determine the criterion validity of the Useful Field of View ( UFOV ) assessment and Stroke Drivers ' Screening Assessment ( SDSA ) through comparison to the results of on-road assessment . METHOD This was a prospect i ve study with people with stroke . Outcome measures used were UFOV , SDSA , and the results of on-road assessment . RESULTS Both the results on UFOV ( Divided Attention subtest , p<.01 ; Selective Attention subtest , p<.05 ) and SDSA ( p<.05 ) were significantly related to the recommendation from on-road assessment . The Divided Attention subtest of the UFOV had the highest sensitivity value ( 88.9 % ) . CONCLUSIONS UFOV and SDSA are valid assessment s of driving ability for stroke . The Divided Attention subtest of the UFOV can guide decision making of occupational therapists in stroke driver rehabilitation and in determining those who require further assessment on road because they pose a safety risk . Screening assists people with stroke to decide whether they are ready to have an on-road assessment Background . No long-term studies have been reported on the effect of training programs on driving after stroke . Objectives . The authors ’ primary aim was to determine the effect of simulator versus cognitive rehabilitation therapy on fitness-to-drive at 5 years poststroke . A second aim was to investigate differences in clinical characteristics between stroke survivors who resumed and stopped driving . Methods . In a previously reported r and omized controlled trial , 83 stroke survivors received 15 hours of simulator training ( n = 42 ) or cognitive therapy ( n = 41 ) . In this 5-year follow-up study , 61 participants were reassessed . Fitness-to-drive decisions were obtained from medical , visual , neuropsychological , and on-road tests ; 44 participants ( simulator group , n = 21 ; cognitive group , n = 23 ) completed all assessment s. The primary outcome measures were fitness-to-drive decision and current driving status . Results . The authors found that 5 years after stroke , 18 of 30 participants ( 60 % ) in the simulator group were considered fit to drive , compared with 15 of 31 ( 48 % ) in the cognitive group ( P = .36 ) ; 34 of 61 ( 56 % ) participants were driving . Current drivers were younger ( P = .04 ) , had higher Barthel scores ( P = .008 ) , had less comorbidity ( P = .01 ) , and were less severely depressed ( P = .02 ) than those who gave up driving . Conclusions . The advantage of simulator-based driving training over cognitive rehabilitation therapy , evident at 6 months poststroke , had faded 5 years later . Poststroke drivers were younger and less severely affected and depressed than nondrivers OBJECTIVE The aim of this prospect i ve study was to confirm the accuracy of a short assessment battery , used previously in a study to predict fitness-to-drive after stroke , in a new cohort of stroke survivors without severe deficits . DESIGN A prospect i ve study . SUBJECTS A total of 43 ( 39 men and 4 women ) consecutive survivors after stroke who were not severely impaired and who performed the pre-driving assessment , which included a st and ardized on-road test at the Belgian Road Safety Institute in Brussels , Belgium . On average , participants were 6 months post-stroke , independently ambulant with or without assistive devices , possessed valid drivers ' licenses and actively drove prior to stroke onset . METHODS Fitness-to-drive decisions based on performance in 15 tests of a full-scale assessment battery were predicted using only the scores from the 3 predictive tests previously identified . RESULTS When the discriminant equation from the previous study including performance in the 3 tests ( figure of Rey , visual neglect ( lateralized mean reaction time ) and on-road test ) was applied , 37 ( 86 % ) of the 43 participants were correctly predicted to pass or fail the pre-driving assessment . The sensitivity and specificity of the predictions were 77 % and 92 % , respectively . CONCLUSION This study shows that the short assessment battery is a good predictor of fitness-to-drive in stroke survivors with moderate physical and cognitive impairments UNLABELLED Crotty M , George S. Retraining visual processing skills to improve driving ability after stroke . OBJECTIVE To evaluate the effectiveness of retraining using the Dynavision on driving performance of people with stroke . DESIGN R and omized controlled trial . SETTING Outpatient rehabilitation clinic in Australia . PARTICIPANTS People with stroke ( N=26 ) referred for driving assessment . INTERVENTIONS Eligible participants were r and omized to either receive retraining with the Dynavision apparatus for 18 sessions or to receive no intervention and go onto a waitlist . MAIN OUTCOME MEASURES The primary outcome was an assessment of on-road ability . Secondary outcomes included measures of response speed , visual scanning , and self-efficacy . All assessment s were conducted by assessors blinded to group assignment . RESULTS No significant difference ( P=.223 ) was found between the intervention and control groups in results of on-road assessment in terms of pass or fail ; the primary outcome measure ; or the results on the secondary outcome measures of response speed , visual scanning , and self-efficacy . CONCLUSIONS In this small trial , training underlying skills ( such as executing a continuous wide scan , combining motor and visual processing into a motor response ) using the Dynavision apparatus did not improve the outcomes of an on-road assessment for people after strokes . Larger trials are needed to evaluate devices that cl aim to retrain underlying skills related to driving OBJECTIVE To compare the effectiveness of a visual attention retraining program using the Useful Field of View ( UFOV ) with a traditional visuoperception treatment program on the driving performance of clients with stroke . DESIGN R and omized controlled trial . SETTING Rehabilitation hospital located in Quebec , Canada . PARTICIPANTS Ninety-seven individuals referred for driving evaluation after a stroke . INTERVENTIONS Participants were r and omized to receive 20 sessions of either UFOV training of visual processing speed , divided attention , and selective attention or traditional computerized visuoperception retraining . MAIN OUTCOME MEASURES Subjects were evaluated with an on-road driving evaluation , visuoperception tests , and the Test of Everyday Attention . An occupational therapist unaware of group assignment conducted all evaluations . RESULTS Eighty-four participants completed the outcome evaluation . There were no significant differences between groups on any of the outcome measures . There was , however , almost a 2-fold increase ( 52.4 % vs 28.6 % ) in the rate of success on the on-road driving evaluation after UFOV training for subjects with right-sided lesions . CONCLUSIONS Rehabilitation that targets visual attention skills was not significantly more beneficial than traditional perceptual training in improving the outcome of an on-road driving evaluation . However , results suggest a potential improvement for subjects with right-sided lesions , indicating that training must target specific skills Object Output:
Conclusions : The Road Sign Recognition , Compass , and TMT B are clinical ly administrable office-based tests that can be used to identify persons with stroke at risk of failing an on-road assessment .
MS2_1shot61
***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 previously shown that capsaicin nasal challenge in subjects with allergic rhinitis produces a dose-dependent increase in the albumin content of nasal lavage fluids . In the present set of studies , we determined whether this observation represents plasma extravasation that is neuronally mediated . To evaluate whether gl and ular secretions contribute to the albumin increase in nasal lavage fluids , volunteers with allergic rhinitis were pretreated with atropine or placebo before capsaicin challenge . Atropine significantly reduced the volume of returned lavage fluids and their lysozyme content but increased their albumin and fibrinogen content . To assess the contribution of sensory nerve stimulation , subjects with allergic rhinitis were pretreated in a second study with lidocaine or placebo before capsaicin challenge . Lidocaine significantly attenuated the capsaicin-induced increases in the volume of nasal lavage fluids , as well as their lysozyme and albumin content . To rule out the possibility of a direct effect of lidocaine on blood vessels rather than on nerves , healthy subjects were pretreated in a third study with lidocaine or placebo before bradykinin nasal challenge . Lidocaine did not affect the bradykinin-induced increase in the albumin content of nasal fluids . We conclude that , in allergic rhinitis , high-dose capsaicin induces plasma extravasation in the human nose and that this effect is neuronally mediated . This provides more definitive evidence that neurogenic inflammation can occur in vivo in the human upper airway Neuronal involvement has been implicated in the pathophysiology of non‐allergic and allergic rhinitis , contributing to the typical exacerbation of these conditions upon exposure to non‐specific environmental irritants BACKGROUND Nerve involvement has been implicated in the pathophysiology of chronic respiratory inflammatory diseases . Peptidergic nerve stimulation has been shown to induce leukocyte activation and plasma extravasation in the airways of various animal species . The occurrence of this phenomenon of neurogenic inflammation in the human airway , however , has not been established . OBJECTIVE We conducted this study to determine whether neuronal stimulation can induce reproducible and dose-dependent inflammatory changes in the human upper airway . METHODS Ten volunteers with active allergic rhinitis participated in the study . Capsaicin , the pungent component of hot pepper that specifically stimulates afferent nerve fibers , was administered by means of nasal spray in doses of 1 microg , 10 microg , and 100 microg in a double-blind , r and omized , crossover manner with 1 week between doses . Symptom scores before and after capsaicin nasal challenge were recorded by using visual analog scales . Nasal lavage fluids collected before and at 30 minutes , 1 hour , and 4 hours after capsaicin challenge were analyzed for leukocyte counts ; albumin and lysozyme levels were measured to evaluate effects on plasma leakage and gl and secretion , respectively . RESULTS Capsaicin nasal challenge produced symptoms of burning , congestion , and rhinorrhea . Leukocyte counts or albumin and lysozyme levels were not significantly increased after administration of 1 microg of capsaicin at any time point . On the other h and , there were significant increases in leukocyte counts 1 hour ( p < 0.05 ) and 4 hours ( p = 0.008 ) after 10 microg of capsaicin and 30 minutes ( p = 0.009 ) , 1 hour ( p = 0.007 ) , and 4 hours ( p = 0.007 ) after 100 microg of capsaicin . Albumin and lysozyme levels were both significantly increased 30 minutes after 10 microg and 100 microg of capsaicin ( p = 0.005 for both ) . Comparison of changes in symptom scores , leukocyte counts , and albumin and lysozyme levels among the three capsaicin challenges indicated generally increasing effects with higher capsaicin doses . CONCLUSION Capsaicin-sensitive nerve stimulation in subjects with active allergic rhinitis produces reproducible and dose-dependent leukocyte influx , albumin leakage , and gl and ular secretion . These results provide in vivo evidence for the occurrence of neurogenic inflammation in the human upper airway with active allergic disease In a recent placebo‐controlled study we demonstrated that capsaicin is an efficacious substance in the treatment of non‐allergic non‐infectious rhinitis . In this study the therapeutic effect lasted more than 9 months . This effect was not based on modulation of inflammation Output:
A small pharmacological effect on clinical histamine dose response was found . After treatment , leukotriene levels in nasal lavage did not increase in the capsaicin group . There is insufficient evidence to assess the use of capsaicin in clinical practice
MS2_1shot62
***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 Acute exacerbations of chronic obstructive pulmonary disease ( AE COPD ) impair health-related quality of life ( HRQL ) . We evaluated the effect of an abbreviated repeat pulmonary rehabilitation ( PR ) program on HRQL after an AE COPD . METHODS Patients who had completed PR were followed for up to 12 months to identify an AE COPD and then placed in r and omized groups to receive a 3-week repeat-PR intervention or usual care . Measures of HRQL ( Chronic Respiratory Disease Question naire , CRQ ) and functional exercise capacity ( 6-minute walk distance , 6MWD ) were collected at 2 ( T1 ) , 5 ( T2 ) , and 12 weeks ( T3 ) post-AE COPD . The repeat-PR program was undertaken between T1 and T2 . Between-group differences were examined using repeated- measures analysis of variance or covariance . RESULTS Of the 60 patients ( 30 men , age 69±8 years , forced expiratory volume in 1 second 0.86±0.40 L , 6MWD 367±99 m ) followed , 41 experienced an AE COPD 14 ± 11 weeks after completion of the initial PR program and 33 completed the study . Of these , 16 and 17 were r and omized to the intervention and control groups , respectively . No between-group differences were demonstrated at T2 or T3 . With the exclusion of 5 subjects who experienced a second AE COPD between T1 and T3 , the participants in the intervention group demonstrated greater reduction in dyspnea when compared to those in the control group at T3 ( 0.8±1.6 vs −0.4±1.3 points per item , P = .04 ) . CONCLUSIONS The reduction in dyspnea in those who did not experience a second AE COPD provides preliminary evidence for the role of repeat programs . The application of repeat PR should be refined in larger trials BACKGROUND Pulmonary rehabilitation programmes improve the health of patients disabled by lung disease but their cost effectiveness is unproved . We undertook a cost/utility analysis in conjunction with a r and omised controlled clinical trial of pulmonary rehabilitation versus st and ard care . METHODS Two hundred patients , mainly with chronic obstructive pulmonary disease , were r and omly assigned to either an 18 visit , 6 week rehabilitation programme or st and ard medical management . The difference between the mean cost of 12 months of care for patients in the rehabilitation and control groups ( incremental cost ) and the difference between the two groups in quality adjusted life years ( QALYs ) gained ( incremental utility ) were determined . The ratio between incremental cost and utility ( incremental cost/utility ratio ) was calculated . RESULTS Each rehabilitation programme for up to 20 patients cost £ 12 120 . The mean incremental cost of adding rehabilitation to st and ard care was £ –152 ( 95 % CI –881 to 577 ) per patient , p = NS . The incremental utility of adding rehabilitation was 0.030 ( 95 % CI 0.002 to 0.058 ) QALYs per patient , p=0.03 . The point estimate of the incremental cost/utility ratio was therefore negative . The bootstrapping technique was used to model the distribution of cost/utility estimates possible from the data . A high likelihood of generating QALYs at negative or relatively low cost was indicated . The probability of the cost per QALY generated being below £ 0 was 0.64 . CONCLUSIONS This outpatient pulmonary rehabilitation programme produces cost per QALY ratios within bounds considered to be cost effective and is likely to result in financial benefits to the health service In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Background The feasibility of r and omized trials often depends on successful patient recruitment . Although numerous recruitment barriers have been identified it is unclear which of them complicate recruitment most . Also , most surveys have focused on the patients ' perspective of recruitment barriers whereas the perspective of recruiting physicians has received less attention . Therefore , our aim was to conduct a postal survey among recruiting physicians of a multi-center trial to weigh barriers according to their impact on recruitment . Methods We identified any potential recruitment barriers from the literature and from our own experience with a multi-center trial of respiratory rehabilitation in patients with chronic obstructive pulmonary disease . We developed and pilot-tested a self-administered question naire where recruiting physicians were asked to express their agreement with statements about recruitment barriers on a Likert-type scale from 1 ( full agreement with statement = very substantial recruitment barrier ) to 7 ( no agreement with statement = no recruitment barrier ) . Results 38 of 55 recruiting physicians returned question naires ( 69 % response rate ) , of which 35 could be analyzed ( 64 % useable response rate ) . Recruiting physicians reported that " time constraints " ( median agreement of 3 , interquartile range 2–5 ) had the most negative impact on recruitment followed by " difficulties including identified eligible patients " ( median agreement of 5 , IQR 3–6 ) . Other barriers such as " trial design barriers " , " lack of access to treatment " , " individual barriers of recruiting physicians " or " insufficient training of recruiting physicians " were perceived to have little or no impact on patient recruitment . Conclusion Physicians perceived time constraints as the most relevant recruitment barrier in a r and omized trial . To overcome recruitment barriers interventions , that are affordable for both industry- and investigator-driven trials , need to be developed and tested in r and omized trials . Trial registration IS RCT We examined the feasibility of home-based walking training to maintain the benefits of a short-term exercise training in patients with severe chronic obstructive pulmonary disease ( COPD ) . After initial recovery from an exacerbation , 46 patients were r and omized into a training and a control group , and 30 patients completed the programme ( mean + /- SD FEV1 , 36 + /- 7 % predicted ) . The training group performed a 10-day walking training programme in the hospital , followed by a 6-month programme of supervised walking training at home , integrated into daily activities . The control group did not have exercise training in the hospital or at home . Until 6 months after discharge , lung function , exercise performance and symptom scores were assessed . Six-minute walking distance in the training group improved from day 1 to day 10 ( P<0.001 ) and this effect was maintained over 6 months ( P<0.001 ) . On average , daily walking distance at home was 2308 m and walking was reported on 157 days . Quality of life ( QoL ) scores changed significantly over 6 months ( P<0.001 ) . The control group showed no significant changes in exercise performance or QoL scores throughout the whole study period . Therefore , ( i ) significant improvements in exercise performance and Chronic Respiratory Disease Question naire ( CRQ ) scores could be achieved after recovery from an exacerbation and ( ii ) these improvements were maintained after discharge , when supported by a home-based walking training The aim of this study was to assess long-term mortality and predictive factors of death after hospital admission for acute exacerbation of chronic obstructive pulmonary disease ( COPD ) . 1824 patients ( 23.2 % female ; mean age 70.3±11.3 years ) consecutively admitted for acute exacerbation of COPD in the respiratory medicine departments of 68 general hospitals between October 2006 and June 2007 were prospect ively enrolled in a follow-up cohort . Their vital status was documented between October 2010 and April 2011 . Vital status was available for 1750 patients ( 95.9 % ) , among whom 787 ( 45 % ) died during follow-up . Multivariate analysis found that age ( 60–80 years and ≥80 years versus < 60 years , relative risk 2.99 , 95 % CI 2.31–3.89 ) , lower body mass index ( 25–30 kg·m−2 versus ≤20 kg·m−2 , relative risk 0.80 , 95 % CI 0.66–0.97 ) , lung cancer ( relative risk 2.08 , 95 % CI 1.43–3.01 ) , cardiovascular comorbidity ( relative risk 1.35 , 95 % CI 1.16–1.58 ) , previous hospital admissions for acute exacerbation of COPD ( four or more versus none , relative risk 1.91 , 95 % CI 1.44–2.53 ) , use of accessory respiratory muscles ( relative risk 1.19 , 95 % CI 1.01–1.40 ) or lower-limb oedema ( relative risk 1.74 , 95 % CI ( 1.44–2.12 ) ) at admission and treatment by long-term oxygen therapy at discharge ( relative risk 2.09 , 95 % CI 1.79–2.45 ) were independent risk factors of death . Mortality rate during the 4 years following hospital admission for acute exacerbation of COPD was high ( 45 % ) . Simple clinical information relating to respiratory and general status can help in identifying high-risk patients and targeting more intensive follow-up and care . Interestingly , cardiovascular comorbidities and past hospitalisations for acute exacerbation of COPD , but not forced expiratory volume in 1 s , independently predicted the risk of death . Long-term risk of death after hospitalisation for acute exacerbation of COPD is high but can be readily identified Clinical trials identifier NCT02329873 Background Acute exacerbation ( AE ) of COPD is characterized by a sudden worsening of COPD symptoms . Previous studies have explored the effectiveness of respiratory rehabilitation for patients with COPD ; however , no training program specific to acute exacerbation in elderly patients or unstable periods during hospitalization has been developed . Objective To evaluate the effects of a respiratory rehabilitation exercise training package on dyspnea , cough , exercise tolerance , and sputum expectoration among hospitalized elderly patients with AE COPD . Methods A r and omized control trial was conducted . Pretest and posttest evaluations of 61 elderly in patients with AE COPD ( experimental group n=30 ; control group n=31 ) were performed . The experimental group received respiratory rehabilitation exercise training twice a day , 10–30 minutes per session for 4 days . The clinical parameters ( dyspnea , cough , exercise tolerance , and sputum expectoration ) were assessed at the baseline and at the end of the fourth day . Results All participants ( median age = 70 years , male = 60.70 % , and peak expiratory flow 140 L ) completed the study . In the patients of the experimental group , dyspnea and cough decreased and exercise tolerance and sputum expectoration increased significantly compared with those of the patients in the control group ( all P<0.05 ) . Within-group comparisons revealed that the dyspnea , cough , and exercise tolerance significantly improved in the experimental group by the end of the fourth day ( all P<0.05 ) . Conclusion Results of this study suggest that the respiratory rehabilitation exercise training package reduced symptoms and enhanced the effectiveness of the care of elderly in patients with AE COPD Background : Around the world , the timing of referral of chronic obstructive pulmonary disease ( COPD ) patients for pulmonary rehabilitation differs from immediately after exacerbation ( early ) to later on when patients are in a stable state ( late ) . There are no trials comparing the different time points of referral for pulmonary rehabilitation . Objectives : Our aim was to compare the effects of early and late pulmonary rehabilitation on exacerbation rates and health-related quality of life ( HRQOL ) in COPD patients with exacerbations . Methods : We r and omized COPD patients ( Global Initiative for Chronic Obstructive Lung Disease stages II – IV ) with a recent exacerbation to early ( within 2 weeks ) or late pulmonary rehabilitation ( starting 6 months after r and omization and in a stable state ) . The primary outcome was the exacerbation rate over 18 months , and secondary outcomes included HRQOL and mortality . We used multivariate analyses and an intention-to-treat analysis approach . Results : We r and omized 36 patients to pulmonary rehabilitation . On average , patients with early rehabilitation ( n = 19 ) had 2.61 ( SD 2.96 ) exacerbations requiring systemic corticosteroids and /or antibiotics , compared to 2.77 ( SD 3.41 ) in patients with late rehabilitation ( adjusted incidence rate ratio 0.83 , 95 % confidence interval Output:
Hospital readmissions and mortality studies newly included in this up date showed , on average , significantly smaller effects of rehabilitation than were seen in earlier studies .High- quality evidence suggests that pulmonary rehabilitation after an exacerbation improves health-related quality of life . AUTHORS ' CONCLUSIONS Overall , evidence of high quality shows moderate to large effects of rehabilitation on health-related quality of life and exercise capacity in patients with COPD after an exacerbation .
MS2_1shot63
***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: Sequential ascending venographic studies were used to assess the healing of deep venous thrombosis in 50 patients r and omly assigned to streptokinase or heparin therapy . Various degrees of thrombolysis and /or recanalization were demonstrated by venograms performed on the fourth and tenth days of treatment . Late follow-up studies ( mean , 7 months after treatment ) showed three basic patterns of resolution : ( 1 ) return to normal , ( 2 ) complete recanalization , and ( 3 ) incomplete recanalization and /or collateralization . Loss of valves or their function was associated with recanalization . The character , speed , and outcome of healing reflected the nature and extent of thrombosis , prior thrombotic disease in the extremity , and the type and timing of treatment . Streptokinase was highly effective and preferable to heparin in patients with deep vein thrombosis when therapy was begun within 4 days of onset of symptoms . In later stages of acute or recurrent deep vein thrombosis , the effectiveness of both drugs was significantly reduced Objectives . We compared the efficacy and safety of percutaneous endovenous intervention ( PEVI ) plus anticoagulation with anticoagulation alone in the reduction of venous thromboembolism ( VTE ) and post‐thrombotic syndrome ( PTS ) in acute proximal deep venous thrombosis ( DVT ) . Background . Recurrent VTE and PTS are common complications of DVT . There are no r and omized trials investigating the efficacy of PEVI in the reduction of the above complications . Methods . Patients with symptomatic proximal DVT were r and omized to receive PEVI plus anticoagulation or anticoagulation alone . Anticoagulation consisted of intravenous unfractionated heparin or subcutaneous low‐molecular weight heparin plus warfarin . PEVI consisted of one or more of a combination of thrombectomy , balloon venoplasty , stenting , or local low‐dose thrombolytic therapy . Results . At 6 months follow‐up , recurrent VTE developed in 2 of 88 patients of the PEVI plus anticoagulation group versus 12 of 81of the anticoagulation‐alone group ( 2.3 % vs. 14.8 % , P = 0.003 ) . PTS developed in 3 of 88 patients of the PEVI plus anticoagulation Group and 22 of 81 of the anticoagulation‐alone group ( 3.4 % vs. 27.2 % , P < 0.001 ) . Conclusions . In patients with symptomatic proximal DVT , PEVI plus anticoagulation may be superior to anticoagulation — alone in the reduction of VTE and PTS at 6 months . © 2010 Wiley‐Liss , Heparin or streptokinase was administered in a prospect i ve r and omized fashion to 50 patients with phlebographically confirmed venous thrombosis of the extremities of 14 days or less duration . A total of 49 patients completed the investigative protocol with 26 receiving heparin and 23 receiving streptokinase . All patients were evaluated with sequential phlebograms . Complete thrombolysis with restoration of venous valve function occurred in one of 26 patients receiving heparin and in six of 23 patients receiving streptokinase . Fifty per cent of the patients treated with streptokinase with a total duration of symptoms of three days or less achieved complete lysis . The total incidence of therapeutic complications was similar in the two groups , but was more severe in the streptokinase treated patients Twenty-two patients who had an acute episode of thrombosis in the deep veins of the legs were studied by a new technique of ascending functional cinephlebography 6 to 12 months after the episode of thrombosis . If the condition was diagnosed within 36 hours and the thrombus was dissolved rapidly valve function was preserved . When diagnosis was delayed there was a very great risk of permanent damage to the valves Patients with symptoms of deep vein thrombosis for less than 10 days were treated with a st and ard dose of heparin . In the open label phase of the trial , 11 patients received 100 mg rt-PA on the first day and 50 mg on the subsequent day in an 8 hour infusion . In the double-blind phase , 8 patients were r and omized to the same rt-PA regimen , 6 patients to an infusion of 50 mg rt-PA over 8 hours on days 1 and 2 , and 7 patients to placebo infusions . The mean change in venographic score in all patients treated with rt-PA plus heparin is -3.8 units compared to -0.6 units in patients treated with heparin alone ( p = 0.06 ) . Bleeding complications classified as major were noted in 8/25 patients receiving the combined treatment The management of acute deep vein thrombosis ( DVT ) by medical therapy with anticoagulation has long been supported by evidence -based clinical practice guidelines outlined in the American College of Chest Physicians supplement . Early thrombus removal in patients with iliofemoral DVT has been reported to lead to improved venous valve function , improved quality of life , and decreased incidence of postthrombotic syndrome over anticoagulation alone . The ATTRACT trial will r and omize patients to medical management with st and ard anticoagulation versus catheter-directed thrombolysis in addition to st and ard anticoagulation after stratification to iliofemoral versus femoropopliteal DVT in order to determine the primary outcome of postthrombotic syndrome over a 24-month follow-up Treatment with streptokinase ( ' Kabikinase ' ) was given to 26 patients with venographically confirmed deep vein thrombosis extending into the popliteal vein or above . Treatment was continued for 4 days and the patients were allocated r and omly to oral anticoagulant therapy or a course of treatment with ancrod ( ' Arvin ' ) for 6 days followed by oral anticoagulant therapy . The degree of thrombolysis as judged by further venographic examination at 10 days was not significantly different between the 2 groups . The majority of patients showed clinical improvement but there was no appreciable difference between the groups at 3 and 6 months . Haemorrhagic complications were a more serious problem during the period of treatment with ancrod than during the equivalent period in the control group Output:
Thrombolysis increases the patency of veins and reduces the incidence of PTS following proximal DVT by a third . In those who are treated there is a small increased risk of bleeding . In recent years CDT is the most studied route of administration , and results appear to be similar to systemic administration
MS2_1shot64
***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: Dance and movement therapy are consisted of music , easy exercises and sensorial stimulus and provide drugless treatment for the depression on low rates . In this study , it has been aim ed to examine the effect of dance over the depression . A total of 120 healthy male and female conservatory students ranged from 20 and 24 ages volunteered to participate in this study . They were divided r and omly into 1 of 2 groups : dance training group ( DTG ; N = 60 ) and control group ( CG ; N = 60 ) . A dance training program was applied to the subjects three days a week ( Tuesday , Thursday , and Saturday ) during 12 weeks . The subjects in the control group did not participate in the training and participated only in the pre and post test measurements . Beck Depression Scale was used for the pre and post test measurements of subjects . 12 weeks of dance training has been found to be effective on the depression levels of the subjects participating in the research as the training group ( p < 0.05 ) . The depression level of males and females before training has meaningfully decreased after 12 weeks of dance training ( p < 0.05 ) . When the depression levels of the subjects participated in research as the control group were separately evaluated for males and females , no meaningful change has been found in the depression levels during 12 weeks ( p > 0.05 ) . In conclusion , it has been seen that dance affects the depression levels of university students positively and decreases their depression levels The relative lack of research on movement therapy in inpatient versus outpatient setting s stems from the difficulty of conducting an interpretable study in clinical situations where multiple treatments exist . To control for the multiple treatment confound , this study used a r and omized single-case experimental design with 12 replications . Results indicated that the movement therapy , which was design ed to target the syndrome of a major depressive episode had a positive effect on mood across experiments ( p < .001 ) . From a clinical perspective , these results support the use of a movement program as adjunctive treatment , and challenge the view that movement is recreation but not therapy The purpose of this pilot study was to compare the effectiveness of conservative therapy involving medical exercise therapy ( MET ) versus arthroscopic surgery in patients with knee pain , with MRI-verified degenerative meniscus . The patients were r and omly assigned either to MET ( n = 9 ) or to arthroscopic surgery ( n = 8) . Patients receiving MET had 3 treatments a week for 3 months , a total of 36 treatments . The arthroscopy consisted of meniscectomy with no structured conservative therapy after surgery . Assessment of pain , function , anxiety and depression were performed at inclusion and after 3 months . At the end of treatment , which was 3 months after inclusion , there were no statistical differences between the two groups regarding pain and function . However , anxiety and depression were significantly reduced in the MET group compared with the patients receiving arthroscopic surgery . Bearing in mind the low number of included patients in this pilot study , arthroscopy was found to be no better than MET regarding knee pain and overall daily function . The results from this pilot study are similar to other clinical studies , thereby demonstrating that conservative therapy is just as effective as surgery OBJECTIVE The primary goal of the study was to assess the efficacy of mindfulness-based meditation therapy on anxiety , depression , and spiritual well-being of Japanese patients undergoing anticancer treatment . A secondary goal was to assess the relationships among anxiety , depression , spiritual well-being , growth , appreciation , pain , and symptoms . METHODS The subjects were 28 patients who were receiving anticancer treatment . The subjects participated in two sessions of mindfulness-based meditation therapy , including breathing , yoga movement and meditation . Each patient was taught the program in the first session , then exercised at home with a CD , and subsequently met the interviewer in a second session after 2 weeks . Primary physicians recruited the patients and interviews were conducted individually by nurses or psychologists with training in the program . Patients completed preintervention and postintervention question naires on anxiety and depression ( Hospital Anxiety and Depression Scale [ HADS ] ) , spiritual well-being ( Functional Assessment of Chronic Illness Therapy-Spiritual [ FACIT-Sp ] ) , and appreciation , growth , pain , and symptoms . RESULTS HADS scores significantly decreased from 12 + /- 5.3 to 8.6 + /- 6.3 ( p = 0.004 ) after the intervention , and FACIT-Sp increased from 32 + /- 6.5 to 33 + /- 6.9 ( p = 0.69 ) , but the change was not significant . There were significant associations between FACIT-Sp and HADS ( r = -0.78 , p = 000 ) , FACIT-Sp and growth ( r = -0.35 , p = 0.04 ) , FACIT-Sp and pain ( r = -0.41 , p = 0.02 ) , and growth and appreciation ( r = 0.45 , p = 0.009 ) . CONCLUSIONS Mindfulness-based meditation therapy may be effective for anxiety and depression in Japanese cancer patients , and spiritual well-being is related to anxiety and depression , growth , and pain . The negative correlation of spirituality with growth differs from the results of previous studies and the mechanism of this effect needs to be investigated further Background The increasing prevalence of psychological health problems among adolescent girls is alarming . Knowledge of beneficial effects of physical activity on psychological health is widespread . Dance is a popular form of exercise that could be a protective factor in preventing and treating symptoms of depression . The aim of this study was to assess the cost-effectiveness of a dance intervention in addition to usual school health services for adolescent girls with internalizing problems , compared with usual school health services alone . Methods A cost-utility analysis from a societal perspective based on a r and omized controlled intervention trial was performed . The setting was a city in central Sweden with a population of 130 000 . A total of 112 adolescent girls , 13–18 years old , with internalizing problems participated in the study . They were r and omly assigned to intervention ( n = 59 ) or control ( n = 53 ) group . The intervention comprised dance twice weekly during eight months in addition to usual school health services . Costs for the stakeholder of the intervention , treatment effect and healthcare costs were considered . Gained quality -adjusted life-years ( QALYs ) were used to measure the effects . Quality of life was measured with the Health Utility Index Mark 3 . Cost-effectiveness ratios were based on the changes in QALYs and net costs for the intervention group compared with the control group . Likelihood of cost-effectiveness was calculated . Results At 20 months , quality of life had increased by 0.08 units more in the intervention group than in the control group ( P = .04 ) , translating to 0.10 gained QALYs . The incremental cost-effectiveness ratio was USD $ 3,830 per QALY and the likelihood of cost-effectiveness was 95 % . Conclusions Intervention with dance twice weekly in addition to usual school health services may be considered cost-effective compared with usual school health services alone , for adolescent girls with internalizing problems . Trial registration Name of the trial registry : “ Influencing Adolescent Girls ’ With Creative Dance Twice Weekly”Trial registration number : Background : The Social Functioning Question naire ( SFQ ) , an eight-item selfreport scale ( score range 0–24 ) , was developed from the Social Functioning Schedule ( SFS ) , a semi-structured interview which has been used primarily with non-psychotic patients and has good test-retest and inter-rater reliability as well as construct validity . The SFQ was developed following the need for a quick assessment of perceived social function . Aims : To give further details of old and new data sets from studies involving over 4000 subjects assessed with the SFQ illustrating its epidemiological and clinical associations . Method : New data were analysed from a national epidemiological study , a comparison of key-worker and subject versions of the SFQ , and re analysis of data from three earlier clinical studies , of psychiatric emergencies , general practice psychiatric patients and those with recurrent psychotic illnesses . These data were examined further to determine their range , their relationship to other clinical measures , and change over time in clinical trials . Results : The population mean score in 4164 subjects was 4.6 and the data from all studies suggested that a score of 10 or more indicated poor social functioning . Those presenting as psychiatric emergencies had the poorest social function ( mean 11.4 ) and psychiatric patients from general practice the best function ( mean 7.7 ) of the clinical population s. The eight item scores had a normal distribution in psychiatric population s and a skewed one in a normal population ; scores were relatively stable over the short ( weeks ) and long-term ( months ) , and were high in the presence of acute mental health disturbance and personality disorder , giving support to the validity of the scale . The results from a UK sample of a r and omly selected population specifically weighted for ethnic minorities showed similar social function across groups OBJECTIVE In 2006 the psychosomatic day hospital for the treatment of acute mental illness of elderly people opened as the first clinic of its kind in Germany . The aim of this study was to determine treatment effectiveness and identify possible effects on health care utilization . METHODS Design ed as a naturalistic study with waiting time before admission as a control condition , the primary outcome was the level of depressive symptoms as measured by the hospital anxiety and depression scale . Secondary outcomes were depressive and somatoform symptoms and syndromes as measured with the patient health question naire , patient perception of interpersonal problems and health care use before and after treatment . RESULTS After treatment significant improvement ( p<0.01 ) with moderate effect sizes ( ES ) was found in all variables from admission to discharge ( ES from 0.3 to 0.8 ) and also to follow-up ( ES from 0.2 to 0.6 ) . Improvement remained stable at follow-up . Furthermore , after psychosomatic treatment a reduction in medical service usage was visible . Number of consultations ( pre : 13 , post : 9 ) , number and length of hospital stays ( pre : 1 , 7 weeks , post : 0 , 3 weeks ) were both significantly ( p<0.001 ) reduced six months after treatment as compared to the period six months prior to treatment . CONCLUSION Results indicate that the psychosomatic day hospital treatment of the elderly is successful . Reduced usage of health care and the lower costs for day hospital treatment compared to inpatient treatment point to a positive cost-effect-ratio . Exp and ing this psychosomatic intervention would be useful in reducing the current gap in mental health care for the elderly BACKGROUND Depressive symptoms are common among older adults , particularly those living in long-term care facilities . However , little is known about factors associated with depressive symptoms among long-term care residents in the Czech Republic and in other Eastern European countries . Moreover , the role of mobility and pain in depressive symptoms among long-term care residents is relatively understudied . OBJECTIVE We examined the relationship between functional status and depressive symptoms in 308 older adults from residential care facilities ( RCFs ) in the Czech Republic . METHOD We used baseline data from two r and omized controlled trials testing the effects of dance and reminiscence therapies on quality of life in older RCF residents . Functional status was measured as cognitive function , general ability to perform basic Activities of Daily Living ( ADLs ) , mobility , and functional limitation by pain . Depressive symptoms were measured using the 15-item Geriatric Depression Scale . RESULTS In multiple regression analyses adjusted for sociodemographic factors and taking antidepressants , we found that cognitive function and functional limitation by pain were most strongly associated with depressive symptoms . The ability to perform basic ADLs and mobility were also related to depressive symptoms . CONCLUSION Our findings suggest factors that may be important in efforts to improve psychological well-being in this population The present study has been carried out to investigate the effects of group-based Turkish folkloric dances on physical performance , balance , depression and quality of life ( QoL ) in 40 healthy adult elderly females over the age of 65 years . Subjects were r and omly allocated into Group 1 ( folkloric dance-based exercise ) and Group 2 ( control ) . A 8-week dance-based exercise program was performed . Outcome measures included a 20-m walk test , a 6-min walk test , stair climbing and chair rise time , Berg balance scale ( BBS ) , the Medical Outcomes Study ( MOS ) 36-item short form health survey ( SF-36 ) , and geriatric depression scale ( GDS ) question naires . In Group 1 statistically significant improvements were found in most of the physical performance tests , BBS and some SF-36 subscales after the exercise ( p<0.05 ) . In the Group 2 there was no clinical ly significant change in the variables . Comparing the groups , significant improvements in favor of Group 1 have emerged in most of the functional performance tests , in some of the SF-36 subscales and BBS score ( p<0.05 ) . We achieved improvements in physical performance , balance and QoL in elderly females . Application of folkloric dance specific to countries as an exercise program for elderly people may be helpful BACKGROUND In order to improve the treatment of medication-resistant negative symptoms in schizophrenia , new interventions are needed . Neuropsychological considerations and older reports in the literature point towards a potential benefit of body-oriented psychological therapy ( BPT ) . This is the first r and omized controlled trial specifically design ed to test the effectiveness of manualized BPT on negative symptoms in chronic schizophrenia . METHOD Out- patients with DSM-IV continuous schizophrenia were r and omly allocated to either BPT ( n=24 ) or supportive counseling ( SC , n=21 ) . Both therapies were administered in small groups in addition to treatment as usual ( 20 sessions over 10 weeks ) . Changes in negative symptom scores on the Positive and Negative Symptom Scale Output:
The low- quality evidence from three small trials with 147 participants does not allow any firm conclusions to be drawn regarding the effectiveness of DMT for depression .
MS2_1shot65
***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: Men with erectile dysfunction ( ED ) frequently have a disproportionate burden of comorbid vascular disorders including atherosclerotic disease . We investigated whether scheduled tadalafil is better than on-dem and ( OD ) in improving endothelium-dependent vasodilatation of cavernous arteries in men with ED and whether this effect is also exerted on markers of endothelial function . We did an open-label , r and omized , crossover study including 20 male outclinic patients aged 18 years or older ( mean age 54 years ) who had at least a 3-month history of ED of any severity or etiology . Tadalafil ( 20 mg ) on alternate days ( ADs ) or OD was administered for 4 weeks . Primary end points were variations of basal inflow ( peak systolic velocity ( PSV ) ) and flow-mediated dilatation ( FMD ) of cavernous arteries compared with baseline at penile Duplex ultrasound . Secondary end points were variations of Q13-SIEDY scores regarding morning erections and of markers of endothelial function , that is , vascular cell adhesion molecule ( VCAM ) , intercellular cell adhesion molecule , endothelin-1 ( ET-1 ) , insulin and C-reactive protein ( CRP ) . PSVs and FMD were higher after AD treatment when compared with OD and baseline , respectively ( P=0.0001 ) , and improvements were maintained from 2 weeks after discontinuation ( P<0.005 ) . Patients receiving tadalafil AD experienced a significant improvement of morning erections as compared to AD treatment ( P<0.0001 ) ; ET1 , VCAM and CRP showed a robust decrease after chronic vs OD regimes ( P<0.05 ) , with concomitant increase in insulin levels ( P<0.05 ) , without any variation in blood pressure and other laboratory parameters . Chronic but not OD tadalafil improves endothelial function with sustained effects from its discontinuation . Chronic treatment also produces a dramatic increase in morning erections , which determines better oxygenation to the penis , thus providing a rationale for vascular rehabilitation PURPOSE We determined the effects of intracavernosal injection ( ICI ) of recombinant basic fibroblast growth factor ( rbFGF ) on corporal tissue in hypercholesterolemic rabbits . METHODS Twenty New Zeal and White rabbits were fed a 1 % cholesterol diet for 6 weeks and were r and omly divided into four groups . Group 1 ( N = 5 ) received an ICI of phosphate buffered saline solution ( PBS ) once and again 3 weeks later . Group 2 ( N = 4 ) received an ICI of 2.5 microg rbFGF once and PBS 3 weeks later . Group 3 ( N = 6 ) received an ICI of 2.5 microg rbFGF once and again 3 weeks later . Group 4 ( N = 5 ) received an ICI of 2.5 microg rbFGF once . All animals were maintained on the high cholesterol diet until sacrifice , 3 weeks after last injection . Strips of corporal tissue were submaximally contracted with norepinephrine , and dose-response curves were generated to evaluate endothelial-dependent ( acetylcholine , ACH ) and endothelial-independent ( sodium nitroprusside , SNP ) vasoreactivity . Protein levels of bFGF and vascular endothelial growth factor ( VEGF ) were assessed by enzyme-linked immunosorbent assay . Neuronal nitric oxide synthase ( nNOS ) protein and mRNA were detected by Western blot and semi-quantitative polymerase chain reaction , respectively . RESULTS Vasoreactivity was improved by bFGF treatment as shown by higher ED50[-log(M ) ] of ACH and SNP in Groups 2 , 3 , and 4 . The expression of bFGF protein , VEGF protein , nNOS protein , and mRNA were all increased after bFGF treatment . CONCLUSIONS ICI of bFGF improved vasoreactivity in hypercholesterolemic rabbit corporal tissue , offering a new direction to explore for the treatment of erectile dysfunction Penile NO release test ( PNORT ) has been design ed to try to evaluate clinical ly the penile endothelial function ( PEF ) . The shear-stress flow-mediated vasodilation ( FMD ) of the cavernous arteries is evaluated in two groups of patients with neurogenic ( n=23 ) and vasculogenic ( n=23 ) erectile dysfunction ( ED ) by measuring their percent of increase after a 5 min occlusion of the flow . Both groups show an important FMD decrease ( 17.78±11.78 and 17.82±13 % ) as compared to the age-matched control group ( n=12 ) ( 65.14±30.5 % , P<0.001 ) . In the vasculogenic and control groups , mean FMD is lower in patients with one or more arterial risk factors(41 vs 67 % , P=0.025 ) , and show a positive correlation with the plasmatic levels of bioavailable testosterone ( r=0.37 , P=0.03 ) and of DHEA-S ( r=0.46 , P=0.014 ) . Patients achieving full erection at pharmacological test with visual sexual stimulation have a higher FMD ( 43.8±38 % ) than those who did not ( 18.52±14.37 % , P=0.008 ) . We confirm clinical ly that PEF is strongly impaired in organic ED linked to neurological , vascular and endocrine factors Circulating angiogenic cells ( CACs ) contribute to repair of the vessel wall and dysfunctional CACs are associated to endothelial dysfunction in men with vascular risk factors ( VRFs ) . We investigated whether inhibition of phosphodiesterase type 5 ( PDE5 ) in men with erectile dysfunction ( ED ) and VRFs is accompanied to changes of CACs and to changes of endothelial function . Thirty-six men with ED and VRFs were r and omised to 4 weeks of tadalafil ( 20mg/other day ) or placebo treatment . The number of ex vivo exp and ed functional CAC 's , identified by uptake of 1,1'-dioctadecyl-3 , 3,3 ' , 3'-tetramethylindocarbocyanine-labelled acetylated low-density lipoprotein ( DiLDL ) and concomitant Ulex europaeus agglutinin I ( UEA-1 ) binding , was determined at baseline and after treatment . The number of cells double positive for DiLDL and for UEA-1 , per high-power field fluorescence microscopy was significantly reduced in patients compared to 10 controls ( 26.88+/-6.3 and 74.41+/-17.1 , respectively ; P<0.0001 ) and was markedly increased after tadalafil treatment ( 40.69+/-13.07 versus 25.82+/-6.49 ; P<0.0001 ) . The percentage variation of CACs number and of flow-mediated dilation in the brachial artery by ultrasound after treatment was significantly associated to the presence of endothelial dysfunction at baseline . In conclusion , the increased number of functional CACs after tadalafil treatment suggests a beneficial effect of prolonged PDE5 inhibition on vascular homeostasis BACKGROUND The aim of this study was first to compare the widely used flow mediated dilation ( FMD ) method with the iontophoretically induced acetylcholine vasodilation ( IAV ) procedure . The ultimate goal was to examine the endothelial activity ( EA ) in patients with various cardiovascular risk factors compared with control subjects . PATIENTS AND METHODS In the upper extremities of 27 subjects , comparisons of EA by FMD and IAV measured with laser Doppler flux method ( LDF ) were conducted . IAV-EA was then measured using LDF in an additional 93 subjects with various cardiovascular ( CVD ) risk factors and /or a diagnosis of coronary heart disease ( CHD ) . RESULTS The mean age of the subjects was 56.2 years and 54 % were male . There was a robust and significant correlation between FMD vs IAV endothelial activity ( r = 0.87 , p = 0.025 ) . After adjustment for age , there were significant differences in LDF-measured , acetylcholine-induced EA by diagnosis of CHD ( p = 0.02 ) , hyperlipidemia ( p = 0.03 ) and diabetes ( p < 0.01 ) , as well as by sex ( p < 0.01 ) . The difference by hypertension status was of borderline significance ( p = 0.07 ) . LDF EA was higher in non-smokers compared to smokers but this difference was not statistically significant ( p = 0.3 ) . After adjustment for age and gender , a 10-unit increase in LDF-measured EA was associated with a 12 % lower odds for a diagnosis of CHD ( p = 0.07 ) . CONCLUSIONS Measurement of IAV-EA by LDF is a simple , noninvasive methodology which is highly correlated with post-occlusive FMD EA and is also significantly associated with a diagnosis of CHD INTRODUCTION There is considerable clinical and scientific evidence that endothelial dysfunction may be an important clinical link connecting erectile dysfunction ( ED ) with cardiovascular diseases . AIMS To modify the method of assessment of endothelial function of cavernosal arteries , to develop a new algorithm for evaluating its results , and to investigate the relationship between postocclusive changes in the diameter of brachial and cavernous arteries . METHODS The study participants were 212 patients presenting to our department complaining of ED and 40 healthy volunteers without sexual problems , which formed the control group . All patients with ED underwent complex evaluation and ultrasound assessment of postocclusive changes in the diameter of cavernosal arteries modified by us and st and ard ultrasound assessment of endothelium-dependent flow-mediated dilation of the brachial artery . MAIN OUTCOME MEASURES As the main outcome measure , the percent of increase of the cavernosal arteries diameter ( PICAD ) was recorded . RESULTS In the patients with arteriogenic ED , PICAD values were significantly less than in other groups ( P < 0.001 for pairs of comparison ) . At the same time there were no differences between the control group and groups of patients with psychogenic and organic nonarterial ED . The sensitivity and specificity of a PICAD value of 50 % in diagnosis of arteriogenic ED were 100 % and 98.2 % , respectively . In all groups and in the entire sample of patients studied we did not find a correlation between PICAD and postocclusive changes in the diameter of brachial arteries . CONCLUSION The method of ultrasound assessment of postocclusive changes in the diameter of cavernosal arteries is reliable and a highly informative tool for diagnosis of arteriogenic ED . It can not be substituted by technically simpler method of ultrasound examination of brachial arteries , while results of the latter could help to define the necessity of performing an examination of cavernous arteries INTRODUCTION Human postocclusive forearm skin reactive hyperemia is not only a potential means of identifying early signs of cardiovascular diseases , it can also be used in the assessment of local microvascular response to topically applied compounds on skin . The method is not fully characterized . In this study , we investigated the influence of occlusion time on postocclusive forearm skin reactive hyperemia using laser Doppler fluximetry ( LDF ) . METHODS Twenty healthy male volunteers were studied on three separate days ( at least 24 h apart ) via a r and omized design . Volunteers were studied in a supine position while fasted . Laser Doppler probes were placed on the volar surface of the antebrachium . In preliminary studies , 3 min of upper arm blood flow occlusion at suprasystolic pressure was found to be the upper limit of tolerability . Subsequently , volunteers were r and omized to receive 1 , 2 , or 3 min occlusion on 3 different days . Skin blood flux was measured before , during , and after occlusion using LDF . The primary outcome calculated was maximal change in skin blood flux before and after occlusion , expressed in arbitrary units ( AU ) . RESULTS Skin blood flux changes ( mean+/-S.E.M. ) after 1 , 2 , and 3 min occlusion period were 15.39+/-1.27 AU , 24.84+/-1.62 AU , and 32.14+/-1.73 AU , respectively . Using repeated- measures analysis of variance ( ANOVA ) , significant difference ( P<.05 ) in skin blood flux changes were revealed between these three occlusion duration s , where 3 min occlusion produced significantly greater in skin blood flux occlusion change compared to 1 and 2 min occlusion . DISCUSSION Three minutes of occlusion produces the greater postocclusive reactive hyperemia . It is recommended that studies using postocclusive forearm skin reactive hyperemia should occlude the forearm for at least 3 min PURPOSE We investigated changes in serum biomarkers of vascular function after short-term , continuous sildenafil dosing in men with type 2 diabetes with erectile dysfunction . MATERIAL S AND METHODS Men with erectile dysfunction associated with type 2 diabetes mellitus were r and omized to receive continuous , daily s Output:
The established endothelial-erectile dysfunction connection was thoroughly revised , from basic mechanisms to the clinical importance of endothelial dysfunction assessment as diagnosis for generalized vascular disease .
