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MS2_dynamic_1_shot_test

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MS2_dynamic_1_shot600

***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: OBJECTIVES To study the effect of st and ard and low-dose estrogen-progestin therapy ( EPT ) , tibolone and raloxifene on the incidence of vaginal spotting/bleeding and endometrial thickness over a 5-year period . METHODS Seven hundred eighty-six postmenopausal women were studied in an open prospect i ve design . Vaginal spotting/bleeding and endometrial thickness as assessed by transvaginal ultrasonography was compared between six categories of women over a 5-year period : three categories in women on continuous combined estrogen-progestin therapy , one category under tibolone , one category under raloxifene and one under no treatment . More specifically , women received tibolone 2.5 mg ( N = 204 ) , raloxifene HCl 60 mg ( N = 137 ) , conjugated equine estrogens 0.625 mg/medroxyprogesterone acetate 5 mg ( N = 122 ) , 17beta-estradiol 2mg/norethisterone acetate 1 mg ( N = 58 ) , 17beta-estradiol 1mg/norethisterone acetate 0.5 mg ( N = 76 ) or no therapy ( controls , N = 189 ) . Women with suspected endometrial pathology were referred for hysteroscopy . RESULTS Bleeding/spotting incidence was highest among st and ard dose EPT users ( conjugated equine estrogens 0.625 mg/medroxyprogesterone acetate 5 mg : 40.1 % , 17beta-estradiol 2mg/norethisterone acetate 1 mg : 44.8 % , p < 0.001 compared to controls ) . Low-dose EPT associated with lower incidence of spotting/bleeding ( 34.1 % ) . The incidence under tibolone and raloxifene was 22.5 % and 2.9 % , respectively , while 3.2 % of women not receiving therapy reported vaginal spotting/bleeding . Mean endometrial thickness was not significantly affected in any of the groups studied . The drop-out rate due to spotting/bleeding was higher in the two higher dose EPT regimens . After logistic regression analysis , age at baseline was the only significant predictor of subsequent spotting/bleeding ( b = -0.25 , S.E. = 0.09 , p = 0.006 ) , while menopausal age and pre-treatment serum FSH had marginal significance . CONCLUSIONS EPT , tibolone and raloxifene do not appear to associate with significant changes in endometrial thickness in the majority of cases . The low-dose EPT regimen associated with a decreased incidence of unscheduled spotting/bleeding compared to the st and ard dose regimens . Tibolone expressed a favorable endometrial profile , as seen in its effect on unscheduled spotting/bleeding and mean endometrial thickness . Raloxifene associated with the lowest incidence in S/B and the lowest drop-out rate.s Raloxifene is a selective estrogen receptor modulator that in experimental animals acts as an estrogen receptor antagonist in breast and endometrium but as an estrogen receptor agonist in the skeletal and cardiovascular systems . We conducted a 1-year prospect i ve , r and omized , double-blind trial in 143 postmenopausal osteoporotic women ( mean + /- SD age , 68.4+/-5.0 years ) with at least one prevalent vertebral fractures and low bone mineral density ( BMD ) , comparing groups receiving raloxifene at 60 mg/day ( RLX60 ) or 120 mg/day ( RLX120 ) and a control group receiving supplements of 750 mg/day of calcium and 400 IU/day of vitamin D. There were no differences among groups in the occurrence of uterine bleeding , thrombophlebitis , breast abnormalities , or increased endometrial thickness ( assessed by ultrasonography ) . As compared with controls , the changes in values over 1 year for RLX60 and RLX120 , respectively , were significant for serum bone alkaline phosphatase ( -14.9 % , -8.87 % ) , serum osteocalcin ( -20.7 % , -17.0 % ) , and urinary C-telopeptide fragment of type I collagen/creatinine ( -24.9 % , -30.8 % ) , markers of bone turnover ; for serum total cholesterol ( -7.0 % for RLX60 ) and low density lipoprotein cholesterol ( LDL ) ( -11.4 % for RLX60 ) and for the LDL/HDL cholesterol ratio ( -13.2 % , -8.3 % ) . BMD increased significantly in the total hip ( 1.66 % for RLX60 ) and ultradistal radius ( 2.92 % , 2.50 % ) . There were nonsignificant trends toward increases over controls in BMD for lumbar spine , total body , and total hip ( for RLX120 ) . Using a > 15 % cutoff definition , raloxifene had no effect on incident fractures , but using a > 30 % cutoff , there was a dose-related reduction ( p = 0.047 ) . We conclude that raloxifene therapy is well tolerated , reduces serum lipids , and does not stimulate the uterus or breasts . It has beneficial effects on bone , although , under the conditions of this study , these appear to be of a smaller magnitude than have been reported with estrogen therapy BACKGROUND Three clinical trials on the use of tamoxifen to prevent breast cancer have reported mixed results OUTPUT: Tamoxifen increased the incidence of endometrial cancer and cataracts compared with placebo and raloxifene . Many women do not take tamoxifen because of associated harms . Thirteen risk-stratification models were modest predictors of breast cancer . Medications reduced the incidence of invasive breast cancer and fractures and increased the incidence of thromboembolic events . Tamoxifen was more effective than raloxifene but also increased the incidence of endometrial cancer and cataracts . INPUT: Objective To assess the effects of tibolone on climacteric symptoms , endometrium and serum lipid/lipoproteins in postmenopausal women receiving tamoxifen after surgery for breast cancer OBJECTIVE To assess the effect of tibolone on markers of vascular risk in postmenopausal women who were receiving hemodialysis . DESIGN One-year open-label study . SETTING " Zvezdara " University Medical Center , Bel grade , Serbia . PATIENT(S ) Twenty-eight postmenopausal women undergoing chronic hemodialysis . INTERVENTION(S ) Fifteen women received tibolone 2.5 mg three times per week ; 13 other women served as controls . MAIN OUTCOME MEASURE(S ) Mean arterial pressure and weight were measured at baseline and at 6 and 12 months , and blood was collected for insulin , total cholesterol , low-density lipoprotein , high-density lipoprotein , triglycerides , lipoprotein(a ) , high-sensitivity C-reactive protein ( hs-CRP ) , endothelin-1 ( ET-1 ) , vascular endothelial growth factor ( VEGF ) , and markers of renal function . RESULT ( S ) Mean arterial pressure fell in the tibolone but not in the control group at 6 and 12 months versus baseline ( mean [ SD ] : 93 [ 15 ] vs. 105 [ 11 ] mmHg and 94 [ 10 ] vs. 105 [ 11 ] mmHg , respectively ) . Weight , insulin , lipids , lipoprotein(a ) , hs-CRP , ET-1 , VEGF , and renal function remained unchanged within each group , but high-density lipoprotein concentrations fell in the tibolone group after 12 months ( 1.2 [ 0.3 ] vs. 1.6 [ 0.6 ] mmol/L ) . CONCLUSION ( S ) The effects of tibolone on markers of vascular risk in postmenopausal women who are receiving hemodialysis and healthy women appear to differ . This should be taken into account when tailoring menopausal therapies to the specific requirements of each individual Background : Lipoprotein(a ) ( Lp(a ) ) has been regarded in some studies as an independent risk factor of atherosclerotic vascular disease . However , the use of a baseline plasma Lp(a ) concentration as a screening tool for future acute vascular events ( AVE ) is controversial . We therefore investigated whether progressively increasing change in plasma Lp(a ) concentration is associated with the development of AVE . Methods : We investigated prospect i ve analyses of 985 participants ( 464 women and 521 men ) who had either clinical ly evident vascular disease ( VD group , n=443 ) or its risk factor(s ) ( RF group , n=542 ) . Blood sample s were taken from all participants every six months to measure inflammatory markers such as Lp(a ) and C-reactive protein during a 10-year follow-up period . Results : During the follow-up , 223 new cases of myocardial infa rct ion , stroke , and peripheral arterial disease were identified . In the RF group , the relative risk of positive ∆ Lp(a ) for predicting AVE was 4.36 ( 95 % confidence interval [ CI ] 1.76 - 10.85 ; P=0.002 ) . In the VD group , the relative risk of positive ∆ Lp(a ) for predicting AVE was 6.35 ( 95 % CI 3.68 - 10.97 ; P<0.001 ) . Conclusions : These results suggest that a progressively increasing change in Lp(a ) concentration has a highly significant predictive value in AVE in both the VD and the RF groups The effects of hormone replacement therapy in hypertensive women are controversial . This r and omised placebo controlled trial assessed the effect of tibolone 2.5 mg on blood pressure and fasting plasma lipids in 29 hypertensive postmenopausal women over 6 months using a 2:1 r and omisation to tibolone . The primary clinical end-point was mean office blood pressure . At 6 months systolic blood pressure declined by 5.30 ± 2.87 % vs4.94 ± 3.37 % whilst diastolic blood pressure declined 5.38 ± 2.65 % vs 0.85 ± 3.69 % on tibolone and placebo respectively . These differences were not statistically significant . Triglycerides decreased by 33.3 ± 6.1 % vs 7.6 ± 7.9 % ( P < 0.01 ) and high-density lipoprotein (hdl)-cholesterol by 21.7 ± 3.8 % vs2.4 ± 2.6 % ( P < 0.01 ) with tibolone as opposed to placebo . no significant differences were observed in total cholesterol , low-density lipoprotein (ldl)-cholesterol and lipoprotein ( a ) . fibrinogen levels were reduced by 13.6 ± 6.8 % on tibolone compared to a 19.3 ± 15.4 % rise ( P < 0.05 ) on placebo . this study suggests that tibolone has no deleterious effect on blood pressure in women with hypertension but has contrasting effects on biochemical risk factors . large-scale studies are required to determine the overall effect of tibolone on cardiovascular morbidity and mortality Tibolone , a synthetic steroid with estrogenic , and rogenic , and progestogenic properties relieves climacteric symptoms and prevents postmenopausal bone loss . The influence of tibolone treatment on coagulation , fibrinolysis , and lipid metabolism was investigated in 91 healthy late postmenop OUTPUT:

This meta- analysis shows that oral tibolone treatment significantly lowers circulating Lp(a ) levels in postmenopausal women .

MS2_dynamic_1_shot601

***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: Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results This study evaluated individual differences in levels of C-reactive protein ( CRP ) measured in saliva , cross-sectionally and prospect ively , in relation to systemic inflammation and risk for cardiovascular disease ( CVD ) . Plasma and saliva sample s , later assayed for CRP , were collected multiple times from an ethnically diverse group of women seeking help from domestic violence crisis shelters-agencies ( N=107 ; mean age at study start=34 years ) . Plasma and saliva CRP levels were moderately associated cross-sectionally and across two years . There were indications that saliva CRP levels were , on average , higher in the morning than evening . Higher levels of saliva and plasma CRP were associated with a higher body mass index , but did not differ between women who did and did not smoke . Salivary CRP reliably discriminated between high and low levels of plasma CRP , using a clinical ly relevant cutoff point of 3mg/L , recommended by the American Heart Association . Results build upon an emerging literature suggesting that under specific conditions levels of CRP in saliva may reflect low- grade inflammation and have the potential to serve as a screen for CVD risk status Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Aging is associated with an increased susceptibility to infections and chronic inflammatory diseases . This might be caused by dysregulations of the endocrine system with increased activity of the hypothalamus-pituitary-adrenal ( HPA ) axis and decreased levels of sex steroids . Therefore , we investigated the stress-response of the HPA axis and glucocorticoid ( GC ) sensitivity of pro-inflammatory cytokine production in elderly men , compared to testosterone-treated elderly men and young controls . Stress-induced increases in cortisol did not differ significantly between experimental groups ( F=2.10 ; p>0.10 ) , but GC sensitivity increased significantly in young controls and testosterone-treated elderly men , while a decrease was found in untreated elderly men ( F=5.28 ; p<0.01 ) . We conclude that the increase in GC sensitivity after stress serves to protect the individual from detrimental increases of pro-inflammatory cytokines , a mechanism that is disturbed in elderly men and partly restored by testosterone treatment Psychosocial factors and interleukin-6 ( IL-6 ) levels are both related to risk of morbidity and mortality . The aim of this study was to investigate how a broad range of psychosocial factors related to levels of IL-6 in different media . Fifty-nine men and women aged 30 - 65 were recruited from a larger study and selected to cover a broad range of psychosocial status . IL-6 levels were analyzed in serum , in saliva collected at home at three different time points during a day , and in the supernatant of cell cultures stimulated in vitro with lipopolysaccharide . After adjustments for age , gender , self-reported health problems , and lifestyle factors , IL-6-levels in serum were negatively correlated with coping and self-esteem , and positively correlated with cynicism , hostile affect , hopelessness , depression , and vital exhaustion . In saliva sample s , at all time points , IL-6 levels were positively correlated to cynicism , and IL-6 levels 30 min after awakening were also positively correlated with hopelessness , depression , and vital exhaustion . After adjustment for age and gender , c OUTPUT: Discussion This systematic review will synthesize the evidence regarding salivary markers of inflammation in response to acute stress . We anticipate variation across studies but hypothesize that salivary markers of inflammation will increase in response to acute stress . INPUT: OBJECTIVES The effect of long-term oral zinc supplementation , in addition to st and ard therapy ( protein-restricted diet and lactulose ) on recurrent hepatic encephalopathy , was assessed in a double-blind study . METHODS Ninety cirrhotic patients with stable recurrent hepatic encephalopathy , after following a one month period of st and ard therapy , were r and omized to receive oral zinc acetate supplementation ( 600 mg/day ) in addition to st and ard therapy or to continue only st and ard therapy ( a diet containing 0.8 g/kg/day of protein and 90 g/day of lactulose ) for six months . Psychometric tests , NCT ( number correction test ) and PSE ( portal-systemic encephalopathy ) Index , were used to evaluate the degree of hepatic encephalopathy , both at the beginning and the end of each treatment period . RESULTS Oral zinc supplementation in addition to st and ard therapy was able to normalize serum zinc levels . The patients who never showed clinical signs of hepatic encephalopathy during the trial were 88.6 % in zinc-group and 86 % in only st and ard therapy group . Psychometric tests , NCT and PSE Index , were statistically better than basal values either in zinc-group or in only st and ard therapy group . CONCLUSIONS Final values of psychometric tests were better in zinc-group than only st and ard therapy group but the differences were not statistically significant Hepatic encephalopathy ( HE ) is normally diagnosed by neuropsychological ( NP ) tests , which are not very specific and do not reveal the underlying pathology . Magnetic resonance imaging ( MRI ) and spectroscopy ( MRS ) of the brain offer alternative and possibly more specific markers for HE . These methods were applied in conjunction with NP testing in order to determine their usefulness in the identification of HE and to underst and the pathogenesis of HE more clearly . MR imaging and spectroscopy examinations , in addition to a battery of 15 NP tests , were administered to investigate 31 patients awaiting liver transplantation and 23 healthy controls . MR image intensities from the globus pallidus region were calculated and normalized to those of the thalamus . Absolute concentrations and ratios with respect to creatine ( Cr ) of several metabolites were computed from MR spectra . The MR data were correlated with the results of NP tests . The patients showed impairment in NP tests of attention and visuospatial and verbal fluency . In T1 weighted MRI , the relative intensity of the globus pallidus with respect to that of the thalamus region was significantly elevated in patients and correlated ( negatively ) with three NP tests ( Hooper , FAS , and Trails B ) . The absolute concentrations of myo‐inositol ( mI ) and choline ( Ch ) were significantly reduced in three brain regions . In addition , the absolute concentrations of glutamine ( Gln ) and combined glutamate and glutamine ( Glx ) were increased in all three locations , with Gln increase being significant in all areas while that of Glx only in the occipital white matter . In summary , this study partially confirms a hypothesized mechanism of HE pathogenesis , an increased synthesis of glutamine by brain glutamate in astrocytes due to excessive blood ammonia , followed by a compensatory loss of myo‐inositol to maintain astrocyte volume homeostasis . It also indicates that the hyperintensity observed in globus pallidus could be used as complementary to the NP test scores in evaluating the mental health of HE patients . PACS number : 22 cirrhotic patients with chronic encephalopathy were given oral zinc supplementation or placebo in a double-blind r and omised trial . In the group which received zinc acetate 600 mg a day for 7 days , serum zinc had been restored to normal by day 8 . On day 8 hepatic encephalopathy , as assessed by a trailmaking test , was improved in the supplemented group but not in the placebo group . There was also a significant increase in blood urea nitrogen in the supplemented group . Short-term oral zinc supplementation probably improved hepatic encephalopathy by correcting the zinc deficiency that compromises conversion of ammonia to urea . The duration of this improvement requires further investigation PURPOSE To determine whether hydrogen-1 magnetic resonance ( MR ) spectroscopy of the brain allows detection of sub clinical hepatic encephalopathy ( SCHE ) . MATERIAL S AND METHODS In a double-blind study , overt hepatic encephalopathy ( HE ) and SCHE ( defined with clinical and neuropsychiatric tests ) were compared by means of H-1 MR spectroscopic criteria --reduction in cerebral myo-inositol ( < 2 st and ard deviations [ SDs ] from normal ) and choline ( < 2 SDs from normal ) with or without increased cerebral glutamine ( > 1 SD from normal)--in 20 patients with cirrhosis . RESULTS Concordance between MR spectroscopic and neuropsychiatric test results was 94 % ( kappa = 0.84 ) . MR spectroscopy allowed diagnosis of SCHE in nine of nine patients ( 100 % ) and of HE in seven of eight ( 88 % ) . Myo-inositol depletion alone had 80%-85 % sensitivity for detection of HE and SCHE . CONCLUSION H-1 MR spectroscopy allows accurate diagnosis of SCHE , and the results suggest an important role for myo-inositol in psychomotor and visuopractic functions OUTPUT:

Conclusion Oral zinc supplementation improved performance on the number connection test , but no evidence about other clinical or biochemical outcomes was available

MS2_dynamic_1_shot602

***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: Background Interventions design ed to narrow the gap between research findings and clinical practice may be effective , but also costly . Economic evaluations are necessary to judge whether such interventions are worth the effort . We have evaluated the economic effects of a tailored intervention to support the implementation of guidelines for the use of antihypertensive and cholesterol-lowering drugs . The tailored intervention was evaluated in a r and omized trial , and was shown to significantly increase the use of thiazides for patients started on antihypertensive medication , but had little or no impact on other outcomes . The increased use of thiazides was not expected to have an impact on health outcomes . Methods and Findings We performed cost-minimization and cost-effectiveness analyses on data from a r and omized trial involving 146 general practice s from two geographical areas in Norway . Each practice was r and omized to either the tailored intervention ( 70 practice s ; 257 physicians ) or control group ( 69 practice s ; 244 physicians ) . Only patients that were being started on antihypertensive medication were included in the analyses . A multifaceted intervention was tailored to address identified barriers to change . Key components were an educational outreach visit with audit and feedback , and computerized reminders . Pharmacists conducted the visits . A cost-minimization framework was adopted , where the costs of intervention were set against the reduced treatment costs ( principally due to increased use of thiazides rather than more expensive medication ) . The cost-effectiveness of the intervention was estimated as the cost per additional patient being started on thiazides . The net annual cost ( cost minimization ) in our study population was US$ 53,395 , corresponding to US$ 763 per practice . The cost per additional patient started on thiazides ( cost-effectiveness ) was US$ 454 . The net annual savings in a national program was modeled to be US$ 761,998 , or US$ 540 per practice after 2 y. In this scenario the savings exceeded the costs in all but two of the sensitivity analyses we conducted , and the cost-effectiveness was estimated to be US$ 183 . Conclusions We found a significant shift in prescribing of antihypertensive drugs towards the use of thiazides in our trial . A major reason to promote the use of thiazides is their lower price compared to other drugs . The cost of the intervention was more than twice the savings within the time frame of our study . However , we predict modest savings over a 2-y period OBJECTIVE Direct physician order entry ( POE ) offers many potential benefits , but evidence suggests that POE requires substantially more time than traditional paper-based ordering methods . The Medical Gopher is a well-accepted system for direct POE that has been in use for more than 15 years . The authors hypothesized that physicians using the Gopher would not spend any more time writing orders than physicians using paper-based methods . DESIGN A r and omized controlled trial of POE using the Medical Gopher system in 11 primary care internal medicine practice s. MEASUREMENTS The authors collected detailed time use data using time motion studies of the physicians and surveyed their opinions about the POE system . RESULTS The authors found that physicians using the Gopher spent 2.2 min more per patient overall , but when duplicative and administrative tasks were taken into account , physicians were found to have spent only 0.43 min more per patient . With experience , the order entry time fell by 3.73 min per patient . The survey revealed that the physicians believed that the system improved their patient care and wanted the Gopher to continue to be available in their practice s. CONCLUSIONS Little extra time , if any , was required for physicians to use the POE system . With experience in its use , physicians may even save time while enjoying the many benefits of POE UNLABELLED What is already known about this subject . Computerized prompts and reminders have been shown to be effective in changing the behaviour of health professionals in a variety of setting s. There is little literature describing or evaluating electronic decision-support for pharmacists . What this study adds . An electronic prompt in dispensing software for a targeted clinical intervention has a significant effect on pharmacists ' behaviour . A markedly increased rate of recording and performing the targeted clinical intervention was found . The effect of the prompt reduces markedly once the prompt is deactivated . AIM To evaluate the effect of an electronic prompt in dispensing software on the frequency of clinical interventions recorded by community pharmacists . METHOD An electronic decision-support prompt identifying patients for a targeted proactive clinical intervention was developed and implemented . Each time an oral antidiabetic agent was dispensed , a prompt was displayed reminding pharmacists to discuss the suitability of aspirin therapy in eligible patients with diabetes . The prompt was r and omly assigned to 31 of 52 metropolitan pharmacies in Melbourne ( Australia ) for 6 weeks , with the remaining pharmacies as controls . RESULTS One hundred and fifty pharmacists in 52 pharmacies recorded a total of 2396 clinical interventions at an intervention rate of 0.92 interventions per 100 patients [ 95 % confidence interval ( CI ) 0.58 , 1.23 ] . Pharmacists recorded a total of 201 target interventions related to aspirin therapy in diabetes at an intervention rate of 2.55 interventions per 100 diabetic patients ( 95 % CI 0.85 , 4.24 ) . All of the targeted clinical interventions were recorded in the prompt arm ; no targeted interventions were recorded in the control group . The effect of the prompt decreased over the study period and was not maintained after prompt deactivation . CONCLUSION An electronic prompt significantly increased pharmacists ' recording of the targeted clinical intervention in diabetic patients . An electronic decision-support prompt has significant potential to promote community pharmacists ' contribution to the quality use of medicines BACKGROUND Adverse drug-related events are common in the elderly , and inappropriate prescribing is a preventable risk factor . Our objective was to determine whether inappropriate prescribing could be reduced OUTPUT: Processes of care improved for prescribing and monitoring mostly in hospital setting s , but the few studies measuring clinical outcomes showed small or no improvements . CONCLUSIONS Almost half of MMIT interventions improved the process of care , but few studies measured clinical outcomes . INPUT: Background Interventions design ed to narrow the gap between research findings and clinical practice may be effective , but also costly . Economic evaluations are necessary to judge whether such interventions are worth the effort . We have evaluated the economic effects of a tailored intervention to support the implementation of guidelines for the use of antihypertensive and cholesterol-lowering drugs . The tailored intervention was evaluated in a r and omized trial , and was shown to significantly increase the use of thiazides for patients started on antihypertensive medication , but had little or no impact on other outcomes . The increased use of thiazides was not expected to have an impact on health outcomes . Methods and Findings We performed cost-minimization and cost-effectiveness analyses on data from a r and omized trial involving 146 general practice s from two geographical areas in Norway . Each practice was r and omized to either the tailored intervention ( 70 practice s ; 257 physicians ) or control group ( 69 practice s ; 244 physicians ) . Only patients that were being started on antihypertensive medication were included in the analyses . A multifaceted intervention was tailored to address identified barriers to change . Key components were an educational outreach visit with audit and feedback , and computerized reminders . Pharmacists conducted the visits . A cost-minimization framework was adopted , where the costs of intervention were set against the reduced treatment costs ( principally due to increased use of thiazides rather than more expensive medication ) . The cost-effectiveness of the intervention was estimated as the cost per additional patient being started on thiazides . The net annual cost ( cost minimization ) in our study population was US$ 53,395 , corresponding to US$ 763 per practice . The cost per additional patient started on thiazides ( cost-effectiveness ) was US$ 454 . The net annual savings in a national program was modeled to be US$ 761,998 , or US$ 540 per practice after 2 y. In this scenario the savings exceeded the costs in all but two of the sensitivity analyses we conducted , and the cost-effectiveness was estimated to be US$ 183 . Conclusions We found a significant shift in prescribing of antihypertensive drugs towards the use of thiazides in our trial . A major reason to promote the use of thiazides is their lower price compared to other drugs . The cost of the intervention was more than twice the savings within the time frame of our study . However , we predict modest savings over a 2-y period UNLABELLED What is already known about this subject . Computerized prompts and reminders have been shown to be effective in changing the behaviour of health professionals in a variety of setting s. There is little literature describing or evaluating electronic decision-support for pharmacists . What this study adds . An electronic prompt in dispensing software for a targeted clinical intervention has a significant effect on pharmacists ' behaviour . A markedly increased rate of recording and performing the targeted clinical intervention was found . The effect of the prompt reduces markedly once the prompt is deactivated . AIM To evaluate the effect of an electronic prompt in dispensing software on the frequency of clinical interventions recorded by community pharmacists . METHOD An electronic decision-support prompt identifying patients for a targeted proactive clinical intervention was developed and implemented . Each time an oral antidiabetic agent was dispensed , a prompt was displayed reminding pharmacists to discuss the suitability of aspirin therapy in eligible patients with diabetes . The prompt was r and omly assigned to 31 of 52 metropolitan pharmacies in Melbourne ( Australia ) for 6 weeks , with the remaining pharmacies as controls . RESULTS One hundred and fifty pharmacists in 52 pharmacies recorded a total of 2396 clinical interventions at an intervention rate of 0.92 interventions per 100 patients [ 95 % confidence interval ( CI ) 0.58 , 1.23 ] . Pharmacists recorded a total of 201 target interventions related to aspirin therapy in diabetes at an intervention rate of 2.55 interventions per 100 diabetic patients ( 95 % CI 0.85 , 4.24 ) . All of the targeted clinical interventions were recorded in the prompt arm ; no targeted interventions were recorded in the control group . The effect of the prompt decreased over the study period and was not maintained after prompt deactivation . CONCLUSION An electronic prompt significantly increased pharmacists ' recording of the targeted clinical intervention in diabetic patients . An electronic decision-support prompt has significant potential to promote community pharmacists ' contribution to the quality use of medicines OBJECTIVES To apply and evaluate the effects of a program for computer generated physician reminders , integrated with an electronic patient record ( EPR ) system , for opportunistic health screening in elderly patients . DESIGN A pilot study design ed as a 20-month clinical trial with a control group and a 20-month non-intervention follow-up using a computer reminder program that selects patients for screening in five intervention areas ( diabetes , hypertension , cobalamin deficiency , hypothyroidism and anaemia ) . SETTING Four primary health care ( PHC ) centres in suburban Stockholm . SUBJECTS The intervention was design ed for patients 70 years or older from one health care centre who visited a general practitioner ( GP ) during the first 20-month period . Patients from the three remaining centres served as controls . MAIN OUTCOME MEASURES The number of patients who underwent the tests , who had pathological test results , new diagnoses and new pharmacological treatments in both patient groups . RESULTS In total , 602 patients underwent screening and 1989 were controls . There was a statistically significant , moderate or marked increase ( 13 - 75 % ) in the number of patients who were tested in all five intervention areas . An increase in pathological test results ( 1 - 8 % ) was found in two areas : hypertension and cobalamin deficiency . There was an increase in the number of patients with the diagnosis of c OUTPUT:

Results were inconsistent for changes in CVD risk factors such as systolic and diastolic blood pressure , total and low-density lipoprotein cholesterol , and hemoglobin A1C levels . CONCLUSIONS CDSSs are effective in improving clinician practice s related to screening and other preventive care services , clinical tests , and treatments .

MS2_dynamic_1_shot603

***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: Objectives : To study the prevalence of hypovitaminosis D , the effect of vitamin D supplementation on serum 25-hydroxyvitamin D [ S-25(OH)D ] , and the intakes of vitamin D and calcium in Finnish 9− to 15-year-old athletic and nonathletic girls . Design : 1-year follow-up study ( February 1997-March 1998 ) with three months of vitamin D supplementation ( 10 μg/d ) from October to January . Setting : Turku University Central Hospital , Finl and .Subjects : 191 female volunteers aged 9–15 y ( 131 athletes and 60 controls ) . Methods : Vitamin D and calcium intakes were estimated by a four-day food recording and a semi-quantitative food frequency question naire ( FFQ ) . S-25(OH)D was followed by radioimmunoassay ( RIA ) . Results : At baseline the mean S-25(OH)D concentration was 33.9 nmol/l among all girls . In winter severe hypovitaminosis D ( S-25(OH)D<20 nmol/l ) occurred in 13.4 % of the participants and in 67.7 % S-25(OH)D was below 37.5 nmol/l . By the next summer the mean S-25(OH)D concentration was 62.9 nmol/l and in 1.6 % of the subjects it was below 37.5 nmol/l . The prevalence of severe hypovitaminosis D was not significantly reduced by three months of vitamin D ( 10 μg/d ) supplementation . At baseline , the mean intake of vitamin D was 2.9 μg/d by food recording and 4.3 μg/d by FFQ . The mean calcium intake was 1256 mg/d and 1580 mg/d , respectively . The intakes of vitamin D and calcium remained unchanged during the follow-up period . The athletes consumed more calcium than nonathletic controls , whereas the intake of vitamin D was quite similar among both groups . The vitamin D intake by FFQ correlated with the S-25(OH)D concentration in wintertime ( r=0.28 , P<0.01 ) . Conclusion : Hypovitaminosis D is fairly common in growing Finnish girls in the wintertime , and three months of vitamin D supplementation with 10 μg/d was insufficient in preventing hypovitaminosis D. The daily dietary vitamin D intake was insufficient ( < 5 μg/d ) in the majority of participants , while the calcium intake was usually sufficient . Sponsorship : Supported by the Yrjö Jahnsson Foundation , The Turku University Foundation , and the Medical Research Foundation of the Turku University Central Hospital Objective To investigate whether vitamin D supplementation can decrease the mortality and morbidity of low birthweight infants in low income countries . Design R and omised controlled trial . Setting Large government hospital in New Delhi , India . Participants 2079 low birthweight infants born at term ( > 37 weeks ’ gestation ) . Main outcome measures Primary outcome was admission to hospital or death during the first six months of life . Main secondary outcome was growth . Interventions Weekly vitamin D supplements for six months at a dose of one recommended nutrient intake per day ( 35 µg/week ) . Infants were visited weekly at home for observed supplementation and were brought to the clinic monthly for clinical examination and anthropometric measurements . Results Between group differences were not significant for death or hospital admissions ( 92 among 1039 infants in the vitamin D group v 99 among 1040 infants in the placebo group ; adjusted rate ratio 0.93 , 95 % confidence interval 0.68 to 1.29 ; P=0.68 ) , or referral to the outpatient clinic for moderate morbidity . Vitamin D supplementation result ed in better vitamin D status as assessed by plasma calcidiol levels at six months . In adjusted analyses , vitamin D treatment significantly increased st and ard deviation ( z ) scores at six months for weight , length , and arm circumference and decreased the proportion of children with stunted growth ( length for age z score ≤2 ) or with arm circumference z scores of 2 or less . Conclusion A weekly dose of vitamin D result ed in better vitamin D status and benefited the classic vitamin D function of bone growth but did not decrease the incidence of severe morbidity or death among young low birthweight infants . Trial registration Clinical Trials.gov NCT00415402 BACKGROUND Provision of fortified juices may provide a convenient method to maintain and increase blood fat-soluble vitamins . OBJECTIVE To determine whether children consuming orange juice fortified with calcium and combinations of vitamins D , E , and A could increase serum 25-hydroxyvitamin D [ 25(OH)D ] , α-tocopherol , and retinol levels . DESIGN A 12-week r and omized , double-blind , controlled trial . PARTICIPANTS / SETTING One hundred eighty participants ( aged 8.04±1.42 years ) were recruited at Tufts ( n=70 ) and Boston University ( n=110 ) during 2005 - 2006 . Of those recruited , 176 children were r and omized into three groups : CaD ( 700 mg calcium+200 IU vitamin D ) , CaDEA ( 700 mg calcium+200 IU vitamin D+12 IU vitamin E+2,000 IU vitamin A as beta carotene ) , or Ca ( 700 mg calcium ) . Children consumed two 240-mL glasses of CaD , CaDEA , or Ca fortified orange juice daily for 12 weeks . MAIN OUTPUT: In these two trials there were no obvious differences between supplemented and unsupplemented children regarding episodes of diarrhoea . This may be due to time elapsed at measurement from the last dose , incomplete compliance , or increased need of vitamin D with infant age . INPUT: Young male jockeys compromise bone health by engaging in caloric restriction and high volumes of physical activity during periods of musculoskeletal growth and development . The aim of this r and omised , double-blinded , placebo-controlled trial was to establish whether calcium and vitamin D supplementation would improve bone properties of young male jockeys . We conducted a 6-month trial with two groups of weight- , height- and age-matched apprentice male jockeys ( age=20.2 ± 3.2 yrs ) . Participants were supplemented with 800 mg of calcium and 400 IU of vitamin D ( S , n=8 ) or a placebo ( cellulose ) ( P , n=9 ) daily for 6-months . Baseline calcium intake was ( 669.7 ± 274.3 ( S ) vs 790.4 ± 423.9 ( P ) and vitamin D 64.6 ± 19.5 ( S ) vs 81.2 ± 24.4 ( P ) with no statistical differences . Peripheral quantitative computed tomography ( pQCT ) measured ultra-distal ( 4 % ) and proximal ( 66 % ) tibial bone properties at baseline and 6 months . Blood-borne markers of bone turnover , P1NP and CTX and vitamin D concentration were assessed . After co-varying for height , weight and baseline bone measurements , the supplemented group displayed greater post-intervention bone properties at the 66 % proximal site with cortical content ( mgmm ) 6.6 % greater ( p<0.001 ) , cortical area ( mm(2 ) ) 5.9 % larger ( p<0.001 ) , cortical density ( mgcm(2 ) ) 1.3 % greater ( p=0.001 ) , and total area ( mm(2 ) ) 4 % larger ( p=0.003 ) . No other between group differences in bone variables were observed . Blood analysis indicated higher vitamin D levels ( 18.1 % , p=0.014 ) and lower CTx ( ng/L ) ( -24.8 % , p=0.011 ) in the supplemented group with no differences observed in P1NP . This is the first r and omised controlled trial to examine the efficacy of calcium and vitamin D supplementation in improving bone properties in a highly vulnerable , young athletic , weight-restricted population . Results using pQCT indicate beneficial effects of supplementation on bone properties in as little as six months . Although the study size is small , this intervention appears promising as a strategy for improving bone health in young athletes in weight-restricted sports Vitamin D insufficiency is common in athletes and may lower physical performance . Many cross-sectional studies associate vitamin D status with physical performance in athletes ; however , there have been few prospect i ve r and omized controlled trials with adequate statistical power to test this relationship , and none in the southern hemisphere . Thus , a prospect i ve double-blind , r and omized , placebo-controlled intervention trial was conducted involving 57 professional rugby union players in New Zeal and . Participants were r and omized to receive 50,000 IU of cholecalciferol ( equivalent to 3,570 IU/day ) or placebo once every two weeks over 11 - 12 weeks . Serum 25(OH)D concentrations and physical performance were measured at baseline , weeks 5 - 6 , and weeks 11 - 12 . Mean ( SD ) serum 25(OH)D concentrations for all participants at baseline was 94 ( 18 ) nmol/L , with all players above 50 nmol/L. Vitamin D supplementation significantly increased serum 25(OH)D concentrations compared to placebo , with a 32 nmol/L difference between groups at 11 - 12 weeks ( 95 % CI , 26 - 38 ; p < 0.001 ) . Performance in five of the six tests at study completion , including the primary outcome variable of 30-m sprint time , did not differ between the vitamin D supplemented and placebo groups ( p > 0.05 ) . Performance on the weighted reverse-grip chin up was significantly higher in players receiving vitamin D compared with placebo , by 5.5 kg ( 95 % CI , 2.0 - 8.9 ; p = 0.002 ) . Despite significantly improving vitamin D status in these professional rugby union players , vitamin D supplementation had little impact on physical performance outcomes . Thus , it is unlikely that vitamin D supplementation is an ergogenic aid in this group of athletes In all species tested , except humans , biological differences between vitamins D2 and D3 are accepted as fact . To test the presumption of equivalence in humans , we compared the ability of equal molar quantities of vitamin D2 or D3 to increase serum 25-hydroxyvitamin D [ 25(OH)D ] , the measure of vitamin D nutrition . Subjects took 260 nmol ( approximately 4000 IU ) vitamin D2 ( n=17 ) or vitamin D3 ( n=55 ) daily for 14 d. 25(OH)D was assayed with a method that detects both the vitamin D2 and D3 forms . With vitamin D3 , mean ( + /-SD ) serum 25(OH)D increased from 41.3+/-17.7 nmol/L before to 64.6+/-17.2 nmol/L after treatment . With vitamin D2 , the 25(OH)D concentration went from 43.7+/-17.7 nmol/L before to 57.4+/-13.0 nmol/L after . The increase in 25(OH)D with vitamin D3 was 23.3+/-15.7 nmol/L , or 1.7 times the increase obtained with vitamin D2 ( 13.7 OUTPUT:

Conclusion Although , serum 25(OH)D concentrations after supplementation reached sufficiency was observed , muscle strength did not significantly improve at this point of current meta- analysis .

MS2_dynamic_1_shot604

***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: Study Design . Single blind r and omized study . Objectives . To compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration . Summary of Background Data . To the authors ’ best knowledge , only one r and omized study has evaluated the effectiveness of lumbar fusion . The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician . Patients and Methods . Sixty-four patients aged 25–60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4–L5 and /or L5–S1 at radiographic examination were r and omized to either lumbar fusion with posterior transpedicular screws and postoperative physiotherapy , or cognitive intervention and exercises . The cognitive intervention consisted of a lecture to give the patient an underst and ing that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it . This was reinforced by three daily physical exercise sessions for 3 weeks . The main outcome measure was the Oswestry Disability Index . Results . At the 1-year follow-up visit , 97 % of the patients , including 6 patients who had either not attended treatment or changed groups , were examined . The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery , compared with 42 to 30 after cognitive intervention and exercises . The mean difference between groups was 2.3 ( −6.7 to 11.4 ) ( P = 0.33 ) . Improvements inback pain , use of analgesics , emotional distress , life satisfaction , and return to work were not different . Fear-avoidance beliefs and fingertip-floor distance were reduced more after nonoperative treatment , and lower limb pain was reduced more after surgery . The success rateaccording to an independent observer was 70 % after surgery and 76 % after cognitive intervention and exercises . The early complication rate in the surgical group was 18 % . Conclusion . The main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration r and omized to cognitive intervention and exercises , or lumbar fusion This study examines prospect ively the r and omised , long-term , clinical and radiological results of the treatment of spondylitis patients by ventro-dorsal or ventral spine fusion . Group 1 consisted of 12 patients who ( after ventral removal of the focus of infection and autologous bone grafting ) were treated by dorsal instrumentation . Group 2 consisted of ten patients who , after similar ventral removal and bone interposition , were stabilised by ventral instrumentation . The patients prospect ively underwent clinical and radiological studies . In addition , they were asked to fill in self- assessment question naires such as the short-form (SF)-36 health survey , the Oswestry question naire , and the visual analog scales ( VAS ) . The postoperative follow-ups were at 6 months , 2 years and 5.4 years . It proved possible to demonstrate clinical ly that patients with an isolated ventral spondylodesis feel significantly better and experience significantly less pain in the area of spinal fusion than patients with ventro-dorsal fusion 2 and 5.4 years after the operation . Over a number of years a stable fusion can be achieved through either operation . Ventral stabilisation yields more advantages than dorsal instrumentation in the long term . These advantages result in a clinical ly smoother course after the operation . If , in the individual case , ventral instrumentation is feasible , this method should be used . RésuméLa présente étude a pour but d’examiner de façon prospect i ve et r and omisée le devenir à long terme , clinique et radiologique , du traitement des spondylites après greffe antérieure ou greffe postérieure . Le groupe I a inclus 12 patients après abord antérieur , évacuation de l’abcès et greffe antérieure puis mise en place une instrumentation postérieure . Le groupe II ayant inclus 10 patients après un abord antérieur similaire , la greffe osseuse a été stabilisée par une instrumentation antérieure . Les patients ont été examinés rétrospectivement sur le plan clinique et radiologique . Ils ont répondu au question naire SF-36 , le question naire d’Oswestry et au VAS . Le suivi moyen post opératoire a été réalisé à six mois , deux ans et 5,4 ans . Cette étude a démontré de façon claire que les patients ayant bénéficié d’une greffe antérieure ont eu un résultat significativement plus intéressant en termes de douleur et de fusion que les patients ayant été traités par abord antérieur et une greffe postérieure . Si on la compare à l’instrumentation postérieure , cette stabilisation antérieure présente un certain nombre d’avantages à long terme . L’instrumentation antérieure est bien suffisante pour traiter ces pathologies BACKGROUND Management of degenerative spondylolisthesis with spinal stenosis is controversial . Surgery is widely used , but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials . METHODS Surgical c and i date s from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a r and omized cohort or an observational cohort . Treatment was st and ard decompressive laminectomy ( with or without fusion ) or usual nonsurgical care . The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey ( SF-36 ) bodily pain and physical function scores ( 100-point scales , with higher scores indicating less severe symptoms ) and the modified Oswestry Disability Index ( 100-point scale , with lower scores indicating less severe symptoms ) at 6 weeks , 3 months , 6 months , 1 year , and 2 years . RESULTS We enrolled 304 patients in the r and omized cohort and 303 in the observ OUTPUT: The only intervention that receives strong evidence is discectomy for faster relief in carefully selected patients due to lumbar disc prolapse with sciatica . INPUT: Study Design . Single blind r and omized study . Objectives . To compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration . Summary of Background Data . To the authors ’ best knowledge , only one r and omized study has evaluated the effectiveness of lumbar fusion . The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician . Patients and Methods . Sixty-four patients aged 25–60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4–L5 and /or L5–S1 at radiographic examination were r and omized to either lumbar fusion with posterior transpedicular screws and postoperative physiotherapy , or cognitive intervention and exercises . The cognitive intervention consisted of a lecture to give the patient an underst and ing that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it . This was reinforced by three daily physical exercise sessions for 3 weeks . The main outcome measure was the Oswestry Disability Index . Results . At the 1-year follow-up visit , 97 % of the patients , including 6 patients who had either not attended treatment or changed groups , were examined . The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery , compared with 42 to 30 after cognitive intervention and exercises . The mean difference between groups was 2.3 ( −6.7 to 11.4 ) ( P = 0.33 ) . Improvements inback pain , use of analgesics , emotional distress , life satisfaction , and return to work were not different . Fear-avoidance beliefs and fingertip-floor distance were reduced more after nonoperative treatment , and lower limb pain was reduced more after surgery . The success rateaccording to an independent observer was 70 % after surgery and 76 % after cognitive intervention and exercises . The early complication rate in the surgical group was 18 % . Conclusion . The main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration r and omized to cognitive intervention and exercises , or lumbar fusion OBJECTIVES This report presents health statistics from the 2001 National Health Interview Survey for the civilian noninstitutionalized adult population classified by sex , age , race and Hispanic origin , poverty status , and region of residence for chronic condition prevalence , health status and functional limitations , health care access and utilization , health behaviors , and human immunodeficiency virus ( HIV ) testing . Also , health statistics by education , income , health insurance coverage , marital status , and place of residence are presented for health status and limitations in activity , health care access and utilization , health behaviors , and knowledge and attitudes toward HIV . SOURCE OF DATA The National Health Interview Survey is a multistage probability sample survey conducted annually by interviewers of the U.S. Census Bureau for the Centers for Disease Control and Prevention 's National Center for Health Statistics and is representative of the civilian noninstitutionalized U.S. population . Sociodemographic data are collected for everyone in the family during face-to-face interviews with adults present at the time of the interview . The health information for adults in this report was obtained from one r and omly selected adult per family . HIGHLIGHTS In 2001 , 64 % of adults 18 years of age and over reported excellent or very good health . Fifty-eight percent of adults never participated in any type of vigorous leisure-time physical activity , and 13 % of adults did not have a usual place of health care . Twelve percent of adults had been told by a doctor or health professional that they had heart disease , and 21 % had been told on two or more visits that they had hypertension . Nearly a quarter of all adults were current smokers , and 22 % were former smokers . Based on estimates of body mass index , 36 % of adults were overweight and 23 % were obese OBJECTIVES This report presents health statistics from the 2010 National Health Interview Survey ( NHIS ) for the civilian noninstitutionalized adult population , classified by sex , age , race and Hispanic origin , education , family income , poverty status , health insurance coverage , marital status , and place and region of residence . Estimates are presented for selected chronic conditions and mental health characteristics , functional limitations , health status , health behaviors , health care access and utilization , and human immunodeficiency virus testing . Percentages and percent distributions are presented in both age-adjusted and unadjusted versions . DATA SOURCE NHIS is a household , multistage probability sample survey conducted annually by interviewers of the U.S. Census Bureau for the Centers for Disease Control and Prevention 's National Center for Health Statistics . In 2010 , data were collected on 27,157 adults in the Sample Adult question naire . The conditional response rate was 77.3 % , and the final response rate was 60.8 % . The health information for adults in this report was obtained from one r and omly selected adult per family . In very rare instances where the sample adult was not able to respond for himself or herself , a proxy was used . HIGHLIGHTS In 2010 , 61 % of adults aged 18 years and over had excellent or very good health . Twelve percent of adults had been told by a doctor or health professional that they had heart disease , 25 % had been told on two or more visits that they had hypertension , 9 % had been told they had diabetes , and 22 % had been told they had some form of arthritis , rheumatoid arthritis , gout , lupus , or fibromyalgia . Twenty-one percent of adults were current smokers , and 21 % were former smokers . Based on estimates of body mass index , 35 % of adults were overweight and 27 % were obese OBJECTIVE To investigate the effects of squat exercises combined with whole-body vibration on the plasma concentration of inflammatory markers OUTPUT:

Inflammatory markers were most commonly measured followed by neurotransmitter-related genes and metabolite-detecting genes . After exercise interventions , changes in biomarkers involved in neurotransmission and inflammation suggest a hypoalgesic exercise effect . Significant biomarker associations were found with pain intensity , fatigue , depression , anxiety , and quality of life . Discussion : It remains a question whether biomarkers can be used as objective measures for risk assessment , diagnosis , or evaluation or as surrogate endpoints in chronic pain . Regardless , the potential translational value of biomarkers in chronic pain is evident .

MS2_dynamic_1_shot605

***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: AIMS Dapagliflozin , a highly selective inhibitor of sodium-glucose cotransporter 2 ( SGLT2 ) , reduces hyperglycaemia and weight in patients with type 2 diabetes mellitus ( T2DM ) by increasing urinary glucose excretion . Long-term glycaemic control , body composition and bone safety were evaluated in patients with T2DM after 102 weeks of dapagliflozin treatment . METHODS This r and omized , double-blind , placebo-controlled study ( NCT00855166 ) enrolled patients with T2DM [ mean : age 60.7 years ; HbA1c 7.2 % ; body mass index ( BMI ) 31.9 kg/m(2 ) ; body weight 91.5 kg ] inadequately controlled on metformin . Patients ( N = 182 ) were r and omly assigned 1 : 1 to receive dapagliflozin 10 mg/day or placebo added to open-label metformin for a 24-week double-blind treatment period followed by a 78-week site- and patient-blinded extension period . At week 102 , changes from baseline in HbA1c , weight , waist circumference , total body fat mass as measured by dual-energy X-ray absorptiometry ( DXA ) , serum markers of bone turnover , bone mineral density ( BMD ) as measured by DXA , and adverse events were evaluated . RESULTS A total of 140 patients ( 76.9 % ) completed the study . Over 102 weeks , dapagliflozin-treated patients showed reductions in HbA1c by -0.3 % , weight by -4.54 kg , waist circumference by -5.0 cm and fat mass by -2.80 kg without increase in rate of hypoglycaemia . Compared with placebo , no meaningful changes from baseline in markers of bone turnover or BMD were identified over 102 weeks . One fracture occurred in each treatment group . The frequency of urinary tract infection ( UTI ) and genital infection was similar in both treatment groups . CONCLUSIONS Over 102 weeks , dapagliflozin improved glycaemic control , and reduced weight and fat mass , without affecting markers of bone turnover or BMD in patients with T2DM inadequately controlled on metformin OBJECTIVE To determine whether dapagliflozin , which selectively inhibits renal glucose reabsorption , lowers hyperglycemia in patients with type 2 diabetes that is poorly controlled with high insulin doses plus oral antidiabetic agents ( OADs ) . RESEARCH DESIGN AND METHODS This was a r and omized , double-blind , three-arm parallel-group , placebo-controlled , 26-center trial ( U.S. and Canada ) . Based on data from an insulin dose-adjustment setting cohort ( n = 4 ) , patients in the treatment cohort ( n = 71 ) were r and omly assigned 1:1:1 to placebo , 10 mg dapagliflozin , or 20 mg dapagliflozin , plus OAD(s ) and 50 % of their daily insulin dose . The primary outcome was change from baseline in A1C at week 12 ( dapagliflozin vs. placebo , last observation carried forward [ LOCF ] ) . RESULTS At week 12 ( LOCF ) , the 10- and 20-mg dapagliflozin groups demonstrated −0.70 and −0.78 % mean differences in A1C change from baseline versus placebo . In both dapagliflozin groups , 65.2 % of patients achieved a decrease from baseline in A1C ≥0.5 % versus 15.8 % in the placebo group . Mean changes from baseline in fasting plasma glucose ( FPG ) were + 17.8 , + 2.4 , and −9.6 mg/dl ( placebo , 10 mg dapagliflozin , and 20 mg dapagliflozin , respectively ) . Postpr and ial glucose ( PPG ) reductions with dapagliflozin also showed dose dependence . Mean changes in total body weight were −1.9 , −4.5 , and −4.3 kg ( placebo , 10 mg dapagliflozin , and 20 mg dapagliflozin ) . Overall , adverse events were balanced across all groups , although more genital infections occurred in the 20-mg dapagliflozin group than in the placebo group . CONCLUSIONS In patients receiving high insulin doses plus insulin sensitizers who had their baseline insulin reduced by 50 % , dapagliflozin decreased A1C , produced better FPG and PPG levels , and lowered weight more than placebo Sodium – glucose cotransporter 2 ( SGLT2 ) inhibitors are a newly approved class of glucose-lowering medications with a novel mechanism of action . These agents increase glycosuria , which leads to improved glucose control . They also produce an osmotic diuresis that , in part , contributes to blood pressure reduction and calorie loss secondary to glycosuria leading to weight loss ( 1,2 ) . A recent review of SGLT2 inhibitors focuses on the blood pressure – lowering effects of the two approved glucose-lowering agents , dapagliflozin and canagliflozin ( 3 ) . While not approved as antihypertensive agents , they may potentially aid in lowering blood pressure in patients with diabetes . A review of studies in both hypertensive and normotensive patients with type 2 diabetes demonstrates a 4–10 mmHg reduction of systolic blood pressure ( 3 ) . In this issue of Diabetes Care , Tikkanen et al. ( 4 ) investigate the effectiveness and safety OUTPUT: The drug class effect of SUA reduction suggesting SGLT2 inhibitors might be beneficial for diabetic patients with hyperuricemia INPUT: BACKGROUND A high fructose intake can lead to postpr and ial hypertriacylglycerolemia . The underlying mechanism is unclear . OBJECTIVE The objective of the study was to investigate the mechanisms involved in fructose-induced hypertriacylglycerolemia and the contribution of de novo lipogenesis in an acute setting . DESIGN In a r and omized , crossover study , 14 subjects were given a fructose or glucose test meal after an overnight fast . [(2)H2]Palmitate and [U(13)C]d-fructose or [U(13)C]d-glucose were added to trace the h and ling of dietary fats and the fate of dietary sugars in the body . Blood sample s were taken before and after the meal . Respiratory exchange ratio was measured by using indirect calorimetry , and breath sample s were collected . RESULTS Plasma triacylglycerol and VLDL-triacylglycerol concentrations were significantly higher ( P = 0.001 for both ) , whereas the concentrations of insulin and [(2)H2]palmitate in nonesterified fatty acids were significantly lower after fructose than after glucose ( P = 0.002 and 0.03 , respectively ) . The respiratory exchange ratio was higher after fructose ( P = 0.04 ) ; significantly ( P = 0.003 ) more carbon from sugars was recovered in breath carbon dioxide over 6 h after fructose ( 30.5 % ) than after glucose ( 24.5 % ) . At 240 min , newly synthesized fatty acids from fructose made up approximately 0.4 % of circulating VLDL-triacylglycerol , whereas newly synthesized triacylglycerol-glycerol made up 38 % . Newly synthesized fatty acids and triacylglycerol-glycerol from glucose contributed almost none of VLDL-triacylglycerol ( P = 0.002 and 0.007 for glucose and fructose , respectively ) . CONCLUSIONS The lower insulin excursion after fructose may result in less activation of adipose tissue lipoprotein lipase , which led to impaired triacylglycerol clearance . The contribution of de novo lipogenesis to fructose-induced hypertriacylglycerolemia is small , but its effect on altering the partitioning of fatty acids toward esterification may be considerable OBJECTIVE In normal adults , a small ( catalytic ) dose of fructose administered with glucose decreases the glycemic response to a glucose load , especially in those with the poorest glucose tolerance . We hypothesized that an acute catalytic dose of fructose would also improve glucose tolerance in individuals with type 2 diabetes . RESEARCH DESIGN AND METHODS Five adults with type 2 diabetes underwent an oral glucose tolerance test ( OGTT ) on two separate occasions , at least 1 week apart . Each OGTT consisted of 75 g glucose with or without the addition of 7.5 g fructose ( OGTT + F or OGTT - F ) , in r and om order . Arterialized blood sample s were collected from a heated dorsal h and vein twice before ingestion of the carbohydrate and every 15 min for 3 h afterward . RESULTS The area under the curve ( AUC ) of the plasma glucose response was reduced by fructose administration in all subjects ; the mean AUC during the OGTT + F was 14 % less than that during the OGTT - F ( P < 0.05 ) . The insulin AUC was decreased 21 % with fructose administration ( P = 0.2 ) . Plasma glucagon concentrations declined similarly during OGTT - F and OGTT + F. The incremental AUC of the blood lactate response during the OGTT - F was approximately 50 % of that observed during the OGTT + F ( P < 0.05 ) . Neither nonesterified fatty acid nor triglyceride concentrations differed between the two OGTTs . CONCLUSIONS Low-dose fructose improves the glycemic response to an oral glucose load in adults with type 2 diabetes , and this effect is not a result of stimulation of insulin secretion The effect of dietary fructose ( 20 % of carbohydrate calories , 45 - 65 g day-1 for 4 weeks ) on glycaemic control , serum lipid , lipoprotein and apoprotein A-I and A-II concentrations and on insulin sensitivity was studied in 10 type 2 diabetic patients . The study was done in a r and omized , double-blind fashion with crystalline fructose or placebo administered evenly during 4 meals or snacks per day . The patients were hospitalized throughout the study periods . The fasting plasma glucose concentration decreased during the fructose ( from 10.7 + /- 1.4 mmol l-1 to 8.0 + /- 0.8 mmol l-1 , P < 0.02 ) and the control diet ( from 10.1 + /- 0.9 mmol l-1 to 8.0 + /- 0.7 mmol l-1 , P < 0.05 ) . The mean diurnal blood glucose concentration also fell both during the fructose ( from 10.8 + /- 0.5 mmol l-1 to 8.4 + /- 0.3 mmol l-1 , P < 0.001 ) and the control diet ( from 10.3 + /- 0.3 mmol l-1 to 8.8 + /- 0.9 mmol l-1 , P < 0.01 ) . The HbA1 concentration improved ( P < 0.02 ) only during the f OUTPUT:

Pooled analyses demonstrated conditional triglyceride-raising and total cholesterol – lowering effects of isocaloric fructose exchange for carbohydrate in type 2 diabetes .