MS2_1shot66
***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 To evaluate the efficacy and safety of treating HBV-positive mothers with telbivudine in early and middle pregnancy to prevent mother-to-infant HBV transmission . Methods The subject population comprised pregnant women with chronic hepatitis B ( CHB ; n = 188 ) from January 2013 to June 2015 , with HBV DNA ≥1.0 × 107copies/mL and increased alanine aminotransferase levels . Groups A ( n = 62 ) and B ( n = 61 ) were treated with telbivudine starting at 12 weeks or 20–28 weeks after gestation , respectively . Telbivudine was discontinued at postpartum 12 weeks . Group C ( n = 65 ) received no antiviral . All infants were vaccinated with hepatitis B immunoglobulin ( 200 IU ) and HBV vaccine ( 20 with hepatitis B The maternal HBV DNA levels of the groups were compared . Mother-to-infant transmission of HBV was indicated by the presence of HBsAg in infants 7 months after birth . Results Before treatment , the HBV DNA levels of the 3 groups were similar . Before delivery and 12 weeks after delivery , the HBV DNA levels of groups A and B were similar , but both were significantly lower than that of group C ( P < 0.01 , all ) . No infants in groups A and B were HBsAg-positive , but the infection rate of group C was 18.4 % ( P < 0.01 ) . The HBV infection rate of infants was positively associated with the HBV DNA levels of the pregnant mothers . Conclusion Administration of telbivudine to HBV-infected mothers , started during early and middle pregnancy , completely blocked mother-to-infant HBV transmission . Trial registration The study was registered retrospectively on Janurary 25 in 2016 at Chinese Clinical Trial Registry ( ChiCTR-OPC-16007899 ) Infection of hepatitis B virus ( HBV ) occurs in ~10 % of infants of HBV-infected mothers with positive hepatitis B e antigen ( HBeAg ) after immunoprophylaxis . We aim ed to evaluate the safety and efficacy of telbivudine used during late pregnancy for preventing mother-to-child transmission of HBV . We conducted a multicenter prospect i ve cohort study in 5 hospitals from 2012 to 2014 , which enrolled HBV-infected singleton pregnant women with positive HBeAg . By their choice , women were divided into therapy ( telbivudine 600 mg/day , from gestation 28 - 32 weeks to 3 - 4 weeks postpartum ) and control ( no antiviral agent ) groups . Infants received passive-active immunoprophylaxis and follow-up at the age of 7 - 14 months . Totally , 328 pregnant women were included : 149 in the telbivudine group and 179 in the control group . Baseline HBV DNA levels were similar in the 2 groups ( 7.43 vs 7.37 log10 IU/mL , P = .711 ) . At delivery , HBV DNA levels in the telbivudine and control groups were 3.80 and 7.26 log10 IU/mL , respectively ( P < .0001 ) . Of the infants , 128 ( 85.9 % ) in the telbivudine group and 156 ( 87.2 % ) in the control group were followed up . No infant in the telbivudine group had chronic infection , while 2 ( 1.28 % ) infants in the control group did ( P = .503 ) . Three ( 2.34 % ) infants in the telbivudine group , but none in the control group , had severe congenital or developmental abnormalities ( P = .090 ) . The data indicate that telbivudine may block perinatal HBV transmission . However , larger studies are required to clarify whether anti-HBV therapy in pregnancy is associated with severe adverse effects in the foetuses and infants Telbivudine , an FDA pregnancy category B drug , has been found to reduce hepatitis B virus ( HBV ) perinatal transmission with no safety concerns in infants aged up to 1 year . This study evaluated the long-term efficacy and safety of telbivudine in 214 infants born to 210 pregnant women with chronic hepatitis B infection who were treated with telbivudine during pregnancy ( weeks 20 - 32 of gestation ) . The infants were followed for up to 5 years after birth . The efficacy endpoint was the rate of perinatal transmission , which was established by HBsAg and HBV DNA levels at 7 and 12 months . Safety endpoints included head circumference , weight , height , congenital abnormality and hospitalization rates . In addition , the Denver Developmental Screening Test was performed in 92 r and omly selected infants . None of the 214 infants born to these women were infected with HBV , and all had effective serum hepatitis B surface antibody ( HBsAb ) levels . Compared with Chinese st and ard values , there were few differences in the infants ' mean head circumference , weight , and height values . No birth defects were diagnosed , and the congenital abnormality rate was 0.934 % . Serious adverse events requiring hospitalization occurred in 20 infants ( 9.35 % ) . The qualified Denver Developmental Screening Test rate in 92 infants was 97.82 % , which was comparable to a rate of 92 % in normal Chinese children . Thus , treatment with telbivudine during the second or third trimesters of pregnancy safely blocked perinatal transmission of HBV . Infants born to telbivudine-treated mothers showed normal growth and development during long-term follow-up of up to 5 years BACKGROUND Few data are available regarding the use of tenofovir disoproxil fumarate ( TDF ) during pregnancy for the prevention of mother-to-child transmission of hepatitis B virus ( HBV ) . METHODS In this trial , we included 200 mothers who were positive for hepatitis B e antigen ( HBeAg ) and who had an HBV DNA level higher than 200,000 IU per milliliter . Participants were r and omly assigned , in a 1:1 ratio , to receive usual care without antiviral therapy or to receive TDF ( at an oral dose of 300 mg per day ) from 30 to 32 weeks of gestation until postpartum week 4 ; the participants were followed until postpartum week 28 . All the infants received immunoprophylaxis . The primary outcomes were the rates of mother-to-child transmission and birth defects . The secondary outcomes were the safety of TDF , the percentage of mothers with an HBV DNA level of less than 200,000 IU per milliliter at delivery , and loss or seroconversion of HBeAg or hepatitis B surface antigen at postpartum week 28 . RESULTS At delivery , 68 % of the mothers in the TDF group ( 66 of 97 women ) , as compared with 2 % in the control group ( 2 of 100 ) , had an HBV DNA level of less than 200,000 IU per milliliter ( P<0.001 ) . At postpartum week 28 , the rate of mother-to-child transmission was significantly lower in the TDF group than in the control group , both in the intention-to-treat analysis ( with transmission of virus to 5 % of the infants [ 5 of 97 ] vs. 18 % [ 18 of 100 ] , P=0.007 ) and the per- protocol analysis ( with transmission of virus to 0 vs. 7 % [ 6 of 88 ] , P=0.01 ) . The maternal and infant safety profiles were similar in the TDF group and the control group , including birth-defect rates ( 2 % [ 2 of 95 infants ] and 1 % [ 1 of 88 ] , respectively ; P=1.00 ) , although more mothers in the TDF group had an increase in the creatine kinase level . After the discontinuation of TDF , alanine aminotransferase elevations above the normal range occurred more frequently in mothers in the TDF group than in those in the control group ( 45 % [ 44 of 97 women ] vs. 30 % [ 30 of 100 ] , P=0.03 ) . The maternal HBV serologic outcomes did not differ significantly between the groups . CONCLUSIONS In a cohort of HBeAg-positive mothers with an HBV DNA level of more than 200,000 IU per milliliter during the third trimester , the rate of mother-to-child transmission was lower among those who received TDF therapy than among those who received usual care without antiviral therapy . ( Funded by Gilead Sciences ; Clinical Trials.gov number , NCT01488526 . ) Women with chronic hepatitis B should maintain nucleotide analogue treatment to prevent disease progression during pregnancy . The aim of this study was to prospect ively evaluate the efficacy and safety of telbivudine used throughout pregnancy for preventing hepatitis B virus ( HBV ) mother-to-child transmission ( MTCT ) . From January 2012 to June 2014 , women who were receiving telbivudine therapy and became pregnant were enrolled in group A at 28 weeks of gestation . Pregnant women with an HBV DNA level > 106 IU/mL were enrolled in either group B ( telbivudine started at 28 weeks of gestation ) or group C ( control group without treatment ) . MTCT was defined as infants who were positive for serum hepatitis B surface antigen at 7 months after birth . There were 41 , 179 and 177 pregnant women ( 397 infants ) enrolled in groups A , B and C , respectively . The HBV DNA load at 28 weeks of gestation and delivery was 1.50 ± 0.62 vs 1.45 ± 0.61 , 8.05 ± 0.37 vs 4.24 ± 0.89 and 7.94 ± 0.62 vs 7.86 ± 0.73 log10 IU/mL in groups A , B and C , respectively . The rate of MTCT in group C was 4.60 % , which was significantly higher than the rates in groups A and B ( 0 % and 0.6 % , respectively ) ( P = .043 ) . The difference between group A and group B was not significant . The rates of neonatal congenital abnormalities were 2.4 % , 0.6 % and 2.3 % in groups A , B and C , respectively , and there were no significant differences ( P = .140 ) . Telbivudine used throughout pregnancy may be safe and effective for mothers and infants , but it may not enhance the efficacy of an HBV MTCT block compared with treatment starting at 28 weeks of gestation ( NCT02253485 ) BACKGROUND In China , women with chronic HBV infection and who are of childbearing age receive lamivudine at an early age . Thus , viral resistance becomes a challenge for intervention to prevent mother-to-infant transmission . We prospect ively assessed the efficacy of tenofovir in pregnant women with lamivudine-resistant HBV . METHODS Chronic HBV-infected mothers resistant to lamivudine were enrolled . Tenofovir was administrated at gestation weeks 24 or 28 . Virological and biochemical parameters were assessed . All infants received combined immunoprophylaxis and were followed for 1 year . RESULTS Of the 48 mothers enrolled , 21 started tenofovir therapy at gestation week 24 and 27 started at week 28 . Tenofovir result ed in an HBV DNA decline of 5.23 ± 1.68 log10 IU/ml at delivery . The group starting therapy at week 24 exhibited a more rapid viral inhibition ( P<0.001 ) and more significant HBV DNA load decline ( 5.89 ± 1.66 versus 4.72 ± 1.55 ; P=0.019 ) than the group starting at week 28 . At delivery , all mothers had a viral titre < 10(6 ) IU/ml , 76.2 % from the week 24 starting group displayed virus < 10(4 ) IU/ml , and 52.4 % showed undetectable virus at delivery , much higher than the week 28 starting group ( 29.6 % ) , although there was no statistically significant difference in viral levels at delivery between the two groups . Congenital abnormalities and neonatal growth were comparable to the normal population . No case of perinatal transmission was diagnosed . CONCLUSIONS This investigation clarifies the efficacy of tenofovir for reducing vertical transmission of HBV in mothers with lamivudine-resistant HBV and demonstrates that tenofovir is well-tolerated in the second and third trimesters This study sought to assess the antiviral efficacy of lamivudine ( LMV ) administered during third trimester to reduce maternal viraemia and to identify the emergence of LMV resistance . A prospect i ve observational analysis was performed on 26 mothers with high viral load ( > 10⁷ IU/mL ) . Twenty-one women received LMV ( treated group ) for an average of 53 days ( range 22 - 88 days ) , and the remaining five formed the untreated control group . Serum Output:
The average HBV-DNA level before treatment was approximately 8 log10 copies/mL. Compared to the onset of antiviral intervention in the third trimester , the beginning of treatment in the second trimester distinctly reduced maternal predelivery HBV-DNA levels . However , no significant difference in HBV MTCT was found between the second and third trimester groups . Furthermore , the subgroup analysis showed that there were no significant differences between groups beginning treatment at different times ( second or third trimester ) with regard to HBV MTCT or other evaluated endpoints . For pregnant women with HBV-DNA levels less than or equal to 8 log10 copies/mL , the beginning of antiviral treatment can be delayed until the third trimester
MS2_1shot67
***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: Glutamine has been demonstrated to be an important source of fuel for the gut . The purpose of this study was to evaluate the effect of glutamine-supplemented hyperalimentation on gut immune function . Thirty-six female Fischer rats were r and omized into three groups : group 1 ( chow ) was fed rat chow and water ad libitum , group 2 ( total parenteral nutrition ) received a st and ard hyperalimentation formula , and group 3 ( total parenteral nutrition-glutamine ) received a hyperalimentation solution that contained 2 % glutamine . Animals were maintained on their respective diets for 2 weeks and then killed . Mesenteric lymph nodes were harvested for culture , bile was assayed for secretory IgA , and bowel was excised to assay bacterial adherence . Results indicated that glutamine-supplemented total parenteral nutrition protects against bacterial translocation from the gut seen with st and ard formulas . This effect may be mediated by the secretory IgA immune system A r and omized clinical trial was carried out to compare a packaged ready‐to‐mix rice oral rehydration solution ( ORS ) to the st and ard glucose ORS for the treatment of childhood diarrhoea . Children were of either gender , aged 3–35 months , presenting with a history of watery diarrhoea for 72 h or less . The main outcomes examined were stool output , ORS intake , duration of diarrhoea and nutritional recovery during follow‐up at 16 d of illness . Stool output in the first 24 h ( 106 vs 107 g kg‐1 ) , ORS intake in clinic ( 93 vs 102 ml per motion ) and duration of diarrhoea ( 88 h vs 81 h ) were similar in the two treatment groups . The few episodes that became persistent were similar ( 2 % ) in the two groups . The weight gain during follow‐up was similar in the two ORS groups Twenty male infants less than 1 year of age with acute diarrhea and dehydration were r and omly assigned to a study group and studied in blind fashion in a metabolic unit to assess the efficacy of the addition of 30 mmol/L alanine to the st and ard World Health Organization ( WHO ) oral rehydration solution ( ORS ) . Patients were exclusively rehydrated with one of two types of ORS during the first 24 hours of treatment . On the second day , oral feedings were started with a lactose-free formula , and ORS was given to replace stool losses . Body weight , ORS , food intake , vomitus , stool , and urine output were recorded at 6-hour intervals . Blood was drawn at the time of admission , after rehydration , and at 24 and 48 hours of hospitalization to monitor blood gases and electrolytes . Rehydration was satisfactory in both groups of patients . ORS that contained alanine did not reduce the purging rates of the infants compared with those who received st and ard ORS . Clinical ly no adverse effect of the alanine-based ORS was observed during hospitalization . None of the patients had significant hypernatremia or hyponatremia , and serum amino acid levels were not altered . These data show that the addition of 30 mmol/L alanine to the st and ard WHO-ORS produces no further improvement in the outcome of the infants with acute diarrhea compared with those fed the st and ard WHO-ORS In a double‐blind r and omized controlled clinical trial , moderately malnourished Bangladeshi children ( 61–75 % of the median weight/age ) were studied for the effect of zinc and /or vitamin A supplementation on the clinical outcome of persistent diarrhea . Children 6 mo to 2 y of age with diarrhea for more than 14 d were r and omly allocated into 4 groups of 24 receiving a multivitamin syrup and ( i ) zinc ( 20 mg elemental ) , ( ii ) vitamin A , ( iii ) both zinc and vitamin A , or ( iv ) neither , in 2 doses daily for 7 d. Clinical data on recovery and on stool output , consistency and frequency were recorded for 7 d , and weight change from day 1 to day 7 was assessed . The baseline characteristics of the four study groups were comparable . The mean daily stool outputs from days 2 to 7 of therapy were significantly less in the zinc and zinc plus vitamin A groups , but not in the vitamin A group , in comparison with the control group . In children receiving zinc , the cumulative stool weight in the 7 d was 39 % less than in the control group ( p < 0.001 ) and 32 % less than in the vitamin A group ( p= 0.006 ) . The cumulative stool weight in the zinc plus vitamin A group was 24 % less than in the control group ( p < 0.001 ) , but the 14 % lower output than in the vitamin A group was not statistically different The change in body weight over the 7d study period was significantly different between the group receiving zinc and the control group ( + 111 g vs –90 g , p = 0.045 ) . The rate of clinical recovery of children within 7 d was significantly greater in the zinc group ( 88 % ) compared with the control group ( 46 % , p= 0.002 ) or vitamin A group ( 50 % , p= 0 005 ) , but not statistically different from the zinc plus vitamin A group ( 67 % , p= 0.086 ) BACKGROUND Probiotics have a possible role in the treatment of pediatric acute gastroenteritis . We report the effect of the probiotic Lactobacillus rhamnosus GG ( LGG ) on intestinal function , immune response , and clinical outcomes in Indian children with cryptosporidial or rotavirus diarrhea . METHODS Children with gastroenteritis aged 6 months to 5 years , testing positive for either rotavirus or Cryptosporidium species in stool ( coinfections were excluded ) , were r and omized to LGG ( ATCC 53103 ) or placebo , once daily for 4 weeks . Baseline demographic and clinical details were obtained . Sera were tested for immunoglobulin G ( IgG ) and immunoglobulin A ( IgA ) antibodies to Cryptosporidium and rotavirus , and the lactulose to mannitol ratio for intestinal permeability was determined at baseline and at the end of follow-up . RESULTS Of the 124 children enrolled , 82 and 42 had rotavirus and cryptosporidial diarrhea , respectively . Median diarrheal duration was 4 days ; one-third of the children had severe diarrhea . Baseline and clinical parameters were comparable between children receiving LGG and placebo . At the end of follow-up , fewer children with rotavirus diarrhea on LGG had repeated diarrheal episodes ( 25 % vs 46 % ; P = .048 ) and impaired intestinal function ( 48 % vs 72 % ; P = .027 ) . Significant increase in IgG levels postintervention ( 456 vs 2215 EU ; P = .003 ) was observed in children with rotavirus diarrhea receiving LGG . Among children with cryptosporidial diarrhea , those receiving LGG showed significant improvement in intestinal permeability . CONCLUSIONS LGG has a positive immunomodulatory effect and may be useful in decreasing repeated episodes of rotavirus diarrhea . Improvement in intestinal function in children with rotavirus and cryptosporidial gastroenteritis emphasizes the role of probiotics in treating intestinal impairment after infection . CLINICAL TRIALS REGISTRATION CTRI/2010/091/000339 Introduction Diarrhoeal disease is the second-leading cause of death in young children . Current guidelines recommend treating children with acute non-bloody diarrhea with oral rehydration solutions and zinc , but not antimicrobials . However , in many re source -limited setting s , infections with treatable enteric bacterial and protozoan pathogens are common . Probiotics have shown promise as an adjunct treatment for diarrhoea but have not been studied in sub-Saharan Africa . Methods We conducted a pilot , factorial , r and omized , placebo-controlled trial of children aged 2–60 months hospitalized in Botswana for acute non-bloody diarrhoea . A rapid test- and -treat intervention , consisting of multiplex PCR testing of rectal swabs taken at enrolment , accompanied by targeted antimicrobial therapy if treatable pathogens were detected , was compared to the reference st and ard of no stool testing . Additionally , Lactobacillus reuteri DSM 17938 x 60 days was compared to placebo treatment . The main objective of this pilot study was to assess feasibility . The primary clinical outcome was the increase in age-st and ardized height ( HAZ ) at 60 days adjusted for baseline HAZ . Results Seventy-six patients were enrolled over a seven-month study period . We judged that the recruitment rate , lab processing times , communication protocol s , provision of specific antimicrobials , and follow-up rates were acceptable . Compared to the reference arm ( no stool testing and placebo treatment ) , the combination of the rapid test- and -treat strategy plus L. reuteri DSM 17938 was associated with an increase of 0.61 HAZ ( 95 % CI 0.09–1.13 ) and 93 % lower odds of recurrent diarrhoea ( OR 0.07 , 95%CI 0.01–0.61 ) at 60 days . Discussion We demonstrated that it was feasible to evaluate the study interventions in Botswana . Despite the small sample size , we observed a statistically significant increase in HAZ at 60 days and significantly lower odds of recurrent diarrhoea in children receiving both rapid test- and -treat and L. reuteri . There is sufficient evidence to warrant proceeding with a larger follow-up trial in a similar setting BACKGROUND Uncontrolled hospital-based studies in developing countries have reported promising results of dietary rehabilitation of children with persistent diarrhea . OBJECTIVE The objective was to determine the immediate and long-term effects of a dietary supplement and micronutrients given to children with persistent diarrhea during the episode and for 1 wk during convalescence . DESIGN The study was open , controlled , and community-based and was conducted in a periurban area in Guinea-BISSAU : Children <3 y of age with persistent diarrhea were identified during weekly household visits . The children r and omly assigned to the treatment and control groups were examined by a physician and all medical conditions were treated . The children in the treatment group were offered home-based dietary treatment consisting of locally available foods and micronutrient supplements . RESULTS There were 141 episodes of persistent diarrhea during the study : 70 in the treatment group ( in 58 children ) and 71 in the control group ( in 62 children ) . During the intervention period ( median : 17 d ) , weight gain in the treatment group exceeded that of the control group by 61.5 g/wk ( 95 % CI : 49.2 , 73.8 ) , whereas there was no significant difference in linear growth on the basis of knee-heel length . At a median follow-up period of 6.6 mo after the intervention was stopped , weight gain in the treatment group exceeded that of the control group by 12.5 g/wk ( 95 % CI : 7.7 , 17.3 ) ; knee-heel length was 7.5 mm/y ( 4.8 , 10.2 ) greater and total length was 0.65 cm/y ( 0.11 , 1.19 ) greater in the treatment group . CONCLUSION Therapeutic feeding and micronutrient supplementation had an immediate and sustained beneficial effect on growth in children with persistent diarrhea In a controlled clinical trial , we examined the effect of the short-term feeding of an energy-dense milk cereal formula in malnourished children with clinical ly severe dysentery due to acute shigellosis . Seventy-five malnourished children , aged 12 - 48 mo , passing blood or blood with mucous in the stool for < or = 96 h , were offered a hospital diet . In addition , study children ( n = 36 ) were offered a milk-cereal formula with an energy of 5 kJ/g ( an 11 % protein diet ) ; similarly , control children ( n = 39 ) were offered a milk-cereal formula with an energy content of 2.5 kJ/g ( an 11 % protein diet ) . Patients were admitted to the metabolic ward of the Clinical Research and Service Centre , Dhaka , at the International Centre for Diarrhoeal Disease Research , Bangladesh . Patients were studied for 10 hospital days and were then followed up at home after 30 d. After 10 d of dietary intervention , children in the study group had a significantly greater increase vs. controls in weight-for-age ( 6 vs. 3 % , P < 0.001 ) and in weight-for-height ( 7 vs. 3 % , P < 0.001 ) . Serum prealbumin concentrations were significantly higher ( study vs. control ) after 5 d ( 0.214 vs. 0.170 g/L , P = 0.01 ) and after 10 d ( 0.244 vs. 0.193 g/L , P = 0.006 ) of the study . Greater weight-for-age was sustained at home 1 mo after discharge ( 8 vs. 5 % , P = 0.005 ) Output:
There were mixed results for dietary interventions affecting growth and diarrhea outcomes in the post-acute period .
MS2_1shot68
***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 Community-based approaches have been increasing in the effort to raise awareness and early detection for cancer and other chronic disease . However , many times , such interventions are tested in r and omized trials , become evidence -based , and then fail to reach further use in the community . Project HEAL ( Health through Early Awareness and Learning ) is an implementation trial that aims to compare two strategies of implementing evidence -based cancer communication interventions in African American faith-based organizations . Method This article describes the community-engaged process of transforming three evidence -based cancer communication interventions into a coherent , br and ed strategy for training community health advisors with two delivery mechanisms . Peer community health advisors receive training through either a traditional classroom approach ( with high technical assistance/support ) or a web-based training portal ( with low technical assistance/support ) . Results We describe the process , outline the intervention components , report on the pilot test , and conclude with lessons learned from each of these phases . Though the pilot phase showed feasibility , it result ed in modifications to data collection protocol s and team and community member roles and expectations . Conclusions Project HEAL offers a promising strategy to implement evidence -based interventions in community setting s through the use of technology . There could be wider implication s for chronic disease prevention and control Colorectal cancer screening has clear benefits in terms of mortality reduction ; however , it is still underutilized and especially among medically underserved population s , including African Americans , who also suffer a disproportionate colorectal cancer burden . This study consisted of a theory-driven ( health belief model ) spiritually based intervention aim ed at increasing screening among African Americans through a community health advisor-led educational series in 16 churches . Using a r and omized design , churches were assigned to receive either the spiritually based intervention or a nonspiritual comparison , which was the same in every way except that it did not contain spiritual/religious content and themes . Trained and certified peer community health advisors in each church led a series of two group educational sessions on colorectal cancer and screening . Study enrollees completed a baseline , 1-month , and 12-month follow-up survey at their churches . The interventions had significant pre – post impact on awareness of all four screening modalities , and self-report receipt of fecal occult blood test , flexible sigmoidoscopy , and colonoscopy . There were no significant study group differences in study outcomes , with the exception of fecal occult blood test utilization , whereas those in the nonspiritual intervention reported significantly greater pre – post change . Both of these community-engaged , theory-driven , culturally relevant approaches to increasing colorectal cancer awareness and screening appeared to have an impact on study outcomes . Although adding spiritual/religious themes to the intervention was appealing to the audience , it may not result in increased intervention efficacy OBJECTIVES Body and Soul was a collaborative effort among two research universities , a national voluntary agency ( American Cancer Society ) , and the National Institutes of Health to disseminate and evaluate under real-world conditions the impact of previously developed dietary interventions for African Americans . METHODS Body and Soul was constructed from two successful research -based interventions conducted in African-American churches . Components deemed essential from the prior interventions were combined , and then tested in a cluster r and omized-effectiveness trial . The primary outcome was fruit and vegetable intake measured with two types of food frequency question naires at baseline and 6-month follow-up . RESULTS At the 6-month follow-up , intervention participants showed significantly greater fruit and vegetable ( F&V ) intake relative to controls . Post-test differences were 0.7 and 1.4 servings for the 2-item and 17-item F&V frequency measures , respectively . Statistically significant positive changes in fat intake , motivation to eat F&V , social support , and efficacy to eat F&V were also observed . CONCLUSIONS The results suggest that research -based interventions , delivered collaboratively by community volunteers and a health-related voluntary agency , can be effectively implemented under real-world conditions BACKGROUND Using community-based participatory research ( CBPR ) as a guiding framework , a faith-based diet , nutrition and physical activity intervention for African Americans was implemented and evaluated as a small-scale r and omized trial . METHODS Five churches were recruited ( intervention=3 , control=2 ) , result ing in an enrolled sample of 106 adults ( intervention=74 , control=32 ) . The control group received a minimal intervention consisting of one educational workshop . The Living Well By Faith intervention group received a more intensive 8-week program . Classes were held twice a week and included educational workshops and exercise sessions . Both interventions were delivered at participating churches . Assessment s for program evaluation occurred at baseline and 2-month follow-up . These included weight , blood pressure , percent body fat , and physical fitness using the step test . RESULTS The sample was predominantly African American , female and well educated . At baseline , no significant differences between intervention and control groups were found for any of the primary endpoints . At 2-months follow up , the intervention group , compared to the control group , showed significant decreases in weight ( P<.02 ) , BMI ( P<.05 ) , and % body fat ( P<.03 ) , with a significant increase in physical fitness ( P<.02 ) . Systolic blood pressure also showed group differences in the predicted direction ( P=.10 ) . CONCLUSION This study provides an exemplar of CBPR . The results obtained are sufficiently promising to support more research involving similar interventions of longer duration and with longer-term follow-up for evaluation Objective . The authors tested the impact on cardiovascular risk profiles of African American women ages 40 years and older after one year of participation in one of three church-based nutrition and physical activity strategies : a st and ard behavioral group intervention , the st and ard intervention supplemented with spiritual strategies , or self-help strategies . Methods . Women were screened at baseline and after one year of participation . The authors analyzed intention-to-treat within group and between groups using a generalized estimating equations adjustment for intra-church clustering . Because spiritual strategies were added to the st and ard intervention by participants themselves , the results from both active groups were similar and , thus , combined for comparisons with the self-help group . Results . A total of 529 women from 16 churches enrolled . Intervention participants exhibited significant improvements in body weight ( −1.1 lbs ) , waist circumference ( −0.66 inches ) , systolic blood pressure ( −1.6 mmHg ) , dietary energy ( −117 kcal ) , dietary total fat ( −8 g ) , and sodium intake ( −145 mg ) . The self-help group did not . In the active intervention group , women in the top decile for weight loss at one year had even larger , clinical ly meaningful changes in risk outcomes ( −19.8 lbs ) . Conclusions . Intervention participants achieved clinical ly important improvements in cardiovascular disease risk profiles one year after program initiation , which did not occur in the self-help group . Church-based interventions can significantly benefit the cardiovascular health of African American women Physical activity ( PA ) is low among African American women despite awareness of its positive impact on health . Learning and Developing Individual Exercise Skills for a Better Life ( L.A.D.I.E.S. ) compares three strategies for increasing PA among African American women using a cluster r and omized , controlled trial . Underactive adult women from 30 churches ( n=15 participants /church ) were recruited . Churches were r and omized to a faith-based intervention , a non-faith based intervention , or an information only control group . Intervention groups will meet 25 times in group sessions with other women from their church over a 10-month period . Control group participants will receive st and ard educational material promoting PA . All participants will be followed for an additional 12 months to assess PA maintenance . Data will be collected at baseline , 10 , and 22 months . The primary outcome is PA ( steps/day , daily moderate-to-vigorous PA ) . We expect treatment effects indicating that assignment to either of the active interventions is associated with greater magnitude of change in PA compared to the control group . In exploratory analyses , we will test whether changes in the faith-based intervention group are greater than changes in the non-faith-based intervention group . L.A.D.I.E.S. focuses on a significant issue-increasing PA levels-in a segment of the population most in need of successful strategies for improving health . If successful , L.A.D.I.E.S. will advance the field by providing an approach that is successful for initiating and sustaining change in physical activity , which has been shown to be a primary risk factor for a variety of health outcomes , using churches as the point of delivery BACKGROUND Faith-based interventions using a community-based participatory approach hold promise for eliminating ethnic health disparities . This study evaluated the effects of a volunteer-led statewide program to increase physical activity among members of African-American churches . METHODS African Method ist Episcopal churches within six regions ( Conferences ) were r and omly assigned to receive training in the program immediately or 1 year later . A cohort of 20 r and omly selected churches and 571 members within them took part in telephone surveys at baseline ( May-September 2003 ) and 1 year ( May-August 2004 ) and 2 years later ( June-September 2005 ) . Primary outcomes were physical activity participation , meeting physical activity recommendations , and stage of readiness for physical activity change . Statistical analyses were completed in April 2006 . RESULTS Volunteers ( N=889 ) from 303 churches were trained . Among survey respondents , physical activity did not increase significantly over time , although 67 % were aware of the program . Program awareness was significantly related to all three physical activity outcomes and to fruit and vegetable consumption . Pastoral support was significantly associated with physical activity . CONCLUSIONS Although this intervention reached a large number of churches and created awareness of intervention components , no effects on physical activity behaviors were found . Potential reasons for the lack of significant effects are discussed Despite multidisciplinary efforts to control the nation 's obesity epidemic , obesity has persisted as one of the U.S. 's top public health problems , particularly among African Americans . Innovative approaches to address obesity that are sensitive to the unique issues of African Americans are needed . Thus , a faith-based weight-loss intervention using a community-based participatory research approach was developed , implemented , and evaluated with a rural African American faith community . A two-group , quasi-experimental , delayed intervention design was used , with church as the unit of assignment ( treatment n = 2 , control n = 2 ) and individual as the unit of observation ( treatment n = 36 , control n = 37 ) . Weekly small groups led by trained community members met for 8 weeks and emphasized healthy nutrition , physical activity , and faith 's connection with health . The mean weight loss of the treatment group was 3.60 ± 0.64 lbs . compared to the 0.59 ± 0.59-lb loss of the control group OBJECTIVE To examine the extent to which participants in a combined physical activity ( PA ) and dietary intervention achieved changes in multiple health behaviors . DESIGN Group r and omized trial ; includes only participants assigned to the intervention group only . SETTING Thirty-six churches in South Carolina . PARTICIPANTS Three hundred sixty African American church members . INTERVENTION A 15-month PA and dietary intervention , guided by the structural ecological model , targeting environmental ( i.e. , social , cultural , physical ) and organizational ( ie , policies , practice s ) changes within the church . MAIN OUTCOME MEASURES Self-reported PA , fruit and vegetable consumption , fat- , and fiber-related behaviors . ANALYSIS Change in each behavior was defined as unadjusted pretest-posttest improvement ≥ 0.20 of the baseline st and ard deviation . The total number and each combination of behaviors changed were calculated . RESULTS Up to 19 % changed no health behaviors as defined above , 31 % changed 1 health behavior , 31 % changed 2 health behaviors , 13 % changed 3 health behaviors , and 5 % changed all 4 of the targeted health behaviors . Combinations of multiple behavior change included PA and dietary behaviors , which suggests that both behaviors can be changed simultaneously . CONCLUSIONS AND IMPLICATION S Nearly half of participants changed at least 2 health behaviors . Faith-based interventions targeting environmental and organizational change can successfully change multiple behaviors , potentially leading to greater improvements in public health BACKGROUND African Americans are at increased risk for cardiovascular disease and cancer morbidity and mortality . Physical activity and healthy dietary practice s can reduce this risk . The church is a promising setting to address health disparities , and community-based participatory research is a preferred approach . OBJECTIVES Using a community-based participatory approach and the social ecologic model , the FAN trial aims to increase self-reported moderate-intensity physical activity and fruit and vegetable consumption and reduce blood pressure in African American church members . Secondary aims are to increase objective ly measured moderate-intensity physical activity and fiber/whole grain consumption and reduce fat consumption . DESIGN FAN is a group r and omized trial ( GRT ) with two levels of clustering : participants ( N=1279 ; n=316 accelerometer subgroup ) within church and church within church cluster . In the first wave , seven clusters including 23 churches were r and omized to an immediate intervention or delayed intervention . In subsequent waves , 51 churches were r and omized to an immediate or delayed intervention . METHODS Church committee members , pastors , and cooks participate in full-day trainings to learn how to implement physical activity and dietary changes in the church . Monthly mailings and technical assistance calls are delivered over the 15-month intervention . Members complete measurements at baseline and 15 months . A detailed process evaluation is included . SUMMARY FAN focuses on modifying the social , cultural , and policy environment in a faith-based setting . The use of a community-based participatory research approach , engagement of church leaders , inclusion of a detailed process evaluation , and a formal plan for sustainability and dissemination make FAN unique BACKGROUND Faith-based interventions hold promise for Output:
A systematic review of topic-specific faith-based health programs determined that health outcomes can be improved though faith-based health interventions .
MS2_1shot69
***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: RATIONALE Inhaled tobramycin has been shown to transiently clear Pseudomonas from lower airways in early cystic fibrosis ( CF ) , but does not markedly reduce lung inflammation , a key factor in disease progression . OBJECTIVE Test the hypothesis that systemic antibiotics are more effective than inhaled antibiotics for reducing lower airways inflammation . METHODS Clinical ly stable CF children with recent Pseudomonas were r and omized to receive 4 weeks of inhaled tobramycin or 2 weeks of systemic antibiotics ( intravenous ceftazidime and tobramycin ) . Bronchoalveolar lavage fluid was obtained just before and 4 - 6 weeks after treatment . The primary outcome was change in % neutrophils in lavage fluid . RESULTS Fifteen subjects ( inhaled = 6 , systemic = 9 ) completed the protocol . Three Systemic Group subjects could not have central venous access established and were treated with oral ciprofloxacin ( plus inhaled tobramycin ) for 2 weeks as an alternative " systemic " regimen , per protocol . Groups were well matched in age , markers of disease severity , and initial % neutrophils . The Systemic Group showed a modest median change in percent neutrophils ( -7 % ) which was not statistically significant compared to inhaled ( + 5.4 % , P = 0.07 ) . However , the Systemic Group had significantly greater reductions in total cells ( -50 % vs. -3 % , P < 0.01 ) and neutrophils ( -74 % vs. -10 % , P = 0.02 ) per ml lavage fluid . Both groups had reduced bacterial quantity after treatment , but there was no significant difference between groups . CONCLUSIONS In clinical ly stable children with CF , systemic antibiotics result in greater short-term reduction in lower airways inflammation than inhaled antibiotics Purpose To assess efficacy and safety of a new dry powder formulation of inhaled colistimethate sodium in patients with cystic fibrosis ( CF ) aged ≥6 years with chronic Pseudomonas aeruginosa lung infection . Study design and methods A prospect i ve , central ly r and omised , phase III , open-label study in patients with stable CF aged ≥6 years with chronic P aeruginosa lung infection . Patients were r and omised to Colobreathe dry powder for inhalation ( CDPI , one capsule containing colistimethate sodium 1 662 500 IU , twice daily ) or three 28-day cycles with twice-daily 300 mg/5 ml tobramycin inhaler solution ( TIS ) . Study duration was 24 weeks . Results 380 patients were r and omised . After logarithmic transformation of data due to a non-normal distribution , adjusted mean difference between treatment groups ( CDPI vs TIS ) in change in forced expiratory volume in 1 s ( FEV1 % predicted ) at week 24 was −0.98 % ( 95 % CI −2.74 % to 0.86 % ) in the intention-to-treat population ( n=373 ) and −0.56 % ( 95 % CI −2.71 % to 1.70 % ) in the per protocol population ( n=261 ) . The proportion of colistin-resistant isolates in both groups was ≤1.1 % . The number of adverse events was similar in both groups . Significantly more patients receiving CDPI rated their device as ‘ very easy or easy to use ’ ( 90.7 % vs 53.9 % respectively ; p<0.001 ) . Conclusion CDPI demonstrated efficacy by virtue of non-inferiority to TIS in lung function after 24 weeks of treatment . There was no emergence of resistance of P aeruginosa to colistin . Overall , CDPI was well tolerated . Trial Reg No EudraCT 2004 - 003675 - 36 OBJECTIVES To determine whether bronchoalveolar lavage (BAL)-directed therapy for infants and young children with cystic fibrosis ( CF ) , rather than st and ard therapy , was justified on the grounds of a decrease in average costs and whether the use of BAL reduced treatment costs associated with hospital admissions . STUDY DESIGN Costs were assessed in a r and omized controlled trial conducted in Australia and New Zeal and on infants diagnosed with CF after newborn screening and assigned to receive either BAL-directed or st and ard therapy until they reached 5 years of age . A health care funder perspective was adopted . Re source use measurement was based on st and ardized data collection forms administered for patients across all sites . Unit costs were obtained primarily from government schedules . RESULTS Mean costs per child during the study period were Australian dollars (AUD)92 860 in BAL-directed therapy group and AUD90 958 in st and ard therapy group ( mean difference AUD1902 , 95 % CI AUD-27 782 to 31 586 , P = .90 ) . Mean hospital costs per child during the study period were AUD57 302 in the BAL-directed therapy group and AUD66 590 in the st and ard therapy group ( mean difference AUD-9288 ; 95 % CI AUD-35 252 to 16 676 , P = .48 ) . CONCLUSIONS BAL-directed therapy did not result in either lower mean hospital admission costs or mean costs overall compared with managing patients with CF by a st and ard protocol based upon clinical features and oropharyngeal culture results alone . Following on our previous findings that BAL-directed treatment offers no clinical advantage over st and ard therapy at age 5 years , flexible bronchoscopy with BAL can not be recommended for the routine management of preschool children with CF on the basis of overall cost savings Six children with cystic fibrosis who had persistently had Pseudomonas aeruginosa isolated from their respiratory tract , completed a double-blind cross-over comparison of oral flucloxacillin and nebulized aminoglycoside versus double placebo . The patients had higher FEV1 results at the end of the month of active treatment than after the month of placebo Background Initial pulmonary Pseudomonas aeruginosa infection in patients with cystic fibrosis ( CF ) is currently treated with intensive antibiotic therapy . At this stage , inflammation and tissue injury might have already occurred . Moreover , bacterial eradication is not always achieved . Prophylactic treatment against P aeruginosa seemed to have a preventive effect in retrospective studies . A study was undertaken to establish prospect ively the effect of cycled prophylactic treatment on prevention of initial P aeruginosa infection in children with CF . Methods This 3-year triple-blind r and omised controlled trial included 65 children with CF without P aeruginosa infection . Intervention existed of 3-monthly 3-week treatments with oral ciprofloxacin and inhaled colistin or both placebo controls . The primary outcome was P aeruginosa infection . Secondary outcomes were serum anti-Pseudomonas antibodies , pulmonary function , exacerbations , chest x-ray scores , inflammation parameters , respiratory pathogens and antimicrobial resistance . Results There was no difference in acquisition of P aeruginosa infection between the control and treatment groups ( annual incidence 14 % vs 11 % ; HR 0.738 , 95 % CI 0.299 to 1.822 ) . Anti-Pseudomonas antibodies emerged earlier in the control group , but this difference had disappeared after 3 years . Chronic infection was observed in 19 % of controls and 12 % of treated patients . Decline in pulmonary function and other clinical outcomes did not differ between the two groups . In the treatment group , significantly fewer Gram-positive bacteria and Enterobacteriaceae were observed but there were more non-P aeruginosa non-fermentative Gram-negative bacteria . Conclusions Three-monthly cycled anti-P aeruginosa prophylaxis does not reduce the risk of initial and chronic infection in P aeruginosa-negative children with CF of all ages . Shifts in bacterial colonisation dem and caution . Trial Registration Number IS RCT N 11604593 Rationale In cystic fibrosis ( CF ) , the paranasal sinuses are sites of first and persistent colonization by pathogens such as Pseudomonas aeruginosa . Pathogens subsequently descend to the lower airways , with P. aeruginosa remaining the primary cause of premature death in patients with the inherited disease . Unlike conventional aerosols , vibrating aerosols applied with the PARI Sinus ™ nebulizer deposit drugs into the paranasal sinuses . This trial assessed the effects of vibrating sinonasal inhalation of the antibiotic tobramycin in CF patients positive for P. aeruginosa in nasal lavage . Objectives To evaluate the effects of sinonasal inhalation of tobramycin on P. aeruginosa quantification in nasal lavage ; and on patient quality of life , measured with the Sino-Nasal Outcome Test ( SNOT-20 ) , and otologic and renal safety and tolerability . Methods Patients were r and omized to inhalation of tobramycin ( 80 mg/2 mL ) or placebo ( 2 mL isotonic saline ) once daily ( 4 minutes/nostril ) with the PARI Sinus ™ nebulizer over 28 days , with all patients eligible for a subsequent course of open-label inhalation of tobramycin for 28 days . Nasal lavage was obtained before starting and 2 days after the end of each treatment period by rinsing each nostril with 10 mL of isotonic saline . Results Nine patients participated , six initially receiving tobramycin and three placebo . Sinonasal inhalation was well tolerated , with serum tobramycin < 0.5 mg/L and stable creatinine . P. aeruginosa quantity decreased in four of six ( 67 % ) patients given tobramycin , compared with zero of three given placebo ( non-significant ) . SNOT-20 scores were significantly lower in the tobramycin than in the placebo group ( P=0.033 ) . Conclusion Sinonasal inhalation of vibrating antibiotic aerosols appears promising for reducing pathogen colonization of paranasal sinuses and for control of symptoms in patients with CF BACKGROUND Pulmonary administration of colistin is one of the antimicrobial treatments used in Cystic Fibrosis ( CF ) patients chronically infected with Pseudomonas aeruginosa . Dry powder inhalation of colistin may be an attractive alternative to nebulization of colistin . However , nebulized colistin can cause bronchoconstriction in CF patients . Therefore , in the progress of developing a dry powder formula , the choice of the inhaler and its contents should be guided by optimal efficacy and the least possible side effects . To investigate the side effects , a study was initiated to compare the tolerability of colistin sulphate to colistin sulphomethate per nebulization in CF- patients . METHODS Nine CF- patients chronically infected with P. aeruginosa participated in a double blind , r and omized cross over study . On two visits to the outpatient clinic , patients were su bmi tted to either nebulized colistin sulphate or colistin sulphomethate solution . Lung function tests were performed immediately before and 15 and 30 min after nebulization . RESULTS Nebulization of colistin sulphate caused a significant larger mean decrease in lung function compared to nebulized colistin sulphomethate . A significant decrease in mean changes ( SD ) in FEV1 at 30 min and FVC at 15 and 30 min after nebulization compared to baseline of -7.3 % ( 8.6 % ) , -5.7 % ( 7.3 % ) and -8.4 % ( 7.5 % ) respectively was seen after colistin sulphate nebulization compared to colistin sulphomethate ( P < 0.05 ) . Seven patients were not able to complete the nebulization of colistin sulphate because of throat irritation and severe cough . CONCLUSION Based on these results it was concluded that inhalation with nebulized colistin sulphate is not suitable for treatment of CF patients chronically infected with P. aeruginosa . Colistin sulphomethate is the drug of choice for pulmonary administration of colistin BACKGROUND A light-porous-particle , dry-powder formulation of tobramycin was developed , using PulmoSphere ® technology , to improve airway delivery efficiency , substantially reduce delivery time , and improve patient convenience and satisfaction . We evaluated the safety , efficacy and convenience of tobramycin inhalation powder ( TIP ™ ) versus tobramycin inhalation solution ( TIS , TOBI ® ) for treating Pseudomonas aeruginosa infection in cystic fibrosis ( CF ) patients aged ≥6 years . METHODS In this open-label study , 553 patients were r and omized 3:2 to TIP ( total 112 mg tobramycin ) via the Novartis T-326 Inhaler or TIS 300mg/5mL via PARI LC ® PLUS nebulizer twice daily for three treatment cycles ( 28 days on-drug , 28 days off-drug ) . Safety , efficacy , and treatment satisfaction outcomes were evaluated . RESULTS TIP was generally well-tolerated ; adverse events were similar in both groups . The rate of cough suspected to be study drug related was higher in TIP-treated patients ( TIP : 25.3 % ; TIS : 4.3 % ) , as was the overall discontinuation rate ( TIP : 26.9 % ; TIS : 18.2 % ) . Increases in FEV(1)% predicted from baseline to Day 28 of Cycle 3 were similar between groups ; the mean reduction in sputum P. aer Output:
Tinnitus and voice alteration were the only adverse events significantly more common in the inhaled antibiotics group . No significant differences were found in the remaining comparisons with regard to lung function . Inhaled anti-pseudomonal antibiotic treatment probably improves lung function and reduces exacerbation rate , but pooled estimates of the level of benefit were very limited . The best evidence is for inhaled tobramycin .
MS2_1shot70
***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: Noninvasive , quantitative , and accurate assessment of liver iron concentration ( LIC ) by MRI is useful for patients receiving transfusions , but R2 and R2 * MRI techniques have not been systematic ally compared in sickle cell anemia ( SCA ) . We report baseline LIC results from the TWiTCH trial , which compares hydroxyurea with blood transfusion treatment for primary stroke prophylaxis assessed by transcranial Doppler sonography in pediatric SCA patients . Liver R2 was collected and processed using a FDA ‐approved commercial process ( FerriScan ® ) , while liver R2 * quality control and processing were performed by a Core Laboratory blinded to clinical site and patient data . Baseline LIC studies using both MRI techniques were available for 120 participants . LICR2 * and LICR2 results were highly correlated ( r2 = 0.93 ) . A proportional bias of LIC(R2*)/LIC(R2 ) , decreasing with average LIC , was observed . Systematic differences between LICR2 * and LICR2 were also observed by MRI manufacturer . Importantly , LICR2 * and LICR2 estimates had broad 95 % limits of agreement with respect to each other . We recommend LICR2 and LICR2 * not be used interchangeably in SCA patients to follow individual patient trends in iron burden . Am . J. Hematol . 90:806–810 , 2015 . © 2015 Wiley Periodicals , Hydroxyurea has hematologic and clinical efficacy in sickle cell anemia ( SCA ) , but its effects on transcranial Doppler ( TCD ) flow velocities remain undefined . Fifty-nine children initiating hydroxyurea therapy for clinical severity had pretreatment baseline TCD measurements ; 37 with increased flow velocities ( > or = 140 cm/s ) were then enrolled in an institutional review board (IRB)-approved prospect i ve phase 2 trial with TCD velocities measured at maximum tolerated dose ( MTD ) and one year later . At hydroxyurea MTD ( mean + /- 1 SD = 27.9 + /- 2.7 mg/kg per day ) , significant decreases were observed in the right middle cerebral artery ( MCA ) ( 166 + /- 27 cm/s to 135 + /- 27 cm/s , P < .001 ) and left ( MCA ) ( 168 + /- 26 cm/s to 142 + /- 27 cm/s , P < .001 ) velocities . The magnitude of TCD velocity decline was significantly correlated with the maximal baseline TCD value . At hydroxyurea MTD , 14 of 15 children with conditional baseline TCD values improved , while 5 of 6 with abnormal TCD velocities whose families refused transfusions became less than 200 cm/s . TCD changes were sustained at follow-up . These prospect i ve data indicate that hydroxyurea can significantly decrease elevated TCD flow velocities , often into the normal range . A multicenter trial is warranted to determine the efficacy of hydroxyurea for the management of increased TCD values , and ultimately for primary stroke prevention in children with SCA The Stroke With Transfusions Changing to Hydroxyurea ( SWiTCH ) trial compared st and ard ( transfusions/chelation ) to alternative ( hydroxyurea/phlebotomy ) treatment to prevent recurrent stroke and manage iron overload in children chronically transfused over 7 years before enrollment . St and ardized brain magnetic resonance imaging/magnetic resonance angiography ( MRA ) and transcranial Doppler ( TCD ) exams were performed at entry and exit , with a central blinded review . A novel MRA vasculopathy grading scale demonstrated frequent severe baseline left/right vessel stenosis ( 53%/41 % ≥ Grade 4 ) ; 31 % had no vessel stenosis on either side . Baseline parenchymal injury was prevalent ( 85%/79 % subcortical , 53%/37 % cortical , 50%/35 % subcortical and cortical ) . Most children had low or uninterpretable baseline middle cerebral artery TCD velocities , which were associated with worse stenoses ( incidence risk ratio [ IRR ] = 5.1 , P ≤ .0001 and IRR = 4.1 , P < .0001 ) than normal velocities ; only 2 % to 12 % had any conditional/abnormal velocity . Patients with adjudicated stroke ( 7 ) and transient ischemic attacks ( 19 in 11 st and ard/8 alternative arm subjects ) had substantial parenchymal injury/vessel stenosis . At exit , 1 child ( alternative arm ) had a new silent infa rct , and another had worse stenosis . SWiTCH neuroimaging data document severe parenchymal and vascular abnormalities in children with SCA and stroke and support concerns about chronic transfusions lacking effectiveness for preventing progressive cerebrovascular injury . The novel SWiTCH vasculopathy grading scale warrants validation testing and consideration for use in future clinical trials . This trial was registered at www . clinical trials.gov as # NCT00122980 The Stroke Prevention Trial in Sickle Cell Anemia ( STOP ) was a r and omized multicenter controlled trial comparing prophylactic blood transfusion with st and ard care in sickle cell anemia ( SCA ) children aged 2 to 16 years selected for high stroke risk by transcranial Doppler ( TCD ) . More than 2000 children were screened with TCD to identify the 130 high-risk children who entered the r and omized trial . A total of 5613 TCD studies from 2324 children were evaluated . We also collected information on stroke . We describe the changes in TCD with repeated testing and report the outcome without transfusion in the STOP screened cohort . Risk of stroke was higher with abnormal TCD than with normal or conditional TCD ( P < .001 ) or inadequate TCD ( P = .002 ) , and risk with conditional TCD was higher than with normal TCD ( P < .001 ) . Repeated TCD in 1215 children showed that the condition of 9.4 % of children became abnormal during observation . Younger patients and those with higher initial flow velocities were most likely to convert to abnormal TCDs . Screening in STOP confirmed the predictive value of TCD for stroke . Substantial differences in the probability of conversion to abnormal TCD were observed , with younger children and those with higher velocity more likely to have an abnormal TCD with rescreening BACKGROUND A substantial minority of neurologically normal children with sickle cell disease have lesions consistent with cerebral infa rct ion as seen on magnetic resonance imaging ( MRI ) . OBJECTIVES To determine if transfusion therapy affects the rate at which silent infa rcts develop and to evaluate the contribution of MRI of the brain to stroke prediction by transcranial Doppler ( TCD ) ultrasonography . STUDY DESIGN Children with elevated TCD ultrasonographic velocity were r and omized to receive long-term transfusion therapy or st and ard care . Magnetic resonance imaging of the brain was obtained at r and omization , annually , and with clinical neurologic events . The risk for new silent lesions and /or stroke was compared for each treatment arm . RESULTS Among the 37 % of subjects with silent infa rcts , those receiving st and ard care were significantly more likely to develop new silent lesions or stroke than were those who received transfusion therapy . For subjects receiving st and ard care , those with lesions at baseline were significantly more likely to develop stroke or new silent lesions than those whose MRI studies showed no abnormality . CONCLUSIONS Transfusion therapy lowers the risk for new silent infa rct or stroke for children having both abnormal TCD ultrasonographic velocity and silent infa rct . However , those with both abnormalities who are not provided transfusion therapy are at higher risk for developing a new silent infa rct or stroke than are those whose initial MRI showed no abnormality . The finding of a silent infa rct reinforces the need for TCD ultrasonographic screening and consideration of transfusion therapy if the abnormalities are seen . Similarly , elevated TCD ultrasonographic velocity warrants MRI of the brain because children with both abnormalities seem to be at increased risk for developing new silent infa rct or stroke The Stroke Prevention Trial in Sickle Cell Anemia ( STOP ) was a r and omized trial to evaluate whether chronic transfusion could prevent initial stroke in children with sickle-cell anemia at high risk as determined by transcranial Doppler ( TCD ) . The trial demonstrated a large benefit of transfusion and was halted early . After termination of the trial , patients participated in a post-trial follow-up study . More patients in the transfusion group ( 70 % ) elected transfusion for primary stroke prevention compared with those on st and ard care ( 45 % ) . Six patients with persistently abnormal TCD results developed stroke . A minority with initially abnormal TCD results remained stroke-free without transfusion . Except for lower baseline and follow-up TCD velocities compared with those with stroke , no predictive features of this apparent lower-risk subgroup could be determined . TCD results at last testing in 108 patients that did not have stroke were : normal ( 44.4 % ) , conditional ( 26.9 % ) , abnormal ( 22.2 % ) , and inadequate ( 6.5 % ) . Patients on transfusion were more likely to have normal TCD results . Transfusion result ed in iron overload and alloimmunization , but no infection . The study provides new information on acceptance rates and long-term effects of transfusion . Persistent TCD elevation signals ongoing stroke risk . Reduction in TCD results over time without transfusion is observed in some patients and requires further study Background : Silent cerebral infa rct ( SCI ) is the most common cause of serious neurological disease in sickle cell anemia ( SCA ) , affecting approximately 22 % of children . The goal of this trial is to determine whether blood transfusion therapy will reduce further neurological morbidity in children with SCI , and if so , the magnitude of this benefit . Procedure : The Silent Cerebral Infa rct Transfusion ( SIT ) Trial includes 29 clinical sites and 3 subsites , a Clinical Coordinating Center , and a Statistical and Data Coordinating Center , to test the following hypothesis : prophylactic blood transfusion therapy in children with SCI will result in at least an 86 % reduction in the rate of subsequent overt strokes or new or progressive cerebral infa rcts as defined by magnetic resonance imaging ( MRI ) of the brain . The intervention is blood transfusion versus observation . Two hundred and four participants ( 102 in each treatment assignment ) will ensure 85 % power to detect the effect necessary to recommend transfusion therapy ( 86 % reduction ) , after accounting for 10 % drop out and 19 % crossover rates . MRI examination of the brain is done at screening , immediately before r and omization and study exit . Each r and omly assigned participant receives a cognitive test battery at study entry , 12–18 months later , and study exit and an annual neurological examination . Blood is obtained from all screened participants for a biologic repository containing serum and a renewable source of DNA . Conclusion : The SIT Trial could lead to a change in st and ard care practice s for children affected with SCA and SCI , with a consequent reduction in neurological morbidity The Silent Cerebral Infa rct Multicenter Transfusion ( SIT ) Trial is a multi-institutional intervention trial in which children with silent cerebral infa rcts are r and omized to receive either blood transfusion therapy or observation ( st and ard care ) for 36 months . The SIT Trial is scheduled to enroll approximately 1,880 children with sickle cell disease from 29 clinical sites in the United States , Canada , UK , and France . Each child undergoes a screening magnetic resonance imaging ( MRI ) of the brain to detect the presence of silent cerebral infa rct -like lesions , a pre-r and omization ( baseline ) MRI and exit MRI to determine if there are new or enlarged cerebral infa rcts , using a design ated , prospect i ve imaging protocol . The objective of this manuscript is to describe the innovative method used to process and adjudicate imaging studies for an international trial with a primary endpoint that includes neuroimaging . Institution investigators at each site were provided with computer hardware and software for transmission of MRI images that allow them to strip the scans of all personal information and add unique study identifiers . Three neuroradiologists at separate academic centers review MRI studies and determine the presence or absence of silent cerebral infa rct -like lesions . Their findings are subsequently placed on web-based case report forms and sent to the Statistical Coordinating Center . The average time from imaging center receipt of the MRI study to the radiology committee report back to the local site is less than two working days . This novel strategy was design ed to maximize efficiency and minimize cost of a complex large multicenter trial that depends heavily on neuroimaging for entry criteria and assessment for the primary outcome measures . The technology , process , and expertise used in the SIT Trial can be adapted to virtually any clinical research trial with digital imaging requirements BACKGROUND Prophylactic transfusion prevents strokes in children with sickle cell anemia who have abnormalities on transcranial Doppler ultrasonographic examination . However , it is not known how long transfusion should be continued in these children . METHODS We studied children with sickle cell disease who had a high risk of stroke on the basis of a transcranial Doppler screening examination and who had received transfusions for 30 months or longer , during which time the Doppler readings became normal . The children were r and omly assigned to continued transfusion or no continued transfusion . Children with severe stenotic les Output:
There is no evidence for managing adults , or children who do not have HbSS sickle cell disease . In children who are at higher risk of stroke and have not had previous long-term transfusions , there is moderate quality evidence that long-term red cell transfusions reduce the risk of stroke , and low quality evidence they also reduce the risk of other sickle cell disease-related complications . In primary and secondary prevention of stroke there is low quality evidence that switching to hydroxyurea with phlebotomy has little or no effect on the liver iron concentration . In secondary prevention of stroke there is low- quality evidence that switching to hydroxyurea with phlebotomy increases the risk of sickle cell disease-related events .
MS2_1shot71
***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: Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials BACKGROUND Traditional approaches to mechanical ventilation use tidal volumes of 10 to 15 ml per kilogram of body weight and may cause stretch-induced lung injury in patients with acute lung injury and the acute respiratory distress syndrome . We therefore conducted a trial to determine whether ventilation with lower tidal volumes would improve the clinical outcomes in these patients . METHODS Patients with acute lung injury and the acute respiratory distress syndrome were enrolled in a multicenter , r and omized trial . The trial compared traditional ventilation treatment , which involved an initial tidal volume of 12 ml per kilogram of predicted body weight and an airway pressure measured after a 0.5-second pause at the end of inspiration ( plateau pressure ) of 50 cm of water or less , with ventilation with a lower tidal volume , which involved an initial tidal volume of 6 ml per kilogram of predicted body weight and a plateau pressure of 30 cm of water or less . The primary outcomes were death before a patient was discharged home and was breathing without assistance and the number of days without ventilator use from day 1 to day 28 . RESULTS The trial was stopped after the enrollment of 861 patients because mortality was lower in the group treated with lower tidal volumes than in the group treated with traditional tidal volumes ( 31.0 percent vs. 39.8 percent , P=0.007 ) , and the number of days without ventilator use during the first 28 days after r and omization was greater in this group ( mean [ + /-SD ] , 12+/-11 vs. 10+/-11 ; P=0.007 ) . The mean tidal volumes on days 1 to 3 were 6.2+/-0.8 and 11.8+/-0.8 ml per kilogram of predicted body weight ( P<0.001 ) , respectively , and the mean plateau pressures were 25+/-6 and 33+/-8 cm of water ( P<0.001 ) , respectively . CONCLUSIONS In patients with acute lung injury and the acute respiratory distress syndrome , mechanical ventilation with a lower tidal volume than is traditionally used results in decreased mortality and increases the number of days without ventilator use RATIONALE In a clinical trial by the Acute Respiratory Distress Syndrome Network ( ARDSNet ) , mechanical ventilation with tidal volumes of 6 ml/kg decreased mortality from acute lung injury . However , interpretations of these results generated controversy and it was unclear if this trial would change usual-care practice s. OBJECTIVES First , to determine if clinical practice s at ARDSNet hospitals changed after the tidal volume trial . Second , to determine if tidal volume and plateau pressure ( Pplat ) within 48 hours before r and omization affected hospital mortality in patients subsequently managed with 6 ml/kg predicted body weight ( PBW ) . METHODS We used preenrollment data from 2,451 patients enrolled in six trials ( 1996 - 2005 ) to describe changes in tidal volume over time . We used logistic regression to determine if preenrollment tidal volume or Pplat affected mortality . MEASUREMENTS AND MAIN RESULTS Median preenrollment tidal volume decreased from 10.3 ml/kg PBW ( range , 4.3 - 17.1 ) during the tidal volume trial ( 1996 - 1999 ) to 7.3 ml/kg PBW ( range , 3.9 - 16.2 ) after its completion ( P < 0.001 ) . Preenrollment tidal volume was not associated with mortality ( P = 0.566 ) . The odds of death increased multiplicatively with each cm H(2)O of preenrollment Pplat ( P < 0.001 ) ( e.g. , the odds of death was 1.37 times greater when preenrollment Pplat increased by 10 cm H(2)O ) . CONCLUSIONS Physicians used lower tidal volumes after publication of the tidal volume trial . Preenrollment Pplat was strongly associated with mortality , and may reflect disease severity independent of tidal volume . Pplat measured early in the course of acute lung injury , after accounting for tidal volume , is a respiratory system-specific value with strong prognostic significance We conducted clinical trials in patients with acute lung injury ( ALI ) associated with systemic inflammatory response syndrome using a selective neutrophil elastase inhibitor , sivelestat sodium hydrate ( Sivelestat ) , to investigate the involvement of neutrophil elastase in ALI . In the phase III double-blind study ( Study 1 ) in 230 patients , the efficacy of Sivelestat was evaluated with the pulmonary function improvement ( PFI ) rating as the primary endpoint , and the weaning rate from mechanical ventilator , the discharge rate from intensive care unit ( ICU ) , and the survival rate as secondary endpoints . Afterwards , an unblinded study ( Study 2 ) in 20 patients was conducted using procedures for weaning from mechanical ventilation to reevaluate its efficacy with ventilator-free days ( VFD ) value , the primary endpoint , and to compare with that of Study 1 subgroup , which met the selection criteria used in Study 2 . Sivelestat increased PFI rating , reduced duration of mechanical ventilation , and shortened stay in ICU in Study 1 , although there was no significant efficacy on the survival rate . VFD value in Study 2 was comparable to that in the optimal-dose group of Study 1 subgroup , and increase in VFD value correlated with PFI rating and increase in ICU free days . It was concluded that neutrophil elastase may be involved in the pathogenesis of ALI in humans Sivelestat sodium hydrate ( sivelestat ) is a selective inhibitor of polymorphonuclear leukocyte elastase ( PMN-E ) . We administered sivelestat to patients with septic acute lung injury ( ALI ) to examine its usefulness . The primary endpoints in the study were the duration of artificial ventilation and pulmonary oxygenation ability , and the secondary endpoints were mortality and the concentrations of PMN-E , SP-D , TNF-alpha and IL-8 in blood . In the sivelestat group , the duration of artificial ventilation , pulmonary oxygenation ability , and the blood PMN-E , SP-D , TNF-alpha and IL-8 concentrations decreased significantly . Administration of sivelestat was found to reduce alveolar dysfunction and improve respiratory function , and it was suggested that early administration might be useful Objective To assess multicentre , r and omised , controlled trials ( MC- RCTs ) of systemic inflammatory response syndrome ( SIRS ) and sepsis conducted in Japan , published in Japanese and not available to English- language medical data bases . Design Method ological review .SubjectsAll Japanese RCTs relevant to SIRS and sepsis . Intervention Identification of manuscripts using a Japanese electronic library . Critical analysis of methodology and reporting quality using a modified Method ological Quality Assessment Score and the CONSORT group check list . Measurements and results Three MC- RCTs were identified . In the first , 147 patients with septic shock were r and omised to methylprednisolone ( 1000 mg i.v . ) or placebo . In the second , 221 patients were r and omised to 0.20 mg/kg per h or 0.004 mg/kg per h of sivelestat for acute lung injury with SIRS . In the third , 504 patients were r and omised to immunoglobulin ( 5 g for 3 days ) or to a control group . The average method ological quality score was higher than that of equivalent Western trials . The reporting quality ( CONSORT checklist ) was comparable to Western studies published during the same period . Conclusions Despite sound methodology and quality , the information obtained from relatively large Japanese critical care trials is not widely available to English-speaking investigators and therefore might be ignored in meta-analyses Evidence has linked neutrophil elastase to acute respiratory distress syndrome ( ARDS ) , suggesting that inhibiting the activity of this enzyme could prevent the development and progression of ARDS . However , few clinical trials have examined this notion . We therefore examined the effects of ONO-5046 ( sivelestat , a specific inhibitor of neutrophil elastase ; sodium N-[2-[4-(2,2-dimethylpropionyloxy ) phenylsulfonylaminobenzoyl]amino-acetate tetrahydrate ] ) in a r and omized , double-blinded trial in patients with ARDS . We r and omly assigned 24 patients with ARDS to groups that received conventional therapy without or with sivelestat ( 0.2 mg·kg−1·h−1 ) for 14 days . The variables of interest associated with clinical outcome were the duration of mechanical ventilation ; changes in oxygenation from baseline ; changes in cytokine levels from baseline ; number of patients alive at 30 days who did not need mechanical ventilation ; and mortality rate . The length of intensive care unit stay , number of ventilation days , and mortality rates did not statistically differ between groups . ARDS was more persistent in the control than in the sivelestat group ( control , 19.5 ± 7.4 days ; sivelestat , 13.5 ± 5.9 days ; P = 0.039 ) . Neutrophil elastase activity significantly differed between groups at 72 h after treatment . Levels of interleukin-6 were lower in the sivelestat group than in the controls at 24 , 48 , and 72 h after treatment . ONO-5046 apparently did not affect survival or the duration of mechanical ventilation Objective : Neutrophil elastase is believed to be an important mediator of acute lung injury . Sivelestat ( ONO-5046 , Elaspol ) is a small molecular weight inhibitor of neutrophil elastase . The primary objectives of this study were to determine whether sivelestat would reduce 28-day all-cause mortality or increase the number of ventilator-free days ( days alive and free from mechanical ventilation from day 1 to day 28 ) compared with placebo in mechanically ventilated patients with acute lung injury . Design : Multiple-center , double-blind , placebo-controlled trial administering a continuous infusion of sivelestat at a dose of 0.16 mg·kg−1·hr−1 . Setting : One hundred and five institutions in the United States , Canada , Belgium , Spain , Australia , and New Zeal and . Patients : A total of 492 mechanically ventilated patients with acute lung injury . Interventions : Patients were r and omized in a 1:1 fashion to sivelestat or placebo . Study drug was administered as a continuous infusion for the duration of mechanical ventilation plus 24 hrs for a maximum of 14 days . All patients were managed using low tidal volume mechanical ventilation . Measurements and Main Results : The study was stopped prematurely at the recommendation of an external Data and Safety Monitoring Board , which noted a negative trend in long-term mortality rate . Final analysis revealed no effect of sivelestat on the primary end points of ventilator-free days ( day 1–day 28 ) or 28-day all-cause mortality . There were 64 deaths in each treatment group within the 28-day study period , and the mean number of ventilator-free days was 11.4 and 11.9 in the sivelestat and placebo treatment groups , respectively ( p = .536 ) . There was no evidence of effect on measures of pulmonary function , including Pao2/Fio2 , static lung compliance , and time to meeting weaning criteria . There was no difference in adverse events or serious adverse events between treatment groups . A comparison of the Kaplan-Meier 180-day survival curves showed no difference between treatment groups ( p = .102 ) , but there was an increase in 180-day all-cause mortality in Output:
Sivelestat was not associated with decreased mortality , even when including studies published in Japanese language
MS2_1shot72
***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 Intermittent preventive treatment in infants ( IPTi ) is a new malaria control tool . However , it is uncertain whether IPTi works mainly through chemoprophylaxis or treatment of existing infections . Underst and ing the mechanism is essential for development of replacements for sulfadoxine-pyrimethamine ( SP ) where it is no longer effective . This study investigated how protection against malaria given by SP , chlorproguanil-dapsone ( CD ) and mefloquine ( MQ ) , varied with time since administration of IPTi . Methods and Findings A secondary analysis of data from a r and omised , placebo-controlled trial in an area of high antifolate resistance in Tanzania was conducted . IPTi using SP , CD , MQ or placebo was given to 1280 infants at 2 , 3 and 9 months of age . Poisson regression with r and om effects to adjust for potential clustering of malaria episodes within children was used to calculate incidence rate ratios for clinical malaria in defined time strata following IPTi . The short-acting antimalarial CD gave no protection against clinical malaria , whereas long-acting MQ gave two months of substantial protection ( protective efficacy ( PE ) 73.1 % ( 95 % CI : 23.9 , 90.5 ) and 73.3 % ( 95 % CI : 0 , 92.9 ) in the first and second month respectively ) . SP gave some protection in the first month after treatment ( PE 64.5 % ( 95 % CI : 10.6 , 85.9 ) ) although it did not reduce the incidence of malaria up to 12 months of age . There was no evidence of either long-term protection or increased risk of malaria for any of the regimens . Conclusion Post-treatment chemoprophylaxis appears to be the main mechanism by which IPTi protects children against malaria . Long-acting antimalarials are therefore likely to be the most effective drugs for IPTi , but as monotherapies could be vulnerable to development of drug resistance . Due to concerns about tolerability , the mefloquine formulation used in this study is not suitable for IPTi . Further investigation of combinations of long-acting antimalarials for IPTi is needed . Trial Registration Clinical trials.gov Background Intermittent Preventive Treatment for malaria control in infants ( IPTi ) consists of the administration of a treatment dose of an anti-malarial drug , usually sulphadoxine-pyrimethamine , at scheduled intervals , regardless of the presence of Plasmodium falciparum infection . A pooled analysis of individually r and omized trials reported that IPTi reduced clinical episodes by 30 % . This study evaluated the effect of IPTi on child survival in the context of a five-district implementation project in southern Tanzania . [ Trial registration : clinical trials.gov NCT00152204 ] . Methods After baseline household and health facility surveys in 2004 , five districts comprising 24 divisions were r and omly assigned either to receive IPTi ( n = 12 ) or not ( n = 12 ) . Implementation started in March 2005 , led by routine health services with support from the research team . In 2007 , a large household survey was undertaken to assess the impact of IPTi on survival in infants aged two-11 months through birth history interviews with all women aged 13 - 49 years . The analysis is based on an " intention-to-treat " ecological design , with survival outcomes analysed according to the cluster in which the mothers lived . Results Survival in infants aged two-11 months was comparable in IPTi and comparison areas at baseline . In intervention areas in 2007 , 48 % of children aged 12 - 23 months had documented evidence of receiving three doses of IPTi , compared to 2 % in comparison areas ( P < 0.0001 ) . Over the three years of the study there was a marked improvement in survival in both groups . Between 2001 - 4 and 2005 - 7 , mortality rates in two-11 month olds fell from 34.1 to 23.6 per 1,000 person-years in intervention areas and from 32.3 to 20.7 in comparison areas . In 2007 , divisions implementing IPTi had a 14 % ( 95 % CI -12 % , 49 % ) higher mortality rate in two-11 month olds in comparison with non-implementing divisions ( P = 0.31 ) . Conclusion The lack of evidence of an effect of IPTi on survival could be a false negative result due to a lack of power or imbalance of unmeasured confounders . Alternatively , there could be no mortality impact of IPTi due to low coverage , late administration , drug resistance , decreased malaria transmission or improvements in vector control and case management . This study raises important questions for programme evaluation design Background As a result of rising levels of drug resistance to conventional monotherapy , the World Health Organization ( WHO ) and other international organisations have recommended that malaria endemic countries move to combination therapy , ideally with artemisinin-based combinations ( ACTs ) . Cost is a major barrier to deployment . There is little evidence from field trials on the cost-effectiveness of these new combinations . Methods and Findings An economic evaluation of drug combinations was design ed around a r and omised effectiveness trial of combinations recommended by the WHO , used to treat Tanzanian children with non-severe slide-proven malaria . Drug combinations were : amodiaquine ( AQ ) , AQ with sulfadoxine-pyrimethamine ( AQ+SP ) , AQ with artesunate ( AQ+AS ) , and artemether-lumefantrine ( AL ) in a six-dose regimen . Effectiveness was measured in terms of re source savings and cases of malaria averted ( based on parasitological failure rates at days 14 and 28 ) . All costs to providers and to patients and their families were estimated and uncertain variables were subjected to univariate sensitivity analysis . Incremental analysis comparing each combination to monotherapy ( AQ ) revealed that from a societal perspective AL was most cost-effective at day 14 . At day 28 the difference between AL and AQ+AS was negligible ; both result ed in a gross savings of approximately US$ 1.70 or a net saving of US$ 22.40 per case averted . Varying the accuracy of diagnosis and the subsistence wage rate used to value unpaid work had a significant effect on the number of cases averted and on programme costs , respectively , but this did not change the finding that AL and AQ+AS dominate monotherapy . Conclusions In an area of high drug resistance , there is evidence that AL and AQ+AS are the most cost-effective drugs despite being the most expensive , because they are significantly more effective than other options and therefore reduce the need for further treatment . This is not necessarily the case in parts of Africa where recrudescence following SP and AQ treatment ( and their combination ) is lower so that the relative advantage of ACTs is smaller , or where diagnostic services are not accurate and as a result much of the drug goes to those who do not have malaria The aim of this study is to compare the safety efficacy and cost effectiveness of vaginal misoprostol and intravenous oxytocin in induction of labor . A r and omized trial was performed in 142 women requiring labor induction in Muhimbili National Hospital Dar es Salaam Tanzania from June to December 2004 . Inclusion criteria were singleton vertex presentation ; gestational age > 36 weeks . Exclusion criteria were previous myomectomy uteroplasty or cesarean section . Sequential sealed envelopes generated by computer were used . Patients were assigned to receive either oxytocin or 25 mcg 4-hourly vaginal misoprostol ( Continental pharma Inc Belgium ; maximum dose 100 mcg ) . If contractions were not established 4 h after the insertion of the fourth misoprostol induction was considered a failure and the patient was managed according to hospital protocol s. In the oxytocin group infusion of 5 I in 500 ml of 5 % dextrose ( 10 mU/ ml ) was started ( maximum dosage 40 mU/min ) . If labor was not established within 12 h induction was regarded as a failure and the patient was managed according to hospital protocol s. ( excerpt BACKGROUND The aim of the CRASH-2 trial was to assess the effects of early administration of tranexamic acid on death , vascular occlusive events , and blood transfusion in trauma patients with significant haemorrhage . Tranexamic acid significantly reduced all-cause mortality . Because tranexamic acid is thought to exert its effect through inhibition of fibrinolysis , we undertook exploratory analyses of its effect on death due to bleeding . METHODS The CRASH-2 trial was undertaken in 274 hospitals in 40 countries . 20,211 adult trauma patients with , or at risk of , significant bleeding were r and omly assigned within 8 h of injury to either tranexamic acid ( loading dose 1 g over 10 min followed by infusion of 1 g over 8 h ) or placebo . Patients were r and omly assigned by selection of the lowest numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number . Both participants and study staff ( site investigators and trial coordinating centre staff ) were masked to treatment allocation . We examined the effect of tranexamic acid on death due to bleeding according to time to treatment , severity of haemorrhage as assessed by systolic blood pressure , Glasgow coma score ( GCS ) , and type of injury . All analyses were by intention to treat . The trial is registered as IS RCT N86750102 , Clinical Trials.gov NCT00375258 , and South African Clinical Trial Register/Department of Health DOH-27 - 0607 - 1919 . FINDINGS 10,096 patients were allocated to tranexamic acid and 10,115 to placebo , of whom 10,060 and 10,067 , respectively , were analysed . 1063 deaths ( 35 % ) were due to bleeding . We recorded strong evidence that the effect of tranexamic acid on death due to bleeding varied according to the time from injury to treatment ( test for interaction p<0.0001 ) . Early treatment ( ≤1 h from injury ) significantly reduced the risk of death due to bleeding ( 198/3747 [ 5.3 % ] events in tranexamic acid group vs 286/3704 [ 7.7 % ] in placebo group ; relative risk [ RR ] 0.68 , 95 % CI 0.57 - 0.82 ; p<0.0001 ) . Treatment given between 1 and 3 h also reduced the risk of death due to bleeding ( 147/3037 [ 4.8 % ] vs 184/2996 [ 6.1 % ] ; RR 0.79 , 0.64 - 0.97 ; p=0.03 ) . Treatment given after 3 h seemed to increase the risk of death due to bleeding ( 144/3272 [ 4.4 % ] vs 103/3362 [ 3.1 % ] ; RR 1.44 , 1.12 - 1.84 ; p=0.004 ) . We recorded no evidence that the effect of tranexamic acid on death due to bleeding varied by systolic blood pressure , Glasgow coma score , or type of injury . INTERPRETATION Tranexamic acid should be given as early as possible to bleeding trauma patients . For trauma patients admitted late after injury , tranexamic acid is less effective and could be harmful . FUNDING UK NIHR Health Technology Assessment programme , Pfizer , BUPA Foundation , and J P Moulton Charitable Foundation Output:
Conclusion Country specific pharmacoeconomic analyses are too scarce and inconsistently used to have had a significant influence on the selection of essential medicines in Tanzania .
MS2_1shot73
***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 Surgical treatment of varicose veins with preservation of the greater saphenous vein ( GSV ) was studied . METHODS Patients with reflux at the saphenofemoral junction and grossly normal GSV were treated with two different surgical techniques : perivalvular b and ing valvuloplasty ( PVBV-A ) of the saphenous valve , wherein the diameter of the uppermost saphenous valve was narrowed by Dacron-reinforced silicone b and ( 12 patients , 15 extremities ) ; and high ligation ( HL-A ) of the saphenous vein , wherein the GSV was ligated flush with the femoral vein ( 14 patients , 16 extremities ) . Both groups also had varicose tributaries of GSV avulsed through multiple stab incisions . RESULTS In the HL-A group two GSV ( 13 % ) remained completely patent , 10 GSV ( 62.5 % ) thrombosed partially , and the remaining four GSV ( 25 % ) had complete thrombosis . In the PVBV-A group 12 GSV ( 80 % ) remained completely patent and without reflux , one GSV ( 7 % ) remained patent but showing reflux . Two GSV ( 13 % ) thrombosed completely . There were no surgical complications or recurrences ( mean follow-up was 9.4 months for PVBV-A and 9.5 months for HL-A ) , and the postoperative recovery time was similar for both groups . CONCLUSIONS Both techniques are equally effective in the early elimination of varicosities . Preservation of the saphenous vein is significantly better after PVBV-A ( p < 0.01 ) . A prospect i ve r and omized trial with long-term follow-up is required Three techniques for treatment of chronic venous incompetence on an out patients basis were compared in a r and omised study . One hundred thirty eight limbs ( 107 patients ) with superficial venous incompetence were r and omly treated with the dentist 's technique ( DT ) [ Group A , 44 limbs ] , compression sclerotherapy ( CS ) [ Group B , 45 limbs ] or the SAVAS ( section en Ambulatoire des Varices avec Sclérothérapie ) technique [ Group C , 49 limbs ] . Patients were evaluated and followed up ( every year for 4 years ) with ambulatory venous pressure ( AVP ) measurements and Quantum angiodynography ( colour duplex scanning ) . DT consisted in the section under local anesthesia of incompetent veins . CS was done injecting polidocanol 3 % with compression applied for 4 weeks . The SAVAS was done with a combination of DT and CS with section of the incompetent veins under local anesthesia and retro grade injection in the distal vein of polidocanol 3 % . With this type of injection only incompetent veins were perfused . After 4 years there was a significantly lower refilling time ( RT ) with AVP in the SAVAS group ( 21 sec ) . RT was 13 sec in group B and 16 in A. The number of significantly incompetent residual veins was in average 0.5 in the SAVAS group , significantly lower than in the other two groups . Also the average cost per treated limb was significantly lower in the SAVAS group ( 917 francs in comparison with 1100 in group A and 1211 in group B ) . In conclusion considering the four year follow up , the SAVAS technique is a more effective treatment of superficial venous incompetence , its hemodynamic value is superior to sclerotherapy alone and its costs are lower The influence of compression sclerotherapy upon hemostasis activation was investigated in 41 consecutive patients with lower extremity varices by serial measurement of thrombin-antithrombin III complexes ( TAT ) , D-dimer , fibrinogen and C-reactive protein ( CRP ) . Blood sampling was carried out before operation and on the 7th and 28th post-operative day in patients r and omly assigned to either the control group ( n = 18 ) , in which high ligation of sapheno-femoral junction and local excision of varices were performed , or the sclerotherapy group ( n = 23 ) in which the comparable surgical intervention and compression sclerotherapy using hypertonic saline were performed simultaneously . In both groups , the TAT , D-dimer and fibrinogen concentrations at day 7 were significantly elevated compared to the value before operation while CRP showed no significant change during the observation period . In the sclerotherapy group , higher incidence of superficial thrombosis was observed and the TAT concentration at day 7 was significantly higher than that in the control group ( p < 0.01 ) , and the TAT at day 28 was still significantly elevated compared to the pre-operative level ( p < 0.05 ) . However , no relationship between TAT and D-dimer concentrations and the extent of superficial thrombosis was observed . We conclude that compression sclerotherapy for lower extremity varices causes latent activation of coagulation system and can be a risk factor for venous thromboembolism A prospect i ve observational study of 63 legs in 49 patients was undertaken to evaluate the adequacy of primary varicose vein surgery performed by surgical trainees . Appropriate surgery was carried out by a surgical senior house officer ( SHO ) under direct consultant supervision . All patients underwent pre- and postoperative duplex scanning . The preoperative duplex scan demonstrated incompetence of the saphenofemoral junction ( SFJ ) or long saphenous vein ( LSV ) in 59 limbs , a mid-thigh perforator ( MTP ) in 11 limbs , and saphenopopliteal junction ( SPJ ) in 5 limbs . Surgery successfully abolished all sites of pre-existing reflux . The postoperative duplex scan revealed that 17 new sites of reflux , not identified preoperatively , had developed in 12 limbs . With a consultant-led service and accurate preoperative identification of sites of reflux , the surgical trainee can adequately perform varicose vein surgery . This would seem a reasonable approach to training and eliminating recurrence owing to inadequate surgery . The development of new sites of reflux within 6 months of varicose vein surgery may be owing to altered venous haemodynamics consequent upon this surgery OBJECTIVE The aim of this r and omized study was to compare a new method of endovenous saphenous vein obliteration ( Closure System , VNUS Medical Technologies , Inc , Sunnyvale , Calif ) with the conventional stripping operation in terms of short-term recovery and costs . METHODS Twenty-eight selected patients for operative treatment of primary greater saphenous vein tributary varicose veins were r and omly assigned to endovenous obliteration ( n = 15 ) or stripping operation ( n = 13 ) . Postoperative pain was daily assessed during the 1st week and on the 14th postoperative day . The length of sick leave was determined . The R AND -36 health survey was used to assess the patient health-related quality of life . The patient conditions were controlled 7 to 8 weeks after surgery , and patients underwent examination with duplex ultrasonography . The comparison of costs included both direct medical costs and costs result ing from lost of productivity of the patients . Costs that were similar in the study groups were not considered in the analysis . RESULTS All operations were successful , and the complication rates were similar in the two groups . Postoperative average pain was significantly less severe in the endovenous obliteration group as compared with the stripping group ( at rest : 0.7 , st and ard deviation [ SD ] 0.5 , versus 1.7 , SD 1.3 , P = .017 ; on st and ing : 1.3 , SD 0.7 , versus 2.6 , SD 1.9 , P = .026 ; on walking : 1.8 , SD 0.8 , versus 3.0 , SD 1.8 , P = .036 ; with t test ) . The sick leaves were significantly shorter in the endovenous obliteration group ( 6.5 days , SD 3.3 days , versus 15.6 days , SD 6.0 days ; 95 % CI , 5.4 to 12.9 ; P < .001 , with t test ) . Physical function was also restored faster in the endovenous obliteration group . The estimated annual investment costs of the closure operation were US $ 3360 . The other direct medical costs of the Closure operation were about $ 850 , and those of the conventional treatment were $ 360 . With inclusion of the value of the lost working days , the Closure treatment was cost-saving for society , and when 40 % of the patients are retired ( or 60 % of the productivity loss was included ) , the Closure procedure became cost-saving at a level of 43 operations per year . CONCLUSION Endovenous obliteration may offer advantages over the conventional stripping operation in terms of reduced postoperative pain , shorter sick leaves , and faster return to normal activities , and it appears to be cost-saving for society , especially among employed patients . Because the procedure is also associated with shorter convalescence , this new method may potentially replace conventional varicose vein surgery OBJECTIVE AND DESIGN in 1978 Sheppard described using a flap of pectineus fascia in an attempt to reduce the further development of neovascularised veins at the saphenofemoral junction . The perceived benefits of this manoeuvre have not been tested by a prospect i ve r and omised trial . MATERIAL S AND METHODS consecutive patients with symptomatic recurrent varicose veins referred to a single consultant were examined for evidence of further reflux from the saphenofemoral junction . This was subsequently confirmed in forty limbs ( thirty-seven patients ) by descending venography . All had features of a neovascularised segment . These patients were treated by complete exposure and ligation of the recurrences arising from the common femoral vein , with or without the placement of a flap of pectineus fascia ( prospect ively r and omised ) . The patients were assessed a minimum of eighteen months later by both clinical examination and duplex ultrasound scanning . RESULTS six patients were lost to follow-up . This left seventeen limbs remaining in each half of the study . The characteristics in each group were broadly matched . CONCLUSIONS this study failed to demonstrate any apparent benefit from the application of a flap of pectineus fascia . Most patients showed evidence of re-recurrence arising from the common femoral vein In a prospect i ve study of 100 sequential varicose patients treated with sclerotherapy , 15 had some light brown pigmentations at the end of the treatment . One year later , 1 patient still had some linear pigmentations , while 4 other patients had a single , macular , barely visible pigmentation of no cosmetic significance BACKGROUND Although no r and omized controlled trial has assessed the effects of either compression sclerotherapy or ambulatory phlebectomy , both techniques are used to treat varicose veins worldwide . We performed a r and omized controlled trial to compare recurrence rates of varicose veins and complications after compression sclerotherapy and ambulatory phlebectomy . METHODS From September 1996 to October 1998 , we r and omly allocated 49 legs to compression sclerotherapy and 49 legs to ambulatory phlebectomy . Our primary outcome parameters were as follows : recurrence rates at 1 and 2 years and complications related to therapy . Eighty-two patients were included , of whom 16 were included with both of their legs . The number of treated legs was therefore 98 , but two patients were lost to follow-up . RESULTS One year recurrence amounted to 1 out of 48 for phlebectomy and 12 out of 48 for compression sclerotherapy ( P < 0.001 ) ; at 2 years , six additional recurrences were found , but then solely for compression sclerotherapy ( P < 0.001 ) . Significant differences in complications occurring more in phlebectomy than in compression sclerotherapy therapy were blisters , teleangiectatic matting , scar formation , and bruising from b and aging . CONCLUSION Our results show that ambulatory phlebectomy is an effective therapy for varicose veins of the leg . Recurrence rates are significantly lower than for compression sclerotherapy therapy . If varicose veins persist 4 weeks after compression sclerotherapy , it can be argued that to reduce the risk of future recurrence ambulatory phlebectomy should be considered as the better treatment option The study was planned to evaluate efficacy and costs of endovascular sclerotherapy ( ES ) in comparison with surgery and surgery associated with sclerotherapy in a prospect i ve ( 10-year follow-up ) , good- clinical - practice study . Patients with varicose veins and pure , superficial venous incompetence were included . Of the patients r and omized into the three groups 39 ( group A ) were treated with ES , 40 ( B ) with surgery + sclerotherapy , and 42 with surgery only ( C ) . Surgery consisted of ligation of the SFJ ( saphenofemoral junction ) and of incompetent veins detected with color duplex . Of the preselected 150 patients , 121 subjects entered the study ; 96 completed the 10-year follow-up ( mean age 52.6 ±6 years ; 51 men , 45 women ) . Dropouts were due to nonmedical problems . At 10 years no incompetence was observed in subjects treated with SPJ ligation ( B and C ) . In the ES group 18.8 % of the SFJs were patent and incompetent and in 43.8 % of limbs the distal ( below-knee ) venous system was still incompetent [ 16.1 % in the surgery + scle rotherapy group ( p < 0.05 ) and 36 % in the group treated Output:
However , the trend was for sclerotherapy to be evaluated as significantly better than surgery at one year ; after one year ( sclerotherapy result ed in worse outcomes ) the benefits with sclerotherapy were less , and by three to five years surgery had better outcomes . REVIEW ERS ' CONCLUSIONS There was insufficient evidence to preferentially recommend the use of sclerotherapy or surgery .
MS2_1shot74
***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 benefits of paramedic practitioners assessing and , when possible , treating older people in the community after minor injury or illness . Paramedic practitioners have been trained with extended skills to assess , treat , and discharge older patients with minor acute conditions in the community . Design Cluster r and omised controlled trial involving 56 clusters . Weeks were r and omised to the paramedic practitioner service being active ( intervention ) or inactive ( control ) when the st and ard 999 service was available . Setting A large urban area in Engl and . Participants 3018 patients aged over 60 who called the emergency services ( n=1549 intervention , n=1469 control ) . Main outcome measures Emergency department attendance or hospital admission between 0 and 28 days ; interval from time of call to time of discharge ; patients ' satisfaction with the service received . Results Overall , patients in the intervention group were less likely to attend an emergency department ( relative risk 0.72 , 95 % confidence interval 0.68 to 0.75 ) or require hospital admission within 28 days ( 0.87 , 0.81 to 0.94 ) and experienced a shorter total episode time ( 235 v 278 minutes , 95 % confidence interval for difference −60 minutes to −25 minutes ) . Patients in the intervention group were more likely to report being highly satisfied with their healthcare episode ( relative risk 1.16 , 1.09 to 1.23 ) . There was no significant difference in 28 day mortality ( 0.87 , 0.63 to 1.21 ) . Conclusions Paramedics with extended skills can provide a clinical ly effective alternative to st and ard ambulance transfer and treatment in an emergency department for elderly patients with acute minor conditions . Trial registration IS RCT N27796329 Over a 2-week period a prospect i ve study was undertaken of patients brought to an inner city accident and emergency department by the emergency ambulance service . Criteria for assessing the appropriateness of use of the emergency ambulance service are not well defined and at worst entirely subjective . The author 's finding that , of patients attending after a ‘ 999 ’ call , 49.8 % were discharged with no follow-up suggests that many of these journeys represented inappropriate use of the emergency ambulance service . Close liaison between senior medical staff and the emergency ambulance service may allow more appropriate and effective use of the service , improving patient care in the pre-hospital setting Background : A scheme to train paramedics to undertake a greater role in the care of older people following a call for an emergency ambulance was developed in a large city in the UK . Objectives : To assess the cost effectiveness of the paramedic practitioner ( PP ) scheme compared with usual emergency care . Methods : A cluster r and omised controlled trial was undertaken of PP compared with usual care . Weeks were allocated to the study group at r and om to the PP scheme either being active ( intervention ) or inactive ( control ) . Re source use data were collected from routine sources , and from patient-completed question naires for events up to 28 days . EQ-5D data were also collected at 28 days . Results : Whereas the intervention group received more PP contact time , it reduced the proportion of emergency department ( ED ) attendances ( 53.3 % vs 84.0 % ) and time in the ED ( 126.6 vs 211.3 minutes ) . There was also some evidence of increased use of health services in the days following the incident for patients in the intervention group . Overall , total costs in the intervention group were £ 140 lower when routine data were considered ( p = 0.63 ) . When the costs and QALY were considered simultaneously , PP had a greater than 95 % chance of being cost effective at £ 20 000 per QALY . Conclusion : Several changes in re source use are associated with the use of PP . Given these economic results in t and em with the clinical , operational and patient-related benefits , the wider implementation and evaluation of similar schemes should be considered Introduction : The Department of Health document Reforming emergency care stated that new initiatives need to be developed to improve the care and assessment of patients . The Audit Commission has suggested that ambulance services should be allowed to decide who should be sent to each type of emergency and treat some patients at home . Aims : This scheme explores a new way of providing clinical assessment of older patients in their homes or in care homes within Sheffield . It sets out to provide a very patient centred model of care by providing community based clinical assessment for patients presenting to the emergency services with minor acute conditions . Scope , development , and structure of scheme : The scheme trains paramedic practitioners in the assessment and treatment of minor conditions to emergency nurse practitioner level . It consists of a three week full time theory based course and a 45 day period of supervised clinical practice based in the emergency department , minor injury unit , care of the elderly falls clinic , and with community services . Subsequently , the competence of the practitioners is assessed . Service delivery : The service will be activated by a 999 call between 0800 to 2000 each day . It is anticipated that between 25 % to 50 % of patients eligible to receive the service will be assessed and treated within the home . This approach to providing emergency care is untested and the frequency of use , patient acceptability , safety , and cost effectiveness are unknown , therefore rigorous assessment is essential through a r and omised controlled trial To determine whether paramedics can safely treat and discharge insulin-dependent diabetic patients experiencing uncomplicated hypoglycemic events , we conducted a prospect i ve , observational study with a convenience sample of diabetic patients whose hypoglycemia resolved after intravenous administration of dextrose and before they were transported by paramedics . On-line medical control was contacted to obtain approval and informed consent for participation from interested patients who met all eligibility criteria for the study . Participating patients were given instructions upon discharge from the study and were contacted by telephone 24 hours later to ascertain their medical outcomes and their opinions of the study protocol . We enrolled a total of 36 patients with 38 incidents of hypoglycemia . Of these , 91 % reported no complications after discharge . Two patients developed recurrent hypoglycemia but treated themselves and did not require further emergency care . One further patient was found unresponsive on the morning following discharge and was subsequently admitted to a long-term care facility with hypoglycemic encephalopathy . Of the study participants , 85 % were very satisfied with not being transported to an emergency department ( ED ) and 91 % were very satisfied with the care they had received . All ( 100 % ) of the patients surveyed favored a permanent protocol allowing discharge of hypoglycemic patients without admission to an ED . We conclude that paramedics successfully treated , without complication , most of the patients with uncomplicated hypoglycemic events who were examined in our study . These patients generally preferred discharge without transportation to an ED BACKGROUND The role of paramedics with extended skills is evolving , enabling them to assess and treat patients in the community . A United Kingdom service led by extended-role paramedic practitioners ( PPs ) is aim ed at managing minor acute illness and injury among older people in the home when appropriate , avoiding unnecessary transfer to the emergency department ( ED ) . OBJECTIVES The objectives were to evaluate the safety of clinical decisions made by PPs operating within the new service . METHODS As part of a cluster-r and omized controlled trial , patients aged > 60 years contacting the emergency medical services ( EMS ) with a minor injury or illness were included in the study . The safety of the new PP intervention was compared with st and ard practice of EMS transfer and ED treatment . Outcomes included unplanned ED attendance within 7 days of the index episode . Clinical records were rated independently by two senior ED clinicians to identify related episodes , avoidable subsequent episodes , and suboptimal care . RESULTS Of the 2,025 patients included in this analysis , 219 ( 10.9 % ) went on to have an unplanned ED attendance within 7 days . Of these , 162 ( 74.0 % ) re-presented with a condition related to their index episode . The independent raters agreed on suboptimal care 83.4 % of the time . There were 16 agreed upon episodes related to suboptimal care ( 0.80 % ) . No significant differences were found between intervention and control groups in relation to re-presentation at hospital within 7 days for a related condition or rates of assessed suboptimal care . CONCLUSIONS This study suggests that appropriately trained paramedics with extended skills treating older people with minor acute conditions in the community are as safe as st and ard EMS transfer and treatment within the ED Objective To evaluate the impact of emergency care practitioners ( ECPs ) on the patient care pathway for children presenting with minor conditions in unscheduled care setting s. Design A pragmatic quasi-experimental multi-site community intervention trial comparing ECPs with usual care providers . Setting Three pairs of emergency and urgent care services in the UK : minor injury unit ( MIU ) , urgent care centre ( UCC ) and general practitioner out of hours . Patients Paediatric acute episodes ( n=415 intervention and n=748 control ) in participating services presenting with minor conditions . Main outcome measures Percentage of patients discharged following care episode and percentage of patients referred to hospital and primary care services . Interventions ECPs operational in emergency and unscheduled care setting s. Results ECPs discharged significantly fewer patients than usual care providers ( percentage difference 7.3 % , 95 % CI 13.6 % to 0.9 % ) . ECPs discharged fewer patients within all three pairs of services ( out of hours percentage difference 6.33 % , 95 % CI 15.17 % to 2.51 % ; UCC percentage difference 8.73 % , 95 % CI 19.22 % to 1.76 % ; MIU percentage difference 6.80 % , 95 % CI 24.36 % to 10.75 % ) . ECPs also referred more patients to hospital ( percentage difference 4.6 % , 95 % CI –2.9 % to 12.0 % ) and primary care providers ( percentage difference 3.0 % , 95 % CI 3.7 % to 9.7 % ) . Conclusions ECPs are not as effective as usual health providers in discharging children after assessment of urgent healthcare problems . This has implication s for the workload of other paediatric providers such as the emergency department . ECPs may be better targeted to setting s and patients groups in which there is more evidence of their effectiveness in patient care pathways Output:
Community paramedicine research to date is lacking , but programs in the United Kingdom , Australia , and Canada are perceived to be promising , and one RCT shows that paramedics can safely practice with an exp and ed scope and improve system performance and patient outcomes .
MS2_1shot75
***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 Abstract Objectives To evaluate postoperative medical complications and the association between these complications and mortality at 30 days and one year after surgery for hip fracture and to examine the association between preoperative comorbidity and the risk of postoperative complications and mortality . Design Prospect i ve observational cohort study . Setting University teaching hospital . Participants 2448 consecutive patients admitted with an acute hip fracture over a four year period . We excluded 358 patients : all those aged < 60 ; those with periprosthetic fractures , pathological fractures , and fractures treated without surgery ; and patients who died before surgery . Interventions Routine care for hip fractures . Main outcome measures Postoperative complications and mortality at 30 days and one year . Results Mortality was 9.6 % at 30 days and 33 % at one year . The most common postoperative complications were chest infection ( 9 % ) and heart failure ( 5 % ) . In patients who developed postoperative heart failure mortality was 65 % at 30 days ( hazard ratio 16.1 , 95 % confidence interval 12.2 to 21.3 ) . Of these patients , 92 % were dead by one year ( 11.3 , 9.1 to 14.0 ) . In patients who developed a postoperative chest infection mortality at 30 days was 43 % ( 8.5 , 6.6 to 11.1 ) . Significant preoperative variables for increased mortality at 30 days included the presence of three or more comorbidities ( 2.5 , 1.6 to 3.9 ) , respiratory disease ( 1.8 , 1.3 to 2.5 ) , and malignancy ( 1.5 , 1.01 to 2.3 ) . Conclusions In elderly people with hip fracture , the presence of three or more comorbidities is the strongest preoperative risk factor . Chest infection and heart failure are the most common postoperative complications and lead to increased mortality . These groups offer a clear target for specialist medical assessment 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 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 ) . No differences were seen between the three groups when major morbidity and mortality were combined , P=0.24 ( chi-squared , 2 df ) . Postoperative recovery for survivors , as defined by time to be deemed medically fit for discharge , was significantly faster , in comparison with Gp CON , in both the Gp CVP ( 10 vs 14 ( 95 % confidence interval 8 - 12 vs 12 - 17 ) days , P=0.008 ( t-test ) ) , and Gp DOP ( 8 vs 14 ( 95 % confidence interval 6 - 12 vs 12 - 17 ) days , P=0.023 ( t-test ) . There were no significant differences between groups , for survivors , with respect to acute orthopaedic hospital and total hospital stay . CONCLUSIONS Invasive intraoperative haemodynamic monitoring with fluid challenges during repair of femoral fracture under general anaesthetic shortens time to being medically fit for discharge 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 Background Approximately 70,000 patients /year undergo surgery for repair of a fractured hip in the United Kingdom . This is associated with 30-day mortality of 9 % and survivors have a considerable length of acute hospital stay postoperatively ( median 26 days ) . Use of oesophageal Doppler monitoring to guide intra-operative fluid administration in hip fracture repair has previously been associated with a reduction in hospital stay of 4 - 5 days . Most hip fracture surgery is now performed under spinal anaesthesia . Oesophageal Doppler monitoring may be unreliable in the presence of spinal anaesthesia and most patients would not tolerate the probes . An alternative method of guiding fluid administration ( minimally-invasive arterial pulse contour analysis ) has been shown to reduce length of stay in high-risk surgical patients but has never been studied in hip fracture surgery . Methods Single-centre r and omised controlled parallel group trial . R and omisation by website using computer generated concealed tables . Setting : University hospital in UK . Participants : 128 patients with acute primary hip fracture listed for operative repair under spinal anaesthesia and aged > 65 years . Intervention : Stroke volume guided intra-operative fluid management . Continuous measurement of SV recorded by a calibrated cardiac output monitor ( LiDCOplus ) . Maintenance fluid and 250 ml colloid boluses given to achieve sustained 10 % increases in stroke volume . Control group : fluid administration at the responsible ( blinded ) anaesthetist 's discretion . The intervention terminates at the end of the surgical procedure and post-operative fluid management is at the responsible anaesthetist 's discretion . Primary outcome : length of acute hospital stay is determined by a blinded team of clinicians . Secondary outcomes include number of complications and total cost of care . Funding NIHR/RfPB : PB-PG-0407 - 13073.Trial registration numberTrial registration : Current Controlled Trials IS RCT N88284896 Background Intraoperative hypovolemia is common and is a potential cause of organ dysfunction , increased postoperative morbidity , length of hospital stay , and death . The objective of this prospect i ve , r and omized study was to assess the effect of goal -directed intraoperative fluid administration on length of postoperative hospital stay . Methods One hundred patients who were to undergo major elective surgery with an anticipated blood loss greater than 500 ml were r and omly assigned to a control group ( n = 50 ) that received st and ard intraoperative care or to a protocol group ( n = 50 ) that , in addition , received intraoperative plasma volume expansion guided by the esophageal Doppler monitor to maintain maximal stroke volume . Length of postoperative hospital stay and postoperative surgical morbidity were assessed . Results Groups were similar with respect to demographics , surgical procedures , and baseline hemodynamic variables . The protocol group had a significantly higher stroke volume and cardiac output at the end of surgery compared with the control group . Patients in the protocol group had a shorter duration of hospital stay compared with the control group : 5 ± 3 versus 7 ± 3 days ( mean ± SD ) , with a median of 6 versus 7 days , respectively ( P = 0.03 ) . These patients also tolerated oral intake of solid food earlier than the control group : 3 ± 0.5 versus 4.7 ± 0.5 days ( mean ± SD ) , with a median of 3 versus 5 days , respectively ( P = 0.01 ) . Conclusions Goal -directed intraoperative fluid administration results in earlier return to bowel function , lower incidence of postoperative nausea and vomiting , and decrease in length of postoperative hospital stay Background A r and omized , controlled trial , intended to include 460 patients , is currently study ing peroperative goal -directed hemodynamic treatment ( GDHT ) of aged hip-fracture patients . Interim efficacy analysis performed on the first 100 patients was statistically uncertain ; thus , the trial is continuing in accordance with the trial protocol . This raised the present investigation ’s main question : Is it reasonable to continue to fund the trial to decrease uncertainty ? To answer this question , a previously developed probabilistic cost-effectiveness model was used . That model depicts ( 1 ) a choice between routine fluid treatment and GDHT , given uncertainty of current evidence and ( 2 ) the monetary value of further data collection to decrease uncertainty . This monetary value , that is , the expected value of perfect information ( EVPI ) , could be used to compare future research costs . Thus , the primary aim of the present investigation was to analyze EVPI of an ongoing trial with interim efficacy observed . Methods A previously developed probabilistic decision analyt Output:
Five studies including a total of 403 participants provided no evidence that fluid optimization strategies improve outcomes for participants undergoing surgery for PFF .