MS2_dynamic_1_shot606

***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: Methods : Various developmental problems including attention-deficit/hyperactivity disorder ( ADHD ) have been linked to biological deficiencies in polyunsaturated fatty acids ( PUFAs ) . Additionally , there is evidence that symptoms may be reduced with PUFA supplementation . This study investigated effects of supplementation with PUFAs on symptoms typically associated with ADHD . Because nutrients work synergistically , additional effects of micronutrient supplementation were also investigated . A total of 132 Australian children aged 7 to 12 years with scores ≥2 SD above the population average on the Conners ADHD Index participated in a r and omized , placebo-controlled , double-blind intervention over 15 weeks , taking PUFAs alone , PUFAs + micronutrients , or placebo . Due to unreturned question naires , data were only available for 104 children . Results : Significant medium to strong positive treatment effects were found on parent ratings of core ADHD symptoms , inattention , hyperactivity/impulsivity , on the Conners Parent Rating Scale ( CPRS ) in both PUFA treatment groups compared with the placebo group ; no additional effects were found with the micronutrients . After a one-way crossover to active supplements in all groups for a further 15 weeks , these results were replicated in the placebo group , and the treatment groups continued to show significant improvements on CPRS core symptoms . No significant effects were found on Conners Teacher Rating Scales . Conclusion : These results add to preliminary findings that ADHD-related problems with inattention , hyperactivity , and impulsivity might respond to treatment with PUFAs and that improvements may continue with supplementation extending to 30 weeks This pilot study evaluated the effects of supplementation with PUFA on blood FA composition and behavior in children with Attention-Deficit/Hyperactivity Disorder (AD/HD)-like symptoms also reporting thirst and skin problems . Fifty children were r and omized to treatment groups receiving either a PUFA supplement providing a daily dose of 480 mg DHA , 80 mg EPA , 40 mg arachidonic acid ( AA ) , 96 mg GLA , and 24 mg α-tocopheryl acetate , or an olive oil placebo for 4 mon of doubleblind parallel treatment . Supplementation with the PUFA led to a substantial increase in the proportions of EPA , DHA , and α-tocopherol in the plasma phospholipids and red blood cell ( RBC ) total lipids , but an increase was noted in the plasma phospholipid proportions of 18∶3n-3 with olive oil as well . Significant improvements in multiple but outcomes ( as rated by parents ) were noted in both groups , but a clear benefit from PUFA supplementation for all behaviors characteristic of AD/HD was not observed . For most outcomes , improvement of the PUFA group was consistently nominally better than that of the olive oil group ; but the treatment difference was significantly , by secondary intent-to-treat analysis on only 2 out of 16 outcome measures : conduct problems rated by parents ( −42.7 vs. −9.9 % , n=47 , P=0.05 ) , and attention symptoms rated by teachers ( −14.8 vs. + 3.4 % , n=47 , P=0.03 ) . PUFA supplementation led to a greater number of participants showing improvement in oppositional defiant behavior from a clinical to a non clinical range compared with olive oil supplementation ( 8 out of 12 vs. 3 out of 11 , n=33 , P=0.02 ) . Also , significant correlations were observed when comparing the magnitude of change between increasing proportions of EPA in the RBC and decreasing disruptive behavior as assessed by the Abbreviated Symptom Question naire ( ASQ ) for parents ( r=−0.38 , n=31 , P<0.05 ) , and for EPA and DHA in the RBC and the teachers ' Disruptive Behavior Disorders ( DBD ) Rating Scale for Attention ( r=−0.49 , n=24 , P<0.05 ) . Interestingly , significant correlations were observed between the magnitude of increase in α-tocopherol concentrations in the RBC and a decrease in scores for all four subscales of the teacher 's DBD ( Hyperactivity , r=−0.45 ; Attention , r=−0.60 ; Conduct , r=−0.41 ; Oppositional/Defiant Disorder , r=−0.54 ; n=24 , P<0.05 ) as well as the ASQ for teachers ( r=−0.51 , n=24 , P<0.05 ) . Thus , the results of this pilot study suggest the need for further research with both n−3 FA and vitamin E in children with behavioral disorders We examined the effects of omitting breakfast on the cognitive functions of three groups of children : stunted , nonstunted controls , and previously severely malnourished . They were admitted to a metabolic ward twice . After an overnight fast half the children received breakfast on their first visit and a cup of tea the second time . The treatment order was reversed for the other half . When breakfast was omitted , both the stunted and previously malnourished groups responded similarly . The malnourished groups had lower scores in fluency and coding whereas the control group had higher scores in arithmetic . The children were divided into wasted and nonwasted groups . Wasted children were adversely affected in the digit span backwards tests , and wasted members of the malnourished groups were adversely affected in efficiency of problem solving and those in the control group in digit span forwards . These results indicate that cognitive functions are more vulnerable to missing breakfast in poorly nourished children Effects of skipping breakfast on speed and accuracy of response in a number of problem solving tasks were assessed in 9- to 11-yr-old , well-nourished children . The conceptual framework for this study was derived from an experimental model of the effects of mild environmental stress , e.g. , noise , on human performance . Plasma glucose , beta-hydroxybutyr OUTPUT: However , there is emerging evidence for the effects of certain fatty acids which appear to be a function of dose and time . Whilst the importance of diet in educational attainment remains under investigation , the evidence for promotion of lower-fat , -salt and -sugar diets , high in fruits , vegetables and complex carbohydrates , as well as promotion of physical activity remains unequivocal in terms of health outcomes for all schoolchildren INPUT: This pilot study evaluated the effects of supplementation with PUFA on blood FA composition and behavior in children with Attention-Deficit/Hyperactivity Disorder (AD/HD)-like symptoms also reporting thirst and skin problems . Fifty children were r and omized to treatment groups receiving either a PUFA supplement providing a daily dose of 480 mg DHA , 80 mg EPA , 40 mg arachidonic acid ( AA ) , 96 mg GLA , and 24 mg α-tocopheryl acetate , or an olive oil placebo for 4 mon of doubleblind parallel treatment . Supplementation with the PUFA led to a substantial increase in the proportions of EPA , DHA , and α-tocopherol in the plasma phospholipids and red blood cell ( RBC ) total lipids , but an increase was noted in the plasma phospholipid proportions of 18∶3n-3 with olive oil as well . Significant improvements in multiple but outcomes ( as rated by parents ) were noted in both groups , but a clear benefit from PUFA supplementation for all behaviors characteristic of AD/HD was not observed . For most outcomes , improvement of the PUFA group was consistently nominally better than that of the olive oil group ; but the treatment difference was significantly , by secondary intent-to-treat analysis on only 2 out of 16 outcome measures : conduct problems rated by parents ( −42.7 vs. −9.9 % , n=47 , P=0.05 ) , and attention symptoms rated by teachers ( −14.8 vs. + 3.4 % , n=47 , P=0.03 ) . PUFA supplementation led to a greater number of participants showing improvement in oppositional defiant behavior from a clinical to a non clinical range compared with olive oil supplementation ( 8 out of 12 vs. 3 out of 11 , n=33 , P=0.02 ) . Also , significant correlations were observed when comparing the magnitude of change between increasing proportions of EPA in the RBC and decreasing disruptive behavior as assessed by the Abbreviated Symptom Question naire ( ASQ ) for parents ( r=−0.38 , n=31 , P<0.05 ) , and for EPA and DHA in the RBC and the teachers ' Disruptive Behavior Disorders ( DBD ) Rating Scale for Attention ( r=−0.49 , n=24 , P<0.05 ) . Interestingly , significant correlations were observed between the magnitude of increase in α-tocopherol concentrations in the RBC and a decrease in scores for all four subscales of the teacher 's DBD ( Hyperactivity , r=−0.45 ; Attention , r=−0.60 ; Conduct , r=−0.41 ; Oppositional/Defiant Disorder , r=−0.54 ; n=24 , P<0.05 ) as well as the ASQ for teachers ( r=−0.51 , n=24 , P<0.05 ) . Thus , the results of this pilot study suggest the need for further research with both n−3 FA and vitamin E in children with behavioral disorders BACKGROUND Previous research has shown positive effects of Omega 3/6 fatty acids in children with inattention and reading difficulties . We aim ed to investigate if Omega 3/6 improved reading ability in mainstream schoolchildren . METHODS We performed a 3-month parallel , r and omized , double-blind , placebo-controlled trial followed by 3-month active treatment for all subjects . Mainstream schoolchildren aged 9 - 10 years were r and omized 1:1 to receive three Omega 3/6 capsules twice daily or identical placebo . Assessment s were made at baseline , 3 months , and 6 months . The primary outcome measure was the Logos test battery for evaluating reading abilities . The trial is registered with Clinical Trials.gov , number NCT02557477 . RESULTS The study enrolled 154 children ( active n = 78 ; placebo n = 76 ) , of whom 122 completed the first 3 months ( active n = 64 ; placebo n = 58 ) and 105 completed the whole study ( active/active n = 55 ; placebo/active n = 50 ) . Outcomes were assessed by per protocol ( PP ) and intention-to-treat ( ITT ) analyses . Active treatment was superior to placebo at 3 months for improvement in phonologic decoding time ( PP active/placebo difference -0.16 ; 95 % CI -0.03 , -0.29 ; effect size ( ES ) .44 ; p = .005 ; and ITT ES .37 ; p = .036 ) , in visual analysis time ( PP active/placebo difference -0.19 ; 95 % CI -0.05 , -0.33 ; ES .49 ; p = .013 ; and ITT ES .40 ; p = .01 ) , and for boys in phonologic decoding time ( PP -0.22 ; 95 % CI -0.03 , -0.41 ; ES .62 ; p = .004 ) . Children with ADHD-RS scores above the median showed treatment benefits in visual analysis time ( PP ES .8 , p = .009 ) , reading speed per word ( PP ES .61 , p = .008 ) , and phonologic decoding time per word ( PP ES .85 , p = .006 ) . Adverse events were rare and mild , mainly stomach pain/diarrhea ( active n = 9 , placebo n = 2 ) . CONCLUSIONS Compared with placebo , 3 months of Omega 3/6 treatment improved reading ability - specifically the clinical ly relevant ' phonologic decoding time ' and ' visual analysis time ' - in mainstream schoolchildren . In particular , children with attention problems showed treatment benefits Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without OUTPUT:

Reading , working memory , and behavior change scores showed no consistent differences between intervention and placebo group . Some behavioral subscales showed minor group differences . Conclusions This RCT did not replicate results of the earlier DOLAB 1 study on the effectiveness of nutritional supplementation with DHA for learning and behavior .

MS2_dynamic_1_shot607

***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: Background —In patients with atrial fibrillation ( AF ) undergoing radiofrequency ( RF ) electrical disconnection of multiple pulmonary veins ( PVs ) , the incidence of late conduction recurrences has not been systematic ally determined . Methods and Results —Using a prospect ively design ed , multistep approach , we aim ed at assessing the correlation between acute achievement and chronic maintenance of electrical conduction block across RF lesions disconnecting the distal tract of the PV in 43 patients ( 52.3±8.2 years ) with AF . Forty-one left superior ( LS ) , 42 right superior ( RS ) , 25 left inferior ( LI ) , and 9 right inferior ( RI ) PVs were targeted during 108 EP procedures ( 2.6±0.5 per patient ) . Seventeen patients underwent 2 procedures , 23 patients underwent 3 procedures , and 3 patients underwent 4 procedures . During the first attempt , electrical disconnection was achieved in 112 PVs ( 95.7 % ) . During a next procedure ( time interval , 4.6±1.9 months ) , conduction recurrence was observed in 32 of 39 LSPVs ( 82.1 % ) , 29 of 40 RSPVs ( 72.5 % ) , 20 of 24 LIPVs ( 83.3 % ) , and 7 of 9 RIPV ( 77.8 % ) . After reablation at gap sites , a later procedure ( time interval , 5.1±2.4 months ) revealed a second recurrence in 13 of 22 LSPVs ( 59.1 % ) and 14 of 19 RSPVs ( 73.7 % ) . Conclusions —Conduction recurrence across disconnecting RF lesions can be observed in ≈80 % of cases 4 months after ablation . After reablation , similar recurrence rates are observed 5 months later . This high rate of late conduction recurrence may contribute significantly to AF recurrence in patients undergoing catheter ablation aim ing at disconnection of multiple PVs BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium . OBJECTIVE The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes . METHODS Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter . In 25 patients , ablation was guided by real-time contact force measurements ( CF group ; SmartTouch , Biosense Webster ) . A control group of 50 patients underwent PVI using a st and ard nonforce sensing catheter ( st and ard group ; ThermoCool , Biosense Webster ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed up at 3 , 6 , and 12 months and by transtelephonic monitoring as well . RESULTS Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs ( 8 % ; 16 % of patients ) in the CF group and 35 PV pairs ( 35 % ; 52 % of patients ) in the st and ard group ( P = .0004 per PV pair ; P = .0029 per patient ) . The single-procedure , off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88 % in the CF group vs 66 % in the st and ard group ( P = .047 ) . Procedure duration and fluoroscopy time were significantly longer in the CF group ( P = .0038 and P = .0001 , respectively ) . CONCLUSION The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias . The utility of a contact force-guided approach requires evaluation in a long-term prospect i ve r and omized study BACKGROUND Contact force ( CF ) information may improve the safety and efficacy of ablation for paroxysmal atrial fibrillation ( PAF ) . OBJECTIVE The purpose of this study was to assess the impact of CF data on ablation for PAF . METHODS Patients undergoing first-time PAF ablation were r and omized at 7 UK centers to ablation with ( CF-on ) or without ( CF-off ) CF data available to the operator , using the same ablation catheter and mapping system . An ablation CF of 5 - 40 g was targeted . Pulmonary vein ( PV ) reconnection was assessed with adenosine at 60 minutes . Follow-up for arrhythmia recurrence was for 1 year with 7-day Holter recordings at 6 and 12 months . RESULTS One hundred seventeen patients were studied ( 59 CF-on , 58 CF-off ) . In the CF-on group , a reduction in acute PV reconnection rates ( 22 % vs 32 % , P = .03 ) but no significant difference in 1-year success rates off antiarrhythmic drugs ( 49 % vs 52 % , P = .9 ) was observed . There was no difference in major complication rates : 2 of 59 ( 3 % ) CF-on , 3 of 58 ( 5 % ) CF-off ( P = .7 ) . Procedural and fluoroscopy times were not significantly different ( P>.5 ) . Overall mean CFs per ablation were not different between groups ( 13.4 [9.1 - 19.6]g CF-on , 13.4 [7.4 - 22.4]g CF-off , P = .5 ) , but a greater proportion of readings in the CF-on group were in the target range OUTPUT: Conclusion : CF‐guided RF catheter ablation was associated with a significant AF/atrial tachycardia‐free survival benefit compared with non‐CF‐guided ablation in patients with paroxysmal AF rather than persistent AF . In addition , CF‐guided ablation strategy also reduced the procedure time , fluoroscopy time , as well as RF time despite no distinct effect on the alleviation of procedure‐related complications INPUT: BACKGROUND Contact force ( CF ) monitoring could be useful in accomplishing circumferential pulmonary vein ( PV ) isolation ( CPVI ) for atrial fibrillation ( AF ) . OBJECTIVE The purpose of this study was to compare procedure parameters and outcomes between CF-guided and non-guided CPVI . METHODS Thirty-eight consecutive AF patients ( mean age 60 ± 11 years , 28 paroxysmal AF ) undergoing CPVI were r and omized to non-CF-guided ( n = 19 ) and CF-guided ( n = 19 ) groups . CPVI was performed with the ThermoCool SmartTouch catheter in both groups . The end-point was bidirectional block between the left atrium ( LA ) and PV . In the CF group , CF was kept between 10 and 20 g during CPVI , whereas in the non-CF group , all CF information was blanked . Radiofrequency energy at 30 W in the anterior and 25 W in the posterior LA wall was applied for 20 - 25 seconds at each point . RESULTS CPVI was successfully accomplished without any major complications in both groups . Mean CF in the non-CF and CF groups were 5.9 ± 4.5 g and 11.1 ± 4.3 g , respectively , for left-side CPVI , and 9.8 ± 6.6 g and 12.1 ± 4.8 g , respectively , for right-side CPVI ( both P < .001 ) . The procedure and fluoroscopy times for CPVI in the non-CF and CF groups were 96 ± 39 minutes and 59 ± 16 minutes , respectively ( P < .001 ) , and 22 ± 63 seconds and 9 ± 20 seconds ( P = NS ) , respectively . Total number of residual conduction gaps was 6.3 ± 3.0 in the non-CF group and 2.8 ± 1.9 in the CF group ( P < .001 ) . During 6-month follow-up , 84.2 % of patients in the non-CF group and 94.7 % in the CF group were free from any atrial tachyarrhythmias ( P = .34 ) . CONCLUSION CF-guided CPVI is effective in reducing procedure time and additional touch-up ablation and may improve long-term outcome Background The aim of this study was to evaluate the impact of contact force ( CF ) visualization on the incidence of low and high CF during left atrial ( LA ) mapping and pulmonary vein isolation ( PVI ) . Methods CF was assessed in 70 patients who underwent PVI . Three highly experienced operators performed all procedures . The operators were blinded to CF in group A ( 35 patients ) , and CF was displayed in group B ( 35 patients ) . In group B , optimal CF was defined as mean CF between 10 and 39 g , and operators attempted to acquire points and ablate within this range . Results A total of 8401 mapping points were analyzed during LA mapping ( group A : 4104 , group B : 4297 ) . Low CF < 10 g and high CF ≥40 g were noted in a significantly larger number of points in group A ( 37.7 vs. 12.0 % , P < 0.001 ; 11.5 vs. 1.5 % , P < 0.001 ) . At the mitral isthmus and ridge areas , CF was significantly lower ( 7.7 vs. 12.2 g , P < 0.001 ; 5.3 vs. 11.7 g , P < 0.001 ) in group A than in group B. PVI was successfully achieved in all patients . There were significant site-dependent CF differences between the two groups . Optimal CF was achieved in significantly more applications in group B ( P < 0.001 ) . There was no significant difference in atrial fibrillation ( AF ) recurrence rates after a minimum follow-up of 1 year between the two groups in this cohort ( P = 0.24 ) . No significant peri-procedural complications occurred in either group . Conclusions CF visualization can assist in avoiding both low and high CF , which may have the potential to improve lesion formation and patient safety profile . In this study , CF-guided ablation did not affect AF recurrence Purpose We prospect ively investigated the differences in pulmonary vein reconnections ( PVRs ) and clinical outcomes between contact force (CF)-guided and conventional circumferential PV isolation ( CPVI ) of atrial fibrillation ( AF ) . Methods One hundred twenty consecutive AF patients ( 63 ± 10 years ; 88 males ) undergoing an initial CPVI were r and omized to ablation with a target CF of 20 g ( CF group ; n = 60 ) or that with operators blinded to the CF information ( blind group ; n = 60 ) . Results The CF group had fewer PVRs ( 0.67 ± 0.91/patient vs. 1.16 ± 1.16/patient ; P = 0.007 ) , a lower incidence of persistent PVRs ( 13.2 vs. 41.2 % ; P < 0.001 ) , and a shorter procedural time for the CPVI ( 50 vs. 56 min ; P = 0.019 ) than the blind group . The mean CF was higher in the CF group than the blind group ( 18.0 vs. 16.1 g ; P < 0.001 ) , with the most significant difference observed along the posterior right-sided PVs ( P-RPVs ) and anterior left-sided PVs ( A-LPVs ) . In logistic regression models , the mean CF was a negative predictor of PVRs along the P-RPVs and A-LPVs in the blind group ( odds ratios , 0.728 and 0.786 ; P < 0.001 and 0.007 ) , while no significant predictor was identified in the CF group OUTPUT:

CF-sensing catheter ablation of AF can reduce the incidence of major complications and generate better outcomes compared with NCF-sensing catheters during the 12-month follow-up period

MS2_dynamic_1_shot608

***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: 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 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 . INPUT: OBJECTIVE To show the possible effect of left- and right-side total hip arthroplasty ( THA ) on the ability to perform an emergency stop when driving a car . DESIGN Inception cohort . SETTING A driving simulator using an actual car cabin , specifically developed for the experiment , was used for testing driving ability . PARTICIPANTS Patients ( N=40 ; 20 left-side THA/20 right-side THA ) were tested preoperatively and in increments of 8 days and 6 , 12 , and 52 weeks after surgery . INTERVENTIONS Left- and right-side THA . MAIN OUTCOME MEASURES Reaction time , movement time , total brake response time ( TBRT ) , and maximum brake force . RESULTS Eight days postoperatively , measurements on driving performance indicated a slight worsening for all outcome parameters in patients after left-side THA and considerably more worsening in patients after right-side THA . For both patient groups , significant improvements in outcome measures were noted during the 1-year follow-up . Brake force declined significantly in patients with left-side THA ( P=.012 ) and in patients after right-side THA ( P<.001 ) . A total of 35 % of the patients with right-side THA and 15 % with left-side THA could not meet the 600 ms TBRT threshold 6 weeks postoperatively . CONCLUSIONS Most patients who underwent right-side THA reached their preoperative baseline 6 weeks after surgery . Most of the patients with left-side THA showed no TBRT limitations 8 days postoperatively . Because of the patients ' highly individual rehabilitation course and considering the possible consequences of the premature resumption of driving a motor vehicle , individual examination and recommendation are necessary Doctors are frequently asked by patients whether it is safe to drive with an upper limb immobilised in a cast . In the literature there are no objective measurements of the effects of upper-limb immobilisation upon driving performance . Eight healthy volunteers performed four 20-min driving circuits in a driving simulator ( STISIM 400W ) , circuits 1 and 4 without immobilisation and circuits 2 and 3 with immobilisation . Immobilisation involved a lightweight below-elbow cast with the thumb left free . Volunteers were r and omised to right or left immobilisation for circuit 2 , and the contralateral wrist was immobilised for circuit 3 . Circuits included urban and rural environments and specific hazards ( pedestrians crossing , vehicles emerging from a concealed entrance , traffic lights changing suddenly , avoidance of an oncoming vehicle in the driver 's carriageway ) . Limb immobilisation led to more cautious rural and urban driving , with less adjustment of speed and lateral road position than when unrestricted . However when responding to hazards immobilisation caused less safe driving , with higher speeds , a greater proximity to the hazard before action was taken and less steering adjustment . The effects of restriction upon performance were more prevalent and severe with right-arm immobilisation . Upper-limb immobilisation appears to have little effect on the ability to drive a car unchallenged , but to adversely affect responses to routine hazards . Advice on ability to drive safely should be cautious , as the impact of immobilisation appears to be more subtle and wide ranging than previously thought PROBLEM To develop appropriate assessment criteria to measure the performance of older drivers using an interactive PC-based driving simulator , and to determine which measures were associated with the occurrence of motor-vehicle crash . METHOD One hundred and twenty-nine older drivers residing in a metropolitan city volunteered to participate in this retrospective cohort study . Using the driving simulator , appropriate driving tasks were devised to test the older drivers , whose performances were assessed by 10 reliable assessment criteria . Logistic regression analysis was then undertaken to determine those criteria that influence the self-reported crash outcome . RESULTS As expected , driving skill of older drivers was found to decline with age . Over 60 % of the sample participants reported having at least one motor-vehicle crash during the past year . Adjusting for age in a logistic regression analysis , the cognitive abilities associated with the crash occurrence were working memory , decision making under pressure of time , and confidence in driving at high speed . SUMMARY The findings of this retrospective study indicated those individuals at inflated risk of vehicle crashes could be identified using the PC-based interactive driving simulator . Prospect i ve studies need to be undertaken to determine whether the driving simulator can predict future crash events . IMPACT ON INDUSTRY This study demonstrated an economical driving simulator approach to screen out problematic or unsafe older drivers before a more detailed but expensive road test is considered Patients undergoing total knee arthroplasty often ask when they can safely resume car driving . There is little evidence available on which physicians can rely when advising patients on this issue . In a prospect i ve study we assessed the brake response time of 24 patients admitted to the clinic for left total knee arthroplasty preoperatively and then 10 days after surgery . On each measurement day the patients performed two tasks , a simple and a complex brake response time task in a car simulator . Ten days after left TKA the brake response time for the simple task had decreased by 3.6 % ( p=0.24 ) , the reaction time by 3.1 % ( p=0.34 ) and the movement time by 6.6 % ( p=0.07 ) . However , the performance improvement was not statistically significant . Task complexity increased brake response time at both time points . A 5.8 % increase was significant ( p=0.01 ) at 10 days after surgery . Based on our results , we suggest that patients who have undergone left total knee arthroplasty may resume car driving 10 days after surgery as long as they drive a car with automatic transmission BACKGROUND The purpose of this study was to evaluate the effect of sling immobilization on driving performance with use of a driving simulator . METHODS This is a prospect i ve trial with a cohort of 21 healthy volunteers comparing their driving ability with and without sling immobilization on their dominant ( driving ) extremity . Multiple variables , including number of collisions , off OUTPUT:

Observer-reported outcome measures showed that patients ’ driving abilities often are impaired when wearing an immobilizing cast above or below the elbow or a shoulder sling on their dominant arm . Conclusions The available evidence provides a best-case scenario for when patients can return to driving . Survey data suggest that patients are returning to driving before observer-reported outcome measures have normalized , indicating that physicians should tell patients to wait longer before driving .

MS2_dynamic_1_shot609

***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: OBJECTIVE : To assess the acute metabolic and cardiovascular responses to walking exercise at an intensity corresponding to the heart rate of claudication pain onset and to investigate the effects of a 12-week walking training program at this intensity on walking capacity . METHODS : Twenty-nine patients with intermittent claudication were r and omly allocated to the walking training ( n = 17 ) or control ( CO , n = 12 ) group . The walking training group performed an acute exercise session comprising 15 × 2-min bouts of walking at the heart rate of claudication pain onset , with 2-min interpolated rest intervals . The claudication symptoms and cardiovascular and metabolic responses were evaluated . Walking training was then performed at the same intensity twice each week for 12 weeks , while the control group engaged in twice weekly stretching classes . The claudication onset distance and total walking distance were evaluated before and after the interventions . Brazilian Registry Clinical Trials : RBR-7M3D8W . RESULTS : During the acute exercise session , the heart rate was maintained within tight limits . The exercise intensity was above the anaerobic threshold and > 80 % of the heart rate peak and VO2peak . After the exercise training period , the walking exercise group ( n = 13 ) showed increased claudication onset distance ( 309±153 vs. 413±201 m ) and total walking distance ( 784±182 vs. 1,100±236 m ) compared to the control group ( n = 12 ) ( p<0.05 ) . CONCLUSION : Walking exercise prescribed at the heart rate of claudication pain onset enables patients with intermittent claudication to exercise with tolerable levels of pain and improves walking performance BACKGROUND This prospect i ve , r and omized controlled clinical trial determined whether an optimal exercise program length exists to efficaciously change claudication onset time ( COT ) and peak walking time ( PWT ) in patients with peripheral artery disease and claudication . METHODS The study r and omized 142 patients to supervised exercise ( n = 106 ) or a usual care control group ( n = 36 ) , with 80 completing the exercise program and 27 completing the control intervention . The exercise program consisted of intermittent walking to nearly maximal claudication pain 3 days per week . COT and PWT were the primary outcomes obtained from a treadmill exercise test at baseline and bimonthly during the study . RESULTS After exercise , changes in COT ( P < .001 ) and PWT ( P < .001 ) were consistently greater than changes after the control intervention . In the exercise program , COT and PWT increased from baseline to month 2 ( P < .05 ) and from months 2 to 4 ( P < .05 ) but did not significantly change from months 4 to 6 ( P > .05 ) . When changes were expressed per mile walked during the first 2 months , middle 2 months , and final 2 months of exercise , COT and PWT only increased during the first 2 months ( P < .05 ) . CONCLUSIONS Exercise-mediated gains in COT and PWT occur rapidly within the first 2 months of exercise rehabilitation and are maintained with further training . The clinical significance is that a relatively short 2-month exercise program may be preferred to a longer program to treat claudication because adherence is higher , costs associated with personnel and use of facilities are lower per patient , and more patients can be trained for a given amount of personnel time and re source utilization BACKGROUND In patients with intermittent claudication , a supervised walking exercise program increases peak exercise performance and community-based functional status . Patients with peripheral arterial disease also have muscle weakness in the affected extremity that may contribute to the walking impairment . However , the potential benefits of training modalities other than walking exercise , such as strength training , have not been critically evaluated in this patient population . The present study tested the hypothesis that a strength training program would be as effective as treadmill walking exercise and that combinations of strengthening and walking exercise would be more effective than either alone in improving exercise performance . METHODS AND RESULTS Twenty-nine patients with disabling claudication were r and omized to 12 weeks of supervised walking exercise on a treadmill ( 3 h/wk at a work intensity sufficient to produce claudication ) , strength training ( 3 h/wk of resistive training of five muscle groups of each leg ) , or a nonexercising control group . Grade d treadmill testing was performed to maximally tolerated claudication pain to define changes in peak exercise performance . After 12 weeks , patients in the treadmill training program had a 74 + /- 58 % increase in peak walking time as well as improvements in peak oxygen consumption ( VO2 ) and the onset of claudication pain . Patients in the strength-trained group had a 36 + /- 48 % increase in peak walking time but no change in peak VO2 or claudication onset time . Control subjects had no changes in any of these measures over the 12-week period . After the first 12 weeks , patients in the initial walking exercise group continued for 12 more weeks of supervised treadmill training . This result ed in an additional 49 + /- 53 % increase in peak walking time ( total of 128 + /- 99 % increase over the 24 weeks ) . After the initial 12 weeks , patients in the strength-trained group began 12 weeks of supervised treadmill training , and patients in the control group participated in a 12-week combined program of strengthening and treadmill walking exercise . The combined strength and treadmill training program and treadmill training after 12 weeks of strength training result ed in increases in peak exercise performance similar to those observed with 12 weeks of treadmill training alone . CONCLUSIONS A supervised treadmill walking exercise program is an effective means to improve exercise performance in patients with intermittent claudication , with continued improvement over 24 weeks of training . In contrast , 12 weeks of strength training OUTPUT: Subgroup analyses indicated that a lesser improvement in MWD was observed in the subgroup with more diabetes patients , and that the subgroup with better baseline walking ability exhibited greater improvement in walking performance . In addition , similar improvements in walking performance were observed for exercise programs of different duration s and modalities . Regardless of exercise length and modality , regularly intensive walking exercise improves walking ability in PAD patients more than usual care . The presence of diabetes may attenuate the improvements in walking performance in patients with PAD following exercise INPUT: BACKGROUND This prospect i ve , r and omized controlled clinical trial determined whether an optimal exercise program length exists to efficaciously change claudication onset time ( COT ) and peak walking time ( PWT ) in patients with peripheral artery disease and claudication . METHODS The study r and omized 142 patients to supervised exercise ( n = 106 ) or a usual care control group ( n = 36 ) , with 80 completing the exercise program and 27 completing the control intervention . The exercise program consisted of intermittent walking to nearly maximal claudication pain 3 days per week . COT and PWT were the primary outcomes obtained from a treadmill exercise test at baseline and bimonthly during the study . RESULTS After exercise , changes in COT ( P < .001 ) and PWT ( P < .001 ) were consistently greater than changes after the control intervention . In the exercise program , COT and PWT increased from baseline to month 2 ( P < .05 ) and from months 2 to 4 ( P < .05 ) but did not significantly change from months 4 to 6 ( P > .05 ) . When changes were expressed per mile walked during the first 2 months , middle 2 months , and final 2 months of exercise , COT and PWT only increased during the first 2 months ( P < .05 ) . CONCLUSIONS Exercise-mediated gains in COT and PWT occur rapidly within the first 2 months of exercise rehabilitation and are maintained with further training . The clinical significance is that a relatively short 2-month exercise program may be preferred to a longer program to treat claudication because adherence is higher , costs associated with personnel and use of facilities are lower per patient , and more patients can be trained for a given amount of personnel time and re source utilization BACKGROUND In patients with intermittent claudication , a supervised walking exercise program increases peak exercise performance and community-based functional status . Patients with peripheral arterial disease also have muscle weakness in the affected extremity that may contribute to the walking impairment . However , the potential benefits of training modalities other than walking exercise , such as strength training , have not been critically evaluated in this patient population . The present study tested the hypothesis that a strength training program would be as effective as treadmill walking exercise and that combinations of strengthening and walking exercise would be more effective than either alone in improving exercise performance . METHODS AND RESULTS Twenty-nine patients with disabling claudication were r and omized to 12 weeks of supervised walking exercise on a treadmill ( 3 h/wk at a work intensity sufficient to produce claudication ) , strength training ( 3 h/wk of resistive training of five muscle groups of each leg ) , or a nonexercising control group . Grade d treadmill testing was performed to maximally tolerated claudication pain to define changes in peak exercise performance . After 12 weeks , patients in the treadmill training program had a 74 + /- 58 % increase in peak walking time as well as improvements in peak oxygen consumption ( VO2 ) and the onset of claudication pain . Patients in the strength-trained group had a 36 + /- 48 % increase in peak walking time but no change in peak VO2 or claudication onset time . Control subjects had no changes in any of these measures over the 12-week period . After the first 12 weeks , patients in the initial walking exercise group continued for 12 more weeks of supervised treadmill training . This result ed in an additional 49 + /- 53 % increase in peak walking time ( total of 128 + /- 99 % increase over the 24 weeks ) . After the initial 12 weeks , patients in the strength-trained group began 12 weeks of supervised treadmill training , and patients in the control group participated in a 12-week combined program of strengthening and treadmill walking exercise . The combined strength and treadmill training program and treadmill training after 12 weeks of strength training result ed in increases in peak exercise performance similar to those observed with 12 weeks of treadmill training alone . CONCLUSIONS A supervised treadmill walking exercise program is an effective means to improve exercise performance in patients with intermittent claudication , with continued improvement over 24 weeks of training . In contrast , 12 weeks of strength training was less effective than 12 weeks of supervised treadmill walking exercise . Finally , strength training , whether sequential or concomitant , did not augment the response to a walking exercise program PURPOSE A pilot study was conducted to test the feasibility of supervised treadmill exercise training to improve functioning in study participants with peripheral arterial disease who did not have classical symptoms of intermittent claudication . METHODS For this study , 32 men and women with peripheral arterial disease but no symptoms of claudication were r and omized to exercise training or usual care . The intervention was a 12-week supervised treadmill walking program . Outcomes included 6-minute walk distance , maximum treadmill walking distance , and 4-meter walking velocity . Participant-reported community walking ability was measured with the Walking Impairment Question naire ( WIQ ) . Inflammatory blood factor levels also were measured . RESULTS Altogether , 25 participants who completed follow-up testing were included in intention-to-treat analyses . Of 24 participants ( 58 % ) r and omized to exercise , 14 completed the entire exercise training program . The participants r and omized to the intervention showed greater improvement in their WIQ walking speed score than the control subjects ( P = .05 ) . The participants r and omized to the intervention showed improvements in their 6-minute walk distance ( 1134 + /- 347 vs 1266 + /- 295 feet ; P = .03 ) , maximal treadmill walking distance ( 389 + /- 248 vs 585 + /- 293 feet ; P < .001 ) , WIQ distance score ( 52.3 + /- 29.1 vs 63.1 + /- 25.1 ; P = .0 OUTPUT:

SET was still beneficial for maximal and pain-free walking distances at 12 months , but it did not have a significant effect on quality of life parameters . AUTHORS ' CONCLUSIONS SET has statistically significant benefit on treadmill walking distance ( maximal and pain-free ) compared with non-supervised regimens .

MS2_dynamic_1_shot610

***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: BACKGROUND Neoadjuvant chemotherapy is widely used to downstage breast cancers before surgery and is an accepted st and ard of care among patients with early-stage breast cancer in whom adjuvant chemotherapy would be recommended . Pathologic complete response ( pCR ) rate is a robust predictor of outcome for certain breast cancer subtypes , including Her2-overexpressing breast cancer . The incorporation of Her2-targeted therapies has significantly increased the pCR rate in the neoadjuvant setting . Although regimens composed of trastuzumab , nab-paclitaxel , and vinorelbine have demonstrated clinical efficacy in patients with metastatic breast cancer , few studies have examined this combination in early-stage Her2 + breast cancer . We hypothesized that the combination of neoadjuvant nab-paclitaxel followed by vinorelbine could represent a nonanthracycline-based treatment option for early-stage Her2-overexpressing breast cancer . PATIENTS AND METHODS Patients received 4 cycles of nab-paclitaxel 260 mg/m(2 ) intravenously ( IV ) every 14 days for 4 cycles followed by vinorelbine 25 mg/m(2 ) IV weekly for 12 weeks with concurrent trastuzumab ( 4 mg/kg loading dose , and then 2 mg/kg/wk ) . The primary endpoint was the rate of pCR . Secondary endpoints included clinical response , toxicity , and survival rates . RESULTS A total of 27 patients were accrued to the trial . The median tumor size was 4.0 cm , and more than 50 % of patients had axillary lymph node involvement . The pCR rate was 48.1 % . Among the 40 % of patients who had hormone receptor-positive disease , the pCR rate was 18.2 % , compared with 68.8 % among patients with estrogen receptor/progesterone receptor-negative tumors . CONCLUSIONS The combination of trastuzumab with nab-paclitaxel followed by vinorelbine was well tolerated and had promising activity in the neoadjuvant setting Purpose : Tigatuzumab ( TIG ) , an agonistic anti-DR5 antibody , triggers apoptosis in DR5 + human tumor cells without crosslinking . TIG has strong in vitro/in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents . This study evaluates activity of TIG and chemotherapy in patients with metastatic triple-negative breast cancer ( TNBC ) . Experimental Design : R and omized 2:1 phase II trial of albumin-bound paclitaxel ( nab-PAC ) ± TIG in patients with TNBC stratified by prior chemotherapy . Patients received nab-PAC weekly × 3 ± TIG every other week , every 28 days . Primary objective was within-arm objective response rate ( ORR ) . Secondary objectives were safety , progression-free survival ( PFS ) , clinical benefit , and TIG immunogenicity . Metastatic research biopsies were required . Results : Among 64 patients ( 60 treated ; TIG/nab-PAC n = 39 and nab-PAC n = 21 ) , there were 3 complete remissions ( CR ) , 8 partial remissions ( PR ; 1 almost CR ) , 11 stable diseases ( SD ) , and 17 progressive diseases ( PD ) in the TIG/nab-PAC arm ( ORR , 28 % ) , and no CRs , 8 PRs , 4 SDs , and 9 PDs in the nab-PAC arm ( ORR , 38 % ) . There was a numerical increase in CRs and several patients had prolonged PFS ( 1,025 + , 781 , 672 , 460 , 334 ) in the TIG/nab-PAC arm . Grade 3 toxicities were 28 % and 29 % , respectively , with no grade 4–5 . Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm . Conclusions : ORR and PFS were similar in both . Pre clinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR5 agents . ROCK pathway activation merits further evaluation . Clin Cancer Res ; 21(12 ) ; 2722–9 . © 2015 AACR . See related article by Paoletti et al. , p. 136 Background : Nanoparticle Albumin-Bound Paclitaxel ( nab-PTX ) is a new solvent free taxane-based anticancer drug . According to CA024 trial , nab-PTX 100mg/m2 demonstrated superior response to docetaxel ( DTX ) in patients with metastatic breast cancer . Besides , nab-PTX 100mg/m2 was less toxicity . In operable breast cancer , GeparSepto study was reported that the pCR rate were significantly higher with nab-PTX 125/150 mg/m2 compared to paclitaxel . We planned the r and omized parallel design phase II trial to evaluate nab-PTX 100mg/m2 in early breast cancer . METHODS Stage II-III HER2-negative breast cancer patients were included in this trial and received either 4 cycles of DTX ( 75 mg/m2 day1 ) q 3 w or 4 cycles of nab-PTX ( 100 mg/m2 day1/8/15 ) q4w followed by 4 cycles of FE100C . The primary end point is pCR ( ypT0/is ypN0 ) rate , and the secondary end points are response rate , histological effect of treatment , breast conservation rate , and toxicity . RESULTS Between March 2011 to March 2014 , 152 eligible patients were enrolled at 6 centers ( 75 pts were allocated for nab-PTX ) . Baseline characteristics were well balanced ; OUTPUT: Adverse event profiles of nab-paclitaxel were generally similar to those reported from previous studies . Conclusions nab-Paclitaxel continues to demonstrate promising efficacy in breast cancer . Recent studies demonstrate high pathological complete response rates in early-stage breast cancer , particularly in triple-negative breast cancer , an area of high unmet need , and encouraging overall survival in metastatic breast cancer across doses and schedules . INPUT: Background Adjuvant treatment decision-making based on conventional clinical /pathological and prognostic single molecular markers or genomic signatures is a therapeutic area in which over-/under-treatment are still key clinical problems even though substantial and continuous improvement of outcome has been achieved over the past decades . Response to therapy is currently not considered in the decision-making procedure . ADAPT is one of the first new generation (neo)adjuvant trials dealing with individualization of (neo)adjuvant decision-making in early breast cancer and aims to establish early predictive surrogate markers , e.g. , Ki-67 , for therapy response under a short induction treatment in order to maximally individualize therapy and avoid unnecessary toxicity by ineffective treatment . Methods / design The prospect i ve , multi-center , controlled , non-blinded , r and omized , investigator initiated phase II/III ADAPT trial has an innovative “ umbrella ” protocol design . The “ umbrella ” is common for all patients , consisting of dynamic testing of early therapy response . ADAPT will recruit 4,936 patients according to their respective breast cancer subtype in four distinct sub-trials at 80 trial sites in Germany ; 4,000 patients with hormone receptor positive ( HR+ ) and HER2 negative disease will be included in the ADAPT HR+/HER2- sub-trial , where treatment decision is based on risk assessment and therapy response to induction therapy , and 380 patients will be included in ADAPT HER2+/HR+ . A further 220 patients will be included in ADAPT HER2+/HR- and 336 patients will be recruited for ADAPT Triple Negative . These three sub-trials focus on identification of early surrogate markers for therapy success in the neoadjuvant setting . Patients will be allocated to the respective sub-trial according to the result of their diagnostic core biopsy , as reported by local/ central pathology for HR and HER2 status . Discussion Recent trials , such as the GeparTrio , have shown that response-guided therapy using clinical response may improve outcome . For chemotherapy or HER2-targeted treatment , pathologic complete response in a neoadjuvant setting is an excellent predictor of outcome . For endocrine therapy , response to short induction treatment – as defined by decrease in tumor cell proliferation – strongly correlates with outcome . ADAPT now aims to combine static prognostic and dynamic predictive markers , focusing not just on single therapeutic targets , but also on general markers of proliferation and cell death . Biomarker analysis will help to optimize selection of subtype-specific treatment . Trial registration Clinical Trials.gov : ADAPT Umbrella : NCT01781338 ; ADAPT HR+/HER2- : NCT01779206 ; ADAPT HER2+/HR+ : NCT01745965 ; ADAPT HER2+/HR- : NCT01817452 ; ADAPT TN : NCT01815242 BACKGROUND Studies with pertuzumab , a novel anti-HER2 antibody , show improved efficacy when combined with the established HER2-directed antibody trastuzumab in breast cancer therapy . We investigated the combination of pertuzumab or trastuzumab , or both , with docetaxel and the combination of pertuzumab and trastuzumab without chemotherapy in the neoadjuvant setting . METHODS In this multicentre , open-label , phase 2 study , treatment-naive women with HER2-positive breast cancer were r and omly assigned ( 1:1:1:1 ) central ly and stratified by operable , locally advanced , and inflammatory breast cancer , and by hormone receptor expression to receive four neoadjuvant cycles of : trastuzumab ( 8 mg/kg loading dose , followed by 6 mg/kg every 3 weeks ) plus docetaxel ( 75 mg/m(2 ) , escalating , if tolerated , to 100 mg/m(2 ) every 3 weeks ; group A ) or pertuzumab ( loading dose 840 mg , followed by 420 mg every 3 weeks ) and trastuzumab plus docetaxel ( group B ) or pertuzumab and trastuzumab ( group C ) or pertuzumab plus docetaxel ( group D ) . The primary endpoint , examined in the intention-to-treat population , was pathological complete response in the breast . Neither patients nor investigators were masked to treatment . This study is registered with Clinical Trials.gov , number NCT00545688 . FINDINGS Of 417 eligible patients , 107 were r and omly assigned to group A , 107 to group B , 107 to group C , and 96 to group D. Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate ( 49 of 107 patients ; 45·8 % [ 95 % CI 36·1 - 55·7 ] ) compared with those given trastuzumab plus docetaxel ( group A ; 31 of 107 ; 29·0 % [ 20·6 - 38·5 ] ; p=0·0141 ) . 23 of 96 ( 24·0 % [ 15·8 - 33·7 ] ) women given pertuzumab plus docetaxel ( group D ) had a pathological complete response , as did 18 of 107 ( 16·8 % [ 10·3 - 25·3 ] ) given pertuzumab and trastuzumab ( group C ) . The most common adverse events of grade 3 or higher were neutropenia ( 61 of 107 women in group A , 48 of 107 in group B , one of 108 in group C , and 52 of 94 OUTPUT:

Longer trastuzumab duration ( hera : 2 years vs. 1 year ) showed no improvement in dfs or os and a higher rate of cardiac events . In the neoadjuvant setting ( neoaltto , GeparQuinto , Neosphere ) , trastuzumab alone or in combination with another anti-her2 agent ( lapatinib , pertuzumab ) was compared with either lapatinib or pertuzumab alone and showed superior or equivalent rates of pathologic complete response . In the adjuvant setting , lapatinib alone or in combination with trastuzumab , compared with trastuzumab alone ( altto ) or with placebo ( teach ) , was not superior in dfs .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE To evaluate the effectiveness of a worksite health promotion program on improving cardiovascular disease risk factors . METHODS In St Louis , Missouri from 2005 to 2006 , 151 employees ( 134 F , 17 M , 81 % overweight/obese ) participated in a cohort-r and omized trial comparing assessment s + intervention ( worksite A ) with assessment s only ( worksite B ) for 1 year . All participants received personal health reports containing their assessment results . The intervention was design ed to promote physical activity and favorable dietary patterns using pedometers , healthy snack cart , WeightWatchers(R ) meetings , group exercise classes , seminars , team competitions , and participation rewards . Outcomes included BMI , body composition , blood pressure , fitness , lipids , and Framingham 10-year coronary heart disease risk . RESULTS 123 participants , aged 45+/-9 yr , with BMI 32.9+/-8.8 kg/m(2 ) completed 1 year . Improvements ( P < or = 0.05 ) were observed at both worksites for fitness , blood pressure , and total- , HDL- , and LDL-cholesterol . Additional improvements occurred at worksite A in BMI , fat mass , Framingham risk score , and prevalence of the metabolic syndrome ; only the changes in BMI and fat mass were different between worksites . CONCLUSION A multi-faceted worksite intervention promoted favorable changes in cardiovascular disease risk factors , but many of the improvements were achieved with worksite health assessment s and personalized health reports in the absence of an intervention Background Worksite obesity prevention interventions using an ecological approach may hold promise for reducing typical weight gain . The purpose of this study was to examine the effectiveness of Go ! , an innovative 12-month multi-component worksite obesity prevention intervention . Methods A quasi-experimental non-equivalent control group design was utilized ; 407 eligible hospital employees ( intervention arm ) and 93 eligible clinic employees ( comparison arm ) participated . The intervention involved pedometer distribution , labeling of all foods in the worksite cafeteria and vending machines ( with calories , step equivalent , and a traffic light based on energy density signaling recommended portion ) , persuasive messaging throughout the hospital , and the integration of influential employees to reinforce healthy social norms . Changes in weight , BMI , waist circumference , physical activity , and dietary behavior after 6 months and 1 year were primary outcomes . Secondary outcomes included knowledge , perceptions of employer commitment to employee health , availability of information about diet , exercise , and weight loss , perceptions of coworker support and frequency of health discussion s with coworkers . A process evaluation was conducted as part of the study . Results Repeated measures ANCOVA indicated that neither group showed significant increases in weight , BMI , or waist circumference over 12 months . The intervention group showed a modest increase in physical activity in the form of walking , but decreases in fruit and vegetable servings and fiber intake . They also reported significant increases in knowledge , information , perceptions of employer commitment , and health discussion s with peers . Employees expressed positive attitudes towards all components of the Go ! intervention . Conclusions This low-intensity intervention was well-received by employees but had little effect on their weight over the course of 12 months . Such results are consistent with other worksite obesity prevention studies using ecological approaches . Implementing low-impact physical activity ( e.g. , walking , stair use ) may be more readily incorporated into the worksite setting than more challenging behaviors of altering dietary habits and increasing more vigorous forms of physical activity . Trial Registration This study was registered with clinical trials.gov ( NCT01585480 ) on April 24 , 2012 Background The work setting provides an opportunity to introduce overweight ( i.e. , Body Mass Index ≥ 25 kg/m2 ) adults to a weight management programme , but new approaches are needed in this setting . The main purpose of this study was to investigate the effectiveness of lifestyle counselling by phone or e-mail on body weight , in an overweight working population . Secondary purpose s were to establish effects on waist circumference and lifestyle behaviours , and to assess which communication method is the most effective . Methods A r and omized controlled trial with three treatments : intervention material s with phone counselling ( phone group ) ; a web-based intervention with e-mail counselling ( internet group ) ; and usual care , i.e. lifestyle brochures ( control group ) . The interventions used lifestyle modification and lasted a maximum of six months . Subjects were 1386 employees , recruited from seven companies ( 67 % male ; mean age 43 ( SD 8.6 ) y ; mean BMI 29.6 ( SD 3.5 ) kg/m2 ) . Body weight was measured by research personnel and by question naire . Secondary outcomes fat , fruit and vegetable intake , physical activity and waist circumference were assessed by question naire . Measurements were done at baseline and after six months . Missing body weight was multiply imputed . Results Body weight reduced 1.5 kg ( 95 % CI -2.2;-0.8 , p < 0.001 ) in the phone group and 0.6 kg ( 95 % CI -1.3 ; -0.01 , p = 0.045 ) in the internet group , compared with controls . In completers analyses , weight and waist circumference in the phone group were reduced with 1.6 kg ( 95 % CI -2.2;-1.0 , p < 0.001 ) and 1.9 cm ( 95 % CI -2.7;-1.0 , p < 0.001 ) respectively , fat intake decreased with 1 fatpoint ( 1 to 4 grams)/day ( 95 % CI -1.7;-0.2 , p = 0.01 ) and physical activity increased with 866 METminutes/week ( OUTPUT: Overall , moderate- to high-intensity behavioral strategies , using any mode of intervention delivery ( phone , face-to-face , or Internet ) , delivered by a trained professional were effective in improving weight-related outcomes . Environmental strategies were effective in improving healthier habits . Self-directed strategies worked better for motivated employees . Discussion : Multicomponent interventions offered in health care setting s may be successful in improving employee weight . INPUT: OBJECTIVE To evaluate the effectiveness of a worksite health promotion program on improving cardiovascular disease risk factors . METHODS In St Louis , Missouri from 2005 to 2006 , 151 employees ( 134 F , 17 M , 81 % overweight/obese ) participated in a cohort-r and omized trial comparing assessment s + intervention ( worksite A ) with assessment s only ( worksite B ) for 1 year . All participants received personal health reports containing their assessment results . The intervention was design ed to promote physical activity and favorable dietary patterns using pedometers , healthy snack cart , WeightWatchers(R ) meetings , group exercise classes , seminars , team competitions , and participation rewards . Outcomes included BMI , body composition , blood pressure , fitness , lipids , and Framingham 10-year coronary heart disease risk . RESULTS 123 participants , aged 45+/-9 yr , with BMI 32.9+/-8.8 kg/m(2 ) completed 1 year . Improvements ( P < or = 0.05 ) were observed at both worksites for fitness , blood pressure , and total- , HDL- , and LDL-cholesterol . Additional improvements occurred at worksite A in BMI , fat mass , Framingham risk score , and prevalence of the metabolic syndrome ; only the changes in BMI and fat mass were different between worksites . CONCLUSION A multi-faceted worksite intervention promoted favorable changes in cardiovascular disease risk factors , but many of the improvements were achieved with worksite health assessment s and personalized health reports in the absence of an intervention Background Worksite nutrition and physical activity interventions are important to help overweight and obese employees lose weight , but costs and insufficient sustained motivation prevent the majority of these programs from succeeding . Tailored text messaging in aiding weight management has been effective in several studies , but no studies have evaluated the effect of a tailored text message service on weight loss in a worksite health promotion program . Objective We studied the efficacy of a tailored text-messaging intervention for obese male participants in a worksite weight loss program of 6 months duration . Methods The study was an unblinded , r and omized controlled trial . Men with a body mass index greater than 25 kg/m2 were recruited from the Korea District Heating Corporation , the Korea Expressway Corporation , and the Korea Gas Corporation . The participants were identified by nurse managers . Participants were r and omly allocated to 1 of the following 2 groups for 24 weeks : ( 1 ) intervention group , which received tailored text message reminders every other day plus 4 offline education sessions and brief counseling with monthly weight check by nurses for weight control over 6 months and ( 2 ) control group , which received the 4 offline education sessions and brief counseling with monthly weight check by nurses about weight control over 6 months . The primary outcome was the difference in weight loss at 6 months . A mixed-model repeated- measures analysis was performed to evaluate the effect of the intervention group ’s weight loss compared with the control group . Results A total of 205 obese men were r and omized into either the intervention ( n=104 ) or the control group ( n=101 ) . At the end of 6 months , the intervention group ( n=63 ) had lost 1.71 kg ( 95 % CI –2.53 to –0.88 ) and the control group ( n=59 ) had lost 1.56 kg ( 95 % CI –2.45 to –0.66 ) ; the difference between the 2 groups was not significant ( mean difference –0.15 , 95 % CI –1.36 to 1.07 ) . At the end of the study , 60 % ( 34/57 ) of the intervention group rated the message program as helpful for weight control and 46 % ( 26/57 ) would recommend the text message service to their friends . Conclusions Tailored text message reminders did not have a significant effect on weight loss in obese men as part of a worksite weight loss program . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 39629189 ; http://www.is rct n.com/IS RCT N39629189?q=39629189&filters=&sort=&offset=1&total Results = 1&page=1&pageSize=10 & search Type = basic- search ( Archived by WebCite at http://www.webcitation.org/6VsFkwJH6 ) Background Young women are a group at high risk of weight gain . This study examined a range of perceived personal , social and environmental barriers to physical activity and healthy eating for weight maintenance among young women , and how these varied by socioeconomic status ( SES ) , overweight status and domestic situation . Methods In October-December 2001 , a total of 445 women aged 18–32 years , selected r and omly from the Australian electoral roll , completed a mailed self-report survey that included questions on 11 barriers to physical activity and 11 barriers to healthy eating ( relating to personal , social and environmental factors ) . Height , weight and socio-demographic details were also obtained . Statistical analyses were conducted mid-2003 . Results The most common perceived barriers to physical activity and healthy eating encountered by young women were related to motivation , time and cost . Women with children were particularly likely to report a lack of social support as an important barrier to physical activity , and lack of social support and time as important barriers to healthy eating . Perceived barriers did not differ by SES or overweight status . Conclusions Health promotion strategies aim ed at preventing weight gain should take into account the specific perceived barriers to physical activity and healthy eating faced by women in this age group , particularly lack of motivation , lack of time , and cost . Strategies targeting perceived lack of time and lack of social support are particularly required for young women with children AIMS To investigate a virtual assistance-based lifestyle intervention to reduce risk factors for Type OUTPUT:

Reduction in blood pressure , lipids and blood glucose was not statistically significant . Conclusions Workplace interventions significantly reduced body weight , BMI and waist circumference . Non-significant results for biochemical markers could be due to them being secondary outcomes in most studies .

MS2_dynamic_1_shot612

***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: 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 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 . 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 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 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 OUTPUT:

The overall results for modifiable risk factors suggested improvements in dietary and exercise outcomes but no overall effect on smoking outcomes .