MS2_1shot76
***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 measurement of Samarium-153 ethylenediaminetetramethylene phosphonic acid ( (153)Sm-EDTMP ) bone uptake rate using whole-body scintigraphy and analyze the relationship between bone uptake rate and therapeutic effect . METHODS Sixty-six patients with painful bony metastases from prostate ( n = 15 ) , lung ( n = 20 ) , breast ( n= 18 ) , nasopharyngeal carcinoma ( NPC ) ( n=5 ) , colon ( n=2 ) , kidney ( n=2 ) and unknown cause ( n=4 ) carcinoma were examined with whole-body scintigraphy 10 min and 5 h post administration of (153)Sm-EDTMP . Bone uptake rate was then calculated . ( 1 ) Complete response ( CR ) : disappearance of > 2 metastases , Karnofsky Performance Score ( KPS ) increase > 20 , moderate or complete remission of bone pain 7 d post injection of (153)Sm-EDTMP . ( 2 ) Partial response ( PR ) : disappearance of 1 - 2 metastases , KPS increase 10 - 20 , moderate remission of bone pain in 3 wk . ( 3 ) Non-response ( NR ) : no disappearance or shrinkage of metastases , KPS increase < 10 , no or slight remission of bone pain . RESULTS The range of bone uptake rate in 66 patients was 31 .9 % - 86.6 % ( mean = 56 . 0 % ) . The bone uptake rate in the CR group ( 17 cases , 25.7 % ) , PR group ( 24 cases , 36.4 % ) , and NR group ( 25 cases , 37.9 % ) was 52.4 % - 86.6 % ( mean = 68.7 % ) , 43.7 % - 70.4 % ( mean = 58.3 % ) , and 31.9%- 51 .5 % ( mean = 41 . 0 % ) respectively . Statistical analysis showed that there was a significant difference between the CR and PR groups ( t = 4.258 , P = 0.001 ) as well as between PR and NR groups ( t = 8.48,P = 0.001 ) . CONCLUSIONS Using a simple and reliable whole-body scintigraphic technique to calculate prospect ively the bone uptake rate , we have , for the first time in China , reported the relationship between bone uptake rate and therapeutic effect . This allows nuclear medicine physicians to calculate a safe and effective dose of (153)Sm-EDTMPin individual patients to palliate bone cancer pain without myelotoxicity Output:
Although the data are limited , radioisotopes seem to reduce pain with a rapid onset of action and duration of response of 1 to 3 months . The evidence that bisphosphonates or denosumab reduce or prevent pain in patients with NSCLC and bone metastases or that they have an influence on QoL is very weak . Radioisotopes can be used to reduce diffuse pain , although there is no high-level evidence supporting such use
MS2_1shot77
***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 Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five . Presently , approximately 70 percent of children in the United States are currently enrolled in early childcare facilities , making this an ideal setting to implement and evaluate childhood obesity prevention efforts . We describe here the methods for conducting an obesity prevention r and omized trial in the child care setting . Methods / design A r and omized , controlled obesity prevention trial is currently being conducted over a three year period ( 2010-present ) . The sample consists of 28 low-income , ethnically diverse child care centers with 1105 children ( sample is 60 % Hispanic , 15 % Haitian , 12 % Black , 2 % non-Hispanic White and 71 % of caregivers were born outside of the US ) . The purpose is to test the efficacy of a parent and teacher role-modeling intervention on children ’s nutrition and physical activity behaviors . . The Healthy Caregivers-Healthy Children ( HC2 ) intervention arm schools received a combination of ( 1 ) implementing a daily curricula for teachers/parents ( the nutritional gatekeepers ) ; ( 2 ) implementing a daily curricula for children ; ( 3 ) technical assistance with meal and snack menu modifications such as including more fresh and less canned produce ; and ( 4 ) creation of a center policy for dietary requirements for meals and snacks , physical activity and screen time . Control arm schools received an attention control safety curriculum . Major outcome measures include pre-post changes in child body mass index percentile and z score , fruit and vegetable and other nutritious food intake , amount of physical activity , and parental nutrition and physical activity knowledge , attitudes , and beliefs , defined by intentions and behaviors . All measures were administered at the beginning and end of the school year for year one and year two of the study for a total of 4 longitudinal time points for assessment . Discussion Although few attempts have been made to prevent obesity during the first years of life , this period may represent the best opportunity for obesity prevention . Findings from this investigation will inform both the fields of childhood obesity prevention and early childhood research about the effects of an obesity prevention program housed in the childcare setting .Trial registration Trial registration number : This pilot study examined the effects of a teacher-taught , locomotor skill (LMS)-based physical activity ( PA ) program on the LMS and PA levels of minority preschooler-aged children . Eight low-socioeconomic status preschool classrooms were r and omized into LMS-PA ( LMS-oriented lesson plans ) or control group ( supervised free playtime ) . Interventions were delivered for 30 min/day , five days/week for six months . Changes in PA ( accelerometer ) and LMS variables were assessed with MANCOVA . LMS-PA group exhibited a significant reduction in during-preschool ( F ( 1,16 ) = 6.34 , p = .02 , d = 0.02 ) and total daily ( F ( 1,16 ) = 9.78 , p = .01 , d = 0.30 ) percent time spent in sedentary activity . LMS-PA group also exhibited significant improvement in leaping skills , F ( 1 , 51 ) = 7.18 , p = .01 , d = 0.80 ) . No other , significant changes were observed . The implementation of a teacher-taught , LMS-based PA program could potentially improve LMS and reduce sedentary time of minority preschoolers INTRODUCTION A pilot intervention was conducted to promote physical activity and nutrition in public preschool education ( near half a million children in Chile ) , in order to prevent obesity . OBJECTIVE To assess the primary ( body fat ) and secondary outcomes ( physical activity and energy intake ) of a nutrition and physical activity pilot intervention for preschool children , attending day care centres . METHODS A pilot intervention in six day care centres selected at r and om ( n = 530 ) , in 4 - 5 years old preschool children , Santiago , Chile intending to : provide nutritional and physical activity education to educators and health promotion activities for the family , which in turn , will affect the primary ( body fat ) , and secondary outcomes ( physical activity pattern and energy food intake ) were measured in a representative sub sample of 120 intervened and 145 controls children . RESULTS In relation to secondary outcomes monitoring , moderate-vigorous activity was duplicated in the intervention group ( + 5.4 % and + 4.7 % , respectively ) , in both obese and eutrophic children . Energy intake decreased in 11.7 % in obese and 7.5 % in eutrophic children . Dietary fat intake was reduced ( -11 g in obese and -8.4 g in eutrophic children ) . Intervened obese children reduced body fat in 1.5 % , meanwhile in control obese children , body fat increased 1.3 % ( p < 0.01 ) . CONCLUSIONS The pilot intervention demonstrated the feasibility to influence dietary risk factors and physical activity at the day care centres and families . Therefore , the implementation of the vali date d intervention program will be tested in different weather conditions , to prevent unhealthy habits in preschool children and their families Objective To assess the effect of a governmentally-led center based child care physical activity program ( Youp’là Bouge ) on child motor skills . Patients and methods We conducted a single blinded cluster r and omized controlled trial in 58 Swiss child care centers . Centers were r and omly selected and 1:1 assigned to a control or intervention group . The intervention lasted from September 2009 to June 2010 and included training of the educators , adaptation of the child care built environment , parental involvement and daily physical activity . Motor skill was the primary outcome and body mass index ( BMI ) , physical activity and quality of life secondary outcomes . The intervention implementation was also assessed . Results At baseline , 648 children present on the motor test day were included ( age 3.3 ± 0.6 , BMI 16.3 ± 1.3 kg/m2 , 13.2 % overweight , 49 % girls ) and 313 received the intervention . Relative to children in the control group ( n = 201 ) , children in the intervention group ( n = 187 ) showed no significant increase in motor skills ( delta of mean change ( 95 % confidence interval : -0.2 ( −0.8 to 0.3 ) , p = 0.43 ) or in any of the secondary outcomes . Not all child care centers implemented all the intervention components . Within the intervention group , several predictors were positively associated with trial outcomes : 1 ) free-access to a movement space and parental information session for motor skills 2 ) highly motivated and trained educators for BMI 3 ) free-access to a movement space and purchase of mobile equipment for physical activity ( all p < 0.05 ) . Conclusion This “ real-life ” physical activity program in child care centers confirms the complexity of implementing an intervention outside a study setting and identified potentially relevant predictors that could improve future programs . Trial registration Clinical trials.gov OBJECTIVE The purpose of the present study was to evaluate the effects of a school-based , 2-year , multi-component intervention on BMI , eating and physical activity behaviour in Fl and ers , Belgium , targeting children aged 3 - 6 years in communities of high and low socio-economic status ( SES ) . DESIGN Cluster-r and omized controlled trial . SETTING Thirty-one pre- primary and primary schools in three different intervention communities and three paired-matched ( on SES profile ) control communities in Fl and ers , Belgium . SUBJECTS BMI Z-scores at baseline and follow-up were calculated for 1102 children . Question naires with sociodemographic data and FFQ were available from 694 of these 1102 children . RESULTS No significant effects were found on BMI Z-scores for the total sample . However , there was a significant decrease in BMI Z-score of 0·11 in the low-SES intervention community compared with the low-SES control community , where the BMI Z-score increased by 0·04 ( F = 6·26 , P = 0·01 ) . No significant intervention effects could be found for eating behaviour , physical activity or screen-time . There were no significant interaction effects of age and gender of the children on the outcome variables . CONCLUSIONS Although no significant effects were found for BMI Z-scores in the total sample , this intervention had a promising effect in the low-SES community of reducing excess weight gain among young children This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS  Boston University Patricia Cortes  Harvard University Claudia Goldin  Swarthmore College Jennifer OBJECTIVE Determine whether Color Me Healthy ( CMH ) , an interactive nutrition and physical activity program for preschool children , increases fruit and vegetable consumption . DESIGN Intervention study . Data were collected at baseline , 1 week post-intervention , and 3 months post-intervention . SETTING Child care centers . PARTICIPANTS Preschool children ( n = 263 ) in 17 child care centers . INTERVENTION Child care centers were r and omly assigned to 1 of 2 conditions ; children ( n = 165 ) in 10 centers received the CMH curriculum , and children ( n = 98 ) in 7 centers acted as comparisons and did not receive the curriculum . MAIN OUTCOME MEASURES Process and outcome evaluation . Consumption of fruit and vegetable snacks . ANALYSIS Data were analyzed using repeated- measures analysis of variance and hierarchical linear modeling . RESULTS Children who received CMH significantly increased their consumption of fruit snacks by approximately 20.8 % and vegetable snacks by approximately 33.1 % between baseline assessment and the assessment conducted 3 months after the completion of the CMH program . Hierarchical linear modeling determined that group assignment ( ie , CMH or control ) was the only significant predictor of fruit and vegetable consumption . CONCLUSIONS AND IMPLICATION S Findings suggest that CMH may be used in child care setting s for developing healthful eating habits Early childhood is a critical time for promoting physical activity . Few studies have investigated the effect of interventions in this population . The aim of this study was to investigate the effect of a school-based active play intervention on preschool children 's sedentary time and physical activity . Preschool children were recruited from r and omly selected preschools . Schools were r and omly assigned to an intervention or comparison group . One teacher per intervention school received training from active play professionals in the delivery of a 6-week active play programme . Comparison schools continued their usual practice . Children wore a uni-axial accelerometer for 7 days at baseline , immediately after and at 6-month post-intervention . No significant intervention effects were observed for sedentary time or physical activity . However , sex and hours spent at school were significant predictors of physical activity . Children who spent fewer hours ( half-day children ) at school were significantly more active than their full-day counterparts . Physical activity during the intervention classes was high even though neither daily physical activity nor sedentary time changed . Notably children who spent more time at preschool were less active suggesting that preschool was not as conducive to physical activity engagement as other environments Background To address the public health crisis of overweight and obese preschool-age children , the Nutrition And Physical Activity Self Assessment for Child Care ( NAP SACC ) intervention was delivered by nurse child care health consultants with the objective of improving child care provider and parent nutrition and physical activity knowledge , center-level nutrition and physical activity policies and practice s , and children ’s body mass index ( BMI ) . Methods A seven-month r and omized control trial was conducted in 17 licensed child care centers serving predominantly low income families in California , Connecticut , and North Carolina , including 137 child care providers and 552 families with racially and ethnically diverse children three to five years old . The NAP SACC intervention included educational workshops for child care providers and parents on nutrition and physical activity and consultation visits provided by trained nurse child care health consultants . Demographic characteristics and pre - and post-workshop knowledge surveys were completed by providers and parents . Blinded research assistants review ed each center ’s written health and safety policies , observed nutrition and physical activity practice s , and measured r and omly selected children ’s nutritional intake , physical activity , and height and weight pre- and post-intervention . Results Hierarchical linear models and multiple regression models assessed individual- and center-level changes in knowledge , policies , practice s and age- and sex-specific st and ardized body mass index ( z BMI ) , controlling for state , parent education , and poverty level . Results showed significant increases in providers ’ and parents ’ knowledge of nutrition and physical activity , center-level improvements in policies , and child-level changes in children ’s z BMI based on 209 children in the intervention and control centers at both pre- and post-intervention time points . Conclusions The NAP SACC intervention , as delivered by trained child health professionals such as child care health consultants , increases provider knowledge , improves center policies , and lowers BMI for children in child care centers . More health professionals specifically trained in a nutrition and physical activity intervention in child care are needed to help reverse the obesity epidemic . Trial registration National Clinical Trials Number This study examined the effect of an early childhood obesity Output:
Intervention strength was positively correlated with reporting of positive anthropometric outcomes for physical activity , diet , and combined interventions , and parent engagement components increased the strength of these relationships . Study quality was modestly related to percent successful healthy eating outcomes . Relationships between intervention strength and behavioral outcomes demonstrated negative relationships for all behavioral outcomes . Specific components of intervention strength ( number of intervention strategies , potential impact of strategies , frequency of use , and duration of intervention ) were correlated with some of the anthropometric and parent engagement outcomes . The review provided tentative evidence that multi-component , multi-level ECE interventions with parental engagement are most likely to be effective with anthropometric outcomes
MS2_1shot78
***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 AND PURPOSE An active strategy was developed for the implementation of the clinical guidelines on physical therapy for patients with low back pain . The effect of this strategy on patients ' physical functioning , coping strategy , and beliefs regarding their low back pain was studied . SUBJECTS One hundred thirteen primary care physical therapists treated a total of 500 patients . METHODS The physical therapists were r and omly assigned to 1 of 2 groups . The control group received the guidelines by mail ( st and ard passive method of dissemination ) . The intervention group , in contrast , received an additional active training strategy consisting of 2 sessions with education , group discussion , role playing , feedback , and reminders . Patients with low back pain , treated by the participating therapists , completed question naires on physical functioning , pain , sick leave , coping , and beliefs . RESULTS Physical functioning and pain in the 2 groups improved substantially in the first 12 weeks . Multilevel longitudinal analysis showed no differences between the 2 groups on any outcome measure during follow-up . DISCUSSION AND CONCLUSION The authors found no additional benefit to applying an active strategy to implement the physical therapy guidelines for patients with low back pain . Active implementation strategies are not recommended if patient outcomes are to be improved Background The effects of lumbosacral orthoses ( LSOs ) on neuromuscular control of the trunk are not known . There is a concern that wearing LSOs for a long period may adversely alter muscle control , making individuals more susceptible to injury if they discontinue wearing the LSOs . The purpose of this study was to document neuromuscular changes in healthy subjects during a 3-week period while they regularly wore a LSO . Methods Fourteen subjects wore LSOs 3 hrs a day for 3 weeks . Trunk muscle activity prior to and following a quick force release ( trunk perturbation ) was measured with EMG in 3 sessions on days 0 , 7 , and 21 . A longitudinal , repeated- measures , factorial design was used . Muscle reflex response to trunk perturbations , spine compression force , as well as effective trunk stiffness and damping were dependent variables . The LSO , direction of perturbation , and testing session were the independent variables . Results The LSO significantly ( P < 0.001 ) increased the effective trunk stiffness by 160 Nm/rad ( 27 % ) across all directions and testing sessions . The number of antagonist muscles that responded with an onset activity was significantly reduced after 7 days of wearing the LSO , but this difference disappeared on day 21 and is likely not clinical ly relevant . The average number of agonist muscles switching off following the quick force release was significantly greater with the LSO , compared to without the LSO ( P = 0.003 ) . Conclusions The LSO increased trunk stiffness and result ed in a greater number of agonist muscles shutting-off in response to a quick force release . However , these effects did not result in detrimental changes to the neuromuscular function of trunk muscles after 3 weeks of wearing a LSO 3 hours a day by healthy subjects BACKGROUND CONTEXT Although previous studies suggest braces/corsets can reduce acute pain , no prior study has assessed back function after bracing with both self-reported and objective measures . Use of both self-reported and objective measures of spine function together may be important given evidence they assess unique aspects of function . PURPOSE The aim was to assess both self-reported and objective measures of spinal function before , and after , use of a nonrigid , inelastic lumbar brace . STUDY DESIGN / SETTING This was a non-r and omized clinical trial . PATIENT SAMPLE The sample included acute low back pain ( LBP ) participants and asymptomatic controls . OUTCOME MEASURES Oswestry Disability Index ( ODI ) , spinal stiffness , and muscle endurance were the outcome measures . METHODS Three groups were studied : -LBP/-Brace ( n=19 ) , -LBP/+Brace ( n=18 ) , and + LBP/+Brace ( n=17 ) . Both groups of braced participants were instructed to wear the brace continually for 2 weeks with the exception of bedroom and bathroom activities . Before and after the 2-week period , three measures of spinal function were performed : spinal stiffness via motorized indentation of the L3 spinous process , a modified Sorensen test ( timed lumbar extension against gravity ) , and the ODI . Repeated measures analyses of variance were conducted for all three outcomes . RESULTS Among the groups , ODI scores decreased significantly for the + LBP/+Brace group ( p<.001 ) compared with the other two groups . The + LBP/+Brace mean ODI score decreased 3.71 points ( 95 % confidence interval [ CI ] 2.01 - 5.40 ) compared with the -LBP/-Brace group and decreased 3.48 points ( 95 % CI 1.77 - 5.20 ) compared with the -LBP/+Brace group . Change scores for the Sorensen test were significantly increased in the + LBP/+Brace group ( p=.037 ) compared with the -LBP/-Brace group ( 22.47s 95 % CI 8.14 - 36.80 ) . Spinal stiffness did not change significantly between groups . CONCLUSIONS This study demonstrates that lumbar function assessed by self-reported and objective measures does not worsen when nonrigid , inelastic bracing is used for short periods of time for those with , or without , back pain . These data add to the existing literature that suggests short-term use of nonrigid , inelastic bracing for acute LBP does not decrease spinal function when measured separately with subjective or objective tools Study Design . Multicentric , r and omized , and controlled study of clinical evaluation of medical device in subacute low back pain . Objective . To evaluate the effects of an elastic lumbar belt on functional capacity , pain intensity in low back pain treatment , and the benefice on medical cost . Summary of Background Data . There is limited evidence of efficiency of lumbar supports for treatment of low back pain . There is also a lack of the methodology in the studies reported on the efficiency of this device . Methods . This study is r and omized , multicentric , and controlled with 2 groups : a patient group treated with a lumbar belt ( BWG ) and a control group ( CG ) . The main criteria of clinical evaluation were the physical restoration assessed with the EIFEL scale , the pain assessed by a visual analogic scale , the main economical criteria was the overall cost of associated medical treatments . Results . One hundred ninety-seven patients have participated . The results show a higher decrease in EIFEL score in BWG than CG between days 0 and 90 ( 7.6 ± 4.4 vs. de 6.1 ± 4.7;P = 0.023 ) . Respectively significant reduction in visual analogic scale was also noticed ( 41.5 ± 21.4 vs. 32.0 ± 20 ; P = 0.002 ) . Pharmacologic consumption decreased at D90 ( the proportion of patients who did not take any medication in BWG is 60.8 % vs. 40 % in CG;P = 0.029 ) . Conclusion . Lumbar belt wearing is consequent in subacute low back pain to improve significantly the functional status , the pain level , and the pharmacologic consumption . This study may be useful to underline the interest of lumbar support as a complementary and nonpharmacologic treatment beside the classic medication use in low back pain treatment OBJECTIVES To evaluate the effect of lumbopelvic belts on the thickness of lateral abdominal muscles and the cross-sectional area ( CSA ) of lumbar multifidus ( LM ) muscles . DESIGN A single-blinded r and omized controlled trial . SETTING An academic and tertiary care referral spine and sports medicine center . PARTICIPANTS Sixty healthy volunteers with no history of low back pain in the previous year . METHODS The subjects were allocated into belt and control groups . Lumbar belts were given to the subjects in the belt group , and they were asked to use the belts during the study period except during sleeping hours . The subjects were assessed at baseline and at 4 and 8 weeks . MAIN OUTCOME MEASURES The thickness of lateral abdominal muscles and the CSA of the LM muscles were measured by ultrasound with the patient in the hook-lying position on an examination table . RESULTS The thickness of lateral abdominal muscles and the CSA of LM muscles on both sides decreased significantly among healthy subjects in the belt group after 8 weeks . CONCLUSION The results of this study show that lumbopelvic belts might influence the ultrasonographic measurements of lateral abdominal and LM muscles and thereby spine stability One of the major challenges for general practitioners is to manage individuals with acute low back pain appropriately to reduce the risk of chronicity . A prospect i ve study was design ed to assess the actual management of acute low back pain in one primary care setting and to determine whether existing practice patterns conform to published guidelines . Twenty-four family physicians from public primary care centers of the Basque Health Service in Bizkaia , Basque Country ( Spain ) , participated in the study . A total of 105 patients aged 18–65 years presenting with acute low back pain over a 6-month period were included . Immediately after consultation , a research assistant performed a structured clinical interview . The patients ’ care provided by the general practitioner was compared with the Agency for Health Care Policy and Research ( AHCPR ) guidelines and guidelines issued by the Royal College of General Practitioners . The diagnostic process showed a low rate of appropriate use of history ( 27 % ) , physical examination ( 32 % ) , lumbar radiographs ( 31 % ) , and referral to specialized care ( 33 % ) . Although the therapeutic process showed a relatively high rate of appropriateness in earlier mobilization ( 77 % ) and educational advice ( 65 % ) , only 23 % of patients were taught about the benign course of back pain . The study revealed that management of acute low back pain in the primary care setting is far from being in conformance with published clinical guidelines Study Design . Prospect i ve cohort study . Objective . To quantify which 3 common lumbar orthoses of varying rigidity restrict both full , active range of motion ( ROM ) and functional ROM required for activities of daily living ( ADL ) . Summary of Background Data . Spinal orthoses are implemented to restrict lumbar motion . Despite widespread prevalence of lumbar bracing , the efficacy of these appliances for immobilizing the spine has not been definitively established . Methods . The full , active ROM of 10 asymptomatic individuals was quantified using an electrogoniometer that registered maximum rotation in all planes . Subjects subsequently completed 15 simulated ADLs during which time their functional ROM was measured ; performed without a brace and while wearing a corset , semirigid lumbosacral orthosis ( LSO ) , and rigid custom-molded LSO . Results . For flexion/extension , the mean percentage decreases ( with SDs ) in full , active ROM that were recorded with corset , semirigid , and a custom orthosis were 24.1 ± 7.9 % , 46.8 ± 7.1 % , and 64.7 ± 8 % , respectively ( P < 0.001 relative to no brace ) . In the coronal plane , motion was restricted by 33.9 ± 8.8 % , 51.9 ± 9.4 % , and 49.1 ± 11.8 % , respectively ( P < 0.001 ) . Finally , rotation was limited by 39.6 ± 8.8 % , 59.2 ± 10.2 % , and 70.6 ± 5.4 % , respectively ( P < 0.001 ) . There were no significant discrepancies between the ROM recorded in the semirigid and custom LSOs for the ADLs . Likewise , functional ROM associated with corset and semirigid LSOs were only different for 2 ADLs whereas significant disparities between values with corset and custom LSOs were observed for 4 simulations . Conclusion . The full , active ROM allowed by lumbar braces evaluated was greater than employed during ADLs in absence of any brace . The motion decrease beyond actual restriction of the braces suggests they will act primarily as proprioceptive guides to regulate movement This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence Study Design . Cluster r and omized controlled trial for a multifaceted implementation strategy . Objectives . To assess the effectiveness of tailored interventions ( multifaceted implementation strategy ) to implement the Dutch low back pain guideline for general practitioners with regard to adherence to guideline recommendations . Summary of Background Data . Guidelines for the management of low back pain in primary care have been developed in various countries , but little is known about the optimal implementation strategy . A multifaceted implementation strategy was developed to overcome identified barriers to the implementation of the Dutch low back pain guideline for general practitioners . Methods . General practitioners were r and omized to an intervention or a control group . The general practition Output:
The most common measures for motor performances were the maximum strength of the trunk flexors and extensors and the endurance and fatigability of the trunk extensors . The meta-analyses demonstrated no negative effect by the continuous use of an LSO for 1 - 6 months . However , the quality of evidence ranged from low to very low , and more high- quality trials are required to draw a definitive conclusion on the impact of the continuous use of an LSO on trunk motor performances
MS2_1shot79
***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 objective of this study was to determine the effect of a visual rehabilitation intervention on visual field defects in a US cohort . Vision Restoration Therapy ( VRT ) consists of a specific pattern of stimulation that is directed at the border of the blind field . METHODS This retrospective study evaluated individuals with homonymous visual field defect from retrochiasmatic lesions treated with 6 modules of VRT . Suprathreshold visual field testing of the central 43x32 was obtained at baseline and after each module . The main outcome measures were the change in stimuli detection and the shift in the position of the border of the blind field . The impact of age , time from injury and type of visual field defect were analyzed . RESULTS Among 161 patients , the mean absolute improvement in stimuli detection was 12.8 % . The average border shift was 4.87 . Improvements of > or =3 % was noted in 76 % of patients . Absolute change in stimulus detection of > or =3 % at mid-therapy was associated with a greater final improvement . Age , time from lesion and type of visual field defect did not influence the degree of field expansion . CONCLUSIONS VRT improves stimulus detection and results in a shift of the position of the border of the blind field as measured on suprathreshold visual field testing . These results support prior reports and support VRT as a useful rehabilitative intervention for a proportion of patients with visual field defects from retrochiasmatic lesions Background : Neurologically impaired persons seem to benefit from driving-training programs , but there is no convincing evidence to support this notion . The authors therefore investigated the effect of simulator-based training on driving after stroke . Methods : Eighty-three first-ever subacute stroke patients entered a 5-week 15-hour training program in which they were r and omly allocated to either an experimental ( simulator-based training ) or control ( driving-related cognitive tasks ) group . Performance in off-road evaluations and an on-road test were used to assess the driving ability of subjects pre- and post-training . Outcome of an official predriving assessment administered 6 to 9 months poststroke was also considered . Results : Both groups significantly improved in a visual and many neuropsychological evaluations and in the on-road test after training . There were no significant differences between both groups in improvements from pre- to post-training except in the “ road sign recognition test ” in which the experimental subjects improved more . Significant improvements in the three-class decision ( “ fit to drive , ” “ temporarily unfit to drive , ” and “ unfit to drive ” ) were found in favor of the experimental group post-training . Academic qualification and overall disability together determined subjects that benefited most from the simulator-based driving training . Significantly more experimental subjects ( 73 % ) than control subjects ( 42 % ) passed the follow-up official predriving assessment and were legally allowed to resume driving . Conclusions : Simulator-based driving training improved driving ability , especially for well educated and less disabled stroke patients . However , the findings of the study may have been modified as a result of the large number of dropouts and the possibility of some neurologic recovery unrelated to training PURPOSE ( 1 ) To compare the outcomes of orientation and mobility and driving training with Fresnel prisms and the Gottlieb Visual Field Awareness System for patients with homonymous hemianopsia , and ( 2 ) To determine whether the patients continue to use the optical enhancement devices at a 2-year follow-up point . METHODS Patients with homonymous hemianopsia were provided with a rehabilitation program where they were fitted with prism lenses and trained to use them for navigation and driving . Telephone interviews were used to obtain information about device usage 2 years following the completion of the training program . RESULTS Patients ' performance was compared with a test-retest criterion in the visual skills areas of recognition , mobility , peripheral detection , scanning , tracking , and visual memory . Patients with hemianopic loss showed improvements in all of the visual skills categories , ranging from the highest improvements of 26 % of tasks improved in the mobility category to 13 % in the recognition category . The majority of the hemianopic patients reported using the devices at the 2-year follow-up interview . CONCLUSIONS The patients with homonymous hemianopsia showed improvements in visual functioning using prism lenses , although these improvements were smaller than those found in previous studies with central or bilateral peripheral vision loss groups who were trained to use other optical enhancement devices for navigation and driving using a similar curriculum . However , given the evidence of increased risk of accidents for patients with peripheral vision loss , the safety of peripheral enhancement devices for driving must be thoroughly evaluated before their impact on public safety is known This article reports on two studies that examine the relationship between measurements of activities of daily living ( ADL ) and cognitive skills performance . Study 1 is a post hoc analysis of ADL improvement scores collected on acute stroke patients who were either given or not given cognitive skills remediation . An examination of individual ADL scores showed significantly higher personal hygiene , bathing , and toilet activity improvement scores for patients receiving cognitive skills remediation . In Study 2 , cognitive skills and ADL pre- and posttest scores for stroke patients were measured by occupational therapists , who also implemented an ADL as well as a cognitive skills remediation program as part of the patient 's therapy . Some significant positive correlations between initial cognitive skills measurements and ADL outcome were found . The best correlate of patients ' ADL performance at discharge was performance on an auditory attention task . Verbal comprehension correlated with overall ADL improvement , and overall cognitive skills improvement correlated with overall ADL improvement . Implication s of these two studies are discussed BACKGROUND the types of visual impairment followings stroke are wide ranging and encompass low vision , eye movement and visual field abnormalities , and visual perceptual difficulties . OBJECTIVE the purpose of this paper is to present a 1-year data set and identify the types of visual impairment occurring following stroke and their prevalence . METHODS a multi-centre prospect i ve observation study was undertaken in 14 acute trust hospitals . Stroke survivors with a suspected visual difficulty were recruited . St and ardised screening/referral and investigation forms were employed to document data on visual impairment specifically assessment of visual acuity , ocular pathology , eye alignment and movement , visual perception ( including inattention ) and visual field defects . RESULTS three hundred and twenty-three patients were recruited with a mean age of 69 years [ st and ard deviation ( SD ) 15 ] . Sixty-eight per cent had eye alignment/movement impairment , 49 % had visual field impairment , 26.5 % had low vision and 20.5 % had perceptual difficulties . CONCLUSIONS of patients referred with a suspected visual difficulty , only 8 % had normal vision status confirmed on examination . Ninety-two per cent had visual impairment of some form confirmed which is considerably higher than previous publications and probably relates to the prospect i ve , st and ardised investigation offered by specialist orthoptists . However , under-ascertainment of visual problems can not be ruled out Objective : An acquired right-sided homonymous hemianopia can result in slowed left-to-right text reading , called hemianopic alexia ( HA ) . Patients with HA lack essential visual information to help guide ensuing reading fixations . We tested two hypotheses : first , that practice with a visual rehabilitation method that induced small-field optokinetic nystagmus ( OKN ) would improve reading speeds in patients with HA when compared to a sham visual rehabilitation therapy ; second , that this therapy would preferentially affect reading saccades into the blind field . Methods : Nineteen patients with HA were entered into a two-armed study with two therapy blocks in each arm : one group practice d reading moving text ( MT ) that scrolled from right to left daily for two 4-week blocks ( Group1 ) , while the other had sham therapy ( spot the difference ) for the first block and then crossed over to MT for the second . Results : Group 1 showed significant improvements in static text reading speed over both therapy blocks ( 18 % improvement ) , while Group 2 did not significantly improve over the first block ( 5 % improvement ) but did when they crossed over to the MT block ( 23 % improvement ) . MT therapy was associated with a direction-specific effect on saccadic amplitude for rightward but not leftward reading saccades . Conclusion : Optokinetic nystagmus inducing therapy preferentially affects reading saccades in the direction of the induced ( involuntary ) saccadic component . This is the first study to demonstrate the effectiveness of a specific eye movement based therapy in patients with hemianopic alexia ( HA ) in the context of a therapy-controlled trial . A free Web-based version of the therapy used in this study is available online to suitable patients with HA Background : In patients with postgenicular lesions of the visual system , areas of residual vision ( ARVs ) are the main predictor of recovery induced by vision restoration therapy ( VRT ) . In these partially defective regions , the elevated perceptual thresholds can be acutely reduced by attentional cueing . Objective : To examine whether directing attention to ARVs using a visuospatial cue also increases long-term neural plasticity and thus enhances permanent training outcome . Methods : In a prospect i ve , r and omized clinical trial , treatment outcome was compared in patients with postgenicular visual system lesions who received either st and ard VRT ( control group [ CG ] ; n = 10 ) or VRT with attentional cueing ( experimental group [ EG ] ; n = 9 ) . Visual field size was determined before and after a 6-month treatment period using Tübingen Automated Perimetry and computer-based high-resolution perimetry ( HRP ) and in regular intervals throughout this period by HRP and detection performance in VRT . Results : In the area of the cue , restoration of vision was significantly greater than during VRT without cueing : cued patients showed a much more pronounced shift of the visual field border toward the blind area than that observed in the CG or in uncued regions of the EG . Focusing attention at ARVs during treatment changed topographic and temporal patterns of recovery as compared with uncued regions of the visual field . Conclusions : Use of a visuospatial cue to focus attention at areas of residual vision amplifies long-term neuronal plasticity . The authors propose that top-down signals preactivate partially damaged areas of V1 , thus linking visual and attentional neuronal networks , with the effect of permanently increasing conscious visual perception Objective : Patients with homonymous hemianopia are disabled on everyday exploratory activities . We examined whether explorative saccade training ( EST ) , compared with flicker-stimulation training ( FT ) , would selectively improve saccadic behavior on the patients ’ blind side and benefit performance on natural exploratory tasks . Methods : Twenty-eight hemianopic patients were r and omly assigned to distinct groups performing for 6 weeks either EST ( a digit- search task ) or FT ( blind-hemifield stimulation by flickering letters ) . Outcome variables ( response times [ RTs ] during natural search , number of fixations during natural scene exploration , fixation stability , visual fields , and quality -of-life scores ) were collected before , directly after , and 6 weeks after training . Results : EST yielded a reduced ( post/pre , 47 % ) digit- search RT for the blind side . Natural search RT decreased ( post/pre , 23 % ) on the blind side but not on the seeing side . After FT , both sides ’ RT remained unchanged . Only with EST did the number of fixations during natural scene exploration increase toward the blind and decrease on the seeing side ( follow-up/pre difference , 238 % ) . Even with the target located on the seeing side , after EST more fixations occurred toward the blind side . The EST group showed decreased ( post/pre , 43 % ) fixation stability and increased ( post/pre , 482 % ) asymmetry of fixations toward the blind side . Visual field size remained constant after both treatments . EST patients reported improvements in social domain . Conclusions : Explorative saccade training selectively improves saccadic behavior , natural search , and scene exploration on the blind side . Flicker-stimulation training does not improve saccadic behavior or visual fields . The findings show substantial benefits of compensatory exploration training , including subjective improvements in mastering daily-life activities , in a r and omized controlled trial Partial blindness after brain injury has been considered non-treatable . To evaluate whether patients with visual-field defects can profit from computer-based visual restitution training ( VRT ) , two independent clinical trials were conducted using patients with optic nerve ( n = 19 ) or post-chiasmatic brain injury ( n = 19 ) . In post-chiasma patients , VRT led to a significant improvement ( 29.4 % ) over baseline in the ability to detect visual stimuli ; in optic nerve patients , the effects were even more pronounced ( 73.6 % improvement ) . Visual-field enlargements were confirmed by the observation of a visual-field expansion of 4.9 ° –5.8 ° of visual angle and improved acuity in optic nerve patients . Ninety five percent of the VRT-treated patients showed improvements , 72.2 % confirmed visual improvements subjectively . Patients receiving a placebo training did not show comparable improvements . In conclusion , VRT with a computer program improves vision in patients with visual-field defects and offers a new , cost-effective therapy for partial blindness Visual field deficits in patients have long been considered to be nontreatable , but in previous studies we have found an enlargement of the intact visual field following vision restoration therapy ( VRT ) . In the present pilot study , we wished to determine whether a double-stimulation approach would facilitate visual field enlargements beyond those achieved by the single-stimulus paradigm used in st and ard VRT . This was motivated by the findings that following visual cortex injury in animals , the size of receptive fields could be enlarged by systematic costimulation , where two stimuli were used to excite visual cortex neurons ( Eysel , Eyding , & Schweigart , 1998 ) . Patients ( n = 23 ) with stable homonymous field deficits after trauma , cerebral ischemia , or hemorrhage ( lesion age > 6 months ) carried out either ( a ) st and ard VRT with a single stimulation ( n = 9 ) , or vision therapy with ( b ) a parallel cost Output:
AUTHORS ' CONCLUSIONS There is limited evidence which supports the use of compensatory scanning training for patients with visual field defects ( and possibly co-existing visual neglect ) to improve scanning and reading outcomes . There is insufficient evidence to reach a conclusion about the impact of compensatory scanning training on functional activities of daily living . There is insufficient evidence to reach generalised conclusions about the benefits of visual restitution training ( VRT ) ( restitutive intervention ) or prisms ( substitutive intervention ) for patients with visual field defects after stroke
MS2_1shot80
***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 Small food store interventions show promise to increase healthy food access in under-re source d areas . However , none have tested the impact of price discounts on healthy food supply and dem and . We tested the impact of store-directed price discounts and communications strategies , separately and combined , on the stocking , sales and prices of healthier foods and on storeowner psychosocial factors . Design Factorial design r and omized controlled trial . Setting Twenty-four corner stores in low-income neighbourhoods of Baltimore City , MD , USA . Subjects Stores were r and omized to pricing intervention , communications intervention , combined pricing and communications intervention , or control . Stores that received the pricing intervention were given a 10–30 % price discount by wholesalers on selected healthier food items during the 6-month trial . Communications stores received visual and interactive material s to promote healthy items , including signage , taste tests and refrigerators . Results All interventions showed significantly increased stock of promoted foods υ . control . There was a significant treatment effect for daily unit sales of healthy snacks ( β = 6·4 , 95 % CI 0·9 , 11·9 ) and prices of healthy staple foods ( β = −0·49 , 95 % CI −0·90 , −0·03 ) for the combined group υ . control , but not for other intervention groups . There were no significant intervention effects on storeowner psychosocial factors . Conclusions All interventions led to increased stock of healthier foods . The combined intervention was effective in increasing sales of healthier snacks , even though discounts on snacks were not passed to the consumer . Experimental research in small stores is needed to underst and the mechanisms by which store-directed price promotions can increase healthy food supply and dem and Background Lowering the price of fruit and vegetables is a promising strategy in stimulating the purchase of those foods . However , the true effects of this strategy are not well studied and it is unclear how the money saved is spent . The aim of this study is to examine the effects of a 25 % discount on fruits and vegetables on food purchases in a supermarket environment . Methods A r and omized controlled trial with two research conditions was conducted : a control condition with regular prices ( n = 52 ) and an experimental condition with a 25 % discount on fruits and vegetables ( n = 63 ) . The experiment was carried out using a three-dimensional web-based supermarket , which is a software application in the image of a real supermarket . Data were collected in 2010 in the Netherl and s. Participants received a fixed budget and were asked to buy weekly household groceries at the web-based supermarket . Differences in fruit and vegetable purchases , differences in expenditures in other food categories and differences in total calories were analyzed using independent sample s t-tests and multiple linear regression models accounting for potential effect modifiers and confounders . Results The purchased amount of fruit plus vegetables was significantly higher in the experimental condition compared to the control condition ( Δ984 g per household per week , p = .03 ) after appropriate adjustments . This corresponds to a 25 % difference compared to the control group . Both groups had similar expenditures in unhealthier food categories , including desserts , soda , crisps , c and y and chocolate . Furthermore , both groups purchased an equal number of food items and an equal amount of calories , indicating that participants in the discount condition did not spend the money they saved from the discounts on other foods than fruits and vegetables . Conclusion A 25 % discount on fruits and vegetables was effective in stimulating purchases of those products and did neither lead to higher expenditures in unhealthier food categories nor to higher total calories purchased . Future studies in real supermarkets need to confirm these findings Twenty-four-hour urine collection , as a gold st and ard method of measuring salt intake , is costly and re source consuming , which limits its use in monitoring population salt reduction programs . Our study aim ed to determine whether a salt sales survey could serve as an alternative method . This was a sub study of China Rural Health Initiative-Sodium Reduction Study ( CRHI-SRS ) , in which 120 villages were r and omly allocated ( 1:1:2 ) into a price subsidy+health education ( PS+HE ) group , a HE-only group or a control group . Salt substitutes ( SS ) were supplied to shops in the intervention groups ; 24-h urine was collected from 2567 r and omly selected adults at the end of the trial to evaluate the effects of the intervention . Ten villages were r and omly selected from each group ( that is , 30 villages in total ) , and 166 shops from these villages were invited to participate in the monthly salt sales survey . The results showed that during the intervention period , mean monthly sales of SS per shop were 38.0 kg for the PS+HE group , 19.2 kg for the HE only and 2.2 kg for the control group ( P<0.05 ) , which was consistent with the results from the 24-h urine sodium and potassium data . The intervention effects of CRHI-SRS on sodium and potassium intake estimated from SS sales were 101 % and 114 % , respectively , of those observed from the 24-h urine data . Furthermore , the salt sales survey cost only 14 % of the cost of the 24-h urine method and had greater statistical power . The results indicate that a salt sales survey could serve as a simple , sensitive and cost-effective method to evaluate community-based salt reduction programs in which salt is mainly added by the consumers OBJECTIVE Fiscal policies may form a solution in improving dietary intake . This study aim ed to examine the effectiveness of varying taxing and subsiding schemes to stimulate healthier food purchases . METHODS A r and omized controlled trial with three levels of price reduction on healthy foods ( no ; 25 % ; 50%) × three levels of price increase on unhealthy foods ( 5 % ; 10 % ; 25 % ) factorial design was used . 150 participants were r and omized into one of nine conditions and were asked to purchase groceries at a web-based supermarket . Data were collected in the Netherl and s in January-February 2010 and analyzed using analysis of covariance . RESULTS Subjects receiving 50 % discount purchased significantly more healthy foods than subjects receiving no ( mean difference=6.62 items , p<0.01 ) or 25 % discount ( mean difference=4.87 items , p<0.05 ) . Moreover , these subjects purchased more vegetables ( mean difference=821 g;p<0.05 compared to no discount ) . However , participants with the highest discount also purchased significantly more calories . No significant effects of the price increases on unhealthy foods were found . CONCLUSION Price decreases are effective in stimulating healthy food purchases , but the proportion of healthy foods remains unaffected . Price increases up to 25 % on unhealthier products do not significantly affect food purchases . Future studies are important to vali date these results in real supermarkets and across different countries Background Two strategies commonly recommended to improve population diets include food labels and food taxes/subsidies . The aim of this study was to examine the effects of both strategies separately and in combination . Findings An experiment with a 3x3 factorial design was conducted , including : three levels of price reduction ( 10 % ; 25 % ; and 50 % ) x three labels ( ‘ special offer ’ , ‘ healthy choice ’ and ‘ special offer & healthy choice ’ ) on healthy foods defined following the Choices front-of-pack nutrition label . N = 109 participants completed the experiment by conducting a typical weekly shop for their household at a three-dimensional web-based supermarket . Data were analysed using analysis of covariance . Participants receiving a 50 % price discount purchased significantly more healthy foods for their household in a typical weekly shop than the 10 % discount ( + 8.7 items ; 95%CI = 3.8 - 13.6 ) and the 25 % discount group ( + 7.7 items ; 95%CI = 2.74 – 12.6 ) . However , the proportion of healthy foods was not significantly higher and the discounts lead to an increased amount of energy purchased . No significant effects of the labels were found . Conclusion This study brings some relevant insights into the effects of price discounts on healthier foods coupled with different labels and shows that price effects over shadowed food labels . However , price discounts seem to have ambiguous effects ; they do encourage the purchase of healthy products , but also lead to increased energy purchases . More research is needed to examine how pricing strategies can work in directing consumers towards interchanging unhealthier options for healthier alternatives OBJECTIVE This study tested the efficacy of a multicomponent supermarket point-of-purchase intervention featuring in-person nutrition education on the nutrient composition of food purchases . DESIGN The design was a r and omized trial comparing the intervention with usual care ( no treatment ) . SETTING AND PARTICIPANTS A supermarket in a socioeconomically diverse region of Phoenix , AZ . One hundred fifty-three adult shoppers were recruited onsite . INTERVENTION The intervention consisted of brief shopping education by a nutrition educator and an explanation and promotion of a supermarket point-of-purchase healthful shopping program that included posted shelf signs identifying healthful foods , sample shopping lists , tips , and signage . MAIN OUTCOME MEASURES Outcomes included purchases of total , saturated , and trans fat ( grams/1,000 kcal ) , and fruits , vegetables , and dark-green/yellow vegetables ( servings/1,000 kcal ) derived through nutritional analysis of participant shopping baskets . ANALYSIS Analysis of covariance compared the intervention and control groups on food purchasing patterns while adjusting for household income . RESULTS The intervention result ed in greater purchasing of fruit and dark-green/yellow vegetables . No other group differences were observed . CONCLUSIONS AND IMPLICATION S Long-term evaluations of supermarket interventions should be conducted to improve the evidence base and to determine the potential for influence on food choices associated with decreased chronic disease incidence OBJECTIVES Financial constraint is the underpinning determinant of household food insecurity ; however , there has been little research examining the impact that increasing the ‘ money available ’ to food-insecure households could have on food purchasing . The main objective of the present study was to examine the effect of additional money ( in the form of supermarket vouchers ) on food expenditure in food-insecure households with children . DESIGN A parallel r and omized controlled trial with a 4-week baseline phase followed by a 4-week intervention phase . Households were r and omized to either receive vouchers ( coupons ) for 4 weeks or a control group that did not receive any vouchers . SETTING Dunedin , New Zeal and . SUBJECTS Low-income households with children ≥ 18 years ) reporting food insecurity ( n 214 ) . RESULTS The mean monetary value of the vouchers received by households was $ NZ 17?00 per week . The voucher group spent ≥ NZ 15.20 ( 95 % CI 1.46 , 28.94 ) more per week on food during the intervention phase compared with the control group ( P50.030 ) . There were no differences in expenditure between the voucher and the control group for the food groups ‘ fruit and vegetables ’ ( mean difference : ≥ NZ 0?46 ; 95 % CI 21.97 , 2.89 ; P50.709 ) , ‘ meat and poultry ’ ( mean difference : ≥ NZ 0.29 ; 95 % CI 23.07 , 3.64 ; P50.866 ) and ‘ dairy ’ ( mean difference : ≥ NZ 0.82 ; 95 % CI 20.75 , 2.42 ; P50.302 ) . CONCLUSIONS Providing money via supermarket vouchers to food-insecure result ed in an increase in overall expenditure on food Background : Nutrition labeling is a prominent policy to promote healthy eating . Objective : We aim ed to evaluate the effects of 2 interpretive nutrition labels compared with a noninterpretive label on consumer food purchases . Design : In this parallel-group r and omized controlled trial , we enrolled household shoppers across New Zeal and who owned smartphones and were aged ≥18 y. Eligible participants were r and omly assigned ( 1:1:1 ) to receive either traffic light labels ( TLLs ) , Health Star Rating labels ( HSRs ) , or a control [ nutrition information panel ( NIP ) ] . Smartphone technology allowed participants to scan barcodes of packaged foods and to receive allocated labels on their smartphone screens . The primary outcome was the mean healthiness of all packaged food purchases over the 4-wk intervention period , which was measured by using the Food St and ards Australia New Zeal and Nutrient Profiling Scoring Criterion ( NPSC ) . Results : Between October 2014 and November 2015 , 1357 eligible shoppers were r and omly assigned to TLL ( n = 459 ) , HSR ( n = 443 ) , or NIP ( n = 455 ) labels . Overall difference in the mean transformed NPSC score for the TLL group compared with the NIP group was -0.20 ( 95 % CI : -0.94 , 0.54 ; P = 0.60 ) . The corresponding difference for HSR compared with NIP was -0.60 ( 95 % CI : -1.35 , 0.15 ; P = 0.12 ) . In an exploratory per- protocol analysis of participants who used the labeling intervention more often than average ( n = 423 , 31 % ) , those who were assigned to TLL and HSR had significantly better NPSC scores [ TLL compared with NIP : -1.33 ( 95 % CI : -2.63 , -0.04 ; P = 0.04 ) ; HSR compared with NIP : -1.70 ( 95 % CI : -2. Output:
Store environment interventions showed mixed effects . Education-only interventions appeared effective in simulated environments but not in real stores . Available data suggested that effects of economic interventions did not differ by socioeconomic status , whereas for other interventions impact was variable . In our qualitative comparative analysis , economic interventions ( regardless of setting ) and environmental and swap interventions in real stores were associated with statistically significant changes in purchasing in the desired direction for ≥1 of the foods targeted by the intervention , whereas education-only interventions in real stores were not . Conclusions Findings suggest that interventions implemented in grocery stores-particularly ones that manipulate price , suggest swaps , and perhaps manipulate item availability-have an impact on purchasing and could play a role in public health strategies to improve health .