MS2_dynamic_1_shot613

***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: C48.401-Ba cream , containing 0·05 % halomethasone * was compared in a double-blind between- patients trial with a cream containing 0·1 % betamethasone valerate * * in forty-eight patients suffering from atopic dermatitis and in thirty-nine patients suffering from seborrhoeic dermatitis . A similar comparison was made with ointments containing the same concentration of active ingredient in forty-six patients suffering from atopic dermatitis . Both ointments were also compared in a within-patient double-blind trial in thirty patients suffering from psoriasis . The analysis of the results showed that for the treatment of the above-mentioned dermatoses , both drugs , the cream as well as the ointment , are equally effective and well tolerated Seborrheic dermatitis ( SD ) , a common dermatosis associating hyperseborrhea , erythema , itching , and d and ruff , has frequent scalp involvement . Malassezia furfur infection seems to play an important role in the condition 's etiopathology . Treatment of SD usually consists of corticosteroids or antifungals , such as ketoconazole . The aim of this multicenter , r and omized , investigator-blinded , parallel-group pilot study was to evaluate the efficacy and safety of clobetasol propionate shampoo 0.05 % after different short-contact application times compared with its vehicle and ketoconazole foaming gel 2 % in the treatment of SD of the scalp . For 4 weeks , 55 subjects received one of the following treatments twice weekly : clobetasol propionate shampoo for 2.5 , 5 , or 10 minutes ; clobetasol propionate vehicle for 10 minutes ; or ketoconazole foaming gel for 5 minutes before rinsing off . Efficacy criteria included total severity score ( TSS ) and individual scores of signs such as itching and global improvement . Safety included reporting of burning , overall tolerance , and adverse events . Results showed that an application of clobetasol propionate for 5 and 10 minutes provided a similar mean percentage decrease of TSS , and the mean percentage decrease of TSS for all active groups was significantly superior to that of the vehicle ( P < .01 ) . Overall and local safety were good for all treatment groups . The present pilot study demonstrated that a short-contact application of clobetasol propionate shampoo is effective and safe in the treatment of SD of the scalp Sixty-two patients with seborrhoeic dermatitis were treated topically with a 2 % ketoconazole foaming gel or with a 0.05 % betamethasone dipropionate lotion in a single-blind study for 4 months . Changes in the number of Pityrosporum ovale were scored by a mycologist . The investigator rated the severity of erythema , scaling and itching of the patients ' scalp , eyelashes , nasolabial folds and thorax . In addition , both the investigator and the patients evaluated the treatments globally . At the end of treatment , the response rate for ketoconazole 2 % foaming gel was significantly higher than that for betamethasone dipropionate 0.05 % lotion according to the global evaluation by the physician ( 89 vs. 62 % , p less than 0.05 ) and the patient ( 89 vs. 65 % , p less than 0.05 ) . Ketoconazole was also superior to betamethasone with reference to the evolution of the symptoms , irrespective of their localization . This efficacy manifested itself by a significant reduction of the number of P. ovale on the scalp in the ketoconazole group ( p less than 0.001 ) compared to the betamethasone group , in which the count was hardly changed during therapy . The treatment was also better tolerated in the ketoconazole group ( 5 vs. 16 patients with side-effects , p less than 0.001 ) . It is concluded that ketoconazole 2 % foaming gel offers an excellent alternative to local corticosteroids in the treatment of seborrhoeic dermatitis The effectiveness of intermittent topical tacrolimus to prevent relapse in patients with stabilized facial seborrhoeic dermatitis has not been evaluated . The aim of this study was to determine whether proactive use of 0.1 % tacrolimus ointment can keep adult facial seborrhoeic dermatitis in remission . A total of 75 patients who had stabilized facial seborrhoeic dermatitis after 2 weeks ' ( open-label induction ) treatment with 0.1 % tacrolimus were r and omized in a double-blind fashion to treatment with 0.1 % tacrolimus once a week , twice a week , or vehicle twice a week , for 10 weeks ( maintenance ) . Significant improvement in erythema , scaling and pruritus compared with baseline was maintained during the maintenance phase in both tacrolimus groups , but not in the vehicle group . The mean recurrence rate according to global assessment was significantly higher in the tacrolimus once-weekly group than in the twice-weekly group . In conclusion , twice-weekly treatment with 0.1 % tacrolimus ointment had superior effects in keeping facial seborrhoeic dermatitis in remission Seventy-two patients with seborrheic dermatitis were treated once daily with 2 % ketoconazole cream ( n = 36 ) or 1 % hydrocortisone cream ( n = 36 ) on a double-blind basis for 4 weeks . For the global evaluation , no significant difference could be seen between the two groups . The clinical response was 80.5 % in the ketoconazole group and 94.4 % in the hydrocortisone group . For the different symptoms combined ( scaling , redness , itching , and papules ) , no significant difference was seen between the two groups when the total scores at week 2 and at week 4 were compared with the initial scores . The incidence of side effects in both groups was comparably low OUTPUT: We found mild ( class I and II ) and strong ( class III and IV ) steroids comparable in the assessed outcomes , including adverse events . Topical steroids are an effective treatment for seborrhoeic dermatitis of the face and scalp in adolescents and adults , with no differences between mild and strong steroids in the short-term . There is some evidence of the benefit of topical calcineurin inhibitor or lithium salt treatment . Treatment with azoles seems as effective as steroids concerning short-term total clearance , but in other outcomes , strong steroids were more effective . Calcineurin inhibitor and azole treatment appeared comparable . Lithium salts were more effective than azoles in producing total clearance . Steroids are similarly effective to calcineurin inhibitors but with less adverse effects . INPUT: Introduction 0.05 % betamethasone valerate cream is generally used as an alternative to circumcision for the treatment of phimosis in boys . The aim of this study is to determine whether the half-strength formula ( 0.025 % ) of betamethasone is as effective as 0.05 % betamethasone . Method All boys with phimosis seen at our institution between 2010 and 2012 , whose parents complained that their children had problems of micturition , i.e. , crying and ballooning , and sought for some instructions or treatments , were instructed to apply betamethasone valerate cream . Two strengths , 0.05 and 0.025 % , were r and omly applied to each patient twice a day for 2 months . The patients whose parents were not willing to the conservative treatment underwent circumcision . Results Of the 47 patients , 23 boys with an average age of 16.65 ± 4.052 months ( range 11–24 months ) were given 0.025 % betamethasone cream , whereas the remaining 24 boys in control group with an average age of 18.42 ± 5.030 months ( range 10–24 months ) were instructed to apply with 0.05 % betamethasone valerate cream . Using unpaired t test , the age in both groups were comparable ( p = 0.1932 ) . There was a decrease in phimosis grade by the end of the therapeutic course in both groups . Further analysis using Mann – Whitney test revealed that the phimosis grade in the half-strength group ( 0.025 % strength ) was significantly lower to the phimosis grade in the control ( 0.05 % betamethasone ) group ( p = 0.0003 ) . There was no diversion from steroid application to circumcision or any side effects in the both groups . Conclusions 0.025 % betamethasone valerate cream produced a clinical improvement . However , the half-strength formula was not effective as the conventional formula of 0.05 % betamethasone valerate cream PURPOSE To compare the efficacy of three different formulations containing Betamethasone Valerate versus placebo in the topical treatment of phimosis . As a secondary goal , we compared the outcomes after 30 and 60 days of treatment . MATERIAL S AND METHODS Two hundred twenty boys aged 3 to 10 years old with clinical diagnosis of phimosis were enrolled . Patients were r and omized to one of the following groups : Group 1 : Betamethasone Valerate 0.2 % plus Hyaluronidase ; Group 2 : Betamethasone Valerate 0.2 % ; Group 3 : Betamethasone Valerate 0.1 % or Group 4 : placebo . Parents were instructed to apply the formula twice a day for 60 days and follow-up evaluations were scheduled at 30 , 60 and 240 days after the first consultation . Success was defined as complete and easy foreskin retraction . RESULTS One hundred ninety-five patients were included at our final analysis . Group 1 ( N = 54 ) , 2 ( N = 51 ) and 3 ( N = 52 ) had similar success and improvement rates , all treatment groups had higher success rates than placebo ( N = 38 ) . After 60 days of treatment , total and partial response rates for Groups 1 , 2 and 3 were 54.8 % and 40.1 % , respectively , while placebo had a success rate of 29 % . Success and improvement rates were significantly better in 60 days when compared to 30 days . CONCLUSIONS Betamethasone Valerate 0.1 % , 0.2 % and 0.2 % in combination with Hyaluronidase had equally higher results than placebo in the treatment of phimosis in boys from three to ten years-old . Patients initially with partial or no response can reach complete response after 60 days of treatment PURPOSE To compare the efficacy and costs of circumcision versus topical treatment using a prospect i ve pharmacoeconomic protocol . MATERIAL S AND METHODS We treated 59 patients ( 3 - 10 years of age ) r and omized into two groups : 29 underwent an 8-week course of topical treatment with 0.2 % betamethasone-hyaluronidase cream twice a day ; and 30 underwent circumcision . Topical treatment success was defined as complete exposure of the glans . In cases of treatment failure , circumcision was performed and its cost imputed to that of the initial treatment . The pharmacoeconomic aspects were defined according to the Brazilian National Public Health System data base and the Brazilian Community Pharmacies Index . RESULTS The two groups were statistically similar for all clinical parameters evaluated . Topical treatment result ed in complete exposure of the glans in 52 % of the patients . Topical treatment was associated with preputial pain and hyperemia . However , treatment suspension was unnecessary . Minor complications were observed in 16.6 % of the surgical group patients . The mean cost per patient was US$ 53.70 and US$ 125.20 , respectively , for topical steroid treatment ( including the costs related to treatment failure ) and circumcision . The total costs were US$ 2,825.32 and US$ 3,885.73 for topical treatment and circumcision , respectively . CONCLUSIONS Topical treatment of phimosis can reduce costs by 27.3 % in comparison with circumcision . Therefore , topical treatment of phimosis should be considered prior to the decision to perform surgery Objectives Topical steroids have been advocated as an effective alternative treatment to circumcision in boys with phimosis . We evaluated the effectiveness of topical steroid therapy compared to a placebo neutral cream in 240 patients with phimosis . Methods A prospect i ve study was carried out over a 24-months period , on an out-patient basis on two OUTPUT:

Topical corticosteroids offer an effective alternative for treating phimosis in boys . Although sub optimal reporting among the included studies meant that the size of the effect remains uncertain , corticosteroids appear to be a safe , less invasive first-line treatment option before undertaking surgery to correct phimosis in boys

MS2_dynamic_1_shot614

***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: We conducted a prospect i ve , nested , case-control study of inflammatory markers as predictors of type 2 diabetes among 32,826 women who provided blood sample s in 1989 through 1990 in the Nurses ' Health Study . Among women free of diabetes , cardiovascular disease , or cancer at baseline , 737 had developed diabetes by 2000 . Control women ( n = 785 ) were selected matched on age , fasting status , race , and BMI for cases in the top BMI decile . Baseline levels of tumor necrosis factor (TNF)-alpha receptor 2 , interleukin (IL)-6 , and C-reactive protein ( CRP ) were significantly higher among case than control subjects ( all P < /= 0.001 ) . After adjusting for BMI and other lifestyle factors , all three biomarkers significantly predicted diabetes risk ; the odds ratios ( ORs ) comparing extreme quintiles were 1.64 ( 95 % CI 1.10 - 2.45 ) for TNF-alphaR2 , 1.91 ( 1.27 - 2.86 ) for IL-6 , and 4.36 ( 2.80 - 6.80 ) for CRP ( P for trend < 0.001 for all biomarkers ) . In a multivariate model simultaneously including the three biomarkers , only CRP levels were significantly associated with risk of diabetes ( OR comparing extreme quintiles of CRP = 3.99 , P for trend < 0.001 ) . These data support the role of inflammation in the pathogenesis of type 2 diabetes . Elevated CRP levels are a strong independent predictor of type 2 diabetes and may mediate associations of TNF-alphaR2 and IL-6 with type 2 diabetes Background —Indian Asians in the United Kingdom have increased coronary heart disease ( CHD ) mortality compared with European whites , but the causes are not well understood . Increased circulating concentrations of C-reactive protein ( CRP ) are an independent risk factor for CHD . Therefore , we investigated this marker of inflammation in healthy UK Indian Asian and European white men . Methods and Results —We measured serum CRP concentrations and conventional CHD risk factors in 1025 healthy male subjects ( 518 Indian Asians and 507 European whites ) aged 35 to 60 years who were recruited at r and om from general practitioner lists . The geometric mean CRP concentration was 17 % higher ( 95 % confidence interval , 3 % to 33 % ) in Indian Asians compared with European whites . CRP values were strongly associated with conventional CHD risk factors , measures of obesity , and metabolic disturbances associated with insulin resistance in both racial groups . The difference in CRP concentrations between Indian Asians and European whites remained after adjustment for conventional CHD risk factors but was eliminated by an adjustment for central obesity and insulin resistance score in Asians . On the basis of these results , we estimate that the processes underlying elevated CRP and /or increased CRP production itself are associated with an ≈14 % increase in population CHD risk among Indian Asians compared with European whites . Conclusions —CRP concentrations are higher in healthy Indian Asians than in European whites and are accounted for by greater central obesity and insulin resistance in Indian Asians . Our results suggest that inflammation or other mechanisms underlying elevated CRP values may contribute to the increased CHD risk among Indian Asians Background —C-reactive protein ( CRP ) has repeatedly been associated with blood pressure and prevalent and incident hypertension , but whether a causal link exists is uncertain . Methods and Results —We assessed the cross-sectional relations of CRP to systolic blood pressure , pulse pressure , and prevalent hypertension in a representative sample of > 3500 British women aged 60 to 79 years . For both outcomes , substantial associations were observed . However , these associations were greatly attenuated by adjustment for a wide range of confounding factors acting over the life course . We further investigated causality using a Mendelian r and omization approach by examining the association of the 1059G/C polymorphism in the human CRP gene with CRP and with blood pressure , pulse pressure , and hypertension . The polymorphism was associated with a robust difference in CRP , and the expectation would be for higher blood pressure and pulse pressure and greater prevalence of hypertension among those carrying the genetic variant associated with higher CRP levels . This was not observed , and the predicted causal effects of CRP on blood pressure , pulse pressure , and hypertension using instrumental variables methods were close to 0 , although with wide CIs . Conclusions —CRP levels are associated with blood pressure , pulse pressure , and hypertension , but adjustment for life course confounding and a Mendelian r and omization approach suggest the elevated CRP levels do not lead to elevated blood pressure BACKGROUND C-reactive protein ( CRP ) predicts risk of myocardial infa rct ion ( MI ) and stroke among apparently healthy men , but in women , virtually no data are available . METHODS AND RESULTS CRP was measured in baseline blood sample s from 122 apparently healthy participants in the Women 's Health Study who subsequently suffered a first cardiovascular event and from 244 age- and smoking-matched control subjects who remained free of cardiovascular disease during a 3-year follow-up period . Women who developed cardiovascular events had higher baseline CRP levels than control subjects ( P=0.0001 ) , such that those with the highest levels at baseline had a 5-fold increase in risk of any vascular event ( RR=4.8 ; 95 % CI , 2.3 to 10.1 ; P=0.0001 ) and a 7-fold increase in risk of MI or stroke ( RR=7.3 ; 95 % CI , 2.7 to 19.9 ; P=0.0001 ) . Risk estimates were independent of other risk factors , and prediction models OUTPUT: Conclusion Increasing poverty and non-white race was associated with elevated CRP levels among adults . INPUT: We conducted a prospect i ve , nested , case-control study of inflammatory markers as predictors of type 2 diabetes among 32,826 women who provided blood sample s in 1989 through 1990 in the Nurses ' Health Study . Among women free of diabetes , cardiovascular disease , or cancer at baseline , 737 had developed diabetes by 2000 . Control women ( n = 785 ) were selected matched on age , fasting status , race , and BMI for cases in the top BMI decile . Baseline levels of tumor necrosis factor (TNF)-alpha receptor 2 , interleukin (IL)-6 , and C-reactive protein ( CRP ) were significantly higher among case than control subjects ( all P < /= 0.001 ) . After adjusting for BMI and other lifestyle factors , all three biomarkers significantly predicted diabetes risk ; the odds ratios ( ORs ) comparing extreme quintiles were 1.64 ( 95 % CI 1.10 - 2.45 ) for TNF-alphaR2 , 1.91 ( 1.27 - 2.86 ) for IL-6 , and 4.36 ( 2.80 - 6.80 ) for CRP ( P for trend < 0.001 for all biomarkers ) . In a multivariate model simultaneously including the three biomarkers , only CRP levels were significantly associated with risk of diabetes ( OR comparing extreme quintiles of CRP = 3.99 , P for trend < 0.001 ) . These data support the role of inflammation in the pathogenesis of type 2 diabetes . Elevated CRP levels are a strong independent predictor of type 2 diabetes and may mediate associations of TNF-alphaR2 and IL-6 with type 2 diabetes Summary Vitamin D status was assessed in 142 elderly Dutchmen participating in a prospect i ve population -based study of environmental factors in the aetiology of non-insulin-dependent diabetes mellitus . Of the men aged 70–88 years examined between March and May 1990 , 39 % were vitamin D depleted . After adjustment for confounding by age , BMI , physical activity , month of sampling , cigarette smoking and alcohol intake the 1-h glucose and area under the glucose curve during a st and ard 75-g oral glucose tolerance test ( OGTT ) were inversely associated with the serum concentration of 25-OH vitamin D ( r = −0.23 , p < 0.01 ; r = −0.26 , p < 0.01 , respectively ) . After excluding newly diagnosed diabetic patients total insulin concentrations during OGTT were also inversely associated with the concentration of 25-OH vitamin D ( r = −0.18 to −0.23 , p < 0.05 ) . Hypovitaminosis D may be a significant risk factor for glucose intolerance . [ Diabetologia ( 1997 ) 40 : 344–347 To determine the relations of diet with risk of clinical noninsulin-dependent diabetes , we analyzed data from a prospect i ve cohort of 84360 US women . During 6 y of follow-up we identified 702 definite incident cases . Because body mass index ( BMI ) is a powerful risk factor for diabetes , we examined the relations of fat ( including type ) , fiber , sucrose , and other components of diet to risk of diabetes , among women with BMI s ( in kg/m2 ) less than 29 kg/m2 . After controlling for body mass index , previous weight change , and alcohol intake , we observed no associations between intakes of energy , protein , sucrose , carbohydrate , or fiber and risk of diabetes . Compared with women in the lowest quintile of energy-adjusted intake , and relative risks ( and tests for trend ) for those in the highest quintile were 0.61 ( P trend = 0.03 ) for vegetable fat , 0.62 ( P trend = 0.008 ) for potassium , 0.70 ( P trend = 0.005 ) for calcium , and 0.68 ( P trend = 0.02 ) for magnesium . These inverse associations were attenuated among obese women ( BMI s greater than or equal to 29 ) Vitamin D has been shown to increase insulin release from pancreatic islet cells in vitro , and to improve insulin secretion in vitamin D-deficient animals . Few attempts have been made to evaluate this issue directly in humans . We studied 35 otherwise healthy diabetic subjects in the early spring at the seasonal nadir of 25-hydroxyvitamin D [ 25(OH)D ] concentrations ( mean 35 + /- 7 nmol/L ) . Fasting glucose , insulin , C-peptide , and glucagon concentrations , and their responses to Sustacal stimulation were not related to indexes of mineral metabolism . In 20 subjects , a double-blinded , placebo-controlled , crossover trials of 1,25-dihydroxyvitamin D[1,25](OH)2D ] treatment ( 1 micrograms/d for 4 d ) had no effect on fasting or stimulated glucose , insulin , C-peptide , or glucagon concentrations . However , insulin and C-peptide responses to Sustacal after 1,25(OH)2D treatment were related to duration of diabetes ( r2 = 0.28 , P = 0.052 and r2 = 0.25 , P = 0.002 , respectively ) in that short duration correlated with improvement after 1,25(OH)2D treatment . Hence , vitamin D nutrition , or 1,25(OH OUTPUT:

Evidence from trials with vitamin D and /or calcium supplementation suggests that combined vitamin D and calcium supplementation may have a role in the prevention of type 2 DM only in population s at high risk ( i.e. glucose intolerance ) . Vitamin D and calcium insufficiency may negatively influence glycemia , whereas combined supplementation with both nutrients may be beneficial in optimizing glucose metabolism

MS2_dynamic_1_shot615

***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: BACKGROUND Postoperative delirium and cognitive decline are common in elderly surgical patients after non-cardiac surgery . Despite this prevalence and clinical importance , no specific aetiological factor has been identified for postoperative delirium and cognitive decline . In experimental setting in a rat model , nitrous oxide ( N(2)O ) produces neurotoxic effect at high concentrations and in an age-dependent manner . Whether this neurotoxic response may be observed clinical ly has not been previously determined . We hypothesized that in the elderly patients undergoing non-cardiac surgery , exposure to N(2)O result ed in an increased incidence of postoperative delirium than would be expected for patients not receiving N(2)O. METHODS Patients who were > or=65 yr of age , undergoing non-cardiac surgery and requiring general anaesthesia were r and omized to receive an inhalational agent and either N(2)O with oxygen or oxygen alone . A structured interview was conducted before operation and for the first two postoperative days to determine the presence of delirium using the Confusion Assessment Method . RESULTS A total of 228 patients were studied with a mean ( range ) age of 73.9 ( 65 - 95 ) yr . After operation , 43.8 % of patients developed delirium . By multivariate logistic regression , age [ odds ratio ( OR ) 1.07 ; 95 % confidence interval ( CI ) 1.02 - 1.26 ] , dependence on performing one or more independent activities of daily living ( OR 1.54 ; 95 % CI 1.01 - 2.35 ) , use of patient-controlled analgesia for postoperative pain control ( OR 3.75 ; 95 % CI 1.27 - 11.01 ) and postoperative use of benzodiazepine ( OR 2.29 ; 95 % CI 1.21 - 4.36 ) were independently associated with an increased risk for postoperative delirium . In contrast , the use of N(2)O had no association with postoperative delirium . CONCLUSIONS Exposure to N(2)O result ed in an equal incidence of postoperative delirium when compared with no exposure to OBJECTIVES To determine whether donepezil hydrochloride can reduce the prevalence and severity of delirium in older adults undergoing hip fracture repair . DESIGN Pilot double-masked r and omized placebo-controlled trial . SETTING Large academic medical center . PARTICIPANTS Sixteen individuals aged 70 and older with hip fracture . INTERVENTION Donepezil 5 mg or placebo was r and omly allocated and initiated within 24 hours of surgery , preoperatively or postoperatively . Daily treatment was continued for 30 days or until side effects or the clinical situation required termination . MEASUREMENTS All outcomes were ascertained masked to treatment status . Information on drug tolerability and safety was obtained from the participant , nurse , and medical record . Delirium presence and severity were measured during daily hospital interviews and at 2 , 4 , and 6 weeks after surgery after a st and ardized assessment using the Confusion Assessment Method ( CAM ) and the Memorial Delirium Assessment Scale ( MDAS ) . RESULTS Participants in the donepezil and placebo arms had similar baseline characteristics . Participants in the donepezil arm experienced significantly more side effects . In longitudinal models , there were no significant differences between the donepezil and placebo arms with regard to delirium presence over time ( odds ratio = 0.9 , 95 % confidence interval ( CI ) = 0.4 - 2.3 ) or delirium severity over time ( effect size = -0.2 on 30-point MDAS scale , 95%CI = -1.5 - 1.2 ) . CONCLUSION Participants r and omized to donepezil had no significant improvement in delirium presence or severity but experienced more side effects . Overall , sufficient evidence was not found from this pilot study to warrant a definitive Phase III trial Background and objectives : Postoperative confusion and delirium is a common complication in the elderly with a poorly understood pathophysiology . The aim of this study was to examine whether the type of anaesthesia ( general or regional ) plays a role in the development of cognitive impairment in elderly patients during the immediate postoperative period . Methods : Forty‐seven patients > 60 yr of age and undergoing major surgery were r and omly allocated to receive either regional or general anaesthesia . The mental status of the patients was assessed preoperatively and during the first three postoperative days with the Mini Mental State Examination . The incidence of delirium was also examined during the same period with the use of DSM III criteria . Results : Overall , during the first three postoperative days , the mean Mini Mental State Examination score decreased significantly ( P < 0.001 ) . However , this decline was very significant only in patients assigned to receive general anaesthesia ( P < 0.001 ) compared to regional anaesthesia . Nine patients developed delirium but the type of anaesthesia did not affect its incidence . The only important factor for the development of delirium was pre‐existing cardiovascular disease irrespective of anaesthesia type ( P < 0.025 ) . Conclusions : Elderly patients subjected to general anaesthesia displayed more frequent cognitive impairment during the immediate postoperative period in comparison to those who received a regional technique OBJECTIVE To determine whether limiting intraoperative sedation depth during spinal anesthesia for hip fracture repair in elderly patients can decrease the prevalence of postoperative delirium . PATIENTS AND METHODS We performed a double-blind , r and omized controlled trial at an academic medical center of elderly patients ( > or=65 years ) without preoperative delirium or severe dementia who underwent hip fracture repair under spinal anesthesia with propofol OUTPUT: This meta- analysis has shown that peri-operative geriatric consultations with multicomponent interventions and lighter anaesthesia are potentially effective in decreasing the incidence of postoperative delirium INPUT: Background Postoperative delirium can result in increased postoperative morbidity and mortality , major dem and for postoperative care and higher hospital costs . Hypnotics serve to induce and maintain anaesthesia and to abolish patients ' consciousness . Their persisting clinical action can delay postoperative cognitive recovery and favour postoperative delirium . Some evidence suggests that these unwanted effects vary according to each hypnotic 's specific pharmacodynamic and pharmacokinetic characteristics and its interaction with the individual patient . We design ed this study to evaluate postoperative delirium rate after general anaesthesia with various hypnotics in patients undergoing surgical procedures other than cardiac or brain surgery . We also aim ed to test whether delayed postoperative cognitive recovery increases the risk of postoperative delirium . Methods / Design After local ethics committee approval , enrolled patients will be r and omly assigned to one of three treatment groups . In all patients anaesthesia will be induced with propofol and fentanyl , and maintained with the anaesthetics desflurane , or sevoflurane , or propofol and the analgesic opioid fentanyl . The onset of postoperative delirium will be monitored with the Nursing Delirium Scale every three hours up to 72 hours post anaesthesia . Cognitive function will be evaluated with two cognitive test batteries ( the Short Memory Orientation Memory Concentration Test and the Rancho Los Amigos Scale ) preoperatively , at baseline , and postoperatively at 20 , 40 and 60 min after extubation . Statistical analysis will investigate differences in the hypnotics used to maintain anaesthesia and the odds ratios for postoperative delirium , the relation of early postoperative cognitive recovery and postoperative delirium rate . A subgroup analysis will be used to categorize patients according to demographic variables relevant to the risk of postoperative delirium ( age , sex , body weight ) and to the preoperative score index for delirium . Discussion The results of this comparative anaesthesiological trial should whether each the three hypnotics tested is related to a significantly different postoperative delirium rate . This information could ultimately allow us to select the most appropriate hypnotic to maintain anaesthesia for specific subgroups of patients and especially for those at high risk of postoperative delirium . Registered at Trial.gov Number Clinical Trials.gov : OBJECTIVES There are conflicting reports on the influence of different anesthetic techniques , such as regional versus general anesthesia , on intraoperative blood loss . The purpose of this study was to eluci date the effects of anesthetic technique on intraoperative blood loss in men undergoing radical retropubic prostatectomy ( RRP ) . METHODS One hundred patients undergoing RRP for prostate cancer were r and omly assigned to receive either epidural anesthesia ( EA ) , combined epidural and general anesthesia ( EG ) , or general anesthesia alone ( GA ) . Intraoperative blood loss was calculated by using a formula that accounted for the volume and hematocrit of the fluid suctioned from the surgical field , blood absorbed on surgical pads , and the patient 's hematocrit . RESULTS Mean blood loss in the EA group ( 1490 + /- 90 mL ; mean + /- SEM ) was significantly less than mean blood loss in both the EG group ( 1810 + /- 100 mL ) and the GA group ( 1940 + /- 130 mL ) ( P = 0.01 ) . Blood loss was not different between the EG and the GA groups ( P = 0.7 ) . Significantly less blood was transfused during surgery in the EA group ( 730 + /- 50 mL ) compared with the EG ( 960 + /- 60 mL ) and GA ( 950 + /- 70 mL ) groups ( P = 0.02 ) . CONCLUSIONS Similar blood loss in patients receiving general anesthesia , either alone or when combined with epidural anesthesia , implies that epidural anesthesia did not reduce bleeding , but , rather , that general anesthesia increased blood loss One hundred and fifty patients who presented for transurethral prostatectomy were r and omly allocated to one of three groups for the purpose of anaesthesia . Group A received spinal intradural analgesia , Group B general anaesthesia with spontaneous ventilation and Group C general anaesthesia with controlled ventilation . The comparability of the three groups was established Peroperative blood loss , arterial blood pressure and central venous pressure were studied in patients subjected to retropubic prostatectomy . The patients were r and omly allocated to two groups , continuous lumbar epidural analgesia for up to 24 hours and a thiopentone-oxyg n-nitrous oxide-alcuronium-pethidine sequence with intermittent positive pressure ventilation . The mean peroperative blood loss during operations under epidural analgesia was significantly less than that under general anaesthesia ( 370±34 ml vs. 590∓35 ml , mean ∓SE ) . Only one patient out of 17 cases of epidural analgesia needed a peroperative blood transfusion , in contrast to 5 out of 21 general anaesthesias . Both the arterial systolic and diastolic pressures , and central venous pressure were significantly lower under epidural analgesia than general anaesthesia . It was concluded that decreased arterial and venous pressure were responsible for the reduced blood loss under epidural analgesia Purpose Radical prostatectomy is associated with substantial blood loss frequently requiring allogeneic blood transfusion . We investigated the efficacy of deliberate hypotension using combined epidural/general anesthesia in reducing allogeneic transfusion requirements in patients undergoing radical prostatectomy . Methods In a prospect i ve , r and omized , single-blind trial , 102 patients undergoing radical prostatectomy were allocated to OUTPUT:

At the moment , the evidence available can not prove that neuraxial anesthesia is more effective and safer than general anesthesia for urological surgery . There were insufficient data to pool the results relating to mortality , stroke , myocardial infa rct ion , length of hospitalization , quality of life , degree of satisfaction , postoperative cognitive dysfunction and blood transfusion requirements

MS2_dynamic_1_shot616

***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: The purpose of this study was to develop a new two-regression model relating Actigraph activity counts to energy expenditure over a wide range of physical activities . Forty-eight participants [ age 35 yr ( 11.4 ) ] performed various activities chosen to represent sedentary , light , moderate , and vigorous intensities . Eighteen activities were split into three routines with each routine being performed by 20 individuals , for a total of 60 tests . Forty-five tests were r and omly selected for the development of the new equation , and 15 tests were used to cross-vali date the new equation and compare it against already existing equations . During each routine , the participant wore an Actigraph accelerometer on the hip , and oxygen consumption was simultaneously measured by a portable metabolic system . For each activity , the coefficient of variation ( CV ) for the counts per 10 s was calculated to determine whether the activity was walking/running or some other activity . If the CV was < or=10 , then a walk/run regression equation was used , whereas if the CV was > 10 , a lifestyle/leisure time physical activity regression was used . In the cross-validation group , the mean estimates using the new algorithm ( 2-regression model with an inactivity threshold ) were within 0.75 metabolic equivalents ( METs ) of measured METs for each of the activities performed ( P > or= 0.05 ) , which was a substantial improvement over the single-regression models . The new algorithm is more accurate for the prediction of energy expenditure than currently published regression equations using the Actigraph accelerometer BACKGROUND Risk stratification of patients with end-stage congestive heart failure is a critical component of the transplant c and i date selection process . Accurate identification of individuals most likely to survive without a transplant would facilitate more efficient use of scarce donor organs . METHODS AND RESULTS Multivariable proportional hazards survival models were developed with the use of data on 80 clinical characteristics from 268 ambulatory patients with advanced heart failure ( derivation sample ) . Invasive and noninvasive models ( with and without catheterization-derived data ) were constructed . A prognostic score was determined for each patient from each model . Stratum-specific likelihood ratios were used to develop three prognostic-score risk groups . The models were prospect ively vali date d on 199 similar patients ( validation sample ) by calculation of the area under the receiver operating characteristic curve for 1-year event-free survival , the censored c-index for event-free survival , and comparison of event-free survival curves for prognostic-score risk strata . Outcome events were defined as urgent transplant or death without transplant . The noninvasive model performed well in both sample s , and increased performance was not attained by the addition of catheterization-derived variables . Prognostic-score risk groups derived from the noninvasive model in the derivation sample effectively stratified the risk of an outcome event in both sample s ( 1-year event-free survival for derivation and validation sample s , respectively : low risk , 93 % and 88 % ; medium risk , 72 % and 60 % ; high risk , 43 % and 35 % ) . CONCLUSIONS Selection of c and i date s for cardiac transplantation may be improved by use of this noninvasive risk-stratification model PURPOSE The purpose of this study was to use an accelerometer to measure daily walking performance in patients with chronic heart failure ( CHF ) to investigate if this parameter is a determinant of New York Heart Association class and indicative of maximal and functional exercise capacity . METHODS Fifty patients with CHF were instructed to wear an accelerometer for 7 consecutive days while going about their daily business . Maximal and functional exercise capacity was assessed by cardiopulmonary ( VO(2peak ) ) and 6-minute walk testing , respectively . RESULTS Patients in New York Heart Association I , II , and III reached an average total walking time ( TWT ) of 160.6 + /- 35.8 minutes , 133.9 + /- 59.0 minutes , and 76.1 + /- 22.5 minutes per day of which 19 % , 19 % , and 9 % where spent in the fast walking mode ( > 83 m/minute ) , respectively . The TWT correlated strongly with VO(2peak ) ( r = 0.72 ; P < .001 ) and 6-minute walk testing distance ( r = 0.68 ; P < .001 ) . The TWT and time spent in fast walking mode were the strongest determinants in discriminating moderate CHF . CONCLUSION Daily walking performance is a clear determinant of maximal and functional exercise capacities in patients with CHF . Walking intensity in particular is an independent predictor in discriminating patients with advanced heart failure . Monitoring of daily walking performance might aid in detecting disease progression and improve clinical outcome Background Physical activity has not been objective ly measured in prospect i ve cohorts with sufficiently large numbers to reliably detect associations with multiple health outcomes . Technological advances now make this possible . We describe the methods used to collect and analyse accelerometer measured physical activity in over 100,000 participants of the UK Biobank study , and report variation by age , sex , day , time of day , and season . Methods Participants were approached by email to wear a wrist-worn accelerometer for seven days that was posted to them . Physical activity information was extracted from 100Hz raw triaxial acceleration data after calibration , removal of gravity and sensor noise , and identification of wear / non-wear episodes . We report age- and sex-specific wear-time compliance and accelerometer measured physical activity , overall and by hour-of-day , week-weekend day and season . Results 103,712 data sets were received ( 44.8 % response ) , with a median wear-time of 6.9 days ( IQR:6.5–7.0 ) . 96,600 participants ( 93.3 % ) provided valid data for physical activity analyses . Vector magnitude , a proxy for overall physical activity , was 7.5 % ( 2.35 mg ) lower per decade of age OUTPUT: Overall , AQPA showed a strong inverse relationship with mortality and predictive utility when combined with established risk scores , and prognostic roles in morbidity , predicting cognitive function , New York Heart Association functional class and intercurrent events ( e.g. hospitalisation ) , but weak relationships with health-related quality of life scores . AQPA has a strong prognostic role in CHF . Big data and machine learning strategies will potentially yield better predictive value of AQPA in CHF patients INPUT: Purpose We performed a study to determine the best appropriate wearing site of a triaxial accelerometer at different exercise speeds . Material s and Methods We conducted an observational study with 66 healthy Korean adults ( 26 men and 40 women ) . Resting metabolic rate ( RMR ) before exercise , physical activity-related energy expenditure ( PAEE ) by cardiorespiratory gas analyzer and Signal Vector Magnitude ( SVM ) were measured while wearing four triaxial accelerometers on four different sites ( wrist , waist , upper arm , and ankle ) at exercise speeds from 2 - 10 km/h . Results The mean RMR was 4.03 mL/kg/min and Actual METs ( oxygen consumption at different exercise speeds divided by individual RMR ) compared with the calculated METs ( oxygen consumption divided by 3.5 mL/kg/min ) showed relatively low value . The overall correlation between PAEE and SVM was highest when the accelerometer was worn on the wrist at low exercise speed ( r=0.751 , p<0.001 ) , waist at a moderate speed ( r=0.821 , p<0.001 ) , and ankle at a high speed ( r=0.559 , p<0.001 ) . Using regression analysis , it was shown that the ankle at a low speed ( R2=0.564 , p<0.001 ) , high speed ( R2=0.559 , p<0.001 ) , and the waist at a moderate speed ( R2=0.821 , p<0.001 ) were the best appropriate sites . Conclusion When measuring the PAEE and SVM at different exercise speeds , the ankle in low and high exercise speed , and waist in moderate speed are the most appropriate sites for an accelerometer Background We hypothesized that a fully automated mobile health ( mHealth ) intervention with tracking and texting components would increase physical activity . Methods and Results mActive enrolled smartphone users aged 18 to 69 years at an ambulatory cardiology center in Baltimore , Maryl and . We used sequential r and omization to evaluate the intervention 's 2 core components . After establishing baseline activity during a blinded run‐in ( week 1 ) , in phase I ( weeks 2 to 3 ) , we r and omized 2:1 to unblinded versus blinded tracking . Unblinding allowed continuous access to activity data through a smartphone interface . In phase II ( weeks 4 to 5 ) , we r and omized unblinded participants 1:1 to smart texts versus no texts . Smart texts provided smartphone‐delivered coaching 3 times/day aim ed at individual encouragement and fostering feedback loops by a fully automated , physician‐written , theory‐based algorithm using real‐time activity data and 16 personal factors with a 10 000 steps/day goal . Forty‐eight out patients ( 46 % women , 21 % nonwhite ) enrolled with a mean±SD age of 58±8 years , body mass index of 31±6 kg/m2 , and baseline activity of 9670±4350 steps/day . Daily activity data capture was 97.4 % . The phase I change in activity was nonsignificantly higher in unblinded participants versus blinded controls by 1024 daily steps ( 95 % confidence interval [ CI ] , −580 to 2628 ; P=0.21 ) . In phase II , participants receiving texts increased their daily steps over those not receiving texts by 2534 ( 95 % CI , 1318 to 3750 ; P<0.001 ) and over blinded controls by 3376 ( 95 % CI , 1951 to 4801 ; P<0.001 ) . Conclusions An automated tracking‐texting intervention increased physical activity with , but not without , the texting component . These results support new mHealth tracking technologies as facilitators in need of behavior change drivers . Clinical Trial Registration URL : http:// Clinical Trials.gov/. Unique identifier : NCT01917812 Purpose : The SenseWear ™ Armb and is an activity monitor developed to improve lifestyle self-monitoring . Currently , few studies assess electronic self-monitoring and weight loss with a lifestyle intervention program . To our knowledge , only one study has used the SenseWear Armb and in combination with a lifestyle intervention to improve weight loss , and no studies have evaluated whether a self-monitoring intervention based solely on the armb and can promote weight loss . Consequently , the aims of the study were to assess weight loss from electronic self-monitoring , to compare these values to the lifestyle intervention and st and ard care groups , and to compare weight loss with lifestyle intervention with and without the armb and . Patients and methods : We recruited 197 sedentary overweight or obese adults ( age , 46.8 ± 10.8 years ; BMI , 33.3 ± 5.2 kg/m2 ) to participate in the 9-month study . Participants were r and omized into one of four weight loss groups : 1 ) the st and ard care group received a self-directed weight loss program , complete with an evidence -based weight loss manual ( st and ard care , n = 50 ) ; 2 ) a 14-week group-based behavioral weight loss program followed by weekly , biweekly , and monthly telephone counseling calls ( GWL , n = 49 ) ; 3 ) the use of the armb and to help improve lifestyle self-monitoring ( SWA alone , n = 49 ) ; or ( 4 ) the group-based behavioral weight loss program and follow-up telephone counseling calls plus the armb and ( GWL + SWA , n = 49 ) . All participants received the evidence -based weight loss manual at baseline . All measures were performed at baseline and months 4 and 9 . The primary outcomes were weight loss and waist circumference reduction . Results : This study is a well- design ed OUTPUT:

CONCLUSIONS Utilizing a consumer-based wearable activity tracker as either the primary component of an intervention or as part of a broader physical activity intervention has the potential to increase physical activity participation .

MS2_dynamic_1_shot617

***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: Background and Purpose — This study compared the psychometric properties of 3 clinical balance measures , the Berg Balance Scale ( BBS ) , the Balance subscale of the Fugl-Meyer test ( FM-B ) , and the Postural Assessment Scale for Stroke Patients ( PASS ) , in stroke patients with a broad range of neurological and functional impairment from the acute stage up to 180 days after onset . Methods — One hundred twenty-three stroke patients were followed up prospect ively with the 3 balance measures 14 , 30 , 90 , and 180 days after stroke onset ( DAS ) . Reliability ( interrater reliability and internal consistency ) and validity ( concurrent validity , convergent validity , and predictive validity ) of each measure were examined . A comparison of the responsiveness of each of the 3 measures was made on the basis of the entire group of patients and 3 separate groups classified by degree of neurological severity . Results — The FM-B and BBS showed a significant floor or ceiling effect at some DAS points , whereas the PASS did not show these effects . The BBS , FM-B , and PASS all had good reliability and validity for patients at different recovery stages after stroke . The results of effect size demonstrated fair to good responsiveness of all 3 measures within the first 90 DAS but , as expected , only a low level of responsiveness at 90 to 180 DAS . The PASS was more responsive to changes in severe stroke patients at the earliest period after stroke onset , 14 to 30 DAS . Conclusions — All 3 measures tested showed very acceptable levels of reliability , validity , and responsiveness for both clinicians and research ers . The PASS showed slightly better psychometric characteristics than the other 2 measures Objective The primary objective of this study was to develop a quantitative test to assess ambulation in multiple sclerosis ( MS ) patients that is more accurate and sensitive than the Timed 25-foot walk ( T25FW ) . For this purpose , we developed the Six Spot Step Test ( SSST ) , which besides speed includes co-ordination and balance , to be a lower limb counterpart to the 9-Hole Peg Test ( 9HPT ) . Background The T25FW , which is the ambulation test of the MS Functional Composite ( MSFC ) , reflects only the speed component of walking . The lack of sensitivity to other components of gait adds to the floor effect . Methods and patients In the SSST , the patient is instructed to walk as quickly as possible from one end to the other of a rectangular field measuring 1 × 5 m , while kicking five cylinder blocks out of five circles marked on the floor . Some 151 MS patients with the Exp and ed Disability Status Scale ( EDSS ) score 0 - 6.5 and 64 normal controls performed the SSST and the T25FW . In addition , 41 patients performed the tests twice . Results The range of the SSST ( 4.7 - 35.1 seconds ) was wider than that of the T25FW ( 3.5 - 22.6 seconds ) . Using control mean+ 2 SD as cut off , 107 patients had abnormal SSST , while 100 patients had abnormal T25FW . The T25FW ( mean ) increased 2.1 seconds over the EDSS range of 0 - 4.0 , while the SSST increased 4.9 seconds . The intra-class correlation between repeated tests ( r ) was 0.95 for the SSST and 0.96 for the T25FW . The correlation between the SSST and the T25FW was high ( r=0.92 ) . Conclusion The SSST seems to be superior to the T25FW in terms of dynamic range , floor effect and discriminatory power . The SSST is a relevant alternative for the T25FW as the ambulation component of the MSFC Background The COSMIN checklist is a tool for evaluating the method ological quality of studies on measurement properties of health-related patient-reported outcomes . The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist ( n = 114 ) . Methods 75 articles evaluating measurement properties were r and omly selected from the bibliographic data base compiled by the Patient-Reported Outcome Measurement Group , Oxford , UK . Raters were asked to assess the method ological quality of three articles , using the COSMIN checklist . In a one-way design , percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item . Results 88 raters participated . Of the 75 selected articles , 26 articles were rated by four to six participants , and 49 by two or three participants . Overall , percentage agreement was appropriate ( 68 % was above 80 % agreement ) , and the kappa coefficients for the COSMIN items were low ( 61 % was below 0.40 , 6 % was above 0.75 ) . Reasons for low inter-rater agreement were need for subjective judgement , and accustom to different st and ards , terminology and definitions . Conclusions Results indicated that raters often choose the same response option , but that it is difficult on item level to distinguish between articles . When using the COSMIN checklist in a systematic review , we recommend getting some training and experience , completing it by two independent raters , and reaching consensus on one final rating . Instructions for using the checklist are improved Background and Purpose — This study compared the validity , responsiveness , and interrater reliability of 3 mobility measures in stroke patients from the acute stage up to 180 days after stroke onset . The 3 measures were the Rivermead Mobility Index ( RMI ) , a modified RMI ( MRMI ) , and the Mobility Subscale of the Stroke Rehabilitation Assessment of Movement ( STREAM ) . Methods — The validity and responsiveness of the 3 mobility measures were prospect ively examined by monitoring 57 stroke patients with the measures and the Barthel Index at 14 , 30 , 90 , and 180 days after stroke onset . Two individual raters used the 3 measures to evaluate a different sample of 4 OUTPUT: Results / Discussion : Based on survey results , the CPG focuses on OMs that have acceptable clinical utility and can be used to assess change over time in a patient 's balance , gait , transfers , and patient-stated goals . Strong , level I evidence supports the use of the Berg Balance Scale to assess changes in static and dynamic sitting and st and ing balance and the Activities-specific Balance Confidence Scale to assess changes in balance confidence . Strong to moderate evidence supports the use of the Functional Gait Assessment to assess changes in dynamic balance while walking , the 10 meter Walk Test to assess changes in gait speed , and the 6-Minute Walk Test to assess changes in walking distance . Best practice evidence supports the use of the 5 Times Sit-to-St and to assess sit to st and ing transfers . Evidence was insufficient to support use of a specific OM to assess patient-stated goals across adult neurologic conditions . INPUT: Background The Berg Balance Scale ( BBS ) is a balance measure commonly used for people with multiple sclerosis ( MS ) . The Mini-BESTest is an alternative based on balance systems . Objective The study objective was to compare the BBS and the Mini-BESTest for sensitivity to change , likelihood ratios for walking aid use and falls , and associations with clinical variables in people who have MS and are ambulatory . Design This was a cohort study with measurements before and after exposure to 8 weeks of routine physical therapy intervention . Methods For 52 participants who had a primary diagnosis of MS and who were independently mobile , with or without an aid , demographic details and a history of falls and near falls were collected . Participants completed the Mini-BESTest , Multiple Sclerosis Impact Scale-29 , Multiple Sclerosis Walking Scale-12 , BBS , Modified Fatigue Impact Scale , and Six-Minute Walk Test . Results No participant started with a baseline Mini-BESTest maximum score of 28 , whereas 38.5 % ( n=20 ) started with a baseline BBS maximum score of 56 . Statistically significant changes in the Mini-BESTest score ( X̅=5.31 , SD=3.5 ) and the BBS score ( X̅=1.4 , SD=1.9 ) were demonstrated . Effect sizes for the Mini-BESTest and the BBS were 0.70 and 0.37 , respectively ; st and ard response means for the Mini-BESTest and the BBS were 1.52 and 0.74 , respectively . Areas under the receiver operating characteristic curves for the Mini-BESTest and the BBS were 0.88 and 0.77 , respectively , for detecting mobility device use and 0.88 and 0.75 , respectively , for detecting self-reported near falls . The Mini-BESTest had a higher correlation for each secondary measure than did the BBS . Limitations This study involved a sample of convenience ; 61 % of the participants did not use a walking aid . The order of testing was not r and omized , and fall status was obtained through retrospective recall . Conclusions The Mini-BESTest had a lower ceiling effect and higher values on responsiveness tests . These findings suggest that the Mini-BESTest may be better at detecting changes in balance in people who have MS , are ambulatory , and have relatively little walking disability Background Evaluation of walking capacity and risk of falls in people with multiple sclerosis often are performed in rehabilitation . The Dynamic Gait Index ( DGI ) evaluates walking during different tasks , but the feasibility in identifying people at risk for falls needs to be further investigated . Objective The objective of this study was to investigate ( 1 ) the construct validity ( known groups , convergent , and discriminant ) of the DGI and ( 2 ) the accuracy of predicting falls and establishing a cutoff point to identify fallers . Design This trial was a multicenter , cross-sectional study . Methods A convenience sample was composed of 81 people with multiple sclerosis with subjective gait and balance impairment who were able to walk 100 m ( comparable to Exp and ed Disability Status Scale 1–6 ) . Mean age of the participants was 49 years ; 76 % were women . The 25-Foot Timed Walk Test , Timed “ Up & Go ” Test , Four Square Step Test , Timed Sit-to-St and Test , MS Walking Scale , Multiple Sclerosis Impact Scale , and self-reported falls during the previous 2 months were used for validation , to establish cutoff points for identifying fallers , and to investigate predictive values . Results Significantly lower DGI scores ( P≤.001 ) were found for participants reporting falls ( n=31 ) . High sensitivity ( 87 % ) in identifying fallers was found , with a cutoff score ≤19 . The positive predictive value was 50 % , and the negative predictive value was 87 % . The positive likelihood ratio was 1.77 , and the negative likelihood ratio was 0.26 . The convergent validity was moderate to strong ( ρ=0.58–0.80 ) , with the highest correlation coefficient found for the 25-Foot Timed Walk Test . Discriminant validity was shown with low correlation for the psychological subscale of the Multiple Sclerosis Impact Scale . Limitations The sample included ambulatory people participating in a r and omized controlled trial investigating balance training . Conclusions The DGI is a valid measure of dynamic balance during walking for ambulatory people with multiple sclerosis . With the cutoff point of ≤19 , sensitivity was high in identifying people at risk of falls Abstract Purpose : People with Multiple Sclerosis ( PwMS ) have a high incidence of accidental falls that have a potentially detrimental effect on their daily life participation . The effect of balance specific rehabilitation on clinical balance measures and frequency of falls in PwMS was studied . Method : A bi-centre r and omised rater-blinded controlled trial . Participants in both groups received 20 treatment sessions . Participants in the intervention group received treatment aim ed at improving balance and mobility . Participants in the control group received treatments to reduce limitations at activity and body function level . Primary measures were frequency of fallers ( > 1 fall in two months ) and responders ( > 3 points improvement ) at the Berg Balance Scale ( BBS ) . Data was analysed according to an intention to treat approach . Results : One hundred and nineteen participants were r and omised . Following treatment frequency of fallers was 22 % in the intervention group and 23 % in the control group , odds ratio ( OR ) and ( confidence limits ) : 1.05 ( 0.41 to 2.77 ) . Responders on the BBS were 28 % in the intervention group and 33 % in the control group , OR = 0.75 ( 0.30 to 1.91 ) . At follow up ORs for fallers and responders at BBS were 0.98 ( 0.48 to 2.01 ) and 0.7 OUTPUT:

Meta- analysis demonstrated fallers perform significantly worse than non-fallers on all measures analysed except the Timed Up and Go Cognitive ( p < 0.05 ) , but discriminative ability of the measures is commonly not reported . Of those reported , the Activities-specific Balance Confidence Scale had the highest area under the receiver operating characteristic curve value ( 0.92 ) , but without reporting corresponding measures of clinical utility . Conclusion : Clinical measures of balance differ significantly between fallers and non-fallers but have poor predictive ability for falls risk in people with multiple sclerosis

MS2_dynamic_1_shot618

***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: The present study compares visible-light Delton with Duraphat fluoride varnish for the prevention of occlusal caries in permanent first molars . A clinical trial was carried out in three groups of 6 - 8-yr-old schoolchildren : a sealant group ( 100 children ) , in which Delton light-polymerized fissure sealant was applied to permanent first molars ; a varnish group ( 98 children ) , in which Duraphat was applied to permanent first molars ; and a control group ( 116 children ) . Replacement ( sealant ) and reapplication ( varnish ) was carried out every 6 months . Percent effectiveness at 24 months ( percentage of saving from caries taking molars as analysis unit ) for those molars initially healthy and with complete occlusal eruption was analyzed . 272 , 252 and 238 molars met the inclusion criteria in the control , varnish and sealant groups , respectively . Of these , 45.2 % , 28.2 % and 10.5 % developed caries after 24 months . The effectiveness was greater in the sealed molars than in the varnished molars ( 62.7 % ) PURPOSE The aim of this work is to study and compare the retention rate , caries-preventing and antibacterial effects of resin-modified glass ionomer and flowable composite in comparison to conventional fissure sealant . METHODS Forty-five children aged 7 - 10 years with newly erupted lower first permanent molars were r and omly divided into three equal treatment groups . Group I : sealed by a conventional resin sealant ; Group II : sealed by resin modified glass ionomer ( RMGI ) ; and Group III : sealed by flowable composite . Retention and caries status of the sealed teeth were recorded after 1 month , 6 months , year and 2 years . In addition , Streptococcus mutans counts were assessed at baseline , 1 day , 1 month , 6 months , 1 year and 2 years after sealant application . Data were analyzed by Fisher exact , chi-square and ANOVA tests . RESULTS Group III and Group I showed significantly higher retention rates than Group II fissure sealant ( p<0.05 ) . There were no differences of the caries-preventive effects between the tested sealant material s throughout the duration of the study . Streptococcus mutans counts were significantly lower in group II compared to group I or group III up to 6 months of the study ( p<0.05 ) . After 1 year of the study the differences of Streptococcus mutans counts were not significant ( p>0.05 ) . CONCLUSION This study indicated a lower retention of RMGI compared to flowable composite and resin sealant without significant difference in caries prevention or long-term bacterial inhibition A 24-month clinical study was carried out to evaluate and compare the retention rate , marginal integrity and caries preventing effects of a polyacid-modified resin composite based fissure sealant , Dyract Seal , to that of a resin based fluoride fissure sealant , Delton FS+ . Fifty-three patients ( 27 female and 26 male ) , 7 to 10 years old , were included in the study . At baseline , a total of 192 permanent first molars were sealed with either fissure sealant ( n=96 , each ) , using invasive technique . The sealed teeth were evaluated at post-operative 3 , 6 , 12 and 24 months with respect to evaluation parameters . The data were analyzed with the Chi-Square tests where alpha=0.05 . There were no statistically significant differences between fissure sealants as regards to retention and prevention of caries for all periods of the evaluation ( p>0.05 ) . However , regarding marginal integrity of the sealants , Delton FS+ gave significantly better results than Dyract Seal for the 3- , 6- and 12-month evaluations , respectively ( p<0.05 ) . In conclusion , the use of Dyract Seal on permanent molars with invasive technique was found to be clinical ly comparable to Delton FS+ for the 24-month evaluation period Abstract Fissure sealing using partially filled resins is an established caries preventive practice . Glass ionomer cement ( GIC ) sealants may offer additional advantages due to their ability to bond chemically to enamel and release fluoride . The aim of this study was to compare the caries preventive effect and retention of a GIC and a resin-based sealant . Ketac-fil ® was tested against a chemically cured resin-based material ( Delton ® ) using a split mouth design . Perth ( Western Australia ) schoolchildren ( n= 465 ) , mean age 7 yr±0.72 ( S.D. ) , received sealants on the occlusal surfaces of sound homologous permanent first molar pairs . Test ( GIC ) and control ( resin ) sealants were systematic ally allocated to left and right sides based on the child 's month of birth , and were placed by dental therapists . After 3.64±0.11 yr , 415 children were examined by different clinicians , and the clinical status of the teeth and the extent of sealant retention recorded . Sealants were deemed retained when at least 2/3 of the fissure pattern was still sealed . In 252 tooth pairs , neither sealant was retained to this extent . In 71 pairs , the GIC was not retained and the resin sealant retained . In 40 pairs the reverse occurred ( McNemar 's test , χ2= 8.66 , P < 0.005 ) . Net gain ( additional lesions prevented by the test agent per 100 treatments ) was 6.1%(95 % CI 3.3 % , 8.9 % ) . Effectiveness of the GIC was 80.6 % ( 95 % CI 59.6 % , 90.7 % ) . The relative risk of caries in test teeth OUTPUT: They also concluded that sealants could minimize the progression of non-cavitated occlusal carious lesions ( also referred to as initial lesions ) that receive a sealant . Finally , based on the available limited evidence , the panel was unable to provide specific recommendations on the relative merits of 1 type of sealant material over the others . INPUT: The treatment of proximal caries has changed during the last decade . The present study evaluates a recently developed material , applied in box-only preparations in primary molars . At the twelve-month evaluation of this clinical study , it became obvious that Dyract can be an alternative for Tytin in the primary dentition , though there is some change in color of the Dyract material . In time , the marginal adaptation of Dyract seems to improve . The preparation time for both material s is comparable . The total treatment time of box-only Dyract restorations ( including an occlusal sealant ) , however , is longer compared to conventional class II Tytin restorations . Although in both groups radiolucencies were found at the baseline radiograph evaluation , no sign was found of secondary caries . One recurrent caries lesion was found adjacent to a Dyract restoration . It should be emphasized that one-year data do not indicate the longterm success of restorations OBJECTIVES To assess and compare the cumulative survival rate of amalgam and atraumatic restorative treatment ( ART ) restorations in primary molars over 3 years . METHODS 280 children aged 6 - 7 years old were enrolled in a cluster r and omized controlled clinical trial using a parallel group design covering two treatment groups : conventional restorative treatment with amalgam ( CRT ) and atraumatic restorative treatment ( ART ) using a high-viscosity glass-ionomer ( HVGIC ) Ketac Molar Easymix . Three pedodontists placed 750 restorations ( 364 amalgam and 386 ART in 126 and 154 children , respectively ) which were evaluated at 0.5 , 1 , 2 and 3 years . The proportional hazard rate regression model with frailty correction , ANOVA and Wald tests , and the Jackknife procedure were applied in analysing the data . RESULTS The cumulative survival rates over 3 years for all , single- and multiple-surface CRT/amalgam restorations ( 72.6 % , 93.4 % , 64.7 % , respectively ) were no different from those of comparable ART/HVGIC restorations ( 66.8 % ; 90.1 % and 56.4 % , respectively ) ( p=0.10 ) . Single-surface restorations had higher survival rates than multiple-surface restorations for the both treatment procedures ( p<0.0001 ) . A higher proportion of restorations failed because of mechanical reasons ( 94.8 % ) than of secondary caries ( 5.2 % ) . No difference in reasons for restoration failures between all types of amalgam and ART/HVGIC restorations were observed ( p=0.24 ) . SIGNIFICANCE The high-viscosity glass-ionomer used in this study in conjunction with the ART is a viable option for restoring carious dentin lesions in single surfaces in vital primary molars Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models are applied to an illustrative data set and posterior parameter distributions are compared . We discuss model critique and model selection , illustrating the role of Bayesian deviance analysis , and node-based model criticism . The assumptions underlying the MTC models and their parameterization are also discussed Objectives To evaluate the clinical performance of a compomer material ( Dyract ® ) in comparison with dental amalgam ( Contour ® ) for management of proximal caries in primary molars in young children . Setting General dental practice , and a dental hospital paediatric clinic . Method This was a prospect i ve study . A split mouth design was used with identical pairs of minimal Class II cavities , of matched tooth type inthe same dental arch , usually diagnosed with the use of bitewing radiographs . Seventy-eight pairs of restorations were completed ofwhich 60 pairs were available for evaluation after 24 months . Results Comparable retention rates were observed for both Dyract and amalgam . The retention rates were high for both material s , with only four amalgam and two Dyract restorations failing over 24 months . Significantly better marginal integrity ( P < 0.05 ) was observed for Dyract compared with amalgam with no significant differences between the two material s for recurrent caries , wear or surface texture . Conclusions Dyract seemed to be a suitable alternative to amalgam for proximal restorations in primary molars of young children for use in general dental practice OBJECTIVE To compare the clinical performance of two glass-ionomer cements (GICs)for Class II restorations in primary molars : a conventional cement ( Fuji II ) and a resin-modified cement ( Vitremer ) . DESIGN Split mouth and r and om assignment to the two material s were used for the majority of the molars . SAMPLE AND METHODS Forty consecutive 4 - 7-year-old children were included . One operator made 115 restorations : 53 with Vitremer and 62 with Fuji II . The restorations were evaluated clinical ly , radiographically and from colour photographs . RESULTS The cumulative success rate of the Vitremer restorations was 94 % and that of the Fuji II restorations 81 % . The difference is statistically significant . The risk of a failed restoration was more than five times higher with Fuji II than with Vitremer as the restorative material . OUTPUT:

Restorations of primary molars with conventional glass ionomer cement showed increased risk of failure than compomer , resin-modified glass ionomer cement , amalgam , and composite resin .