MS2_1shot81
***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: Remote ischemic preconditioning reduces myocardial infa rct ion ( MI ) in animal models . We tested the hypothesis that the systemic protection thus induced is effective when ischemic preconditioning is administered during ischemia ( PerC ) and before reperfusion and examined the role of the K(+)-dependent ATP ( K(ATP ) ) channel . Twenty 20-kg pigs were r and omized ( 10 in each group ) to 40 min of left anterior descending coronary artery occlusion with 120 min of reperfusion . PerC consisted of four 5-min cycles of lower limb ischemia by tourniquet during left anterior descending coronary artery occlusion . Left ventricular ( LV ) function was assessed by a conductance catheter and extent of infa rct ion by tetrazolium staining . The extent of MI was significantly reduced by PerC ( 60.4 + /- 14.3 vs. 38.3 + /- 15.4 % , P = 0.004 ) and associated with improved functional indexes . The increase in the time constant of diastolic relaxation was significantly attenuated by PerC compared with control in ischemia and reperfusion ( P = 0.01 and 0.04 , respectively ) . At 120 min of reperfusion , preload-recruitable stroke work declined 38 + /- 6 % and 3 + /- 5 % in control and PerC , respectively ( P = 0.001 ) . The force-frequency relation was significantly depressed at 120 min of reperfusion in both groups , but optimal heart rate was significantly lower in the control group ( P = 0.04 ) . There were fewer malignant arrhythmias with PerC during reperfusion ( P = 0.02 ) . These protective effects of PerC were abolished by glibenclamide . Intermittent limb ischemia during myocardial ischemia reduces MI , preserves global systolic and diastolic function , and protects against arrhythmia during the reperfusion phase through a K(ATP ) channel-dependent mechanism . Underst and ing this process may have important therapeutic implication s for a range of ischemia-reperfusion syndromes BACKGROUND Remote ischaemic preconditioning attenuates cardiac injury at elective surgery and angioplasty . We tested the hypothesis that remote ischaemic conditioning during evolving ST-elevation myocardial infa rct ion , and done before primary percutaneous coronary intervention , increases myocardial salvage . METHODS 333 consecutive adult patients with a suspected first acute myocardial infa rct ion were r and omly assigned in a 1:1 ratio by computerised block r and omisation to receive primary percutaneous coronary intervention with ( n=166 patients ) versus without ( n=167 ) remote conditioning ( intermittent arm ischaemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff ) . Allocation was concealed with opaque sealed envelopes . Patients received remote conditioning during transport to hospital , and primary percutaneous coronary intervention in hospital . The primary endpoint was myocardial salvage index at 30 days after primary percutaneous coronary intervention , measured by myocardial perfusion imaging as the proportion of the area at risk salvaged by treatment ; analysis was per protocol . This study is registered with Clinical Trials.gov , number NCT00435266 . FINDINGS 82 patients were excluded on arrival at hospital because they did not meet inclusion criteria , 32 were lost to follow-up , and 77 did not complete the follow-up with data for salvage index . Median salvage index was 0.75 ( IQR 0.50 - 0.93 , n=73 ) in the remote conditioning group versus 0.55 ( 0.35 - 0.88 , n=69 ) in the control group , with median difference of 0.10 ( 95 % CI 0.01 - 0.22 ; p=0.0333 ) ; mean salvage index was 0.69 ( SD 0.27 ) versus 0.57 ( 0.26 ) , with mean difference of 0.12 ( 95 % CI 0.01 - 0.21 ; p=0.0333 ) . Major adverse coronary events were death ( n=3 per group ) , reinfa rct ion ( n=1 per group ) , and heart failure ( n=3 per group ) . INTERPRETATION Remote ischaemic conditioning before hospital admission increases myocardial salvage , and has a favourable safety profile . Our findings merit a larger trial to establish the effect of remote conditioning on clinical outcomes . FUNDING Fondation Leducq OBJECTIVES We sought to relate left ventricular ejection fraction ( EF ) , end-systolic volume index ( ESVI ) and infa rct size ( IS ) , as measured in a single r and omized trial , to six-month mortality after myocardial infa rct ion ( MI ) treated with thrombolysis . BACKGROUND These three prognostic indicators have never been compared in the same study group . METHODS Radionuclide angiographic and single-photon emission computed tomographic sestamibi measurements of IS were performed in 1,194 and 1,181 patients , respectively , of the 2,948 patients enrolled in the Collaborative Organization for RheothRx Evaluation ( CORE ) trial . Ejection fraction , ESVI and IS , as measured by central laboratories in these radionuclide sub studies , were tested for their association with six-month mortality . RESULTS Ejection fraction ( n = 1,137 ; p < 0.0001 ) , ESVI ( n = 945 ; p = 0.055 ) and IS ( n = 1,164 ; p = 0.03 ) were all associated with six-month mortality . Each of these measurements was significantly correlated with the other two , regardless of MI location . In an " overlap " group of 753 patients ( 25.5 % of the population ; 13 deaths ) in whom all three measurements were available , EF ( p = 0.001 ) was a stronger predictor than ESVI ( p = 0.005 ) or IS ( p = 0.01 ) . Neither of the other two measurements added independent prognostic information . The highest risk subgroup ( EF < 30 % ) had an 11 % six-month mortality , but comprised only 95 patients ( 8.3 % ) . CONCLUSIONS Ejection fraction , ESVI and IS measurements performed one to two weeks after MI can each predict six-month mortality . Ejection fraction was superior to the other two measurements . However , this study had limited power to detect independent significance of ESVI or IS BACKGROUND Contrast medium-induced acute kidney injury ( CI-AKI ) is a cardiovascular complication after myocardial infa rct ion treated with emergency percutaneous coronary intervention . The aim of this r and omized , sham-controlled trial was to evaluate the impact of remote ischemic preconditioning ( RIPC ) on CI-AKI in patients with ST-elevation myocardial infa rct ion who received emergency primary percutaneous coronary intervention . METHODS AND RESULTS Patients with a suspected ST-elevation myocardial infa rct ion were r and omly assigned at a 1:1 ratio to receive percutaneous coronary intervention either with ( n=63 ) or without ( n=62 ) RIPC ( intermittent arm ischemia through three cycles of 5min of inflation and 5min of deflation of a blood pressure cuff ) . A total of 47 RIPC patients and 47 control patients met all study criteria . The primary endpoint was the incidence of CI-AKI , which was defined as an increase in serum creatinine > 0.5mg/dL or > 25 % over the baseline value 48 - 72h after administration of contrast medium . The incidence of CI-AKI was 10 % ( n=5 ) in the RIPC group and 36 % ( n=17 ) in the control group ( p=0.003 ) . The odds ratio of CI-AKI in patients who received RIPC was 0.18 ( 95 % confidence interval : 0.05 - 0.64 ; p=0.008 ) . CONCLUSIONS In patients with ST-elevation myocardial infa rct ion , RIPC before percutaneous coronary intervention reduced the incidence of CI-AKI Introduction Myocardial injury after percutaneous coronary intervention ( PCI ) occurs in approximately 30 % of procedures , and is related to worse prognosis . Effects of remote ischemic preconditioning ( RIPC ) on reperfusion injury have been investigated before , yielding conflicting results . Aim To assess the impact of a single episode of RIPC on myocardial injury after elective PCI . Material and methods One hundred and four patients undergoing elective PCI , with normal baseline cardiac troponin-I ( cTn-I ) values , were r and omized to two groups . Two patients were excluded due to data loss , and 102 patients were analyzed . Five minutes of ischemic preconditioning was delivered just before the intervention to the preconditioning group , by inflating the blood pressure cuff up to 200 mm Hg on the non-dominant arm . Postprocedural 16th hour cTn-I , ΔcTn-I ( difference between the 16th h and baseline cTn-I values ) and the prevalence of type 4a myocardial infa rct ion were compared between the two groups . Results Median cTn-I values after the procedure were compared . 16th hour cTn-I was insignificantly lower in the preconditioning arm ( 0.026 μg/l vs. 0.045 μg/l , p = 0.186 ) . The incidence of cTn-I elevation 5-fold above the upper reference limit ( URL ) ( > 0.115 μg/l ) was lower in the preconditioning group , but it was also not significant ( 21.6 % vs. 11.8 % , p = 0.184 ) . Conclusions A single episode of RIPC before elective PCI demonstrated less troponin elevation but failed to show a significant effect Background Remote ischemic postconditioning ( RIPC ) is suggested to protect the myocardium against ischemia in various setting s. However , the effect of RIPC in patients with acute ST-elevation myocardial infa rct ion ( STEMI ) who undergo thrombolysis has yet to be examined . Patients and methods In this single-center , r and omized controlled trial , we examined the effect of RIPC on the resolution of ST-segment elevation ( STR ) in response to thrombolysis . Patients in the RIPC group had three cycles of 5‑min cuff inflation followed by 5‑min deflation to the upper arm . Results The study comprised 78 patients ( 15 women ) , of whom 41 were r and omized to the RIPC group and 37 to the control group . STR occurred in 61 % of the patients in the RIPC group , while it was detected only in 35 % of controls ( p = 0.026 ) . Although STR was more common in the RIPC group , there was no difference in the extent of ΣCK-48 h between the two groups . Furthermore , the length of hospital stay and the frequency of adverse events were similar between the RIPC and control groups . Conclusion RIPC during thrombolytic therapy in STEMI was associated with a higher frequency of STR . However , it did not affect enzymatic infa rct size or the frequency of adverse events . ( Clinical trial registration number : I RCT 2014011916229N2.)ZusammenfassungHintergrundDie indirekte ischämische Postkonditionierung ( „ remote ischemic postconditioning “ , RIPC ) soll das Myokard gegen Ischämie in verschiedenen Situationen schützen . Die Wirksamkeit der RIPC bei Patienten mit akutem ST-Strecken-Hebungs-Infarkt ( STEMI ) , bei denen eine Thrombolyse erfolgt , muss allerdings noch untersucht werden . Patienten und Method enIn der vorliegenden r and omisierten kontrollierten Einzelzentrumsstudie wurde die Wirksamkeit des RIPC auf die Rückbildung der ST-Strecken-Hebung ( STR ) als Reaktion auf die Thrombolyse untersucht . Patienten in der RIPC-Gruppe hatten 3 Zyklen mit 5‑minütigem Aufpumpen der Manschette und anschließendem 5‑minütigem Ablassen der Manschette am Oberarm . ErgebnisseAn der Studie nahmen 78 Patienten ( davon 15 Frauen ) teil , von denen 41 r and omisiert der RIPC-Gruppe und 37 der Kontrollgruppe zugeteilt wurden . Eine STR trat bei 61 % der Patienten in der RIPC-Gruppe auf , aber nur bei 35 % der Kontrollen ( p = 0,026 ) . Zwar gab es eine STR häufiger in der RIPC-Gruppe , aber es best and kein Unterschied i m Ausmaß von ΣCK-48 h zwischen den beiden Gruppen . Darüber hinaus waren die Verweildauer und die Häufigkeit unerwünschter Ereignisse zwischen der RIPC- und der Kontrollgruppe ähnlich . SchlussfolgerungEine RIPC während der Thromobolysetherapie bei STEMI ging mit größerer Häufigkeit einer STR einher . Sie hatte jedoch keine Auswirkung auf die enzymatische Infarktgröße oder die Häufigkeit unerwünschter Ereignisse . ( Nummer i m Register klinischer Studien , „ clinical trial registration number “ : I Output:
Conclusions : Despite a statistically significant reduction of myocardial damage in STEMI patients , the magnitude of the reduction was small and a significant impact on clinical events is unlikely . With respect to elective percutaneous coronary intervention , remote ischaemic conditioning had no influence on myocardial injury and its use is not supported by our analysis
MS2_1shot82
***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 This trial evaluated the efficacy and safety of sorafenib plus gemcitabine/cisplatin in chemotherapy-naive patients with unresectable stage IIIB to IV nonsquamous non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Between February 2007 and March 2009 , 904 patients were r and omly assigned to daily sorafenib ( 400 mg twice a day ) or matching placebo plus gemcitabine ( 1,250 mg/m(2 ) per day on days 1 and 8) and cisplatin ( 75 mg/m(2 ) on day 1 ) for up to six 21-day cycles . Because of safety findings from the Evaluation of Sorafenib , Carboplatin and Paclitaxel Efficacy in NSCLC ( ESCAPE ) trial , patients with squamous cell histology were withdrawn from the trial in February 2008 and excluded from analysis . The primary end point was overall survival ( OS ) , and secondary end points included progression-free survival ( PFS ) and time-to-progression ( TTP ) . RESULTS The primary analysis population consisted of 772 patients ( sorafenib , 385 ; placebo , 387 ) ; the two groups had similar demographic and baseline characteristics . Median OS was similar in the sorafenib and placebo groups ( 12.4 v 12.5 months ; hazard ratio [ HR ] , 0.98 ; P = .401 ) . By investigator assessment , sorafenib improved median PFS ( 6.0 v 5.5 months ; HR , 0.83 ; P = .008 ) and TTP ( 6.1 v 5.5 months ; HR , 0.73 ; P < .001 ) . Grade 3 to 4 drug-related adverse events more than two-fold higher in the sorafenib group included h and -foot skin reaction ( 8.6 % v 0.3 % ) , fatigue ( 7.3 % v 3.6 % ) , rash ( 5.7 % v 0.5 % ) , and hypertension ( 4.2 % v 1.8 % ) . No unexpected toxicities were observed . CONCLUSION This study did not meet its primary end point of improved OS when sorafenib was added to first-line gemcitabine/cisplatin in patients with advanced nonsquamous NSCLC . Identification of predictive biomarkers is warranted in future trials of sorafenib Purpose : Hypertension is a commonly reported side effect in antiangiogenic therapy . We investigated the hypothesis that telatinib , a small molecule angiogenesis inhibitor , impairs vascular function , induces rarefaction , and causes hypertension . Experimental Design : A side- study was done in a phase I trial of telatinib , a small molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptors 2 and 3 , platelet-derived growth factor receptor , and c-KIT in patients with advanced solid tumors . Measurements of blood pressure , flow-mediated dilation , nitroglycerin-mediated dilation , aortic pulse wave velocity , skin blood flux with laser Doppler flow , and capillary density with sidestream dark field imaging were done at baseline and after 5 weeks of treatment . Blood pressure and proteinuria were measured weekly . Results : Mean systolic and diastolic blood pressure values increased significantly at + 6.6 mm Hg ( P = 0.009 ) and + 4.7 mm Hg ( P = 0.016 ) , respectively . Mean flow-mediated dilation and mean nitroglycerin-mediated dilation values significantly decreased by −2.1 % ( P = 0.003 ) and −5.1 % ( P = 0.001 ) , respectively . After 5 weeks of treatment , mean pulse wave velocity significantly increased by 1.2 m/s ( P = 0.001 ) . A statistically significant reduction of mean skin blood flux of 532.8 % arbitrary units was seen ( P = 0.015 ) . Capillary density statistically significantly decreased from 20.8 to 16.7 capillary loops ( P = 0.015 ) . Proteinuria developed or increased in six patients during telatinib treatment . Conclusion : The increase in blood pressure observed in the treatment with telatinib , an angiogenesis inhibitor , may be caused by functional or structural rarefaction BACKGROUND Hypertension ( HTN ) , a recognized adverse effect of angiogenesis inhibitors , may be a potential biomarker of activity of these agents . We conducted a retrospective analysis to examine the incidence and predictors of the development of on-treatment HTN with the vascular endothelial growth factor receptor tyrosine kinase inhibitor cediranib , and the relationship of this adverse event with treatment outcomes . PATIENTS AND METHODS BR24 was a double-blind placebo-controlled phase II trial of carboplatin/paclitaxel chemotherapy with either daily oral cediranib or placebo in patients ( n = 296 ) with advanced non-small-cell lung cancer ( NSCLC ) . Exploratory analyses characterized relationships between HTN , baseline variables , and efficacy outcomes . RESULTS New onset or worsening of preexisting HTN ( treatment-emergent HTN ) was more frequent in patients receiving cediranib ( 68 versus 45 % , P < 0.0001 ) . Factors associated with HTN in all r and omized patients were good performance status and treatment with cediranib . In both arms , treatment-emergent HTN was associated with improved efficacy outcomes , but there was no evidence of a differential treatment effect , with nonsignificant interaction P values . CONCLUSIONS In advanced NSCLC , HTN is frequent in patients receiving chemotherapy , with or without cediranib . The development of HTN was favorably prognostic in these patients , but not predictive of a differential outcome with cediranib Background : Anlotinib ( AL3818 ) is a novel multitarget tyrosine kinase inhibitor , inhibiting tumour angiogenesis and proliferative signalling . The objective of this study was to assess the safety and efficacy of third-line anlotinib for patients with refractory advanced non-small-cell lung cancer ( RA-NSCLC ) . Methods : Eligible patients were r and omised 1 : 1 to receive anlotinib ( 12 mg per day , per os ; days 1–14 ; 21 days per cycle ) or a placebo . The primary end point was progression-free survival ( PFS ) . Results : A total of 117 eligible patients enrolled from 13 clinical centres in China were analysed in the full analysis set . No patients received immune check-point inhibitors and epidermal growth factor receptor status was unknown in 60.7 % of the population . PFS was better with anlotinib compared with the placebo ( 4.8 vs 1.2 months ; hazard ratio (HR)=0.32 ; 95 % confidence interval ( CI ) , 0.20–0.51 ; P<0.0001 ) , as well as overall response rate ( ORR ) ( 10.0 % ; 95 % CI , 2.4–17.6 % vs 0 % ; 95 % CI , 0–6.27 % ; P=0.028 ) . The median overall survival ( OS ) was 9.3 months ( 95 % CI , 6.8–15.1 ) for the anlotinib group and 6.3 months ( 95 % CI , 4.3–10.5 ) for the placebo group ( HR=0.78 ; 95 % CI , 0.51–1.18 ; P=0.2316 ) . Adverse events were more frequent in the anlotinib than the placebo group . The percentage of grade 3–4 treatment-related adverse events was 21.67 % in the anlotinib group . Conclusions : Anlotinib as a third-line treatment provided significant PFS benefits to patients with RA-NSCLC when compared with the placebo , and the toxicity profiles showed good tolerance PURPOSE This phase II/III double-blind study assessed efficacy and safety of cediranib with st and ard chemotherapy as initial therapy for advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Paclitaxel ( 200 mg/m(2 ) ) and carboplatin ( area under the serum concentration-time curve 6 ) were given every 3 weeks , with daily oral cediranib or placebo at 30 mg ( first 45 patients received 45 mg ) . Progression-free survival ( PFS ) was the primary outcome of the phase II interim analysis ; phase III would proceed if the hazard ratio ( HR ) for PFS < or = 0.77 and toxicity were acceptable . Results A total of 296 patients were enrolled , 251 to the 30-mg cohort . The phase II interim analysis demonstrated a significantly higher response rate ( RR ) for cediranib than for placebo , HR of 0.77 for PFS , no excess hemoptysis , and a similar number of deaths in each arm . The study was halted to review imbalances in assigned causes of death . In the primary phase II analysis ( 30-mg cohort ) , the adjusted HR for PFS was 0.77 ( 95 % CI , 0.56 to 1.08 ) with a higher RR for cediranib than for placebo ( 38 % v 16 % ; P < .0001 ) . Cediranib patients had more hypertension , hypothyroidism , h and -foot syndrome , and GI toxicity . Hypoalbuminemia , age > or = 65 years , and female sex predicted increased toxicity . Survival up date ( N = 296 ) 10 months after study unblinding favored cediranib over placebo ( median of 10.5 months v 10.1 months ; HR , 0.78 ; 95 % CI , 0.57 to 1.06 ; P = .11 ) . Causes of death in the cediranib 30-mg cohort were NSCLC ( 81 % ) , protocol toxicity + /- NSCLC ( 13 % ) , and other ( 6 % ) ; for the placebo group , they were 98 % , 0 % , and 2 % , respectively . CONCLUSION The addition of cediranib to carboplatin/paclitaxel results in improved response and PFS , but does not appear tolerable at a 30-mg dose . Consequently , the National Cancer Institute of Canada Clinical Trials Group and the Australasian Lung Cancer Trials Group initiated a r and omized , double-blind , placebo-controlled trial of cediranib 20 mg with carboplatin and paclitaxel in advanced NSCLC Using MRI techniques , we show here that normalization of tumor vessels in recurrent glioblastoma patients by daily administration of AZD2171-an oral tyrosine kinase inhibitor of VEGF receptors-has rapid onset , is prolonged but reversible , and has the significant clinical benefit of alleviating edema . Reversal of normalization began by 28 days , though some features persisted for as long as four months . Basic FGF , SDF1alpha , and viable circulating endothelial cells ( CECs ) increased when tumors escaped treatment , and circulating progenitor cells ( CPCs ) increased when tumors progressed after drug interruption . Our study provides insight into different mechanisms of action of this class of drugs in recurrent glioblastoma patients and suggests that the timing of combination therapy may be critical for optimizing activity against this tumor BACKGROUND V and etanib ( ZACTIMA ; ZD6474 ) is a once-daily , oral inhibitor of vascular endothelial growth factor receptor and epidermal growth factor receptor signaling . The safety and tolerability of v and etanib plus pemetrexed was assessed in patients with advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Patients with previously treated NSCLC ( stage IIIB/IV ) received once-daily oral v and etanib ( 100 or 300 mg ) with pemetrexed ( 500 mg/m(2 ) i.v . infusion every 21 days ) . RESULTS Patients received v and etanib 100 mg + pemetrexed ( n=10 ) or v and etanib 300 mg + pemetrexed ( n=11 ) . The protocol definition of a tolerable dose [ v and etanib-related dose-limiting toxicity ( DLT ) in less than 2 patients ] was met in both dose cohorts , with one DLT reported in each : asymptomatic QTc prolongation ( > 100 ms increase from baseline , but absolute QTc<500 ms ) in the 100 mg cohort and interstitial lung disease , which resolved after steroid therapy , in the 300 mg cohort . The most common adverse events were rash , anorexia , fatigue and diarrhea ( all n=10 ) . CONCLUSION V and etanib and pemetrexed in combination were generally well tolerated in patients with advanced NSCLC Background The efficacy and safety of axitinib , a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1 , 2 , and 3 in combination with pemetrexed and cisplatin was evaluated in patients with advanced non-squamous non – small-cell lung cancer ( NSCLC ) . Methods Overall , 170 patients were r and omly assigned to receive axitinib at a starting dose of 5-mg twice daily continuously plus pemetrexed 50 Output:
The incidence of some high grade ( ≥ 3 ) AEs increased , such as hemorrhage , hypertension and neutropenia . Conclusions : Our study demonstrated that regimens with VEGFR-TKIs combined with chemotherapy improved PFS , ORR and DCR in patients with advanced NSCLC , but had no impact on OS . VEGFR-TKIs induced more frequent and serious AEs compared with control therapies
MS2_1shot83
***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 There are very limited data regarding the effects of blueberry flavonoid intake on vascular function in healthy humans . OBJECTIVES We investigated the impact of blueberry flavonoid intake on endothelial function in healthy men and assessed potential mechanisms of action by the assessment of circulating metabolites and neutrophil NADPH oxidase activity . DESIGN Two r and omized , controlled , double-blind , crossover human-intervention trials were conducted with 21 healthy men . Initially , the impact of blueberry flavonoid intake on flow-mediated dilation ( FMD ) and polyphenol absorption and metabolism was assessed at baseline and 1 , 2 , 4 , and 6 h after consumption of blueberry containing 766 , 1278 , and 1791 mg total blueberry polyphenols or a macronutrient- and micronutrient-matched control drink ( 0 mg total blueberry polyphenols ) . Second , an intake-dependence study was conducted ( from baseline to 1 h ) with 319 , 637 , 766 , 1278 , and 1791 mg total blueberry polyphenols and a control . RESULTS We observed a biphasic time-dependent increase in FMD , with significant increases at 1 - 2 and 6 h after consumption of blueberry polyphenols . No significant intake-dependence was observed between 766 and 1791 mg . However , at 1 h after consumption , FMD increased dose dependently to ≤766 mg total blueberry polyphenol intake , after which FMD plateaued . Increases in FMD were closely linked to increases in circulating metabolites and by decreases in neutrophil NADPH oxidase activity at 1 - 2 and 6 h. CONCLUSIONS Blueberry intake acutely improves vascular function in healthy men in a time- and intake-dependent manner . These benefits may be mechanistically linked to the actions of circulating phenolic metabolites on neutrophil NADPH oxidase activity . This trial was registered at clinical trials.gov as NCT01292954 and NCT01829542 SCOPE Blueberries are a rich source of flavonoids and phenolic acids . Currently , little information is available regarding the impact of processing on the bioavailability and the bioactivity of blueberry (poly)phenols . METHODS AND RESULTS In a r and omized , controlled crossover trial , ten healthy volunteers consumed ( a ) blueberry-containing baked products , ( b ) an unprocessed blueberry drink containing the same amount of freeze-dried blueberry powder as used in the baked products , and ( c ) matched control baked products . Endothelial function was measured as flow-mediated dilation ( FMD ) and plasma sample s taken at baseline and at 1 , 2 , 4 , and 6 h postconsumption . Although processing did not significantly change the total (poly)phenolic amount , the processed products contained significantly less anthocyanins ( -42 % ) , more chlorogenic acid ( 23 % ) , no flavanol nonamers or decamers , and significantly more flavanol dimers and trimers ( 36 % and 28 % , respectively ) . FMD increased after 1 , 2 , and 6 h consumption of the baked products to a similar degree as the unprocessed blueberries , despite significant differences in the levels of individual plasma metabolites . No changes were observed after the consumption of the control product . CONCLUSION Careful processing can preserve important biological activities of blueberries despite changing the blueberry (poly)phenol composition and plasma metabolite profile SCOPE Underst and ing the metabolic fate of polyphenols from plant foods can aid in developing dietary recommendations that maximize their health benefits . Wild blueberries ( WBB ) provide a distinctive composition of dietary anthocyanins and chlorogenic acid ( CGA ) . METHODS AND RESULTS This is a single blind , r and omized , two-arm crossover controlled study . Human subjects ingested a WBB beverage ( 25 g freeze dried WBB powder ) or placebo beverage with a meal and plasma was collected over 24 h. Anthocyanins , CGA and their metabolites were characterized and quantified in beverages and in plasma using targeted and non-targeted mass analyses . Bioavailability of WBB anthocyanins and 3-CGA was 1.1 and 0.2 % , respectively . Parent anthocyanins and 3-CGA peaked ≈2 h post ingestion , while phase II metabolites , including glucuronide conjugates of peonidin , delphinidin , cyanidin and petunidin peaked ≈ 2.6 , 6.3 , 7 and 8.8 h , respectively . Phenolic acids ( metabolites ) peaked between 0.5 and 24 h. Biphasic responses were evident suggesting preferential enterohepatic recycling for some compounds . CONCLUSION The data indicate bioavailability of early and late phase WBB metabolites peaking at different times during the 24 h period , which may be important for maximizing their biological activity Using a r and omized , double-blinded , placebo-controlled , parallel group design , this investigation determined if the combination of two weeks of flavonoid supplementation ( 329 mg/day , quercetin , anthocyanins , flavan-3-ols mixture ) and a 45-minute walking bout ( 62.2 ± 0.9 % VO2max ( maximal oxygen consumption rate ) ) enhanced the translocation of gut-derived phenolics into circulation in a group of walkers ( n = 77 ) . The walkers ( flavonoid , placebo groups ) were r and omized to either sit or walk briskly on treadmills for 45 min ( thus , four groups : placebo – sit , placebo – walk , flavonoid – sit , flavonoid – walk ) . A comparator group of runners ( n = 19 ) ingested a double flavonoid dose for two weeks ( 658 mg/day ) and ran for 2.5 h ( 69.2 ± 1.2 % VO2max ) . Four blood sample s were collected ( pre- and post-supplementation , immediately post- and 24 h post-exercise/rest ) . Of the 76 metabolites detected in this targeted analysis , 15 increased after the 2.5 h run , and when grouped were also elevated post-exercise ( versus placebo – sit ) for the placebo– and flavonoid – walking groups ( p < 0.05 ) . A secondary analysis showed that pre- study plasma concentrations of gut-derived phenolics in the runners were 40 % higher compared to walkers ( p = 0.031 ) . These data indicate that acute exercise bouts ( brisk walking , intensive running ) are linked to an increased translocation of gut-derived phenolics into circulation , an effect that is amplified when combined with a two-week period of increased flavonoid intake or chronic training as a runner Output:
However , significant within-group effects for change from baseline were prevalent , suggesting that high inter-individual variability precluded significant treatment effects . Berry consumption in general appears to cause a fluctuation in the pools of small molecule metabolites already present at baseline , rather than the appearance of unique berry-derived metabolites , which likely reflects the ubiquitous nature of (poly)phenols in the background diet
MS2_1shot84
***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 : Portal hypertension is one of the most frequent complications of cirrhosis . β-adrenergic blockers , with or without organic nitrates , are currently used as hypotensive agents . Statins such as simvastatin seem to be safe for patients with chronic liver diseases and exert multiple pleiotropic actions . This study aim ed to assess PTH using Doppler ultrasound in patients with cirrhosis before and after simvastatin administration . Methods : This r and omized controlled clinical trial was conducted on 40 patients with cirrhosis who were r and omized into 2 groups : group I included 20 patients with cirrhosis who were administered 20 mg of simvastatin daily for 2 weeks and then 40 mg daily for another 2 weeks , and group II included 20 patients with cirrhosis who did not receive simvastatin as a control group . All patients underwent full clinical examination , laboratory investigations , and abdominal Doppler ultrasound at baseline and after 30 days to evaluate portal vein diameter , blood flow volume , direction and velocity of portal vein blood flow , hepatic artery resistance and pulsatility indices , splenic artery resistance index , portal hypertension index ( PHI ) , liver vascular index , and modified liver vascular index ( MLVI ) . Results : There was a highly significant decrease in the hepatic artery resistance index in group I , from 0.785 ± 0.088 to 0.717 ± 0.086 ( P < 0.001 ) . There was a significant decrease in the PHI in group I , from 3.915 ± 0.973 m/sec to 3.605 ± 1.168 m/sec ( P = 0.024 ) . Additionally , there was a significant increase in the MLVI in group I from 11.540 ± 3.266 cm/sec to 13.305 ± 3.222 cm/sec , an increase of 15.3 % from baseline ( P = 0.009 ) . No significant adverse effects were detected . Conclusions : Simvastatin is safe and effective in lowering portal hypertension . [ Clinical Trials.gov Identifier : NCT02994485 BACKGROUND In r and omized clinical trials statins and placebo treated patients showed the same degree of coronary artery calcium ( CAC ) progression . We reanalyzed data from two clinical trials to further investigate the time and dose dependent effects of statins on CAC . Additionally , we investigated whether CAC progression was associated with incident cardiovascular events . METHODS AND RESULTS Data were pooled from two clinical trials : St. Francis Heart Study ( SFHS ) ( 419 and 432 patients treated with placebo and 20 mg atorvastatin daily , respectively ) and EBEAT Study ( 164 and 179 patients respectively treated with 10 mg and 80 mg atorvastatin daily ) . CAC scores were assessed at baseline , 2 years and 4 - 6 years in SFHS ; in EBEAT they were measured at baseline and 12 months . After a short-term follow-up ( 12 to 24 months ) placebo and low dose atorvastatin showed a similar CAC increase , although 80 mg/daily atorvastatin increased CAC an additional 12 - 14 % over placebo ( p<0.001 ) . In the long-term , atorvastatin caused a greater progression of CAC compared to placebo ( additional 1.1 % , p=0.04 ) . In SFHS 42 cardiovascular events occurred after the second CT scan . The baseline and progression of CAC were greater in patients with events . However , only baseline CAC and family history of premature cardiovascular disease but not CAC progression were independent predictors of events . CONCLUSIONS Despite a greater CAC increase with high dose and long-term statin therapy , events did not occur more frequently in statin treated patients . This suggests that CAC growth under treatment with statins represents plaque repair rather than continuing plaque expansion BACKGROUND & AIMS In cirrhosis , an insufficient release of nitric oxide contributes to increased hepatic resistance and portal pressure and enhances the postpr and ial increase in portal pressure . We hypothesized that simvastatin , which enhances Akt-dependent endothelial nitric oxide synthase phosphorylation , may increase hepatic nitric oxide release and decrease hepatic resistance in patients with cirrhosis and portal hypertension . METHODS In protocol 1 , 13 patients had measurements of the hepatic venous pressure gradient , hepatic blood flow , mean arterial pressure , cardiac output , and nitric oxide products before and 30 and 60 minutes after 40 mg of simvastatin . In protocol 2 , 17 patients were r and omized to receive placebo or simvastatin ( 40 mg ) 12 hours and 1 hour before the study . After baseline measurements of the hepatic venous pressure gradient , hepatic blood flow , and nitric oxide products , a st and ard liquid meal was given , and measurements were repeated at 15 , 30 , and 45 minutes . RESULTS In protocol 1 , acute simvastatin did not modify the hepatic venous pressure gradient but increased the hepatic blood flow ( 21 % + /- 13 % at 30 minutes ; P = 0.01 ) and decreased hepatic sinusoidal resistance by 14 % + /- 11 % ( P = 0.04 ) . Nitric oxide product levels significantly increased in hepatic venous blood ( from 31.4 + /- 12.3 nmol . mL(-1 ) to 35.8 + /- 10.7 nmol . mL(-1 ) ; P = 0.04 ) , but not in peripheral blood . Systemic hemodynamics were not modified . In protocol 2 , simvastatin pretreatment significantly attenuated the postpr and ial increase in hepatic venous pressure gradient ( mean peak increase , 10 % + /- 9 % vs. 21 % + /- 6 % in placebo ; P = 0.01 ) . Hepatic blood flow increased similarly in the 2 groups . Hepatic nitric oxide products increased in the simvastatin group but not in the placebo group . CONCLUSIONS Simvastatin administration increases the hepatosplanchnic output of nitric oxide products and decreases hepatic resistance in patients with cirrhosis BACKGROUND & AIMS Simvastatin improves liver generation of nitric oxide and hepatic endothelial dysfunction in patients with cirrhosis , so it could be an effective therapy for portal hypertension . This r and omized controlled trial evaluated the effects of continuous simvastatin administration on the hepatic venous pressure gradient ( HVPG ) and its safety in patients with cirrhosis and portal hypertension . METHODS Fifty-nine patients with cirrhosis and portal hypertension ( HVPG > or = 12 mm Hg ) were r and omized to groups that were given simvastatin 20 mg/day for 1 month ( increased to 40 mg/day at day 15 ) or placebo in a double-blind clinical trial . R and omization was stratified according to whether the patient was being treated with beta-adrenergic blockers . We studied splanchnic and systemic hemodynamics and variables of liver function and safety before and after 1 month of treatment . RESULTS Simvastatin significantly decreased HVPG ( -8.3 % ) without deleterious effects in systemic hemodynamics . HVPG decreases were observed in patients who were receiving beta-adrenergic blockers ( -11.0 % ; P = .033 ) and in those who were not ( -5.9 % ; P = .013 ) . Simvastatin improved hepatic , fractional , and intrinsic clearance of indocyanine green , showing an improvement in effective liver perfusion and function . No significant changes in HVPG and liver function were observed in patients receiving placebo . The number of patients with adverse events did not differ significantly between groups . No patient was withdrawn from the study based on adverse events . CONCLUSIONS Simvastatin decreased HVPG and improved liver perfusion in patients with cirrhosis . These effects were additive with those of beta-adrenergic blockers . The beneficial effects of simvastatin should be confirmed in long-term clinical trials for portal hypertension BACKGROUND Pleiotropic effects of statins decrease intrahepatic resistance and portal hypertension . AIM We evaluated the effects of simvastatin on hepatic venous pressure gradient ( HVPG ) and azygos vein blood flow in cirrhotic patients . METHODS A 3-month prospect i ve , r and omized , triple-blind trial with simvastatin ( 40 mg/day ) vs. placebo was conducted in patients with cirrhotic portal hypertension . HVPG and azygos blood flow , measured by colour Doppler endoscopic ultrasound , were assessed before and after treatment . The primary endpoint was a decrease in the HVPG of at least 20 % from baseline or to ≤12 mmHg after the treatment . RESULTS 34 patients were prospect ively enrolled , and 24 completed the protocol . In the simvastatin group 6/11 patients ( 55 % ) presented a clinical ly relevant decrease in the HVPG ; no decrease was observed in the placebo group ( p=0.036 ) . Patients with medium/large oesophageal varices and previous variceal bleeding had a higher response rate to simvastatin . HVPG and azygos blood flow values were not correlated . No significant adverse events occurred . CONCLUSION Simvastatin lowers portal pressure and may even improve liver function . The haemodynamic effect appears to be more evident in patients with severe portal hypertension Background and aim Statins can modulate portal microvascular dynamics in patients with cirrhosis . We present data from a proof-of-concept study aim ed at comparing combination of propranolol and atorvastatin versus propranolol alone in reducing portal pressure in patients with cirrhosis . Patients and methods In this open-label proof-of-concept study , 23 consecutive patients with cirrhosis were r and omized into group A ( incremental dose propranolol , n=12 ) or group B ( atorvastatin 20 mg daily with propranolol in incremental dose , n=11 ) . Hepatic venous pressure gradient ( HVPG ) was estimated at baseline , and after 30 days , clinical outcomes were evaluated after 1 year . Results The two groups were matched with respect to etiology of cirrhosis ; clinical , biochemical , and endoscopic parameters ; child status ; and baseline HVPG . Decreases of wedged hepatic venous pressure , free hepatic venous pressure , and HVPG in group A and group B after 30 days were 4.67±2.57 versus 6.09±3.56 ( P=0.290 ) , 1.83±2.62 versus 1.27±1.67 ( P=0.546 ) , and 2.58±1.88 versus 4.81±2.82 mmHg ( P=0.041 ) , respectively . The proportion of HVPG responders in group A and group B were 50.00 and 90.91 % , respectively . The two groups did not , however , differ significantly in terms of clinical outcomes ( variceal bleed , endoscopic variceal ligation sessions , hepatic encephalopathy , requirement of therapeutic paracentesis , spontaneous bacterial peritonitis , and death ) . Conclusion Decrease of HVPG in patients with cirrhosis treated with atorvastatin and propranolol is significantly more than those treated with only propranolol . Atorvastatin , with its pleiotropic effects , may be useful in portal hypertension in cirrhosis . Larger data sets are required for ratification BACKGROUND & AIMS Concerns related to hepatotoxicity frequently lead to discontinuation or non-initiation of 3-hydroxy-3-methylglutaryl-coenzyme A reductase therapy in patients with cirrhosis despite data supporting statin use . We investigated the independent effects of hyperlipidemia and statin exposure on mortality , hepatic decompensation , and hepatocellular carcinoma development in a large national cohort of patients with cirrhosis . METHODS We performed a retrospective cohort study of patients with newly diagnosed cirrhosis from January 1 , 2008 through June 30 , 2016 in the Veterans Health Administration . Subjects were divided into 2 cohorts : 21,921 patients with prior statin exposure ( existing users ) and 51,023 statin-naïve individuals , of whom 8794 subsequently initiated statin therapy ( new initiators ) and 44,269 did not ( non-initiators ) . Multivariable Cox proportional hazard models with inverse probability weighting were constructed to assess the effects of time-updating lipid profiles and cumulative exposure to statins on survival and hepatic decompensation . Statin-naïve new initiators were propensity matched with non-initiators to simulate a r and omized controlled trial of statin use in cirrhosis . RESULTS In statin-naïve subjects , every 10-mg/dL increase in baseline total cholesterol was associated with a 3.6 % decrease in mortality . In existing users , each year of continued statin exposure was associated with a hazard ratio of 0.920 ( 95 % confidence interval 0.0.897 - 0.943 ) for mortality . After risk Output:
Hepatic portal hemodynamic parameters were improved in statin users for a short-term response . Statin seemed not to decrease the risk of esophageal variceal bleeding and spontaneous bacterial peritonitis . However , statin was proved to decrease the risk of hepatic encephalopathy and ascites . Incidence of drug related adverse events did n’t increase in statin users . Dose-dependent effects of statin on hepatocellular carcinoma development , decompensated cirrhosis events occurrence , and liver cirrhosis progression . ConclusionS tatin influenced parameters of hepatic portal vessel pressure in short-term treatment . Prognosis of liver cirrhosis benefited from statin treatment in long term follow-up . The efficacy and safety of statin in liver cirrhosis treatment is confirmed .
MS2_1shot85
***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 Depressive symptoms have debilitating effects on the physical health and functioning of people with serious mental illness . We examined change in depressive symptoms among overweight and obese adults with serious mental illness ( n = 343 ) using data combined from two r and omized trials comparing the 12-month In SHAPE program to a gym membership control condition . In SHAPE consists of a gym membership , weekly individual meetings with a fitness trainer , and instruction on healthy eating and nutrition . Depressive symptoms were measured at baseline , 3 , 6 , and 12 months . Change in depressive symptoms did not differ between groups , but depressive symptoms decreased over time across the entire sample ( p = 0.045 ) . At 12 months , reduced depressive symptoms were associated with clinical ly significant improved cardiorespiratory fitness ( p = 0.030 ) , 10 % or more weight loss ( p = 0.044 ) , and cardiovascular risk reduction ( p = 0.028 ) across both groups . Our findings suggest that participation in health promotion programs result ing in cardiovascular risk reduction may be associated with reduced depressive symptoms Objective : Weight gain is common for individuals with serious mental illness ( SMI ) receiving antipsychotic drug therapy . Contingency management ( CM ) is a behavioral intervention that rewards positive performance and has demonstrated effectiveness in reducing drug use in SMI population s. This study evaluated the feasibility of using CM to promote weight loss in individuals with SMI over 8 weeks . Method : 30 individuals ( BMI ≥ 28 kg/m2 ) were r and omized to one of three conditions : i ) The combination of a st and ardized lifestyle modification ( LM ) program for individuals with SMI and payment for group attendance ( CMattendance ) , ii ) The combination of LM and payment for weight loss ( CMweight ) , and iii ) waitlist control ( CON ) . After the waitlist period , those participants joined a LM group and received payment for behavioral change ( CMbehavior ) . Results : Subjects in the CMattendance and in the CMweight group lost a mean of 1.16 kg and 1.23 kg , respectively , while subjects in the CON gained a mean of 0.68 kg . Subjects receiving CMbehavior , lost a mean of 2.54 kg , which was a significant weight loss compared to the control period . Conclusion : LM supplemented with CM may facilitate weight loss in patients taking antipsychotic medications ; financial reimbursement for behavioral change may be particularly effective in this population BACKGROUND Individuals with serious mental illness have high rates of obesity and a need for specialized weight loss intervention programs . This study examines the efficacy of the RENEW weight loss intervention and examines the impact of the intervention setting on outcomes . METHOD 136 individuals with serious mental illness from 4 different setting s were r and omly assigned to receive the RENEW weight loss intervention or a control condition of treatment as usual . The RENEW intervention is a one year program that includes an intensive , maintenance and intermittent supports phase . RESULTS The intervention group experienced a modest weight loss of 4.8 lbs at 3 months , 4.1 lbs at 6 months and a slight weight gain of 1.5 lbs at 12 months . The control group gained a total of 6.2 lbs at 12 months . However when setting s were examined separately the responder sites had a weight loss of 9.4 lbs at 3 months , 10.9 lbs at 6 months and 7 lbs at 12 months . DISCUSSION These results suggest that the setting s in which individuals receive services may act as a support or hindrance toward response to weight loss interventions . The concept of the obesogenic environment deserves further examination as a factor in the success of weight loss programs How should health care professionals choose among the many therapies cl aim ed to be efficacious for treating specific disorders ? The practice of evidence -based medicine provides an answer . Advocates of this approach urge health care professionals to base treatment choices on the best evidence from systematic research on both the efficacy and adverse effects of various therapeutic alternatives . Ideally , health care professionals would compare different treatments by referring to r and omized , double-blind , head-to-head trials that compared the treatment options . Although individual medications are typically well research ed when these placebo-controlled studies are performed , studies that directly compare treatments are rare . In the absence of direct head-to-head trials , other evidence comes from indirect comparisons of two or more therapies by examining individual studies involving each treatment . This article provides an introductory review of methods of such indirect comparisons of therapies across studies , provides examples of how these methods can be used to make treatment decisions , and presents a general overview of relevant issues and statistics for readers interested in underst and ing these methods more thoroughly Obesity and diabetes have caused problems for individuals with schizophrenia long before atypical antipsychotic agents . The prevalence of obesity , insulin resistance , impaired glucose tolerance , type 2 diabetes mellitus , dyslipidemia , and the Metabolic Syndrome has increased in people with schizophrenia as compared to the general population . Risk reduction studies for persons with obesity , diabetes , and cardiovascular disease indicate that cognitive/behavioral interventions that promote motivation and provide strategies to overcome the barriers in adherence to diet and activity modification are effective interventions for weight management and risk reduction . In the l and mark multi-center r and omized-controlled trial study , the Diabetes Prevention Project ( DPP ) , a cognitive/behavioral intervention , was more successful in producing weight loss and preventing diabetes than the drugs metformin , troglitazone or placebo . This pilot study examined the effectiveness of a cognitive/behavioral group intervention , modified after the DPP program , in individuals with schizophrenia or schizoaffective disorder taking atypical antipsychotics in a large urban public mental health system . Outcome measures included body weight , body mass index , waist-hip ratios , and fasting glucose levels . Both groups demonstrated elevated fasting glucose levels and were obese with a mean BMI of 33 . The group that received the cognitive/behavioral group intervention lost more weight than the treatment as usual group . The CB group participants lost an average of 5.4 lb or 2.9 % of body weight , and those in the control group lost 1.3 lb or 0.6 % body weight . The range of weight loss for the treatment group was from 1 to 20 lb . This pilot study has demonstrated that weight loss is possible with cognitive/behavioral interventions in a population with a psychotic disorder BACKGROUND Available data on atypical antipsychotic-induced weight gain are limited by a number of method ological factors . The objective of this report is to evaluate short-term ( N=1742 ) and long-term ( N=1649 ) weight effects in patients receiving st and ard doses of amisulpride , haloperidol , olanzapine , risperidone , ziprasidone , and placebo based on 21 r and omized , placebo-controlled , parallel-group studies from an integrated clinical trial data base . METHOD Analyses of the integrated ziprasidone schizophrenia trials data base were performed to estimate the weighted average of weight change and the percentage of subjects experiencing weight gain ( or weight loss ) across studies for each agent studied , based on fixed- and r and om-effects models . Duration s of treatment exposure in long-term trials were controlled by well-defined time windows ( 6 month : 150 to 210 days ; 1 year : 330 to 390 days ) . Weight gain or loss was defined using a 7 % change from baseline threshold . RESULTS During long-term therapy with 1-year treatment duration , incidence of weight gain for subjects treated with ziprasidone ( 17 % ) was not significantly different from the placebo ( 13 % ) or haloperidol ( 41 % ) groups based on 95 % confidence interval . In contrast , significantly greater weight gain incidence was observed for the olanzapine ( 57 % ) and risperidone ( 39 % ) groups compared to placebo . Median weight change of + 0.49 , -0.18 , + 1.50 and + 0.55 lb/month was observed for haloperidol , ziprasidone , olanzapine and risperidone subjects , respectively , indicating differential weight change patterns compared to placebo ( -0.32 ) . Similar results were observed for the short-term ( 4 - 12 weeks ) and 6-month treatment exposure cohorts . CONCLUSIONS Our results confirm significant differences in long-term weight effects among atypical antipsychotics , consistent with findings from prior meta- analysis of antipsychotic-induced weight gain [ Allison , D.B. , Mentore , J.L. , Heo , M. , Ch and ler , L.P. , Capelleri , J.C. , Infante , M.C. , Weiden , P.J. , 1999 . Antipsychotic induced weight gain : a comprehensive research synthesis . Am J Psychiatry 156 , 1686 - 1696 ] and the CATIE schizophrenia study [ Lieberman , J.A. , Stroup , T.S. , McEvoy , J.P. , et al. , 2005 . Effectiveness of antipsychotic drugs in patients with chronic schizophrenia . N Engl J Med 353 , 1209 - 1223 ] Approximately one fourth of the U.S. adult population nearly 50 million peoplehas hypertension ( 1 , 2 ) . Taking a broader perspective , more than half of the adult population has higher than optimal blood pressure ( 1 ) , defined as systolic blood pressure greater than 120 mm Hg and diastolic blood pressure greater than 80 mm Hg ( 2 ) . These persons are at significantly increased risk for cardiovascular disease and stroke ( 3 ) . Although pharmacologic treatment for hypertension significantly reduces morbidity and mortality from cardiovascular diseases ( 4 , 5 ) , long-term pharmacologic therapy can have undesirable side effects and requires the expense of continuing medical supervision . Furthermore , pharmacologic therapy is not usually initiated when blood pressure is higher than optimal yet below diagnostic thresholds for hypertension . Thus , lifestyle interventions for primary prevention and initial treatment of high blood pressure remain a vital strategy for controlling this highly prevalent condition ( 2 ) . Weight loss has been shown to reduce blood pressure in overweight hypertensive patients ( 6 - 9 ) and in overweight persons with high-normal blood pressure ( 10 - 12 ) . Two review s of r and omized trials of weight reduction to reduce blood pressure examined the results of nine studies ( 13 , 14 ) . Most of these trials were small , only one had more than 500 participants ( 11 ) , and most had short-term follow-up ( 1 year or less ) . Only three studies had follow-up of 3 to 5 years ( 8 , 10 , 11 ) . Compared with controls , weight loss averaged nearly 7 kg in the short-term trials and approximately 3 kg in the three longer-term trials . In almost all trials , systolic blood pressure and diastolic blood pressure were reduced in the intervention groups . Since these review s were published , the Trials of Hypertension Prevention ( TOHP ) Phase I reported mean weight reduction of 3.9 kg at 18 months in 564 overweight participants with high-normal blood pressure , result ing in significant decreases in systolic blood pressure and diastolic blood pressure compared with a usual care control group ( 12 , 15 ) . To investigate whether nonpharmacologic interventions can prevent hypertension over the long term , TOHP II was initiated . This was a r and omized , controlled trial examining the effects of weight loss and dietary sodium reduction , alone and in combination , in reducing blood pressure in overweight adults with high-normal diastolic blood pressure ( 16 ) . This target population is at high risk for hypertension as they age . The primary outcome paper from this trial ( 17 ) provided only a brief overview of the effects of weight loss on blood pressure . Here , we provide more detailed analysis of weight loss and blood pressure in TOHP II . Of special interest are the long-term effects of weight loss on blood pressure , the magnitude of the doseresponse relationship at 36 months , the effect of patterns of weight loss on blood pressure , and the predictors of weight loss and blood pressure response . Methods Participants Participants in TOHP II were overweight adults with nonmedicated diastolic blood pressure of 83 to 89 mm Hg and systolic blood pressure less than 140 mm Hg . Other eligibility criteria included age 30 to 54 years and a body mass index of 26.1 to 37.4 kg/m2 for men and 24.4 to 37.4 kg/m2 for women , approximately 110 % to 165 % of ideal weight ( 18 ) . Principal exclusion criteria were current treatment with medications that might affect blood pressure , clinical or laboratory evidence of cardiovascular disease , diabetes mellitus , renal insufficiency ( serum creatinine concentration 150 mol/L [ 1.7 mg/dL ] for men and 132 mol/L [ 1.5 mg/dL ] for women ) , and current or planned pregnancy . Detailed descriptions of recruitment and participant characteristics have been published elsewhere ( 19 , 20 ) . The study was review ed and approved by the institutional review boards at all nine TOHP centers and the coordinating center , and all participants signed informed consent forms . Design Eligible participants were r and omly assigned with equal probability to one of four groups : weight loss only , sodium reduction only , combined weight loss and sodium reduction , or usual care ( controls ) . Measurements Age , sex , ethnicity , and years of education were obtained by question Output:
Lifestyle interventions appear effective for treating overweight and obesity among people with serious mental illness . Interventions of ≥12-months duration compared to ≤6-months duration appear to achieve more consistent outcomes , though effect sizes are similar for both shorter and longer duration interventions
MS2_1shot86
***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 estimate and compare the cost-effectiveness and safety of nebivolol with sustained-release metoprolol in reducing blood pressure by 1 mm of Hg per day in hypertensive patients . Material s and Methods : This was a prospect i ve , r and omized , open label , observational analysis of cost-effectiveness , in a question naire-based fashion to compare the cost of nebivolol ( 2.5 mg , 5 mg , 10 mg ) and sustained released metoprolol succinate ( 25 mg , 50 mg , 100 mg ) in hypertensive patients using either of the two drugs . A total of 60 newly detected drug naïve hypertensive patients were considered for the comparison , of which 30 patients were prescribed nebivolol and the other 30 were prescribed metoprolol succinate as per the recommended dosage . Based on the data , statistical analysis was carried out using GraphPad Prism 5 and MS Excel Spreadsheet 2007 . Result : The cost of reducing 1 mm of Hg blood pressure per day with nebivolol was 0.60 , 0.70 , and 1.06 INR , whereas that of metoprolol succinate was 0.93 , 1.18 , and 1.25 INR at their respective equivalent doses , hence significantly lower with the nebivolol group as compared to the metoprolol group ( P < 0.05 ) . Conclusion : This pharmacoeconomic analysis shows that nebivolol is more cost-effective as compared to metoprolol when the cost per reduction in blood pressure per day is considered . This may affect the patients economically during their long-term use of these molecules for the treatment of hypertension In hypertensive patients with chronic renal disease , angiotensin receptor blockers ( ARBs ) are among the first-line drugs , and calcium channel blockers ( CCBs ) are recommended as a second line . We examined the effects of two therapeutic strategies using ARBs and benidipine , a CCB , on blood pressure ( BP ) , urinary albumin excretion ( UAE ) , and cost-effectiveness in hypertensive patients with albuminuria . Patients whose BP was 140/90 mmHg or higher despite treatment with low- or medium-dose ARBs were assigned r and omly to two groups . In Group A ( n=14 ) , the ARB dose was maximized and then benidipine was added until BP targets were reached ( < 130/85 mmHg ) . In Group B ( n=18 ) , benidipine was administered first and then the ARB dose was increased until BP targets were reached . The BP targets were achieved by ARB alone in 36 % of Group A patients and by the addition of benidipine in 83 % of Group B patients . Finally , BP decreased in each group , reaching the targets in 93 % of Group A patients and 94 % of Group B patients after a 4-month therapeutic period . UAE was decreased in both groups after a 4-month therapeutic period compared to the allocation period ( −33±6 % in Group A , −31±6 % in Group B ; p<0.001 , respectively ) . The monthly drug cost was higher ( 11,426±880 vs. 8,955±410 yen , p=0.012 ) and the cost-effectiveness of antihypertensive treatment was lower ( p=0.003 ) in Group A than in Group B. We conclude that the addition of benidipine to low- or medium-dose ARB is , in light of the renal protection and the cost-effectiveness of this approach , a useful therapeutic strategy for controlling BP in hypertensive patients with albuminuria Abstract Background : In the Ramipril Efficacy In Nephropathy ( REIN ) trial , ramipril significantly lowered the rate of reaching the combined end-point of doubling of baseline serum creatinine levels or end-stage renal failure ( ESRF ) . Objective : To determine the additional cost per patient-year of chronic ( long term ) dialysis avoided ( PYCDA ) when the ACE inhibitor , ramipril , was added to conventional treatment of patients with non-diabetic nephropathy and hypertension . Study perspective : Statutory Health Insurance ( SHI ) provider in Germany . Design and setting : Data from the REIN Study were used in a cost-effectiveness analysis ( CEA ) . A modelling approach was used , which was based on secondary analysis of published data , and costs were those incurred by the SHI provider ( i.e. SHI expenses ) . In the base-case analysis , average case-related SHI expenses were applied and PYCDA were quantified using the cumulative incidence of ESRF as observed in the REIN trial . Main outcome measures and results : The incremental cost-effectiveness ratios ( ICERs ) of ramipril varied between about − 76 700 deutschmarks ( DM ) and -DM81 900 per PYCDA(DM1 ≈ 0.55 US dollars ; 1999 values ) , according to the treatment periods of 1 year and 3 years , respectively . In the sensitivity analysis , the robustness of the model and its results were shown when the extent of influence of different model variables on the base-case results was investigated . First , probabilities of ESRF and PYCDA were estimated according to the Weibull method . Second , the influence of the model variables on the target variable was quantified using a deterministic model . Third , the dependency of the target variable ( ICER ) on r and om variables was described in a simulation . The cost for chronic dialysis had by far the greatest impact on the target variable , which was 28 times greater than the impact of clinical effectiveness of ramipril , i.e. the number of PYCDA . There were net savings per PYCDA with ramipril treatment after 1 , 2 and 3 years : 95 % of the 10 000 simulation steps result ed in savings of between DM69 500 and DM94 600 per PYCDA after 3 years . Conclusions : Results from this evaluation show that ramipril offers enormous savings from the perspective of the SHI provider ( third-party payer ) in Germany when added to the conventional treatment of patients with non-diabetic nephropathy and hypertension Objective To evaluate the cost-effectiveness of first-line treatments for hypertension . Background The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ( ALLHAT ) found that first-line treatment with lisinopril or amlodipine was not significantly superior to chlorthalidone in terms of the primary endpoint , so differences in costs may be critical for optimizing decision-making . Methods Cost-effectiveness analysis was performed using bootstrap resampling to evaluate uncertainty . Results Over a patient ’s lifetime , chlorthalidone was always least expensive ( mean $ 4,802 less than amlodipine , $ 3,700 less than lisinopril ) . Amlodipine provided more life-years ( LYs ) than chlorthalidone in 84 % of bootstrap sample s ( mean 37 days ) at an incremental cost-effectiveness ratio of $ 48,400 per LY gained . Lisinopril provided fewer LYs than chlorthalidone in 55 % of bootstrap sample s ( mean 7-day loss ) despite a higher cost . At a threshold of $ 50,000 per LY gained , amlodipine was preferred in 50 % , chlorthalidone in 40 % , and lisinopril in 10 % of bootstrap sample s , but these findings were highly sensitive to the cost of amlodipine and the cost-effectiveness threshold chosen . Incorporating quality of life did not appreciably alter the results . Overall , no reasonable combination of assumptions led to 1 treatment being preferred in over 90 % of bootstrap sample s. Conclusions Initial treatment with chlorthalidone is less expensive than lisinopril or amlodipine , but amlodipine provided a nonsignificantly greater survival benefit and may be a cost-effective alternative . A r and omized trial with power to exclude “ clinical ly important ” differences in survival will often have inadequate power to determine the most cost-effective treatment Background Although angiotensin receptor blockers have different receptor binding properties , no comparative r and omized studies with cardiovascular event endpoints have been performed for this class of drugs . The aim of this study was to assess the long-term cost-effectiveness of c and esartan ( Atac and ® ) versus generic losartan in the primary preventive treatment of hypertension . Methods A decision-analytic model was developed to estimate costs and health outcomes over a patient ’s lifetime . Data from a clinical registry study were used to estimate event rates for cardiovascular complications , such as myocardial infa rct ion and heart failure . Costs and quality of life data were from published sources . Costs were in Swedish kronor and the outcome was quality -adjusted life-years ( QALYs ) . Results Due to reduced rates of cardiovascular complications , c and esartan was associated with a QALY gain and lower health care costs compared with generic losartan ( 0.053 QALYs gained and reduced costs of approximately 4700 Swedish kronor for women ; and 0.057 QALYs gained and reduced costs of approximately 4250 Swedish kronor for men ) . This result was robust in several sensitivity analyses . Conclusion When modeling costs and health outcomes based on event rates for cardiovascular complications from a real-world registry study , c and esartan appears to bring a QALY gain and a reduction in costs compared with generic losartan in the primary preventive treatment of hypertension in Sweden BACKGROUND The Losartan Intervention For Endpoint reduction ( LIFE ) study was a r and omized , doubleblind trial that compared the effects of losartan-based treatment with those of atenolol-based treatment on cardiovascular disease (CVD)-related morbidity and mortality in 9193 patients with hypertension and left-ventricular hypertrophy ( LVH ) . Compared with atenolol , losartan reduced the combined risk for CVD-related morbidity and mortality by 13 % ( P = 0.021 ) , and reduced the risk for stroke by 25 % ( P = 0.001 ) , with comparable blood pressure control in both trial arms . OBJECTIVE The aim of this study was to analyze the cost-effectiveness of losartan compared with atenolol in the treatment of stroke from the Dutch health care perspective . METHODS Utilization of losartan and atenolol within the trial period ( mean , 4.8 years ) and an estimation of direct medical costs of stroke for The Netherl and s were combined with estimates of reduction in life expectancy through stroke . Medication costs and stroke incidence during 5.5 years of patient follow-up were estimated separately , adjusted for the baseline degree of LVH and Framingham risk score . To estimate lifetime stroke costs , the cumulative incidence of stroke was multiplied by the lifetime direct medical costs attributable to stroke . All costs are in 2006 Dutch prices and discounted following the former ( 4 % costs and effects ) and new Dutch guideline ( 4 % costs , 1.5 % effects ) for conducting pharmacoeconomic analyses . RESULTS With 4 % discounting , prevention of stroke was associated with a gain of 3.7 life-years . As a consequence , losartan treatment was associated with 0.059 life-year gained ( LYG ) per patient treated with losartan . Losartan reduced stroke-related costs by 1,076 Euros ( US $ 1,349 ) per patient . After inclusion of study medication cost , net cost per patient was 51 Euros ( $ 64 ) higher for losartan than atenolol . The net cost per LYG was 864 Euros ( $ 1083 ) , which is below the Dutch pharmacoeconomic threshold of 20,000 Euros/LYG ( ~$25,000/LYG ) for accepting interventions . The corresponding probability of a cost-effectiveness ratio below this Dutch threshold was 0.95 . Discounting money and health following the new Dutch guideline result ed in an even more favorable cost-effectiveness for losartan . CONCLUSIONS Results from the present analysis suggest that , in The Netherl and s , treatment with losartan compared with atenolol may well be a cost-effective intervention based on the reduced risk for stroke observed in the LIFE trial Background Systemic hypertension often accompanies chronic renal failure and can accelerate its progression to end-stage renal disease ( ESRD ) . Adjunctive moxonidine appeared to have benefits versus adjunctive nitrendipine , in a r and omised double-blind six-month trial in hypertensive patients with advanced renal failure . To underst and the longer term effects and costs of moxonidine , a decision analytic model was developed and a cost-effectiveness analysis performed . Methods A Markov model was used to extrapolate results from the trial over three years . All patients started in a non-ESRD state . After each cycle , patients with a glomerular filtration rate below 15 ml/min had progressed to an ESRD state . The cost-effectiveness analysis was based on the Dutch healthcare perspective . The main outcome measure was incremental cost per life-year gained . The percentage of patients progressing to ESRD and cumulative costs were also compared after three years . In the base case analysis , all patients with ESRD received dialysis . Results The model predicted that after three years , 38.9 % ( 95%CI 31.8–45.8 ) of patients treated with nitrendipine progressed to ESRD compared to 7.5 % ( 95%CI 3.5–12.7 ) of patients treated with moxonidine . Treatment with st and ard antihypertensive therapy and adjunctive moxonidine was predicted to reduce the number of ESRD cases by 81 % over three years compared to adjunctive nitrendipine . The cumulative costs per patient were significantly lower in the moxon Output:
All antihypertensives were cost effective compared with no treatment . ARBs appeared to be more cost effective than CCBs , ACEIs , and β-blockers .
MS2_1shot87
***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 Advice can have a small but clinical ly important effect in promoting smoking cessation . Where studied , the rate of delivery has been found to be low . Training has been found to increases this rates , but there is little research on effectiveness in terms of smoking cessation rates . This study aim ed to assess the effectiveness and cost-effectiveness of an health professionals educational program to increase long-term rates of nicotine abstinence in smoking out patients . METHODS We conducted a pragmatic cluster-r and omized , controlled trial in 35 primary health care centers in Spain . Participants were all 830 health professionals who attended 5,970 smokers during recruiting period . After that we measured continuous abstinence 6 months after the intervention and biochemically vali date d ( saliva cotinine test ) 1 year following intervention . Cost-effectiveness was measured in terms of cost per life year gained . RESULTS After 6 months , the rate of continuous abstinence was significantly higher in the intervention group ( 2.1 % vs. 0.3 % , p > .0001 ) with an odds ratio of 6.5 ( 95 % CI = 3.3 - 12.7 ) . After 1 year , biochemical validation was performed on 31 of the 67 patients previously registered as abstinent . All of them were abstinent and belonged to intervention group . The incremental cost per life year gained after 6 months was € 969 . CONCLUSIONS A primary care training program on smoking cessation based on scientific evidence , behavioral theory , and active learning methods increases long-term continuous nicotine abstinence rate among out patients in a significant way . These may be relevant for planning training of professionals , clinical assistance , and public health programs PURPOSE Dental hygienists report a lack of confidence in initiating Tobacco Dependence Counseling ( TDC ) with their patients who smoke . The purpose of this study was to determine if the confidence of dental hygiene students in providing TDC can be increased by St and ardized Patient ( SP ) training , and if that confidence can be sustained over time . METHODS This 2-parallel group r and omized design was used to compare the confidence of students receiving SP training to stu dents with no SP training . After a classroom lecture , all subjects ( n=27 ) received a baseline test of knowledge and confidence . Subjects were r and omly assigned to test and control groups with equivalent mean knowledge scores . The test group subjects participated in a SP TDC session . Both groups gained parallel experience to treating patients who were smokers and giving TDC in clinical scenarios during the 6 month time period . One week end-training and 6 month post-training assessment s were administered to both groups . ANCOVA compared mean confidence scores . RESULTS End-training scores at 1 week showed a statistically significant increase ( p=0.002 ) in overall mean confidence following SP training for individuals in the test group . The 6 month follow-up test results showed a slight decline in confidence scores among subjects in the test group and an overall gain in confidence for control group participants . However , overall confidence scores were comparable for the groups . CONCLUSION SP training improved dental hygiene students ' initial confidence in providing TDC and was sustained , but not to a significant degree . Clinical experience alone increased confidence . Further studies may help determine how the initial confidence gained by SP training can be sustained and what the role of clinical experience plays in overall confidence in providing TDC BACKGROUND An increase in the number of dentists conducting tobacco-use cessation treatment is needed . The authors assessed the effects of high-intensity training ( HIT ) or low-intensity training ( LIT ) and reimbursement on general dentists ' tobacco-use-related attitudes and treatment behaviors . METHODS The authors r and omly selected 265 dentists in three states and assigned them to one of five groups : HIT workshop groups with and without tobacco-use cessation counseling reimbursement , LIT mailed self- study groups with and without reimbursement or a control group . Outcomes at follow-up were dentists ' self-reported tobacco-use-related attitudes and behaviors and patients ' reports of dentists ' behaviors . RESULTS Significantly more dentists in the intervention groups reported having positive attitudes and behaviors at follow-up than did dentists in the control group . Dentists in the HIT groups , however , reported assessing patients ' willingness to quit and assisting them with the quitting process significantly more often than did dentists in the LIT groups . Significantly more patients of dentists in the intervention groups who used tobacco reported receiving advice and assistance from their dentists than did patients of dentists in the control group . Adding reimbursement to HIT or LIT conditions did not provide additional intervention effect . CONCLUSION Dentists trained by means of a workshop or self- study program used components of a recommended guideline more frequently and felt more positive toward tobacco-use cessation counseling than did dentists in the control group . CLINICAL IMPLICATION S Although the workshop training was more successful than the self- study training , the latter 's reach among dentists could have a more significant public health impact . The effect of reimbursement needs further study OBJECTIVE Family physicians ( FPs ) are cornerstone for tobacco control . It was aim ed to compare the effect of training on their smoking cessation practice , knowledge level and attitudes towards smoking and tobacco control . METHODS AND MATERIAL S The cross-sectional and multi-centered study was carried out using structured survey modified WHO based question naire . It was delivered to 1500 FPs r and omly selected among approximately 23000 family physicians across the country . The study survey was self-reported by FPs , assessing their knowledge , attitudes , status of post-graduate training , and practice about tobacco control . Participants were assigned into two groups as non-trainee groups ( Group 1 ) and post-graduate trainee ( Group 2 ) . RESULTS The mean age was 38.4 ± 7.1 years-old . The percentage of male and female FPs in the study was 53.1 % and 46.9 % . The ratio of family physicians who participated in training program Group 2 ) was 26.5 % ( n = 327 ) . The ratio of female FPs who participated the SCP training course was significantly higher than that of male FPs ( 27.3 % versus 22.5 % , p = 0.035 ) . There was no significant difference for smoking status between groups ( p = 0.686 ) . When the number FPs whose consulted by the smokers over ≥ 5 a week was compared , the ratio of FPs was significantly higher in group 2 than group 1 ( p < 0.001 ) , but overall ratio of FPs ( 2.8 % ) who consulted within a week smokers was considerably lower Statements of Competence and confidence items stated by all FPs were 24.2 % and 32.2 % , respectively . Physicians who had attended post-graduate training on SCP were more competent and confident , compared to non-trained FPs ( p = 0.002 and p = 0.001 ) . CONCLUSION Post-graduate training on tobacco control improved self-confidence and competence of FPs . With post-graduate training , significant improvement was seen in practical skills of physicians . A continuing training program should be introduced to FPs , to engage them for smoking cessation practice The use of st and ardized patients ( SPs ) shows promise in tobacco cessation treatment ( TCT ) training by providing a simulated clinical environment for dental students to practice counseling skills with individuals trained to portray patients . The purpose of this study was to determine if there was a difference in attitudes , perceptions , and knowledge between dental students who received a lecture and practice sessions with SPs and those who received a lecture only . Dental students in an introductory clinical course at one dental school were invited to participate in the study by completing a pre and post question naire . The pre question naire was administered to all students prior to a tobacco cessation lecture . Students were group-r and omized to either the intervention or control group . The intervention group completed the post question naire after the lecture and practice sessions with SPs , and the control group completed it after the lecture only . Of ninety-eight students who attended the lecture and were invited to participate in the study , a total of ninety-four from the two groups ( 96 percent ) provided two linkable question naires for analysis . In the results , training with lecture and SPs increased the students ' underst and ing of barriers , subjective norms , perceived skills , self-efficacy , and intentions to provide TCT more than those in the lecture only ; however , it did not significantly increase their attitudes and knowledge . These findings suggest that using SPs is a valuable educational method to promote the provision of TCT by dental students and graduates OBJECTIVE Few continuing education programs to train behavioral health professionals to deliver tobacco treatment services have been described and evaluated . METHODS The effectiveness of two-day training on changing practice was examined by review of clinical charts from 20 clinicians who attended in 2012 . Ten medical records were r and omly selected for review from each clinician 's outpatient practice at a large behavioral health system . Five charts from smokers seen within six months before and after training were review ed per clinician , for a total of 200 . Records were electronically search ed on " cigarette , " " nicotine , " " tobacco , " " quit , " " smoking , " and " smoke . " RESULTS were compared via chi square tests ( all p<.05 ) . RESULTS Almost half of the smokers indicated that they were interested in quitting , although baseline rates of tobacco use treatment were very low . Documentation of tobacco use significantly increased between baseline and posttraining , both on the problem list ( 35 % versus 74 % ) and treatment plan ( 20 % versus 60 % ) . Also posttraining , clinicians advised significantly more out patients to quit ( 9 % versus 36 % ) or referred them to individual or group counseling . Discussion of nicotine replacement was documented more frequently in charts ( 10 % versus 31 % ) , and prescriptions for tobacco treatment medications increased significantly in the posttraining period , although overall prescribing remained low . The proportion of patients making quit attempts also significantly increased in the posttraining period ( 10 % versus 39 % ) , suggesting that providers were delivering more tobacco treatment than was reflected in charts . CONCLUSIONS An intensive training program for behavioral health professionals increased tobacco treatment and patient quit attempts . Strategies beyond training may be needed to enhance prescribing by these practitioners BACKGROUND Health professionals have a proven , positive impact on patients ' ability to quit smoking , yet few integrate cessation counseling into routine practice .The aim of this study was to evaluate the impact of continuing education training on physicians ' and pharmacists ' cessation counseling . METHODS A group-r and omized trial of health care providers ( 87 physicians and 83 pharmacists ) from 16 Texas communities compared smoking cessation training ( intervention group ) with skin cancer prevention training ( control group ) . Pretraining , posttraining , and extended follow-up surveys were collected from providers . Perceived ability , confidence , and intention ( ACI ) to address smoking with patients were assessed with a composite ACI index . Patient exit interviews ( at baseline , 1452 patients completed interviews ; after 12 months , 1303 completed interviews ) assessed counseling practice s. RESULTS There was a significant increase in the percentage of physicians with a high ACI index in the intervention group from pretraining to posttraining ( 27 % to 73 % ; P < .001 ) vs the control group ( 27 % to 34 % ; P = .42 ) and for pharmacists ( 4 % to 60 % ; P < .001 ) vs the control group ( 10 % to 14 % ; P = .99 ) . Similar results were seen from pretraining to extended follow-up . At baseline , fewer pharmacy patients reported being asked about smoking compared with patients seen by physicians ( 7 % vs 33 % ; P = .001 ) . There was an increase in assisting patients to quit ( 6 % to 36 % ; P = .002 ) by physicians ( baseline vs 12 months ) in the intervention group , but not in the control group . CONCLUSIONS Training led to significant and lasting improvement in counseling among physicians . Low levels of counseling were seen among pharmacists OBJECTIVES Tobacco use adversely affects oral health . Clinical guidelines recommend that oral health professionals promote tobacco abstinence and provide patients who use tobacco with brief tobacco use cessation counselling . Research shows that these guidelines are seldom implemented successfully . This study aim ed to evaluate two interventions to enhance tobacco use prevention and cessation ( TUPAC ) counselling among oral health professionals in Finl and . METHODS We used a cluster-r and omized community trial to test educational and fee-for-service interventions in enhancing TUPAC counselling among a sample of dentists ( n=73 ) and dental hygienists ( n=22 ) in Finl and . Educational intervention consisted of 1 day of training , including lectures , interactive sessions , multimedia demonstrations and a role play session with st and ard patient cases . Fee-for-service intervention consisted of monetary compensation for providing tobacco use prevention or cessation counselling . TUPAC counselling procedures provided were reported and measured using an electronic dental records system . In data analysis , intent-to-treat principles were followed at both individual and cluster levels . Descriptive analysis included chi-square and t-tests . A general linear model for repeated measures was used to compare the outcome measures by intervention group . RESULTS Of 95 providers , 73 participated ( 76.8 % ) . In preventive counselling , there was no statistically significant time effect or group-by-time interaction . In cessation counselling , statistically significant group-by-time interaction was found after a 6-month follow-up ( F=2 Output:
Implication s This systematic review summarizes existing tobacco-related curriculum components ( content , intensity , competency evaluation , and barriers ) and training interventions for health-care professionals worldwide and demonstrates that they are associated with positive health-care professional outcomes ( knowledge , attitudes , behaviors , and skills ) and client outcomes ( quit attempts and smoking abstinence )
MS2_1shot88
***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 efficacy and tolerability of a new ionic silver alginate matrix ( Askina Calgitrol Ag ) with that of a st and ard silver-free alginate dressing ( Algosteril ) . METHOD Patients with locally infected chronic wounds ( pressure ulcers , venous or mixed aetiology leg ulcers , diabetic foot ulcers ) or acute wounds were eligible for this prospect i ve , open-label , controlled and r and omised trial . Patients were r and omised to receive one of the two dressings for a two-week period . Criteria of efficacy were based on the evolution , from day 1 to day 15 , of local signs of infection using a clinical score ranging from 0 to 18 , and the evolution of the bacteriological status for each wound . The latter was determined by ( blind ) bacteriological examinations of results obtained from two biopsies performed at days 1 and 15 . A three-point scale ( deterioration , unchanged , improvement ) was also used . Acceptability , usefulness and tolerance were also assessed . RESULTS Forty-two patients ( 20 women and 22 men , 68.9 + /- 18.8 and 66.5 + /- 15.7 years old respectively ) were r and omly assigned to receive either Askina Calgitrol Ag ( n=20 ) or Algosteril ( n=22 ) . Most had chronic wounds such as pressure ulcers ( 57 % ) or venous or mixed aetiology leg ulcers and diabetic foot ulcers ( 29 % ) ; few had acute wounds ( 14 % ) . Clinical scores of infection were comparable in both groups at inclusion , 8.9 + /- 2.4 and 8.6 + /- 3.2 in the Askina Calgitrol Ag group and the Algosteril group respectively ( not significant ) , but decreased significantly in both groups at day 15 , 3.8 + /- 2.9 in the Askina Calgitrol Ag group ( p=0.001 ) and 3.8 + /- 3.4 in the Algosteril group ( p=0.007 ) . There was no significant difference between the two groups at day 15 . Although there was also no significant difference in bacteriological status between the treatment groups , a trend in favour of Askina Calgitrol Ag was found for the relative risk of improvement , especially in patients who were not treated with antibiotics either at the beginning of the study or during it . No differences between groups were observed regarding local tolerance , acceptability and usefulness of the dressings . CONCLUSION The regression of local signs of infection , local tolerance , acceptability and usefulness were similar for the two dressings . However , Askina Calgitrol Ag improved the bacteriological status of the wounds . Further trials are required to show that it has a positive impact on the healing process Pressure ulcers are common among elderly nursing home residents . To be effective in managing these wounds , a dressing should maintain a moist environment , facilitate healing , absorb exu date , remain in place for a number of days , and prevent trauma to the surrounding skin . An 8-week , open , r and omized , multicenter , controlled study was conducted to compare the effects of a new self-adherent soft silicone dressing and a self-adherent hydropolymer dressing on Stage II pressure ulcers . Thirty-eight ( 38 ) residents participated in the study . Eighteen residents ( mean age 83.8 years , range 74.9 to 95.1 years ) were r and omized to wound management with a soft silicone dressing , and the ulcers of 20 residents ( mean age 82.5 years , range 66.4 to 91.9 years ) were managed with a hydropolymer dressing . Wound healing , wound and surrounding skin characteristics , and ease of dressing removal were measured and documented . During the study , eight ( 44 % ) ulcers in the soft silicone group and 10 ( 50 % ) in the hydropolymer dressing group healed . Both dressings were changed approximately once a week and no differences in signs of inflammation , amount of exu date and odor , or incidence of leakage were observed . Damage to the surrounding skin , maceration , and dressing removal difficulties were less common with the soft silicone dressing . Differences in tissue damage between the two dressings were significant during weeks 1 , 2 , and 3 ( P < 0.05 ) . Studies with a larger sample size are needed to confirm these findings Objectives To evaluate if ‘ wrap therapy ’ using food wraps , which is widely used in Japanese clinical sites , is not inferior when compared to guideline adhesion treatments . Design Multicentre , prospect i ve , r and omised , open , blinded endpoint clinical trial . Setting 15 hospitals in Japan . Patients 66 older patients with new National Pressure Ulcer Advisory Panel stage II or III pressure ulcers . Interventions Of these 66 patients , 31 were divided into the conventional treatment guidelines group and 35 into the wrap therapy group . Main outcome measures The primary end point was the period until the pressure ulcers were cured . The secondary end point was a comparison of the speed of change in the Pressure Ulcer Scale for Healing score . Results 64 of the 66 patients were analysed . The estimated mean period until healing was 57.5 days ( 95 % CI 45.2 to 69.8 ) in the control group as opposed to 59.8 days ( 95 % CI 49.7 to 69.9 ) in the wrap therapy group . By the extent of pressure ulcer infiltration , the mean period until healing was 16.0 days ( 95 % CI 8.1 to 23.9 ) in the control group as opposed to 18.8 days ( 95 % CI 10.3 to 27.2 ) in the wrap therapy group with National Pressure Ulcer Advisory Panel stage II ulcers , and 71.8 days ( 95 % CI 61.4 to 82.3 ) as opposed to 63.2 days ( 95 % CI 53.0 to 73.4 ) , respectively , with stage III ulcers . There is no statistical significance in difference in Pressure Ulcer Scale for Healing scores . Conclusions It might be possible to consider wrap therapy as an alternative choice in primary care setting s as a simple and inexpensive dressing care . Clinical Trial registration UMIN Clinical Trials Registry UMIN000002658 . Summary protocol is available on https://upload.umin.ac.jp/cgi-bin/ctr/ctr.cgi?function=brows&action=brows&type=detail&recptno=R000003235&admin=0 & language = Background The treatment of pressure ulcers is complicated , given the various wound dressing products available . The cost of different treatments varies and the cost-effectiveness of each product has not been thoroughly evaluated . We compare two wound dressing protocol s-alginate silver dressing ( AlSD ) and silver zinc sulfadiazine cream ( AgZnSD ) with regard to wound healing and cost-effectiveness . Methods Patients with grade III or IV sacral or trochanteric pressure ulcers were eligible for this prospect i ve , r and omized controlled trial . The patients were r and omized to receive one of the two dressings for an eight-week period . The criteria of efficacy were based on the Pressure Ulcer Scale for Healing ( PUSH ) scoring tool . The cost of treatment was also assessed . Results Twenty patients ( 12 women and 8 men ) were r and omly assigned to receive either AlSD ( n=10 ) or AgZnSD cream ( n=10 ) . The demographic data and wound characteristics were comparable in the two groups . The two groups showed no significant difference in the reduction of PUSH score , wound size , or volume of exu date . The tissue type score was significantly lower in the AlSD group ( 3.15±0.68 - 1.85±0.68 vs. 2.73±0.79 - 2.2±0.41 ; P=0.015 ) . The cost of treatment was significantly lower in the AlSD group ( 377.17 vs. 467.74 USD , respectively ; P<0.0001 ) . Conclusions Alginate silver dressing could be effectively used in the treatment of grade III and IV pressure ulcers . It can improve wound tissue characteristics and is cost-effective Background There are many barriers to patient participation in r and omised controlled trials of cancer treatments . To increase participation in trials , strategies need to be identified to overcome these barriers . Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in r and omised controlled trials ( RCTs ) of cancer treatments . Methods A systematic review was conducted . Published and unpublished studies in any language were search ed for in fifteen electronic data bases , including MEDLINE , EMBASE , CINAHL and PsycINFO , from inception to the end of 2004 . Studies of any interventions to improve cancer patient participation in RCTs , which reported the change in recruitment rates , were eligible for inclusion . RCTs and non-r and omised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included . Data were extracted by one review er into structured summary tables and checked for accuracy by a second review er . Each included study was assessed against a checklist for method ological quality by one review er and checked by a second review er . A narrative synthesis was conducted . Results Eight studies were identified that met the inclusion criteria : three RCTs , two non-r and omised controlled trials and three observational studies . Six of the studies had an intervention that had some relevance to the UK . There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs , though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer . Although there was no evidence of an effect in any of the studies , the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work . Conclusion There is not a strong evidence -base for interventions that increase cancer patient participation in r and omised trials . Further research is required to evaluate the effectiveness of strategies to increase participation in cancer treatment trials In a prospect i ve , r and omised , controlled trial of 92 patients with full-thickness pressure ulcers , the efficacy of an alginate wound dressing was compared to that of an established local treatment with dextranomer paste . During treatment , a minimal 40 % reduction in wound area was obtained in 74 % of the patients in the alginate group and in 42 % of those in the dextranomer group . The median time taken to achieve this goal was four weeks with alginate and more than eight weeks in the control group . Mean surface area reduction per week was 2.39cm2 ( sd 3.54 ) and 0.27cm2 ( sd 3.21 ) in the alginate and dextranomer groups respectively ( p=0.0001 ) . This difference was still highly significant when the sub-groups of almost completely healed subjects at the end of the study were considered . This striking healing efficacy of an alginate dressing suggests it possesses pharmacological properties which require further investigation BACKGROUND There have been no studies that have tested the Braden Scale for predictive validity and established cutoff points for assessing risk specific to different setting s. OBJECTIVES To evaluate the predictive validity of the Braden Scale in a variety of setting s ( tertiary care hospitals , Veterans Administration Medical Centers [ VAMCs ] , and skilled nursing facilities [ SNFs ] ) . To determine the critical cutoff point for classifying risk in these setting s and whether this cutoff point differs between setting s. To determine the optimal timing for assessing risk across setting s. METHOD R and omly selected subjects ( N= 843 ) older than 19 years of age from a variety of care setting s who did not have pressure ulcers on admission were included . Subjects were 63 % men , 79 % Caucasian , and had a mean age of 63 ( + /-16 ) years . Subjects were assessed for pressure ulcers using the Braden Scale every 48 to 72 hours for 1 to 4 weeks . The Braden Scale score and skin assessment were independently rated , and the data collectors were blind to the findings of the other measures . RESULTS One hundred eight of 843 ( 12.8 % ) subjects developed pressure ulcers . The incidence was 8.5 % , 7.4 % , and 23.9 % in tertiary care hospitals , VAMCs , and SNFs , respectively . Subjects who developed pressure ulcers were older and more likely to be female than those who did not develop ulcers . Braden Scale scores were significantly ( p = .0001 ) lower in those who developed ulcers than in those who did not develop ulcers . Overall , the critical cutoff score for predicting risk was 18 . Risk assessment on admission is highly predictive of pressure ulcer development in all setting s but not as predictive as the assessment completed 48 to 72 hours after admission . CONCLUSIONS Risk assessment on admission is important for timely planning of preventive strategies . Ongoing assessment in SNFs and VAMCs improves prediction and permits fine-tuning of the risk-based prevention protocol s. In tertiary care the most accurate prediction occurs at 48 to 72 hours after admission and at this time the care plan can be refined Background Pressure ulcers ( PrUs ) are ischemic wounds in the skin and underlying tissues caused by long-st and ing pressure force over an external bone or cartilaginous surface . PrUs are an important challenge for the overall health system because can prolong patient hospitalization and reduce quality of life . Moreover , 95 % of PrUs are avoidable , suggesting they are caused by poor quality care assistance . PrUs are also costly , increasing national costs . For example , they represent about 5 % of overall annual health expenses in Spain . Stages I and II PrUs have a combined prevalence of 65 % . According main clinical guidelines , Output:
Where data were available there was no evidence of a difference between alginate dressings and alternative treatments in terms of complete wound healing or adverse events . AUTHORS ' CONCLUSIONS The relative effects of alginate dressings compared with alternative treatments are unclear .
MS2_1shot89
***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 aim of the present study was to determine if a sugarless mint containing CaviStat ( an arginine bicarbonate calcium carbonate complex ) is capable of preventing the development of dental caries in the primary molars and first permanent molars of 10 1/2- to 11-year-old Venezuelan children . METHODS Two-hundred children were entered into this one-year study who showed the following : ( i ) age between 10 1/2 and 11 years ; ( ii ) first and second primary molars still present ; ( iii ) sound primary molars or early caries lesions in any of these teeth ; and ( iv ) at least some caries in the primary or permanent teeth as evidence of caries activity . Out of the 200 children initially selected , 195 finished and provided complete data . Children entered into the study were examined and then r and omly divided into two groups ( A and B ) , with distribution performed on the basis of the DMFS levels of the first permanent molars . All subjects were examined visually by a single examiner using good artificial light , mirror , and probe . Group A received a sugarless confection containing CaviStat ( BasicMints ) ; Group B received a sugarless mint control that contained all ingredients except for the CaviStat . Packaging and appearance of both types of mints were identical , except for their A and B design ations . RESULTS Mean differences in DMFS , defs , and DMFS + defs scores between Groups A and B were determined . In the first permanent molars and some early erupting premolars and second molars , the data showed 75.6 % fewer caries in Group A than in Group B children after six months , and 50.7 % fewer after 12 months . Corresponding defs scores showed reduced development of dental caries in deciduous molars of 76.7 % after six months and 131.3 % after 12 months . Combined DMFS and defs scores showed 76.2 and 74.8 % fewer caries lesions at six and 12 months , respectively . As exfoliation of primary molars occurred during the study period ( approximately equal in the two groups ) , a proportion correction was made to allow for caries score reductions due to lesions lost because of such exfoliation . When this was done , the results at the end of the study still showed larger caries reductions in Group A than in the Group B subjects , and statistical analyses showed these differences were still highly significant ( p < 0.001 ) . Noncavitated caries lesions in the first permanent molars were also determined . These showed once again less caries development in Group A than in Group B subjects , and did so at both six and twelve months ( 57.0 and 52.4 % , respectively ) . Levels of statistical significance at these times were p = 0.013 and 0.005 . CONCLUSION It was evident from this clinical trial that mint confections containing CaviStat are able to inhibit both caries onset and caries progression . As a result , one can conclude that CaviStat mint confection technology is a simple and economical means for reducing substantially one of the most prevalent diseases in these children Objective : We aim ed to evaluate the efficacy of oral hygiene instruction , fluoride varnish and casein phosphopeptide-amorphous calcium phosphate ( CPP-ACP ) for remineralizing white spot lesions ( WSL ) , and the effect of these on the dmft index in primary teeth . Subjects and Methods : In this 1-year , r and omized clinical trial , 140 children aged 12 - 36 months with WSL in the anterior maxillary teeth were selected and r and omly divided into 4 groups of 35 children each . Group 1 ( control ) received no preventive intervention . In group 2 , there was oral hygiene and dietary counseling . In group 3 , there was oral hygiene and the application of fluoride varnish at 4 , 8 and 12 months after baseline . In group 4 , there was oral hygiene and tooth mousse was applied by the parents twice a day over a 12-month period . At baseline and 4 , 8 and 12 months after the intervention , the size of WSL in millimeters and the dmft index were recorded . One hundred and twenty-two children completed the study . Data were analyzed using the repeated- measures ANOVA test . Results : In group 1 , the mean percent WSL area and dmft index values had increased significantly at 12 months after baseline ( p < 0.001 ) . The interventions led to significant decreases in the size of the WSL ; the greatest reduction was in group 4 ( 63 % ) followed by group 3 ( 51 % ) and group 2 ( 10 % ) after 12 months . The smallest increase in the dmft index was in group 4 ( 0.17 ) , followed by groups 3 ( 0.3 ) and 2 ( 0.42 ) . However , there were no significant differences between the groups ( p < 0.001 ) . Conclusions : Oral hygiene along with four fluoride varnish applications or constant CPP-ACP during the 12- month period reduced the size of WSL in the anterior primary teeth and caused a small increase in dmft index values PURPOSE The purpose of this study was to compare twice daily tooth-brushing using 0.304 percent fluoride toothpaste alone with : ( 1 ) twice daily tooth-brushing plus once daily 10 % casein phosphopeptide-amorphous calcium phosphate ( CPP-ACP ) paste ; and ( 2 ) twice daily tooth-brushing plus once daily 0.12 % chlorhexidine gel ( CHX ) for reducing early childhood caries ( ECC ) and mutans streptococci ( MS ) colonization . METHODS Subjects ( n=622 ) recruited at birth were r and omized to receive either CPP-ACP or CHX or no product ( study control [ SC ] ) . All children were examined at 6 , 12 , and 18 months old in their homes , and at 24 months old in a community dental clinic . RESULTS At 24 months old , the caries incidence was 1 % ( 2/163 ) in CPP-ACP , 2 % ( 4/180 ) in CHX , and 2 % ( 3/188 ) in SC groups . In children who were previously MS colonized at 12 and 18 months old , 0 % ( 0/11 ) and 5 % ( 3/63 ) , respectively , of the CPP-ACP group remained MS-positive versus 22 % ( 2/9 ) and 72 % ( 18/25 ) in CHX and 16 % ( 4/25 ) and 50 % ( 7/14 ) in SC groups ( P<.001 ) . CONCLUSIONS There is insufficient evidence to justify the daily use of casein phosphopeptide-amorphous calcium phosphate or chlorhexidine gel to control early childhood caries OBJECTIVES . This r and omised , controlled trial compared the effectiveness of 0.12 % chlorhexidine ( CHX ) gel and 304 % fluoride toothpaste to prevent early childhood caries ( ECC ) in a birth cohort by 24 months . METHODS . The participants were r and omised to receive either ( i ) twice daily toothbrushing with toothpaste and once daily 0.12 % CHX gel ( n = 110 ) or ( ii ) twice daily toothbrushing with toothpaste only ( study controls ) ( n = 89 ) . The primary outcome measured was caries incidence and the secondary outcome was percentage of children with mutans streptococci ( MS ) . All mothers were contacted by telephone at 6 , 12 , and 18 months . At 24 months , all children were examined at a community dental clinic . RESULTS . At 24 months , the caries prevalence was 5 % ( 3/61 ) in the CHX and 7 % ( 4/58 ) in the controls ( P = 0.7 ) . There were no differences in percentages of MS-positive children between the CHX and control groups ( 54%vs 53 % ) . Only 20 % applied the CHX gel once daily and 80 % less than once daily . CONCLUSIONS . Toothbrushing using 304 % fluoride toothpaste with or without the application of chlorhexidine gel ( 0.12 % ) reduces ECC from 23 % found in the general community to 5 - 7 % . The lack of effect with chlorhexidine is likely to be due to low compliance All field studies have unequivocally reported significant reductions in dental caries occurrence associated with the use of chewing gum containing xylitol . No other xylitol products besides chewing gum have so far been tested in field trials . A 5-year follow-up study with 2- or 3-year xylitol consumption periods began in Estonia in 1994 with 740 10-year-old children in 12 schools at baseline examinations . For the study , 3 clusters each including 3 - 5 schools were formed on the basis of baseline caries experience . The products were used under the supervision of the teachers 3 times per day during school days but not during weekends or during the 3-month summer holiday . The daily dose of xylitol was 5 g in all groups . The children were examined every year in September by two experienced clinicians . Dental caries was recorded according to WHO criteria . After 3 years , all xylitol groups showed a highly significant 35%-60 % reduction in caries incident , compared with the corresponding control groups . The differences between c and ies , between c and ies and chewing gum , and between 2- and 3-year users in the xylitol groups were non- systematic , indicating no trends between the groups . The results suggest that not only xylitol chewing gum but also xylitol c and ies are effective in caries prevention , and that a school-based delivery system seems to offer a practical way to distribute and control the use of the xylitol products OBJECTIVE The aim of this study was to investigate the caries prevention efficacy of chlorhexidine-thymol ( CHX-T ) varnish on newly erupted permanent first molars . METHODS Fifty-seven six- to eight-year-old school children were included in a program of sequential CHX-T varnish application . For inclusion , they had to have at least two homologous , newly erupted first permanent molars with visually sound occlusal surfaces . A clinical examination was used to determine the molar eruption stage , biofilm presence , and whole caries status . There were 99 pairs of molars in the study population . A split-mouth design was used where each child r and omly had one first molar treated with six applications of CHX-T varnish , and the other with a placebo varnish , every 15 days for 75 days . The children were then revaluated for caries one year following the conclusion of treatment . RESULTS Fourteen pairs of teeth presented incipient enamel caries lesions in both molars ( one CHX-T and one placebo varnish ) , four developed lesions in the placebo-treated molars only , and eight developed lesions in CHX-T varnish-treated molar only . No significant statistical differences were found between the two groups with regard to caries increment ( p = 0.20 ) . CONCLUSION Six applications of CHX-T varnish had no protective effect against caries development Objective . The aim was to investigate the effect of high and low amounts of xylitol on the interdental plaque-pH , directly and after sucrose challenge , in schoolchildren with habitual consumption . Material and methods . The study group consisted of 11 healthy children ( 10–15 years ) with low caries risk and the experiment had a single-blind crossover ( Latin square ) design . After a 2-week run-in period with a daily 4.0 g xylitol intake , the children were subjected to single-dose exposures of chewing gums with ( i ) paraffin ( CTR ; no xylitol ) , ( ii ) low-dose xylitol ( LX ; 2.0 g xylitol ) , and ( iii ) high-dose xylitol ( HX ; 6.0 g xylitol ) in a r and omized order separated by a washout period of 1 week . Sample s of chewing-stimulated whole saliva were collected prior to and after the experimental period for determination of bacterial counts . The outcome measures were in situ plaque-pH ( micro-touch method ) and area under the pH curve ( AUC ) . Results . The AUC was significantly greater ( p<0.05 ) in the HX group compared to the LX and control groups during the first 5 min after chewing . After a 10 % sucrose rinse , the interdental plaque-pH dropped in all groups but the HX regimen displayed significantly less reduction 0–5 min after chewing ( p<0.05 ) . No significant alterations of the total viable counts or mutans streptococci levels in saliva were disclosed during the 4-week experimental period . Conclusions . The present results suggested that a high single dose of xylitol had a short and limited beneficial effect on interdental plaque-pH in habitual xylitol consumers , while a low single dose , resembling normal chewing gum use , did not differ from the control The aim was to evaluate the effect of chlorhexidine gel treatment on the incidence of approximal caries in preschool children . One hundred and seventeen 4-year-olds , divided into two groups , participated : ( 1 ) chlorhexidine gel group ( n = 59 ) , and ( 2 ) placebo gel group ( n = 58 ) . Group 1 was treated 4 times a year with a 1 % chlorhexdine gel and group 2 with a placebo gel . Approximately 0.7 ml of gel was applied interdentally by means of a flat dental floss . A control group ( group 3 ) , which did not receive any flossing or Output:
There is evidence that the use of certain doses of xylitol may be effective in arresting dental caries in primary dentition . Chlorhexidine and CPP-ACP may be more effective than a placebo in managing caries in primary dentition , but their effectiveness is borderline when compared with fluoride . Arginine-containing mint confection and 0.3 % triclosan varnish were found to reduce caries development in primary teeth but the evidence was at high risk of bias .