MS2_dynamic_1_shot619

***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: Background —This investigation compares the results of contemporary percutaneous coronary intervention ( PCI ) with st and ard balloon angioplasty among patients with multivessel coronary disease . Patients having balloon angioplasty in the Bypass Angioplasty Revascularization Investigation ( BARI ) and those within the Dynamic Registry meeting BARI eligibility criteria were studied . Methods and Results — Clinical features and in-hospital and 1-year outcomes of 857 BARI-eligible patients in the Dynamic Registry ( contemporary PCI ) were compared with the 904 r and omized patients who underwent percutaneous transluminal coronary angioplasty in BARI . Compared with BARI patients , Registry patients had fewer lesions attempted ( 1.53 versus 2.56 , P = 0.001 ) , more frequent single-vessel PCI ( 76 % versus 33 % , P < 0.001 ) , greater use of intracoronary stents ( 76 % versus 1 % , P < 0.001 ) , and GP IIb/IIIa receptor antagonist ( 24 % versus 0 % , P < 0.001 ) . Angiographic success was achieved more often among Registry patients ( 91 % versus 72 % , P < 0.001 ) , whereas abrupt closure ( 1.5 % versus 9.5 % , P < 0.001 ) and in-hospital coronary artery bypass graft ( CABG ) ( 1.9 % versus 10.2 % , P < 0.001 ) and myocardial infa rct ion ( 0.8 % versus 2.1 % , P = 0.025 ) were less common . No differences were observed in either in-hospital or 1-year death , but 1-year death/myocardial infa rct ion was lower in the Registry . Registry patients had lower 1-year rates of subsequent CABG ( 8.6 % versus 22.7 % , P < 0.001 ) and PCI ( 12.4 % versus 22.5 % , P < 0.001 ) . By multivariate analysis , contemporary PCI was independently associated with reduced risk for in-hospital CABG , 1-year CABG , and 1-year PCI . Conclusions —Among patients with multivessel disease , contemporary PCI result ed in safer and more durable revascularization . These results support the role of PCI for selected patients with multivessel coronary artery disease Background —Few studies have compared long-term status of bypass grafts between patients with and without diabetes , and uncertainty exists as to whether diabetes independently predicts poor clinical outcome after CABG . Methods and Results —Among 1526 patients in BARI who underwent CABG as initial revascularization , 99 of 292 ( 34 % ) with treated diabetes mellitus ( TDM ) ( those on insulin or oral hypoglycemic agents ) and 469 of 1234 ( 38 % ) without TDM had follow-up angiography . Angiograms with the longest interval from initial surgery and before any percutaneous graft intervention ( mean 3.9 years ) were review ed . An average of 3.0 grafts were placed at initial CABG for patients with TDM ( n=297 ; internal mammary artery [ IMA ] , 33 % ) and 2.9 grafts for patients without TDM ( n=1347 ; IMA , 34 % ) . Patients with TDM were more likely than those without to have small ( < 1.5 mm ) grafted distal vessels ( 29 % versus 22 % ) and vessels of poor quality ( 9 % versus 6 % ) . On follow-up angiography , 89 % of IMA grafts were free of stenoses ≥50 % among patients with TDM versus 85 % among patients without TDM ( P = 0.23 ) . For vein grafts , the corresponding percentages were 71 % versus 75 % ( P = 0.40 ) . After statistical adjustment , TDM was unrelated to having a graft stenosis ≥50 % ( adjusted odds ratio , 0.87 ; 95 % CI , 0.58 to 1.32 ) . Conclusions —Despite diabetic patients ’ having smaller distal vessels and vessels judged to be of poorer quality , diabetes does not appear to adversely affect patency of IMA or vein grafts over an average of 4-year follow-up . Previously observed differences in survival between CABG-treated patients with and without diabetes may be largely a result of differential risk of mortality from noncardiac causes BACKGROUND The impact of percutaneous transluminal coronary angioplasty ( PTCA ) and coronary artery bypass grafting ( CABG ) on long-term mortality rates in the presence of various demographic , clinical , and angiographic factors is uncertain in the population of patients suitable for both procedures . METHODS AND RESULTS In the Bypass Angioplasty Revascularization Investigation ( BARI ) r and omized trial and registry , 3610 patients who were eligible to receive PTCA and CABG were revascularized between 1989 and 1992 . Multivariate Cox models were used to identify factors associated with 5-year mortality and cardiac mortality , with particular attention to factors that interact with treatment . Diabetic patients receiving insulin had higher mortality and cardiac mortality rates with PTCA compared with CABG ( relative risk [ RR ] 1.78 and 2.63 , respectively , P<0.001 ) , and patients with ST elevation had higher cardiac mortality rates with CABG than with PTCA ( RR 4.08 , P<0.001 ) . Factors most strongly associated with high overall mortality rates were insulin-treated diabetes OUTPUT: Early and mid-term follow-up of diabetic patients after revascularization indicates that the incidence of myocardial infa rct ion and repeat revascularization are reduced in surgically treated patients compared with those treated by balloon angioplasty alone . Percutaneous coronary intervention ( PCI ) with bare metal stents has reduced the surgical advantage ( for reintervention ) in the early-mid-term ; however , repeat revascularization in diabetic patients continues to be substantially higher after PCI . INPUT: OBJECTIVES We sought to investigate the impact of body mass index ( BMI ) on short- and long-term outcomes after initial revascularization with percutaneous transluminal coronary angioplasty ( PTCA ) or coronary artery bypass graft surgery ( CABG ) . BACKGROUND Equivocal results exist on the impact of BMI on the risk of in-hospital complications after PTCA or CABG , and no long-term mortality data exist from a large series of revascularized patients . METHODS From the r and omized series and observational registry of the Bypass Angioplasty Revascularization Investigation ( BARI ) , 2,108 patients who had PTCA and 1,526 patients who had CABG were evaluated by taking their BMI at study entry . They were classified as follows : low ( < 20 kg/m(2 ) ) , normal ( 20 to 24.9 kg/m(2 ) ) , overweight ( 25 to 29.9 kg/m(2 ) ) , class I obese ( 30 to 34.9 kg/m(2 ) ) and class II/III obese ( greater-than-or-equal 35 kg/m(2 ) ) . In-hospital complications and short- and long-term mortalities were compared between levels of BMI within each mode of initial revascularization . RESULTS Among patients who had PTCA , each unit increase in BMI was associated with a 5.5 % lower adjusted risk of a major in-hospital event ( death , myocardial infa rct ion , stroke , coma ) ; among patients who had CABG , no difference in the in-hospital outcome was observed according to BMI . In contrast , BMI was not associated with five-year mortality in the PTCA group ; among the CABG group , adjusted relative risks of five-year cardiac mortality according to levels of BMI were 0.0 ( low ) , 1.0 ( normal ) , 2.02 ( overweight ) , 3.16 ( class I obese ) and 4.85 ( class II/III obese ) ( linear p < 0.001 ) . CONCLUSIONS Body mass index appears to have a differential impact on short- and long-term outcomes after coronary revascularization . These results underscore the need for further research to identify factors responsible for the apparent short-term protective effect of a higher BMI in patients undergoing PTCA and to study the impact of weight reduction on the long-term survival of obese patients undergoing CABG Purpose Obesity influences risk stratification in cardiac surgery in everyday practice . However , some studies have reported better outcomes in patients with a high body mass index ( BMI ): this is known as the obesity paradox . The aim of this study was to quantify the effect of diverse degrees of high BMI on clinical outcomes after cardiac surgery , and to assess the existence of an obesity paradox in our patients . Methods A total of 2,499 consecutive patients requiring all types of cardiac surgery with cardiopulmonary bypass between January 2004 and February 2009 were prospect ively studied at our institution . Patients were divided into four groups based on BMI : normal weight ( 18.5–24.9 kg∙m−2 ; n = 523 ; 21.4 % ) , overweight ( 25–29.9kg∙m−2 ; n = 1150 ; 47 % ) , obese ( ≥30–≤34.9kg∙m−2 ; n = 624 ; 25.5 % ) and morbidly obese ( ≥35kg∙m−2 ; n = 152 ; 6.2 % ) . Follow-up was performed in 2,379 patients during the first year . Results After adjusting for confounding factors , patients with higher BMI presented worse oxygenation and better nutritional status , reflected by lower PaO2/FiO2 at 24h and higher albumin levels 48h after admission respectively . Obese patients showed a higher risk for Perioperative Myocardial Infa rct ion ( OR : 1.768 ; 95 % CI : 1.035–3.022 ; p = 0.037 ) and septicaemia ( OR : 1.489 ; 95 % CI : 1.282–1.997 ; p = 0.005 ) . In-hospital mortality was 4.8 % ( n = 118 ) and 1-year mortality was 10.1 % ( n = 252 ) . No differences were found regarding in-hospital mortality between BMI groups . The overweight group showed better 1-year survival than normal weight patients ( 91.2 % vs. 87.6 % ; Log Rank : p = 0.029 . HR : 1.496 ; 95 % CI : 1.062–2.108 ; p = 0.021 ) . Conclusions In our population , obesity increases Perioperative Myocardial Infa rct ion and septicaemia after cardiac surgery , but does not influence in-hospital mortality . Although we found better 1-year survival in overweight patients , our results do not support any protective effect of obesity in patients undergoing cardiac surgery BACKGROUND Obesity has become a public health crisis . Although prior studies in obese patients undergoing cardiac surgical procedures have shown variable effects on outcomes , data are limited for extremely obese patients ( body mass index [ BMI ] > or = 45 ) . We undertook this study to evaluate outcomes in this cohort . METHODS A retrospective analysis was performed on 14,571 patients in our data base who underwent cardiac operations from 1992 to 2005 . Patient demographics , comorbidities , and outcomes were recorded . A univariate analysis between two groups : BMI 21 to 34.9 and BMI 45 or more was performed . Logistic regression models were used to identify independent risk OUTPUT:

In the present series , overweight and obese patients had similar or slightly lower in-hospital mortality rates after cardiac surgery compared with normal-weight individuals . Conversely , postoperative complication rates increased with higher BMI levels . Most studies included in the review showed that overweight and obese patients had at least the same mortality rate as normal-weight patients , or even a lower death risk . Pooled- data of the meta- analysis provided evidence on the association between higher BMI levels and a lower all-cause in-hospital mortality rate after cardiac surgery

MS2_dynamic_1_shot620

***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: This study compared the efficacy of a tetrahydrocannabinol : cannabidiol ( THC : CBD ) extract , a nonopioid analgesic endocannabinoid system modulator , and a THC extract , with placebo , in relieving pain in patients with advanced cancer . In total , 177 patients with cancer pain , who experienced inadequate analgesia despite chronic opioid dosing , entered a two-week , multicenter , double-blind , r and omized , placebo-controlled , parallel-group trial . Patients were r and omized to THC : CBD extract ( n = 60 ) , THC extract ( n = 58 ) , or placebo ( n = 59 ) . The primary analysis of change from baseline in mean pain Numerical Rating Scale ( NRS ) score was statistically significantly in favor of THC : CBD compared with placebo ( improvement of -1.37 vs. -0.69 ) , whereas the THC group showed a nonsignificant change ( -1.01 vs. -0.69 ) . Twice as many patients taking THC : CBD showed a reduction of more than 30 % from baseline pain NRS score when compared with placebo ( 23 [ 43 % ] vs. 12 [ 21 % ] ) . The associated odds ratio was statistically significant , whereas the number of THC group responders was similar to placebo ( 12 [ 23 % ] vs. 12 [ 21 % ] ) and did not reach statistical significance . There was no change from baseline in median dose of opioid background medication or mean number of doses of breakthrough medication across treatment groups . No significant group differences were found in the NRS sleep quality or nausea scores or the pain control assessment . However , the results from the European Organisation for Research and Treatment of Cancer Quality of Life Cancer Question naire showed a worsening in nausea and vomiting with THC : CBD compared with placebo ( P = 0.02 ) , whereas THC had no difference ( P = 1.0 ) . Most drug-related adverse events were mild/moderate in severity . This study shows that THC : CBD extract is efficacious for relief of pain in patients with advanced cancer pain not fully relieved by strong opioids R and omized controlled trials ( RCTs ) in palliative cancer care often experience method ological problems . In this paper we discuss issues of major concern , including recruitment , patient attrition and compliance , arising from an RCT that compared comprehensive palliative care to conventional care . The main criteria for trial entry were incurable malignant disease and a survival expectancy of between 2 and 9 months . Patients ' health-related quality of life ( HRQL ) , self-assessed by multi-item question naires , was a defined endpoint . The planned number of patients was successfully recruited , although the patients were referred late in the course of their disease so that follow-up tended to be short . Compliance in completing HRQL question naires was good up to 1 month before the patient 's death ; but in the final weeks it was found to drop substantially . Based on our experience , recommendations are given for those planning similar research . Procedures for improving patient recruitment are suggested , stressing the need for local data management , repeated information to referral sources , extensive screening for potentially eligible patients and simple referral routines . Precise inclusion criteria , including prognostic factors other than physicians ' estimates of life expectancy , should be used to ensure a sufficient follow-up period . For HRQL assessment , multi-item question naires can achieve excellent compliance up to 1 month before patients ' death , but in order to evaluate the very final weeks of life we recommend the use of simpler methods Rationale No studies to date have directly compared the tolerability and efficacy of smoked marijuana and oral dronabinol in HIV+ marijuana smokers . Objectives The aim of this study was to compare dronabinol ( 0 , 10 , 20 , 30 mg p.o . ) and marijuana [ 0.0 , 1.8 , 2.8 , 3.9 % Δ9-tetrahydrocannabinol ( THC ) ] in two sample s of HIV+ marijuana smokers : those with ( n=15 ) and those without ( n=15 ) a clinical ly significant loss of muscle mass ( < 90 % body cell mass/height ) , which is one component of AIDS wasting . Methods Mood , physical symptoms , self-selected food intake , cardiovascular data , and cognitive task performance were measured before and repeatedly after dronabinol and marijuana administration in eight 7-h sessions . Marijuana and dronabinol were administered in r and omized order using a within-subject , staggered , double-dummy design . Results As compared to placebo , ( 1 ) marijuana ( 1.8 , 2.8 , 3.9 % THC ) and the lower dronabinol doses ( 10 , 20 mg ) were well tolerated ( e.g. , few physical symptoms , significant increases in ratings of “ good drug effect ” ) in both groups of participants ; the highest dose of dronabinol ( 30 mg ) was poorly tolerated in a subset of participants ; ( 2 ) marijuana and dronabinol significantly increased caloric intake in the low bioelectrical impedance analysis ( BIA ) group but not in the normal BIA group ; and ( 3 ) drug effects on cognitive performance were minor . Conclusions These data suggest that for experienced marijuana smokers with clinical ly significant muscle mass loss , both dronabinol ( at acute doses at least four to eight times the current recommendation ) and marijuana produce substantial and comparable increases in food intake without producing adverse effects BACKGROUND A pilot study ( NCT00316563 ) to determine if delta-9-tetrahydrocannabinol ( THC ) can improve taste and smell ( chemosensory ) perception as well as appetite , caloric intake , and quality of life ( QOL ) for cancer patients with chemosensory alterations . PAT OUTPUT: In one moderate quality study of 469 cancer patients with cancer-associated anorexia , megestrol was superior to cannabinoids in improving appetite , producing > 10 % weight gain and tolerability . In another study comparing megestrol to dronabinol in HIV patients , megestrol treatment led to higher weight gain without any differences in tolerability and safety . We found no convincing , unbiased , high quality evidence suggesting that cannabinoids are of value for anorexia or cachexia in cancer or HIV patients INPUT: UNLABELLED We assessed the efficacy of dronabinol ( Marinol capsules ; Solvay Pharmaceuticals , Brussels , Belgium ) , a synthetic Delta(9)-THC ( tetrahydrocannabinol ) , in 30 patients taking opioids for chronic pain to determine its potential analgesic effects as an adjuvant treatment . Phase I of this 2-phase study was a r and omized , single-dose , double-blinded , placebo-controlled , crossover trial in which subjects were r and omly administered either 10 mg or 20 mg of dronabinol or identical placebo capsules over the course of three , 8-hour visits . Baseline self-report measures , hourly ratings of pain intensity , pain relief , pain bothersomeness , treatment satisfaction , mood , side effects , and blood serum levels were obtained . Phase II was an extended open-label titrated trial of dronabinol as add-on medication to patients on stable doses of opioids . Results of the Phase I study showed that patients who received dronabinol experienced decreased pain intensity and increased satisfaction compared with placebo . No differences in benefit were found between the 20 mg and 10 mg doses . In the Phase II trial , titrated dronabinol contributed to significant relief of pain , reduced pain bothersomeness , and increased satisfaction compared with baseline . The incidence of side effects was dose-related . Overall , the use of dronabinol was found to result in additional analgesia among patients taking opioids for chronic noncancer pain . PERSPECTIVE This study examines the effect of adding a cannabinoid to the regimen of patients with chronic pain who report significant pain despite taking stable doses of opioids . The results of our preliminary study suggest that dronabinol , a synthetic THC , may have an additive effect on pain relief Abstract Objective To evaluate the effect of the oral synthetic δ-9-tetrahydrocannabinol dronabinol on central neuropathic pain in patients with multiple sclerosis . Design R and omised double blind placebo controlled crossovertrial . Setting Outpatient clinic , University Hospital of Aarhus , Denmark . Participants 24 patients aged between 23 and 55 years with multiple sclerosis and central pain . Intervention Orally administered dronabinol at a maximum doseof 10 mg daily or corresponding placebo for three weeks ( 15 - 21days ) , separated by a three week washout period . Main outcome measure Median spontaneous pain intensity ( numericalrating scale ) in the last week of treatment . Results Median spontaneous pain intensity was significantlylower during dronabinol treatment than during placebo treatment(4.0 ( 25th to 75th centiles 2.3 to 6.0 ) v 5.0 ( 4.0 to 6.4),P = 0.02 ) , and median pain relief score ( numerical rating scale)was higher ( 3.0 ( 0 to 6.7 ) v > 0 ( 0 to 2.3 ) , P = 0.035 ) . Thenumber needed to treat for 50 % pain relief was 3.5 ( 95 % confidenceinterval 1.9 to 24.8 ) . On the SF-36 quality of life scale , thetwo items bodily pain and mental health indicated benefits fromactive treatment compared with placebo . The number of patients with adverse events was higher during active treatment , especiallyin the first week of treatment . The functional ability of themultiple sclerosis patients did not change . Conclusions Dronabinol has a modest but clinical ly relevantanalgesic effect on central pain in patients with multiple sclerosis . Adverse events , including dizziness , were more frequent withdronabinol than with placebo during the first week of treatment The objective was to determine whether a cannabis-based medicinal extract ( CBME ) benefits a range of symptoms due to multiple sclerosis ( MS ) . A parallel group , double-blind , r and omized , placebo-controlled study was undertaken in three centres , recruiting 160 out patients with MS experiencing significant problems from at least one of the following : spasticity , spasms , bladder problems , tremor or pain . The interventions were oromucosal sprays of matched placebo , or whole plant CBME containing equal amounts of delta-9- tetrahydrocannabinol ( THC ) and cannabidiol ( CBD ) at a dose of 2.5- 120 mg of each daily , in divided doses . The primary outcome measure was a Visual Analogue Scale ( VAS ) score for each patient ’s most troublesome symptom . Additional measures included VAS scores of other symptoms , and measures of disability , cognition , mood , sleep and fatigue . Following CBME the primary symptom score reduced from mean ( SE ) 74.36 ( 11.1 ) to 48.89 ( 22.0 ) following CBME and from 74.31 ( 12.5 ) to 54.79 ( 26.3 ) following placebo [ ns ] . Spasticity VAS scores were significantly reduced by CBME ( Sativex ) in comparison with placebo ( P- 0.001 ) . There were no significant adverse effects on cognition or mood and intoxication was generally mild Objectives : To determine whether plant-derived cannabis medicinal extracts ( CME ) can alleviate neurogenic symptoms unresponsive to st and ard treatment , and to quantify adverse effects . Design : A consecutive series of double-blind , r and omized , placebo-controlled single-patient cross-over trials with two-week treatment periods . Setting : Patients attended as out patients , but took the CME at home . Subjects : Twenty-four patients with multiple sclerosis ( 18 ) , spinal cord injury ( 4 ) , brachial plexus damage ( 1 ) , and limb amputation due to neurofibromatosis ( 1 ) . Intervention : Whole-plant extracts of delta OUTPUT:

Pain intensity of chronic non-cancer patients was reduced by cannabinoids consumption , but effect sizes were small . Efficacy for neuropathic and non-neuropathic pain was similar

MS2_dynamic_1_shot621

***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: OBJECTIVE To test whether a theory-based , literacy , and culturally tailored self-management intervention , Latinos en Control , improves glycemic control among low-income Latinos with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 252 patients recruited from community health centers were r and omized to the Latinos en Control intervention or to usual care . The primarily group-based intervention consisted of 12 weekly and 8 monthly sessions and targeted knowledge , attitudes , and self-management behaviors . The primary outcome was HbA1c . Secondary outcomes included diet , physical activity , blood glucose self-monitoring , diabetes knowledge and self-efficacy , and other physiological factors ( e.g. , lipids , blood pressure , and weight ) . Measures were collected at baseline and at 4- and 12-month follow-up . Change in outcomes over time between the groups and the association between HbA1c and possible mediators were estimated using mixed-effects models and an intention-to-treat approach . RESULTS A significant difference in HbA1c change between the groups was observed at 4 months ( intervention −0.88 [ −1.15 to −0.60 ] versus control −0.35 [ −0.62 to 0.07 ] , P < 0.01 ) , although this difference decreased and lost statistical significance at 12 months ( intervention −0.46 [ −0.77 to −0.13 ] versus control −0.20 [ −0.53 to 0.13 ] , P = 0.293 ) . The intervention result ed in significant change differences in diabetes knowledge at 12 months ( P = 0.001 ) , self-efficacy ( P = 0.001 ) , blood glucose self-monitoring ( P = 0.02 ) , and diet , including dietary quality ( P = 0.01 ) , kilocalories consumed ( P < 0.001 ) , percentage of fat ( P = 0.003 ) , and percentage of saturated fat ( P = 0.04 ) . These changes were in turn significantly associated with HbA1c change at 12 months . CONCLUSIONS Literacy-sensitive , culturally tailored interventions can improve diabetes control among low-income Latinos ; however , strategies to sustain improvements are needed BACKGROUND Type 2 diabetes is up to four times more common in British Asians , but they know little about its management and complications . AIM To design and evaluate a structured pictorial teaching programme for Pakistani Moslem patients in Manchester with type 2 diabetes . METHOD A r and omized controlled trial of pictorial flashcard one-to-one education in 201 patients attending a hospital outpatient clinic or diabetic clinics in ten general practice s in Manchester . Patients ' knowledge , self-caring skills and attitudes to diabetes were measured on four topics before the structured teaching , and compared with results six months later . RESULTS All parameters of knowledge were increased in the study group ; for example , percentage scores for correctly identifying different food values increased from 57 % to 71 % ( Analysis of Variance ( ANOVA ) adjusted difference + 11.8 % ) and knowledge of one diabetic complication from 18 % to 78 % . Self-caring behaviour improved , with 92 % of patients doing regular glucose tests at six months compared with 63 % at the start . Attitudinal views were more resistant to change , with patients still finding it hard to choose suitable foods at social occasions . Haemoglobin A1c control improved by 0.34 % over six months ( ANOVA adjusted difference , 95 % CI -0.8 % to + 0.1 % ) . CONCLUSION It is concluded that this health education programme can empower Asian diabetics to take control of their diets , learn to monitor and interpret glucose results , and underst and the implication s of poor glycaemic control for diabetic complications OBJECTIVES Diabetes self-management is a key element in the overall management of diabetes . Identifying barriers to disease self-management is a critical step in achieving optimal health outcomes . Our goal was to explore patients ' perceptions about barriers to self-management of diabetes that could possibly help explain poor health outcomes among minority patients . STUDY DESIGN Four focus groups were conducted among 31 predominately African American patients with diabetes who were enrolled in the Baltimore Cardiovascular Partnership Study , a NIH-funded multiyear prospect i ve partnership study . The topic guide consisted of a series of open-ended questions about knowledge of current health status , medication use , continuity of care , blood glucose level and nutrition . RESULTS The focus groups confirmed that previously reported barriers to self-management persisted and identified new concerns that could be associated with poor health outcomes among minority patients with diabetes . Attitudes , perceptions and behaviors surrounding diabetes and self-management of the condition did vary across individuals , however , the variation appeared to reflect the individual 's knowledge and opinions rather than patient 's age , sex , or culture . The primary barrier to diabetes self-management result ed from lack of knowledge of target blood glucose and blood pressure . Several participants found some of the health information to be quite confusing . CONCLUSIONS Diabetes is a major public health concern and the lack of awareness of target blood glucose and blood pressure further complicates the problem . The limited health literacy seen in this study could help explain several of the barriers to self-management . The barriers to self-management identified in this qualitative study are amenable to intervention that could improve health outcomes 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 ( RE OUTPUT: Most programs obtained some benefits over st and ard care in improving diabetes knowledge , self-management behaviors and clinical outcomes . Meta-regressions showed larger reduction in glycated hemoglobin in individual and face to face delivered interventions , as well as in those involving peer educators , including cognitive reframing techniques , and a lower number of teaching methods . The long-term effects remain unknown and cost-effectiveness was rarely estimated . Conclusions Diabetes self-management educational programs targeted to racial/ethnic minority groups can produce a positive effect on diabetes knowledge and on self-management behavior , ultimately improving glycemic control . INPUT: OBJECTIVE To test whether a theory-based , literacy , and culturally tailored self-management intervention , Latinos en Control , improves glycemic control among low-income Latinos with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 252 patients recruited from community health centers were r and omized to the Latinos en Control intervention or to usual care . The primarily group-based intervention consisted of 12 weekly and 8 monthly sessions and targeted knowledge , attitudes , and self-management behaviors . The primary outcome was HbA1c . Secondary outcomes included diet , physical activity , blood glucose self-monitoring , diabetes knowledge and self-efficacy , and other physiological factors ( e.g. , lipids , blood pressure , and weight ) . Measures were collected at baseline and at 4- and 12-month follow-up . Change in outcomes over time between the groups and the association between HbA1c and possible mediators were estimated using mixed-effects models and an intention-to-treat approach . RESULTS A significant difference in HbA1c change between the groups was observed at 4 months ( intervention −0.88 [ −1.15 to −0.60 ] versus control −0.35 [ −0.62 to 0.07 ] , P < 0.01 ) , although this difference decreased and lost statistical significance at 12 months ( intervention −0.46 [ −0.77 to −0.13 ] versus control −0.20 [ −0.53 to 0.13 ] , P = 0.293 ) . The intervention result ed in significant change differences in diabetes knowledge at 12 months ( P = 0.001 ) , self-efficacy ( P = 0.001 ) , blood glucose self-monitoring ( P = 0.02 ) , and diet , including dietary quality ( P = 0.01 ) , kilocalories consumed ( P < 0.001 ) , percentage of fat ( P = 0.003 ) , and percentage of saturated fat ( P = 0.04 ) . These changes were in turn significantly associated with HbA1c change at 12 months . CONCLUSIONS Literacy-sensitive , culturally tailored interventions can improve diabetes control among low-income Latinos ; however , strategies to sustain improvements are needed PURPOSE We compared a 3-month diabetes self-management education ( DSME ) program followed by a 12-month peer support intervention with a 3-month DSME program alone in terms of initial and sustained improvements in glycated hemoglobin ( HbA1c ) . Secondary outcomes were risk factors for cardiovascular disease ( CVD ) , diabetes distress , and social support . METHODS We r and omized 106 community-dwelling African American adults with type 2 diabetes to a 3-month DSME program followed by 12 months of weekly group sessions and supplementary telephone support delivered by peer leaders or to a 3-month DSME program with no follow-up peer support . Assessment s were conducted at baseline , 3 , 9 , and 15 months . RESULTS No changes in HbA1c were observed at 3 months or at 15 months for either group . The peer support group either sustained improvement in key CVD risk factors or stayed the same while the control group worsened at 15 months . At 15 months , the peer-support group had significantly lower low-density lipoprotein cholesterol levels ( −15 mg/dL , P = .03 ) , systolic blood pressure ( −10 mm Hg , P = .01 ) , diastolic blood pressure ( −8.3 mm Hg , P = .001 ) , and body mass index ( −0.8 kg/m2 , P = .032 ) than the DSME-alone group . CONCLUSIONS In this population of African American adults , an initial DSME program , whether or not followed by 12 months of peer support , had no effect on glycemic control . Participants in the peer-support arm of the trial did , however , experience significant improvements in some CVD risk factors or stay approximately the same while the control group declined Objective To evaluate the effectiveness on glycaemic control of a training programme in consultation skills for paediatric diabetes teams . Design Pragmatic cluster r and omised controlled trial . Setting 26 UK secondary and tertiary care paediatric diabetes services . Participants 79 healthcare practitioners ( 13 teams ) trained in the intervention ( 359 young people with type 1 diabetes aged 4 - 15 years and their main carers ) and 13 teams allocated to the control group ( 334 children and their main carers ) . Intervention Talking Diabetes programme , which promotes shared agenda setting and guiding communication style , through flexible menu of consultation strategies to support patient led behaviour change . Main outcome measures The primary outcome was glycated haemoglobin ( HbA1c ) level one year after training . Secondary outcomes were clinical measures ( hypoglycaemic episodes , body mass index , insulin regimen ) , general and diabetes specific quality of life , self reported and proxy reported self care and enablement , perceptions of the diabetes team , self reported and carer reported importance of , and confidence in , undertaking diabetes self management measured over one year . Analysis was by intention to treat . An integrated process evaluation included audio recording a sample of 86 routine consultations to assess skills shortly after training ( intervention group ) and at one year follow-up ( intervention and control group ) . Two key domains of skill assessment were use of the guiding communication style and shared agenda setting . Results 660/693 patients ( 95.2 % ) provided blood sample s at follow-up . Training diabetes care teams had no effect on HbA1c levels ( intervention effect 0.01 , 95 % confidence interval −0.02 to 0.04 , P=0.5 OUTPUT:

Overall , family support had a positive impact on healthy diet , increased perceived support , higher self-efficacy , improved psychological well-being and better glycemic control . This systematic review found evidence that DSME with family support improved self-management behaviors and health outcomes among uncontrolled glycaemia T2D patients .

MS2_dynamic_1_shot622

***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: BACKGROUND Although statins reduce coronary and cerebrovascular morbidity and mortality in middle-aged individuals , their efficacy and safety in elderly people is not fully established . Our aim was to test the benefits of pravastatin treatment in an elderly cohort of men and women with , or at high risk of developing , cardiovascular disease and stroke . METHODS We did a r and omised controlled trial in which we assigned 5804 men ( n=2804 ) and women ( n=3000 ) aged 70 - 82 years with a history of , or risk factors for , vascular disease to pravastatin ( 40 mg per day ; n=2891 ) or placebo ( n=2913 ) . Baseline cholesterol concentrations ranged from 4.0 mmol/L to 9.0 mmol/L. Follow-up was 3.2 years on average and our primary endpoint was a composite of coronary death , non-fatal myocardial infa rct ion , and fatal or non-fatal stroke . Analysis was by intention-to-treat . FINDINGS Pravastatin lowered LDL cholesterol concentrations by 34 % and reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo ( hazard ratio 0.85 , 95 % CI 0.74 - 0.97 , p=0.014 ) . Coronary heart disease death and non-fatal myocardial infa rct ion risk was also reduced ( 0.81 , 0.69 - 0.94 , p=0.006 ) . Stroke risk was unaffected ( 1.03 , 0.81 - 1.31 , p=0.8 ) , but the hazard ratio for transient ischaemic attack was 0.75 ( 0.55 - 1.00 , p=0.051 ) . New cancer diagnoses were more frequent on pravastatin than on placebo ( 1.25 , 1.04 - 1.51 , p=0.020 ) . However , incorporation of this finding in a meta- analysis of all pravastatin and all statin trials showed no overall increase in risk . Mortality from coronary disease fell by 24 % ( p=0.043 ) in the pravastatin group . Pravastatin had no significant effect on cognitive function or disability . INTERPRETATION Pravastatin given for 3 years reduced the risk of coronary disease in elderly individuals . PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle aged people Background —Microalbuminuria is associated with increased risk of cardiovascular events . We assessed whether therapeutic intervention aim ed at lowering urinary albumin excretion would reduce cardiovascular events in microalbuminuric subjects ( 15 to 300 mg/24 hours ) . Methods and Results —From the Prevention of Renal and Vascular Endstage Disease ( PREVEND ) cohort ( n=8592 ) , 1439 subjects fulfilled the inclusion criteria of the PREVEND Intervention Trial ( PREVEND IT ) . Of these subjects , 864 were r and omized to fosinopril 20 mg or matching placebo and to pravastatin 40 mg or matching placebo . The mean follow-up was 46 months , and the primary end point was cardiovascular mortality and hospitalization for cardiovascular morbidity . Mean age was 51±12 years ; 65 % of subjects were male , and 3.4 % had a previous cardiovascular event . Mean cholesterol level was 5.8±1.0 mmol/L , mean systolic/diastolic blood pressure was 130±18/76±10 mm Hg , and median urinary albumin excretion was 22.8 ( 15.8 to 41.3 ) mg/24 hours . The primary end point occurred in 45 subjects ( 5.2 % ) . Fosinopril reduced urinary albumin excretion by 26 % ( P<0.001 ) . Subjects treated with fosinopril showed a 40 % lower incidence of the primary end point ( hazard ratio 0.60 [ 95 % CI 0.33 to 1.10 ] , P=0.098 , log-rank ) . Pravastatin did not reduce urinary albumin excretion , and subjects treated with pravastatin showed a 13 % lower incidence of the primary end point than subjects in the placebo group ( 0.87 [ 0.49 to 1.57 ] , P=0.649 , log-rank ) . Conclusions —In microalbuminuric subjects , treatment with fosinopril had a significant effect on urinary albumin excretion . In addition , fosinopril treatment was associated with a trend in reducing cardiovascular events . Treatment with pravastatin did not result in a significant reduction in urinary albumin excretion or cardiovascular events OBJECTIVE —Cardiovascular disease ( CVD ) risk is increased in type 2 diabetes . The purpose of this study was to assess the effect of 10 mg of atorvastatin versus placebo on CVD prevention in subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets . RESEARCH DESIGN AND METHODS —Subjects were r and omly assigned to receive 10 mg of atorvastatin or placebo in a 4-year , double-blind , parallel-group study . The composite primary end point comprised cardiovascular death , nonfatal myocardial infa rct ion , nonfatal stroke , recanalization , coronary artery bypass surgery , resuscitated cardiac arrest , and worsening or unstable angina requiring hospitalization . RESULTS —A total of 2,410 subjects with type 2 diabetes were r and omized . Mean LDL cholesterol reduction in the ator OUTPUT: This literature -based meta- analysis did not find evidence for the benefit of statin therapy on all-cause mortality in a high-risk primary prevention set-up INPUT: Editors ' Notes Context Clinical guidelines provide conflicting recommendations about whether to prescribe statins in persons aged 75 years or older for primary prevention of unwanted cardiovascular outcomes . Contribution This study used information from clinical trials to model the tradeoffs between benefits and harms and found that using statins in all persons aged 75 to 94 years would prevent new myocardial infa rct ions and deaths from coronary heart disease at an acceptable cost . Caution Small increases in the frequency or severity of harms would negate the benefits . Implication Additional research is warranted to better underst and the tradeoffs between benefits and harms in this age group . Statins are commonly used in adults aged 75 years or older ( 1 ) . Despite their widespread use , evidence for their effectiveness for primary prevention in elderly adults is unclear , and guidelines for their use in this population are inconsistent . The recently published American College of Cardiology/American Heart Association ( ACC/AHA ) Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults gave limited recommendations for statin use for primary prevention in adults aged 75 years or older ( 2 ) , noting that few data were available to indicate an atherosclerotic cardiovascular disease event reduction benefit in primary prevention among individuals > 75 years of age who do not have clinical year atherosclerotic cardiovascular disease , and suggesting that comorbid conditions , safety , and priorities of care are recommended for joint provider and patient decision making . The American Medical Directors Association , a professional group of long-term care providers , recommended that statins not be routinely prescribed in adults aged 70 years or older as part of the American Board of Internal Medicine Choosing Wisely campaign ( 3 ) . This recommendation was based on the lack of an association between high cholesterol levels and outcomes in older adults as well as the potential for an increased risk for statin-related adverse events , including cognitive impairment , falls , neuropathy , and muscle damage ( 3 ) . The variation in these treatment recommendations reflects uncertainty about the balance between the benefits and risks of statin use in older adults compared with younger adults as well as the more limited evidence base in this population . Adults aged 75 years or older have been underrepresented in trials of statins for primary prevention , so the effectiveness of statins is less clear in this population . Results from observational studies suggest that the associations between low-density lipoprotein ( LDL ) cholesterol levels and outcomes are attenuated in older adults ( 47 ) . Although the baseline risk for cardiovascular disease is increased in older adults , their life expectancy is shorter and their risks for competing mortality are greater . Finally , there has been concern about geriatric-specific adverse effects , especially functional limitation due to muscle pain , weakness , and mild cognitive impairment ( 816 ) . In the presence of uncertainty about the riskbenefit tradeoff , computer simulations can provide estimates of the potential benefits of various treatment strategies as well as the costs and potential risk for harms . We evaluated the population benefit and cost-effectiveness of statins in persons aged 75 years or older without a history of cardiovascular disease in the United States . This investigation was conducted using the Cardiovascular Disease Policy Model ( CVDPM ) , a Markov model of the U.S. population ( 17 ) . We simulated the impact of statins for primary prevention based on treatment of the high-risk groups identified by the ACC/AHA guidelines , the associated costs , and potential harms that could offset the potential cardiovascular benefits in the U.S. population of adults aged 75 to 94 years over the next 10 years . Methods The Model The CVDPM is an established state-transition ( Markov ) model of the incidence , prevalence , mortality , and cost of CHD and stroke in U.S. residents aged 35 to 94 years ( 17 ) . The present study was limited to adults aged 75 to 94 years . The model comprises 3 components . First , the demographic-epidemiologic submodel estimates the incidence of coronary heart disease ( CHD ) ( cardiac arrest , myocardial infa rct ion [ MI ] , angina , or CHD death ) , ischemic stroke , and death from other causes on the basis of age , sex , systolic blood pressure , smoking , high-density lipoprotein and LDL cholesterol levels , diabetes , body mass index , and statin use . Second , the bridge submodel characterizes the initial CHD or stroke event and related events in the subsequent 30 days . Third , the disease-history submodel predicts the number of subsequent CHD and stroke events , revascularization procedures , and deaths among patients with cardiovascular disease , stratified according to age , sex , and history of cardiovascular disease events . In addition , persons may exit the model at any stage through a non-CHD , nonstroke mortality function , allowing for competing risk . Modifiable components of the model include population distributions , risk factor levels , risk factor coefficients , event rates , case-fatality rates , costs , and disability adjustments ( 17 ) . Costs for stroke requiring hospitalization , CHD , and acute stroke rehabilitation were estimated using California hospital data ( 18 ) and were deflated using costcharge ratios and the ratio of the U.S. national average costs to the California average ( 19 , 20 ) . Age- and sex-specific background health care costs were estimated using national data ( 21 ) . All model costs were inflated to 2014 costs by using the medical component of the Consumer Price Index ( 22 ) . All disability weights associated with the CHD and stroke event states were based on the Global Burden of Disease Study ( 23 , 24 ) . Additional details are provided in the Appendix . Simulation Inputs We modeled the effect of statins on LDL cholesterol level based on PROSPER ( Prospect i ve Study of Pravastatin in the Elderly at Risk of Vascular Disease ) , a r and omized , placebo-controlled OUTPUT:

LDL-C and TC lowering was significantly greater in the evening dose than in the morning dose in case of short-acting statins . Besides slight but significant effect on LDL-C , the efficacy of long-acting statins was equivalent for both regimens .

MS2_dynamic_1_shot623

***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: The effect of periconceptional multivitamin supplementation on postnatal development was studied in a r and omised controlled trial comparing the use of a multivitamin tablet ( Elevit Pronatal ) with a tablet containing trace elements as part of the Hungarian Optimal Family Planning Programme . Of 4122 liveborn infants , 3356 were examined after the eighth month of life and medical records were obtained for a further 357 ; thus the total number of infants evaluated was 3713 ( 90.1 % ) . The mortality was not significantly different between the groups receiving the multivitamins ( 9.6/1000 ) and trace elements ( 7.1/1000 ) . There was no significant difference in the rates of serious or chronic disorders between the study groups except for atopic dermatitis , which was reported more often in the group receiving multivitamins ( 15 v four cases ) . Somatic development ( body weight , body length , and head circumference ) did not show a significant difference between the two groups . Mental and behavioural development was also similar in the two groups Abstract Background : Atopic dermatitis is a chronically relapsing , highly pruritic and inflammatory skin disease . This study was done to assess the effects of vitamins D and E supplementation on the clinical manifestation of atopic dermatitis . Methods : Forty-five atopic dermatitis patients were included in a r and omized , double-blind , placebo-controlled trial . They were r and omly divided into four groups and treated for 60 days : group P ( n = 11 ) , vitamins D and E placebos ; group D ( n = 12 ) , 1600 IU vitamin D3 plus vitamin E placebo ; group E ( n = 11 ) , 600 IU synthetic all-rac-α-tocopherol plus vitamin D placebo ; and group DE ( n = 11 ) , 1600 IU vitamin D3 plus 600 IU synthetic all-rac-α-tocopherol . Serum 25(OH ) vitamin D and plasma α-tocopherol were determined before and after the trial . The clinical improvement was evaluated with SCORing Atopic Dermatitis ( SCORAD ) . Data were analyzed by analysis of variance ( ANOVA ) and Kruskal-Wallis tests . Results : SCORAD was reduced after 60 days in groups D , E and DE by 34.8 % , 35.7 % and 64.3 % , respectively ( p = 0.004 ) . Objective SCORAD also showed significant improvement . There was a positive correlation between SCORAD and intensity , objective , subjective and extent ( p < 0.001 ) . We found a significant negative association between plasma α-tocopherol and SCORAD , intensity , objective and extent ( p = 0.02 ) . Conclusion : This study supports the contributing and beneficial effects of vitamins D and E in the treatment of atopic dermatitis OBJECTIVE To evaluate the impact of childhood atopic eczema on families and assess the personal financial cost of its management . DESIGN Cross sectional survey . SETTING Paediatric dermatology and paediatric diabetology outpatient clinics . PATIENTS Parents of 48 r and omly selected children with atopic eczema and 46 with insulin dependent diabetes mellitus . MAIN OUTCOME MEASURES The impact on family score , the reported cost of relevant medical treatments , medical consultations , relevant hospitalisation , and income loss . RESULTS Families of children with moderate or severe atopic eczema had a significantly higher impact on family score than families of diabetic children . A conservative estimate of the annual personal financial cost of managing mild , moderate , and severe eczema was Aus$330 , 818 , and 1255 , respectively . The financial cost to the community for the management of atopic eczema in the study groups was greater . The personal financial cost of managing eczema was greater than for asthma . CONCLUSION Childhood atopic eczema has a profound impact on the social , personal , emotional , and financial perspectives of families It is uncertain whether B group vitamins are risk or preventive factors for allergic disorders . We prospect ively investigated the association between maternal intake of folate and vitamins B(12 ) , B(6 ) , and B(2 ) during pregnancy and the risk of wheeze and eczema in the infants aged 16 - 24 months . Subjects were 763 Japanese mother-child pairs . Data on maternal intake during pregnancy were assessed with a diet history question naire ( DHQ ) . Symptoms of wheeze and eczema were based on criteria of the International Study of Asthma and Allergies in Childhood . Among 763 infants , 169 ( 22.1 % ) and 142 ( 18.6 % ) had symptoms of wheeze and eczema , respectively . There were no evident relationships between maternal consumption of folate , vitamin B(12 ) , vitamin B(6 ) , and vitamin B(2 ) during pregnancy and the risk of wheeze or eczema in the offspring after adjustment for maternal age , gestation at baseline , residential municipality at baseline , family income , maternal and paternal education , maternal and paternal history of asthma , atopic eczema , and allergic rhinitis , changes in maternal diet in the previous 1 month , season when data at baseline were collected , maternal smoking during pregnancy , baby 's older siblings , baby 's sex , baby 's birth weight , household smoking in the same room as the infant , breastfeeding duration , age at which solid foods were introduced , age of infant at the third survey , and maternal intake of docosahexaenoic acid , n-6 polyunsaturated fatty acids , vitamin D , calcium , vitamin E , and β-carotene during pregnancy . Further investigation is warranted to draw conclusions as to the question of OUTPUT: There is no convincing evidence of the benefit of dietary supplements in eczema , and they can not be recommended for the public or for clinical practice at present . Whilst some may argue that at least supplements do not do any harm , high doses of vitamin D may give rise to serious medical problems , and the cost of long-term supplements may also mount up INPUT: Abstract Background : Atopic dermatitis is a chronically relapsing , highly pruritic and inflammatory skin disease . This study was done to assess the effects of vitamins D and E supplementation on the clinical manifestation of atopic dermatitis . Methods : Forty-five atopic dermatitis patients were included in a r and omized , double-blind , placebo-controlled trial . They were r and omly divided into four groups and treated for 60 days : group P ( n = 11 ) , vitamins D and E placebos ; group D ( n = 12 ) , 1600 IU vitamin D3 plus vitamin E placebo ; group E ( n = 11 ) , 600 IU synthetic all-rac-α-tocopherol plus vitamin D placebo ; and group DE ( n = 11 ) , 1600 IU vitamin D3 plus 600 IU synthetic all-rac-α-tocopherol . Serum 25(OH ) vitamin D and plasma α-tocopherol were determined before and after the trial . The clinical improvement was evaluated with SCORing Atopic Dermatitis ( SCORAD ) . Data were analyzed by analysis of variance ( ANOVA ) and Kruskal-Wallis tests . Results : SCORAD was reduced after 60 days in groups D , E and DE by 34.8 % , 35.7 % and 64.3 % , respectively ( p = 0.004 ) . Objective SCORAD also showed significant improvement . There was a positive correlation between SCORAD and intensity , objective , subjective and extent ( p < 0.001 ) . We found a significant negative association between plasma α-tocopherol and SCORAD , intensity , objective and extent ( p = 0.02 ) . Conclusion : This study supports the contributing and beneficial effects of vitamins D and E in the treatment of atopic dermatitis BACKGROUND Subjects with atopic dermatitis ( AD ) have defects in antimicrobial peptide ( AMP ) production possibly contributing to an increased risk of infections . In laboratory models , vitamin D can alter innate immunity by increasing AMP production . OBJECTIVE To determine if AD severity correlates with baseline vitamin D levels , and to test whether supplementation with oral vitamin D alters AMP production in AD skin . METHODS This was a multi-centre , placebo-controlled , double-blind study in 30 subjects with AD , 30 non-atopic subjects , and 16 subjects with psoriasis . Subjects were r and omized to receive either 4000 IU of cholecalciferol or placebo for 21 days . At baseline and day 21 , levels of 25-hydroxyvitamin D ( 25OHD ) , cathelicidin , HBD-3 , IL-13 , and Eczema Area and Severity Index ( EASI ) and Rajka-Langel and scores were obtained . RESULTS At baseline , 20 % of AD subjects had serum 25OHD below 20 ng/mL. Low serum 25OHD correlated with increased Fitzpatrick Skin Type and elevated BMI , but not AD severity . After 21 days of oral cholecalciferol , mean serum 25OHD increased , but there was no significant change in skin cathelicidin , HBD-3 , IL-13 or EASI scores . CONCLUSIONS This study illustrated that darker skin types and elevated BMI are important risk factors for vitamin D deficiency in subjects with AD , and highlighted the possibility that seasonality and locale may be potent contributors to cathelicidin induction through their effect on steady state 25OHD levels . Given the molecular links between vitamin D and immune function , further study of vitamin D supplementation in subjects with AD is warranted BACKGROUND The role of vitamin D in Atopic Dermatitis ( AD ) is ambiguous and clinical trials are needed to assess the role of vitamin D in the treatment of AD . The aim of this clinical trial study to evaluate the effect of vitamin D supplementation on patients with AD . MATERIAL AND METHODS sixty AD patients were included in a r and omized , double-blind , placebo-controlled trial study . They were r and omly divided into two groups and treated for 60 days : group vitamin D ( n=30 ) , and placebo group ( n=30 ) . The two groups were as follows : Group D , 1600 IU cholecalciferol ( vitamin D ) and second group placebo . The severity of AD was evaluated based on SCORAD ( Scoring Atopic Dermatitis ) and TIS ( Three Item Severity score ) value by the same trained physician before and after the trial . RESULTS According to SCORAD and TIS value index in the vitamin D group showed significant improvement in patients with mild , moderate and severe AD ( P<0.05 ) and in patients who the intake placebo , this improvement did n't showed ( P>0.05 ) . CONCLUSION Results mention that supplementation with oral vitamin D dramatically improved disease severity in AD patients BACKGROUND Vitamin E ( VE ) is a potent antioxidant that can improve the immune macrophage-mediated response , decrease the production and /or release of prostagl and ins in humans , and decrease the serum levels of immunoglobulin E ( IgE ) in atopic subjects . AIM To compare the effects of placebo ( PL ) and VE intake ( 400 IU/day ) on subjective symptoms and serum IgE levels in 96 subjects with atopic dermatitis . MATERIAL S AND METHODS A single-blind clinical analysis was performed on 96 subjects r and omly divided into two groups . Fifty subjects were given orally 400 IU ( 268 mg ) of VE of natural origin , once a day for 8 months , and 46 took PL for the same period . Complete blood count , serum IgE levels , radioallergosorbent test ( OUTPUT:

Vitamin D has a potentially significant role for improving the symptoms of AD . The results from this study suggest that vitamin D supplementation may help ameliorate the severity of AD , and can be considered as a safe and tolerable therapy .

MS2_dynamic_1_shot624

***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: BACKGROUND Treatment of hypertension with diuretics , beta-blockers , or both leads to improved outcomes . It has been postulated that agents that inhibit the renin-angiotensin system confer benefit beyond the reduction of blood pressure alone . We compared the outcomes in older subjects with hypertension who were treated with angiotensin-converting-enzyme ( ACE ) inhibitors with the outcomes in those treated with diuretic agents . METHODS We conducted a prospect i ve , r and omized , open-label study with blinded assessment of end points in 6083 subjects with hypertension who were 65 to 84 years of age and received health care at 1594 family practice s. Subjects were followed for a median of 4.1 years , and the total numbers of cardiovascular events in the two treatment groups were compared with the use of multivariate proportional-hazards models . RESULTS At base line , the treatment groups were well matched in terms of age , sex , and blood pressure . By the end of the study , blood pressure had decreased to a similar extent in both groups ( a decrease of 26/12 mm Hg ) . There were 695 cardiovascular events or deaths from any cause in the ACE-inhibitor group ( 56.1 per 1000 patient-years ) and 736 cardiovascular events or deaths from any cause in the diuretic group ( 59.8 per 1000 patient-years ; the hazard ratio for a cardiovascular event or death with ACE-inhibitor treatment was 0.89 [ 95 percent confidence interval , 0.79 to 1.00 ] ; P=0.05 ) . Among male subjects , the hazard ratio was 0.83 ( 95 percent confidence interval , 0.71 to 0.97 ; P=0.02 ) ; among female subjects , the hazard ratio was 1.00 ( 95 percent confidence interval , 0.83 to 1.21 ; P=0.98 ) ; the P value for the interaction between sex and treatment-group assignment was 0.15 . The rates of nonfatal cardiovascular events and myocardial infa rct ions decreased with ACE-inhibitor treatment , whereas a similar number of strokes occurred in each group ( although there were more fatal strokes in the ACE-inhibitor group ) . CONCLUSIONS Initiation of antihypertensive treatment involving ACE inhibitors in older subjects , particularly men , appears to lead to better outcomes than treatment with diuretic agents , despite similar reductions of blood pressure CONTEXT Hypertension is associated with a significantly increased risk of morbidity and mortality . Only diuretics and beta-blockers have been shown to reduce this risk in long-term clinical trials . Whether newer antihypertensive agents reduce the incidence of cardiovascular disease ( CVD ) is unknown . OBJECTIVE To compare the effect of doxazosin , an alpha-blocker , with chlorthalidone , a diuretic , on incidence of CVD in patients with hypertension as part of a study of 4 types of antihypertensive drugs : chlorthalidone , doxazosin , amlodipine , and lisinopril . DESIGN R and omized , double-blind , active-controlled clinical trial , the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial , initiated in February 1994 . In January 2000 , after an interim analysis , an independent data review committee recommended discontinuing the doxazosin treatment arm based on comparisons with chlorthalidone . Therefore , outcomes data presented herein reflect follow-up through December 1999 . SETTING A total of 625 centers in the United States and Canada . PARTICIPANTS A total of 24,335 patients ( aged > or = 55 years ) with hypertension and at least 1 other coronary heart disease ( CHD ) risk factor who received either doxazosin or chlorthalidone . INTERVENTIONS Participants were r and omly assigned to receive chlorthalidone , 12.5 to 25 mg/d ( n=15,268 ) , or doxazosin , 2 to 8 mg/d ( n=9067 ) , for a planned follow-up of 4 to 8 years . MAIN OUTCOME MEASURES The primary outcome measure was fatal CHD or nonfatal myocardial infa rct ion ( MI ) , analyzed by intent to treat ; secondary outcome measures included all-cause mortality , stroke , and combined CVD ( CHD death , nonfatal MI , stroke , angina , coronary revascularization , congestive heart failure [ CHF ] , and peripheral arterial disease ) ; compared by the chlorthalidone group vs the doxazosin group . RESULTS Median follow-up was 3.3 years . A total of 365 patients in the doxazosin group and 608 in the chlorthalidone group had fatal CHD or nonfatal MI , with no difference in risk between the groups ( relative risk [ RR ] , 1.03 ; 95 % confidence interval [ CI ] , 0.90 - 1.17 ; P=.71 ) . Total mortality did not differ between the doxazosin and chlorthalidone arms ( 4-year rates , 9.62 % and 9.08 % , respectively ; RR , 1.03 ; 95 % CI , 0.90 - 1.15 ; P=.56 . ) The doxazosin arm , compared with the chlorthalidone arm , had a higher risk of stroke ( RR , 1.19 ; 95 % CI , 1.01 - 1.40 ; P=.04 ) and combined CVD ( 4-year rates , 25.45 % vs 21.76 % ; RR , 1.25 ; OUTPUT: Our data suggest that the best available evidence seems to favor TL diuretics as the drug of choice when thiazide treatment is considered for hypertension INPUT: BACKGROUND Treatment of hypertension with diuretics , beta-blockers , or both leads to improved outcomes . It has been postulated that agents that inhibit the renin-angiotensin system confer benefit beyond the reduction of blood pressure alone . We compared the outcomes in older subjects with hypertension who were treated with angiotensin-converting-enzyme ( ACE ) inhibitors with the outcomes in those treated with diuretic agents . METHODS We conducted a prospect i ve , r and omized , open-label study with blinded assessment of end points in 6083 subjects with hypertension who were 65 to 84 years of age and received health care at 1594 family practice s. Subjects were followed for a median of 4.1 years , and the total numbers of cardiovascular events in the two treatment groups were compared with the use of multivariate proportional-hazards models . RESULTS At base line , the treatment groups were well matched in terms of age , sex , and blood pressure . By the end of the study , blood pressure had decreased to a similar extent in both groups ( a decrease of 26/12 mm Hg ) . There were 695 cardiovascular events or deaths from any cause in the ACE-inhibitor group ( 56.1 per 1000 patient-years ) and 736 cardiovascular events or deaths from any cause in the diuretic group ( 59.8 per 1000 patient-years ; the hazard ratio for a cardiovascular event or death with ACE-inhibitor treatment was 0.89 [ 95 percent confidence interval , 0.79 to 1.00 ] ; P=0.05 ) . Among male subjects , the hazard ratio was 0.83 ( 95 percent confidence interval , 0.71 to 0.97 ; P=0.02 ) ; among female subjects , the hazard ratio was 1.00 ( 95 percent confidence interval , 0.83 to 1.21 ; P=0.98 ) ; the P value for the interaction between sex and treatment-group assignment was 0.15 . The rates of nonfatal cardiovascular events and myocardial infa rct ions decreased with ACE-inhibitor treatment , whereas a similar number of strokes occurred in each group ( although there were more fatal strokes in the ACE-inhibitor group ) . CONCLUSIONS Initiation of antihypertensive treatment involving ACE inhibitors in older subjects , particularly men , appears to lead to better outcomes than treatment with diuretic agents , despite similar reductions of blood pressure Effects of once‐daily doses of 50 mg triamterene with 25 mg hydrochlorothiazide and 5 mg amiloride with 50 mg hydrochlorothiazide were compared in a r and omized , multicenter study of 84 adult subjects with mild to moderate hypertension ( diastolic blood pressure 90 to 114 mm Hg ) . After a 3‐wk placebo lead‐in period , the subjects entered a 6‐wk treatment period . The two drug regimens were compared with respect to antihypertensive effects and effects on serum potassium and magnesium levels during the final week of drug therapy , with the use of the last week of placebo therapy as a covariate . Both drug regimens substantially reduced mean supine systolic and diastolic blood pressures to well within normal limits ; there was no significant difference between the two groups . Twenty‐four of the 41 subjects receiving triamterene‐hydrochlorothiazide ( 59 % ) and 29 of the 43 patients receiving amiloride‐hydrochlorothiazide ( 67 % ) had diastolic blood pressure < 90 mm Hg at week 9 . Five subjects receiving amiloride‐hydrochlorothiazide ( 12 % ) and two subjects receiving triamterene‐hydrochlorothiazide ( 5 % ) had hypokalemia ( serum potassium level < 3.5 mEq/l ) at week 9 . The average decrease in serum potassium levels during amiloride‐hydrochlorothiazide therapy ( −0.33 ± 0.08 mEq/l ) was greater than that after triamterene‐hydrochlorothiazide ( −0.08 ± 0.07 mEq/l ) . Serum magnesium levels were not changed by either regimen . Weight loss was greater in the amiloride‐hydrochlorothiazide group than in the triamterene‐hydrochlorothiazide group . It is reasonable to assume that the greater potassium loss during amiloride‐hydrochlorothiazide therapy than during triamterene‐hydrochlorothiazide therapy was a consequence of the larger dose of hydrochlorothiazide in the former ( 50 mg ) compared with the latter ( 25 mg ) . Although the effect on lowering blood pressure by amiloride‐hydrochlorothiazide was slightly greater than that by triamterene‐hydrochlorothiazide ( also consistent with the larger dose of hydrochlorothiazide ) , the difference was small and not significant . Triamterene‐hydrochlorothiazide at low doses is effective in the treatment of hypertension 1 . The relationship between fall in systolic blood pressure and initial systolic blood pressure has been investigated in 255 mixed normotensive and hypertensive subjects given placebo or one of five types of antihypertensive drug ( ACE inhibitors , calcium antagonists , direct vasodilators , alpha-adrenoceptor blocker , beta-adrenoceptor blocker ) . 2 . In all cases there was a significant correlation between the change in blood pressure and initial blood pressure . When Oldham 's transformation was used ( replacing the initial blood pressure by the mean of the initial and minimum pressures ) the correlation coefficients were all reduced , although five out of six were still statistically significant . 3 . In a subset of 43 hypertensive subjects given four anti OUTPUT:

Differences in antihypertensive effect were due to potency rather than efficacy . This synthesis accomplishes for PSDs what has already been achieved for thiazide-type diuretics and other antihypertensives and can guide the application of these underutilized medicines

MS2_dynamic_1_shot625

***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: Neuroendocrine abnormalities , such as activation of the hypothalamic-pituitary-adrenal ( HPA ) axis , are associated with obesity ; however , few large-scale population -based studies have examined HPA axis and markers of obesity . We examined the cross-sectional association of the cortisol awakening response ( CAR ) and diurnal salivary cortisol curve with obesity . The Multi-Ethnic Study of Atherosclerosis ( MESA ) Stress Study includes 1,002 White , Hispanic , and Black men and women ( mean age 65±9.8 years ) who collected up to 18 salivary cortisol sample s over 3 days . Cortisol profiles were modeled using regression spline models that incorporated r and om parameters for subject-specific effects . Cortisol curve measures included awakening cortisol , CAR ( awakening to 30 minutes post-awakening ) , early decline ( 30 minutes to 2 hours post-awakening ) , late decline ( 2 hours post-awakening to bedtime ) , and the corresponding areas under the curve ( AUC ) . Body-mass-index ( BMI ) and waist circumference ( WC ) were used to estimate adiposity . For the entire cohort , both BMI and WC were negatively correlated with awakening cortisol ( p<0.05 ) , AUC during awakening rise and early decline and positively correlated to the early decline slope ( p<0.05 ) after adjustments for age , race/ethnicity , gender , diabetes status , socioeconomic status , beta blockers , steroids , hormone replacement therapy and smoking status . No heterogeneities of effects were observed by gender , age , and race/ethnicity . Higher BMI and WC are associated with neuroendocrine dysregulation , which is present in a large population sample , and only partially explained by other covariates Chronically stressed rodents who are allowed to eat calorie-dense " comfort " food develop greater mesenteric fat , which in turn dampens hypothalamic-pituitary-adrenocortical ( HPA ) axis activity . We tested whether similar relations exist in humans , at least cross-sectionally . Fifty-nine healthy premenopausal women were exposed to a st and ard laboratory stressor to examine HPA response to acute stress and underwent diurnal saliva sampling for basal cortisol and response to dexamethasone administration . Based on perceived stress scores , women were divided into extreme quartiles of low versus high stress categories . We found as hypothesized that the high stress group had significantly greater BMI and sagittal diameter , and reported greater emotional eating . In response to acute lab stressor , the high stress group showed a blunted cortisol response , lower diurnal cortisol levels , and greater suppression in response to dexamethasone . These cross-sectional findings support the animal model , which suggests that long-term adaptation to chronic stress in the face of dense calories result in greater visceral fat accumulation ( via ingestion of calorie-dense food ) , which in turn modulates HPA axis response , result ing in lower cortisol levels 11beta-Hydroxysteroid dehydrogenase type 1 ( 11HSD1 ) regenerates cortisol from cortisone within adipose tissue and liver . 11HSD1 inhibitors may enhance insulin sensitivity in type 2 diabetes and be most efficacious in obesity when 11HSD1 is increased in subcutaneous adipose biopsies . We examined the regeneration of cortisol in vivo in obesity , and the effects of the 11HSD1 inhibitor carbenoxolone . We compared six lean and six obese men and performed a r and omized , placebo-controlled crossover study of carbenoxolone in obese men . The obese men had no difference in their whole-body rate of regenerating cortisol ( measured with 9,11,12,12-[(2)H(4)]cortisol tracer ) , but had more rapid conversion of [(3)H]cortisone to [(3)H]cortisol in abdominal subcutaneous adipose tissue ( measured with microdialysis ) . During insulin infusion , adipose 11HSD1 activity fell markedly in lean but not in obese men . Carbenoxolone inhibited whole-body cortisol regeneration , but did not significantly inhibit adipose 11HSD1 and had no effects on insulin sensitivity ( measured by [(2)H(2)]glucose infusion with or without hyperinsulinemia ) . Thus , in vivo cortisol generation is increased selectively within adipose tissue in obesity , perhaps reflecting resistance to insulin-mediated downregulation of 11HSD1 . However , obese men are less susceptible than lean men to the insulin-sensitizing effects of carbenoxolone . To be useful in obese patients , 11HSD1 inhibitors will need to inhibit the enzyme more effectively in adipose tissue Free cortisol measured in saliva has been shown to have the same diurnal rhythm as serum cortisol , one that typically declines rapidly throughout the waking day . A recent study showed that over 15 % of a sample of community individuals who were monitored over two days did not show the typical diurnal rhythm . The present study specifically tested the hypothesis that there is significant between-subject variation ( individual differences ) in diurnal rhythms using multi-level , r and om regression models . Analyses of participants from four studies were conducted ; studies varied in terms of the number of saliva sample s taken per day , the number of days studied , and participants ' demographic and health status . Significant individual differences of diurnal cycle in each of the four sample s were found . In at least 10 % of each sample no significant diurnal cycles was detected ; however , the overall mean level of cortisol of those with flat cycles differed among the sample s. These results suggest that some people do not have the expected diurnal rhythm of cortisol OUTPUT: RESULTS A general pattern of findings emerged where greater abdominal fat is associated with greater responsivity of the HPA axis , reflected in morning awakening and acute stress reactivity , but some studies did show underresponsiveness . When examined in adipocytes , there is a clear upregulation of cortisol output ( due to greater expression of 11β-HSD1 ) , but in hepatic tissue this cortisol is downregulated . Overall obesity ( BMI ) appears to also be related to a hyperresponsive HPA axis in many but not all studies , such as when acute reactivity is examined . INPUT: AIMS Type 2 diabetes mellitus ( DM ) develops when insulin resistance overcomes the capacity of compensatory insulin secretion . Insulin resistance may be induced via psychoneuroendocrine pathways , a possibility which has received little previous attention . METHODS We have used salivary cortisol measurements to monitor the activity of the hypothalamic-pituitary-adrenal ( HPA ) axis , the major controller of hormones involved in the regulation of peripheral insulin sensitivity under everyday conditions . The influence of external challenges , as well as the sensitivity of feedback regulation , were followed in r and omly selected middle-aged population sample s. RESULTS In health there is a rhythmicity of cortisol secretion , with a high plasticity and efficient feedback control . In contrast , a group of subjects were identified with a flat , rigid day curve and poor feedback control , who showed consistent abnormalities in stress-related cortisol secretion , including inhibited secretions of sex steroids and growth hormone ; insulin resistance ; abdominal obesity ; elevated leptin levels ; hyperglycaemia ; dyslipidaemia and hypertension with elevated heart rate . The endocrine abnormalities are probably responsible for the anthropometric and metabolic abnormalities . The circulatory perturbations seem to be induced by a parallel activation of the central sympathetic nervous system suggesting an ' hypothalamic arousal syndrome ' , gradually developing into an independent risk for disease . An associated cluster of environmental factors , including psychosocial and socio-economic stress , traits of depression and anxiety , alcohol consumption and smoking , all factors known to activate hypothalamic centres , has been identified . A polymorphism of the glucocorticoid receptor gene , with 13.7 % homozygotes in the male Swedish population , parallels receptor dysfunction , and may be responsible for the associated insulin resistance , central obesity and hypertension . CONCLUSIONS This is the first detailed examination of psychoneuroendocrinological processes in the natural environment on a population basis in relation to somatic health . The results suggest that an hypothalamic arousal syndrome , with parallel activation of the HPA axis and the central sympathetic nervous system , is responsible for development of endocrine abnormalities , insulin resistance , central obesity , dyslipidaemia and hypertension , leading to frank disease , including Type 2 DM . We suggest that this syndrome is probably based on environmental pressures in genetically susceptible individuals Background Type 2 diabetes is a major health problem in many countries including India . Yoga may be an effective type 2 diabetes prevention strategy in India , particularly given its cultural familiarity . Methods This was a parallel , r and omized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes . Primary outcomes included : changes in BMI , waist circumference , fasting blood glucose , postpr and ial blood glucose , insulin , insulin resistance , blood pressure , and cholesterol . We also looked at measures of psychological well-being including changes in depression , anxiety , positive and negative affect and perceived stress . Forty-one participants with elevated fasting blood glucose in Bangalore , India were r and omized to either yoga ( n = 21 ) or a walking control ( n = 20 ) . Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks . R and omization and allocation was performed using computer-generated r and om numbers and group assignments delivered in sealed , opaque envelopes generated by off-site study staff . Data were analyzed based on intention to treat . Results This study was feasible in terms of recruitment , retention and adherence . In addition , yoga participants had significantly greater reductions in weight , waist circumference and BMI versus control ( weight −0.8 ± 2.1 vs. 1.4 ± 3.6 , p = 0.02 ; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2 , p < 0.01 ; BMI −0.2 ± 0.8 vs. 0.6 ± 1.6 , p = 0.05 ) . There were no between group differences in fasting blood glucose , postpr and ial blood glucose , insulin resistance or any other factors related to diabetes risk or psychological well-being . There were significant reductions in systolic and diastolic blood pressure , total cholesterol , anxiety , depression , negative affect and perceived stress in both the yoga intervention and walking control over the course of the study . Conclusion Among Indians with elevated fasting blood glucose , we found that participation in an 8-week yoga intervention was feasible and result ed in greater weight loss and reduction in waist circumference when compared to a walking control . Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being . Trial registration Clinical Trials.gov Identified NCT00090506 Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design In a prospect i ve , r and omised , controlled trial to determine whether comprehensive lifestyle changes affect coronary atherosclerosis after 1 year , 28 patients were assigned to an experimental group ( low-fat vegetarian diet , stopping smoking , OUTPUT:

This meta- analysis uncovered clinical ly improved effects of yoga intervention on glycemic control , lipid profiles and other parameters of T2DM management in prediabetic population . These results suggest that yoga intervention may be considered as a comprehensive and alternative approach to preventing T2DM .

MS2_dynamic_1_shot626

***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: OBJECTIVE In a naturalistic follow-up of adult bipolar patients , the authors examined the contributions of demographic , phenomenological , and clinical variables , including antidepressant use , to prospect ively observed mood episode frequency . METHOD For 1,742 bipolar I and II patients in the Systematic Treatment Enhancement Program for Bipolar Disorder ( STEP-BD ) , episodes of mood disorders were evaluated for up to 1 year of treatment . RESULTS At entry , 32 % of the patients met the DSM-IV criteria for rapid cycling in the pre study year . Of the 1,742 patients , 551 ( 32 % ) did not complete 1 year of treatment . Among the 1,191 patients remaining , those with prior rapid cycling ( N=356 ) were more likely to have further recurrences , although not necessarily more than four episodes per year . At the end of 12 months , only 5 % ( N=58 ) of the patients could be classified as rapid cyclers ; 34 % ( N=409 ) had no further mood episodes , 34 % ( N=402 ) experienced one episode , and 27 % ( N=322 ) had two or three episodes . Patients who entered the study with earlier illness onset and greater severity were more likely to have one or more episodes in the prospect i ve study year . Antidepressant use during follow-up was associated with more frequent mood episodes . CONCLUSIONS While DSM-IV rapid cycling was prospect ively observed in only a small percentage of patients , the majority of these patients had continued recurrences at lower but clinical ly significant rates . This suggests that cycling is on a continuum and that prevention of recurrences may require early intervention and restricted use of antidepressants To determine the risk factors for suicide , 6,891 psychiatric out patients were evaluated in a prospect i ve study . Subsequent deaths for the sample were identified through the National Death Index . Forty-nine ( 1 % ) suicides were determined from death certificates obtained from state vital statistics offices . Specific psychological variables that could be modified by clinical intervention were measured using st and ardized scales . Univariate survival analyses revealed that the severity of depression , hopelessness , and suicide ideation were significant risk factors for eventual suicide . A multivariate survival analysis indicated that several modifiable variables were significant and unique risk factors for suicide , including suicide ideation , major depressive disorder , bipolar disorder , and unemployment status BACKGROUND Clinical factors related to suicide and suicide attempts have been studied much more extensively in unipolar depression compared with bipolar disorder . We investigated demographic and course-of-illness variables to better underst and the incidence and potential clinical correlates of serious suicide attempts in 648 out patients with bipolar disorder . METHOD Patients with bipolar I or II disorder ( DSM-IV criteria ) diagnosed with structured interviews were evaluated using self-rated and clinician-rated question naires to assess incidence and correlates of serious suicide attempts prior to study entry . Clinician prospect i ve ratings of illness severity were compared for patients with and without a history of suicide attempt . RESULTS The 34 % of patients with a history of suicide attempts , compared with those without such a history , had a greater positive family history of drug abuse and suicide ( or attempts ) ; a greater personal history of early traumatic stressors and more stressors both at illness onset and for the most recent episode ; more hospitalizations for depression ; a course of increasing severity of mania ; more Axis I , II , and III comorbidities ; and more time ill on prospect i ve follow-up . In a hierarchical logistic regression , a history of sexual abuse , lack of confidant prior to illness onset , more prior hospitalizations for depression , suicidal thoughts when depressed , and cluster B personality disorder remained significantly associated with a serious suicide attempt . CONCLUSION Our retrospective findings , supplemented by prospect i ve follow-up , indicate that a history of suicide attempts is associated with a more difficult course of bipolar disorder and the occurrence of more psychosocial stressors at many different time domains . Greater attention to recognizing those at highest risk for suicide attempts and therapeutic efforts aim ed at some of the correlates identified here could have an impact on bipolar illness-related morbidity and mortality ABSTRACT There is no data on the variation in the suicide risk over lifetime and on the suicide-preventive effect of the long-term treatment of mood-disorder patients with antidepressants and neuroleptics . Our research focused on 186 unipolar ( D ) , 60 bipolar II ( Dm ) , 130 nuclear bipolar I ( MD ) , and 30 preponderantly manic patients ( M/Md ) ; that were followed-up from 1963 to 2003 . By 2003 , 45 ( 11.1 % ) of the 406 patients had committed suicide . Suicide rates were highest among D patients ( St and ardized Mortality Ratio , SMR = 26.4 ) , MD ( SMR = 13.6 ) , Dm ( SMR = 10.6 ) and lowest among M/Md patients ( SMR = 4.7 ) . Prospect ively , the suicide rate decreased over the 44 years ' follow-up ; Lithium , neuroleptics and antidepressants reduced suicides significantly . Long-term treatment also reduced overall mortality , and combined treatments proved more effective than mono-therapy OBJECTIVE Antidepressants are supposed to be withdrawn during a manic episode . The aim of this study was to analyze the characteristics of manic patients who received antidepressants during a manic phase in a large , naturalistic study . METHOD The European Mania in Bipolar Longitudinal Evaluation of Medication was a 2-year prospect i ve observational study of in patients and out patients with acute mania/mixed mania ( DSM-IV or ICD-10 criteria ) conducted in 14 European countries . Of 2,416 manic patients who continued OUTPUT: This meta- analysis confirmed that SA is common in BD and identified a number of factors related to SA . INPUT: As many as 45 % of patients with major depressive episode also meet DSM-IV criteria for bipolar II ( BP II ) disorder . Although some clinicians advocate using a mood stabilizer in treating BP II depression , antidepressant monotherapy has been less well studied in this disorder . As part of a prospect i ve , placebo-controlled , relapse-prevention study in 839 patients , the efficacy and safety of short- and long-term fluoxetine treatment in patients with BP II major depression compared with patients with unipolar ( UP ) major depression was retrospectively examined . Eighty-nine BP II patients ( mean age , 41+/-11 years ) were compared with 89 age- and gender-matched UP patients and with 661 unmatched UP patients ( mean age , 39+/-11 years ) . All received short-term fluoxetine therapy at 20 mg daily for up to 12 weeks . Complete remission was defined as a final Hamilton Rating Scale for Depression score < or = 7 by week 9 that was then maintained for 3 additional weeks . Remitted patients were then r and omly assigned to receive double-blind treatment with one of the following : ( 1 ) fluoxetine 20 mg daily for 52 weeks ; ( 2 ) fluoxetine for 38 weeks , then placebo for 14 weeks ; ( 3 ) fluoxetine for 14 weeks , then placebo for 38 weeks ; or ( 4 ) placebo for 52 weeks . Antidepressant efficacy was similar in BP and UP patients during short-term therapy . Discontinuation for lack of efficacy was lower in BP II ( 5 % ) than in UP ( 12 % ) patients ( p = not significant [ NS ] ) , whereas dropouts for adverse events were similar in BP II ( 11 % ) and UP ( 9 % ) patients . During long-term relapse-prevention therapy , relapse rates were similar in BP II and UP patients ( p = NS ) . During short-term fluoxetine therapy , three BP II ( 3.8 % ) versus no matched UP ( p = NS ) and 0.3 % unmatched UP ( p = 0.01 ) patients had a " manic switch . " During long-term fluoxetine therapy , one ( 2 % ) BP II and three ( 1 % ) unmatched UP patients ( one taking placebo ) had a manic switch ( p = NS ) . In conclusion , fluoxetine may be a safe and effective antidepressant monotherapy for the short-term treatment of BP II depression with a relatively low manic switch rate . Fluoxetine may also be effective in relapse-prevention therapy in patients with BP II disorder CONTEXT The phenomenology of bipolar I disorder affects treatment and prognosis . OBJECTIVE To describe the duration of bipolar I mood episodes and factors associated with recovery from these episodes . DESIGN Subjects with Research Diagnostic Criteria bipolar I disorder were prospect ively followed up for as long as 25 years . The probability of recovery over time from multiple successive mood episodes was examined with survival analytic techniques , including a mixed-effects grouped-time survival model . SETTING Five US academic medical centers . PARTICIPANTS Two hundred nineteen subjects with bipolar I disorder . MAIN OUTCOME MEASURES Level of psychopathology was assessed with the Longitudinal Interval Follow-up Evaluation every 6 months for the first 5 years of follow-up and annually thereafter . RESULTS The median duration of bipolar I mood episodes was 13 weeks . More than 75 % of the subjects recovered from their mood episodes within 1 year of onset . The probability of recovery was significantly less for an episode with severe onset ( psychosis or severe psychosocial impairment in week 1 of the episode ) ( hazard ratio [ HR ] = 0.746 ; 95 % confidence interval [ CI ] , 0.578 - 0.963 ; P = .02 ) and for subjects with greater cumulative morbidity ( total number of years spent ill with any mood episode ) ( HR = 0.917 ; 95 % CI , 0.886 - 0.948 ; P < .001 ) . Compared with the probability of recovery from a major depressive episode , there was a significantly greater probability of recovery from an episode of mania ( HR = 1.713 ; 95 % CI , 1.373 - 2.137 ; P < .001 ) , hypomania ( HR = 4.502 ; 95 % CI , 3.466 - 5.849 ; P < .001 ) , or minor depression ( HR = 2.027 ; 95 % CI , 1.622 - 2.534 ; P < .001 ) and , conversely , a significantly reduced probability of recovery from a cycling episode ( switching from one pole to the other without an intervening period of recovery ) ( HR = 0.438 ; 95 % CI , 0.351 - 0.548 ; P < .001 ) . CONCLUSIONS The median duration of bipolar I mood episodes was 13 weeks , and the probability of recovery was significantly decreased for cycling episodes , mood episodes with severe onset , and subjects with greater cumulative morbidity In a small study of up to 3 years ' duration comparison of the value of amitriptyline alone versus amitriptyline + lithium in unipolar cases ( 27 patients ) and of that of lithium alone versus amitriptyline + lithium in bipolar cases ( 13 patients ) showed no advantage for the combination treatments in terms of efficacy in reducing depressive relapses . There was no effect of treatment , developing depression or developing hypothyroidism upon the psychological tests which were conducted during this prolonged study . Observer and self ratings detected an increase in depression before relapse was clearly present , but of the various psychological assessment s conducted only arousal showed changes in association with developing and definite relapse OUTPUT:

Antidepressants were superior to placebo in reducing new depressive episodes in bipolar disorders without increasing risk of new manic/hypomanic episodes either used as monotherapy or in combination with MS . Subgroup analyses revealed that greater benefit and lower risk may be achieved in BD II than in BD I. However , compared with MS monotherapy , AD monotherapy significantly increased the risk of affective switch with no improvement in prophylaxis of new depressive episodes . CONCLUSIONS Reduced new depressive episodes may be achieved by long-term AD treatment with no significantly increased risk of new manic/hypomanic episodes in BD , particularly in BD II . The elevated risk of affective switch of AD monotherapy compared with MS monotherapy may be contributed to the protective effect of MS in diminishing manic/hypomanic episodes .

MS2_dynamic_1_shot627

***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: BACKGROUND Concerns regarding the risk of estrogen replacement have result ed in a significant increase in the use of soy products by menopausal women who , despite the lack of evidence of the efficacy of such products , seek alternatives to menopausal hormone therapy . Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms . METHODS The study design was a single-center , r and omized , placebo-controlled , double-blind clinical trial conducted from July 1 , 2004 , through March 31 , 2009 . Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were r and omly assigned , in equal proportions , to receive daily soy isoflavone tablets , 200 mg , or placebo . The primary outcome was changes in bone mineral density in the lumbar spine , total hip , and femoral neck at the 2-year follow-up . Secondary outcomes included changes in menopausal symptoms , vaginal cytologic characteristics , N -telopeptide of type I bone collagen , lipids , and thyroid function . RESULTS After 2 years , no significant differences were found between the participants receiving soy tablets ( n = 122 ) and those receiving placebo ( n = 126 ) regarding changes in bone mineral density in the spine ( -2.0 % and -2.3 % , respectively ) , the total hip ( -1.2 % and -1.4 % , respectively ) , or the femoral neck ( -2.2 % and -2.1 % , respectively ) . A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group . No significant differences were found between groups in other outcomes . CONCLUSIONS In this population , the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00076050 Objective This study aims to evaluate the effects of soy isoflavones on breast tissue in postmenopausal women . Methods In this r and omized , double-blind , placebo-controlled study , 80 women ( aged ≥45 y and with amenorrhea > 12 mo ) with vasomotor symptoms were r and omized to receive either 250 mg of st and ardized soy extract corresponding to isoflavone 100 mg/day ( n = 40 ) or placebo ( n = 40 ) for 10 months . Breasts were evaluated through mammographic density and breast parenchyma using ultrasound ( US ) at baseline and 10-month follow-up . Independent t test , analysis of variance , Mann-Whitney U test , and & khgr;2 trend test were used in statistical analysis . Results Baseline clinical characteristics showed no significant differences between the isoflavone group and the placebo group , with mean ( SD ) age of 55.1 ( 6.0 ) and 56.2 ( 7.7 ) years , mean ( SD ) menopause duration of 6.6 ( 4.8 ) and 7.1 ( 4.2 ) years , and mean ( SD ) body mass index of 29.7 ( 5.0 ) and 28.5 ( 4.9 ) kg/m2 , respectively ( P > 0.05 ) . The study was completed by 32 women on isoflavone and 34 women on placebo . The groups did not differ in mammographic density or breast parenchyma by US ( P > 0.05 ) . Within each group , the baseline and final moments did not differ in mammography or US parameters significantly ( P > 0.05 ) . Conclusions The use of soy isoflavone extract for 10 months does not affect breast density , as assessed by mammography and US , in postmenopausal women Because soy food consumption may influence breast tissue activity , we examined its effect on the presence of epithelial cells in nipple aspirate fluid ( NAF ) . In a r and omized , crossover design , 82 premenopausal women completed a high-soy and a low-soy diet for 6 mo each , separated by a 1-mo washout period . They provided NAF sample s at baseline , 6 mo , and 13 mo during the midluteal phase of the menstrual cycle . Papanicolaou-stained cytology slides ( for 33 women at baseline , 24 at low-soy , and 36 at high-soy ) were evaluated in women with sufficient NAF . Mixed models evaluated the effect of the high-soy diet on epithelial cytology as compared to baseline and the low-soy diet . At the end of the high-soy diet , cytological subclass had decreased in 8 ( 24 % ) and increased in 3 ( 9 % ) women as compared to baseline , whereas the respective values were 3 ( 14 % ) and 6 ( 29 % ) for the low-soy diet sample s ( P = 0.32 ) . Only the change in subclass indicated a trend in lower cytological class ( P = 0.06 ) . Contrary to an earlier report , the number of NAF sample s with hyperplastic epithelial cells did not increase after a soy intervention in amounts consumed by Asians Background . Risk-benefit issues raised after the WHI have significantly increased the use of alternative treatments for the menopause . Despite this , data regarding the effect of soy isoflavones over mood and menopausal symptoms in high risk population s is still lacking . Objective . To evaluate the effect of soy derived isoflavones over hot flushes , menopausal symptoms and mood in climacteric women with increased body mass index ( BMI ) . Methods . Fifty symptomatic climacteric women aged 40 to 59 OUTPUT: The citation analysis revealed a growing interest for this topic and the papers on thyroid function are the most cited . In particular , literature show that a specific dosage of isoflavones reduces cardiovascular disease ( from 20 to 100 mg/die ) , may be protective in osteoporosis and muscular fatigue ( from 20 to 80 mg/die ) , may be useful for cancer prevention on endometrium , mammary gl and s and liver ( from 50 to 100 mg/die ) , might improve menopausal symptoms , particularly in reducing the frequency of hot flashes ( from 50 to 120 mg/die ) , can reduce abdominal fat and circulating inflammatory markers ( from 80 to 160 mg/die ) , may ameliorate the possible interaction between endogenous estrogen and thyroid function ( 75 mg/die ) and improve visual memory ( from 50 to 100 mg/die ) INPUT: The aim of this study was to test the hypothesis that increased dietary intake of phytoestrogens reduces the health impact of the menopause . To test this hypothesis , a double-blind , r and omized , entry-exit , cross-over study was conducted to assess the effects of three dietary manipulations -- soy and linseed diets ( high in phytoestrogens ) and a wheat diet ( low in phytoestrogens ) . Postmenopausal women were recruited and r and omly assigned to one of the three dietary regimens . Urinary phytoestrogen concentrations , hot flush rate , vaginal smears , bone mineral density and bone mineral content were assessed for two 12-week periods . Comparative analysis showed no significant differences , but , when analyzed separately , groups consuming high phytoestrogen diets had between 10 and 30 times higher urinary excretion of phytoestrogens compared to those consuming the low phytoestrogen diet ( p < 0.01 ) . Study participants consuming soy , linseed and wheat diets had a 22 % ( not significant , n.s . ) , 41 % ( p < 0.009 ) and 51 % ( p < 0.001 ) reduction in hot flush rate ; a 103 % ( p < 0.04 ) , 5.5 % ( n.s . ) and 11 % ( n.s . ) increase in vaginal cytology maturation index ; and a 5.2 % ( p < 0.04 ) , 5.2 % ( n.s . ) and 3.8 % ( n.s . ) increase in bone mineral content , respectively . No changes were detected in bone mineral density . The differential effects of high phytoestrogen dietary manipulations on outcomes may represent tissue-specific responses to isoflavones and lignans contained in soy and linseed , respectively . Whilst health outcome measures were not significantly different between groups , the data obtained from separate analysis suggest that phytoestrogens in soy and linseed may be of use in ameliorating some of the symptoms of menopause . Furthermore , the significant decrease in hot flush rate in the wheat group can not be attributable to phytoestrogens measured in this study . Due to subject variability , larger studies are still needed to evaluate population benefit BACKGROUND Concerns regarding the risk of estrogen replacement have result ed in a significant increase in the use of soy products by menopausal women who , despite the lack of evidence of the efficacy of such products , seek alternatives to menopausal hormone therapy . Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms . METHODS The study design was a single-center , r and omized , placebo-controlled , double-blind clinical trial conducted from July 1 , 2004 , through March 31 , 2009 . Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were r and omly assigned , in equal proportions , to receive daily soy isoflavone tablets , 200 mg , or placebo . The primary outcome was changes in bone mineral density in the lumbar spine , total hip , and femoral neck at the 2-year follow-up . Secondary outcomes included changes in menopausal symptoms , vaginal cytologic characteristics , N -telopeptide of type I bone collagen , lipids , and thyroid function . RESULTS After 2 years , no significant differences were found between the participants receiving soy tablets ( n = 122 ) and those receiving placebo ( n = 126 ) regarding changes in bone mineral density in the spine ( -2.0 % and -2.3 % , respectively ) , the total hip ( -1.2 % and -1.4 % , respectively ) , or the femoral neck ( -2.2 % and -2.1 % , respectively ) . A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group . No significant differences were found between groups in other outcomes . CONCLUSIONS In this population , the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00076050 Objective : Postmenopausal decreases in body composition , physical performance , and bone mass have been shown to be reversed by estrogen , but given the concerns regarding its use , women are looking for alternatives such as soy isoflavones . Most studies on the effects of soy on bone mineral density ( BMD ) in postmenopausal women have been short-term , that is , 3 to 6 months , and failed to provide conclusive evidence . There is no evidence of its effects on physical performance . The aim of the present study was to investigate the effects of soy plus isoflavones on BMD and physical performance in postmenopausal women . Methods : This was a 2-year r and omized controlled trial . A total of 203 healthy postmenopausal women were given either 25 g of soy protein without isoflavones , 25 g of soy protein with 90 mg of isoflavones , or 25 g of milk protein ( casein and whey ) as a control agent for 24 months . Women were followed every 6 months with BMD and physical performance measurements for 2 years . Primary analysis was intent-to-treat analysis . Analysis of variance , & khgr;2 and Fisher 's exact tests , and analysis of covariance were used . Results : There was a significant decrease in the BMD of the lumbar spine and femoral neck in those who completed the study in all groups . Soy isoflavones prevented major bone loss from baseline at the femoral trochanter with no between-group significance . Physical performance measurements decreased in all the groups . Conclusions : Twenty-five grams of soy protein with 90 OUTPUT:

Conclusions : Isoflavone treatments exert a moderately beneficial effect against estrogen-deficient bone loss in women . The effect appears dependent on whether isoflavone treatments are in aglycone form ; we conclude that beneficial effects against bone loss may be enhanced for isoflavone aglycones

MS2_dynamic_1_shot628

***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: 4 Background : Adjuvant RT for pT3 R1 or R0 patients ( pts . ) after RP remains controversial . The EORTC-phase-III- study suggested a 20 % better biochemical control ( bNED ) after 10 years for RT but no survival advantage . In contrast , the SWOG trial stated not only a gain in bNED but also an improved metastasis free and overall survival after 12 years follow-up . Now , 10-years results from the ARO 96 - 02 study are available , which are based on the most precisely defined cohort among the three trials . METHODS 385 men with prostate cancer were r and omized to either 60 Gy RT ( arm A ; n=193 ) or WS ( arm B ; n=192 ) before achieving an undetectable PSA . Pts . were stratified for Gleason-score , margin status , neoadjuvant hormonal treatment and stage ( pT3a+b vs. c ) . When the undetectable PSA-level after RP was not achieved , progressive disease was stated and the pts . left arm A/B. Data analysis was by intent-to-treat ( ITT ) . PSA-progression for pts . with undetectable post-RP PSA was defined as two consecutive increasing PSA . The primary endpoint was bNED . The study was powered to demonstrate a 15 % increase in bNED for RT . RESULTS 78 pts . ( 20 % ) did not achieve an undetectable PSA and were stated as progressive disease ( arm A : 45 pts . , arm B : 33 pts . ) . Additionally , 34 pts . ( 23 % ) from the RT-arm did not receive RT . Therefore , 114 pts . had RT ( arm A ) and 159 pts . WS ( arm B ) . Median follow up was 111.3 months for arm A and 113.3 months for arm B . bNED at 10 years increased to 56 % for arm A ( RT ) compared with 35 % for arm B ( WS ) ( hazard ratio= 0.51 ; p = 0.00002 . Out of 307 ITT pts . , 15 died from prostate cancer , 23 for other and 5 for unknown reasons . There was no significant profit from ART regarding the endpoints metastasis-free survival ( p=0.56 ) or overall survival ( p=0.59 ) . Worst late side effects to the rectum were two grade 2 cases after ART . Grade ≥2 bladder toxicity occurred in 4 out of 148 ITT pts . No grade 4 events were reported . CONCLUSIONS With only one grade 3 case of late toxicity , ART was safe in pT3 prostate cancer . At 10 years median follow up , it reduced the risk of bNED by 49 % . The study was not powered to detect differences in OS . CLINICAL TRIAL INFORMATION ARO 96 - 02/AUO AP 09/95 BACKGROUND Although there is r and omized evidence that radical prostatectomy improves survival , there are few data on how benefit varies by baseline risk . OBJECTIVE We aim ed to create a statistical model to calculate the decrease in risk of death associated with surgery for an individual patient , using stage , grade , prostate-specific antigen , and age as predictors . DESIGN , SETTING , AND PARTICIPANTS A total of 695 men with T1 or T2 prostate cancer participated in the Sc and inavian Prostate Cancer Group 4 trial ( SPCG-4 ) . INTERVENTION Patients in SPCG-4 were r and omized to radical prostatectomy or conservative management . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Competing risk models were created separately for the radical prostatectomy and the watchful waiting group , with the difference between model predictions constituting the estimated benefit for an individual patient . RESULTS AND LIMITATIONS Individualized predictions of surgery benefit varied widely depending on age and tumor characteristics . At 65 yr of age , the absolute 10-yr risk reduction in prostate cancer mortality attributable to radical prostatectomy ranged from 4.5 % to 17.2 % for low- versus high-risk patients . Little expected benefit was associated with surgery much beyond age 70 . Only about a quarter of men had an individualized benefit within even 50 % of the mean . A limitation is that estimates from SPCG-4 have to be applied cautiously to contemporary patients . CONCLUSIONS Our model suggests that it is hard to justify surgery in patients with Gleason 6 , T1 disease or in those patients much above 70 yr of age . Conversely , surgery seems unequivocally of benefit for patients who have Gleason 8 , or Gleason 7 , stage T2 . For patients with Gleason 6 T2 and Gleason 7 T1 , treatment is more of a judgment call , depending on patient preference and other clinical findings , such as the number of positive biopsy cores and comorbidities PURPOSE To perform a r and omized trial comparing 70 and 80 Gy radiotherapy for prostate cancer . PATIENTS AND METHODS A total of 306 patients with localized prostate cancer were r and omized . No and rogen deprivation was allowed . The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions . Toxicity was grade d using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective , objective , management , analytic scales ( LENT-SOMA ) scales . The patients ' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Question naire 30-item cancer-specific and 25-item prostate-specific modules . RESULTS The median follow-up was 61 months OUTPUT: EBRT , BT and RP were found to be effective in the management of localised prostate cancer . While higher doses of EBRT seem to be related to favourable survival-related outcomes they might , depending on technique , involve more adverse events , e.g. gastrointestinal and genitourinary toxicity . Aside from mixed findings regarding urinary function , BT and radical prostatectomy were comparable in terms of quality of life and biochemical progression-free survival while favouring BT regarding patient satisfaction and sexual function . There might be advantages of EBRT ( with/without HT ) compared to cryoablation ( with/without HT ) . Based on this systematic review , there is no strong evidence to support one therapy over another as EBRT , BT and RP can all be considered as effective monotherapies for localised disease with EBRT also effective for post-operative management . All treatments have unique adverse events profiles . INPUT: CRA4504 Background : The impact of radiotherapy on overall survival ( OS ) in men with locally advanced CaP is unclear . The SPCG-7 trial recently showed a benefit to RT for CaP specific mortality . Our primary objective was to assess the effect of RT on OS when added to lifelong ADT in men with locally advanced CaP. METHODS Patients with T3/T4 ( 1057 ) or T2 , PSA > 40 μ g/l ( 119 ) or T2 PSA > 20 μ g/l and Gleason ≥ 8 ( 25 ) and N0 /NX , M0 prostate adenocarcinoma were r and omized to lifelong ADT ( bilateral orchiectomy or LHRH agonist ) with or without RT ( 65 - 69 Gy to prostate ± seminal vesicles with or without 45Gy to pelvic nodes ) . The primary endpoint was OS and secondary endpoints included disease specific survival ( DSS ) , time to disease progression and quality of life . RESULTS 1205 patients were r and omized from 1995 to 2005 , 602 to ADT and 603 to ADT+RT ( well balanced with respect to baseline characteristics ) . A protocol specified second interim analysis on OS was performed in Aug 2009 ( data cut-off Dec 31 2008 ) . The DSMC recommended release of the results to the Trial Committee for publication . The median follow-up is 6.0 years and 320 patients have died ( 175 ADT and 145 ADT+RT ) . 10 % of patients had no follow-up data beyond 2006 . The addition of RT to ADT significantly reduced the risk of death ( hazard ratio [ HR ] 0.77 , 95 % CI 0.61 - 0.98 , p=0.033 ) . 140 patients died of disease and /or treatment ( 89 on ADT and 51 on ADT+RT ) The disease specific survival HR was 0.57 ( 95 % CI 0.41 - 0.81 , p=0.001 ) favoring ADT+RT . The 10 year cumulative disease specific death rates were estimated at 15 % with ADT+ RT and 23 % with ADT alone . Grade ≥2 late GI toxicity rates were similar in both arms ( proctitis , 1.3 % ADT alone , 1.8 % ADT+RT ) . CONCLUSIONS The trial results indicate a substantial overall survival and disease specific survival benefit for the combined modality approach ( ADT+RT ) in the management of patients with locally advanced prostate cancer with no significant increase in late treatment toxicity . In view of this data combined modality therapy ( ADT+RT ) should be the st and ard treatment approach for these patients . Supported by NCI-US Grant # 5U10CA077202 - 12 , CCSRI Grant # 15469 . No significant financial relationships to disclose BACKGROUND The optimal upper limit of the normal range for prostate-specific antigen ( PSA ) is unknown . We investigated the prevalence of prostate cancer among men in the Prostate Cancer Prevention Trial who had a PSA level of 4.0 ng per milliliter or less . METHODS Of 18,882 men enrolled in the prevention trial , 9459 were r and omly assigned to receive placebo and had an annual measurement of PSA and a digital rectal examination . Among these 9459 men , 2950 men never had a PSA level of more than 4.0 ng per milliliter or an abnormal digital rectal examination , had a final PSA determination , and underwent a prostate biopsy after being in the study for seven years . RESULTS Among the 2950 men ( age range , 62 to 91 years ) , prostate cancer was diagnosed in 449 ( 15.2 percent ) ; 67 of these 449 cancers ( 14.9 percent ) had a Gleason score of 7 or higher . The prevalence of prostate cancer was 6.6 percent among men with a PSA level of up to 0.5 ng per milliliter , 10.1 percent among those with values of 0.6 to 1.0 ng per milliliter , 17.0 percent among those with values of 1.1 to 2.0 ng per milliliter , 23.9 percent among those with values of 2.1 to 3.0 ng per milliliter , and 26.9 percent among those with values of 3.1 to 4.0 ng per milliliter . The prevalence of high- grade cancers increased from 12.5 percent of cancers associated with a PSA level of 0.5 ng per milliliter or less to 25.0 percent of cancers associated with a PSA level of 3.1 to 4.0 ng per milliliter . CONCLUSIONS Biopsy-detected prostate cancer , including high- grade cancers , is not rare among men with PSA levels of 4.0 ng per milliliter or less -- levels generally thought to be in the normal range PURPOSE Active surveillance for favorable risk prostate cancer is an approach that may reduce the risk of overtreatment of clinical ly insignificant prostate cancer . In fact , some patients with favorable risk disease at diagnosis harbor more aggressive disease and may be at risk for prostate cancer mortality despite close monitoring . This is a detailed report of 5 of 453 patients on surveillance who died of prostate cancer . MATERIAL S AND METHODS A large phase 2 prospect i ve trial of active surveillance in patients with favorable risk prostate cancer was initiated in 1995 . Eligible patients had favorable risk prostate cancer ( prostate specific antigen 10 ng/ml or less , Gleason 6 or less , T1c/T2a ) . Epstein criteria for clinical ly insignificant pro OUTPUT:

Active surveillance represents a viable option in men with low-risk PCa and a long life expectancy . PSA doubling time in <3 yr or a biopsy progression indicates the need for active intervention . In men with locally advanced PCa in whom local therapy is not m and atory , watchful waiting ( WW ) is a treatment alternative to and rogen-deprivation therapy ( ADT ) with equivalent oncologic efficacy . Active treatment is mostly recommended for patients with localised disease and a long life expectancy with radical prostatectomy ( RP ) shown to be superior to WW in a prospect i ve r and omised trial . Nerve-sparing RP represents the approach of choice in organ-confined disease ; neoadjuvant and rogen deprivation demonstrates no improvement of outcome variables . For locally advanced disease , adjuvant ADT for 3 yr results in superior disease-specific and overall survival rates and represents the treatment of choice .

MS2_dynamic_1_shot629

***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: 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 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 . 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 Sustained improvement in blood glucose control is the only treatment outcome which will reduce or eliminate the long term complications of diabetes mellitus . We have design ed and evaluated an electronic information system which facilitates this task . The system is voice-interactive , physician directed and affords , to remote patients , 24 h access via touch-tone telephone . Accordingly , patients access the system each day to report self-measured blood glucose levels or hypoglycaemic symptoms together with dietary changes , planned exercise , stress , illness or other lifestyle events . In turn they receive immediate advice with respect to medication dosing changes , and other pertinent feedback . Preliminary system beta-testing for safety and efficacy was performed for one year in an open study of 204 patients derived from two independent , health-care environments . Among the two testing centres , over 60,000 telephone cells were received by the computer systems during the start-up year . Safety and efficacy expectations were met . In addition , prevalence of diabetes related crises ( hyperglycaemia or hypoglycaemia ) fell approximately 3-fold . Glycated haemoglobin fell significantly ( 1.0 - 1.3 % ) in patients actively using the system . In control groups of patients not actively using the system , there were no improvements in metabolic control while body weights were stable in all groups . The new system was safe and effective in our h and s and empowered our health professionals to provide improved diabetes care BACKGROUND Telehome care has been proposed as a solution to the challenges of providing effective and affordable care for patients with diabetes . METHODS A total of 100 adult patients with type 2 diabetes-divided between insulin and noninsulin requiring-was enrolled in a r and omized , controlled trial aim ed at investigating the effects of telehome monitoring . The experimental group ( n = 50 ) received an in-home wireless glucose monitor and transmitter , whereas the control group ( n = 50 ) was instructed to follow the conventional arrangement . RESULTS There was an overall reduction in HbA1c values in both experimental and control groups after 6 months . A significant difference in HbA1c values between the groups was observed only among the noninsulin-requiring patients ( decline from 6.95 % ± 0.82 % to 6.66 % ± 0.86 % in IB vs. 7.21 % ± 2.02 % to 7.2 % ± 1.86 % in IIB ; p = 0.02 ) . The experimental group reported considerably less hyperglycemic and hypoglycemic events . The profile of the patient who benefited the most from telemonitoring consisted of older , more educated patient who had acquired the disease relatively recently , and who spends most of the time at home . The experimental group had higher overall scores on quality of life measures and sense of control over diabetes . There was a positive association between educational attainment and ability to use the telemonitoring system without help ( p = 0.045 ) . CONCLUSIONS Although not conclusive because of the small sample and short observation period , the study suggests that telehome monitoring is an effective tool in controlling type 2 diabetes in a primary care setting OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P < 0.05 ) when compared with education and usual care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1. OUTPUT:

There were three reported deaths out of 3578 participants .Computer-based diabetes self-management interventions currently have limited effectiveness . Current interventions do not show adequate evidence for improving depression , health-related quality of life or weight . AUTHORS ' CONCLUSIONS Computer-based diabetes self-management interventions to manage type 2 diabetes appear to have a small beneficial effect on blood glucose control and the effect was larger in the mobile phone subgroup . There is no evidence to show benefits in other biological outcomes or any cognitive , behavioural or emotional outcomes

MS2_dynamic_1_shot630

***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: 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 determine whether aspirin and antioxidant therapy , combined or alone , are more effective than placebo in reducing the development of cardiovascular events in patients with diabetes mellitus and asymptomatic peripheral arterial disease . Design Multicentre , r and omised , double blind , 2 × 2 factorial , placebo controlled trial . Setting 16 hospital centres in Scotl and , supported by 188 primary care groups . Participants 1276 adults aged 40 or more with type 1 or type 2 diabetes and an ankle brachial pressure index of 0.99 or less but no symptomatic cardiovascular disease . Interventions Daily , 100 mg aspirin tablet plus antioxidant capsule ( n=320 ) , aspirin tablet plus placebo capsule ( n=318 ) , placebo tablet plus antioxidant capsule ( n=320 ) , or placebo tablet plus placebo capsule ( n=318 ) . Main outcome measures Two hierarchical composite primary end points of death from coronary heart disease or stroke , non-fatal myocardial infa rct ion or stroke , or amputation above the ankle for critical limb ischaemia ; and death from coronary heart disease or stroke . Results No evidence was found of any interaction between aspirin and antioxidant . Overall , 116 of 638 primary events occurred in the aspirin groups compared with 117 of 638 in the no aspirin groups ( 18.2 % v 18.3 % ) : hazard ratio 0.98 ( 95 % confidence interval 0.76 to 1.26 ) . Forty three deaths from coronary heart disease or stroke occurred in the aspirin groups compared with 35 in the no aspirin groups ( 6.7 % v 5.5 % ) : 1.23 ( 0.79 to 1.93 ) . Among the antioxidant groups 117 of 640 ( 18.3 % ) primary events occurred compared with 116 of 636 ( 18.2 % ) in the no antioxidant groups ( 1.03 , 0.79 to 1.33 ) . Forty two ( 6.6 % ) deaths from coronary heart disease or stroke occurred in the antioxidant groups compared with 36 ( 5.7 % ) in the no antioxidant groups ( 1.21 , 0.78 to 1.89 ) . Conclusion This trial does not provide evidence to support the use of aspirin or antioxidants in primary prevention of cardiovascular events and mortality in the population with diabetes studied . Trial registration Current Controlled Trials IS RCT N53295293 A r and omized , double-blind clinical trial was design ed to assess the effect of aspirin ( ASA ) alone or in combination with dipyridamole ( DIP ) on the patency rates of exp and ed PTFE grafts placed in the infrainguinal position . Forty-nine patients were r and omized into three groups who received three times daily either two placebos ( 17 patients ) , 325 mg ASA and placebo ( 16 patients ) , or 325 mg ASA and 75 mg DIP ( 16 patients ) . The patients were seen at 3-month intervals for 1 year , and coded medication bottles were dispensed and returned pills counted to assess patient compliance . Treatment failure was defined as the first graft occlusion . The data were analyzed using the Breslow statistic for progressively censored survival type data . The 1-year cumulative patency rate for the entire series was 59 % . The rates for above-knee grafts in the ASA group ( 100 % ) and the ASA/DIP group ( 100 % ) were significantly higher than the rates for the placebo group ( 50 % ) ( P = 0.05 ) . The 1-year cumulative patency rates for patients with below-knee grafts were not statistically different among the groups , although the patients who received ASA alone had a higher rate than did the other two groups ( 65 % versus 21 % for placebo and 19 % for ASA/DIP ) . There were fewer occlusions in the above-knee grafts as compared to below-knee grafts in all groups , but the differences were statistically significant only in the ASA/DIP group . There were no statistical differences between the two active treatment groups The effect of 7-mono-hydroxyethylrutoside and its combination with acetylsalicylic acid was evaluated in a controlled clinical trial , performed in 105 patients with obliterative atherosclerosis of the lower limbs , and using non-invasive measurement of peripheral haemodynamic parameters -- blood flow during reactive hyperaemia and ankle systolic blood pressure . Patients , r and omized into three groups , received either placebo or 7-mono-hydroxyethylrutoside alone or in combination with acetylsalicylic acid for 12 months . The placebo group showed a decrease in maximum calf blood flow and a decrease in ankle systolic pressure . Administration of 7-mono-hydroxyethylrutoside did not lead to any significant changes in systolic pressure but there was a decrease in the maximum calf blood flow . There were no statistically significant changes in patients receiving the 7-mono-hydroxyethylrutoside and acetylsalicylic acid combination who , by contrast , showed a tendency to increased values of the parameters measured Thirty one r and omised trials of antiplatelet treatment for patients with a history of transient ischaemic attack , occlusive stroke , unstable angina , or myocard OUTPUT: CONCLUSIONS Aspirin use in PVD might not be associated with improved cardiovascular outcomes or worse bleeding outcomes . INPUT: The Persantine Aspirin Trial is a double-blind multi-centered cooperative study focusing primarily on the question of whether the administration of the combination of aspirin and dipyridamole ( Persantine ) will result in a greater reduction of cerebral or retinal infa rct ion or death than the administration of aspirin alone . Fifteen centers in the United States and Canada are participating . More than 750 individuals with a history of recent carotid territory transient ischemic attacks ( TIAs ) have been admitted over the past four years and r and omly allocated to either aspirin ( 325 mg ) plus placebo four times daily or aspirin ( 325 mg ) plus Persantine ( 75 mg ) four times daily . It is anticipated that the study will continue through 1983 . Analysis and publication of results are planned for 1984 604 Patients with atherothrombotic cerebral ischemic events ( transient , 16 % : or completed , 84 % ) referrable either to the carotid or to the vertebral-basilar circulation were entered into a double blind r and omized clinical trial ( AICLA ) to determine whether aspirin ( A ) ( 1 g/day ) or aspirin ( 1 g/day ) + Dipyridamole ( 225 mg/day ) ( AD ) would produce a significant reduction in the subsequent ( 3 years ) occurrence of fatal and nonfatal cerebral infa rct ion . R and omization produced remarkably comparable treatment groups and this good comparability was maintained throughout the study . Adherence to the protocol and drug compliance were excellent . Side effects , particularly symptoms of peptic ulcer and hemorrhagic events were significantly ( p less than 0.03 ) more frequent in the two treatment groups containing aspirin . With the exception of patients who withdrew from the study , each patient was followed for 3 years . At the end of the study , the number of fatal and nonfatal cerebral infa rct ions was 31 in the placebo ( P ) group , 17 in the A group and 18 in the AD group . Taking into account the duration of follow-up for each patient , these figures correspond to cumulative rates of 18 % in the P group and 10.5 % in each of the 2 active treatment groups . Analysis with the Mantel Method showed : 1)--A difference at the 6 % level between the 3 groups and between P and AD ; 2)--A difference at the 5 % level between P and A ; 3)--No difference between ( A and AD ; 4)--A difference at the 2 % level between the P group and the two treated groups taken together ( A + AD ) . Among other diseases occurring during the trial , the only significant difference concerned myocardial infa rct ion , which was less frequent in the 2 treated groups ( P less than 0.05 ) . Subgroup analysis failed to show a significant sex difference in the efficacy of aspirin . It is concluded that , in patients comparable to those defined in the protocol , Aspirin ( 1 g ) has a significantly beneficial effect in the secondary prevention of atherothrombotic cerebral infa rct ion We report the results of a r and omized multicenter clinical trial on the effects of aspirin plus dipyridamole versus placebo on major vascular end points in 231 non-insulin-dependent diabetic men with either a recent amputation for gangrene or active gangrene . Primary end points were death from atherosclerotic vascular disease plus amputation of the opposite extremity for gangrene . There were 24 atherosclerotic deaths in the drug treatment group ( 21.8 % ) and 23 in the placebo group ( 19.0 % ) . There were 22 patients in the drug treatment group ( 20.0 % ) and 29 patients in the placebo group ( 24.0 % ) with opposite-side amputations . Survival curve analyses revealed little difference between these groups for major vascular end points , total mortality , all amputations , or myocardial infa rct ions . The most noteworthy group difference was observed for cerebrovascular end points ( strokes and transient ischemic attacks ) , with an incidence of 8.2 % ( 9 patients ) in the drug treatment group and 19.0 % ( 23 patients ) in the placebo group . We conclude from this study that antiplatelet agents have no effect on the primary vascular end points , vascular deaths and /or amputation of the opposite extremity , in this population . Similarly , no effects were seen on secondary vascular end points , except for a suggestion of protection versus strokes and transient ischemic attacks . However , this finding must be interpreted with caution , since it is a secondary end point and was found only after multiple analyses of the data BACKGROUND Results of trials of aspirin and dipyridamole combined versus aspirin alone for the secondary prevention of vascular events after ischaemic stroke of presumed arterial origin are inconsistent . Our aim was to resolve this uncertainty . METHODS We did a r and omised controlled trial in which we assigned patients to aspirin ( 30 - 325 mg daily ) with ( n=1363 ) or without ( n=1376 ) dipyridamole ( 200 mg twice daily ) within 6 months of a transient ischaemic attack or minor stroke of presumed arterial origin . Our primary outcome event was the composite of death from all vascular causes , non-fatal stroke , non-fatal myocardial infa rct ion , or major bleeding complication , whichever happened first . Treatment was open , but auditing of outcome events was blinded . Primary analysis was by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial ( number IS RCT N73824458 ) and with ( NCT00161070 ) . FINDINGS Mean follow-up was 3.5 years ( SD 2.0 ) . Median aspirin dose was 75 mg in both treatment groups ( range 30 - 325 ) ; extended- OUTPUT:

This result was not influenced by the dose of dipyridamole or type of presenting vascular disease . For patients who presented with arterial vascular disease , there was no evidence that dipyridamole , in the presence or absence of another antiplatelet drug reduced the risk of vascular death , though it reduces the risk of further vascular events . This benefit was found only in patients presenting after cerebral ischaemia . There was no evidence that dipyridamole alone was more efficacious than aspirin

MS2_dynamic_1_shot631

***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: A total of 105 “ high‐risk ” infants born in 1988 were studied prospect ively from birth to 18 months of age . The infants were recommended breastfeeding and /or hypoallergenic formula ( Nutramigen or Profylac ) combined with avoidance of solid foods during the first 6 months of life . All mothers had unrestricted diet . Avoidance of daily exposure to tobacco smoke , furred pets and dust‐collecting material s in the bedroom were advised . This prevention group was compared with a control group consisting of 54 identically defined “ high‐risk ” infants born in 1985 in the same area . All infants had either severe single atopic predisposition combined with cord blood IgE ≥ 0.5 KU/1 or biparental atopic predisposition . The control group had unrestricted diet and was not advised about environmental factors . Apart from the prevention programme and year of birth the prevention group and the control group were comparable . The parents were highly motivated and compliance was good . The rate of participation was 97 % , and 85 % followed the dietary measures strictly . The cumulative prevalence of atopic symptoms was significantly lower at 18 months in the prevention group ( 32 % ) , as compared with the control group ( 74 % ) ( p<0.01 ) , due to reduced prevalence of recurrent wheezing ( 13 % , versus 37 % ; p<0.01 ) , atopic dermatitis ( 14 % versus 31 % ; p<0.01 ) , vomiting/diarrhoea ( 5 % versus 20 % ; p<0.01 ) and infantile colic ( 9 % versus 24 % ; p<0.01 ) . The cumulative prevalence of food allergy was significantly lower in the prevention group ( 6 % versus 17 % ; p<0.05 ) . In both high‐risk groups daily exposure to tobacco smoke increased the risk of recurrent wheezing significantly ( p<0.01 ) . The main difference between the prevention group and the control group was the diet . Thus , feeding with breastmilk and /or hypoallergenic formula combined with avoidance of solid foods until the age of 6 months appeared to reduce the cumulative prevalence of atopic symptoms during the first 18 months of life We have previously reported a protective effect of maternal omega-3 long-chain polyunsaturated fatty acids ( ω-3 LCPUFA ) supplementation in pregnancy and lactation on IgE-associated eczema and food allergy in the infant during the first year of life . Here we investigate whether the effects of the LCPUFA supplementation on IgE-associated diseases last up to 2 yr of age and assess the relationship between plasma proportions of ω-3 PUFAs and the frequency and severity of infant allergic disease . 145 pregnant women , at risk of having an allergic infant , were r and omized to daily supplementation with 1.6 g eicosapentaenoic acid ( EPA ) and 1.1 g docosahexaenoic acid ( DHA ) or placebo starting in the 25th gestational week and continuing through 3.5 months of breastfeeding . Clinical examinations , skin prick tests and analysis of maternal and infant plasma phospholipid fatty acids and infant specific IgE were performed . No difference in the prevalence of allergic symptoms was found between the intervention groups . The cumulative incidence of IgE-associated disease was lower in the ω-3-supplemented group ( 6/54 , 13 % ) compared with the placebo group ( 19/62 , 30 % , p=0.01 ) . Higher maternal and infant proportions of DHA and EPA were associated with lower prevalence of IgE associated disease ( p=0.01 - 0.05 ) in a dose-dependent manner . Higher maternal and infant proportions of DHA and EPA were found if the infants presented none , when compared with multiple allergic symptoms , ( p<0.05 ) regardless of sensitization . In summary , the ω-3 supplementation offered no obvious preventive effect on the prevalence of clinical symptoms of allergic disease , but the decrease in cumulative incidence of IgE-associated disease seen during the first year still remained until 2 yr of age . Furthermore , high proportions of DHA and EPA in maternal and infant plasma phospholipids were associated with less IgE-associated disease and a reduced severity of the allergic phenotype BACKGROUND Partially hydrolyzed whey formula ( pHWF ) has been recommended for infants with a family history of allergic disease at the cessation of exclusive breast-feeding to promote oral tolerance and prevent allergic diseases . OBJECTIVE To determine whether feeding infants pHWF reduces their risk of allergic disease . METHODS A single-blind ( participant ) r and omized controlled trial was conducted to compare allergic outcomes between infants fed a conventional cow 's milk formula , a pHWF , or a soy formula . Before birth , 620 infants with a family history of allergic disease were recruited and r and omized to receive the allocated formula at cessation of breast-feeding . Skin prick tests to 6 common allergens ( milk , egg , peanut , dust mite , rye grass , and cat d and er ) were performed at 6 , 12 , and 24 months . The primary outcome was development of allergic manifestations ( eczema and food reactions ) measured 18 times in the first 2 years of life . RESULTS Follow-up was complete for 93 % ( 575/620 ) at 2 years and 80 % ( 495/620 ) at 6 or 7 years of age . There was no evidence that infants allocated to the pHWF ( odds ratio , 1.21 ; 95 % CI , 0.81 - 1.80 ) or the soy OUTPUT: There was no good evidence to recommend that pregnant or breastfeeding women should change their diet or take supplements to prevent allergies in infants at high or normal risk . There were mixed findings about the preventive benefits of breastfeeding for infants at high or normal risk , but there was evidence to recommend avoiding cow 's milk and substituting with extensively or partially hydrolyzed whey or casein formulas for infants at high risk for the first 4 months . Soy milk and delaying the introduction of solid foods beyond 4 months did not have preventive benefits in those at high or normal risk . There was very little evidence about strategies for preventing food allergy in older children or adults . INPUT: BACKGROUND Iodine deficiency in infants can damage the developing brain and increase mortality . Present recommendations state that oral iodised oil should be given to breastfeeding mothers to correct iodine deficiency in infancy when iodised salt is not available , and that direct supplementation should be given to infants who are not being breastfed or receiving iodine-fortified complimentary foods . However , there is little evidence for these recommendations . We aim ed to assess the safety and efficacy of direct versus indirect supplementation of the infant . METHODS We did this double blind , r and omised , placebo-controlled trial in Morocco . Healthy breastfeeding mothers and their term newborn babies ( aged ≤8 weeks ) were block r and omised by clinic day to receive either : one dose of 400 mg iodine to the mother and placebo to the infant ( indirect infant supplementation ) , or one dose of about 100 mg iodine to the infant and placebo to the mother ( direct infant supplementation ) . R and omisation was masked to participants and investigators . Co primary outcomes were : maternal and infant urinary iodine concentrations , breastmilk iodine concentration , maternal and infant thyroid-stimulating hormone ( TSH ) concentrations , maternal and infant thyroxine ( T4 ) concentrations , and infant growth . These outcomes were measured at baseline , and when infants were aged about 3 months , 6 months , and 9 months , and the two groups were compared using mixed effects models . This study is registered with Clinical Trials.gov , number NCT01126125 . FINDINGS We recruited 241 mother-infant pairs between Feb 25 , and Aug 10 , 2010 , and completed data collection by Aug 6 , 2011 . At baseline , median urinary iodine concentration was 35 μg/L ( IQR 29 - 40 ) in mothers and 73 μg/L ( 29 - 237 ) in infants , suggesting iodine deficiency . During the study , maternal urinary iodine concentration ( p=0.011 ) , breastmilk iodine concentration ( p<0.0001 ) , and infant urinary iodine concentration ( p=0.042 ) were higher in the indirect infant supplementation group than in the direct supplementation group . Maternal TSH ( p=0.276 ) and T4 ( p=0.074 ) concentrations did not differ between the groups over the course of the study , nor did infant TSH ( p=0.597 ) and T4 ( p=0.184 ) concentrations , but the number of infants with thyroid hypofunction was lower ( p=0.023 ) in the indirect supplementation group than the direct supplementation group . The infant groups did not differ in anthropomorphic measures , except that length-for-age Z score was slightly greater in the direct infant supplementation group ( p=0.032 ) . At 3 months and 6 months of age , median infant urinary iodine concentration in the indirect infant supplementation group was sufficient ( > 100 μg/L ) , whereas infant urinary iodine concentration was sufficient only at 6 months in the direct supplementation group . There were no serious adverse events in either group . INTERPRETATION In regions of moderate-to-severe iodine deficiency without effective salt iodisation , lactating women who receive one dose of 400 mg iodine as oral iodised oil soon after delivery can provide adequate iodine to their infants through breastmilk for at least 6 months , enabling the infants to achieve euthyroidism . Direct supplementation is less effective in improving infant iodine status . FUNDING ETH Zurich , Switzerl and ; the Medicor Foundation , Vaduz , Lichtenstein Adequate iodine concentration in breastmilk ( BMI C ) is essential for optimal neonatal thyroid hormone synthesis and neurological development in breastfed infants . For many decades , iodine deficiency has been a public health problem in Nepal . However , recently , excessive iodine intakes among Nepali infants have been reported . This study aim ed to measure BMI C and urinary iodine concentration ( UIC ) among lactating women in a peri-urban area of Nepal . Iodine concentration was measured in spot urine ( n = 485 ) and breastmilk sample s ( n = 291 ) of 500 r and omly selected lactating women . The median ( p25 , p75 ) BMI C and median UIC were 250 ( 130 , 370 ) µg/L and 230 ( 135–377 ) µg/L , respectively . Around 82 % had BMI C > 100 µg/L , 61 % had BMI C > 200 µg/L and 81 % had UIC > 100 µg/L , 37 % had > 300 µg/L and 20 % had > 500 µg/L. In multiple linear regression models , time since birth ( β 3.0 , 95 % CI ( 0.2 , 5.0 ) ) and UIC ( β 1.0 , 95 % CI ( 0.1 , 2.0 ) ) were associated with BMI C , explaining 26 % of the variance . A large proportion of the women had adequate BMI C and UIC ; however , a subset had high iodine concentrations . These findings emphasize the importance of carefully monitoring iodine intake to minimize the risk of iodine excess and subsequently preventing transient iodine-induced hypothyroidism in breastfed infants BACKGROUND Iodine deficiency in infancy can impair neurocognitive development , but there are few available indicators of iodine intake during this critical period . In many countries , access to newborns in maternity clinics in the first few days after birth is high OUTPUT:

The results are thus compatible with the international recommendation that lactating women and infants younger than two years of age who reside in iodine-sufficient countries do not require iodine supplementation

MS2_dynamic_1_shot632

***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: Rationale and objective In animal and human studies , the neurotransmitter serotonin ( 5-hydroxytryptamine ; 5-HT ) has been implicated in mediating impulsiveness and aggression . To test the hypothesis that 5-HT modulates neuro-cognitive brain activation during inhibitory control , we examined the effect of acute tryptophan depletion ( ATD ) , a dietary challenge , which has been shown to decrease 5-HT synthesis in the brain , on functional brain activation during a go/no-go task . Methods Nine healthy , right-h and ed volunteers performed a rapid , event-related go/no-go task in two functional magnetic resonance imaging ( fMRI ) scanning sessions , 5 h after either a tryptophan-free or a balanced amino acid drink in a double-blind , sham depletion-controlled , counterbalanced , crossover design . The task required subjects to selectively execute or inhibit a motor response . Tryptophan depletion significantly lowered total plasma tryptophan concentration by 80 % , but did not significantly alter inhibitory performance or mood ratings . Results ATD significantly reduced right orbito-inferior prefrontal activation during the no-go condition , and increased activation in superior and medial temporal cortices . Conclusions These findings provide neuro-functional evidence of a serotonergic modulation of right inferior prefrontal during inhibitory motor control . The increased engagement of temporal brain regions may reflect compensatory mechanisms The dopamine D2 receptor ( DRD2 ) C957 T polymorphism CC genotype is associated with decreased striatal binding of DRD2 and executive function and working memory impairments in healthy adults . We investigated the relationships between C957 T and acute stress with behavioral phenotypes of impulsivity in 72 young adults r and omly allocated to either an acute psychosocial stress or relaxation induction condition . Homozygotes for 957C showed increased reward responsiveness after stress induction . They were also quicker when making immediate choices on the delay discounting task when stressed , compared with homozygotes who were not stressed . No effects were found for response inhibition , a dimension of impulsivity not related to extrinsic rewards . These data suggest that C957 T is associated with a reward-related impulsivity endophenotype in response to acute psychosocial stress . Future studies should examine whether the greater sensitivity of 957C homozygotes to the effects of stress is mediated through dopamine release In animal and human research , the neurotransmitter serotonin ( 5-HT ) has been implicated in inhibitory control . Using functional magnetic resonance imaging ( fMRI ) , the present study investigated the acute effects of pharmacological modulation of the serotonergic system on brain activation during response inhibition and re-engagement in healthy human volunteers . In a r and omized double-blind placebo-controlled cross-over design 14 men received either a single oral dose of the selective serotonin reuptake inhibitor ( SSRI ) escitalopram ( 10 mg ) or a placebo . At the time of the expected plasma peak concentration , participants performed a stop-change task during fMRI . Escitalopram did not affect behavioural performance , since the main effect did not reveal significant differences between reaction times of go- , stop- or change-trials . During successful response inhibition , escitalopram , however , was associated with enhanced brain activation in right prefrontal cortex , right supplementary/pre-motor and bilateral cingulate cortex , and subcortical regions . During inhibition failures , escitalopram also modulated a broad network of brain regions , including anterior cingulate , right parietal cortex , right orbitofrontal cortex , and areas in right temporal cortex and subcortical regions . During response re-engagement escitalopram increased brain activation in right inferior frontal gyrus and precuneus as well as in left middle temporal gyrus . The results implicate the involvement of 5-HT in neural regulation of response inhibition and re-engagement . This study also provides evidence that 5-HT affects both action restraint and action cancellation through modulation of activation of brain areas . The results support the view for a fronto-striatal circuitry for response inhibition in conjunction with serotonin The functional significance of the N2 in go/no-go tasks was investigated by comparing electrophysiological data obtained from two tasks : a go/no-go task involving both response inhibition as well as response conflict monitoring , and a go/GO task associated with conflict monitoring only . No response was required to no-go stimuli , and a response with maximal force to GO stimuli . The relative frequency of the go stimuli ( 80 % vs. 50 % ) was varied . The N2 peaked on both no-go and GO trials , with larger amplitudes for both signals when presented in a context of frequent ( 80 % ) go signals . These results support the idea that the N2 reflects conflict monitoring not response inhibition In females , most genes on the X chromosome are generally assumed to be transcriptionally silenced on the inactive X as a result of X inactivation . However , particularly in humans , an increasing number of genes are known to " escape " X inactivation and are expressed from both the active ( Xa ) and inactive ( Xi ) X chromosomes ; such genes reflect different molecular and epigenetic responses to X inactivation and are c and i date s for phenotypes associated with X aneuploidy . To identify genes that escape X inactivation and to generate a first-generation X-inactivation profile of the X , we have evaluated the expression of 224 X-linked genes and expressed sequence tags by reverse-transcription-PCR analysis of a panel of multiple independent mouse/human somatic cell hybrids containing a normal human Xi but no Xa . The result ing survey yields an initial X-inactivation profile that is estimated to represent approximately 10 % of all X-linked transcripts . Of the 224 transcripts tested here , 34 ( three of which are pseudoautosomal ) were expressed in as many as nine Xi OUTPUT: We find no evidence of significant associations between those polymorphisms and RI . None of these polymorphisms showed a reliable association with response inhibition performance . INPUT: Abstract Evidence for serotonin involvement in impulsivity has generated interest in the measurement of impulsivity in regular ecstasy users , who are thought to display serotonergic dysfunction . However , current findings are inconsistent . Here , we used a recently developed Information Sampling Test to measure ‘ reflection ’ impulsivity in 46 current ecstasy users , 14 subjects who used ecstasy in the past , 15 current cannabis users and 19 drug-naïve controls . Despite elevated scores on the Impulsivity subscale of the Eysenck Impulsiveness-Venturesomeness-Empathy question naire , the current and previous ecstasy users did not differ significantly from the drug-naive controls on the Information Sampling Test . In contrast , the cannabis users sample d significantly less information on the task , and tolerated a lower level of certainty in their decision-making , in comparison to the drug-naive controls . The effect in cannabis users extends our earlier observations in amphetamine- and opiate-dependent individuals ( Clark , et al. , 2006 , Biological Psychiatry 60 : 515–522 ) , and suggests that reduced reflection may be a common cognitive style across regular users of a variety of substances . However , the lack of effects in the two ecstasy groups suggests that the relationship between serotonin function , ecstasy use and impulsivity is more complex Abstract Exposure therapy is known to be an effective treatment for anxiety disorders . Nevertheless , exposure is not used as much as it should be , and instead patients are often given supportive medications such as serotonin reuptake inhibitors ( SSRIs ) and benzodiazepines , which may even interfere with the extinction learning that is the aim of treatment . Given that r and omized controlled trials are now investigating a few doses of ±3,4-methylenedioxymethamphetamine ( MDMA , ‘ ecstasy ’ ) in combination with psychotherapy for treatment-resistant anxiety disorders , we would like to suggest the following three mechanisms for this potentially important new approach : 1 ) MDMA increases oxytocin levels , which may strengthen the therapeutic alliance ; 2 ) MDMA increases ventromedial prefrontal activity and decreases amygdala activity , which may improve emotional regulation and decrease avoidance and 3 ) MDMA increases norepinephrine release and circulating cortisol levels , which may facilitate emotional engagement and enhance extinction of learned fear associations . Thus , MDMA has a combination of pharmacological effects that , in a therapeutic setting , could provide a balance of activating emotions while feeling safe and in control , as described in case reports of MDMA-augmented psychotherapy . Further clinical and pre clinical studies of the therapeutic value of MDMA are indicated 3,4-Methylenedioxymethamphetamine ( MDMA , ' ecstasy ' ) releases serotonin and norepinephrine . MDMA is reported to produce empathogenic and prosocial feelings . It is unknown whether MDMA in fact alters empathic concern and prosocial behavior . We investigated the acute effects of MDMA using the Multifaceted Empathy Test ( MET ) , dynamic Face Emotion Recognition Task ( FERT ) and Social Value Orientation ( SVO ) test . We also assessed effects of MDMA on plasma levels of hormones involved in social behavior using a placebo-controlled , double-blind , r and om-order , cross-over design in 32 healthy volunteers ( 16 women ) . MDMA enhanced explicit and implicit emotional empathy in the MET and increased prosocial behavior in the SVO test in men . MDMA did not alter cognitive empathy in the MET but impaired the identification of negative emotions , including fearful , angry and sad faces , in the FERT , particularly in women . MDMA increased plasma levels of cortisol and prolactin , which are markers of serotonergic and noradrenergic activity , and of oxytocin , which has been associated with prosocial behavior . In summary , MDMA sex-specifically altered the recognition of emotions , emotional empathy and prosociality . These effects likely enhance sociability when MDMA is used recreationally and may be useful when MDMA is administered in conjunction with psychotherapy in patients with social dysfunction or post-traumatic stress disorder While accumulating evidence suggests that effective real-life decision-making depends upon the functioning of the orbitofrontal cortex , much less is known about the involvement of the monoamine neurotransmitter systems and , in particular , serotonin . In the present study , we explored the impact of depleting the serotonin precursor , tryptophan , on human decision-making . Eighteen healthy volunteers consumed an amino-acid drink containing tryptophan and 18 healthy volunteers consumed an amino-acid drink without tryptophan , before choosing between simultaneously presented gambles , differing in the magnitude of expected gains ( ie reward ) , the magnitude of expected losses ( ie punishment ) , and the probabilities with which these outcomes were delivered . Volunteers also chose between gambles probing identified non-nomative biases in human decision-making , namely , risk-aversion when choosing between gains and risk-seeking when choosing between losses . Tryptophan-depleted volunteers showed reduced discrimination between magnitudes of expected gains associated with different choices . There was little evidence that tryptophan depletion was associated with altered discrimination between the magnitudes of expected losses , or altered discrimination between the relative probabilities with which these positive or negative outcomes were delivered . Risk-averse and risk-seeking biases were also unchanged . These results suggest that serotonin mediates decision-making in healthy volunteers by modulating the processing of reward cues , perhaps represented within the orbitofrontal cortex . It is possible that such a change in the cognition mediating human choice is one mechanism associated with the onset and maintenance of anhedonia and lowered mood in psychiatric illness Abstract . Rationale : ( ± ) 3,4-Methylenedioxymethamphetamine ( MDMA or " OUTPUT:

Thus , the current state of research does not allow for the conclusion that long-term use of MDMA affects decision-making behavior in general .

MS2_dynamic_1_shot633

***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: BACKGROUND A high fructose intake can lead to postpr and ial hypertriacylglycerolemia . The underlying mechanism is unclear . OBJECTIVE The objective of the study was to investigate the mechanisms involved in fructose-induced hypertriacylglycerolemia and the contribution of de novo lipogenesis in an acute setting . DESIGN In a r and omized , crossover study , 14 subjects were given a fructose or glucose test meal after an overnight fast . [(2)H2]Palmitate and [U(13)C]d-fructose or [U(13)C]d-glucose were added to trace the h and ling of dietary fats and the fate of dietary sugars in the body . Blood sample s were taken before and after the meal . Respiratory exchange ratio was measured by using indirect calorimetry , and breath sample s were collected . RESULTS Plasma triacylglycerol and VLDL-triacylglycerol concentrations were significantly higher ( P = 0.001 for both ) , whereas the concentrations of insulin and [(2)H2]palmitate in nonesterified fatty acids were significantly lower after fructose than after glucose ( P = 0.002 and 0.03 , respectively ) . The respiratory exchange ratio was higher after fructose ( P = 0.04 ) ; significantly ( P = 0.003 ) more carbon from sugars was recovered in breath carbon dioxide over 6 h after fructose ( 30.5 % ) than after glucose ( 24.5 % ) . At 240 min , newly synthesized fatty acids from fructose made up approximately 0.4 % of circulating VLDL-triacylglycerol , whereas newly synthesized triacylglycerol-glycerol made up 38 % . Newly synthesized fatty acids and triacylglycerol-glycerol from glucose contributed almost none of VLDL-triacylglycerol ( P = 0.002 and 0.007 for glucose and fructose , respectively ) . CONCLUSIONS The lower insulin excursion after fructose may result in less activation of adipose tissue lipoprotein lipase , which led to impaired triacylglycerol clearance . The contribution of de novo lipogenesis to fructose-induced hypertriacylglycerolemia is small , but its effect on altering the partitioning of fatty acids toward esterification may be considerable Using a within-subjects design , we gave over-weight and normal-weight subjects a 500-mL drink of fructose , glucose , or aspartame diluted in lemon-flavored water or plain water in a r and omized fashion at about weekly intervals . Food intake was assessed at a buffet lunch that began 38 min after the preload was completed . Blood was drawn throughout and assayed for concentrations of glucose , insulin , glucagon , and free fatty acid . When subjects drank the fructose preload , they subsequently ate fewer overall calories and fewer grams of fat than when they drank any of the other preloads . The aspartame load did not stimulate intake beyond the plain-water control . The effects of the oxidation of fructose as a possible mechanism for the reduction in food intake is discussed . The effects of insulin in stimulating intake are also discussed The goal of this study was to determine the magnitude by which acute consumption of fructose in a morning bolus would stimulate lipogenesis ( measured by infusion of 13C1-acetate and analysis by GC-MS ) immediately and after a subsequent meal . Six healthy subjects [ 4 men and 2 women ; aged ( mean + /- SD ) 28 + /- 8 y ; BMI , 24.3 + /- 2.8 kg/m(2 ) ; and serum triacylglycerols ( TG ) , 1.03 + /- 0.32 mmol/L ] consumed carbohydrate boluses of sugars ( 85 g each ) in a r and om and blinded order , followed by a st and ardized lunch 4 h later . Subjects completed a control test of glucose ( 100:0 ) and a mixture of 50:50 glucose : fructose and one of 25:75 ( wt : wt ) . Following the morning boluses , serum glucose and insulin after 100:0 were greater than both other treatments ( P < 0.05 ) and this pattern occurred again after lunch . In the morning , fractional lipogenesis was stimulated when subjects ingested fructose and peaked at 15.9 + /- 5.4 % after the 50:50 treatment and at 16.9 + /- 5.2 % after the 25:75 treatment , values that were greater than after the 100:0 treatment ( 7.8 + /- 5.7 % ; P < 0.02 ) . When fructose was consumed , absolute lipogenesis was 2-fold greater than when it was absent ( 100:0 ) . Postlunch , serum TG were 11 - 29 % greater than 100:0 and TG-rich lipoprotein-TG concentrations were 76 - 200 % greater after 50:50 and 25:75 were consumed ( P < 0.05 ) . The data demonstrate that an early stimulation of lipogenesis after fructose , consumed in a mixture of sugars , augments subsequent postpr and ial lipemia . The postlunch blood TG elevation was only partially due to carry-over from the morning . Acute intake of fructose stimulates lipogenesis and may create a metabolic milieu that enhances subsequent esterification of fatty acids flowing to the liver to elevate TG synthesis postpr and ially Aims /hypothesisType 2 diabetes is regarded as inevitably progressive , with irreversible beta cell failure . The hypothesis was tested OUTPUT: Results : Replacement of either glucose or sucrose by fructose result ed in significantly lowered peak postpr and ial blood glucose , particularly in people with prediabetes and type 1 and type 2 diabetes . Similar results were obtained for insulin . Peak postpr and ial blood triglyceride concentrations did not significantly increase . Conclusions : Strong evidence exists that substituting fructose for glucose or sucrose in food or beverages lowers peak postpr and ial blood glucose and insulin concentrations . Isoenergetic replacement does not result in a substantial increase in blood triglyceride concentrations INPUT: BACKGROUND A high fructose intake can lead to postpr and ial hypertriacylglycerolemia . The underlying mechanism is unclear . OBJECTIVE The objective of the study was to investigate the mechanisms involved in fructose-induced hypertriacylglycerolemia and the contribution of de novo lipogenesis in an acute setting . DESIGN In a r and omized , crossover study , 14 subjects were given a fructose or glucose test meal after an overnight fast . [(2)H2]Palmitate and [U(13)C]d-fructose or [U(13)C]d-glucose were added to trace the h and ling of dietary fats and the fate of dietary sugars in the body . Blood sample s were taken before and after the meal . Respiratory exchange ratio was measured by using indirect calorimetry , and breath sample s were collected . RESULTS Plasma triacylglycerol and VLDL-triacylglycerol concentrations were significantly higher ( P = 0.001 for both ) , whereas the concentrations of insulin and [(2)H2]palmitate in nonesterified fatty acids were significantly lower after fructose than after glucose ( P = 0.002 and 0.03 , respectively ) . The respiratory exchange ratio was higher after fructose ( P = 0.04 ) ; significantly ( P = 0.003 ) more carbon from sugars was recovered in breath carbon dioxide over 6 h after fructose ( 30.5 % ) than after glucose ( 24.5 % ) . At 240 min , newly synthesized fatty acids from fructose made up approximately 0.4 % of circulating VLDL-triacylglycerol , whereas newly synthesized triacylglycerol-glycerol made up 38 % . Newly synthesized fatty acids and triacylglycerol-glycerol from glucose contributed almost none of VLDL-triacylglycerol ( P = 0.002 and 0.007 for glucose and fructose , respectively ) . CONCLUSIONS The lower insulin excursion after fructose may result in less activation of adipose tissue lipoprotein lipase , which led to impaired triacylglycerol clearance . The contribution of de novo lipogenesis to fructose-induced hypertriacylglycerolemia is small , but its effect on altering the partitioning of fatty acids toward esterification may be considerable BACKGROUND About 9 % of average dietary energy intake in the United States comes from fructose . Such a high consumption raises concern about the metabolic effects of this sugar . OBJECTIVE The objective of this study was to determine the effect of dietary fructose on plasma lipids . DESIGN The study was conducted in the General Clinical Research Center at Fairview-University of Minnesota Medical Center . The participants were 24 healthy adult volunteers ( 12 men and 12 women ; 6 of each sex were aged < 40 y and 6 of each sex were aged > /=40 y ) . All subjects received 2 isoenergetic study diets assigned by using a r and omized , balanced crossover design . One diet provided 17 % of energy as fructose . The other diet was sweetened with glucose and was nearly devoid of fructose . Each diet was fed for 6 wk . Both diets were composed of common foods and contained nearly identical amounts of carbohydrate , protein , fat , fiber , cholesterol , and saturated , monounsaturated , and polyunsaturated fatty acids . All meals were prepared in the metabolic kitchen of the General Clinical Research Center . RESULTS The responses to the study diets differed by sex . In men , the fructose diet produced significantly higher fasting , postpr and ial , and daylong plasma triacylglycerol concentrations than did the glucose diet . The daylong plasma triacylglycerol concentration after 6 wk of the fructose diet was 32 % greater in men than the corresponding concentration during the glucose diet ( P : < 0.001 ) . The fructose diet had no significant effect on fasting or postpr and ial plasma triacylglycerol concentrations in women . The fructose diet also had no persistent effect on fasting plasma cholesterol , HDL cholesterol , or LDL cholesterol in either men or women . CONCLUSIONS Dietary fructose was associated with increased fasting and postpr and ial plasma triacylglycerol concentrations in men . Diets high in added fructose may be undesirable , particularly for men . Glucose may be a suitable replacement sugar CONTEXT Elevated nonfasting triglycerides indicate the presence of remnant lipoproteins , which may promote atherosclerosis . OBJECTIVE To test the hypothesis that very high levels of nonfasting triglycerides predict myocardial infa rct ion ( MI ) , ischemic heart disease ( IHD ) , and death . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve cohort study of 7587 women and 6394 men from the general population of Copenhagen , Denmark , aged 20 to 93 years , followed up from baseline ( 1976 - 1978 ) until 2004 . MAIN OUTCOME MEASURES Hazard ratios ( HRs ) for incident MI , IHD , and total death according to baseline nonfasting triglyceride level categories of 1 to 1.99 mmol/L ( 88.5 - 176.1 mg/dL ) , 2 to 2.99 mmol/L ( 177.0 - 264.6 mg/dL ) , 3 to 3.99 mmol/L ( 265.5 - 353.0 mg/dL ) , 4 to 4.99 mmol/L ( 3 OUTPUT:

Pooled analyses show that fructose in isocaloric exchange for other carbohydrate does not increase postpr and ial triglycerides , although an effect can not be excluded under all conditions . Fructose providing excess energy does increase postpr and ial triglycerides .

MS2_dynamic_1_shot634

***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 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 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 OBJECTIVES This study assessed the effects of the Black Churches United for Better Health project on increasing fruit and vegetable consumption among rural African American church members in North Carolina . METHODS Ten counties comprising 50 churches were pair matched and r and omly assigned to either intervention or delayed intervention ( no program until after the follow-up survey ) conditions . A multicomponent intervention was conducted over approximately 20 months . A total of 2519 adults ( 77.3 % response rate ) completed both the baseline and 2-year follow-up interviews . RESULTS The 2 study groups consumed similar amounts of fruits and vegetables at baseline . AT the 2-year follow-up , the intervention group consumed 0.85 ( SE = 0.12 ) servings more than the delayed intervention group ( P < .0001 ) . The largest increases were observed among people 66 years or older ( 1 serving ) , those with education beyond high school ( 0.92 servings ) , those widowed or divorced ( 0.96 servings ) , and those attending church frequently ( 1.3 servings ) . The last improvement occurred among those aged 18 to 37 years and those who were single . CONCLUSIONS The project was a successful model for achieving dietary change among rural African Americans BACKGROUND Many question whether mass media , in the absence of other programming , can produce significant and sustained behavior change . METHODS The 1 % Or Less campaign in Wheeling , West Virginia ( population 35,000 ) , used paid advertising and public relations to encourage members of one community to switch from whole or 2 % milk ( high-fat milk ) to 1 % or fat-free milk ( low-fat milk ) . The study used a quasi-experimental research design with one intervention city and one comparison city . The effectiveness of the campaign was evaluated by collecting milk sales data from supermarkets and conducting pre- and post-intervention telephone surveys in intervention and comparison cities . RESULTS In the intervention city , low-fat milk sales increased from 29 % of overall milk sales before the campaign to 46 % of sales in the month following the campaign . The increase was maintained at the 6-month follow up . According to the telephone surveys , 34.1 % of high-fat-milk drinkers reported switching to low-fat milk in the intervention community compared with 3.6 % in the comparison community ( z = 13.1 , P < 0.0001 ) . CONCLUSIONS A media-only approach was sufficient to encourage a significant proportion of the people in one community to alter the dietary habit targeted by the intervention The purpose of this study was to evaluate the effects of a revised worksite health promotion program that featured an employee steering committee/menu approach to intervention . The “ Take Heart II ” program was evaluated using a quasi-experimental matched-pair design with worksite as the unit of analysis . Experimental and control worksites did not differ on baseline organizational or employee demographic variables or on baseline levels of dependent variables . Outcome and process results revealed consistent , but modest effects favoring intervention worksites on most measures . Cross-sectional analyses generally failed to produce statistically significant intervention effects , but cohort analyses revealed significant beneficial effects of the Take Heart II intervention on eating patterns , behavior change attempts , and perceived social support . Neither analysis detected a beneficial effect of intervention on cholesterol levels Environmental interventions such as labeling and an increased availability of healthy foods may help consumers to meet guidelines for a healthy diet . OUTPUT: Interventions which targeted fruit and vegetable intake were most likely to be successful , particularly in worksites and churches . There was also evidence of small positive effects on reducing fat intake in worksites and churches . Overall the community-based interventions showed little effect . Dietary changes are reported in the relatively short-term studies review ed here but may not be sustained in the long term . INPUT: 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 Interest in the chemopreventive effects of the trace element selenium has spanned the past three decades . Of > 100 studies that have investigated the effects of selenium in carcinogen-exposed animals , two-thirds have observed a reduction in tumor incidence and /or preneoplastic endpoints ( G. F. Combs and S. B. Combs , The Role of Selenium in Nutrition Chapter 10 , pp . 413 - 462 . San Diego , CA : Academic Press , 1986 , and B. H. Patterson and O. A. Lev and er , Cancer Epidemiol . Biomark . Prev . , 6 : 63 - 69 , 1997 ) . The Nutritional Prevention of Cancer Trial , a r and omized clinical trial reported by Clark et al. ( L. C. Clark et al. , JAMA , 276 : 1957 - 1963 , 1996 ) , showed as a secondary end point , a statistically significant decrease in lung cancer incidence with selenium supplementation . The adjusted hazard ratio ( HR ) was 0.56 [ 95 % confidence interval ( CI ) , 0.31 - 1.01 ; P = 0.05 ] . These results were based on active follow-up of 1312 participants . This re analysis used an extended Nutritional Prevention of Cancer Trial participant follow-up through the end of the blinded clinical trial on February 1 , 1996 . The additional 3 years added 8 cases to the selenium-treated group and 4 cases to the placebo group , and increased follow-up to 7.9 years . The relative risk of 0.70 ( 95 % CI , 0.40 - 1.21 ; P = 0.18 ) is not statistically significant . Whereas the overall adjusted HR is not significant ( HR = 0.74 ; 95 % CI , 0.44 - 1.24 ; P = 0.26 ) , and the HR for current and former smokers was not significant , the trend is toward a reduction in risk of incident lung cancer with selenium supplementation . In a subgroup analysis there was a nominally significant HR among subjects with baseline plasma selenium in the lowest tertile ( HR = 0.42 ; 95 % CI , 0.18 - 0.96 ; P = 0.04 ) . The analysis for the middle and highest tertiles of baseline showed HRs of 0.91 and 1.25 . The current re analysis indicates that selenium supplementation did not significantly decrease lung cancer incidence in the full population , but a significant decrease among individuals with low baseline selenium concentrations was observed BACKGROUND A meta- analysis of 19 trials suggested a small increase in the risk of all-cause mortality with high-dose vitamin E supplementation . Little is known , however , about the relation between mortality and circulating concentrations of vitamin E result ing from dietary intake , low-dose supplementation , or both . OBJECTIVE We examined whether baseline serum alpha-tocopherol concentrations are associated with total and cause-specific mortality . DESIGN A prospect i ve cohort study of 29 092 Finnish male smokers aged 50 - 69 y who participated in the Alpha-Tocopherol , Beta-Carotene Cancer Prevention ( ATBC ) Study was carried out . Fasting serum alpha-tocopherol was measured at baseline by using HPLC . Only 10 % of participants reported vitamin E supplement use at baseline , and thus serum concentrations of vitamin E mainly reflected dietary intake and other host factors . Risks of total and cause-specific mortality were estimated by using proportional hazards models . RESULTS During up to 19 y of follow-up , 13 380 deaths ( including 4518 and 5776 due to cancer and cardiovascular disease , respectively ) were identified . Men in the higher quintiles of serum alpha-tocopherol had significantly lower risks of total and cause-specific mortality than did those in the lowest quintile [ relative risk ( RR ) = 0.82 ( 95 % CI : 0.78 , 0.86 ) for total mortality and 0.79 ( 0.72 , 0.86 ) , 0.81 ( 0.75 , 0.88 ) , and 0.70 ( 0.63 , 0.79 ) for deaths due to cancer , cardiovascular disease , and other causes , respectively ; P for trend for all < 0.0001 ] . OUTPUT:

The reporting quality of SRs has improved 3 y after publication of SR reporting st and ards , but the reporting of nutrition variables has not . Improved adherence to consensus methods and reporting st and ards should improve the utility of nutrition SRs

MS2_dynamic_1_shot635

***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: BACKGROUND Recent research on schizophrenia indicates that cognitive deficits in this illness are important predictors of functional outcome , highlighting the need for treatments that have a positive impact on cognitive function . Here we explore the hypothesis that acute administration of d-amphetamine can improve cognitive function in individuals with schizophrenia who are well-treated with typical antipsychotics , as well as in healthy controls performing under dual task conditions design ed to elicit performance deficits analogous to those found in schizophrenia . METHODS Ten individuals with schizophrenia taking haldol or prolixin and 22 healthy controls performed spatial working memory , language production , and Stroop tasks under both placebo and 0.25 mg/kg of D-amphetamine . RESULTS D-Amphetamine improved reactions times on the spatial working memory and Stroop tasks for both individuals with schizophrenia and controls , and improved working memory accuracy in schizophrenia . In addition , D-amphetamine improved language production for both individuals with schizophrenia and controls . CONCLUSIONS These results provide support for the hypothesis that the adjunctive administration of dopamine agonist can improve cognitive in individuals with schizophrenia taking typical antipsychotics . The results are discussed in terms of their implication s for underst and ing the nature of working memory deficits in schizophrenia , and potential future avenues for cognitive enhancement in this illness OBJECTIVE Despite a prevailing assumption that adult ADHD is a childhood-onset neurodevelopmental disorder , no prospect i ve longitudinal study has described the childhoods of the adult ADHD population . The authors report follow-back analyses of ADHD cases diagnosed in adulthood , alongside follow-forward analyses of ADHD cases diagnosed in childhood , in one cohort . METHOD Participants belonged to a representative birth cohort of 1,037 individuals born in Dunedin , New Zeal and , in 1972 and 1973 and followed to age 38 , with 95 % retention . Symptoms of ADHD , associated clinical features , comorbid disorders , neuropsychological deficits , genome-wide association study -derived polygenic risk , and life impairment indicators were assessed . Data sources were participants , parents , teachers , informants , neuropsychological test results , and administrative records . Adult ADHD diagnoses used DSM-5 criteria , apart from onset age and cross- setting corroboration , which were study outcome measures . RESULTS As expected , childhood ADHD had a prevalence of 6 % ( predominantly male ) and was associated with childhood comorbid disorders , neurocognitive deficits , polygenic risk , and residual adult life impairment . Also as expected , adult ADHD had a prevalence of 3 % ( gender balanced ) and was associated with adult substance dependence , adult life impairment , and treatment contact . Unexpectedly , the childhood ADHD and adult ADHD groups comprised virtually nonoverlapping sets ; 90 % of adult ADHD cases lacked a history of childhood ADHD . Also unexpectedly , the adult ADHD group did not show tested neuropsychological deficits in childhood or adulthood , nor did they show polygenic risk for childhood ADHD . CONCLUSIONS The findings raise the possibility that adults presenting with the ADHD symptom picture may not have a childhood-onset neurodevelopmental disorder . If this finding is replicated , then the disorder 's place in the classification system must be reconsidered , and research must investigate the etiology of adult ADHD IMPORTANCE Attention-deficit/hyperactivity disorder ( ADHD ) is now recognized to occur in adulthood and is associated with a range of negative outcomes . However , less is known about the prospect i ve course of ADHD into adulthood , the risk factors for its persistence , and the possibility of its emergence in young adulthood in non clinical population s. OBJECTIVE To investigate childhood risk factors and young adult functioning of individuals with persistent , remitted , and late-onset young adult ADHD . DESIGN , SETTING , AND PARTICIPANTS The study sample was the Environmental Risk ( E-Risk ) Longitudinal Twin Study , a nationally representative birth cohort of 2232 twins born in Engl and and Wales from January 1 , 1994 , to December 4 , 1995 . Evaluation of childhood ADHD ( ages 5 , 7 , 10 , and 12 years ) included prenatal and perinatal factors , clinical characteristics , and aspects of the family environment . Among participants aged 18 years , ADHD symptoms and associated impairment , overall functioning , and other mental health disorders were examined . Data analysis was conducted from February 19 to September 10 , 2015 . MAIN OUTCOMES AND MEASURES Attention-deficit/hyperactivity disorder according to DSM-IV diagnostic criteria in childhood and DSM-5 diagnostic criteria in young adulthood . RESULTS Of 2232 participants in the E-Risk Study , 2040 were included in the present analysis . In total , 247 individuals met diagnostic criteria for childhood ADHD ; of these , 54 ( 21.9 % ) also met diagnostic criteria for the disorder at age 18 years . Persistence was associated with more symptoms ( odds ratio [ OR ] , 1.11 [ 95 % CI , 1.04 - 1.19 ] ) and lower IQ ( OR , 0.98 [ 95 % CI , 0.95 - 1.00 ] ) . At age 18 years , individuals with persistent ADHD had more functional impairment ( school/work : OR , 3.30 [ 95 % CI , 2.18 - 5.00 ] , home/with friends : OR , 6.26 [ 95 % CI , 3.07 - 12.76 ] ) , generalized anxiety disorder ( OR , 5.19 [ 95 % CI OUTPUT: Conclusions We demonstrate a greater presence of ADHD symptomatology in SCZ compared to that reported for ADHD in the general population . INPUT: We prospect ively followed an ethnically and socioeconomically diverse sample of preadolescent girls with ADHD ( n = 140 ) and matched comparison girls ( n = 88 ) over a period of 5 years , from middle childhood through early/mid-adolescence . Our aim was to examine the ability of measures of childhood executive function ( EF ) to predict functional outcomes in adolescence . Measures of neuropsychological functioning comprised the childhood predictors , with academic , social , and global functioning serving as adolescent criterion measures . Results indicated that childhood EF predicted ( a ) academic achievement and social functioning across our entire sample ( independent of diagnostic group status ) and ( b ) global functioning only in girls with ADHD ( independent of IQ ) . These results highlight the non-specificity of EF deficits and suggest the importance of assessing and developing interventions that target EF impairments , particularly in those at high-risk for negative outcomes , in order to prevent long-term difficulties across a range of important functional domains Methylpheni date ( MPH ) often ameliorates attention-deficit/hyperactivity disorder ( ADHD ) behavioral dysfunction according to indirect informant reports and rating scales . The st and ard of care behavioral MPH titration approach seldom includes direct neuropsychological or academic assessment data to determine treatment efficacy . Documenting “ cool ” executive-working memory ( EWM ) and “ hot ” self-regulation ( SR ) neuropsychological impairments could aid in differential diagnosis of ADHD subtypes and determining cognitive and academic MPH response . In this study , children aged 6 to 16 with ADHD inattentive type ( IT ; n = 19 ) and combined type ( n = 33)/hyperactive-impulsive type ( n = 4 ) ( CT ) participated in double-blind placebo-controlled MPH trials with baseline and r and omized placebo , low MPH dose , and high MPH dose conditions . EWM/ SR measures and behavior ratings/classroom observations were rank ordered separately across conditions , with nonparametric r and omization tests conducted to determine individual MPH response . Participants were subsequently grouped according to their level of cool EWM and hot SR circuit dysfunction . Robust cognitive and behavioral MPH response was achieved for children with significant baseline EWM/SR impairment , yet response was poor for those with adequate EWM/ SR baseline performance . Even for strong MPH responders , the best dose for neuropsychological functioning was typically lower than the best dose for behavior . Findings offer one possible explanation for why long-term academic MPH treatment gains in ADHD have not been realized . Implication s for academic achievement and medication titration practice s for children with behaviorally diagnosed ADHD will be discussed This individual differences study examined the separability of three often postulated executive functions-mental set shifting ( " Shifting " ) , information updating and monitoring ( " Updating " ) , and inhibition of prepotent responses ("Inhibition")- and their roles in complex " frontal lobe " or " executive " tasks . One hundred thirty-seven college students performed a set of relatively simple experimental tasks that are considered to predominantly tap each target executive function as well as a set of frequently used executive tasks : the Wisconsin Card Sorting Test ( WCST ) , Tower of Hanoi ( TOH ) , r and om number generation ( RNG ) , operation span , and dual tasking . Confirmatory factor analysis indicated that the three target executive functions are moderately correlated with one another , but are clearly separable . Moreover , structural equation modeling suggested that the three functions contribute differentially to performance on complex executive tasks . Specifically , WCST performance was related most strongly to Shifting , TOH to Inhibition , RNG to Inhibition and Updating , and operation span to Updating . Dual task performance was not related to any of the three target functions . These results suggest that it is important to recognize both the unity and diversity of executive functions and that latent variable analysis is a useful approach to study ing the organization and roles of executive functions OBJECTIVES To determine any long-term effects , 6 and 8 years after childhood enrollment , of the r and omly assigned 14-month treatments in the NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder ( MTA ; N = 436 ) ; to test whether attention-deficit/hyperactivity disorder ( ADHD ) symptom trajectory through 3 years predicts outcome in subsequent years ; and to examine functioning level of the MTA adolescents relative to their non-ADHD peers ( local normative comparison group ; N = 261 ) . METHOD Mixed-effects regression models with planned contrasts at 6 and 8 years tested a wide range of symptom and impairment variables assessed by parent , teacher , and youth report . RESULTS In nearly every analysis , the originally r and omized treatment groups did not differ significantly on repeated measures or newly analyzed variables ( e.g. , grade s earned in school , arrests , psychiatric hospitalizations , other clinical ly relevant outcomes ) . Medication use decreased by 62 % after the 14-month controlled trial , but adjusting for this did not change the results . ADHD symptom trajectory in the first 3 years predicted 55 % of the outcomes . The MTA participants fared worse than the local normative comparison group on 91 % of the variables tested . CONCLUSIONS Type or intensity of 14 months of treatment for ADHD in childhood ( at age 7.0 - 9.9 years ) does not predict functioning 6 to 8 years later . Rather , early ADHD symptom trajectory regardless of treatment type is prognostic . This finding implies that children with behavioral and sociodemographic advantage , with the best response to any treatment , will have the best long-term prognosis . As a group , however , despite initial symptom improvement during treatment that is largely maintained after treatment , children with combined-type ADHD exhibit significant impairment in adolescence . Innovative treatment approaches targeting specific areas of adolescent impairment are needed BACKGROUND Functional brain imaging studies of major depression have consistently revealed hypometabolism or hypoperfusion in specific regions of the prefrontal cortex and basal gang OUTPUT:

Review of the evidence suggests that task performance may be useful in identifying individuals with ADHD at risk for academic impairment . However , the evidence is less compelling for identifying youth at risk for impaired social functioning or poor health outcomes . The review also found that task performance is likely useful for predicting response to treatment with methylpheni date . Across studies , evidence indicated that interpreting task performance in an integrated manner , such as a factor score or mean score , was more consistently useful for predicting outcomes of interest than interpreting performance from a single task .

MS2_dynamic_1_shot636

***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: Purpose People with lung cancer report a higher burden of unmet needs , specifically psychological and daily living unmet needs . They experience more psychological distress and more physical hardship than other tumour sites . This study examined the levels of unmet need and psychological distress in inoperable lung cancer patients at the start of treatment . Methods A cross-section survey methodology was employed using baseline data from a r and omised controlled trial design ed to evaluate a supportive care intervention . Eligible lung cancer patients were approached to participate at the start of treatment . Consenting patients completed question naires prior to or just after the commencement of treatment . Reliable and valid measures included Needs Assessment for Advanced Lung Cancer Patients , Hospital Anxiety and Depression Scale and Brief Distress Thermometer . Results Of the 108 patients participating , the top unmet need was ‘ Dealing with concerns about your family ’s fears and worries ’ ( 62 % ) ; with the next four also coming from the psychological/emotional domain , but , on average , most needs related to medical communication . Thirty two percent of patients reported clinical or sub clinical anxiety and 19 % reported HADS scores suggestive of clinical or sub clinical depression . Moreover , 39.8 % of the sample reported distress above the cut-off on the distress thermometer and this was associated with higher needs for each need subscale ( p < 0.05 ) . Conclusions People with lung cancer have high levels of unmet needs especially regarding psychological/emotional or medical communication . People with lung cancer who are classified as distressed have more unmet needs Abstract Purpose To examine the effect of knowledge of radiographic abnormalities on the mental health of asbestos-exposed people with and without pleural abnormalities . Methods Subjects were former asbestos mine and mill workers and residents of the mining town who had participated in an annual health review program . Pleural abnormalities ( pleural plaques , diffuse pleural thickening and asbestosis ) were determined from plain chest X-rays . All Participants completed a question naire on mental health status ( SF-12 ) and locus of control ( LOC ) . Results There were no significant differences between asbestos-exposed people with and without radiographic abnormalities for either the SF-12 mental health score or LOC . However , the asbestos-exposed cohorts had lower mental health scores compared with a r and om sample of the local population . Conclusion The presence of pleural abnormalities did not further affect the mental health of asbestos-exposed people beyond a decrement associated with exposure per se Purpose Malignant pleural mesothelioma ( MPM ) is a highly aggressive and symptomatic disease . We examined the relationship between health-related quality of life ( HRQoL ) and inflammatory markers , and the prognostic role of HRQoL in MPM patients . Methods MPM patients from two parallel phase II studies ( thalidomide alone or thalidomide with chemotherapy ) were included . HRQoL was assessed at baseline using the modified Lung Cancer Symptom Scale ( LCSS ) . Baseline inflammatory markers and cytokines were measured . Spearman correlation was used to examine the relationship between inflammatory markers and HRQoL measures . The prognostic value of the HRQoL domains was examined using Cox proportional hazard model . Results Sixty-three patients were included : median age 61 years ( range 44–79 ) ; 82 % male ; 77 % Eastern Cooperative Oncology Group ( ECOG ) performance status 0–1 ; 44 % epithelial histology subtype . Baseline systemic symptoms of anorexia and fatigue , the summation symptoms of overall symptomatic distress , interference with normal activity and global QoL and the aggregate score of total LCSS score were all associated with elevated neutrophil-to-lymphocyte ratio , C-reactive protein and vascular endothelial growth factor levels at baseline ( rho ≥ 0.25 ; p < 0.05 ) . Baseline anorexia , fatigue , cough , dyspnoea , pain , overall symptomatic distress , interference with normal activity , global QoL and total LCSS score were all significantly related to survival ( p < 0.05 ) after adjusting for established prognostic factors ( age , gender , histological subtype and performance status ) and treatment effect . Conclusions In conclusion , HRQoL seems to relate to a patient 's systemic inflammatory status and is associated with survival in MPM patients BACKGROUND In patients with malignant pleural mesothelioma undergoing a multimodality therapy , treatment toxicity may outweigh the benefit of progression-free survival . The subjective experience across different treatment phases is an important clinical outcome . This study compares a st and ard with an individual quality of life ( QoL ) measure used in a multi-center phase II trial . PATIENTS AND METHODS Sixty-one patients with stage I-III technically operable pleural mesothelioma were treated with preoperative chemotherapy , followed by pleuropneumonectomy and subsequent radiotherapy . QoL was assessed at baseline , at day 1 of cycle 3 , and 1 , 3 and 6 months post-surgery by using the Rotterdam Symptom Checklist ( RSCL ) and the Schedule for the Evaluation of Quality of Life-Direct Weighting ( SEIQoL-DW ) , a measure that is based on five individually nominated and weighted QoL-domains . RESULTS Completion rates were 98 % ( RSCL ) and 92 % ( SEIQoL ) at baseline and 98%/89 % at cycle 3 , respectively . Of the operated patients ( N=45 ) RSCL and SEIQoL were available from 86%/72 % , 93%/74 % , and 94%/76 % at months 1 , 3 , and 6 post-surgery . Average assessment time for the SEIQoL was 24min compared to 8min needed for the RSCL . OUTPUT: CONCLUSIONS This paper highlights the paucity of studies on the psychological distress and care needs of mesothelioma patients and asbestos-exposed subjects . It confirms that malignant mesothelioma is associated with the physical , emotional , and social functioning of patients , while also suggesting that the risk of developing asbestos-related diseases among asbestos-exposed subjects is associated with high levels of psychological distress , despair , and mental health difficulties INPUT: This study examined the relationship between health utility and psychometric health status measures . Utility scores derived by st and ard gamble and categorical rating methods were also compared to determine if they produce equivalent preference scales . Health status and utility was assessed in 73 chronic renal disease patients with anemia ( hematocrit less than or equal to 30 ) participating in a 48-week clinical study . Patient preferences for current health and three hypothetical states were assessed using st and ard gamble and categorical rating procedures . St and ard gamble utility was related to home management ( P less than .05 ) ; categorical rating utility was related to home management ( P less than .05 ) , energy ( P less than .05 ) , alertness behavior ( P less than .05 ) , social interaction ( P less than .05 ) , and life satisfaction scale scores ( P less than .05 ) . Only 25 - 27 % of the variance in utility scores was explained by the health status measures . St and ard gamble utilities were consistently higher than categorical rating values for end-stage renal disease with hemodialysis ( P less than .0001 ) and severe anemia requiring blood transfusions ( P less than .0001 ) . Patient preferences for current health may be influenced in part by their functional status and well-being , risk aversion or risk-taking attitudes , and the cognitive evaluation processes involved in making judgments necessary for the measurement task , as well as their actual preferences To assess the health values of patients infected with human immunodeficiency virus ( HIV ) and examine the relationships between their health values and health status at two points in time , the authors sought to determine whether patients ' physical and mental health statuses were good predictors of how they valued their current state of health . One hundred thirty-nine patients with various stages of HIV infection were interviewed in a prospect i ve cohort study based in a primary care practice of a community-based teaching hospital . Patients were interviewed twice at 6-month intervals using three health value measures --the time trade off , rating scale , and Quality of Well-being Scale-- and three health status measures : the 18-item Mental Health Inventory , the Dyspnea-Fatigue Index , and the Medical Outcomes Study SF-36 Health Survey . The health status of HIV-infected patients was compromised and , with the exception of mental health , generally was worse among patients with more advanced HIV-infection . Rating scale and Quality of Well-being Scale scores were related inversely to disease stage , but time-trade off scores generally were higher regardless of disease stage . Health value measures showed moderate relationships with measures of physical functioning ( r = 0.34 - 0.68 ) but only a fair relationship with mental health ( r = 0.00 - 0.48 ) . The health status of HIV-infected patients who remained asymptomatic or remained symptomatic but without developing acquired immunodeficiency syndrome ( AIDS ) changed little over 6 months , whereas the health status of patients with AIDS and of patients manifesting progression of HIV-infection deteriorated over time . In contrast , health values , particularly time-tradeoff scores , remained stable even in the face of changes in health status and disease progression . With the exception of mental health , the impact of HIV infection on health status tends to parallel the clinical stage of disease . Health values of HIV-infected patients , however , generally are high and correlate better with physical functioning than with mental health The Health Utilities Index Mark 3 ( HUI3 ) and the EuroQol EQ-5D ( EQ-5D ) were compared to each other and to other quality -of-life ( QoL ) measures in patients treated for intermittent claudication . A total of 88 patients with intermittent claudication completed the HUI3 , EQ-5D , R AND 36-Item Health Survey 1.0 , time tradeoff , st and ard gamble , and rating scale before revascularization and at follow-up at 1 month , 3 months , and 1 year . The effect of treatment on the HUI3 and EQ-5D dimensions and the overall scores , calculated using published formulas based on societal preferences , were compared . After 1 month of treatment , the majority of patients showed improvement on the HUI3 dimensions ambulation and pain and on the EQ-5D dimensions mobility , usual activities , and pain/discomfort . The mean HUI3 score was significantly higher than the mean EQ-5D score ( 0.66 and 0.57 , respectively , p < 0.01 ) before treatment . After treatment , however , they were not significantly different from each other ( e.g. , 12 months after treatment : 0.77 and 0.75 , respectively ( p > 0.05 ) . After 1 month , the scores did not change significantly over time ( p > 0.05 ) . The intraclass correlation coefficient between changes over time in the HUI3 and EQ-5D scores was 0.30 , with other health-related quality -of-life ( HRQoL ) measures the correlations for HUI3 and EQ-5D were very similar . In conclusion , both the HUI3 and EQ-5D demonstrated an effect of treatment in patients with intermittent claudication ; in addition , they showed similar relationships with other ( HRQoL ) measures . To demonstrate the effect of revascularization in patients with intermittent claudication , however , clinicians and research ers should be aware of the differences in the mean HUI3 and EQ-5D scores Despite the perception of many people that lasers represent the cutting edge of high-technology medicine , this form of medical technology has been subject to relatively little rigorous evaluation . This dearth of research relates particularly to economic evaluation , where there have been few attempts to justify the high cost of laser equipment . This paper details an economic evaluation of the use of laser technology as a secondary adjunct to angioplasty to treat peripheral arterial occlusions . Using data from a range of sources , including a published r and omized trial , a cost-utility model is developed to estimate the costs and benefits of the laser , relative to st and ard angioplasty . The best available data indicate a cost-effective role for the laser , but important areas of uncertainty exist , including the OUTPUT:

The results of this study do not support the common view that RS values are lower than TTO values , may suggest that TTO biases largely cancel , and support the validity of formulas for correcting SG bias

MS2_dynamic_1_shot637

***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: BACKGROUND Pharmacotherapy is the main treatment for management of trigeminal neuralgia . However , many patients become refractory to drugs . OBJECTIVES The present study aim ed to evaluate the effect of adding calcitonin to local anesthetic and methylprednisolone using a modified coronoid approach in management of trigeminal neuralgia pain involving the m and ibular and /or maxillary branches . STUDY DESIGN R and omized double blind clinical trial . SETTING Hospital outpatient setting . METHODS Thirty-three patients received maxillary and m and ibular blocks by a modified coronoid approach . Patients were allocated into 2 groups . Group 1 received a block with 3 mL of lidocaine 0.5 % plus 40 mg of methylprednisolone and another syringe contained 1 mL of 0.9 % saline . Group 2 received a block with 3 mL of lidocaine 0.5 % plus 40 mg of methylprednisolone and another syringe contained 50 international units of calcitonin . Pain was evaluated by visual analog scale ( VAS ) before the block ( basal ) , at 2 weeks , one month after the procedure , and monthly for one year . Duration of the effective pain relief of the first block ( VAS = 3 ) was reported . Repeated blockade was allowed for any patient reporting a VAS > 30 mm during one year of follow-up and the number of blocks were reported . Adverse effects were also reported . RESULTS A significantly longer duration of effective pain relief was noticed in group 2 compared with group 1 ( P < 0.0004 ) while the duration of effective pain relief of the second block in group 1 was 28.5 ± 8.9 weeks . Four patients did not need repeated blocks in group 1 versus 15 in group 2 . Six patients received 2 blocks versus 2 patients in each group , respectively . Moreover , 6 patients needed 3 blocks in group1 versus none in group 2 . No serious adverse events were reported during or after the interventional procedure . VAS was comparable in both groups ( P > 0.05 ) . LIMITATIONS Small sample size . CONCLUSION Calcitonin may be a useful additive to local anesthetic and steroid in management of trigeminal neuralgia . Also , a modified coronoid approach for maxillary and m and ibular nerve is simple , free of radiation , safe , and may be an effective percutaneous procedure in trigeminal neuralgia . KEY WORDS Calcitonine , modifed , coronoid approach , trigeminal neuralgia Background In the majority of cases , trigeminal neuralgia ( TN ) is a unilateral condition with ultra-short stabbing pain located along one or more branches of the trigeminal nerve . Although prophylactic pharmacological treatment is first choise , considering of insufficient effect or unacceptable side effects , neurosurgical treatment or lesion treatment should be considered . In addition to all these procedures mentioned above , one approach has been based on local intradermal and /or submucosal injections of Botulinum Toxin Type A ( BTX-A ) . Methods We conducted a r and omized , double-blind , placebo-controlled since November 2012 , and adopted local multi-point injection in 84 cases of classical TN with different doses of BTX-A. Eighty four patients were r and omized into following groups : placebo ( n = 28 ) ; BTX-A 25U ( n = 27 ) ; BTX-A 75U ( n = 29 ) . Follow-up visits were conducted every week after the injection , and the overall duration of the study for each patient were 8 weeks to observe the pain severity , efficacy and adverse reactions at endpoint . Results The visual analogue scale ( VAS ) scores of 25U and 75U groups reduced significantly compared to placebo as early as week 1 , and sustained until week 8 throughout the study . There was no significant difference in VAS between 25U and 75U groups throughout the study . The response rates of 25U group ( 70.4 % ) and 75U group ( 86.2 % ) were significantly higher than placebo group ( 32.1 % ) at week 8 , and there was no significant difference between 25U and 75U groups . Evaluation of the Patient Global Impression of Change ( PGIC ) demonstrated that 66.7 % ( 25U group ) and 75.9 % ( 75U group ) of the patients reported that their pain symptoms were ‘ much improved ’ or ‘ very much improved ’ versus 32.1 % of the placebo group , and there was also no significant difference between 25U and 75U groups . All adverse reactions were grade d as mild or moderate . Conclusions BTX-A injection in TN is safe and efficient . It is a useful treatment for refractory TN . Lower dose ( 25U ) and high dose ( 75U ) were similar in efficacy in short-term Background Carbamazepine ( CBZ ) formed the gold st and ard drug in trigeminal neuralgia ( TN ) treatment but faces high therapeutic failure . This defined the need to explore a second line of drug therapy . The study aim ed at comparing two alternate drugs i.e. Lamotrigine ( LTG ) and Pregabalin ( PGB ) , in the management of TN refractory to therapeutic doses of CBZ . Methods Twenty-two patients with diagnosis of refractory TN were enrolled and r and omly allotted into 2 groups of 11 each . Each group was subjected to a crossover analysis using LTG and PGB together with CBZ , for a period of 6 weeks . Patients maintained a pain diary , the scores of which , along with global evaluation scores , determined the primary outcome . Reevaluation of symptoms after 6 months was done to assess long term efficacy with study drugs . Results Both LTG and PGB were effective over CBZ alone ( p < 0.05 ) ; however , statistically insignificant difference ( p > 0 OUTPUT: Rankogram plots revealed sumatriptan and combined continuous and pulsed radiofrequency thermocoagualtion have the highest probability of being the best treatments in the respective group of interventions . No inconsistency was observed between direct and indirect comparisons . Conclusion We found that drug-related interventions that include sumatriptan , intranasal lidocaine , intravenous lidocaine , and botulinum toxin and combined continuous and pulsed radiofrequency thermocoagulation had significant effects in reducing pain in patients with refractory TN . However , the quality of evidence was grade d as very low for all except botulinum toxin INPUT: Background In the majority of cases , trigeminal neuralgia ( TN ) is a unilateral condition with ultra-short stabbing pain located along one or more branches of the trigeminal nerve . Although prophylactic pharmacological treatment is first choise , considering of insufficient effect or unacceptable side effects , neurosurgical treatment or lesion treatment should be considered . In addition to all these procedures mentioned above , one approach has been based on local intradermal and /or submucosal injections of Botulinum Toxin Type A ( BTX-A ) . Methods We conducted a r and omized , double-blind , placebo-controlled since November 2012 , and adopted local multi-point injection in 84 cases of classical TN with different doses of BTX-A. Eighty four patients were r and omized into following groups : placebo ( n = 28 ) ; BTX-A 25U ( n = 27 ) ; BTX-A 75U ( n = 29 ) . Follow-up visits were conducted every week after the injection , and the overall duration of the study for each patient were 8 weeks to observe the pain severity , efficacy and adverse reactions at endpoint . Results The visual analogue scale ( VAS ) scores of 25U and 75U groups reduced significantly compared to placebo as early as week 1 , and sustained until week 8 throughout the study . There was no significant difference in VAS between 25U and 75U groups throughout the study . The response rates of 25U group ( 70.4 % ) and 75U group ( 86.2 % ) were significantly higher than placebo group ( 32.1 % ) at week 8 , and there was no significant difference between 25U and 75U groups . Evaluation of the Patient Global Impression of Change ( PGIC ) demonstrated that 66.7 % ( 25U group ) and 75.9 % ( 75U group ) of the patients reported that their pain symptoms were ‘ much improved ’ or ‘ very much improved ’ versus 32.1 % of the placebo group , and there was also no significant difference between 25U and 75U groups . All adverse reactions were grade d as mild or moderate . Conclusions BTX-A injection in TN is safe and efficient . It is a useful treatment for refractory TN . Lower dose ( 25U ) and high dose ( 75U ) were similar in efficacy in short-term Objectives : Cumulative evidence support a beneficial effect of botulinum toxin A ( BTX-A ) in postherpetic neuralgia ( PHN ) . We aim ed to assess efficacy , safety , and tolerability of BTX-A in the management of PHN , performing a r and omized , double-blind , single-dose , placebo-controlled trial . Methods : Thirty adults with PHN were r and omized either to BTX-A or placebo . Severity of pain was evaluated by patients using a visual analogue scale ( VAS ) and quality of sleep was assessed using a 5-item question naire . Primary outcome was reduction in VAS score , with a greater than 50 % reduction being considered clinical ly significant . Secondary outcomes were reduction in sleep score and maintenance of VAS score after treatment , with over 50 % maintenance considered clinical ly meaningful . Results : Thirteen patients from the experimental arm achieved an at least 50 % reduction in VAS score , compared with none of the placebo patients ( NNT=1.2 , 95 % CI , 2 - 1 ; ARR=0.87 , 95 % CI , 055 - 096 ; P<0.001 ) . BTX-A patients showed significant reduction in VAS pain scores between baseline and week 2 , which persisted for a median period of 16 weeks . BTX-A patients showed significant reduction in sleep scores between baseline and week 2 , which remained unchanged until 16th week ( P<0.001 ) . Treatment was well tolerated . Discussion : Data confirm that BTX-A is effective and well tolerated in the treatment of PHN Background Botulinum toxin type A ( BTX-A ) has been reported to have analgesic effects independent of its action on muscle tone , mostly by acting on neurogenic inflammatory mediators and controlling the neurotransmitter release of sensory and autonomic nerve terminals that are involved in many chronic painful conditions as chronic intractable trigeminal neuralgia (TN).The aim of our work was evaluating the efficacy , safety , and tolerability of BTX-A for the treatment of intractable idiopathic TN . Methods This was a r and omized , single-blinded , placebo-control study carried out on 20 Egyptian patients with intractable TN . Patients received a one-time subcutaneous administration of BTX-A using “ follow the pain ” method . The primary efficacy measure was reduction in pain severity on the 10-cm VAS score as well as in paroxysms frequency from the baseline to week 12 ( endpoint last observation carried forward [ LOCF ] ) . Secondary efficacy measures included QoL assessment and number of acute medications received from baseline to the endpoint . Results Pain reduction at the 12-week endpoint was significant in BTX-A group ( p<0.0001 ) ; VAS scores at endpoint LOCF relative to baseline for BTX-A group showed a decrease of 6.5 compared with a decrease of 0.3 for placebo , also there was a significant decrease in the number of acute medications and an increase in QoL functioning scale . Conclusion These results indicate that BTX-A has a direct analgesic effect in patients with TN and can represent a therapeutic option for intractable cases BACKGROUND Data from previous studies suggest that botulinum toxin A has analgesic effects against peripheral neuropathic pain , but the quality of the evidence is low . We aim ed to assess the safety and efficacy of repeated administrations of botulinum toxin A in patients with neuropathic pain . METHODS We did a r and omised , double-blind , placebo-control OUTPUT:

Conclusion Based on the current evidence , BTX-A may be an effective and safe option for the treatment of neuralgia .