MS2_1shot90
***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 3- and 12-month angiographic restenosis rates and their clinical impact after infrapopliteal angioplasty . DESIGN Prospect i ve multicenter study . MATERIAL S AND METHODS We analyzed 68 critical ischemic limbs ( tissue loss : 58 limbs ) from 63 consecutive patients due to isolated infrapopliteal lesions who underwent angioplasty alone . Primary endpoint was 3-month angiographic restenosis rate ; secondary endpoints were 12-month angiographic restenosis rate , and 3- and 12-month rates of mortality , major amputation and reintervention . Three- and 12-month frequency of ambulatory status and of freedom from ischemic symptoms , and time to wound healing in the ischemic wound group , were compared between restenotic and non-restenotic groups . Angiographic restenosis predictors were assessed by multivariable analysis . RESULTS 95 % of cases had 3-month angiography ; restenosis rate was 73 % : 40 % restenosis and 33 % re-occlusion . Twelve-month follow-up angiography was conducted for the patients without 3-month angiographic restenosis , and restenosis rate at 12 months was 82 % . Non-administration of cilostazol and statin , and chronic total occlusion were 3-month angiographic restenosis predictors . Three- and 12-month mortality was 5 % and 12 % , respectively . Despite no patients having undergone amputation , 15 % had persistent ischemic symptoms , and 48 % of limbs underwent reintervention within 12 months . During the same study period , ambulatory status and limbs with complete healing were more frequently observed in the non-restenosis group than in the restenosis group . In the tissue loss group , time to wound healing in the restenosis group was longer than in the non-restenosis group ( 127 days vs. 66 days , p = 0.02 ) . CONCLUSION The extremely high angiographic restenosis rate after infrapopliteal angioplasty may adversely impact clinical status improvement 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 OBJECTIVES The study investigated the efficacy and safety of a balloon exp and able , sirolimus-eluting stent ( SES ) in patients with symptomatic infrapopliteal arterial disease . BACKGROUND Results of infrapopliteal interventions using balloon angioplasty and /or bare stents are limited by a relatively high restenosis rate , which could be potentially improved by stabilizing the lesion with a SES . METHODS Two hundred patients ( total lesion length 27 ± 21 mm ) were r and omized to infrapopliteal SES stenting or percutaneous transluminal balloon angioplasty ( PTA ) . The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography . RESULTS Ninety-nine and 101 patients ( mean age 73.4 years ; 64 % diabetics ) were r and omized to SES and PTA , respectively ( 8 crossover bailout cases to SES ) . At 1 year , there were lower angiographic restenosis rates ( 22.4 % vs. 41.9 % , p = 0.019 ) , greater vessel patency ( 75.0 % vs. 57.1 % , p = 0.025 ) , and similar death , repeat revascularization , index-limb amputation rates , and proportions of patients with improved Rutherford class for SES versus PTA . CONCLUSIONS SES implantation may offer a promising therapeutic alternative to PTA for treatment of infrapopliteal peripheral arterial disease Purpose : To report the 6-month angiographic results from a prospect i ve single-center study investigating the efficacy and outcome of sirolimus-eluting stents used for bailout after infrapopliteal revascularization of patients with critical limb ischemia ( CLI ) . Methods : Twenty-nine patients ( 21 men ; mean age 68.7 years ) underwent infrapopliteal revascularization with bare metal stents ( group B ) implanted for bailout in 65 lesions ( 38 stenoses and 27 occlusions ) in 40 infrapopliteal arteries . Another 29 patients ( 21 men ; mean age 68.8 years ) underwent infrapopliteal bailout stenting with sirolimus-eluting stents ( group S ) in 66 lesions ( 46 stenoses and 20 occlusions ) in 41 vessels . Preliminary 6-month angiographic and clinical results were analyzed . Results : Hyperlipidemia and symptomatic cardiac and carotid diseases were more pronounced in group S ( p < 0.05 ) . Technical success was 96.6 % ( 28/29 limbs ) in group B versus 100.0 % in group S ( p=0.16 ) . Six-month primary patency was 68.1 % in group B versus 92.0 % in group S ( p < 0.002 ) . Binary in-stent and in-segment restenosis rates were 55.3 % and 66.0 % , respectively , in patients with bare stents versus 4.0 % and 32.0 % , respectively , in patients treated with the sirolimus-eluting stents ( both p < 0.001 ) . The target lesion reintervention rate at 6 months was 17.0 % in group B versus 4.0 % in group S ( p=0.02 ) . Limb salvage was 100 % in both groups . Six-month mortality and minor amputation rates were 6.9 % and 17.2 % , respectively , in group B versus 10.3 % and 3.4 % , respectively , in group S ( p=0.32 and p=0.04 , respectively ) . Conclusions : Sirolimus-eluting stents seem to restrict neointimal hyperplasia in the infrapopliteal vascular bed PURPOSE To determine the clinical outcome and the success of stent application for high- grade lesions of the infrapopliteal arteries compared with treatment with percutaneous transluminal angioplasty ( PTA ) in critical limb ischemia ( CLI ) . MATERIAL S AND METHODS In this ethics board-approved r and omized prospect i ve study , PTA or stent application was performed on 131 lesions in 88 patients with CLI . The primary end points were clinical improvement after endovascular treatment and limb salvage rate . Secondary end points were defined by the minimal lumen diameter ( MLD ) before and after the revascularization procedure , percentage of residual diameter stenosis ( DS ) , binary restenosis rate ( > 50 % DS and > 70 % DS ) , and incidence of target lesion revascularization at 9-month follow-up . RESULTS At 3 months , the clinical status in the PTA group was less improved than that in the stent group ( P = .008 ) . At 9 months , there had been five minor and two major amputations in the PTA group and five major and five minor amputations in the stent group . MLD was significantly larger and the percentage of DS was significantly less in the stent group at completion angiography . At 9 months , the angiographic control showed better trends for the stent group in comparison to the PTA group despite that no significant differences were detected ( MLD , 1.19 mm ± 0.92 vs 1.02 mm ± 1.02 ; DS , 38.68 % ± 25.47 vs 43.31 % ± 28.37 ) . CONCLUSION Infrapopliteal stent application is an effective treatment modality in CLI . The PTA and stent groups were essentially equal at 3 and 9 months except for the difference in clinical improvement in the stent group at 3 months OBJECTIVES We investigated the efficacy and safety of using balloon exp and able drug-eluting stents ( DES ) to prevent amputations in patients with below-the-knee critical limb ischemia . BACKGROUND Critical limb ischemia patients have a 1-year amputation rate of 30 % and a mortality rate of 25 % . Most patients with critical limb ischemia have severe below-the-knee arterial disease that limits the use of bypass surgery or balloon angioplasty . METHODS In all , 106 patients ( 118 limbs ) were treated with DES in this prospect i ve , nonr and omized trial . No patients were excluded because of comorbidities or unfavorable anatomy . Primary end points were major amputation and mortality , each stratified by Rutherford category . RESULTS The mean patient age was 74 + /- 9 years . There were 228 DES implanted ( 83 % Cypher [ Cordis , Johnson & Johnson , Warren , New Jersey ] , 17 % Taxus [ Boston Scientific , Maple Grove , Minnesota ] ) . The number of stents per limb was 1.9 + /- 0.9 , and 35 % of limbs received overlapping DES ( length of 60 + /- 13 mm ) . There were no procedural deaths , and 96 % of patients were discharged within 24 h. The 3-year cumulative incidence of amputation was 6 + /- 2 % , survival was 71 + /- 5 % , and amputation-free-survival was 68 + /- 5 % . Only 12 % of patients who died had a preceding major amputation . Rutherford category , age , creatinine level , and dialysis ( p < or= 0.001 to 0.04 ) were predictors of death but not amputation . Target limb revascularization occurred in 15 % of patients , and repeat angiography in 35 % of patients revealed a binary restenosis in 12 % . CONCLUSIONS Treating below-the-knee critical limb ischemia with DES is an effective and safe means of preventing major amputation and relieving symptoms . Procedural complications and limb revascularization rates were low . Limb salvage and survival rates in patients treated with DES exceed those of historic controls Output:
Conclusion DES for focal infrapopliteal lesions significantly inhibit vascular restenosis and thereby improve primary patency , decrease repeat procedures , improve wound healing , and prolong overall event-free survival
MS2_1shot91
***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 the use of a blood salvage and reinfusion system with st and ard allogeneic blood transfusion after total knee arthroplasty — a procedure associated with significant postoperative blood loss . Methods . Between June 2002 and May 2004 , 60 patients undergoing total knee arthroplasty were r and omly allocated into a reinfusion group ( n=26 ) or a control group ( n=34 ) . Patients in the reinfusion group had their blood reinfused from drains within 6 hours of surgery . Both groups received allogeneic blood transfusions according to specified transfusion criteria if the haemoglobin level fell below 90 g/l , or in the presence of severe anaemic symptoms . Haemoglobin levels and drain output were recorded daily for 3 consecutive days after surgery . Results . There was no significant difference between the 2 groups in demographic data , drain output , total blood loss , and mean postoperative haemoglobin levels . Significantly more allogeneic blood was required by the control group than by the reinfusion group ( p=0.022 ) . Conclusion . Postoperative reinfusion of drained blood reduced the need for blood transfusion after total knee arthroplasty , while having an effect on postoperative haemoglobin level equivalent to st and ard allogeneic blood transfusion To investigate the safety and efficacy of postoperative autologous blood transfusion ( AT ) using the Shiley hardshell venous reservoir , a prospect i ve , r and omised , controlled study was carried out in two matched groups of twenty patients undergoing elective coronary artery bypass surgery . The mean volume of shed mediastinal blood reinfused in the first 6 h postoperatively was 371.7 + /- 63.23 ml . Use of homologous blood was reduced from 760.5 + /- 108.37 ml in the control patients to 466.25 + /- 87.44 ml in the AT patients , a reduction of 38.7 % ( p less than 0.05 ) . There was no statistically significant difference in the clinical outcome , overall blood loss , use of platelets , fresh frozen plasma and colloids , haematological indices , renal and hepatic functions , or clotting mechanism , although there was a reduction in the fibrinogen level in the patients who received AT ( p less than 0.05 ) . Mediastinal blood did not clot and was defibrinogenated . It contained significant levels of haemoglobin ( 8.175 + /- 0.506 g/dl ) , platelets ( 96.55 + /- 10.39 per mm3 10(3 ) ) , protein ( 42.5 + /- 1.13 g/l ) , calcium ( 2.385 + /- 0.054 mmol/l ) and was well oxygenated ( PO2 = 20.46 + /- 0.81 kPa ) . No patients developed bacteraemia or had any AT-related infections . We conclude that postoperative autologous transfusion using the Shiley hardshell venous reservoir is a safe and efficient method for reducing postoperative homologous blood requirement after coronary artery bypass surgery A series of 40 patients undergoing primary unilateral total knee arthroplasty were entered into a r and omised controlled trial to assess the safety and efficacy of postoperative autologous blood salvage and reinfusion . The mean volume of autologous blood reinfused was 520 ml per patient ( 51 % of the mean total drainage ) . Homologous blood transfusion was required in only 35 % of patients in the study group compared with 95 % of patients in the control group ( P less than 0.001 ) . The mean volume of homologous blood transfused was 0.9 units per patient in the study group compared with 2.5 units in the control group ( P less than 0.001 ) , a saving of 64 % BACKGROUND Aprotinin therapy is now widely used during cardiac surgery . This study examined the clinical and economic effectiveness of high-dose or low-dose aprotinin in comparison to placebo . METHODS In a double blind , r and omized study , three groups of 50 patients received high-dose aprotinin costing AUS$614 per patient ( AUS$ = Australian dollars ) , low-dose aprotinin costing AUS$220 per patient or placebo . Re source use influenced by aprotinin therapy was measured . RESULTS Both doses were effective in reducing chest drainage and postoperative transfusion requirements , high-dose being more effective than low-dose . Both doses reduced the rate of reoperations for hemostasis . A base case of statistically significant differences associated with the high-dose and low-dose aprotinin showed cost savings of AUS$77 and AUS$348 per patient , respectively . If the demonstrated less significant reductions in operating room and ward stay are included , these savings become AUS$463 and AUS$715 , respectively . Alternately , if cross-matches are replaced by group- and -hold and cell savers are not used , the savings per patient would be AUS$196 and AUS$467 , respectively . CONCLUSIONS While high-dose aprotinin is clinical ly more effective than low-dose aprotinin , low-dose therapy demonstrates greater cost savings BACKGROUND : Previous trials have indicated that cell salvage may reduce allogeneic blood transfusion during cardiac surgery , but these studies have limitations , including inconsistent use of other blood transfusion-sparing strategies . We design ed a r and omized controlled trial to determine whether routine cell salvage for elective uncomplicated cardiac surgery reduces blood transfusion and is cost effective in the setting of a rigorous transfusion protocol and routine administration of antifibrinolytics . METHODS : Two-hundred-thirteen patients presenting for first-time coronary artery bypass grafting and /or cardiac valve surgery were prospect ively r and omized to control or cell salvage groups . The latter group had blood aspirate during surgery and mediastinal drainage the first 6 h after surgery processed in a cell saver device and autotransfused . All patients received tranexamic acid and were subjected to an algorithm for red blood cell and hemostatic blood factor transfusion . RESULTS : There was no difference between the two groups in the proportion of patients exposed to allogeneic blood ( 32 % in both groups , relative risk 1.0 P = 0.89 ) . At current blood products and cell saver prices , the use of cell salvage increased the costs per patient by a minimum of $ 103 . When patients who had mediastinal re-exploration for bleeding were excluded ( as planned in the protocol ) , significantly fewer units of allogeneic red blood cells were transfused in the cell salvage compared with the control group ( 65 vs 100 U , relative risk 0.71 P = 0.04 ) . CONCLUSION : In patients undergoing routine first-time cardiac surgery in an institution with a rigorous blood conservation program , the routine use of cell salvage does not further reduce the proportion of patients exposed to allogeneic blood transfusion . However , patients who do not have excessive bleeding after surgery receive significantly fewer units of blood with cell salvage . Although the use of cell savage may reduce the dem and for blood products during cardiac surgery , this comes at an increased cost to the institution To evaluate the safety and effectiveness of the collection and retransfusion of postoperatively shed mediastinal blood as part of a multifaceted approach to blood conservation following cardiac operation , 113 patients were r and omized into either an autotransfusion group ( 54 patients ) or a control group ( 59 patients ) . Intraoperative and postoperative hemodilution was practice d in all patients . The clinical safety of this technique was confirmed by the lack of septic , hematological , pulmonary , renal , or hepatic complications . However , in this setting where blood conservation is already aggressively practice d , the ability of the technique to further reduce the use of banked blood following cardiac surgical procedures was not demonstrated A controlled , r and omised , prospect i ve study was undertaken to assess the efficacy of the use of a blood re-infusion device in the reduction of allogenic blood requirements of patients undergoing bilateral simultaneous total knee replacements . Thirty-three consecutive patients were r and omised to receive allogenic blood only , or a combination of collected and re-infused blood . An average of 1000 ml of drainage blood was salvaged in the study group , result ing in a significant reduction in allogenic blood requirements from 6.3 to 3.8 units in total ( P value=0.002 ) . No patients suffered transfusion reactions . We conclude that autologous re-infusion is a safe and effective method of reducing allogenic blood requirements , and as a result , reducing the risks of transmission of infection , and the rate of post-operative infection BACKGROUND Autotransfusion of shed mediastinal blood may reduce the need for homologous blood transfusions in cardiac surgery . In an earlier study we have shown that the red blood cells ( RBCs ) of shed mediastinal blood have a normal membrane stability ( osmotic fragility ) compared with circulating RBCs after coronary artery bypass grafting and better than stored RBCs . This indicates that RBCs in shed mediastinal blood are not damaged further during salvage . It remains to be determined how autotransfusion affects the survival of RBCs from shed mediastinal blood . METHODS We performed a prospect i ve , r and omized , and controlled study involving 26 patients having elective , uncomplicated coronary artery bypass grafting . Dual-isotope labeling technique ( chromium 51 and technetium 99 m ) was used to investigate the 24-hour survival of RBCs from shed mediastinal blood and RBCs from circulating blood , and to estimate the mean survival time of RBCs . RESULTS There was no significant difference between the 24-hour survival of shed mediastinal RBCs and circulating RBCs . The estimated mean cell lifespan was 20.5 days ( range , 11.6 to 29.0 days ) for shed mediastinal RBCs and 22.7 days ( range , 14.4 to 36.2 days ) for circulating RBCs . CONCLUSIONS The survival of RBCs from shed mediastinal blood after autotransfusion is comparable with the survival of RBCs in the patients ' circulating blood PURPOSE The net benefit of routine intraoperative autotransfusion ( IAT ) in patients undergoing elective infrarenal aortic surgery was studied . METHODS One hundred patients undergoing abdominal aortic aneurysm ( AAA ) repair ( n = 50 ) or aortofemoral bypass ( AFB ) for occlusive disease ( n = 50 ) were r and omized to IAT and control groups . This experience accounted for 58 % of patients undergoing aortic surgery during the 16-month study period . RESULTS IAT and control groups were balanced for preoperative demographics , disease ( 50:50 split of AFB : AAA in each group ) , and risk factors . There were no significant differences between patients r and omized to IAT and control patients in estimated blood loss ( EBL ) , allogeneic blood transfusion ( units administered intraoperatively , postoperatively , and total ) , proportion of patients not receiving allogeneic blood ( 34 % of patients r and omized to IAT and 28 % of control patients ) , postoperative hemoglobin/hematocrit levels , and complications . IAT did not reduce allogeneic blood transfusion among all patients undergoing aortic surgery nor in any subgroups that might be more likely to benefit , such as those undergoing AAA repair , those with 1000 mL or more EBL , and those receiving larger volumes of IAT-processed blood . CONCLUSION We could find no net benefit of IAT in patients undergoing elective , infrarenal aortic surgery The purpose of the study reported here was the determination of the efficacy of a postoperative autologous blood drainage and transfusion device in reducing allogeneic red cell requirements in patients undergoing elective knee arthroplasty . The study was a r and omized controlled trial with adult patients undergoing unilateral elective arthroplastic knee surgery . Patients underwent suction drainage , attached to an autologous blood drainage and transfusion device , or st and ard suction drainage . Allogeneic red cells were given according to strict transfusion guidelines based on blood loss and postoperative hemoglobin values . Outcome measures included the mean number of allogeneic red cell concentrates required and the number of patients in each group who required no transfusion . Patients assigned to st and ard suction drainage had a mean allogeneic red cell utilization of 1.2 units ( SD 1.0 ) , as compared to a mean of 0.4 units ( SD 0.8 ) in the group undergoing drainage with the autologous blood drainage and transfusion device ( p = 0.0007 ) . The percentage of patients not requiring allogeneic red cells was significantly higher in the latter group ( 74.3 % vs. 32.5 % ; p = 0.002 ) . The postoperative drainage and transfusion device was efficacious in reducing the amount of allogeneic red cells required by patients undergoing knee arthroplasty , and its use result ed in a 42 percent reduction in the number of patients requiring allogeneic transfusion BACKGROUND The aim of this study was to ascertain whether cell salvage and autotransfusion after first time elective coronary artery bypass grafting is associated with a significant reduction in the use of homologous blood , a clinical ly significant derangement of postoperative clotting profiles , or an increased risk of Output:
Cell salvage did not appear to impact adversely on clinical outcomes . The results suggest cell salvage is efficacious in reducing the need for allogeneic red cell transfusion in adult elective cardiac and orthopaedic surgery . The use of cell salvage did not appear to impact adversely on clinical outcomes . As the trials were unblinded and lacked adequate concealment of treatment allocation , transfusion practice s may have been influenced by knowledge of the patients ' treatment status potentially biasing the results in favour of cell salvage
MS2_1shot92
***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 This study evaluated the 6-week Chronic Disease Self-Management Program ( CDSMP ) in Hong Kong . Methods A total of 148 subjects with chronic illness were recruited . Subjects were matched on duration of illness and gender , and then r and omly allocated to experimental and comparison groups . The experimental group participated in the CDSMP , while the comparison group joined a Tai-Chi interest class in a mass-activity format . Subjects completed evaluation question naires before beginning their program and 1 week following the program . Results Analysis of covariance showed that the CDSMP participants demonstrated significantly higher self-efficacy in managing their illness , used more cognitive methods to manage pain and symptoms , and felt more energetic than the subjects in the comparison group . The CDSMP participants also demonstrated changes in their profile of coping strategies , having a tendency to adopt the cognitive methods of diverting attention , reinterpreting pain , ignoring sensations , and making positive self-statements . Conclusion The short-term evaluation results showed that the CDSMP primarily increased the self-efficacy , exercise behavior , and application of cognitive coping strategies of the participants . Practice Implication The effect of the CDSMP in a Chinese population is similar to that found in studies in Western cultures , and the CDSMP could be applied effectively in a Chinese population OBJECTIVES We sought to determine the effects of a community-based , culturally tailored diabetes lifestyle intervention on risk factors for diabetes complications among African Americans and Latinos with type 2 diabetes . METHODS One hundred fifty-one African American and Latino adults with diabetes were recruited from 3 health care systems in Detroit , Michigan , to participate in the Racial and Ethnic Approaches to Community Health ( REACH ) Detroit Partnership diabetes lifestyle intervention . The curriculum , delivered by trained community residents , was aim ed at improving dietary , physical activity , and diabetes self-care behaviors . Baseline and postintervention levels of diabetes-specific quality -of-life , diet , physical activity , self-care knowledge and behaviors , and hemoglobin A1C were assessed . RESULTS There were statistically significant improvements in postintervention dietary knowledge and behaviors and physical activity knowledge . A statistically significant improvement in A1C level was achieved among REACH Detroit program participants ( P<.0001 ) compared with a group of patients with diabetes in the same health care system in which no significant changes were observed ( P=.160 ) . CONCLUSIONS A culturally tailored diabetes lifestyle intervention delivered by trained community residents produced significant improvement in dietary and diabetes self-care related knowledge and behaviors as well as important metabolic improvements Abstract Objective To develop and refine a complex intervention for diabetes support and education in minority ethnic groups , delivered through bilingual health advocates . Design Action research framework — a variety of methods used in an emergent and developmental manner , in partnership with clinicians , managers , and service users , drawing especially but not exclusively on narrative methods . Setting Deprived inner London district . Interventions Development and evaluation of three components of the complex intervention : a group based learning set for bilingual health advocates , in which stories about clients with diabetes formed the basis for action learning ; advocate led support and education groups for people with diabetes , which used personal stories as the raw material for learning and action ; organisational support to help to develop these new models and embed them within existing services . Results Both advocate groups and user groups were popular and well evaluated . Through storytelling , advocates identified and met their own educational needs in relation to diabetes and the unmet needs of service users . In the advocate led user groups , story fragments were exchanged in a seemingly chaotic way that the research team initially found difficult to facilitate or follow . Stories were not so much told as enacted and were often centred on discussion of “ what to do . ” Whereas some organisations welcomed , successfully implemented , and sustained the advocate led groups , others failed to do so . A key component of the complex intervention was organisational support . Conclusions An action research approach allowed engagement with an underserved group of health service staff and with hard to reach service users . The study produced subjective benefits to these groups locally as well as a worked-up complex intervention that will now be formally tested in a r and omised controlled trial OBJECTIVES To assess whether group exercise and coping classes reduce physical and psychological impairments and functional disability in older women with prevalent vertebral fractures ( VFs ) . DESIGN R and omized , controlled trial ( modified cross-over ) with site as unit of assignment ; testing at baseline and 3 , 6 , 9 , and 12 months . SETTING Nine North Carolina retirement communities . PARTICIPANTS One hundred eighty-five postmenopausal Caucasian women ( mean age 81 ) , each with at least one VFs . INTERVENTION The intervention group had 6 months of exercise ( 3 meetings weekly , 45 minutes each ) and coping classes ( 2 meetings weekly , 45 minutes each ) in Phase 1 , followed by 6 months of self-maintenance . The control group had 6 months of health education control intervention ( 1 meeting weekly , 45 minutes ) in Phase 1 , followed by the intervention described above . MEASUREMENTS Change in trunk extension strength , change in pain with activities , and change in psychological symptoms . RESULTS Between-group differences in the change in trunk extension strength ( 10.68 foot pounds , P<.001 ) and psychological symptoms ( -0.08 , P=.011 ) were significant for Phase 1 . Changes in pain with activities did not differ between groups ( -0.03 , P=.64 ) ; there was no change in the pain endpoint . In Phase 2 , controls showed significant changes in trunk strength ( 15.02 foot pounds , P<.001 ) and psychological symptoms ( -0.11 , P=.006 ) from baseline . Change in pain with activities was not significant ( -0.03 , P=.70 ) . During self-maintenance , the intervention group did not worsen in psychological symptoms , but improved trunk extension strength was not maintained . CONCLUSION Weak trunk extension strength and psychological symptoms associated with VFs can be improved in older women using group treatment , and psychological improvements are retained for at least 6 months PURPOSE The Women to Women Diabetes Project tested the use of telecommunication technology to deliver diabetes education and social support to rural women with diabetes . The aims were to ( 1 ) test the effects of the computer intervention in providing support , information , and education on selected outcomes , and ( 2 ) evaluate the women 's attitudes toward and satisfaction with the intervention and the support provided . METHODS Thirty women were r and omized into computer and noncomputer groups and participated for 10 months . For 5 months , one group participated in a self-help support and educational group via the computer ; the other group continued to use their usual modes of support and communication . Psychosocial well-being scales were administered and attitudes were surveyed . RESULTS Improving health and higher educational levels positively influenced measures of social support and quality of life . Women who were married or who reported greater support had higher scores on the Personal Re source Question naire . The women expressed positive effects of the computer-based support group on their lives . CONCLUSIONS The intervention was enthusiastically accepted , and could be conducted effectively in isolated rural areas A 10-session , self-management training program was design ed specifically for persons over 60 years of age having Type II diabetes . It targeted social learning variables , especially problem-solving skills and self-efficacy , found to be related to diabetes self-care in earlier correlational research . One hundred two adults were r and omized to immediate or delayed intervention conditions . At posttest , subjects in the immediate intervention condition showed significantly greater reductions in caloric intake and percent of calories from fat than control subjects . The intervention also produced greater weight reductions and increases in the frequency of glucose testing than did the control condition . Improvements among immediate intervention subjects were generally maintained at a 6-month follow-up . Intervention results from subjects receiving delayed intervention closely replicated those for immediate intervention subjects . We conclude that a relatively short-term program can improve self-management skills of older diabetic adults , and that there is an important need for such interventions OBJECTIVE Studies have suggested that the Arthritis Self-Management Program ( ASMP ) course is effective at reducing arthritis pain and health care costs in volunteer participants . There have been no reports of trials of the ASMP in the context of primary care physicians ' practice s , where the potential for spreading the program may be greatest . We conducted a r and omized controlled trial of the ASMP course in a large primary care physician network . METHODS Patients with osteoarthritis , rheumatoid arthritis , or fibromyalgia were recruited for the study . Subjects in the intervention practice s received the 6 week course and those in the control practice s received only the ASMP book , without course . Disability , pain , self-efficacy , mental health , and satisfaction were measured using vali date d instruments at baseline and at 4 months . RESULTS One hundred thirteen patients were recruited for the ASMP course ( intervention ) and completed baseline and 4 month followup question naires . Eighty-four percent completed at least 4 of 6 classes . Seventy-four patients received the ASMP manual ( controls ) and completed both question naires . Patients in the intervention and control groups had similar baseline pain ( p = 0.94 ) , self-efficacy to control pain ( p = 0.90 ) , mental health ( p = 0.10 ) , and vitality scores ( p = 0.21 ) , but those in the intervention arm had slightly less disability ( p = 0.04 ) . At 4 months , there was no significant improvement from baseline in any endpoint and no difference between patients in the intervention and control groups ( all p > 0.2 ) . Patient satisfaction with arthritis care and outcomes was no different for intervention and control patients ( all p > 0.3 ) . All types of health care re source use were similar at baseline and followup for both intervention and control groups ( all p > 0.2 ) . CONCLUSION While the ASMP course has been found to be effective in other patient groups , there were no significant clinical benefits noted at 4 months in patients recruited from primary care practice OBJECTIVES This study evaluated the effectiveness ( changes in health behaviors , health status , and health service utilization ) of a self-management program for chronic disease design ed for use with a heterogeneous group of chronic disease patients . It also explored the differential effectiveness of the intervention for subjects with specific diseases and comorbidities . METHODS The study was a six-month r and omized , controlled trial at community-based sites comparing treatment subjects with wait-list control subjects . Participants were 952 patients 40 years of age or older with a physician-confirmed diagnosis of heart disease , lung disease , stroke , or arthritis . Health behaviors , health status , and health service utilization , as determined by mailed , self-administered question naires , were measured . RESULTS Treatment subjects , when compared with control subjects , demonstrated improvements at 6 months in weekly minutes of exercise , frequency of cognitive symptom management , communication with physicians , self-reported health , health distress , fatigue , disability , and social/role activities limitations . They also had fewer hospitalizations and days in the hospital . No differences were found in pain/physical discomfort , shortness of breath , or psychological well-being . CONCLUSIONS An intervention design ed specifically to meet the needs of a heterogeneous group of chronic disease patients , including those with comorbid conditions , was feasible and beneficial beyond usual care in terms of improved health behaviors and health status . It also result ed in fewer hospitalizations and days of hospitalization A Roy adaptation model-based support and education intervention for women with early-stage breast cancer was tested in a three-group , three-phase r and omized clinical trial of a sample of 125 women . The experimental group received 13 months of combined individual telephone and in-person group support and education , Control Group 1 received 13 months of telephone-only individual support and education , and Control Group 2 received one-time mailed educational information . The experimental group and Control Group 1 reported less mood disturbance at the end of all three phases , less loneliness at the end of Phases II and III , and a higher- quality relationship with a significant other at the end of Phase II than did Control Group 2 . No group differences were found for cancer-related worry or well-being . The findings suggest that individual telephone support may provide an effective alternative to in-person support groups . Further study of telephone interventions is recommended using ethnically and economically heterogeneous sample Background : Older adults after myocardial infa rct ion ( MI ) are a vulnerable group who may benefit from interventions to improve health outcomes . The use of a peer advisor or an advanced practice nurse ( APN ) to provide a self-efficacy intervention is a promising method of improving health outcomes after MI . Aims : The purpose of this paper was to compare the effect of two self-efficacy interventions , a peer advisor and an APN , to a group who received st and ard care after MI . Methods : The study was a three-group r and omized clinical trial with a peer advisor intervention group , an APN intervention group , and a st and ard care group . Outcome data were collected in the hospital after MI and by telephone at 12 weeks after hospital discharge , after the interventions were completed . Results : At 12 weeks after MI , there were no significant differences between the 3 groups in health outcomes . There were similar changes in self-efficacy for performing recovery behaviors , the actual performance of recovery behavior , physical and mental health across both intervention groups and the st and ard care group . Conclusions : Although the data did not vali date the benefits of these self-efficacy interventions , future efforts at identifying changes in health outcomes may need to use more discrete measurements that are more sensitive to changes in the older unpartnered adult after an MI One hundred subjects with arthritis were r and omized into lay-taught , or professional-taught 12-h arthritis self-management courses , or a control group . Outcomes , knowledge , exercise , relaxation , disability , pain , and number of physician visits were measured aat baseline and 4 months . Professional-taught groups Output:
Lay-led self-management education programmes may lead to small , short-term improvements in participants ' self-efficacy , self-rated health , cognitive symptom management , and frequency of aerobic exercise . There is currently no evidence to suggest that such programmes improve psychological health , symptoms or health-related quality of life , or that they significantly alter healthcare use .
MS2_1shot93
***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 Levels of expressed emotion ( EE ) in relatives are consistent predictors of relapse among bipolar and other mood disordered patients followed naturalistically . However , few studies have examined whether levels of EE predict the course of illness for patients engaged in psychosocial interventions . METHODS This study examined whether EE levels among caregivers moderated the success of family-based psychosocial interventions for patients with bipolar disorder . EE was examined as a predictor of symptomatic outcome in two groups : ( 1 ) bipolar patients receiving family-focused psychoeducational treatment ( FFT ) or integrated family and individual treatment ( IFIT ) , and ( 2 ) bipolar patients receiving crisis management ( CM ) , a less intensive intervention design ed to emulate community care . Bipolar patients ( N = 125 ) began the study in an acute illness episode , were stabilized on st and ard pharmacotherapy regimens , and followed for up to 2 years . RESULTS Family EE status was not associated with time to relapse in either group . However , patients with high EE relatives reported higher levels of depression over the 2-year term of follow-up , regardless of treatment condition . An examination of the dimensions of EE ( critical comments and emotional overinvolvement ) indicated that a higher frequency of critical comments predicted higher levels of mania and depression at follow-up . Additionally , the association between EE criticism and levels of mania symptoms was stronger among patients in CM than among patients in family treatment . LIMITATIONS The participants were recruited from two separate treatment protocol s. Patients in the IFIT protocol were not r and omly assigned to treatments . CONCLUSIONS EE is a predictor of symptom severity among bipolar patients undergoing pharmacological and psychosocial treatments , but family intervention may mitigate this association In a sample of 62 patients with Bipolar I disorder , the authors used a repeated measures longitudinal design to examine whether global family functioning was associated with the presence of a concurrent bipolar episode as well as whether global family functioning was associated with the presence of manic and depressive episodes in the following 3 months . Participants were recruited for a r and omized clinical trial examining the efficacy of family treatments combined with pharmacotherapy for bipolar disorder . Global family functioning was repeatedly measured with both clinician-rated and patient-rated assessment instruments over the 28-month study period . Results indicated that mood episodes were associated with concurrent global family functioning within individuals , but global family functioning was not associated with episode status in the subsequent 3 months . The repeated measures nature of these results suggests that global family functioning and bipolar episodes may fluctuate in concert with each other but that global family functioning is not associated with subsequent change in episode status The present study investigated the greater symptom severity and poorer treatment response found in patients with bipolar illness and anxiety comorbidity , and examined depression as a potential mediator of this relationship . The sample consisted of 92 patients in an acute episode of Bipolar I Disorder with a current or past history of an anxiety disorder . Diagnoses were based on structured clinical interview , and participants were assessed at pre-treatment and then r and omly assigned to pharmacotherapy alone or pharmacotherapy plus family intervention . Patients were assessed on a monthly basis by blind assessors over 28 months . Compared to patients without anxiety comorbidity , individuals with bipolar disorder and an anxiety disorder possessed greater current symptom severity , even after controlling for depression severity . Logistic regression analysis identified that being female and having higher current depression but not manic severity predicted comorbid anxiety . Comorbid anxiety was associated with poorer treatment response in the sample regardless of treatment type , particularly in subsequent depressive symptoms . Multiple regression analyses indicated that current depression but not manic severity partially mediated the relationship between comorbid anxiety and treatment outcome . Results from the current study investigating comorbid anxiety disorders are consistent with past research limited to anxiety symptoms . Depression only partially accounted for the link between comorbid anxiety and greater symptom severity and poorer treatment response , and examination of other factors is warranted . Because of the clinical relevance of comorbid anxiety in severe affective disorders , treatments design ed to specifically address both concerns are needed Bipolar disorder ( BPD ) has received increasing attention from public and professional sources . Although pharmacologic treatments are considered the sine qua non in the treatment of youth with BPD , psychosocial interventions are critical to assist the child and family cope with symptoms that carry with them significant morbidity and mortality . Treatments developed to date are few in number ; all are psychoeducationally based , using cognitive-behavioral and family systems interventions within a biopsychosocial framework . This paper review s possible mediators of outcome , including caregiver concordance , children 's social skills , hopelessness , and family stress . The author has developed two family-based psychoeducational interventions for the treatment of youth with BPD : multifamily psychoeducation groups ( MFPG ) and individual family psychoeducation ( IFP ) . These treatments are both described and the results from a previously published r and omized clinical trial ( RCT ) of MFPG are summarized . Then , new findings from an RCT of IFP are presented , along with preliminary pilot data from an exp and ed version of IFP . The paper concludes with recommendations for future research In recent years , lower serum levels have been recommended for maintenance therapy with lithium . We studied 94 patients with bipolar disorder in a r and omized , double-blind , prospect i ve trial of two different doses of lithium for maintenance therapy : the " st and ard " dose , adjusted to achieve a serum lithium concentration of 0.8 to 1.0 mmol per liter , and a " low " dose , result ing in a serum concentration of 0.4 to 0.6 mmol per liter . The group medians of the patients ' average serum lithium levels were 0.83 mmol per liter for the patients in the st and ard-range group and 0.54 mmol per liter for those in the low-range group . Six of 47 patients ( 13 percent ) assigned to receive lithium doses that would produce serum levels in the st and ard range had relapses while on protocol , as compared with 18 of 47 ( 38 percent ) assigned to the low-dose range . The risk of relapse was 2.6 times higher ( 95 percent confidence interval , 1.3 to 5.2 ) among patients in the low-range group than among those in the st and ard-range group . Side effects , including tremor , diarrhea , urinary frequency , weight gain , and a metallic taste in the mouth , were more frequent in the st and ard-range group . We conclude that doses result ing in serum lithium levels from 0.8 to 1.0 mmol per liter are more effective in treating bipolar disorder than those that result in lower serum lithium concentrations , although the higher doses are associated with a higher incidence of side effects . Recent findings about the limited nephrotoxicity of lithium , along with our observations , suggest that physicians should attempt to maintain serum lithium levels between 0.8 and 1.0 mmol per liter in most patients with bipolar disorder and that they should attempt to enhance patients ' underst and ing of and compliance with this regimen BACKGROUND Family therapy is sometimes used as adjunctive treatment to pharmacotherapy to help patients recover from mood episodes of bipolar I disorder . However , the efficacy of this practice is not known . METHODS Ninety-two patients meeting criteria for a current bipolar I mood episode were r and omly assigned to family therapy plus pharmacotherapy , multifamily psychoeducational group therapy plus pharmacotherapy , or pharmacotherapy alone . Time to recovery was analyzed with survival analysis . RESULTS The proportion of subjects within each treatment group who recovered did not significantly differ , nor did time to recovery . LIMITATIONS The analyses did not include other outcomes such as psychosocial functioning , prophylaxis against recurrences of mood episodes , or compliance with pharmacotherapy . CONCLUSIONS Neither adjunctive family therapy nor adjunctive multifamily psychoeducational group therapy significantly improves the rate of recovery from mood episodes of bipolar I disorder , compared to treatment with pharmacotherapy alone Family psychoeducational programs are efficacious adjuncts to pharmacotherapy for patients with schizophrenic and bipolar disorders , but little is known about what these programs change about families . The authors assessed changes in face-to-face interactional behavior over 1 year among families of bipolar patients who received a 9-month family-focused psychoeducational therapy ( FFT ; n = 22 ) or crisis management with naturalistic follow-up ( CMNF ; n = 22 ) , both administered with maintenance pharmacotherapy . Members of families who received FFT showed more positive nonverbal interactional behavior during a 1-year posttreatment problem-solving assessment than families who received CMNF , although no corresponding decreases were seen in negative interactional behaviors . The positive effect of family treatment on patients ' symptom trajectories over 1 year was partially mediated by increases in patients ' positive nonverbal interactional behaviors during this same interval CONTEXT Evidence of psychosocial disability in bipolar disorder is based primarily on bipolar I disorder ( BP-I ) and does not relate disability to affective symptom severity and polarity or to bipolar II disorder ( BP-II ) . OBJECTIVE To provide detailed data on psychosocial disability in relation to symptom status during the long-term course of BP-I and BP-II . DESIGN A naturalistic study with 20 years of prospect i ve , systematic follow-up . SETTING Inpatient and outpatient treatment facilities at 5 US academic centers . Patients One hundred fifty-eight patients with BP-I and 133 patients with BP-II who were followed up for a mean ( SD ) of 15 ( 4.8 ) years in the National Institute of Mental Health Collaborative Depression Study . MAIN OUTCOME MEASURES The relationship , by r and om regression , between Range of Impaired Functioning Tool psychosocial impairment scores and affective symptom status in 1-month periods during the long-term course of illness from 6-month and yearly Longitudinal Interval Follow-up Evaluation interviews . RESULTS Psychosocial impairment increases significantly with each increment in depressive symptom severity for BP-I and BP-II and with most increments in manic symptom severity for BP-I. Subsyndromal hypomanic symptoms are not disabling in BP-II , and they may even enhance functioning . Depressive symptoms are at least as disabling as manic or hypomanic symptoms at corresponding severity levels and , in some cases , significantly more so . At each level of depressive symptom severity , BP-I and BP-II are equally impairing . When asymptomatic , patients with bipolar disorder have good psychosocial functioning , although it is not as good as that of well controls . CONCLUSIONS Psychosocial disability fluctuates in parallel with changes in affective symptom severity in BP-I and BP-II . Important findings for clinical management are the following : ( 1 ) depressive episodes and symptoms , which dominate the course of BP-I and BP-II , are equal to or more disabling than corresponding levels of manic or hypomanic symptoms ; ( 2 ) subsyndromal depressive symptoms , but not subsyndromal manic or hypomanic symptoms , are associated with significant impairment ; and ( 3 ) subsyndromal hypomanic symptoms appear to enhance functioning in BP-II This clinical project compares the relative impact of two types of multiple family groups on psychiatric in patients and their families . Forty patients with a diagnosis of affective disorder , and their family members , were r and omly assigned to a traditional multiple family group with a process orientation that emphasized support , destigmatization , and self-help about common problems ; or to a psychoeducational multiple family group that emphasized the provision of information about the patient 's illness and methods of coping with it effectively . Both groups , which met for four hours on a Saturday afternoon , were an integral part of an ongoing inpatient program specializing in the treatment of affective disorders . Pre- and post- measures were obtained regarding family and patient knowledge about affective disorders , level of personal distress , attitudes about the illness , and dyadic adjustment . In addition , both patients and family members were asked to rate their satisfaction with the group experience . A number of differences in knowledge , attitude and dyadic adjustment were found in the participants of both groups immediately following their respective group sessions , but there were only a few statistically significant differences between the two groups . Those who attended the psychoeducational session , however , reported significantly more satisfaction with the experience Family affect was examined as a predictor of difficulty implementing a 9-month , manual-based , psychoeducational family therapy for recently manic bipolar patients . Prior to therapy , family members were administered measures to assess both their expressed emotion and affective behavior during a family interaction task . Following family treatment , both therapists and independent observers rated the overall difficulty of treating the family , and therapists also rated each participant 's problem behaviors during treatment , in the areas of affect , communication , and resistance . Therapists regarded affective problems among relatives and resistance among patients as central in determining the overall difficulty of treating the family . Relatives ' critical behavior toward patients during the pretreatment interaction task predicted both independent observers ' ratings of overall treatment difficulty and therapists ' perceptions of relatives ' affective problems during treatment . Moreover , patients ' residual symptoms predicted independent observers ' ratings of overall difficulty and therapists ' perceptions of patients ' resistance to the family intervention . Results suggest that difficulties in conducting a manual-based family intervention can be predicted from systematic , pretreatment family and clinical assessment BACKGROUND Few studies have examined the combined effects of psychosocial treatment and pharmacotherapy for bipolar disorder . This study used a r and omized , controlled design to examine a 9-month , manual-based program of family Output:
To date there is only a small and heterogeneous body of evidence on the effectiveness of family oriented approaches for bipolar disorder , and it is not yet possible to draw any definite conclusions to support their use as an adjunctive treatment for bipolar disorder .
MS2_1shot94
***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 collection of a complete , verified medication history is essential to patient safety . The involvement of clinical pharmacists has been shown to improve the completeness and accuracy of medication histories ; however , to our knowledge , involvement of pharmacy technicians has not been studied . OBJECTIVE Our aim was to determine whether verification of medication histories by pharmacy technicians in the emergency department ( ED ) would result in fewer errors in inpatient medication regimens compared to verification by the admitting physician team . METHODS We performed a prospect i ve cohort study of adult ED patients admitted for continuing care . In the intervention group , medication reconciliation was performed by pharmacy technicians in the ED before the creation of physician admitting orders . In the control group , pharmacy technicians conducted their history taking later , after admission . Initial admitting orders were then compared to the pharmacy technicians ' medication reconciliation taken before admission ( intervention group ) or after admission ( control group ) . Medication discrepancies were classified and determined to be justified or unjustified . Unjustified discrepancies were rated for harm potential . RESULTS In our cohort of 113 intervention and 75 control subjects , the mean age was 55 years ( st and ard deviation [ SD ] 16 years ) ; 96 patients ( 51 % ) were male . In the intervention group , 566 changes to home medications were observed on admission ; 352 ( 62 % ) were unjustified . Among controls , 406 changes to home medications were observed ; 228 ( 56 % ) were unjustified . This difference was not statistically significant ( p = 0.0586 ) . The rate of unjustified medication changes per patient was likewise not significantly different ( 3.14 [ SD 2.98 ] in interventions vs. 3.17 [ SD 2.81 ] in controls ; p = 0.9570 ) . The rate of medical errors did not differ between study groups , nor did severity ratings of unjustified changes . CONCLUSIONS Medication reconciliation by pharmacy technicians in the ED did not lead to a significant reduction in unjustified medication discrepancies BACKGROUND Medication reconciliation reduces potential medication discrepancies and adverse drug events . The role of pharmacy technicians in obtaining best possible medication histories ( BPMHs ) and performing reconciliation at the admission and transfer interfaces of care for pediatric patients has not been described . OBJECTIVES To compare the completeness and accuracy of BPMHs and reconciliation conducted by a pharmacy technician ( pilot study ) and by nurses and /or pharmacists ( baseline ) . The severity of identified unintentional discrepancies was rated to determine their clinical importance . METHODS This prospect i ve cohort comparison study involved patients up to 18 years of age admitted to and /or transferred between the Cardiology ward and the Cardiac Critical Care Unit of a pediatric tertiary care teaching hospital . A pharmacy resident conducted two 3-week audits : the first to assess the completeness and accuracy of BPMHs and reconciliation performed by nurses and /or pharmacists and the second to assess the completeness and accuracy of BPMHs and reconciliation performed by a pharmacy technician . RESULTS The total number of patients was 38 in the baseline phase and 46 in the pilot period . There were no statistically significant differences between the baseline and pilot audits in terms of completion of BPMH ( 82 % [ 28/34 ] versus 78 % [ 21/27 ] , p = 0.75 ) or completion of reconciliation ( 70 % [ 23/33 ] versus 75 % [ 15/20 ] , p = 0.76 ) within 24 h of admission . Completeness of transfer reconciliation was significantly higher during the pilot study than at baseline ( 91 % [ 31/34 ] versus 61 % [ 11/18 ] , p = 0.022 ) . No significant differences between the baseline and pilot audits were found in the proportions of patients with at least one BPMH discrepancy ( 38 % [ 13/34 ] versus 22 % [ 6/27 ] , p = 0.27 ) , at least one unintentional discrepancy upon admission ( 21 % [ 7/33 ] versus 10 % [ 2/20 ] , p = 0.46 ) , or at least one unintentional discrepancy at the transfer interface ( 6 % [ 1/18 ] versus 3 % [ 1/34 ] , p = 0.58 ) . None of the 16 unintentional discrepancies were rated as causing severe patient discomfort or clinical deterioration . CONCLUSIONS A trained pharmacy technician can perform admission and transfer medication reconciliation for pediatric patients with completeness and accuracy comparable to those of nurses and pharmacists . Future studies should explore the sustainability and cost-effectiveness of this practice model BACKGROUND Medicare Part D is a voluntary prescription drug benefit for Medicare beneficiaries . As part of the coverage , medication therapy management services ( MTMS ) are m and ated for beneficiaries with chronic diseases who take multiple medications covered under part D and who are likely to incur annual costs that exceed a specified level . OBJECTIVE To predict the behavioral intention of pharmacists to provide Medicare medication therapy management services ( MTMS ) using the theory of planned behavior ( TPB ) and to determine the relationship between pharmacists ' characteristics and intention to provide MTMS . METHODS The population for this cross-sectional descriptive study consisted of all community pharmacists in Iowa . Data collection occurred through a self-administered anonymous mail survey . Two surveys each were mailed to 500 pharmacies selected through a stratified r and om sample , 1 survey for the pharmacy manager and 1 survey for a staff pharmacist if applicable . Descriptive statistics and scale reliability were calculated for each of the 4 TPB scales ( attitude , subjective norm , perceived behavioral control , and intention ) . Linear regression was used to predict intent as a function of the other 3 TPB factors , demographic factors , experience , and type of pharmacy . RESULTS Out of 212 surveys received , 203 had usable data . The usable response rate ranged from 21 % to 41 % . Pharmacists ' intent to provide MTMS was generally positive but varied in strength with a mean score of 22.47 ( + /-4.00 ) and a range of 7 - 30 . Pharmacists mostly agreed that they had appropriate training to provide MTMS but lacked time and support . The linear regression analysis found the constructs of attitude , subjective norm , and perceived behavioral control to be significant predictors of intent ( P<.05 ) . Pharmacists with stronger intent to provide MTMS were those who felt they had more control over providing MTMS , felt their peers approved of the provision of MTMS , and had a positive attitude about providing MTMS . Type of pharmacy and pharmacist demographic variables were not significant predictors of intent to provide MTMS . CONCLUSION Pharmacists showed generally positive intent to provide MTMS . Perceived behavioral control , subjective norm , and attitude were significant predictors of intent ( P<.05 ) . Strategies to help pharmacists provide MTMS should focus on finding time and support to provide MTMS rather than individual educational needs OBJECTIVE To assess the effectiveness and sustainability of a 6-month Team Education and Adherence Monitoring ( TEAM ) intervention for black patients with hypertension in community chain pharmacies . DESIGN Cluster r and omized trial . SETTING 28 chain pharmacies ( 14 TEAM and 14 control ) in five Wisconsin cities from December 2006 to February 2009 . PARTICIPANTS 576 black patients with hypertension . INTERVENTION Trained pharmacist-technician teams implemented a 6-month intervention using scheduled visits , Brief Medication Question naires ( BMQs ) , and novel toolkits for facilitating medication adherence and pharmacist feedback to patients and physicians . Control participants received patient information only . MAIN OUTCOME MEASURES Refill adherence ( ≥80 % days covered ) and changes in systolic blood pressure ( SBP ) , diastolic blood pressure , and blood pressure control using blinded assessment s at 6 and 12 months . RESULTS At baseline , all patients had blood pressure of 140/90 mm Hg or more . Of those eligible , 79 % activated the intervention ( mean 4.25 visits ) . Compared with control participants at 6 months , TEAM participants achieved greater improvements in refill adherence ( 60 % vs. 34 % , P < 0.001 ) , SBP ( -12.62 vs. -5.31 mm Hg , P < 0.001 ) , and blood pressure control ( 50 % vs. 36 % , P = 0.01 ) . Six months after intervention discontinuation , TEAM participants showed sustained improvements in refill adherence ( P < 0.001 ) and SBP ( P = 0.004 ) , though the difference in blood pressure control was not significant ( P < 0.05 ) compared with control participants . Analysis of intervention fidelity showed that patients who received the full intervention during months 1 through 6 achieved significantly greater 6- and 12-month improvements in refill adherence and blood pressure control compared with control participants . CONCLUSION A team-based intervention involving community chain pharmacists , pharmacy technicians , and novel toolkits led to significant and sustained improvements in refill adherence and SBP in black patients with hypertension The impact on the care of breast cancer patients , of a pharmacy technician-led medication review and counselling clinic , provided in an outpatient setting , was investigated using a controlled r and omised study . Compared to the controls , clinic patients showed a significantly improved level of underst and ing of their chemotherapy support medication ( 95 % CI for difference in mean knowledge rating scores=2.165–2.826 , P<0.001 ) and a significant reduction in the median number of support items required ( two compared to five in the control , P<0.001 ) . This result ed in a significant reduction in mean medication expenditure per patient ( £ 26.70 vs £ 10.20 , 95 % CI for the mean difference in cost £ 6.72–£26.26 , P<0.001 ) . The clinic was also associated with significant reductions in chemotherapy delays ( P<0.001 ) and dose reductions due to side effects ( P=0.003 ) . Other benefits from the clinic were a reduction in pharmacy dispensing time and a highly significant reduction in pharmacy time spent resolving post-clinic prescription queries ( P<0.001 ) . Taking into account the initial technician training cost , the scheme represented an annual saving to the Trust of over £ 15 000 . The clinic serves as a model for those wishing to improve outpatient services to breast cancer patients PURPOSE The ability of a pharmacy technician to support the patient screening and documentation-related functions of a pharmacist-driven osteoporosis management service was evaluated . METHODS A two-phase prospect i ve study was conducted within a large integrated health system to assess a pharmacy technician 's performance in supporting a multisite team of clinical pharmacy specialists providing postfracture care . In phase I of the study , a specially trained pharmacy technician provided support to pharmacists at five participating medical offices , helping to identify patients requiring pharmacist intervention and , when applicable , collecting patient-specific clinical information from the electronic health record . In phase II of the study , the amount of pharmacist time saved through the use of technician support versus usual care was evaluated . RESULTS The records of 127 patient cases were review ed by the pharmacy technician during phase I of the study , and a pharmacist agreed with the technician 's determination of the need for intervention in the majority of instances ( 92.9 % ) . An additional 91 patient cases were review ed by the technician in phase II of the research . With technician support , pharmacists spent less time review ing cases subsequently determined as not requiring intervention ( mean ± S.D. , 5.0 ± 3.8 minutes per case compared with 5.2 ± 4.5 minutes under the usual care model ; p = 0.78 ) . In cases requiring intervention , technician support was associated with a reduction in the average pharmacist time spent on care plan development ( 13.5 ± 7.1 minutes versus 18.2 ± 16.6 minutes with usual care , p = 0.34 ) . CONCLUSION The study results suggest that a pharmacy technician can accurately determine if a patient is a c and i date for pharmacist intervention and collect clinical information to facilitate care plan development BACKGROUND Obtaining an accurate and complete medication list ( i.e. , the best possible medication history [ BPMH ] ) is the first step in completing medication reconciliation . The ability of pharmacy technicians to obtain medication histories , relative to that of pharmacists , has not been formally assessed . OBJECTIVES To determine whether pharmacy technicians at the authors ' institution could obtain a BPMH as accurately and completely as pharmacists and if both groups met national norms for unintentional discrepancies and the success index for medication reconciliation . METHODS Pharmacy technicians were trained in obtaining a BPMH at the beginning of the study , before any patients were enrolled . Patients presenting to the emergency department were prospect ively enrolled to be interviewed separately by both a pharmacist and a technician , with information recorded on st and ard medication reconciliation forms . The completed forms for each patient were compared following each set of interviews , and discrepancies were clarified with the Output:
Conclusion : Pharmacy technicians are utilized most often to support MTM through assistance in medication reconciliation . St and ardized training for pharmacy technicians that delineates administrative support from pharmacists ' role of clinical decision making could help pharmacists obtain greater efficiency in MTM delivery
MS2_1shot95
***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 Traditionally , educational attainment , getting a job , living independently , getting married , and parenthood have been considered as markers of successful transition to adulthood . OBJECTIVE To describe and compare the achievement and the age at attainment of the above markers between extremely low-birth-weight ( ELBW ) and normal birth-weight ( NBW ) young adults . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve , longitudinal , population -based study in central -west Ontario , Canada , of 166 ELBW participants who weighed 501 to 1000 g at birth ( 1977 - 1982 ) and 145 sociodemographically comparable NBW participants assessed at young adulthood ( 22 - 25 years ) . Interviewers masked to participant status administered vali date d question naires via face-to-face interviews between January 1 , 2002 , and April 30 , 2004 . MAIN OUTCOME MEASURES Markers of successful transition to adulthood , including educational attainment , student and /or worker role , independent living , getting married , and parenthood . RESULTS At young adulthood , 149 ( 90 % ) of 166 ELBW participants and 133 ( 92 % ) of 145 NBW participants completed the assessment s at mean ( SD ) age of 23.3 ( 1.2 ) years and 23.6 ( 1.1 ) years , respectively . We included participants with neurosensory impairments ( ELBW vs NBW : 40 [ 27 % ] vs 3 [ 2 % ] ) and 7 proxy respondents . The proportion who graduated from high school was similar ( 82 % vs 87 % , P = .21 ) . Overall , no statistically significant differences were observed in the education achieved to date . A substantial proportion of both groups were still pursuing post secondary education ( 47 [ 32 % ] vs 44 [ 33 % ] ) . No significant differences were observed in employment/school status ; 71 ( 48 % ) ELBW vs 76 ( 57 % ) NBW young adults were permanently employed ( P = .09 ) . In a sub analysis , a higher proportion of ELBW young adults were neither employed nor in school ( 39 [ 26 % ] vs 20 [ 15 % ] , P = .02 by Holm 's correction ) ; these differences did not persist when participants with disabilities were excluded . No significant differences were found in the proportion living independently ( 63 [ 42 % ] vs 70 [ 53 % ] , P = .19 ) , married/cohabitating ( 34 [ 23 % ] vs 33 [ 25 % ] , P = .69 ) , or who were parents ( 16 [ 11 % ] vs 19 [ 14 % ] , P = .36 ) . The age at attainment of the above markers was similar for both cohorts . CONCLUSION Our study results indicate that a significant majority of former ELBW infants have overcome their earlier difficulties to become functional young adults OBJECTIVES To investigate the prevalence , correlates , and antecedents of autism spectrum disorders ( ASD ) in extremely preterm children . STUDY DESIGN We conducted a prospect i ve study of all births < 26 weeks gestation in the United Kingdom and Irel and in 1995 . Of 307 survivors at 11 years , 219 ( 71 % ) were assessed and compared with 153 term-born classmates . Parents completed the Social Communication Question naire ( SCQ ) to assess autism spectrum symptoms , and ASD were diagnosed by using a psychiatric evaluation . An IQ test and clinical evaluation were also administered . Longitudinal outcome data were available for extremely preterm children . RESULTS Extremely preterm children had significantly higher SCQ scores than classmates ( mean difference , 4.6 points ; 95 % CI , 3.4 - 5.8 ) . Sixteen extremely preterm children ( 8 % ) were assigned an ASD diagnosis , compared with none of the classmates . By hospital discharge , male sex , lower gestation , vaginal breech delivery , abnormal cerebral ultrasound scanning results , and not having had breast milk were independently associated with autism spectrum symptoms . By 6 years , independent associates were cognitive impairment , inattention and peer problems , withdrawn behavior at 2.5 years , and not having had breast milk . CONCLUSIONS Extremely preterm children are at increased risk for autism spectrum symptoms and ASD in middle childhood . These symptoms and disorders were associated with neurocognitive outcomes , suggesting that ASD may result from abnormal brain development in this population Replacement therapy with exogenous surfactant has been studied for both prevention and treatment of respiratory distress syndrome . Although reports demonstrate improved survival rates for surfactant-treated infants with RDS , the impact of this therapy on outcome of extremely low birth weight infants is unknown . TM Previous studies have not reported outcome after surfactant treatment for the subset of premature infants who are born at ELBWs and who are at the highest risk for complications of prematurity . We report the outcome of infants born with birth weights between 600 and 750 gm who underwent prospect i ve r and om selection to receive either surfactant or placebo as part of a multidose prevention study Poor executive function ( EF ) has been linked to attention-deficit/hyperactivity disorder ( ADHD ) . Children born at extremely low birth weight ( ELBW ; < 1000 g ) have been found to show both poor EF , as well as elevated levels of symptoms of ADHD . In the present study , we examined whether fluid intelligence moderates the link between birth weight and later ADHD symptoms by prospect ively following a cohort of 179 survivors who were born at ELBW . When participants were 8 years-old , they were matched with 145 normal birth weight ( NBW ; ≥2500 g ) control participants . At age 8 , fluid intelligence was measured , and during young adulthood ( ages 22–26 ) , participants ' self-reported levels of ADHD symptoms were examined . We found that ELBW survivors , who also showed poor fluid intelligence , had the highest rates of ADHD symptoms , and particularly , symptoms of inattention . These findings point to the importance of examining developmental trajectories that contribute to risk for psychopathology in those exposed to intrauterine adversity Discrepancies often arise among multiple informants ' reports of child and adolescent psychopathology and related constructs ( e.g. , parenting , family relationship quality and functioning , parental monitoring ) . Recently , studies using various design s ( laboratory , longitudinal , r and omized controlled trial , meta- analysis ) have revealed that discrepancies among informants ' reports ( a ) yield important information regarding where children express behaviors ( time course , features of the context [ s ] of behavioral expression ) and about the informants who observe their expression , ( b ) demonstrate stability over time in both community and clinic setting s , ( c ) predict poor child and adolescent outcomes in ways that the individual informants ' reports do not , and ( d ) can be used to identify meaningful treatment outcomes patterns within r and omized controlled trials . Using existing data sources , the articles in this special section exp and upon this emerging body of research . In particular , the articles illustrate how clinical science and practice can use informant discrepancies to increase underst and ing of the causes and consequences of , as well as treatments for , child and adolescent psychopathology Fetal programming of the hypothalamus-pituitary-adrenal ( HPA ) axis was proposed as one mechanism underlying the link between prenatal stress , adverse birth outcomes ( particularly low birth weight ) and an enhanced vulnerability for several diseases later in life . In recent studies , birth weight was significantly related to basal cortisol levels as well as to cortisol responses to pharmacological stimulation . In order to investigate the association between cortisol responses to psychological challenge , birth weight and length of gestation , 106 young healthy males were exposed to the ' Trier Social Stress Test ' . Salivary cortisol responses to the stress exposure were significantly and inversely related to the subjects ' birth weight , while the analysis of the impact of gestational age yielded inconsistent results . This finding is consistent with the concept of fetal programming of the HPA axis and provides the first preliminary evidence for an association between birth weight and adrenocortical responses to psychosocial stress . As the investigated subjects were twins , possible implication s of this sample characteristic for the present findings are discussed OBJECTIVES Our goals were to determine the mortality risk for infants weighing 501 to 1500 gm according to gestational age , birth weight , and gender and to document birth weight-related changes in mortality and morbidity over a 5-year time period . STUDY DESIGN In this observational study perinatal data were prospect ively collected by the 12 participating centers of the National Institute of Child Health and Human Development Neonatal Research Network from May 1991 through December 1992 and compared with the corresponding data from 1987 through 1990 . St and ard definitions were used to record sociodemographic factors , perinatal events , and the neonatal course to 120 days of life , discharge , or death . RESULTS The 1991 and 1992 cohort included 4279 in-born infants . Among their mothers 10 % were < 18 years old ; 55 % were black , 31 % were white , and 11 % were Hispanic ; 14 % had received no prenatal care ; and 20 % had received antenatal corticosteroids . Multiple gestations accounted for 20 % of the births . Fifty percent of the infants were delivered by cesarean section . During 1991 and 1992 the overall survival for infants weighing 501 to 1500 gm at birth was 81 % , compared with 74 % in 1987 and 1988 . Survival at birth weight 501 to 750 gm was 44 % ; it was 81 % at 751 to 1000 gm , 92 % at 1001 to 1250 gm , and 95 % between 1251 and 1500 gm . Female infants had a significantly greater chance of surviving than male infants at similar birth weights and gestational ages . At any given gestational age , smaller infants were less likely to survive . Survival in all birth weight categories increased between 1987 and 1992 , without accompanying increases in medical morbidity . Major morbidity increased with decreasing birth weight and included late-onset septicemia 22 % , chronic lung disease ( oxygen dependence at 36 weeks ' corrected age ) 18 % , severe intraventricular hemorrhage ( grade s III and IV ) 11 % , and necrotizing enterocolitis 5 % . Twelve percent of all infants were treated with corticosteroids for chronic lung disease , including 36 % of infants who were oxygen dependent at age 28 days . The mean length of hospital stay was 69 days for survivors and 18 days for infants who died . CONCLUSIONS Mortality for infants between 501 and 1500 gm at birth has declined over the past 5 years . There are interactions between birth weight , gestational age , gender , and survival rate . This increase in survival was not accompanied by an increase in medical morbidity OBJECTIVE : To determine the risk for psychiatric disorders among extremely low birth weight ( ELBW ) survivors in their early to mid-30s and to determine whether those born small for gestational age or those exposed to a full course of antenatal corticosteroids ( ACS ) were at particularly high risk . METHODS : A prospect i ve , longitudinal , population -based cohort of 84 ELBW survivors and 90 normal birth weight ( NBW ) control participants born in Ontario , Canada from 1977 to 1982 were assessed by interviewers naive to birth weight status using the Mini-International Neuropsychiatric Interview . RESULTS : ELBW survivors had lower odds of an alcohol or substance use disorder but higher odds of current non – substance-related psychiatric problems ( odds ratio [ OR ] = 2.47 ; 95 % confidence interval [ CI ] , 1.19–5.14 ) . Those born ELBW and SGA exhibited the same patterns with larger effects . ACS-exposed ELBW survivors had even higher odds of any current non – substance-related psychiatric disorder ( OR = 4.41 ; 95 % CI , 1.65–11.82 ) , particularly generalized anxiety disorder ( OR = 3.42 ; 95 % CI , 1.06–11.06 ) , the generalized type of social phobia ( OR = 5.80 ; 95 % CI , 1.20–27.99 ) , and the inattentive subtype of attention-deficit/hyperactivity disorder ( OR = 11.45 ; 95 % CI , 2.06–63.50 ) . CONCLUSIONS : In their early to mid-30s , ELBW survivors were less likely to have alcohol or substance use disorders but may be at greater risk for other psychiatric problems . Those exposed to ACS were at especially high risk and manifested no reduction in alcohol or substance use disorders . ELBW survivors exposed to ACS may be a special group at risk for psychopathology in adulthood Objectives . To investigate behavioral and emotional problems and positive adjustment of 15-to 16-year-olds who were born at extremely low gestational age ( ELGA ) , from the perspective of parents , teachers , and teenagers . Methods . Prospect i ve follow-up was conducted of birth cohorts , with classroom control subjects . All infants who were born before 29 weeks in 1983–1984 ( mean gestational age : 27 weeks ) Output:
Children born at ELBW were reported by parents and teachers to be at significantly greater risk than NBW controls for inattention and hyperactivity , internalizing , and externalizing symptoms . ELBW children were also at greater risk for conduct and oppositional disorders , autistic symptoms , and social difficulties . Risks for parent-reported inattention and hyperactivity , internalizing , and social problems were greater in adolescents born at ELBW . In contrast , ELBW teens self-reported lower inattention , hyperactivity , and oppositional behavior levels than their NBW peers . Depression , anxiety , and social difficulties were elevated in ELBW survivors in adulthood . Group differences were robust to region of birth , era of birth , and the presence of neurosensory impairments .