MS2_dynamic_1_shot638

***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: Background — The objective of the present study was to investigate the effect of cardiac resynchronization therapy ( CRT ) on cardiac autonomic function . Methods and Results — This prospect i ve study included 45 consecutive patients with heart failure who received CRT devices with defibrillator and 20 age-matched , healthy control subjects . At baseline and 3 months and 6 months after CRT , we assessed New York Heart Association ( NYHA ) class , 6-minute walk distance , plasma sympathetic biomarker nerve growth factor , echocardiography , heart rate variability and cardiac presynaptic sympathetic function determined by iodine 123 metaiodobenzylguanidine scintigraphy . After CRT , NYHA class improved by 1 class ( P<0.001 ) , and left ventricular ejection fraction increased by 8 % ( P<0.001 ) . Along with improvement in the st and ard deviation of all normal-to-normal R-R intervals ( 85.63±31.66 ms versus 114.79±38.99 ms ; P=0.004 ) and the st and ard deviation of the averaged normal-to-normal R-R intervals ( 82.62±23.03 ms versus 100.50±34.87 ms ; P=0.004 ) , the delayed heart/mediastinum ( H/M ) ratio increased ( 1.82 [ 0.58 ] versus 1.97 [ 0.59 ] ; P=0.03 ) , whereas the mean ( SD ) H/M washout rate was reduced ( 48 % [ 19 % ] versus 37 % [ 22 % ] ; P=0.01 ) . Twenty-two of 45 study patients responded to CRT , with a reduction of left ventricular end-systolic volume index > 15 % . Compared with nonresponders , responders had a higher delayed H/M ratio ( 2.11 versus 1.48 ; P=0.003 ) and lower H/M washout rate ( 37 % versus 62 % ; P=0.003 ) at baseline . Conclusions — CRT improved sympathetic function . Cardiac sympathetic reserve may be a marker for the reversibility of failing myocardial function AIMS The European cardiac resynchronization therapy ( CRT ) survey is a joint initiative taken by the Heart Failure Association and the European Heart Rhythm Association of the European Society of Cardiology . The primary aim of this survey is to describe current European practice associated with CRT implantations . METHODS AND RESULTS A total of 140 centres from 13 European countries contributed data from consecutive patients successfully implanted with a CRT device with or without an ICD between November 2008 and June 2009 . The total number of patients enrolled was 2438 . The median age of the patients was 70 years ( IQR 62 - 76 ) and 31 % were > or = 75 years . It was found that 78 % were in NYHA functional class III or IV and 22 % in I or II . The mean ejection fraction was 27 % + /- 8 and the mean QRS duration 157 ms + /- 32 . The QRS duration was < 120 ms in 9 % . Atrial fibrillation was reported in 23 % . It was found that 26 % of patients had a previously implanted permanent pacemaker or ICD ; 76 % of procedures were performed by an electrophysiologist ; 82 % had an elective admission for implantation and the median duration of hospitalization was 3 days ( IQR 2 - 7 ) ; and 73 % received a CRT-D device which was more often implanted in men , younger patients , and with ischaemic aetiology . The mean QRS duration was reduced to 133 ms + /- 27 ( P < 0.0001 ) at discharge . Peri-procedural complication rates were comparable to the rates reported in r and omized trials . CONCLUSION This CRT survey provides important information describing current European practice with regard to patient demographics , selection criteria , procedural routines , and status at discharge . These data should be useful for benchmarking individual patient management and national practice against wider experience INTRODUCTION Cardiac resynchronization therapy ( CRT ) and implantable cardioverter-defibrillators ( ICD ) are effective therapies for heart failure ( HF ) patients with cardiac dyssynchrony . Patients receiving primary prevention CRT-defibrillator that positively remodel might no longer qualify for ICD indication due to CRT-induced left ventricular ejection fraction ( LVEF ) improvement . We aim ed to evaluate the outcome of CRT-D patients at the time of device replacement ( DR ) . METHODS AND RESULTS Patients undergoing primary prevention CRT-D DR were prospect ively included from November 2007 to March 2011 in 2 centers . CRT response was as defined as ≥1 NYHA class improvement and an increase in LVEF ≥10 % . Before DR , all patients underwent echocardiography and device interrogation . Patients without theoretical ongoing ICD indication ( TOII ) at DR were defined as those with LVEF ≥40 % without appropriate ICD therapy ( appropriate therapy ) during the first ICD service-life . A total of 107 consecutive patients were enrolled . Sixty-one patients ( 57 % ) were considered CRT responders after the index procedure . At the time of DR ( 56.4 ± 14.4 months from initial implant ) , 87 % of CRT responders were free of appropriate therapy , compared with 70 % of CRT nonresponders ( P = 0.02 ) . Thirty-nine patients ( 37 % ) did not meet the criteria for TOII . During follow-up ( mean 26.4 ± 14.4 months after DR ) , 37 patients ( 95 % ) without TOII were free of appropriate therapy versus 49 of 6 OUTPUT: Recovery of LVEF post-CRT is associated with significantly reduced appropriate ICD therapy . Patients with improvement of LVEF ≥45 % and those with primary prevention indication for ICD appear to be at lowest risk INPUT: Cardiac resynchronization therapy ( CRT ) devices not only deliver effective treatment but may also serve as valuable diagnostic tools in heart failure management . In the present study , the minutes of daily physical activity and heart rate variability , measured by sensors incorporated into such a device , reflected the effects of CRT and were related to New York Heart Association functional class BACKGROUND There are limited data on the prognostic importance of declining activity level in patients with heart failure . OBJECTIVE We aim ed to assess the association of reduced activity level with adverse cardiovascular outcomes in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) . METHODS Final device interrogations from patients enrolled in the MADIT-CRT with cardiac resynchronization devices capable of recording percent daily activity level were assessed . To determine temporal change , st and ardized activity levels ( SALs ) comparing each week to the monthly activity 3 months prior were obtained . Death , heart failure events (HFEs)/death , and ventricular tachyarrhythmias (VTAs)/death were the primary end points of this study . RESULTS The average absolute activity level and SAL of the final week prior to death or end of study were significantly lower in patients who died compared with those in patients who did not . The total cohort ( N = 1008 ) was further r and omized into 2 subgroups to identify ( group 1 ) and vali date an optimal threshold ( group 2 ) . Patients with > 40 % reduced SAL had a significantly increased 77-day short-term cumulative incidence of death ( P = .0006 ) , HFE/death ( P < .0001 ) , or VTA/death ( P = .0248 ) . After adjustment for clinical covariates , these patients remained at an increased risk for death ( hazard ratio [ HR ] , 2.7 ; 95 % confidence interval [ CI ] , 1.5 - 4.9 ; P = .001 ) , HFE/death ( HR , 2.7 ; 95 % CI , 1.8 - 3.9 ; P ≤ .001 ) and VTA/death ( HR , 1.9 ; 95 % CI , 1.31 - 2.6 ; P = .001 ) . A decline in SAL following a nonfatal VTA and HFE was also associated with an increased probability of death . CONCLUSIONS Decline in activity level is a short-term predictor for adverse cardiovascular events in patients with mild to moderate heart failure undergoing cardiac resynchronization AIMS This retrospective analysis sought to develop and vali date a model using the measured diagnostic variables in cardiac resynchronization therapy ( CRT ) devices to predict mortality . METHODS AND RESULTS Data used in this analysis came from two CRT studies : Cardiac Resynchronization Therapy Registry Evaluating Patient Response with RENEWAL Family Devices ( CRT RENEWAL ) ( n = 436 ) and Heart Failure-Heart Rate Variability ( HF-HRV ) ( n = 838 ) . Patients from CRT RENEWAL were used to create a model for risk of death using logistic regression and to create a scoring system that could be used to predict mortality . Results of both the logistic regression and the clinical risk score were vali date d in a cohort of patients from the HF-HRV study . Diagnostics significantly improved over time post-CRT implant ( all P < 0.001 ) and were correlated with a trend of decreased risk of death . The regression model classified CRT RENEWAL patients into low ( 2.8 % ) , moderate ( 6.9 % ) , and high ( 13.8 % ) risk of death based on tertiles of their model predicted risk . The clinical risk score classified CRT RENEWAL patients into low ( 2.8 % ) , moderate ( 10.1 % ) , and high ( 13.4 % ) risk of death based on tertiles of their score . When both the regression model and the clinical risk score were applied to the HF-HRV study , each was able to classify patients into appropriate levels of risk . CONCLUSION Device diagnostics may be used to create models that predict the risk of death BACKGROUND The effect of implantable cardioverter-defibrillator ( ICD ) shock on device-measured activity and patient-reported outcomes is unknown . OBJECTIVE The purpose of this study was to analyze the acute and long-term effects of ICD shock on objective behavioral data ( ie , device-based physical activity ) and subjective patient-reported outcomes ( eg , quality of life and shock anxiety ) . METHODS The PainFree Smart Shock Technology ( SST ) clinical trial included 2770 patients with a single- or dual-chamber ICD or cardiac resynchronization therapy - defibrillator device who were followed for 22 ± 9 months . Participants completed measures of quality of life ( EuroQol-5D [ EQ-5D ] question naire ) and shock anxiety ( Florida Shock Anxiety Scale ) at baseline , biannual visits , and monthly for 6 months after an ICD shock . Daily physical activity data were obtained from a built-in device accelerometer . RESULTS The average daily activity was 185.3 ± 119.4 min/d . Activity was significantly reduced after an ICD shock ( P < .0001 ) and recovered to a normal level after ∼90 days . An ICD shock was also associated with decreased quality of life ( EQ5-D health score ) and increased EQ-5D anxiety scores , but it did not affect mobility , self-care , activity , or pain . Similarly , shock anxiety ( Florida Shock Anxiety Scale ) increased in shocked patients and remained significantly elevated at 24 months , regardless of appropriate or inappropriate shock delivery . CONCLUSION ICD shocks have a long-lasting adverse effect on both objective , device-measured physical activity and subjective patient-reported outcomes of quality of life and shock anxiety . Successful OUTPUT:

CONCLUSIONS Current evidence suggests that D-PA may be useful for assessing physical activity and predicting clinical outcomes in patients with cardiovascular implantable electronic devices when combined with other device parameters .

MS2_dynamic_1_shot639

***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: Depressed out patients ( n = 51 ) resistant to treatment with maprotiline were treated in a blind , r and omized , single-centre study , for 6 weeks with either the reversible and selective monoamine oxidase A-inhibitor ( MAO-A-I ) , brofaromine or lithium addition to maprotiline . The Hamilton Rating Scale for Depression was scored by an independent rater before and after the 6 week treatment period . No significant differences in efficacy were found between the two treatment regimes . In the patients who completed the trial , brofaromine was well tolerated with the exception of insomnia . Anticholinergic effects as well as thyroid dysfunctions ( 17 out of 20 ) were more frequent in the maprotiline/lithium group This open , prospect i ve study investigated the efficacy of lithium augmentation in elderly patients who had failed to respond to a 6-week course of antidepressant medication . Twenty-one patients ( age range , 64 to 88 years ) with DSM-III-R unipolar , nonpsychotic major depression refractory to a 6-week course of nortriptyline , fluoxetine , or phenelzine underwent a minimum of 2 weeks of lithium augmentation . Five patients had a complete response , 3 had a partial response , and 13 did not respond . Half of the patients developed dose-limiting side effects , most commonly neuromuscular or neurologic . Patients developing side effects were significantly older ( p = 0.05 ) , and there was a tendency for side effects to occur more frequently in patients treated with fluoxetine . The rate of response to lithium augmentation in this elderly population was lower than that reported for most open and controlled studies in younger patients . Possible reasons for this are discussed Thirty-four patients with tricyclic-resistant depressive illness took part in a nine-week , double-blind , placebo-controlled trial of lithium augmentation . In addition to the maximum tolerated doses of their tricyclic antidepressant , the experimental group ( n = 16 ) received 250 mg lithium daily for three weeks , followed by 750 mg lithium daily for six weeks , while the controls ( n = 18 ) received placebo for three weeks followed by three weeks each of 250 mg lithium daily and 750 mg lithium daily . There was no significant difference between placebo and 250 mg lithium for weeks 0 - 3 of the trial . However , there was a significantly greater improvement on the MADRS for weeks 3 - 6 for those subjects on 750 mg lithium than for those on 250 mg lithium . In addition , using a 50 % fall in the HRSD as a criterion of drug responsiveness , 22 % responded to placebo , 18 % to 250 mg lithium , and 44 % to 750 mg lithium . Thus , lithium in normal , but not in low , dose has a significant antidepressant effect in TCA-resistant depression . Further controlled studies using lithium in normal dose in trials which have a greater duration of placebo exposure are required to confirm the lithium augmentation effect Resistance to antidepressant therapy is a common clinical problem in the treatment of affective disorders . Adjunctive low dose lithium is a promising strategy based on biochemical models and encouraging clinical trials . After a mean duration of 9.2 months of conventional therapy , 16 healthy patients with treatment-resistant depression were treated for a minimum of 2 weeks with either adjunctive lithium or placebo using a double-blind design . We found no difference between the two groups in rate or degree of response . The two most dramatic responses occurred in patients treated with placebo , although 50 % of patients treated with lithium had at least a partial response . The number of patients studied was clearly inadequate to avoid a type 2 error . The cumulative response rate reported in the literature of greater than 60 % , however , suggests that lithium is indeed an effective adjunct in some patients with treatment-resistant depression . Our patients differed from those in other studies in that they were treated with a lower dose of lithium , the duration of conventional antidepressant therapy was longer , and , finally , they were less depressed and possibly depressed for a longer period . These differences may explain the comparable lithium and placebo responses in this study OBJECTIVE Use of lithium to augment antidepressant medication has been shown to be beneficial in the acute treatment of depression . The authors examined the efficacy of lithium augmentation in the continuation treatment of unipolar major depressive disorder . METHOD Thirty patients with a refractory major depressive episode who had responded to acute lithium augmentation during an open 6-week study participated in a r and omized , parallel-group , double-blind , placebo-controlled trial of lithium augmentation during continuation treatment . After a 2 - 4-week stabilization period following remission , patients were r and omly assigned to receive either lithium or placebo for a 4-month period . Antidepressant medication was continued throughout the study . RESULTS Relapses ( including one suicide ) occurred in seven ( 47 % ) of the 15 patients who received placebo in addition to antidepressants . None ( 0 % ) of the 14 patients who received lithium augmentation with antidepressants suffered a relapse during the double-blind phase of the study . Five of the seven relapsing patients in the placebo group developed a depressive episode , and the other two experienced a manic episode . CONCLUSIONS Lithium augmentation in the continuation phase of treatment of unipolar major depressive disorder effectively protects patients against a relapse . Patients who respond to lithium augmentation should be maintained on lithium augmentation for a minimum of 6 months or even longer The authors conducted an open-label study of the efficacy and tolerability of venlafaxine and of lithium augmentation in out patients with depression who were not responding to venlafaxine . Out patients aged OUTPUT: Animal studies offer robust evidence that lithium augmentation increases 5-HT neurotransmission , possibly by a synergistic action of lithium and the antidepressant on brain 5-HT pathways . Conclusions : Augmentation of antidepressants with lithium is the best-documented augmentation therapy in the treatment of refractory depression . Emerging data from animal studies suggest that the 5-HTergic system is involved in the augmentatory effect of lithium INPUT: Lithium augmentation is one of the best studied strategies for resistant depression . The lithium dosage usually given is around 900 mg/day and plasma level is maintained in the range of 0.5 - 0.8 mEq/L. However , the administration of lithium in this dosage necessitates monitoring of plasma concentration and increases the risk of toxicity and side effects . Since it has been shown that low lithium levels increase serotonin turnover and enhance serotonin neurotransmission , we thought it of interest to assess the efficacy of low dosage lithium augmentation for patients with resistant depression . Fifty one patients suffering from severe unipolar or bipolar depression who had failed to respond to treatment with venlafaxine 300 - 375 mg/day were included in the study and treated as out patients . Patients had previously been exposed to unsuccessful treatment with various antidepressants , mostly SSRIs . After a washout period for previously administered antidepressants of one week , the dosage of venlafaxine was rapidly titrated to 300 or 375 mg/day , corresponding to about 5 mg/kg . The dose remained stable during the next six weeks . Additional antipsychotic medication was allowed to treat psychotic symptoms . Forty seven severely depressed patients who failed to respond to 300 - 375 mg/day venlafaxine were , in addition , given lithium carbonate in low dosage ( 300 - 450 mg/day ) . The Clinical Global Impression Improvement scale was used as the treatment outcome . A score of 1 or 2 was considered as non-response . All patients gave informed consent to participate in the study . Ratings were performed at baseline and after 1,2 and 5 weeks . Lithium plasma concentration measurements were performed after 1 and 4 weeks . After 5 weeks of augmentation , 51 % of the patients were rated as " much " or " very much " improved . Bipolar patients showed a better response than unipolar ( 64.3 % vs 45.5 % , p<0.038 ) . Most patients ( 76 % ) showed a rapid response ( up tp 7 days ) , and only 2 patients ( 4.6 % ) responded after more than 2 weeks The mean lithium plasma level was 0.33±0.09 mEq/L. No significant differences were found in treatment response with regard to sex , family history , psychotic symptomatology and suicidal ideation . No troublesome side effects were reported . Our results show that treatment augmentation with low lithium dosage may be as effective as augmentation with higher dosage , is well tolerated and does not necessitate monitoring of plasma level . Hence , an initial trial of ugmentation at low dosage lithium may be the preferred first choice in non-emergent situations . The low dosage also minimizes the risk of side effects and drug-drug interactions . Prospect i ve controlled studies to confirm our findings are needed as are larger scale comparisons with therapeutic dose lithium augmentation OBJECTIVE Poor response to long-term lithium treatment has been reported to be associated with atypical features of bipolar disorder . The purpose of this study was to investigate the influence of atypical symptoms on the effectiveness and stability of long-term lithium treatment in a prospect i ve , multicenter cohort of bipolar patients in a naturalistic setting . METHOD Patients were initially selected according to International Classification of Diseases , 8th Revision , criteria for bipolar disorder and required long-term treatment . Their diagnoses were reconfirmed according to DSM-IV upon its publication . They were prospect ively followed for an approximately 20-year period ending in 2004 in 5 centers participating in the International Group for the Study of Lithium-Treated Patients . Examinations included a comprehensive psychiatric evaluation , an assessment of typical and atypical features on an 8-item scale , and an evaluation of clinical course using the morbidity index . Unbalanced repeated- measures regression models with structured covariance matrices were used to assess the extent to which the morbidity index was influenced by atypical symptoms , duration of treatment , and pretreatment features . RESULTS A total of 242 patients were followed for a mean period of 10 years . In 142 patients , the number of typical features was greater than the number of atypical features , whereas in 100 patients the number of atypical features was greater than or equal to the number of typical features . The mean morbidity index remained stable over a period of 20 years in both groups of patients and was not significantly associated with the presence of atypical features , the duration of lithium treatment , the number or frequency of episodes , or latency from the onset of bipolar disorder to the start of lithium treatment . CONCLUSION Our study suggests that long-term response to lithium maintenance treatment is stable both in patients with typical and in patients with atypical features . The predominance of either typical or atypical features did not result in different responses to long-term lithium treatment in this sample of bipolar patients ABSTRACT There is no data on the variation in the suicide risk over lifetime and on the suicide-preventive effect of the long-term treatment of mood-disorder patients with antidepressants and neuroleptics . Our research focused on 186 unipolar ( D ) , 60 bipolar II ( Dm ) , 130 nuclear bipolar I ( MD ) , and 30 preponderantly manic patients ( M/Md ) ; that were followed-up from 1963 to 2003 . By 2003 , 45 ( 11.1 % ) of the 406 patients had committed suicide . Suicide rates were highest among D patients ( St and ardized Mortality Ratio , SMR = 26.4 ) , MD ( SMR = 13.6 ) , Dm ( SMR = 10.6 ) and lowest among M/Md patients ( SMR = 4.7 ) . Prospect ively , the suicide rate decreased over the 44 years ' follow-up ; Lithium OUTPUT:

Conclusions Lithium continues as the st and ard and most extensively evaluated treatment for bipolar disorder , especially for long-term prophylaxis

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Several studies document sex differences in premorbid and intermorbid role functioning , showing less functional deficit among females . The specific nature of sex differences in role functioning is still poorly understood . The purpose of the present study was to investigate sex differences in symptomatology and role functioning in a sample of 92 in patients hospitalized for an episode of DSM-III-diagnosed schizophrenic disorder . Patients were r and omized at hospital admission to either of two treatment conditions : ( 1 ) multimodal hospital treatment with the addition of an inpatient family intervention ( IFI ) or ( 2 ) multimodal hospital treatment without IFI . Results indicated ( 1 ) sex differences in levels of substance abuse and antisocial behavior ( worse for males both at admission and followup)--dimensions of psychopathology unrelated to the core features of schizophrenia ; ( 2 ) superior family and occupational functioning in females at followup ; and ( 3 ) superior clinical response of females to IFI . Data on family response to IFI suggest some ameliorative effects of IFI on critical family attitudes toward female patients as well as greater family compliance with IFI treatment among the families of females . Sex differences in intermorbid family and occupational functioning and response to a family-based psychosocial intervention are discussed in light of data on rejecting family attitudes toward the patient and sex differences in symptomatology . The possible influence of sex-differentiated social role dem and s on response to IFI is also discussed Abstract . Background : Despite an acknowledgement of the impact of serious mental disorders on informal caregivers , we still know little about how to best help them . The aim of the study was to evaluate the effectiveness of a two-phased carers ’ intervention comprising family sessions followed by relatives ’ groups . This intervention was design ed to be of ‘ intermediate ’ intensity , that is , one lying between brief educational programmes and long-term family psychoeducational treatments . Methods : An exploratory r and omised controlled trial was conducted comparing the experimental support programme with ‘ st and ard ’ care . All carers of patients with a psychotic disorder from a defined population were approached . Outcome measures were based on a ‘ stress- appraisal -coping ’ model of caregiving . Results : Despite concerted attempts to engage carers , only 42 % participated in the study . The carers ’ programme did not offer any significant advantage on any of the outcome measures : psychological morbidity , negative appraisal , coping or social support . The severity of caregiving difficulties decreased over the study period for the group as a whole . Conclusions : There is still uncertainty about the most effective interventions for carers . Meeting ‘ needs ’ may not improve caregiver distress BACKGROUND Relatives of people with psychosis experience high levels of distress and require support . Family interventions have been shown to be effective in improving outcomes but are difficult to access and not suitable for all relatives . AIMS To assess the feasibility and effectiveness of a supported self-management package for relatives of people with recent-onset psychosis . METHOD A r and omised controlled trial ( n = 103 ) comparing treatment as usual ( TAU ) in early intervention services with TAU plus the Relatives ' Education And Coping Toolkit ( REACT ) intervention ( trial identifier : IS RCT N69299093 ) . RESULTS Compared with TAU only , those receiving the additional REACT intervention showed reduced distress and increased perceived support and perceived ability to cope at 6-month follow-up . CONCLUSIONS The toolkit is a feasible and potentially effective intervention to improve outcomes for relatives . A larger trial is needed to reliably assess the clinical and cost-effectiveness of REACT , and its impact on longer-term outcomes OBJECTIVES To evaluate the effectiveness of a psychoeducation program for Chinese clients with schizophrenia and their family caregivers . METHODS A r and omized controlled trial was conducted . Seventy-three clients with a diagnosis of schizophrenia and their caregivers ( n=73 ) were recruited and r and omized into a study ( n=36 ) and control group ( n=37 ) . Ten psychoeducation sessions were provided to the study group . The outcomes were measured at the baseline , immediately after ( post-1 ) , six months ( post-2 ) , and 12 months after the intervention ( post-3 ) . RESULTS There were significant treatment effects across time for all client outcomes : adherence to medication ( p<0.01 ) , mental status ( p<0.01 ) , and insight into illness ( p<0.01 ) . However , no significant differences were found between groups at the post-3 measures for all client outcomes . For the caregivers , significant group differences were only detected in self-efficacy at the post-1 ( p=0.007 ) and post-2 ( p<0.001 ) measures , the level of satisfaction at the post-1 ( p=0.033 ) and post-2 ( p<0.021 ) measures , and the perception of family burden at the post-2 measures ( p=0.043 ) . CONCLUSION A psychoeducation intervention had positive effects on Chinese clients and their caregivers . However , these effects might not be sustained 12 months after the intervention . PRACTICE IMPLICATION S To substantiate its effects , psychoeducation should be an ongoing intervention , with its outcomes constantly evaluated BACKGROUND Family intervention in schizophrenia can reduce patient relapse and improve medication adherence , but few studies on this have involved a Chinese population . AIMS To examine the effects of a mutual support group for Chinese families of people with schizophrenia , compared with psychoeducation and st and ard care . METHOD R and omised controlled trial in Hong Kong with 96 families of out- patients with schizophrenia , of whom 32 received mutual support , 33 psychoeducation and 31 st and ard care . The psychoeducation group included patients in all the sessions , the mutual support group did not . Intervention was provided over 6 months , and patient- and family-related psychosocial OUTPUT: Meta-regression revealed no significant associations between intervention modality , duration , or contact time and outcomes . INPUT: Summary The associations between social disablement and socio-demographic factors have been examined in a r and om sample of 310 adults drawn from the general population of Camberwell , South London . Neither paternal social class nor the subject 's own social class are associated with social disablement in either men or women , except that men ( but not women ) of very low social class show significantly poorer social performance . Age and sex are not associated with social disablement , despite the fact that women in the general population have consistently been found to have higher rates of psychiatric disorder than men . For a given level of psychiatric disorder men show poorer social performance than women . Men who do not have children at home , or who live entirely alone have significantly poorer social performance , as do men who are widowed , separated or divorced , but these factors are not associated with poor social performance in women . By contrast , an unsatisfactory marital relationship is significantly associated with disablement in women , but not in men . The demographic factors associated with poor social performance are all indices of social disadvantage or social isolation BACKGROUND To our knowledge , this is the first prospect i ve natural history study of weekly symptomatic status of patients with bipolar I disorder ( BP-I ) during long-term follow-up . METHODS Analyses are based on ongoing prospect i ve follow-up of 146 patients with Research Diagnostic Criteria BP-I , who entered the National Institute of Mental Health ( Bethesda , Md ) Collaborative Depression Study from 1978 through 1981 . Weekly affective symptom status ratings were analyzed by polarity and severity , ranging from asymptomatic , to subthreshold levels , to full-blown major depression and mania . Percentages of follow-up weeks at each level as well as number of shifts in symptom status and polarity during the entire follow-up period were examined . Finally , 2 new measures of chronicity were evaluated in relation to previously identified predictors of chronicity for BP-I. RESULTS Patients with BP-I were symptomatically ill 47.3 % of weeks throughout a mean of 12.8 years of follow-up . Depressive symptoms ( 31.9 % of total follow-up weeks ) predominated over manic/hypomanic symptoms ( 8.9 % of weeks ) or cycling/mixed symptoms ( 5.9 % of weeks ) . Subsyndromal , minor depressive , and hypomanic symptoms combined were nearly 3 times more frequent than syndromal-level major depressive and manic symptoms ( 29.9 % vs 11.2 % of weeks , respectively ) . Patients with BP-I changed symptom status an average of 6 times per year and polarity more than 3 times per year . Longer intake episodes and those with depression-only or cycling polarity predicted greater chronicity during long-term follow-up , as did comorbid drug-use disorder . CONCLUSIONS The longitudinal weekly symptomatic course of BP-I is chronic . Overall , the symptomatic structure is primarily depressive rather than manic , and subsyndromal and minor affective symptoms predominate . Symptom severity levels fluctuate , often within the same patient over time . Bipolar I disorder is expressed as a dimensional illness featuring the full range ( spectrum ) of affective symptom severity and polarity Recognition of prodromal symptoms of schizophrenia offers the potential of early intervention to avert relapse and re-hospitalization ( Carpenter & Heinrichs , 1983 ) . The present study investigated how a strategy to detect prodromal signs might be effectively applied in the clinical setting . A st and ard monitoring system was developed involving completion of a new early signs scale ( ESS ) measuring changes in key symptoms phenomenologically ( self-report ) and behaviourally ( observer report ) . The ESS was subject to rigorous psychometric evaluation and tested in a prospect i ve pilot investigation . The ESS reliably identified early signs and predicted relapse with an overall accuracy of 79 % . Several different patterns of relapse were identified . Observer reports compensated for loss of insight in some patients . In two cases where early signs indices were detected , prompt increases in medication appeared to arrest relapse and avert readmission . The ESS offers itself as a reliable , valid and administratively feasible measure and demonstrates considerable potential as a cost-effective procedure for secondary prevention In the UK , psychiatric care of patients with acute and chronic disorders has increasingly moved from hospital to the community . We have evaluated in a controlled trial patients with severe mental illness , who were assigned to early intervention by community services or to st and ard hospital treatment . 100 patients aged 16 to 65 years presenting as psychiatric emergencies to an inner London teaching hospital were r and omly allocated to a multidisciplinary community-based team ( n = 48 ) or conventional hospital-based psychiatric services ( n = 52 ) and assessed over a 3-month period . Ratings of psychopathology and social functioning were made before treatment and after 2 , 4 , and 12 weeks by independent assessors . 85 patients completed all assessment s , and all patients had evaluable data beyond 2 weeks . 3 patients died during the study , 2 from natural causes and 1 from an accident . Patients referred to the community service showed greater improvement in symptoms and were more satisfied with services than those in the hospital-based service . Patients treated in the hospital-based service spent eight times as many days as psychiatric in patients as those treated in the community-based service . Patients both prefer and seem to benefit from community-based psychiatric care , and our early-intervention community service might be a good model for such care 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 OUTPUT:

This review shows a beneficial effect of EWS in time to recurrence , percentage of people hospitalised and functioning in people with bipolar disorder .

MS2_dynamic_1_shot641

***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: BACKGROUND Considering formocresol 's toxicity , Ca(OH)(2 ) partial pulpotomy ( PP ) was studied as a treatment alternative . AIM To compare success rates of Ca(OH)(2 ) PP versus formocresol pulpotomy ( FP ) treatment of pulpally exposed lower primary molars . DESIGN A total of 84 lower primary molars , which met study criteria , from 56 child patients were r and omly assigned for each treatment . After treatment , blinded clinical and radiographic evaluation with 96.9 % and 90 % reliability was performed at 6-month intervals to determine treatment success/failure . Chi-squared test was used to compare success rates between the two treatments . RESULTS The success rates from 6 to 36 months for PP ranged from 95.03 % to 75 % , whereas for FP , it was 92.7 - 74.2 % . The success rates for the two treatments at each 6-month interval were not different ( P ≥ 0.05 ) . The most frequent failure was internal resorption , affecting five FP teeth and three PP teeth . The resorption was arrested in five of the teeth and was replaced by a radiopaque calcified tissue in one case . CONCLUSION Considering the favourable clinical and radiographic success rate of PP and the potentially toxic effects of formocresol leads us to recommend the use of PP instead of FP in primary teeth with deep carious lesions Aim To compare the clinical and radiographic success rates of three different pulpotomy agents in primary molars after 18 months . Methods The study was carried out with 51 primary molars of children aged 5–9 years old . The teeth were r and omly assigned to the experimental or control groups . After coronal pulp removal and haemostasis , the remaining pulp tissue was covered with Biodentine ® or mineral trioxide aggregate in the experimental groups . In the control group , formocresol was placed with a cotton pellet over the pulp tissue for 5 min and after removal the pulp tissue was covered with zinc oxide – eugenol ( ZOE ) paste . All teeth were immediately restored with reinforced ZOE base and resin modified glass-ionomer cement , and later with pre-formed metal crowns . Follow-up assessment s were carried out after 3 , 6 , 12 and 18 months . Results Forty-five teeth were available for follow up at the end of 18 months . All of the available teeth for mineral trioxide aggregate and Biodentine ® were clinical ly successful , as were 73.3 % of the FC group . Radiographic success rate for the formocresol group at 18 months follow up was 73.3 , 100 % for mineral trioxide aggregate and 86.6 % for Biodentine ® group . Conclusion Mineral Trioxide aggregate and Biodentine ® showed more favourable results than formocresol PURPOSE The purpose of this study was to investigate the outcomes of vital primary molar pulpotomy when there is no direct contact between eugenol and the vital pulp . Four pulpotomy techniques were compared : ( 1 ) ferric sulfate ( FS ) pulpotomy ; ( 2 ) eugenol-free FS pulpotomy ; ( 3 ) mineral trioxide aggregate ( MTA ) pulpotomy ; and ( 4 ) FS/MTA pulpotomy . METHODS The pulpotomy technique assigned to each molar was determined by r and om selection . Two blinded , disinterested raters classified each molar into 1 of 3 radiographic outcomes : ( 1 ) N = normal molar without pathologic change ; ( 2 ) Po = pathologic change present , follow-up recommended ; ( 3 ) Px = pathologic change present , extract . RESULTS A total of 92 patients with 227 pulpotomy-treated molars returned for at least 1 recall examination . Median follow-up for molars was 24 months ( range=12 - 38 months ) . MTA molars demonstrated significantly fewer Px radiographic outcomes than FS molars ( P=.002 , chi-square test ) . Eugenol-free FS molars demonstrated significantly more Px radiographic outcomes than MTA ( P<.001 , chi-square test ) or FS/MTA ( P=.002 , chi-square test ) molars . Significantly lower survival was demonstrated for eugenol-free FS molars compared to MTA molars ( P=.02 , log-rank test ) over 6 to 38 months . CONCLUSIONS Outcomes for mineral trioxide aggregate pulpotomy were superior to ferric sulfate and eugenol-free ferric sulfate pulpotomy after a median follow-up of 2 years Introduction : This trial was design ed to evaluate the clinical and radiographic success rates of calcium-enriched mixture ( CEM ) cement with and without low level laser therapy ( LLLT ) and compare them to that of formocresol ( FC ) and ferric sulfate ( FS ) in primary molar pulpotomies . Methods and Material s : This r and omized clinical trial was conducted on a total of 160 teeth selected from 40 patients aged 3 - 9 years . Patients with at least four primary molars needing pulpotomy , were included in order to have each tooth assigned r and omly in one of the four following groups ; FC , FS , CEM , and LLLT/CEM . Six- and twelve-month follow-up periods were conducted in order to enable a clinical and radiographic evaluation of the treated teeth . Collected data were analyzed using Cochran Q Tests . Results : The 12-month clinical success rate for each technique was : FC=100 % , FS=95 % , CEM=97.5 % and LLLT/CEM=100 % with no significant differences ( P>0.05 ) . Furthermore , 12-month radiographic success rate for each technique was : FC=100 % , FS=92.5 % , CEM=95 % and LLLT/CEM=100 % with no significant differences ( P>0.05 ) . Conclusion : F OUTPUT: Mineral trioxide aggregate ( MTA ) , Biodentine and ferric sulphate yielded good clinical results over time and might be safely used in the pulpotomies of primary molars . Among agents , MTA seemed to be the material of choice . On the contrary , calcium hydroxide showed the worst clinical performance . Although clinical ly successful , formocreosol should be replaced by other material s , due to its potential cytotoxicity and carcinogenicity . Conclusion : MTA seemed to be the gold st and ard material in the pulpotomy of primary teeth . Promising results were also provided by calcium silicate-based cements . INPUT: Aim To compare the clinical and radiographic success rates of three different pulpotomy agents in primary molars after 18 months . Methods The study was carried out with 51 primary molars of children aged 5–9 years old . The teeth were r and omly assigned to the experimental or control groups . After coronal pulp removal and haemostasis , the remaining pulp tissue was covered with Biodentine ® or mineral trioxide aggregate in the experimental groups . In the control group , formocresol was placed with a cotton pellet over the pulp tissue for 5 min and after removal the pulp tissue was covered with zinc oxide – eugenol ( ZOE ) paste . All teeth were immediately restored with reinforced ZOE base and resin modified glass-ionomer cement , and later with pre-formed metal crowns . Follow-up assessment s were carried out after 3 , 6 , 12 and 18 months . Results Forty-five teeth were available for follow up at the end of 18 months . All of the available teeth for mineral trioxide aggregate and Biodentine ® were clinical ly successful , as were 73.3 % of the FC group . Radiographic success rate for the formocresol group at 18 months follow up was 73.3 , 100 % for mineral trioxide aggregate and 86.6 % for Biodentine ® group . Conclusion Mineral Trioxide aggregate and Biodentine ® showed more favourable results than formocresol Endodontic treatment of the pulpless tooth with an immature root apex poses a special challenge for the clinician due to lack of an apical stop against which to compact an interim dressing of calcium hydroxide , or the final obturation material . A one-visit apexification protocol with MTA ( Mineral Trioxide Aggregate ) has be seen as an alternative to the traditional treatment practice s with calcium hydroxide [ Ca(OH)2 ] . The aim of this study was to investigate the use of MTA as a 5 mm apical barrier by comparing sealing ability of ProRoot MTA to that of MTA-Angelus . 50 freshly extracted Maxillary and M and ibular single canal sound human incisor teeth were used in this study , which were decoronated to st and ardized 10 mm root lengths . The root segments were prepared to simulate the clinical situation of an open apex with Gates Glidden burs # 51 and r and omly assigned into 2 experimental groups of 20 sample s each ( Group A : ProRoot MTA , Group B : MTA-Angelus ) and 10 root segments were used as control ( Group C ) where no apical barrier was used . After obturation the coronal portion of all sample s were sealed with Glass Ionomer and stored at 37 degrees C and 100 % humidity for 4 weeks . The root segments were then double coated with nail varnish except for the apical 1 mm and apical ends of all root segments were suspended vertically in methylene blue dye for 48 hours at room temperature . After removal from the dye , the sample s were sectioned longitudinally and linear dye penetration was measured using a Grid and stereomicroscope . The measurements were tabulated and statistically analyzed . The mean percentage of dye leakage for Group A was 55.5 % and for Group B was 53.25 % . The results showed no statistically significant difference in the sealing ability of ProRoot MTA and MTA-Angelus when used as apical barriers Objectives The purpose of this study was to evaluate the efficacy of mineral trioxide aggregate ( MTA ) , Biodentine and Propolis as pulpotomy medicaments in primary dentition , both clinical ly and radiographically . Material s and Methods A total of 75 healthy 3 to 10 yr old children each having at least one carious primary molar tooth were selected . R and om assignment of the pulpotomy medicaments was done as follows : Group I , MTA ; Group II , Biodentine ; Group III , Propolis . All the pulpotomized teeth were evaluated at 3 , 6 , and 9 mon clinical ly and radiographically , based on the scoring criteria system . Results The clinical success rates were found to be similar among the three groups at 3 and 6 mon where as a significant decrease in success rate was observed in Group III ( 84 % ) compared to both Group I ( 100 % ) and Group II ( 100 % ) at 9 mon . Radiographic success rates over a period of 9 mon in Groups I , II , and III were 92 , 80 , and 72 % , respectively . Conclusions Teeth treated with MTA and Biodentine showed more favorable clinical and radiographic success as compared to Propolis at 9 mon follow-up Aims Despite various advents in technology , the present era marks a shift to phytotherapeutics and alternative modalities to conventional endodontic treatments . Newer endodontic modalities have been developed inculcating the ancient system of medicine . The present study was done to compare and evaluate the clinical pulp response and radiographic signs after pulpotomy in four groups of primary molar teeth treated with formocresol ( control ) , propolis extract , turmeric gel , and calcium hydroxide respectively . Material s and methods Following ethical clearance , 90 primary molar teeth in 45 pediatric patients , aged between 4 and 9 years , were selected for pulpotomy . These were then r and omly divided by split-mouth technique into two groups as experimental ( propolis extract/turmeric gel/calcium hydroxide ) and control ( formocresol ) groups . The patients were followed up for 6 months for clinical and radiographic signs and symptoms to evaluate the success of treatment . Results A comparable clinical and radiographic success rate was seen with all experimental groups as compared to the control ( formocresol ) group . Conclusion With concerns about the safety of formocresol appearing in the dental and medical literature for more than 20 years , the material s used in this study can be considered as promising alternatives for formocresol in pediatric endodontic treatment . How to cite this article Hugar SM , Kukreja P , Hugar SS , Gokhale N , OUTPUT:

TSA indicated lack of firm evidence for the results of the meta‐analytic outcomes on clinical and radiographic success . Conclusion BD and MTA have similar clinical and radiographic success rates based on limited and low‐ quality evidence .

MS2_dynamic_1_shot642

***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: OBJECTIVES To estimate the impact of the Integrated Management of Childhood Illness ( IMCI ) strategy on early-childhood mortality , we evaluated a malaria-control project in Benin that implemented IMCI and promoted insecticide-treated nets ( ITNs ) . METHODS We conducted a before- and -after intervention study that included a nonr and omized comparison group . We used the preceding birth technique to measure early-childhood mortality ( risk of dying before age 30 months ) , and we used health facility surveys and household surveys to measure process indicators . RESULTS Most process indicators improved in the area covered by the intervention . Notably , because ITNs were also promoted in the comparison area children 's ITN use increased by about 20 percentage points in both areas . Regarding early-childhood mortality , the trend from baseline ( 1999 - 2001 ) to follow-up ( 2002 - 2004 ) for the intervention area ( 13.0 % decrease ; P < .001 ) was 14.1 % ( P < .001 ) lower than was the trend for the comparison area ( 1.3 % increase ; P = .46 ) . CONCLUSIONS Mortality decreased in the intervention area after IMCI and ITN promotion . ITN use increased similarly in both study areas , so the mortality impact of ITNs in the 2 areas might have canceled each other out . Thus , the mortality reduction could have been primarily attributable to IMCI 's effect on health care quality and care-seeking Objective To determine the effect of implementation of the Integrated Management of Neonatal and Childhood Illness strategy on treatment seeking practice s and on neonatal and infant morbidity . Design Cluster r and omised trial . Setting Haryana , India . Participants 29 667 births in nine intervention clusters and 30 813 births in nine control clusters . Main outcome measures The pre-specified outcome was the effect on treatment seeking practice s. Post hoc exploratory analyses assessed morbidity , hospital admission , post-neonatal infant care , and nutritional status outcomes . Interventions The Integrated Management of Neonatal and Childhood Illness intervention included home visits by community health workers , improved case management of sick children , and strengthening of health systems . Outcomes were ascertained through interviews with r and omly selected caregivers : 6204 , 3073 , and 2045 in intervention clusters and 6163 , 3048 , and 2017 in control clusters at ages 29 days , 6 months , and 12 months , respectively . Results In the intervention cluster , treatment was sought more often from an appropriate provider for severe neonatal illness ( risk ratio 1.76 , 95 % confidence interval 1.38 to 2.24 ) , for local neonatal infection ( 4.86 , 3.80 to 6.21 ) , and for diarrhoea at 6 months ( 1.96 , 1.38 to 2.79 ) and 12 months ( 1.22 , 1.06 to 1.42 ) and pneumonia at 6 months ( 2.09 , 1.31 to 3.33 ) and 12 months ( 1.44 , 1.00 to 2.08 ) . Intervention mothers reported fewer episodes of severe neonatal illness ( risk ratio 0.82 , 0.67 to 0.99 ) and lower prevalence of diarrhoea ( 0.71 , 0.60 to 0.83 ) and pneumonia ( 0.73 , 0.52 to 1.04 ) in the two weeks preceding the 6 month interview and of diarrhoea ( 0.63 , 0.49 to 0.80 ) and pneumonia ( 0.60 , 0.46 to 0.78 ) in the two weeks preceding the 12 month interview . Infants in the intervention clusters were more likely to still be exclusively breast fed in the sixth month of life ( risk ratio 3.19 , 2.67 to 3.81 ) . Conclusion Implementation of the Integrated Management of Neonatal and Childhood Illness programme was associated with timely treatment seeking from appropriate providers and reduced morbidity , a likely explanation for the reduction in mortality observed following implementation of the programme in this study . Trial registration Clinical trials NCT00474981 ; ICMR Clinical Trial Registry CTRI/2009/091/000715 To assess the impact on child growth of the nutrition-counseling component of the Integrated Management of Childhood Illnesses ( IMCI ) strategy , a r and omized trial was implemented . All 28 government health centers in a Southern Brazil city were paired according to baseline nutritional indicators . One center from each pair was r and omly selected and its doctors received 20-h training in nutrition counseling . Thirty-three doctors were included and 12 - 13 patients < 18 mo of age from each doctor were recruited . The study included testing the knowledge of doctors , observing consultations and visiting the children at home 8 , 45 and 180 d after the initial consultation . Maternal knowledge , practice s and adherence to nutritional recommendations were assessed , and anthropometric measurements were taken . Day-long dietary intake was evaluated on a sub sample of children . Doctors in the intervention group had better knowledge of child nutrition and improved assessment and counseling practice s. Maternal recall of recommendations was higher in the intervention than in the control group , as was satisfaction with the consultation . Reported use of recommended foods was also increased . Daily fat intake was higher in the intervention than in the control group ; mean daily intakes of energy and zinc also tended to improve . Children 12 mo of age or older had improved weight gain and a positive but nonsignificant improvement in length . Nutrition-counseling training improved doctors ' performances , maternal practice s and the diets OUTPUT: Therefore , we do not know whether IMCI impacts exclusive breast feeding . Implementing the integrated management of childhood illness strategy may reduce child mortality , and packages that include interventions for the neonatal period may reduce infant mortality . IMCI may have little or no effect on nutritional status and probably has little or no effect on vaccine coverage . Maternal care seeking behavior may be more appropriate with IMCI , but study results have been mixed , providing evidence of very low certainty about whether IMCI has effects on adherence to exclusive breast feeding . Key messages This review shows that use of the World Health Organization IMCI strategy may led to fewer deaths among children from birth to five years of age . This review showed that use of IMCI : • may lead to fewer deaths among children from birth to five years of age INPUT: The evaluation of nutritional and immunization services was undertaken in the rural ICDS block Sanwer ( Madhya Pradesh ) where the project is functioning from last 3 years . A door to door survey was conducted in 1993 in six Anganwadi areas in ICDS block and five r and omly selected matched non ICDS rural area served as controls . There were a total of 709 children in ICDS and 500 in non ICDS block in 1 - 6 years age group . The difference was not statistically significant for nutritional status in the two blocks , but a remarkably better immunization status ( p < 0.005 ) was observed in non ICDS block . The coverage for DPT ( 3 doses ) , and measles vaccination in ICDS block was 79.57 % and 45.7 % , respectively , while in non ICDS block it was 94.4 % and 62.03 % , respectively . It seems the ICDS scheme is under utilized by the community and requires immediate attention by the health authorities Past efforts to promote family planning in Pakistan have been disappointing , but between 1990 - 91 and 2000 - 01 contraceptive use has more than doubled . This rise has coincided with a concerted effort on the part of the Pakistani government to increase access to contraceptive services , particularly in rural areas . The Lady Health Worker Programme ( LHWP ) , initiated under the Ministry of Health in the early 1990s , aim ed at integrating family planning into the doorstep provision of primary health care . This paper presents findings from the first national evaluation of this Programme . Data are analyzed from a r and om sample survey of 4277 women living in households served by the LHWP and those living in control areas . Logistic regression analysis was performed to determine the effect of the Programme on the uptake of modern reversible contraceptive methods , controlling for other independent variables . The data provide strong evidence that the LHWP has succeeded in increasing modern contraceptive use among rural women . Women served by Lady Health Workers are significantly more likely to use a modern reversible method than women in communities not served by the Programme ( OR=1.50 , 95 % CI=1.04 - 2.16 , p=0.031 ) , even after controlling for various household and individual characteristics . The model of providing doorstep services through community-based female workers should remain central to achieving universal access to safe family planning methods by the end of the decade -- the long-term objective of Pakistan 's most recent population policy adopted in 2002 BACKGROUND The Integrated Management of Childhood Illness ( IMCI ) strategy is design ed to address major causes of child mortality at the levels of community , health facility , and health system . We assessed the effectiveness of facility-based IMCI in rural Tanzania . METHODS We compared two districts with facility-based IMCI and two neighbouring comparison districts without IMCI , from 1997 to 2002 , in a non-r and omised study . We assessed quality of case-management for children 's illness , drug and vaccine availability , and supervision involving case-management , through a health-facility survey in 2000 . Household surveys were used to assess child-health indicators in 1999 and 2002 . Survival of children was tracked through demographic surveillance over a predefined 2-year period from mid 2000 . Further information on context ual factors was gathered through interviews and record review . The economic cost of health care for children in IMCI and comparison districts was estimated through interviews and record review at national , district , facility , and household levels . FINDINGS During the IMCI phase-in period , mortality rates in children under 5 years old were almost identical in IMCI and comparison districts . Over the next 2 years , the mortality rate was 13 % lower in IMCI than in comparison districts ( 95 % CI -7 to 30 or 5 to 21 , depending on how adjustment is made for district-level clustering ) , with a rate difference of 3.8 fewer deaths per 1000 child-years . Context ual factors , such as use of mosquito nets , all favoured the comparison districts . Costs of children 's health care with IMCI were similar to or lower than those for case-management without IMCI . INTERPRETATION Our findings indicate that facility-based IMCI is good value for money , and support widespread implementation in the context of health-sector reform , basket funding , good facility access , and high utilisation of health facilities As part of a program to integrate schistosomiasis control into the primary health care system in northern Cameroon , an unexpected opportunity to undertake a controlled evaluation of the impact of interventions was recognized . Inadvertently , a large part of Mindjil , one of four assessment villages , had been essentially excluded from the program , creating a unique natural control . The prevalence of infection with Schistosoma hematobium in school-aged children was 7 % in the areas where the control program was implemented , and 71 % in the excluded areas ( P < 0.0002 ) . High intensity infection was 1 % and 26 % in the two areas , respectively ( P < 0.0002 ) . Children in the school where the control interventions were implemented had a significantly lower prevalence of infection with Schistosoma hematobium ( P < 0.005 ) . Subjects in intervention areas demonstrated greater knowledge about the transmission of schistosomiasis than those in the control area . This study documented and quantified program impact in a controlled manner not usually possible in field studies and also illustrated how unrecognized intracultural diversity ( within culture differences ) in target population s may effect disease control programs in communities OBJECTIVES To assess the effect of Integrated Management of Childhood Illness ( IMCI ) relative to routine care on the quality and efficiency of providing care for sick children in first-level health facilities in Tanzania , and to disseminate the results for use in health sector decision-making . DESIGN Non-r and omized controlled trial to compare child health care quality and economic costs in two intervention ( > 90 % of health care workers trained in IMCI ) and two comparison districts in rural OUTPUT:

Our analysis shows few instances where there is full integration of a health intervention or where an intervention is completely non-integrated . Instead , there exists a highly heterogeneous picture both for the nature and also for the extent of integration . Health systems combine both non-integrated and integrated interventions , but the balance of these interventions varies considerably

MS2_dynamic_1_shot643

***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: AIMS To assess the effect of regular diabetic health education on cardiovascular risk factors in Chinese Type 2 diabetic patients . METHODS This was a 1-year prospect i ve r and omized study . One hundred and eighty Type 2 diabetic subjects were recruited from three regional diabetic centres in Hong Kong . Ninety received additional structured reinforcement of diabetic health education by a trained nurse after the doctors ' consultations every 3 months ( intervention group ) . The others received the same medical care except no nursing reinforcement ( control group ) . Outcome measures included fasting plasma glucose , HbA(1c ) , body mass index , waist circumference , blood pressure and lipid profiles , which were assessed before the study and after 1 year . RESULTS Two of the controls defaulted follow-up . The intervention group and controls had similar age and sex distribution . At the end of study , the intervention group had reducted their waist circumference , diastolic blood pressure , HbA(1c ) , total cholesterol and low-density lipoprotein cholesterol levels . The controls had reduced their total cholesterol and low-density lipoprotein cholesterol levels . Other cardiovascular risk factors were not significantly changed in the controls . Addition of drugs and /or dosage increment of anti-diabetic drugs , lipid-lowering agents and anti-hypertensive agents were similar between the two groups . CONCLUSIONS Regular structured reinforcement with diabetic health education is useful . It helps to control more successfully some of the cardiovascular risk factors in Chinese Type 2 diabetic patients OBJECTIVE To evaluate an intervention to improve food label knowledge and skills in diabetes management among older adults with diabetes mellitus . DESIGN A r and omized pretest-posttest control group design was used . SUBJECTS/ SETTING Participants ( 48 experimental , 50 control ) were aged 65 years and older with type 2 diabetes for 1 year or longer ; 93 participants ( 95 % ) completed the study , conducted in an outpatient setting . INTERVENTION The intervention included 10 weekly group sessions led by a dietitian . Information processing , learning theory , and Social Cognitive Theory principles were used in program development and evaluation . MAIN OUTCOME MEASURES Participants ' knowledge , outcome expectations ( expected results of behavior ) , self-efficacy , and decision-making skills were assessed . Instrument validity and reliability were established before program evaluation . STATISTICAL ANALYSES PERFORMED Factor analysis identified underlying factor structures . Analysis of covariance with pretest score as covariate was used to compare groups at posttest . Paired t tests compared results within groups . RESULTS Two factors were identified for outcome expectations ( positive and negative ) and for self-efficacy ( promoters of and barriers to diabetes management ) . The experimental group had greater improvement in total knowledge scores ( mean + /- st and ard error of the mean : 7.8+/-0.7 ) than the control group ( 0.2+/-0.7 ) ( P < .0001 ) , positive outcome expectations ( 0.59+/-0.15 vs 0.06+/-0.15 , P = .01 ) , promoters of diabetes management ( 0.83+/-0.12 vs -0.09+/-0.18 , P < or = .001 ) and decision-making skills ( 5.1+/-0.5 vs 0.3+/-0.5 , P < .0001 ) and greater reduction in barriers to diabetes management ( 1.1+/-0.16 vs 0.34+/-0.16 , P < .01 ) . No significant difference in negative outcome expectations occurred between groups at posttest . APPLICATIONS/ CONCLUSIONS Older adults with diabetes can benefit from nutrition education design ed to improve knowledge and skills necessary for diabetes management Introduction Diabetes self-management education interventions in community gathering places have been moderately effective , but very few studies of intervention effectiveness have been conducted among African Americans with type 2 diabetes . This paper describes a church-based diabetes self-management education intervention for African Americans , a r and omized controlled trial to evaluate the intervention , and baseline characteristics of study participants . Methods A New DAWN : Diabetes Awareness & Wellness Network was conducted among 24 churches of varying size in North Carolina . Each church recruited congregants with type 2 diabetes and design ated a diabetes advisor , or peer counselor , to be part of the intervention team . Participants were enrolled at each church and r and omized as a unit to either the special intervention or the minimal intervention . The special intervention included one individual counseling visit , twelve group sessions , three postcard messages from the participant 's diabetes care provider , and twelve monthly telephone calls from a diabetes advisor . Baseline data included measures of weight , hemoglobin A1c , blood pressure , physical activity , dietary and diabetes self-care practice s , and psychosocial factors . The study to evaluate the intervention ( from enrollment visit to last follow-up ) began in February 2001 and ended in August 2003 . Results Twenty-four churches ( with 201 total participants ) were r and omized . Sixty-four percent of the participants were women . On average , the participants were aged 59 years and sedentary . They had an average of 12 years of education , had been diagnosed with diabetes for 9 years , had a body mass index of 35 , had a hemoglobin A1c level of 7.8 % , and had a reported dietary intake of 39 % of calories from fat . Conclusion A New DAWN is a culturally sensitive , church-based diabetes self-management education program for African Americans with type 2 diabetes that is being evaluated for effectiveness in a r and omized controlled trial . The outcomes of A New DAWN will contribute to the literature on community-based interventions for minority population s and help to inform the selection of approaches to improve diab OUTPUT: Positive effects may be attributable to longer-term interventions with a shorter duration between the end of the intervention and the follow-up evaluation point . There may also be an effect of having a multi-professional team delivering the educational programme . Studies of focused educational interventions did not yield consistent results . Some effects were shown on measures of diabetic control in studies that focused on diet or exercise alone . Although the effects shown were generally small , those that were present did appear to be relatively long-lasting . Based on the evidence , it would seem that education delivered by a team of educators , with some degree of reinforcement of that education made at additional points of contact , may provide the best opportunity for improvements in patient outcomes . From the evidence reported it is unclear what re sources would need to be directed at the educators themselves to ensure that they can deliver programmes successfully . INPUT: AIMS To assess the effect of regular diabetic health education on cardiovascular risk factors in Chinese Type 2 diabetic patients . METHODS This was a 1-year prospect i ve r and omized study . One hundred and eighty Type 2 diabetic subjects were recruited from three regional diabetic centres in Hong Kong . Ninety received additional structured reinforcement of diabetic health education by a trained nurse after the doctors ' consultations every 3 months ( intervention group ) . The others received the same medical care except no nursing reinforcement ( control group ) . Outcome measures included fasting plasma glucose , HbA(1c ) , body mass index , waist circumference , blood pressure and lipid profiles , which were assessed before the study and after 1 year . RESULTS Two of the controls defaulted follow-up . The intervention group and controls had similar age and sex distribution . At the end of study , the intervention group had reducted their waist circumference , diastolic blood pressure , HbA(1c ) , total cholesterol and low-density lipoprotein cholesterol levels . The controls had reduced their total cholesterol and low-density lipoprotein cholesterol levels . Other cardiovascular risk factors were not significantly changed in the controls . Addition of drugs and /or dosage increment of anti-diabetic drugs , lipid-lowering agents and anti-hypertensive agents were similar between the two groups . CONCLUSIONS Regular structured reinforcement with diabetic health education is useful . It helps to control more successfully some of the cardiovascular risk factors in Chinese Type 2 diabetic patients Hypertension ( HTN ) is a leading cause of cardiovascular and cerebrovascular diseases . Lifestyle modification may be the preferential approach to prevent and control HTN . The purpose of this study was to evaluate the effects of a community intervention program , which focused on improving the HTN knowledge , diets and lifestyles in a rural Chinese area . The study was carried out in a rural area of the Hubei Province from May 2003 to April 2006 . A total of 1632 participants were recruited . Of the participants , 826 from the town of Xiaoxita and 806 from the town of Fenxiang were assigned to the intervention group ( group I ) and to the control group ( group C ) , respectively . Group I participants underwent an intervention that included HTN education and dietary and lifestyle guidance . Group C participants were not subjected to an intervention . The outcome measures included HTN knowledge , dietary and lifestyle behaviors , and prevalence , awareness , treatment and control rates of HTN . Along with the changes in HTN education ( P<0.05 ) , the participants in group I exhibited a significantly greater improvement in dietary habits and lifestyle behaviors , including reducing salty food intake ( 13.6 % ) , fat intake ( 22.9 % ) and alcohol consumption ( 9.6 % ) , after 3 years in comparison with those in group C ( 21.7 , 31.9 and 18 % , respectively ) . The prevalence of HTN was significantly lower in group I ( 22.5 % ) than in group C ( 36 % ) after the intervention strategies . The study showed that the implementation of a community intervention program involving HTN education and lifestyle modifications for rural residents is a powerful approach to reduce HTN prevalence and improve long-term health outcomes Background R and omised controlled trials demonstrate a 60 % reduction in type 2 diabetes incidence through lifestyle modification programmes . The aim of this study is to determine whether such programmes are feasible in primary health care . Methods An intervention study including 237 individuals 40–75 years of age with moderate or high risk of developing type 2 diabetes . A structured group programme with six 90 minute sessions delivered during an eight month period by trained nurses in Australian primary health care in 2004–2006 . Main outcome measures taken at baseline , three , and 12 months included weight , height , waist circumference , fasting plasma glucose and lipids , plasma glucose two hours after oral glucose challenge , blood pressure , measures of psychological distress and general health outcomes . To test differences between baseline and follow-up , paired t-tests and Wilcoxon rank sum tests were performed . Results At twelve months participants ' mean weight reduced by 2.52 kg ( 95 % confidence interval 1.85 to 3.19 ) and waist circumference by 4.17 cm ( 3.48 to 4.87 ) . Mean fasting glucose reduced by 0.14 mmol/l ( 0.07 to 0.20 ) , plasma glucose two hours after oral glucose challenge by 0.58 mmol/l ( 0.36 to 0.79 ) , total cholesterol by 0.29 mmol/l ( 0.18 to 0.40 ) , low density lipoprotein cholesterol by 0.25 mmol/l ( 0.16 to 0.34 ) , triglycerides by 0.15 mmol/l ( 0.05 to 0.24 ) and diastolic blood pressure by 2.14 mmHg ( 0.94 to 3.33 ) . Significant improvements were also found in most psychological measures . Conclusion This study provides evidence that a type 2 diabetes prevention programme using lifestyle intervention is feasible in primary health care setting s , with reductions in risk factors approaching those observed in clinical trials . Trial NumberCurrent Controlled Trials IS RCT OBJECTIVE : To investigate the sustained effectiveness of a novel skill-based intervention for weight loss . DESIGN : R and omized , controlled trial . SUBJECTS : A total of 80 overweight/obese women living in Connecticut . MEASUREMENTS : Absolute weight difference measured in pounds and absolute change in body mass index ( BMI ) . Secondary outcomes included changes in food frequency question naire ( FFQ ) data and waist-to-hip ratio . RES OUTPUT:

Community-based programmes achieved good results for most risk factors except BMI and ( glycated haemoglobin ) HbA1c .