MS2_1shot96
***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 Objectives : We undertook a cluster-r and omised controlled trial exploring the effect of a therapeutic companion robot ( PARO ) compared to a look-alike plush toy and usual care on dementia symptoms of long-term care residents . Complementing the reported quantitative outcomes , this paper provides critical reflection and commentary on individual participant responses to PARO , observed through video recordings , with a view to informing clinical practice and research . Method : A descriptive , qualitative design with five participants selected from the PARO intervention arm of the trial . The trial is registered with the Australian New Zeal and Clinical Trials Registry ( ACTRN12614000508673 ) . Results : The five participants and their responses to PARO are presented in terms of three issues : i. ) Different pre-intervention clinical presentations and different responses ; ii . ) Same individual , different response – the need for continual assessment and review ; and iii . ) The ethics of giving and retrieving PARO . Implication s for clinical practice and future research are discussed in relation to each issue . Conclusion : The findings suggest that one approach does not fit all , and that there is considerable variation in responses to PARO . A number of recommendations are discussed to aid the delivery of psychosocial interventions with PARO in practice , as well as to guide future research Background : Behavioral problems may affect individuals with dementia , increasing the cost and burden of care . Pet therapy has been known to be emotionally beneficial for many years . Robotic pets have been shown to have similar positive effects without the negative aspects of traditional pets . Robotic pet therapy offers an alternative to traditional pet therapy . Objective : The study rigorously assesses the effectiveness of the PARO robotic pet , an FDA approved biofeedback device , in treating dementia-related symptoms . Methods : A r and omized block design with repeated measurements guided the study . Before and after measures included reliable , valid tools such as : RAID , CSDD , GDS , pulse rate , pulse oximetry , and GSR . Participants interacted with the PARO robotic pet , and the control group received st and ard activity programs . Five urban secure dementia units comprised the setting . Results : 61 patients , with 77 % females , average 83.4 years in age , were r and omized into control and treatment groups . Compared to the control group , RAID , CSDD , GSR , and pulse oximetry were increased in the treatment group , while pulse rate , pain medication , and psychoactive medication use were decreased . The changes in GSR , pulse oximetry , and pulse rate over time were plotted for both groups . The difference between groups was consistent throughout the 12-week study for pulse oximetry and pulse rate , while GSR had several weeks when changes were similar between groups . Conclusions : Treatment with the PARO robot decreased stress and anxiety in the treatment group and result ed in reductions in the use of psychoactive medications and pain medications in elderly clients with dementia Background and Objectives Recent years have seen social robotic pets introduced as a means of treating behavioral and psychological symptoms of dementia , and many show promising potential . In this study , we sought to explore family members ' perceptions of the Japanese-developed baby harp seal , Paro ( version 9 ) , and a look-alike , nonrobotic Plush Toy , when used by their relative with dementia for 15 min , 3 afternoons per week for 10 weeks . Research Design and Method The study employed a descriptive qualitative approach , which was nested within a larger cluster r and omized controlled trial . A convenience sample of 20 family members ( n = 10 each from the Paro and Plush Toy conditions ) with relatives in 9 long-term care facilities in Queensl and , Australia , completed individual semi-structured interviews ( telephone or face-to-face ) . Inductive , data -driven thematic analysis of the data was undertaken with the assistance of the qualitative management software , ATLAS.ti ® . Results Family members of long-term care residents with dementia expressed positive perceptions of the Paro , perceiving that it improved mood , reduced agitation , and provided opportunity for communication for their relative . Negative perceptions of the Plush Toy were given by family members , primarily because of its lack of movement and engagement . Conclusion Family members were keen for their older relative with dementia to use a social robot that moved and engaged with them , and Plush Toys that were static and unresponsive were perceived as being unimportant in improving quality of life . However , the current cost of Paro was identified by family members as a major limitation to use OBJECTIVES The robotic seal , PARO , has been used as an alternative to animal-assisted therapies with residents with dementia in long-term care , yet underst and ing of its efficacy is limited by a paucity of research . We explored the effects of PARO on motor activity and sleep patterns , as measured by a wearable triaxial accelerometer . STUDY DESIGN Cluster-r and omised controlled trial , involving 28 facilities in Queensl and , Australia . Nine facilities were r and omised to the PARO group ( individual , non-facilitated , 15-min sessions three afternoons per week for 10 weeks ) , 10 to a plush toy ( PARO with robotic features disabled ) and nine to usual care . MAIN OUTCOME MEASURES Changes in day- and nighttime motor activity and sleep after the 10-week intervention , as measured by SenseWear ® armb and s , worn by participants continuously for 24 h at baseline , during two single intervention days in weeks 5 and 10 respectively , and post-intervention ( week 15 ) . Analyses followed intention-to-treat , using repeated- measures mixed-effects models . RESULTS After 10 weeks , the PARO group showed a greater reduction in daytime step count than usual care ( p = 0.023 ) , and in nighttime step count ( p = 0.028 ) and daytime physical activity ( p = 0.026 ) compared with the plush toy group . At post-intervention , the PARO group showed a greater reduction in daytime step count than the plush toy group ( p = 0.028 ) , and at nighttime compared with both the plush toy group ( p = 0.019 ) and the usual-care group ( p = 0.046 ) . The PARO group also had a greater reduction in nighttime physical activity than the usual-care group ( p = 0.015 ) . CONCLUSIONS PARO may have some effect on motor activity of older people with dementia in long-term care , but not on sleep patterns . Australian New Zeal and Clinical Trials Registry ( ACTRN12614000508673 ) AIM The aim of this study was to investigate effects of robot-assisted group activity with Paro on quality of life in older people with dementia . BACKGROUND Nursing home residents with severe dementia often experience social withdrawal and lower quality of life , which are suggested to be enhanced by non-pharmacological interventions . DESIGN A cluster-r and omized controlled trial . Ten nursing home units were r and omized to robot-assisted intervention or control group ( treatment as usual ) . METHODS Data were collected between March 2013-September 2014 . 27 participants participated in group activity for 30 minutes twice a week over 12 weeks , 26 participated in the control group . Change in quality of life was assessed by local nurses through the Quality of Life in Late-Stage Dementia scale at baseline , after end of intervention and at 3 months follow-up . The scale and regular psychotropic medication were analysed stratified by dementia severity . Analysis using mixed model , one-way anova and linear regression were performed . RESULTS An effect was found among participants with severe dementia from baseline to follow-up showing stable quality of life in the intervention group compared with a decrease in the control group . The intervention explained most of the variance in change in the total scale and in the subscales describing Tension and Well-being for the group with severe dementia . The intervention group used significantly less psychotropic medication compared with the control group after end of intervention . CONCLUSION Pleasant and engaging activities facilitated by nursing staff , such as group activity with Paro , could improve quality of life in people with severe dementia . The trial is in adherence with the CONSORT statement and is registered at www . clinical trials.gov ( study ID number : NCT01998490 ) [ corrected ] OBJECTIVES To investigate the affective , social , behavioral , and physiological effects of the companion robot Paro for people with dementia in both a day care center and a home setting . DESIGN A pilot block r and omized controlled trial over 12 weeks . Participants were r and omized to the intervention ( Paro ) or control condition ( st and ard care ) . SETTING Two dementia day care centers and participants ' homes in Auckl and , New Zeal and . PARTICIPANTS Thirty dyads ( consisting of a care recipient with dementia and their caregiver ) took part in this study . All care recipients attended dementia day care centers at Selwyn Foundation and had a formal diagnosis of dementia . INTERVENTION Thirty-minute unstructured group sessions with Paro at the day care center were run 2 to 3 times a week for 6 weeks . Participants also had Paro at home for 6 weeks . MEASUREMENTS At the day care centers , observations of the care recipients ' behavior , affect , and social responses were recorded using a time sampling method . Observations of interactions with Paro for participants in the intervention were also recorded . Blood pressure and salivary cortisol were collected from care recipients before and after sessions at day care . In the home setting , level of cognition , depressive symptoms , neuropsychiatric symptoms , behavioral agitation , and blood pressure were measured at baseline , 6 weeks , and 12 weeks . Hair cortisol measures were collected at baseline and at 6 weeks . RESULTS Observations showed that Paro significantly improved facial expressions ( affect ) and communication with staff ( social interaction ) at the day care centers . Subanalyses showed that care recipients with less cognitive impairment responded significantly better to Paro . There were no significant differences in care recipient dementia symptoms , nor physiological measures between the intervention and control group . CONCLUSION Paro shows promise in enhancing affective and social outcomes for certain individuals with dementia in a community context . Larger r and omized controlled trials in community setting s , with longer time frames , are needed to further specify the context s and characteristics for which Paro is most beneficial OBJECTIVES To explore whether severity of cognitive impairment and agitation of older people with dementia predict outcomes in engagement , mood states , and agitation after a 10-week intervention with the robotic seal , PARO . DESIGN Data from the PARO intervention-arm of a cluster-r and omized controlled trial was used , which involved individual , nonfacilitated , 15-minute sessions with PARO 3 afternoons per week for 10 weeks . SAMPLE AND PARTICIPANTS One hundred thirty-eight residents-aged ≥60 years , with dementia-from 9 long-term care facilities . MEASURES A series of stepwise multiple linear regressions were conducted . Dependent variables were participants ' levels of engagement , mood states , and agitation at week 10 [ assessed by video observation and Cohen Mansfield Agitation Inventory-Short Form ( CMAI-SF ) ] . Predictor variables were baseline levels of cognitive impairment [ assessed by Rowl and Universal Dementia Assessment Scale ( RUDAS ) ] and agitation ( CMAI-SF ) . RESULTS Five models were produced . The strongest finding was that participants with more severe agitation at baseline had higher levels of agitation at week 10 ( R2 = .82 , P < .001 ) . Predictors of positive response were less significant . Low levels of agitation at baseline predicted greater positive behavioral engagement with PARO ( R2 = .054 , P = .009 ) and fewer observed instances of agitation ( R2 = .033 , P = .045 ) at week 10 , whereas greater visual engagement was predicted by both lower levels of agitation and cognitive impairment ( R2 = .082 , P = .006 ) . Less severe cognitive impairment predicted greater pleasure at week 10 ( R2 = .067 , P = .004 ) . CONCLUSIONS / IMPLICATION S Participants with severe agitation had poor response to PARO . Lower levels of agitation and higher cognitive functioning were associated with better responses . In clinical practice , we recommend PARO should be restricted to people with low-moderate severity of agitation . Further research is needed to determine the optimal participant characteristics for response to PARO We recently reported that a companion robot reduced residents ' loneliness in a r and omised controlled trial at an aged‐care facility . This report aims to provide additional , previously unpublished data about how the sessions were run , residents ' interactions with the robot and staff perspectives 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 OBJECTIVES To examine effects on symptoms of agitation and depression in nursing home residents with moderate to severe dementia participating in a robot-assisted group activity with the robot seal Paro . DESIGN A cluster-r and omized controlled trial . Ten nursing home units were r and omized to either robot-assisted intervention or a control group with treatment as usual during 3 intervention periods from 2013 to 2014 . SETTING Ten adapted units in nursing homes in 3 counties in eastern Norway . PARTICIPANTS Sixty residents ( 67 % women , age range 62 - 95 years ) in adapted nursing home units with a dementia diagnosis or cognitive impairment ( Mini-Mental State Examination score lower than 25/30 ) . INTERVENTION Group sessions with Paro took place in a separate room at nursing homes for 30 Output:
Interactions with robopets were described as having a positive impact on aspects of well-being including loneliness , depression and quality of life by residents and staff , although there was no corresponding statistically significant evidence from meta- analysis for these outcomes . Not everyone had a positive experience of robopets . Engagement with robopets appears to have beneficial effects on the health and well-being of older adults living in care homes , but not all chose to engage . IMPLICATION S FOR PRACTICE Robopets have the potential to benefit people living in care homes , through increasing engagement and interaction . With the robopet acting as a catalyst , this engagement and interaction may afford comfort and help reduce agitation and loneliness
MS2_1shot97
***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 Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis ( MS ) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents . In this study , we evaluate the rate of cerebral atrophy in a 6-month period , investigate the predictive and explanatory value of other magnetic resonance imaging ( MRI ) measures in relation to cerebral atrophy , and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure . Methods One hundred thirty-five relapsing – remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change ( PBVC ) and the number and volume of gadolinium (Gd)-enhancing lesions , T2 lesions , and persistent black holes ( PBH ) were determined . By means of multiple linear regression analysis , the relationship between focal MRI variables and PBVC was assessed . Sample size calculations were performed for all patients and subgroups selected for enhancement or a high T2 lesion load at baseline . Results A significant atrophy occurred over 6 months ( PBVC = −0.33 % , SE = 0.061 , p < 0.0001 ) . The number of baseline T2 lesions ( p = 0.024 ) , the on- study Gd-enhancing lesion volume ( p = 0.044 ) , and the number of on- study PBHs ( p = 0.003 ) were associated with an increased rate of atrophy . For a 50 % decrease in rate of atrophy , the sample size calculations showed that approximately 283 patients per arm are required in an unselected sample d population and 185 patients per arm are required in a selected population . Conclusion Within a 6-month period , significant atrophy can be detected and on- study associations of PBVC and PBHs emphasizes axonal loss to be a driving mechanism . Application as primary outcome measure in short-term clinical trials with feasible sample size requires a potent drug to obtain sufficient power Background : Laquinimod is a novel immunomodulatory substance developed as an orally available disease modifying treatment in multiple sclerosis ( MS ) . The purpose of this study was to evaluate safety , tolerability , and efficacy on MRI lesions of two different doses of laquinimod compared with placebo in patients with relapsing MS . Methods : In this multicenter , double-blind , r and omized trial , patients with relapsing MS received 0.1 mg or 0.3 mg laquinimod or placebo as three daily tablets for 24 weeks . Gadolinium-enhanced brain MRI scans were performed at screening , every eighth week during treatment , and 8 weeks after end of treatment . The primary efficacy variable was the cumulative number of active lesions over 24 weeks . Safety measures included adverse events , physical examination , and laboratory variables . Results : Of 256 screened patients , 209 were r and omized ( 67 to 74 patients per group ) in 20 centers . There was a significant difference between laquinimod 0.3 mg and placebo for the primary outcome measure ( mean cumulative number of active lesions reduced by 44 % ) . In the subgroup of patients with at least one active lesion at baseline the reduction was slightly more pronounced ( 52 % ) . No differences with respect to clinical variables ( relapses , disability ) were found . The safety profile was favorable ; there were no clinical signs of undesired inflammatory manifestations . Conclusion : Oral laquinimod in a dosage of 0.3 mg daily was well tolerated and effective in suppressing development of active lesions in relapsing multiple sclerosis Multiple sclerosis ( MS ) has serious negative effects on health- , social- , and work-related issues for the patients and their families , thus causing significant socioeconomic burden . The objective of the study was to determine healthcare costs and indirect illness costs in MS patient in a national sample . We used all national records from the Danish National Patient Registry ( 1998 - 2006 ) , and identified 10,849 MS patients which were compared with 43,396 r and omly age- , sex- and social matched citizens . Healthcare sector costs included frequencies and costs of hospitalizations and weighted outpatient use , frequencies of visits and hospitalizations and costs from primary sectors , and the use and costs of drugs . Productivity costs ( the value of lost productivity from time off from work due to illness ) and all social transfer payments were also calculated . Patients with MS had significantly higher rates of health-related contact and medication use and very low employment rate which incurred a higher socioeconomic cost . The income level of employed MS patients was significantly lower than that of control subjects . The annual total health sector costs and productivity costs were € 14,575 for MS patients vs. € 1163 for control subjects ( p<0.001 ) , corresponding to an annual mean excess health-related cost of € 13,413 for each patient with MS . In addition , the MS patients received an annual mean excess social transfer income of € 6843 . MS present social and economical consequences more than eight years before diagnosis . We conclude that MS causes major socioeconomic consequences for the individual patient and for society . Productivity costs are a far more important economic factor , especially due to reduced employment , which are enhanced by the early age of diagnose onset CONTEXT Interferon beta is widely prescribed to treat multiple sclerosis ( MS ) ; however , its relationship with disability progression has yet to be established . OBJECTIVE To investigate the association between interferon beta exposure and disability progression in patients with relapsing-remitting MS . DESIGN , SETTING , AND PATIENTS Retrospective cohort study based on prospect ively collected data ( 1985 - 2008 ) from British Columbia , Canada . Patients with relapsing-remitting MS treated with interferon beta ( n = 868 ) were compared with untreated contemporary ( n = 829 ) and historical ( n = 959 ) cohorts . MAIN OUTCOME MEASURES The main outcome measure was time from interferon beta treatment eligibility ( baseline ) to a confirmed and sustained score of 6 ( requiring a cane to walk 100 m ; confirmed at > 150 days with no measurable improvement ) on the Exp and ed Disability Status Scale ( EDSS ) ( range , 0 - 10 , with higher scores indicating higher disability ) . A multivariable Cox regression model with interferon beta treatment included as a time-varying covariate was used to assess the hazard of disease progression associated with interferon beta treatment . Analyses also included propensity score adjustment to address confounding by indication . RESULTS The median active follow-up times ( first to last EDSS measurement ) were as follows : for the interferon beta-treated cohort , 5.1 years ( interquartile range [ IQR ] , 3.0 - 7.0 years ) ; for the contemporary control cohort , 4.0 years ( IQR , 2.1 - 6.4 years ) ; and for the historical control cohort , 10.8 years ( IQR , 6.3 - 14.7 years ) . The observed outcome rates for reaching a sustained EDSS score of 6 were 10.8 % , 5.3 % , and 23.1 % in the 3 cohorts , respectively . After adjustment for potential baseline confounders ( sex , age , disease duration , and EDSS score ) , exposure to interferon beta was not associated with a statistically significant difference in the hazard of reaching an EDSS score of 6 when either the contemporary control cohort ( hazard ratio , 1.30 ; 95 % CI , 0.92 - 1.83 ; P = .14 ) or the historical control cohort ( hazard ratio , 0.77 ; 95 % CI , 0.58 - 1.02 ; P = .07 ) were considered . Further adjustment for comorbidities and socioeconomic status , where possible , did not change interpretations , and propensity score adjustment did not substantially change the results . CONCLUSION Among patients with relapsing-remitting MS , administration of interferon beta was not associated with a reduction in progression of disability BACKGROUND A 24-week phase II trial has shown that 0.3 mg of laquinimod given daily to patients with relapsing-remitting multiple sclerosis was well tolerated and reduced the formation of active lesions . We assessed the effect of oral daily 0.3 and 0.6 mg laquinimod on MRI-monitored disease activity in a 36-week double-blind , placebo-controlled phase IIb study . METHODS The study was done in 51 centres in nine countries . Inclusion criteria were one or more relapses in the year before entry and at least one gadolinium enhancing ( GdE ) lesion on screening MRI . Of 720 patients screened , 306 eligible patients were enrolled . Patients , aged 18 - 50 years , were r and omly assigned to placebo ( n=102 ) , laquinimod 0.3 mg a day ( n=98 ) , or 0.6 mg a day ( n=106 ) . Brain MRI scans and clinical assessment s were done at week -4 , baseline , and monthly from week 12 to week 36 . The primary outcome was the cumulative number of GdE lesions at weeks 24 , 28 , 32 , and 36 . The principal analysis of the primary endpoint was done on the intention-to-treat cohort . This study is registered with Clinical Trials.gov , number NCT00349193 . FINDINGS Compared with placebo , treatment with laquinimod 0.6 mg per day showed a 40.4 % reduction of the baseline adjusted mean cumulative number of GdE lesions per scan on the last four scans ( simple means 4.2 [ SD 9.2 ] vs 2.6 [ 5.3 ] , p=0.0048 ) ; treatment with 0.3 mg per day showed no significant effects ( 3.9 [ 5.5 ] vs placebo , p=0.6740 ) . Both doses of laquinimod were well tolerated , with some transient and dose-dependent increases in liver enzymes . A case of Budd-Chiari syndrome-ie , a thrombotic venous outflow obstruction of the liver-occurred after 1 month of exposure in a patient with underlying hypercoagulability who received 0.6 mg laquinimod . Anticoagulant treatment result ed in a decline of liver enzymes to normal without any clinical signs of hepatic decompensation . INTERPRETATION In patients with relapsing-remitting multiple sclerosis , 0.6 mg per day laquinimod significantly reduced MRI-measured disease activity and was well tolerated The aim of this study was to determine evolution of T1 unenhanced hypointense lesions ( acute or chronic black holes ( ABHs , CBHs ) ) by measuring their magnetization transfer ratio ( MTR ) changes over 12 months . 40 glatiramer acetate (GA)-naive patients with relapsing-remitting MS who presented with 1 or more contrast-enhancing lesions ( CELs ) at baseline underwent 1.5-T MRI at baseline and after 12 months . Lesions were classified into 4 patterns based on differences in lesion isointensity or hypointensity over 12 months . Of 115 CELs detected at baseline , 64 , after 12 months , followed pattern A ( isointense-isointense ) , 6 pattern B ( isointense-hypointense ) , 33 pattern C ( hypointense-isointense ) , and 12 pattern D ( hypointense-hypointense ) . MTR significantly increased for all unenhanced T1 hypointense lesions ( p = 0.02 ) . Highest MTR increases were observed for patterns C ( ABHs + 18.2 % , p less than 0.001 ) and D ( CBHs + 34.2 % , p = 0.023 ) , but significant improvement was also detected for pattern A ( + 1.4 % , p = 0.046 ) ; no significant MTR changes were found for pattern B. GA treatment significantly recovered MTR in ABHs and CBHs , possibly indicating a greater potential for remyelination Background : Laquinimod , an oral novel immunomodulator , was shown to reduce MRI-measured disease activity in relapsing — remitting MS ( RRMS ) patients . Objectives : To determine whether the safety and efficacy profile of laquinimod , as shown in a placebo-controlled 36-week trial ( LAQ/5062 ) , is sustained and reproducible . Methods : Two hundred and fifty seven patients entered the extension phase in which MRI was performed at the beginning and at the end of the active extension phase . Clinical assessment s were performed at weeks 4 , 12 and every 12 weeks thereafter . Results : Two hundred and thirty nine ( 93 % ) patients completed the extension phase and 222 ( 86.3 % ) had a final scan available . Gadolinium-enhanced ( GdE ) T1 lesions were significantly reduced for patients switching from placebo to 0.3/ 0.6 mg doses ( 52 % , p = 0.0006 ) . In patients initially r and omized to 0.6 mg in LAQ/5062 the reduction of MRI activity observed in the placebo-controlled phase was maintained in the extension . The proportion of GdE-free patients for those who switched from placebo increased from a baseline of 31 % to 47 % at the end of the extension phase ( p = 0.01 ) . The most prominent safety signal was elevations of liver enzymes , reversible in all cases . Conclusions : The good efficacy and the excellent safety and tolerability profiles of laquinimod 0.6 mg/day are confirmed in this extension study BACKGROUND Two proof-of-concept clinical Output:
Laquinimod had potential benefits in reducing relapse rates and was safe for most patients with RRMS in the short term . The published study suggests that laquinimod at a dose of 0.6 mg orally administered once daily may be safe and have potential benefits for most patients with RRMS in the short term .
MS2_1shot98
***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 if the addition of continuous morphokinetic data improves reproductive outcomes when all embryos are cultured in a closed system . DESIGN Prospect i ve , r and omized , controlled study . SETTING Single academic center . PATIENT(S ) A total of 235 patients undergoing fresh autologous IVF cycles with at least four embryos , cultured in the Embryoscope : 116 patients r and omized to conventional once-daily morphologic embryo screening ( CS ) and 119 to additional time-lapse kinetic monitoring ( TLM ) for selection . INTERVENTION(S ) TLM versus CS . MAIN OUTCOME MEASURE(S ) Intrauterine clinical pregnancy ( CPR ) and implantation ( IR ) rates . RESULT ( S ) CPR and IR were similar overall ( TLM vs. CS , respectively : CPR 68 % vs. 63 % ; IR 51 % vs. 45 % ) and with blastocyst transfers ( CPR 74 % vs. 67 % ; IR 56 % vs. 51 % ) . CPR with day 5 transfer was threefold higher than day 3 transfer , but group ( TLM vs. CS ) was not a significant predictor of clinical pregnancy or implantation . Significantly more multinucleation was detected when CS embryos were retrospectively review ed with the use of TLM ( 7.0 % vs. 35.3 % ) , and multinucleation was independently associated with decreased rates of implantation . Time to the start of blastulation of < 100 hours after insemination and the morphokinetic scoring system used in the TLM group were independently associated with implantation . CONCLUSION ( S ) The addition of time-lapse morphokinetic data did not significantly improve clinical reproductive outcomes in all patients and in those with blastocyst transfers . Absence of multinucleation , timing of blastulation , and morphokinetic score were found to be associated with blastocyst implantation rates . CLINICAL TRIAL REGISTRATION NUMBER NCT02081859 OBJECTIVE To quantify the effect on reproductive outcome of culturing and selecting embryos using a novel time-lapse monitoring system ( TMS ) . DESIGN Retrospective observational cohort study . SETTING University-affiliated private center . PATIENT(S ) Donation and autologous intracytoplasmic sperm injection ( ICSI ) cycles from ten IVF clinics using similar procedures , cultured in TMS ( n = 1,390 ) or in a st and ard incubator ( SI ; n = 5,915 ) . INTERVENTION(S ) None . MAIN OUTCOME MEASURE(S ) Clinical pregnancy rate confirmed by ultrasound in week 7 . RESULT ( S ) A logistic regression analysis , which included all significant confounding factors , was used to evaluate the effect of culturing and selecting embryos with the use of TMS . Comparing clinical pregnancy rates per oocyte retrieval with TMS and SI treatments gave a crude effect of odds ratio [ OR ] 1.190 ( 95 % confidence interval [ CI ] 1.058 - 1.337 ) . Oocyte source , maternal age , day of transfer , and number of retrieved oocytes were identified as significant confounding factors . After accounting for confounding factors , the effect of TMS culture was OR 1.201 ( 95 % CI 1.059 - 1.363 ) . Limiting analysis to treatments with embryo transfer and including number of transferred embryos as a confounding factor likewise gave a significant effect of TMS with OR 1.157 ( 95 % CI 1.018 - 1.315 ) . CONCLUSION ( S ) Analysis of retrospective data indicated that culturing and selecting embryos by TMS significantly improved the relative probability of clinical pregnancy ( + 20.1 % per oocyte retrieval , + 15.7 % per embryo transfer ) . The elevated clinical pregnancy rate was attributed to a combination of stable culture conditions and the use of morphokinetic parameters for embryo selection OBJECTIVE To determine whether incubation in the integrated EmbryoScope time-lapse monitoring system ( TMS ) and selection supported by the use of a multivariable morphokinetic model improve reproductive outcomes in comparison with incubation in a st and ard incubator ( SI ) embryo culture and selection based exclusively on morphology . DESIGN Prospect i ve , r and omized , double-blinded , controlled study . SETTING University-affiliated private in vitro fertilization ( IVF ) clinic . PATIENT(S ) Eight hundred forty-three infertile couples undergoing intracytoplasmic sperm injection ( ICSI ) . INTERVENTION(S ) No patient intervention ; embryos cultured in SI with development evaluated only by morphology ( control group ) and embryos cultured in TMS with embryo selection was based on a multivariable model ( study group ) . MAIN OUTCOME MEASURE(S ) Rates of embryo implantation , pregnancy , ongoing pregnancy ( OPR ) , and early pregnancy loss . RESULT ( S ) Analyzing per treated cycle , the ongoing pregnancy rate was statistically significantly increased 51.4 % ( 95 % CI , 46.7 - 56.0 ) for the TMS group compared with 41.7 % ( 95 % CI , 36.9 - 46.5 ) for the SI group . For pregnancy rate , differences were not statistically significant at 61.6 % ( 95 % CI , 56.9 - 66.0 ) versus 56.3 % ( 95 % CI , 51.4 - 61.0 ) . The results per transfer were similar : statistically significant differences in ongoing pregnancy rate of 54.5 % ( 95 % CI , 49.6 - 59.2 ) versus 45.3 % ( 95 % CI , 40.3 - 50.4 ) and not statistically significant for pregnancy rate at 65.2 % ( 95 % CI , 60.6 - 69.8 ) versus 61.1 % ( 95 % CI , 56.2 - 66.1 ) . Early pregnancy loss was statistically significantly decreased for the TMS group with 16.6 % ( 95 % CI , 12.6 - 21.4 ) versus 25.8 % ( 95 % CI , 20.6 - 31.9 ) . The implantation rate was statistically significantly increased at 44.9 % ( 95 % CI , 41.4 - 48.4 ) versus 37.1 % ( 95 % CI , 33.6 - 40.7 ) . CONCLUSION ( S ) The strategy of culturing and selecting embryos in the integrated EmbryoScope time-lapse monitoring system improves reproductive outcomes . CLINICAL TRIAL REGISTRATION NUMBER NCT01549262 Purpose To assess the effects of light from an integrated optical microscope and evaluate the safety of time-lapse observations using a built-in microscope incubator . Methods We prospect ively compared the fertilization rate and embryonic morphology after intracytoplasmic sperm injection between embryos cultured with time-lapse observations every 15 min in an incubator with an integrated optical microscope and embryos with intermittent observations ( once a day ) in conventional incubators . Results No significant differences were observed in the fertilization rate ( 57.5 % vs. 57.5 % ) or the rate of excellent-good cleavage embryos ( 36.0 % vs. 36.0 % ) . Conclusions These results suggest that time-lapse observations using an incubator with an integrated optical microscope may therefore be safely utilized in clinical practice Background Pharmacokinetic studies with XM17 ( Ovaleap ® ) , a recombinant human follicle-stimulating hormone ( r-hFSH , follitropin alfa ) , have demonstrated good safety and tolerability in healthy women whose endogenous FSH levels were down-regulated with a long agonist protocol . In these studies , Ovaleap ® pharmacokinetics were dose-proportional and bioequivalent to the reference follitropin alfa product ( Gonal-f ® ) . The objective of the present study is to determine whether Ovaleap ® is equivalent to Gonal-f ® with respect to the number of oocytes retrieved in infertile but ovulatory women undergoing assisted reproductive technology ( ART ) therapy . Methods This multinational , multicenter , r and omized ( 1:1 ) , active-controlled , assessor-blind , comparative study included infertile normally gonadotrophic women 18 to 37 years old with a body mass index of 18 to 29 kg/m2 and regular menstrual cycles of 21 to 35 days undergoing ART therapy . During a 5-day fixed-dose phase , women received 150 IU/day of Ovaleap ® ( n = 153 ) or Gonal-f ® ( n = 146 ) , followed by an up to 15-day dose-adaptation phase during which doses could be adjusted every 3 to 5 days , up to a maximum of 450 IU/day . Ovaleap ® was to be deemed equivalent to Gonal-f ® if the two-sided 0.95 confidence interval ( CI ) for the difference in the number of oocytes retrieved fell within the equivalence range of ±3 oocytes . Results Similar numbers of oocytes were retrieved in the 2 treatment groups . The mean ± SD number of oocytes retrieved was 12.2 ± 6.7 in the Ovaleap ® group and 12.1 ± 6.7 in the Gonal-f ® group ( intent-to-treat [ ITT ] population ) . Regression analysis estimated a mean difference of 0.03 oocytes between the treatment groups ( 95 % CI : −0.76 - 0.82 ) , which was well within the prespecified equivalence range of ±3 oocytes . Ovaleap ® and Gonal-f ® showed favorable and comparable safety profiles , with no unexpected safety findings . Conclusions Ovaleap ® has shown the same efficacy and safety as Gonal-f ® for stimulation of follicular development in infertile women ( up to 37 years of age ) who are undergoing ART therapy . Trial Registration EudraCT : 2009 - 017674 - 20 . Current controlled trials : IS RCT N74772901 . Date of trial registration : 19 March 2010 STUDY QUESTION Does culture in a closed system result in an increased number of good quality embryos ( GQE ) on Day 2 compared with culture in a conventional system ? SUMMARY ANSWER Culture in a closed system up to 2 days after microinjection results in similar embryo development and morphological quality compared with culture in a conventional incubation system . WHAT IS KNOWN ALREADY Time-lapse imaging ( TLI ) incubators are rapidly being introduced into IVF laboratories worldwide , despite the lack of large prospect i ve r and omized trials demonstrating improvement in embryo development or pregnancy rates . STUDY DESIGN , SIZE , DURATION A r and omized controlled trial including 364 patients ( 365 cycles ) was conducted between May 2010 and February 2014 . After oocyte collection , r and omization was carried out and all of a patients ' oocytes were allocated to culture in either a conventional incubator or a closed incubator system in proportion 1:2 until embryo transfer on Day 2 . A total of 1979 oocytes were injected and cultured in the closed system , and 1000 in the st and ard incubator . The primary end-point was the number of GQE in the two groups . PARTICIPANTS / MATERIAL S , SETTING S , METHODS In total , 364 patients undergoing their first IVF cycle using ICSI , where at least one oocyte was retrieved , were r and omized in a university hospital setting . Two hundred and forty patients were r and omized for culture in a closed system and 124 patients for culture in the conventional incubator system ( control group ) . Embryo assessment s and final morphological scoring before transfer and cryopreservation were carried out at the same time points for embryos cultured in the conventional incubator and in the closed system . MAIN RESULTS AND THE ROLE OF CHANCE There was no significant difference in the mean ± SD number of GQEs between groups : 2.41 ± 2.27 for the closed system group and 2.19 ± 1.82 for the control group ( P = 0.34 , difference 0.23 , 95 % confidence interval 0.69 ; -0.24 ) . No significant differences were found in the number of 4-cell embryos , implantation- , pregnancy- or ongoing pregnancy rates . A significantly higher miscarriage rate was found in the TLI group compared with the control group ( 33.3 and 10.2 % , P = 0.01 ) . LIMITATIONS , REASONS FOR CAUTION Culture media , temperature and gas levels were similar in the open and closed incubator systems , but different culture dishes were used . Culturing embryos for longer time period ( to the blastocyst stage ) may give different results . Only ICSI patients were included , which may limit the generalizability of the results . Finally , the number of GQEs on Day 2 was used as a surrogate outcome for live birth . WIDER IMPLICATION S OF THE FINDINGS The results are consistent with other , smaller r and omized trials showing no difference in embryo quality when comparing culture in a conventional incubator with that of a closed TLI incubator system Background Recent advances in time-lapse monitoring in IVF treatment have provided new morphokinetic markers for Output:
AUTHORS ' CONCLUSIONS There is insufficient evidence of differences in live birth , miscarriage , stillbirth or clinical pregnancy to choose between TLS and conventional incubation .
MS2_1shot99
***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 the effectiveness of a 1100 ppm fluoride toothpaste used alone , or together with a 0.05 % NaF rinse used once daily or a 0.4 % SnF2 gel applied twice daily , in controlling the decalcification that often accompanies orthodontic treatment . Ninety-five consecutively treated adolescent patients were matched for age and sex and assigned to one of these three regimens . Single blind assessment s of decalcification were performed on all labial surfaces of all erupted teeth before appliances were placed and 3 months after appliances were removed . Because the first molars had the highest decalcification scores , data for the whole mouth and for first molars were analyzed separately . When pre-treatment levels of decalcification were subtracted from post-treatment values , significantly lower decalcification scores ( p < 0.05 ) were found for both whole mouth and first molars in the rinse and gel groups as compared with the control group ( toothpaste alone ) . Although the gel group consistently had less decalcification than the rinse group , this difference only approached statistical significance . These results indicate that twice daily use of a 1100 ppm fluoride toothpaste and either a once-daily 0.05 % NaF rinse or a twice-daily 0.4 % SnF2 gel provides additional protection against decalcification beyond that achieved with toothpaste alone OBJECTIVES The aims of this study were to compare the local and systemic uptake of fluoride released from a compomer material ( Dyract Ortho ) and a resin-modified glass ionomer cement ( Vitremer ) with that of a conventional resin adhesive ( Right-On ) and to compare the cariostatic ability of each of the test material s with that of the resin control . METHODS Twenty six patients were r and omly allocated to have a bracket bonded to a premolar on one side of the arch with one of the test material s and on the opposite side with the control material . Premolars destined for extraction as part of an orthodontic treatment plan were selected for bonding . A non-fluoride toothpaste was used by all participants for 4 weeks prior to bracket bonding and throughout the 4 week trial period . Fluoride release was measured in saliva , plaque and urine sample s taken pre-bonding and 4 weeks post-bonding . Enamel demineralisation was assessed by scoring the buccal surface of each extracted tooth using a caries index . RESULTS Neither Vitremer nor Dyract Ortho altered salivary or urinary fluoride concentration significantly 4 weeks post-bonding but plaque fluoride concentration increased significantly around premolars bonded with Vitremer . The test material s as a combined group were associated with significantly less demineralisation than the control material but there was no significant difference in cariostatic ability detected between either Dyract Ortho or Vitremer when each group was compared separately with the control . CONCLUSIONS Fluoride released from Dyract Ortho or Vitremer is likely to exert a local and not a systemic effect . In a 4-week clinical study , the cariostatic ability of the fluoride-releasing cements , as a combined group , was superior to that of the non-fluoride releasing control but there was no significant difference in cariostatic ability between the two test material s when each test group was compared separately with the control The study aim ed to compare the survival time and cariostatic potential of a compomer to that of a resin adhesive when used to bond stainless steel orthodontic brackets to labial segment teeth only . The effect of the patients ' sex , age at the start of treatment and presenting malocclusion on bracket survival time was assessed also . Forty-five consecutive patients who attended for fixed appliance therapy were r and omly selected . Four hundred twenty-six brackets were bonded ( 213 with compomer and 213 with resin adhesive ) with a split mouth design ; the right or left side allocation of compomer in either arch was alternated . Color transparencies of the maxillary incisors , m and ibular incisors , or both , and transparencies of the canines , were taken before treatment . At the debond stage , the transparencies were projected ( 20x ) and assessed by an experienced examiner , who used a caries index . The survival time distributions for brackets bonded with each bonding agent were not significantly different ( P = .74 , paired Prentice-Wilcoxon test ; P = .75 , Akritas test ) , with bracket failure rates of 17 % and 20 % recorded for compomer and resin adhesive , respectively . Neither the patients ' sex ( P = .85 ) nor malocclusion ( P = .26 ) appear to affect significantly bracket survival , but patient age was identified as a useful prognostic indicator of bracket survival ( P < .001 ) . On average , there was more decalcification related to brackets bonded with resin adhesive than with compomer ( P = .0075 ) . Survival time distributions of brackets bonded with compomer or resin adhesive appear comparable , but decalcification was reduced significantly by bonding with compomer INTRODUCTION Despite the many advances to improve the practice of orthodontics , white spot lesions , or decalcifications , remain a common complication in patients with poor oral hygiene . The purpose of this study was to assess the perceptions and level of awareness of patients , parents , orthodontists , and general dentists toward the development of white spot lesions during orthodontic treatment . METHODS This was a prospect i ve epidemiologic survey of the perceptions of orthodontic patients ( n = 315 ) , parents ( n = 279 ) , orthodontists ( n = 305 ) , and general dentists ( n = 191 ) regarding the significance , prevention , and treatment of white spot lesions . RESULTS All surveyed groups indicated that white spot lesions detracted from the overall appearance of straight teeth , attributed primary responsibility for the prevention of white spot lesions to the patients themselves , and thought that the general dentist should be responsible for treating white spot lesions . Patients regarded themselves as ultimately responsible for the prevention of white spot lesions ( P < 0.05 ) . CONCLUSIONS The patients , parents , orthodontists , and general dentists had similar perceptions regarding the significance , prevention , and treatment of white spot lesions . All groups indicated that patients were the most responsible for the prevention of white spot lesions . Communication among patients , parents , orthodontists , and general dentists needs to improve to decrease the incidence of white spot lesions in the orthodontic population INTRODUCTION Enamel demineralization is a problem in orthodontics . Fluoride is partially effective in addressing this problem , but additional treatment options are needed . The objective of this prospect i ve r and omized controlled trial was to determine the effectiveness of a new product , MI Paste Plus ( GC America , Alsip , Ill ) , in the prevention or reduction of white spot lesions in orthodontic patients . METHODS Sixty patients who were undergoing routine orthodontic treatment were recruited for this prospect i ve r and omized clinical trial . A double-blind method of r and omization was used to determine whether each patient received the MI Paste Plus or a placebo paste ( Tom 's of Maine , Salisbury , United Kingdom ) . Each patient was asked to administer the paste by using a fluoride tray for a minimum of 3 to 5 minutes each day at night after brushing . Photographic records obtained in a light-controlled environment were used to record the presence or absence of white spot lesions in both groups . The enamel decalcification index was used to determine the number of white spot lesions per surface at each time interval . Patients were followed at 4-week intervals for 3 months . A scoring system from 0 to 6 was used to determine the level of caries or cavitations . This system was also used for each tooth at each time interval . RESULTS Fifty patients ( 26 using MI Paste Plus , 24 using the placebo paste ) completed the study . The enamel decalcification index scores for all surfaces were 271 and 135 at the start of treatment and 126 and 258 at the end of treatment for the MI Paste Plus and placebo paste groups , respectively . The enamel decalcification index scores in the MI Paste Plus group reduced by 53.5 % , whereas the placebo group increased by 91.1 % during the study period . A 3-way analysis of variance ( ANOVA ) was done for the average enamel decalcification index scores . The surface type , the product/time interactions , and the product/surface interactions of the mean enamel decalcification index scores were significant ( P < 0.05 ) . CONCLUSIONS MI Paste Plus helped prevent the development of new white spot lesions during orthodontic treatment and decreased the number of white spot lesions already present . The placebo paste had no preventive action on white spot development during orthodontic treatment ; the number of lesions actually increased . MI Paste Plus reduced white spots on the gingival surfaces ; the placebo paste had the opposite effect . The incisal surface effect on the mean enamel decalcification index scores over time and between products was highly significant . The incisal enamel decalcification index scores were consistently higher than those for the other surfaces ( mesial , distal , and gingival ) The purpose of this study was to compare the effectiveness of toothbrushing followed by fluoride rinsing , fluoride gel brushing , or fluoride gel dentifrice brushing alone in controlling the demineralization that often follows orthodontic treatment . Seventy-eight consecutive adolescent patients undergoing orthodontic care were divided into 3 groups : group 1 ( control ) used a low-potency , high-frequency fluoride rinse ; group 2 used a high-potency , high-frequency fluoride brush-on gel ; and group 3 used a high-potency , high-frequency fluoride gel dentifrice . When pretreatment levels of demineralization were subtracted from posttreatment values , both gel groups displayed a significant difference ( P < .05 ) in smooth surface demineralization sites when compared to controls . Reversal of white-spot lesions occurred in 15 % of sites that exhibited pathology as a result of the fluoride and preventive regimen . These results indicate that a daily use of a 5000-ppm fluoride gel along with toothbrushing with a fluoride paste or brushing twice daily with a 5000-ppm fluoride dentifrice alone provides greater protection beyond that of tooth-brushing with a fluoride paste ( 1000 ppm ) and rinsing with a 0.05 % sodium fluoride rinse A prospect i ve examination of 10 consecutively treated orthodontic patients was undertaken to examine the effectiveness of fluoride varnish in reducing enamel demineralization . Pairs of dental quadrants for each patient 's mouth ( ie , maxillary right and m and ibular left ; maxillary left and m and ibular right ) were r and omly assigned to an experimental or control group . After placement of resin-bonded orthodontic brackets , fluoride varnish was applied to the 2 experimental dental quadrants for each patient . Subsequent applications were done every 3 months during 12 months of orthodontic treatment . A double-blinded examination of intraoral photographs of the 100 experimental and 100 control teeth was done . The presence of white spot lesions was registered using the enamel decalcification index and the 2 groups were compared using paired Student t tests with a significance level of 5 % ( P < .05 ) . There was no statistically significant difference between the mean enamel decalcification index for the control and experimental groups before or after treatment , since demineralization increased for both groups . Most importantly , the change in mean enamel decalcification index was significantly smaller for the experimental group ( 0.34 ) , compared to the control group ( 0.51 ) . In other words , there was 44.3 % ( P < .05 ) less demineralization noted for teeth that had been treated with fluoride varnish during orthodontic treatment Background The ' Hawthorne Effect ' may be an important factor affecting the generalisability of clinical research to routine practice , but has been little studied . Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge , no attempt has been made to quantify them . Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia . Methods Participants in a dementia trial were r and omised to intensive follow-up ( with comprehensive assessment visits at baseline and two , four and six months post r and omisation ) or minimal follow-up ( with an abbreviated assessment at baseline and a full assessment at six months ) . Our primary outcomes were cognitive functioning ( ADAS-Cog ) and participant and carer-rated quality of life ( QOL-AD ) . Results We recruited 176 participants , mainly through general practice s. The main analysis was based on Intention to treat ( ITT ) , with available data . In the ANCOVA model with baseline score as a co-variate , follow-up group had a significant effect on outcome at six months on the ADAS-Cog score ( n = 140 ; mean difference = -2.018 ; 95%CI -3.914 , -0.121 ; p = 0.037 favouring the intensive follow-up group ) , and on participant-rated quality of life score ( n = 142 ; mean difference = -1.382 ; 95%CI -2.642 , -0.122 ; p = 0.032 favouring minimal follow-up group ) . There was no significant difference on carer quality of life . Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia result ed in a better outcome than minimal follow-up , as measured by their cognitive functioning . Trial registration Current controlled trials : IS RCT The aim of this study was to test a particular type of intra-oral fluoride releasing device ( IFRD ) , design ed to release 0.0 Output:
Reports of adverse effects from topical fluoride applications were rare and unlikely to be significant . AUTHORS ' CONCLUSIONS This review found a low level of certainty that 12,300 ppm F foam applied by a professional every 6 to 8 weeks throughout fixed orthodontic treatment , might be effective in reducing the proportion of orthodontic patients with new DLs .