MS2_dynamic_1_shot644

***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: The aim of this study was to evaluate the internal fit , marginal adaptation , and bond strengths of inlays made of computer-aided design /computer-aided manufacturing feldspathic ceramic and polymer-infiltrated ceramic . Twenty molars were r and omly selected and prepared to receive inlays that were milled from both material s. Before cementation , internal fit was achieved using the replica technique by molding the internal surface with addition silicone and measuring the cement thicknesses of the pulpal and axial walls . Marginal adaptation was measured on the occlusal and proximal margins of the replica . The inlays were then cemented using resin cement ( Panavia F2.0 ) and subjected to two million thermomechanical cycles in water ( 200 N load and 3.8-Hz frequency ) . The restored teeth were then cut into beams , using a lathe , for microtensile testing . The contact angles , marginal integrity , and surface patterns after etching were also observed . Statistical analysis was performed using two-way repeated measures analysis of variance ( p<0.05 ) , the Tukey test for internal fit and marginal adaptation , and the Student t-test for bond strength . The failure types ( adhesive or cohesive ) were classified on each fractured beam . The results showed that the misfit of the pulpal walls ( p=0.0002 ) and the marginal adaptation ( p=0.0001 ) of the feldspathic ceramic were significantly higher when compared to those of the polymer-infiltrated ceramic , while the bond strength values of the former were higher when compared to those of the latter . The contact angle of the polymer-infiltrated ceramic was also higher . In the present study , the hybrid ceramic presented improved internal and marginal adaptation , but the bond strengths were higher for the feldspathic ceramic Objectives This study was conducted to evaluate a self-adhesive resin luting cement [ RelyX Unicem 3MESPE – RXU ] for luting partial ceramic crowns ( PCCs ) with and without selective enamel etching in a prospect i ve , r and omized clinical trial . Material s and methods Thirty-four patients had received the intended treatment . Two PCCs ( Vita Mark II ; Cerec 3D ; Sirona ) had been placed in a split-mouth design : one with RXU without enamel etching ( RXU ) , the other with RXU with selective enamel etching ( RXU + E ) . Restorations were evaluated at baseline ( BL ) and after 12 , 24 , and 36 months ( USPHS criteria ) . For statistical analysis , the Chi-square test was applied ( α = 0.05 ) . Clinical survival of all restorations ( n = 68 ) after 3 years was determined using Kaplan – Meier analysis . Results Twenty three patients ( 12 male/11 female ) were available for clinical evaluation after 3 years . 19 RXU-PCCs were placed in molars , four in premolars , 18 RXU + E – PCCs in molars , five in premolars . Concerning clinical changes , no significant differences were found between luting strategies RXU/RXU + E at all recalls . Statistically significant changes over time were observed for marginal adaptation and marginal discoloration between BL and 36 m for RXU and RXU + E. For RXU + E , postoperative hypersensitivities decreased significantly from BL ( n = 6 ) to 36 m ( n = 0 ) . Of the 68 restorations originally included , eight RXU and four RXU + E restorations failed . At 3 years , Kaplan – Meier survival of RXU was 72.9 % , that of RXU + E 87.6 % . Survival rates were not statistically significant different . Conclusions Although clinical survival of RXU + E is slightly better at 3 years , restorations of both groups perform similar with respect to clinical changes over time as evaluated by modified USPHS criteria . Clinical relevance The self-adhesive resin cement RXU can be used in conjunction with selective enamel etching , because survival rates of PCCs in the RXU + E group were not lower but , as a trend , even better than without enamel etching Statement of problem Trials comparing the overall performance of digital with that of conventional workflows in restorative dentistry are needed . Purpose The purpose of the third part of a series of investigations was to test whether the marginal and internal fit of monolithic crowns fabricated with fully digital workflows differed from that of crowns fabricated with the conventional workflow . Material and methods In each of 10 participants , 5 monolithic lithium disilicate crowns were fabricated for the same abutment tooth according to a r and omly generated sequence . Digital workflows were applied for the fabrication of 4 crowns using the Lava , iTero , Cerec inLab , and Cerec infinident systems . The conventional workflow included a polyvinyl siloxane impression , manual waxing , and heat‐press technique . The discrepancy between the crown and the tooth was registered using the replica technique with polyvinyl siloxane material . The dimensions of the marginal discrepancy ( Discrepancymarginal ) and the internal discrepancy in 4 different regions of interest ( Discrepancyshoulder , Discrepancyaxial , Discrepancycusp , and Discrepancyocclusal ) were assessed using light microscopy . Post hoc Student t test with Bonferroni correction was applied to detect differences ( & agr;=.05 ) . Results Discrepancymarginal was 83.6 ±51.1 & mgr;m for the Cerec infinident , 90.4 ±66.1 & mgr;m for the conventional , 94.3 ±58.3 & mgr;m for the Lava , 127.8 ±58.3 & mgr;m for the iTero , and 141 OUTPUT: Conclusions Most of the studies reported clinical ly acceptable values for marginal adaptation . The performance of a CAD‐CAM system is influenced by the type of restorative material . A nonretentive cavity preparation exhibited better adaptation than a retentive preparation . Most studies showed that thermomechanical loading affected the quality of marginal adaptation . Cementation increased marginal discrepancies . No statistically significant difference was found for marginal fit of onlays between intraoral and extraoral optical scans using a stone die . The number of milling axes , the type of digital camera , and the region measured were statistically significant in relation to marginal/internal adaptation . Values of adaptation recorded failed to reproduce the preestablished spacer parameters in the software . INPUT: Objectives This study was conducted to evaluate a self-adhesive resin luting cement [ RelyX Unicem 3MESPE – RXU ] for luting partial ceramic crowns ( PCCs ) with and without selective enamel etching in a prospect i ve , r and omized clinical trial . Material s and methods Thirty-four patients had received the intended treatment . Two PCCs ( Vita Mark II ; Cerec 3D ; Sirona ) had been placed in a split-mouth design : one with RXU without enamel etching ( RXU ) , the other with RXU with selective enamel etching ( RXU + E ) . Restorations were evaluated at baseline ( BL ) and after 12 , 24 , and 36 months ( USPHS criteria ) . For statistical analysis , the Chi-square test was applied ( α = 0.05 ) . Clinical survival of all restorations ( n = 68 ) after 3 years was determined using Kaplan – Meier analysis . Results Twenty three patients ( 12 male/11 female ) were available for clinical evaluation after 3 years . 19 RXU-PCCs were placed in molars , four in premolars , 18 RXU + E – PCCs in molars , five in premolars . Concerning clinical changes , no significant differences were found between luting strategies RXU/RXU + E at all recalls . Statistically significant changes over time were observed for marginal adaptation and marginal discoloration between BL and 36 m for RXU and RXU + E. For RXU + E , postoperative hypersensitivities decreased significantly from BL ( n = 6 ) to 36 m ( n = 0 ) . Of the 68 restorations originally included , eight RXU and four RXU + E restorations failed . At 3 years , Kaplan – Meier survival of RXU was 72.9 % , that of RXU + E 87.6 % . Survival rates were not statistically significant different . Conclusions Although clinical survival of RXU + E is slightly better at 3 years , restorations of both groups perform similar with respect to clinical changes over time as evaluated by modified USPHS criteria . Clinical relevance The self-adhesive resin cement RXU can be used in conjunction with selective enamel etching , because survival rates of PCCs in the RXU + E group were not lower but , as a trend , even better than without enamel etching INTRODUCTION The aim of this study was to investigate the effects of pretreatment of gel chlorhexidine ( CHX ) and ethanol ( EtOH ) on the bond strength and durability of the adhesion of the fiber post relined with resin composite to the root dentin using a total etch adhesive system . METHODS Forty bovine incisor roots were divided into four groups after phosphoric acid etching : irrigation with physiologic solution ( control ) , 5 minutes with CHX , 1 minute with EtOH , and 5 minutes with chlorhexidine followed by 1 minute with EtOH . Fiber posts relined with resin composite were cemented with either RelyX ARC ( 3 M ESPE , St Paul , MN ) and a total etch adhesive system Scotchbond Multi- Purpose ( 3 M ESPE ) . Each group was r and omly divided into two subgroups : 24 hours of storage and 12 months of storage . All roots were sectioned transversely , and the push-out test was performed . Failure modes were observed , and the bond strength means were analyzed by analysis of variance and the Tukey test ( α = 0.05 ) . RESULTS CHX irrigation result ed in homogeneous bond strength values at 24 hours and 12 months of storage ( P < .05 ) . A significant bond strength decrease was noticed after 12 months of storage when irrigations were performed with physiologic solution and EtOH application only or associated with CHX ( P < .05 ) . CONCLUSIONS The use of CHX pretreatment could preserve the bond strength of the fiber post relined with resin composite to root dentin for 12 months . The use of EtOH and CHX followed by EtOH did not preserve the bond strength of the total etch adhesive system Scotchbond Multi- Purpose OBJECTIVES To evaluate the push-out bond strength and the sealing ability of five adhesive cements routinely used for fiber-post bonding . METHODS Fifty extracted single-rooted teeth were r and omly divided in five groups and restored using Parapost FiberLux and the following luting agents : Panavia 21 ( PAN ) , Clearfil Esthetic Cement ( CLF ) , Variolink II ( VAR ) , RelyX Unicem ( UNI ) and experimental GC self-adhesive cement ( EGC ) . After 1 week of water storage at 37 degrees C , three sections ( coronal , middle and apical ) of 2 mm thickness were prepared from each specimen . Sealing ability was quantified with a fluid-filtration system ( Flodec ) during 10 min , after which the push-out bond strength was immediately measured . Data were analyzed with ANOVA ( push-out ) and Kruskal-Wallis ( sealing ability ) . RESULTS The push-out bond strength and sealing ability were not significantly different among the coronal , middle and apical sections for each luting agent . The highest push-out bond strength was measured for CLF ( 14.60+/-3.63 MPa ) , which was not significantly different from PAN ( 12.57+/-2.45 MPa ) , but significantly higher than VAR ( 11.09+/-4.09 MPa ) , UNI ( 11.29+/-4.31 MPa ) and EGC ( 7.65+/-4.79 MPa ) . When evaluating the sealing ability , significant differences were not found among PAN , CLF and VAR , and between UNI and EGC . The latter luting agents scored significantly lower than the former ones . OUTPUT:

Endodontic treatment , method of cement application , and post pretreatment are factors that might significantly affect the retention of glass-fiber posts into root canals mainly when cemented with regular resin cement . Self-adhesive resin cements were found to be less technique-sensitive to luting procedures as compared with regular resin cements

MS2_dynamic_1_shot645

***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: Background Prolonged sitting time has been identified as a health risk factor . Sit-st and workstations allow desk workers to alternate between sitting and st and ing throughout the working day , but not much is known about their acceptability and feasibility . Hence , the aim of this study was to qualitatively evaluate the acceptability , feasibility and perceptions of using sit-st and workstations in a group of desk-based office workers . Methods This article describes the qualitative evaluation of the r and omized controlled cross-over St and @Work pilot trial . Participants were adult employees recruited from a non-government health agency in Sydney , Australia . The intervention involved using an Ergotron Workfit S sit-st and workstation for four weeks . After the four week intervention , participants shared their perceptions and experiences of using the sit-st and workstation in focus group interviews with 4–5 participants . Topics covered in the focus groups included patterns of workstation use , barriers and facilitators to st and ing while working , effects on work performance , physical impacts , and feasibility in the office . Focus group field notes and transcripts were analysed in an iterative process during and after the data collection period to identify the main concepts and themes . Results During nine 45-min focus groups , a total of 42 participants were interviewed . Participants were largely intrinsically motivated to try the sit-st and workstation , mostly because of curiosity to try something new , interest in potential health benefits , and the relevance to the participant ’s own and organisation ’s work . Most participants used the sit-st and workstation and three common usage patterns were identified : task-based routine , time-based routine , and no particular routine . Common barriers to sit-st and workstation use were working in an open plan office , and issues with sit-st and workstation design . Common facilitators of sit-st and workstation use were a supportive work environment conducive to st and ing , perceived physical health benefits , and perceived work benefits . When prompted , most participants indicated they were interested in using a sit-st and workstation in the future . Conclusions The use of a sit-st and workstation in this group of desk-based office workers was generally perceived as acceptable and feasible . Future studies are needed to explore this in different desk-based work population s and setting Background Effective interventions to influence workplace sitting are needed , as office-based workers demonstrate high levels of continued sitting , and sitting too much is associated with adverse health effects . Therefore , we developed a theory-driven , Web-based , interactive , computer-tailored intervention aim ed at reducing and interrupting sitting at work . Objective The objective of our study was to investigate the effects of this intervention on objective ly measured sitting time , st and ing time , and breaks from sitting , as well as self-reported context -specific sitting among Flemish employees in a field-based approach . Methods Employees ( n=213 ) participated in a 3-group r and omized controlled trial that assessed outcomes at baseline , 1-month follow-up , and 3-month follow-up through self-reports . A sub sample ( n=122 ) were willing to wear an activity monitor ( activPAL ) from Monday to Friday . The tailored group received an automated Web-based , computer-tailored intervention including personalized feedback and tips on how to reduce or interrupt workplace sitting . The generic group received an automated Web-based generic advice with tips . The control group was a wait-list control condition , initially receiving no intervention . Intervention effects were tested with repeated- measures multivariate analysis of variance . Results The tailored intervention was successful in decreasing self-reported total workday sitting ( time × group : P<.001 ) , sitting at work ( time × group : P<.001 ) , and leisure time sitting ( time × group : P=.03 ) , and in increasing objective ly measured breaks at work ( time × group : P=.07 ) ; this was not the case in the other conditions . The changes in self-reported total nonworkday sitting , sitting during transport , television viewing , and personal computer use , objective ly measured total sitting time , and sitting and st and ing time at work did not differ between conditions . Conclusions Our results point out the significance of computer tailoring for sedentary behavior and its potential use in public health promotion , as the effects of the tailored condition were superior to the generic and control conditions . Trial Registration Clinical trials.gov NCT02672215 ; http:// clinical trials.gov/ct2/show/NCT02672215 ( Archived by WebCite at http://www.webcitation.org/6glPFBLWv Purpose Encouraging office workers to ‘ sit less and move more ’ encompasses two public health priorities . However , there is little evidence on the effectiveness of workplace interventions for reducing sitting , even less about the longer term effects of such interventions and still less on dual-focused interventions . This study assessed the short and mid-term impacts of a workplace web-based intervention ( Walk@WorkSpain , W@WS ; 2010 - 11 ) on self-reported sitting time , step counts and physical risk factors ( waist circumference , BMI , blood pressure ) for chronic disease . Methods Employees at six Spanish university campuses ( n=264 ; 42±10 years ; 171 female ) were r and omly assigned by worksite and campus to an Intervention ( used W@WS ; n=129 ; 87 female ) or a Comparison group ( maintained normal behavior ; n=135 ; 84 female ) . This phased , 19-week program aim ed to decrease occupational sitting time through increased incidental movement and short walks . A linear mixed model assessed changes in outcome measures between the baseline , ramping ( 8 weeks ) , maintenance ( 11 weeks ) and follow-up ( two months ) phases for Intervention versus Comparison groups . Results A significant 2 ( group ) × 2 ( program phases ) interaction was found for self-reported occupational sitting ( F[3]=7.97 , p=0.046 ) , daily step counts ( F[3]=15.68 , p=0.0013 ) and waist circumference ( F[3]=11.67 , p=0.0086 ) . The Intervention group decreased minutes of daily occup OUTPUT: Once tested and refined , this framework has the potential to be incorporated into a practical toolkit , which could be used by a range of organisations to develop , implement and evaluate their own interventions to reduce workplace sitting time amongst staff INPUT: Background Excessive sitting time is a risk factor for cardiovascular disease mortality and morbidity independent of physical activity . This aim of this study was to evaluate the impact of a sit-st and workstation on sitting time , and vascular , metabolic and musculoskeletal outcomes in office workers , and to investigate workstation acceptability and feasibility . Methods A two-arm , parallel-group , individually r and omised controlled trial was conducted in one organisation . Participants were asymptomatic full-time office workers aged ≥18 years . Each participant in the intervention arm had a sit-st and workstation installed on their workplace desk for 8 weeks . Participants in the control arm received no intervention . The primary outcome was workplace sitting time , assessed at 0 , 4 and 8 weeks by an ecological momentary assessment diary . Secondary behavioural , cardiometabolic and musculoskeletal outcomes were assessed . Acceptability and feasibility were assessed via question naire and interview . ANCOVA and magnitude-based inferences examined intervention effects relative to controls at 4 and 8 weeks . Participants and research ers were not blind to group allocation . Results Forty-seven participants were r and omised ( intervention n = 26 ; control n = 21 ) . Relative to the control group at 8 weeks , the intervention group had a beneficial decrease in sitting time ( −80.2 min/8-h workday ( 95 % CI = −129.0 , −31.4 ) ; p = 0.002 ) , increase in st and ing time ( 72.9 min/8-h workday ( 21.2 , 124.6 ) ; p = 0.007 ) and decrease in total cholesterol ( −0.40 mmol/L ( −0.79 , −0.003 ) ; p = 0.049 ) . No harmful changes in musculoskeletal discomfort/pain were observed relative to controls , and beneficial changes in flow-mediated dilation and diastolic blood pressure were observed . Most participants self-reported that the workstation was easy to use and their work-related productivity did not decrease when using the device . Factors that negatively influenced workstation use were workstation design , the social environment , work tasks and habits . ConclusionS hort-term use of a feasible sit-st and workstation reduced daily sitting time and led to beneficial improvements in cardiometabolic risk parameters in asymptomatic office workers . These findings imply that if the observed use of the sit-st and workstations continued over a longer duration , sit-st and workstations may have important ramifications for the prevention and reduction of cardiometabolic risk in a large proportion of the working population .Trial registration Clinical Trials.gov NCT02496507 Background : Seated working positions are often regarded as a cause for discomfort in the musculoskeletal system . Performing work in different working positions — that is , alternating between sitting and st and ing ( sit-st and workstation paradigm)—could help reduce physical complaints . Objective : The questions were whether performing office work partly in a st and ing position leads to reduced complaints and whether st and ing would change the efficiency of data entry office work . Method : We investigated the effect of a sit-st and workstation paradigmd during experimental data entry office work on physical and psychological complaints and data entry efficiency by conducting a r and omized controlled trial with 60 male participants ages 18 to 35 years . Results : In this experiment , musculoskeletal complaints were reduced by a sit-st and workstation paradigm . A trend could be identified indicating a small but nonsignificant loss of efficiency in data entry while st and ing . Conclusion : A sit-st and workstation paradigm reduces musculoskeletal complaints without considerably affecting data entry efficiency under the presented study conditions ( young male participants , short duration , fixed and controlled sit-st and workstation paradigm , simulated experimental working condition ) . Application : According to the present data , implementing a sit-st and workstation paradigm can be an effective workplace health intervention to reduce musculoskeletal complaints . This experiment encourages further studies on the effectiveness of a sit-st and workstation paradigm . Experimental research and field studies that prove the reduction of complaints when introducing a sit-st and workstation paradigm in the workplace could be the basis for evidence -based recommendations regarding such interventions Purpose This study compared cognitive ( attention , learning , and memory ) and typing outcomes during slow treadmill walking or sitting . Seventy-five healthy individuals were r and omly assigned to a treadmill walking group ( n=37 ; 23 female ) or sitting group ( n=38 ; 17 female ) . Methods The treadmill walking group completed a series of tests while walking at 1.5 mph . The sitting group performed the same tests while sitting at a st and ard desk . Tests performed by both groups included : the Rey Auditory Verbal Learning Test and a modified version of the Paced Auditory Serial Attention Test . In addition , typing performance was evaluated . Results Participants in the treadmill walking group performed worse on the Rey Auditory Verbal Learning Test for total learning than the sitting group ; the main effect was significant ( F(1,73)=4.75 , p=0.03 , η p 2=0.06 ) ; however , short- and long-delay recall performance did not differ between groups ( p>0.05 ) . For the Paced Auditory Serial Attention Test , total number of correct responses was lower in the treadmill walking group relative to the sitting group ; the main effect was significant ( F(1,73)=4.97 , p=0.03 , η p 2=0.06 ) . The performance of both groups followed the same learning slope ( Group x Trial interactions were not significant ) for the Rey Auditory Verbal Learning Test and Paced Auditory Serial Attention Test . Individuals in the treadmill walking group performed significantly worse for all measures of typing ( p<0.05 ) . Conclusion Walking on a treadmill desk may result in a modest difference in total learning and typing outcomes relative to sitting , but those declines may not outweigh the benefit OUTPUT:

Conclusion : sit-st and workstations may reduce low back pain among workers . Practitioner Summary : In a sedentary population , changing posture may reduce the chance of developing low back pain .

MS2_dynamic_1_shot646

***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: BACKGROUND Pathways , a multisite school-based study aim ed at promoting healthful eating and increasing physical activity , was a r and omized field trial including 1704 American Indian third to fifth grade students from 41 schools ( 21 intervention , 20 controls ) in seven American Indian communities . METHODS The intervention schools received four integrated components : a classroom curriculum , food service , physical activity , and family modules . The curriculum and family components were based on Social Learning Theory , American Indian concepts , and results from formative research . Process evaluation data were collected from teachers ( n=235 ) , students ( n=585 ) , and families . Knowledge , Attitudes , and Behavior Question naire data were collected from 1150 students including both intervention and controls . RESULTS There were significant increases in knowledge and cultural identity in children in intervention compared to control schools with a significant retention of knowledge over the 3 years , based on the results of repeating the third and fourth grade test items in the fifth grade . Family members participated in Family Events and take-home activities , with fewer participating each year . CONCLUSION A culturally appropriate school intervention can promote positive changes in knowledge , cultural identity , and self-reported healthful eating and physical activity in American Indian children and environmental change in school food service OBJECTIVE To assess the effects of a comprehensive , integrated community-based lifestyle intervention on diet , physical activity and smoking in two Iranian communities . METHODS Within the framework of the Isfahan Healthy Heart Program , a community trial was conducted in two intervention counties ( Isfahan and Najaf-Abad ) and a control area ( Arak ) . Lifestyle interventions targeted the urban and rural population s in the intervention counties but were not implemented in Arak . In each community , a r and om sample of adults was selected yearly by multi-stage cluster sampling . Food consumption , physical exercise and smoking behaviours were quantified and scored as 1 ( low-risk ) or 0 ( other ) at baseline ( year 2000 ) and annually for 4 years in the intervention areas and for 3 years in the control area . The scores for all behaviours were then added to derive an overall lifestyle score . FINDINGS After 4 years , changes from baseline in mean dietary score differed significantly between the intervention and control areas ( + 2.1 points versus -1.2 points , respectively ; P < 0.01 ) , as did the change in the percentage of individuals following a healthy diet ( + 14.9 % versus -2.0 % , respectively ; P < 0.001 ) . Daily smoking had decreased by 0.9 % in the intervention areas and by 2.6 % in the control area at the end of the third year , but the difference was not significant . Analysis by gender revealed a significant decreasing trend in smoking among men ( P < 0.05 ) but not among women . Energy expenditure for total daily physical activities showed a decreasing trend in all areas , but the mean drop from baseline was significantly smaller in the intervention areas than in the control area ( -68 metabolic equivalent task ( MET ) minutes per week versus -114 MET minutes per week , respectively ; P < 0.05 ) . Leisure time devoted to physical activities showed an increasing trend in all areas . A significantly different change from baseline was found between the intervention areas and the control area in mean lifestyle score , even after controlling for age , sex and baseline values . CONCLUSION The results suggest that community-based lifestyle intervention programmes can be effective in a developing country setting The primary aim of the Trial of Activity in Adolescent Girls ( TAAG ) is to test an intervention to reduce by half the age-related decline in moderate to vigorous physical activity ( MVPA ) in middle school girls . The intervention will be evaluated using a group-r and omized trial involving 36 middle schools . The primary endpoint is the mean difference in intensity-weighted minutes ( i.e. , MET-minutes ) of MVPA between intervention and comparison schools assessed using accelerometry . The TAAG study design calls for two cross-sectional sample s , one drawn from 6th grade rs at the beginning of the study and the second drawn from 8th grade rs at the end of the study following the 2-year implementation of the intervention . An important strength of this design over a cohort design is the consistency with the goals of TAAG , which focus on environmental-level rather than individual-level interventions to produce change . The study design specifies a recruitment rate of 80 % and a smaller sample of girls at baseline ( n=48 per school ) than at follow-up ( n=96 per school ) . A two-stage model will be used to test the primary hypothesis . In the first stage , MET-weighted minutes of MVPA will be regressed on school , time ( baseline or follow-up ) , their interaction , ethnicity and week of data collection . The second stage analysis will be conducted on the 72 adjusted means from the first stage . In the main-effects model , we will regress the follow-up school mean MET-weighted minutes of MVPA on study condition , adjusting for the baseline school mean . The TAAG study addresses an important health behavior , and also advances the field of group-r and omized trials through the use of a study design and analysis plan tailored to serve the main study hypothesis Background : Population -based studies directed at promoting physical activity in youth have shown limited success in obesity prevention . Objective : To assess whether an intervention integrating environmental changes to induce sustained changes in physical activity , prevents overweight in adolescents . Design : Four-year r and omized trial started in 2002 in eight middle schools of Eastern France . The intervention , r and omized at school level , was design ed to promote physical activity by changing attitudes through debates and attractive activities , and by providing social support and environmental changes encouraging physical activity . Subjects : Nine hundred and fifty four 12-year-old six- grade rs . Measurements : Body mass index ( BMI ) , body composition , physical activity by question naire , plasma lipids and glucose , insulin resistance . Results : Intervention students had a lower increase in BMI ( P=0.01 ) and age- and gender-adjusted OUTPUT: Generally , the better design ed studies showed no improvement in the primary outcome measure of physical activity at a population level . Some program level effect was observed with more people walking in the intervention community , however this result was not evident in the whole community . Overall , there was a noticeable absence of reporting of benefit in physical activity for community wide interventions in the included studies . However , as a group , the interventions undertaken in China appeared to have the greatest possibility of success with high participation rates reported . The body of evidence in this review does not support the hypothesis that the multi-component community wide interventions studied effectively increased physical activity for the population , although some studies with environmental components observed more people walking INPUT: BACKGROUND Pathways , a multisite school-based study aim ed at promoting healthful eating and increasing physical activity , was a r and omized field trial including 1704 American Indian third to fifth grade students from 41 schools ( 21 intervention , 20 controls ) in seven American Indian communities . METHODS The intervention schools received four integrated components : a classroom curriculum , food service , physical activity , and family modules . The curriculum and family components were based on Social Learning Theory , American Indian concepts , and results from formative research . Process evaluation data were collected from teachers ( n=235 ) , students ( n=585 ) , and families . Knowledge , Attitudes , and Behavior Question naire data were collected from 1150 students including both intervention and controls . RESULTS There were significant increases in knowledge and cultural identity in children in intervention compared to control schools with a significant retention of knowledge over the 3 years , based on the results of repeating the third and fourth grade test items in the fifth grade . Family members participated in Family Events and take-home activities , with fewer participating each year . CONCLUSION A culturally appropriate school intervention can promote positive changes in knowledge , cultural identity , and self-reported healthful eating and physical activity in American Indian children and environmental change in school food service Background . Previous research has shown that children can increase their muscular strength and muscular endurance as a result of regular participation in a progressive resistance training program . However , the most effective exercise prescription regarding the number of repetitions remains question able . Objective . To compare the effects of a low repetition – heavy load resistance training program and a high repetition – moderate load resistance training program on the development of muscular strength and muscular endurance in children . Design . Prospect i ve , controlled trial . Setting . Community-based youth fitness center . Subjects . Eleven girls and 32 boys between the ages of 5.2 and 11.8 years . Intervention . In twice-weekly sessions of resistance training for 8 weeks , children performed 1 set of 6 to 8 repetitions with a heavy load ( n = 15 ) or 1 set of 13 to 15 repetitions with a moderate load ( n = 16 ) on child-size exercise machines . Children in the control group ( n = 12 ) did not resistance train . One repetition maximum ( RM ) strength and muscular endurance ( repetitions performed posttraining with the pretraining 1-RM load ) were determined on the leg extension and chest press exercises . Results . One RM leg extension strength significantly increased in both exercise groups compared with that in the control subjects . Increases of 31.0 % and 40.9 % , respectively , for the low repetition – heavy load and high repetition – moderate load groups were observed . Leg extension muscular endurance significantly increased in both exercise groups compared with that in the control subjects , although gains result ing from high repetition – moderate load training ( 13.1 ± 6.2 repetitions ) were significantly greater than those result ing from low repetition – heavy load training ( 8.7 ± 2.9 repetitions ) . On the chest press exercise , only the high repetition – moderate load exercise group made gains in 1-RM strength ( 16.3 % ) and muscular endurance ( 5.2 ± 3.6 repetitions ) that were significantly greater than gains in the control subjects . Conclusion . These findings support the concept that muscular strength and muscular endurance can be improved during the childhood years and favor the prescription of higher repetition – moderate load resistance training programs during the initial adaptation period BACKGROUND Although school-based behavioral interventions for increasing physical activity ( PA ) in children and adolescents have been conducted , little evidence suggests that these curriculum-based approaches lead to increases in overall activity outside of program days . The overall goal of the " Active by Choice Today " ( ACT ) trial is to exp and the body of knowledge concerning the factors that influence long-term increases in PA in underserved adolescents ( low socioeconomic status , minorities ) during their middle school years . DESIGN AND SETTING An overview of the ACT study design , theoretical framework , process evaluation , and primary hypotheses is presented . The trial involves twenty-four middle schools ( 1560 6th grade rs ) in South Carolina that are r and omly assigned to one of two after-school programs ( motivational and life skills intervention , or general health education ) . INTERVENTION The intervention integrates constructs from Self-Determination and Social Cognitive Theories to enhance intrinsic motivation and behavioral skills for PA . The intervention targets skill development for PA outside of program days and the after-school program social environment ( autonomy , choice , participation , belongingness , fun , enjoyment , support ) is design ed to positively impact cognitive mediators ( self-efficacy , perceived competence ) , and motivational orientation ( intrinsic motivation , commitment , positive self-concept ) . MAIN HYPOTHESES/ OUTCOMES : It is hypothesized that the 17-week motivational and life skills intervention will lead to greater increases in moderate-to-vigorous PA ( based on 7-day accelerometry estimates ) at post-intervention as compared to the general health education program . CONCLUSIONS Implication s of this innovative school-based trial are discussed The primary aim of the Trial of Activity in Adolescent Girls ( TAAG ) is to test an intervention to reduce by half the age-related decline in moderate to vigorous physical activity ( MVPA ) in middle school girls . The intervention will be evaluated using a group-r and omized trial involving 36 middle schools . The primary endpoint is the mean difference in intensity-weighted minutes ( i.e. , MET-minutes ) of MVPA between intervention and comparison schools assessed using accelerometry . The TAAG study design calls for two cross-sectional sample s , one drawn from 6th grade rs at the beginning of the study and the second drawn from 8th grade rs at the end of the study following the 2-year implementation of the intervention . An important strength of this design over a cohort design is the consistency with the goals of TAAG , which focus on environmental-level rather than individual-level interventions to produce change . The study design specifies a recruitment rate of 80 % and a smaller sample of girls at bas OUTPUT:

There was some evidence that school-based physical activity interventions had a positive impact on four of the nine outcome measures . Specifically positive effects were observed for duration of physical activity , television viewing , VO2 max , and blood cholesterol . Generally , school-based interventions had little effect on physical activity rates , systolic and diastolic blood pressure , BMI , and pulse rate . At a minimum , a combination of printed educational material s and changes to the school curriculum that promote physical activity result ed in positive effects . Few changes in outcomes were observed in this up date with the exception of blood cholesterol and physical activity rates . For example blood cholesterol was no longer positively impacted upon by school-based physical activity interventions . The evidence suggests the ongoing implementation of school-based physical activity interventions at this time , given the positive effects on behavior and one physical health status measure .

MS2_dynamic_1_shot647

***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: CONTEXT High levels of lipoprotein(a ) are associated with increased risk of myocardial infa rct ion ( MI ) . OBJECTIVE To assess whether genetic data are consistent with this association being causal . DESIGN , SETTING , AND PARTICIPANTS Three studies of white individuals from Copenhagen , Denmark , were used : the Copenhagen City Heart Study ( CCHS ) , a prospect i ve general population study with 16 years of follow-up ( 1991 - 2007 , n = 8637 , 599 MI events ) ; the Copenhagen General Population Study ( CGPS ) , a cross-sectional general population study ( 2003 - 2006 , n = 29 388 , 994 MI events ) ; and the Copenhagen Ischemic Heart Disease Study ( CIHDS ) , a case-control study ( 1991 - 2004 , n = 2461 , 1231 MI events ) . MAIN OUTCOME MEASURES Plasma lipoprotein(a ) levels , lipoprotein(a ) kringle IV type 2 ( KIV-2 ) size polymorphism genotype , and MIs recorded from 1976 through July 2007 for all participants . RESULTS In the CCHS , multivariable-adjusted hazard ratios ( HRs ) for MI for elevated lipoprotein(a ) levels were 1.2 ( 95 % confidence interval [ CI ] , 0.9 - 1.6 ; events/10,000 person-years , 59 ) for levels between the 22nd and 66th percentile , 1.6 ( 95 % CI , 1.1 - 2.2 ; events/10,000 person-years , 75 ) for the 67th to 89th percentile , 1.9 ( 95 % CI , 1.2 - 3.0 ; events/10,000 person-years , 84 ) for the 90th to 95th percentile , and 2.6 ( 95 % CI , 1.6 - 4.1 ; events/10,000 person-years , 108 ) for levels greater than the 95th percentile , respectively , vs levels less than the 22nd percentile ( events/10,000 person-years , 55 ) ( trend P < .001 ) . Numbers of KIV-2 repeats ( sum of repeats on both alleles ) ranged from 6 to 99 and on analysis of variance explained 21 % and 27 % of all variation in plasma lipoprotein(a ) levels in the CCHS and CGPS , respectively . Mean lipoprotein(a ) levels were 56 , 31 , 20 , and 15 mg/dL for the first , second , third , and fourth quartiles of KIV-2 repeats in the CCHS , respectively ( trend P < .001 ) ; corresponding values in the CGPS were 60 , 34 , 22 , and 19 mg/dL ( trend P < .001 ) . In the CCHS , multivariable-adjusted HRs for MI were 1.5 ( 95 % CI , 1.2 - 1.9 ; events/10,000 person-years , 75 ) , 1.3 ( 95 % CI , 1.0 - 1.6 ; events/10,000 person-years , 66 ) , and 1.1 ( 95 % CI , 0.9 - 1.4 ; events/10,000 person-years , 57 ) for individuals in the first , second , and third quartiles , respectively , as compared with individuals in the fourth quartile of KIV-2 repeats ( events/10,000 person-years , 51 ) ( trend P < .001 ) . Corresponding odds ratios were 1.3 ( 95 % CI , 1.1 - 1.5 ) , 1.1 ( 95 % CI , 0.9 - 1.3 ) , and 0.9 ( 95 % CI , 0.8 - 1.1 ) in the CGPS ( trend P = .005 ) , and 1.4 ( 95 % CI , 1.1 - 1.7 ) , 1.2 ( 95 % CI , 1.0 - 1.6 ) , and 1.3 ( 95 % CI , 1.0 - 1.6 ) in the CIHDS ( trend P = .01 ) . Genetically elevated lipoprotein(a ) was associated with an HR of 1.22 ( 95 % CI , 1.09 - 1.37 ) per doubling of lipoprotein(a ) level on instrumental variable analysis , while the corresponding value for plasma lipoprotein(a ) levels on Cox regression was 1.08 ( 95 % CI , 1.03 - 1.12 ) . CONCLUSION These data are consistent with a causal association between elevated lipoprotein(a ) levels and increased risk of MI A size polymorphism ( K IV VNTR ) and largely unknown sequence variation in the apolipoprotein(a ) [ apo(a ) ] gene on chromosome 6q26–q27 together determine most of the extreme variation in apo(a ) glycoprotein expression and lipoprotein(a ) [ Lp(a ) ] plasma concentration in Caucasians . We have determined Lp(a ) plasma concentrations , the number of kringle IV ( K IV ) repeats in the apo(a ) gene and the expression of the apo(a ) glycoprotein in four ethnic groups ( Khoi San , South African Blacks , Hong Kong Chinese and Caucasians from the Tyrol , total n = 788 ) . The distributions of Lp(a ) concentrations , the frequencies of expressed and non OUTPUT: CONCLUSIONS People with smaller apo(a ) isoforms have an approximately 2-fold higher risk of CHD or ischemic stroke than those with larger proteins . INPUT: CONTEXT High levels of lipoprotein(a ) are associated with increased risk of myocardial infa rct ion ( MI ) . OBJECTIVE To assess whether genetic data are consistent with this association being causal . DESIGN , SETTING , AND PARTICIPANTS Three studies of white individuals from Copenhagen , Denmark , were used : the Copenhagen City Heart Study ( CCHS ) , a prospect i ve general population study with 16 years of follow-up ( 1991 - 2007 , n = 8637 , 599 MI events ) ; the Copenhagen General Population Study ( CGPS ) , a cross-sectional general population study ( 2003 - 2006 , n = 29 388 , 994 MI events ) ; and the Copenhagen Ischemic Heart Disease Study ( CIHDS ) , a case-control study ( 1991 - 2004 , n = 2461 , 1231 MI events ) . MAIN OUTCOME MEASURES Plasma lipoprotein(a ) levels , lipoprotein(a ) kringle IV type 2 ( KIV-2 ) size polymorphism genotype , and MIs recorded from 1976 through July 2007 for all participants . RESULTS In the CCHS , multivariable-adjusted hazard ratios ( HRs ) for MI for elevated lipoprotein(a ) levels were 1.2 ( 95 % confidence interval [ CI ] , 0.9 - 1.6 ; events/10,000 person-years , 59 ) for levels between the 22nd and 66th percentile , 1.6 ( 95 % CI , 1.1 - 2.2 ; events/10,000 person-years , 75 ) for the 67th to 89th percentile , 1.9 ( 95 % CI , 1.2 - 3.0 ; events/10,000 person-years , 84 ) for the 90th to 95th percentile , and 2.6 ( 95 % CI , 1.6 - 4.1 ; events/10,000 person-years , 108 ) for levels greater than the 95th percentile , respectively , vs levels less than the 22nd percentile ( events/10,000 person-years , 55 ) ( trend P < .001 ) . Numbers of KIV-2 repeats ( sum of repeats on both alleles ) ranged from 6 to 99 and on analysis of variance explained 21 % and 27 % of all variation in plasma lipoprotein(a ) levels in the CCHS and CGPS , respectively . Mean lipoprotein(a ) levels were 56 , 31 , 20 , and 15 mg/dL for the first , second , third , and fourth quartiles of KIV-2 repeats in the CCHS , respectively ( trend P < .001 ) ; corresponding values in the CGPS were 60 , 34 , 22 , and 19 mg/dL ( trend P < .001 ) . In the CCHS , multivariable-adjusted HRs for MI were 1.5 ( 95 % CI , 1.2 - 1.9 ; events/10,000 person-years , 75 ) , 1.3 ( 95 % CI , 1.0 - 1.6 ; events/10,000 person-years , 66 ) , and 1.1 ( 95 % CI , 0.9 - 1.4 ; events/10,000 person-years , 57 ) for individuals in the first , second , and third quartiles , respectively , as compared with individuals in the fourth quartile of KIV-2 repeats ( events/10,000 person-years , 51 ) ( trend P < .001 ) . Corresponding odds ratios were 1.3 ( 95 % CI , 1.1 - 1.5 ) , 1.1 ( 95 % CI , 0.9 - 1.3 ) , and 0.9 ( 95 % CI , 0.8 - 1.1 ) in the CGPS ( trend P = .005 ) , and 1.4 ( 95 % CI , 1.1 - 1.7 ) , 1.2 ( 95 % CI , 1.0 - 1.6 ) , and 1.3 ( 95 % CI , 1.0 - 1.6 ) in the CIHDS ( trend P = .01 ) . Genetically elevated lipoprotein(a ) was associated with an HR of 1.22 ( 95 % CI , 1.09 - 1.37 ) per doubling of lipoprotein(a ) level on instrumental variable analysis , while the corresponding value for plasma lipoprotein(a ) levels on Cox regression was 1.08 ( 95 % CI , 1.03 - 1.12 ) . CONCLUSION These data are consistent with a causal association between elevated lipoprotein(a ) levels and increased risk of MI Objective — Lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) is a predictor for incident atherosclerotic disease . We investigated the effect of 3 hypolipidemic drugs that exert their action through different mechanisms on plasma and lipoprotein-associated Lp-PLA2 activity and mass . Methods and Results — In 50 patients with Type IIA dyslipidemia were administered rosuvastatin ( 10 mg daily ) , whereas in 50 Type IIA dyslipidemic patients exhibiting intolerance to previous statin therapy were administered ezetimibe as monotherapy ( 10 mg daily ) . Fifty patients with Type IV dyslipidemia were given micronised fenofibrate ( 20 OUTPUT:

Conclusions Fibrates have a significantly greater effect in reducing plasma Lp(a ) concentrations than statins . Addition of fibrates to statins can enhance the Lp(a)-lowering effect of statins

MS2_dynamic_1_shot648

***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: A double-blind trial was conducted in 138 patients with superficial transitional cell carcinoma of the bladder following transurethral resection to evaluate the prophylaxis of recurrence by an oral Lactobacillus casei preparation ( BLP ) . Patients were stratified into the following 3 subgroups : ( A ) with primary multiple tumors ; ( B ) with recurrent single tumors , and ( C ) with recurrent multiple tumors . In each group , patients were r and omly allocated to receive BLP or placebo . BLP showed a better prophylactic effect in subgroups A and B than placebo , whereas no significant difference was observed in subgroup C. Cox multivariate analysis showed that the outcome with BLP was significantly better than with placebo ( p = 0.01 ) . Slight and tolerable adverse reactions occurred in 3 patients receiving BLP and in 3 of the placebo-treated patients . Oral administration of BLP was thus safe and effective for preventing recurrence of superficial bladder cancer Bacterial infections frequently occur early after liver transplantation . We recently reported significant progress with a synbiotic composition , consisting of one lactic acid bacteria ( LAB ) and one fiber , which reduced the infection rate from 48 % ( with selective bowel decontamination ) to 13 % . Now , our aim is to study if a combination of different LAB and fibers would further improve outcome Objective . To investigate the effect of 2 different species of probiotics in preventing infections in infants attending child care centers . Methods . A double-blind , placebo-controlled , r and omized trial was conducted from December 1 , 2000 , to September 30 , 2002 , at 14 child care centers in the Beer-Sheva area of Israel in healthy term infants 4 to 10 months old . Infants were assigned r and omly to formula supplemented with Bifidobacterium lactis ( BB-12 ) , Lactobacillus reuteri ( American Type Culture Collection 55730 ) , or no probiotics . Duration of feeding , including follow-up , for each participant was 12 weeks . All infants were fed only the assigned formula and were not breastfed due to parental decision before recruitment to the study . Probiotic or prebiotic food products or supplements were not allowed . Main outcome measures were number of days and number of episodes with fever ( > 38 ° C ) and number of days and number of episodes with diarrhea or respiratory illness . Results . Participants ( n = 201 ) were similar regarding gestational age , birth weight , gender , and previous breastfeeding . The controls ( n = 60 ) , compared with those fed B lactis ( n = 73 ) or L reuteri ( n = 68 ) , had significantly more febrile episodes ( mean [ 95 % confidence interval ] : 0.41 [ 0.28–0.54 ] vs 0.27 [ 0.17–0.37 ] vs 0.11 [ 0.04–0.18 ] , respectively ) . The controls also had more diarrhea episodes ( 0.31 [ 0.22–0.40 ] vs 0.13 [ 0.05–0.21 ] vs 0.02 [ 0.01–0.05 ] , respectively ) and episodes of longer duration ( 0.59 [ 0.34–0.84 ] vs 0.37 [ 0.08–0.66 ] vs 0.15 [ 0.12–0.18 ] days , respectively ) . The L reuteri group , compared with BB-12 or controls , had a significant decrease of number of days with fever , clinic visits , child care absences , and antibiotic prescriptions . Rate and duration of respiratory illnesses did not differ significantly between groups . Conclusions . Child care infants fed a formula supplemented with L reuteri or B lactis had fewer and shorter episodes of diarrhea , with no effect on respiratory illnesses . These effects were more prominent with L reuteri , which was also the only supplement to improve additional morbidity parameters Objective : Patients undergoing pancreas resection carry several risk factors for nosocomial bacterial infections . Pre- and probiotics ( synbiotics ) are potentially useful for prevention of these infections . Summary Background Data : First trials in patients following major abdominal surgery including liver transplantation using one Lactobacillus ( LAB ) and one fiber showed significant reduction of infection rates and reduced length of antibiotic therapy compared with a control group . The present study was design ed to analyze whether a combination of different LAB and fibers would further improve outcome . Methods : A prospect i ve r and omized monocentric double-blind trial was undertaken in 80 patients following pylorus-preserving pancreatoduodenectomy ( PPPD ) . All patients received enteral nutrition immediately postoperatively . One group ( A ) received a composition of 4 LAB and 4 fibers , and another group ( B ) received placebo ( fibers only ) starting the day before surgery and continuing for 8 days . Thirty-day infection rate , length of hospital stay , duration of antibiotic therapy , noninfectious complications , and side effects were recorded . Results : The incidence of postoperative bacterial infections was significantly lower with LAB and fibers ( 12.5 % ) than with fibers only ( 40 % ) . In addition , the duration of antibiotic therapy was significantly shorter in the latter group . Fibers and LAB were well tolerated . Conclusion : Early enteral nutrition supplemented with a mixture of LAB and fibers reduces bacterial infection rates and antibiotic therapy following PPPD BACKGROUND Animal studies suggest that prebiotics and probiotics exert protective effects against tumor development in the colon , but human data supporting this suggestion are weak . OBJECTIVE The objective was to verify whether the prebiotic concept ( selective interaction with colonic flora of nondigested carboh OUTPUT: In addition , probiotics may be useful for preventing respiratory infections , dental caries , necrotizing enterocolitis , and certain aspects of inflammatory bowel disease . Data also suggest that probiotics may promote good health in day care and work setting s , and may enhance growth in healthy as well as ill and malnourished children . Specific strains are effective in specific disease states . INPUT: UNLABELLED The aim of the study is to compare the role of killed ( KP ) Lactobacillus acidophilus with living ( LP ) in reducing incidence of sepsis ( NS ) and necrotizing enterocolitis ( NEC ) in neonates . R and omized double blind placebo study , included 150 neonates admitted to NICU at day 1 , sixty received oral ( LP ) and 60 received ( KP ) and 30 received placebo . One gram of stools was collected on admission , at day 7 , at end of the study , as well as on suspected NEC or NS and was sent for culture . RESULTS LP and KP were preventive factors for NEC with absolute risk reduction ( AAR ) 16 , 15 % , respectively and 18 % for NS compared to placebo . Incidence of NEC and NS did not differ significantly between neonates supplemented with LP and those with KP . Preterm neonates supplemented with KP showed significantly lower incidence of NEC compared to placebo , while incidence of NS showed no significant difference between both groups . There is significant reduction in NS and NEC among neonates with positive Lactobacillus colonization of gut compared to those none colonized at day 7 ( 27.9 vs. 85.9 % , 0 vs. 7.8 % ) and at day 14 ( 48.7 vs. 91.7 % for NS and 0 vs. 20.8 % for NEC ) . Overall comparison between the three groups showed statistical significant reduction in the incidence of NEC . Present conclusions are that early gut colonization with beneficial bacteria lowers the incidence of NEC and NS . KP retained similar benefits to live bacteria BACKGROUND Probiotics are used for the prevention of necrotizing enterocolitis ( NEC ) because of their positive effects on intestinal motor function , modulation of inflammatory response , and mucosal barrier function . OBJECTIVE The objective was to assess whether the combined use of Lactobacillus casei and Bifidobacterium breve may prevent the occurrence of NEC stage ≥ 2 by the criteria of Bell in very-low-birth-weight preterm infants . DESIGN A double-blind , r and omized , controlled clinical trial was conducted in 231 preterm infants weighing from 750 to 1499 g at birth . The intervention group was composed of 119 infants who received human milk with probiotic supplementation ( B. breve and L. casei ) and a control group of 112 infants who received human milk containing no probiotics . The primary outcome was the occurrence of NEC stage ≥ 2 as defined by Bell 's modified criteria . RESULTS Four confirmed cases of NEC stage ≥ 2 by Bell 's criteria occurred only in the control group . CONCLUSIONS Oral supplementation of B. breve and L. casei reduced the occurrence of NEC ( Bell 's stage ≥ 2 ) . It was considered that an improvement in intestinal motility might have contributed to this result . This trial was registered at www.is rct in.org as number 67165178 ( International St and ard R and omized Controlled Trial ) ABSTRACT The gastrointestinal microbiota of preterm infants in a neonatal intensive care unit differs from that of term infants . In particular , the colonization of preterm infants by bifidobacteria is delayed . A double-blind , placebo-controlled , r and omized clinical study was performed on 69 preterm infants to investigate the role of Bifidobacterium lactis Bb12 supplementation in modifying the gut microbiota . Both culture-dependent and culture-independent approaches were used to study the gut microbiota . Bifidobacterial numbers , determined by fluorescence in situ hybridization , were significantly higher in the probiotic than in the placebo group ( log10 values per g of fecal wet weight : probiotic , 8.18 + 0.54 [ st and ard error of the mean ] ; placebo , 4.82 + 0.51 ; P < 0.001 ) . A similar trend for bifidobacterial numbers was also obtained with the culture-dependent method . The infants supplemented with Bb12 also had lower viable counts of Enterobacteriaceae ( log10 values of CFU per g of fecal wet weight : probiotic , 7.80 + 0.34 ; placebo , 9.03 + 0.35 ; P = 0.015 ) and Clostridium spp . ( probiotic , 4.89 + 0.30 ; placebo , 5.99 + 0.32 ; P = 0.014 ) than the infants in the placebo group . Supplementation of B. lactis Bb12 did not reduce the colonization by antibiotic-resistant organisms in the study population . However , the probiotic supplementation increased the cell counts of bifidobacteria and reduced the cell counts of enterobacteria and clostridia BACKGROUND It is known that the bifidobacteria flora play important roles in mucosal host defense and can prevent infectious diseases . Because bacterial population s develop during the first day of life , the authors examined whether the early administration of bifidobacteria has a positive effect on the health of low birth weight infants . METHODS The effects of oral administration of Bifidobacterium breve ( B. breve ) supplements were studied in a controlled trial with low birth weight infants ( average birth weight 1489 g ) . The infants were divided into three groups : Group A and B received a dose of 1.6 x 10(8 ) cells of B. breve supplement twice a day , commencing either from several hours after birth ( group A ) or 24 h after birth ( group B ) . Group C , the control group , received no supplement . RESULTS There were no significant differences in birth weight , treatment with antibiotics , and the starting time of breast-feeding among OUTPUT:

Enteral supplementation of probiotics prevents severe NEC and all cause mortality in preterm infants . There is insufficient data with regard to the benefits and potential adverse effects in the most at risk infants weighing less than 1000 grams at birth

MS2_dynamic_1_shot649

***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: Abstract Aims To describe self-care of T2DM patients and to evaluate outcomes associated with self-care in T2DM patients . Methods A multicentre cross-sectional study was conducted on a sample of 302 r and omly selected T2DM patients . Clinical and socio-demographic data were collected by medical records . The Summary of Diabetes Self-care Activities was used to measure self-care about diet , blood testing , exercise and foot care . The EQ-5D was used to measure perceived quality of life . Multiple regression models were used to evaluate the associations between self-care and body mass index ( BMI ) , glycated haemoglobin ( HbA1c ) , presence of diabetes complications and quality of life ( QoL ) . Results Self-care was lower about exercise ( median = 2.0 ) and foot care ( median = 3.5 ) than about diet ( median = 5.2 ) and blood testing ( median = 4.5 ) . HbA1c was associated with diet ( p = 0.025 ) , exercise ( p = 0.017 ) and blood testing ( p = 0.034 ) . BMI was associated with exercise ( p = 0.0071 ) . Diabetes complications were associated with exercise ( p = 0.031 ) and blood testing ( p < 0.009 ) . QoL was associated with exercise ( p < 0.0001 ) , blood testing ( p = 0.032 ) and foot care ( p = 0.013 ) . Conclusions Self-care influences both clinical outcomes and quality of life of T2DM patients . Although exercise is more frequently associated with positive outcomes , it is particularly poor in T2DM population . Blood testing and foot care should be performed to prevent complications and not only when a health problem is already occurred . Interventions aim ed to improve exercise are recommended . Further research is needed to explore barriers to exercise AIM This study describes the development and validation of the Nursing Profession Self-Efficacy Scale . BACKGROUND Self-efficacy can be useful in predicting performance , job satisfaction or well-being . In the nursing field , there is a shortage of studies on self-efficacy with regard to nurses ' global confidence in coping ability across a range of everyday , challenging work situations . METHODS To define the theoretical framework of nursing professional self-efficacy , two focus groups and a literature review were performed . An empirical study was then conducted to test validity and reliability . Face and content validity , construct validity , concurrent validity , internal consistency and test-retest reliability were examined . The content validity index was evaluated by 12 experts who suggested deleting 11 redundant items . The final developed tool was tested for construct analysis using a cross-validation approach , r and omly splitting the overall sample of 917 nurses in two sub-groups . FINDINGS The construct validity indicated two dimensions . The face and content validity were adequate . Test-retest reliability displayed a good stability , and internal consistency ( Cronbach 's α ) was acceptable . Moreover , concurrent validity using the Generalized Self-Efficacy Scale was in line with the theoretical framework . CONCLUSION The scale showed evidence of validity and reliability . The major limitation is the strong influence of the Italian context in the tool development . IMPLICATION S FOR NURSING AND HEALTH POLICY The Nursing Profession Self-Efficacy Scale could be a fruitful tool that facilitates the application of theories ( i.e. social-cognitive theory ) in the nursing field and even development of interventions . Furthermore , a measurement of self-efficacy could be used to predict nursing clinical performance BACKGROUND Burnout ( BO ) is increasingly considered a public health problem : it is not only harmful to the individual , but also for the organization . Therefore , in recent years , research has given particular attention to the study of the phenomenon and its antecedents among the nursing profession . In the last ten years , the literature shows the prevalence of BO in different clinical setting s , but there are few recent data describing the phenomenon and its relationship with educational preventive programs . OBJECTIVES The aims of this study are : a ) to describe the prevalence of nurses ' risk of BO in the northern Italy area b ) to describe nurses ' coping and their perception of the BO antecedents . c ) to describe the effects of education on the nurses ' coping and their recognition of BO antecedents . METHODS The study is structured into two main parts . The first was cross-sectional , the second was prospect i ve . Burnout Potential Inventory ( BPI ) question naire was used in the cross-sectional part to survey risk of BO in three big hospitals in Northern Italy . The Health Profession Stress and Coping Scale ( HPSCS ) was used in the prospect i ve part to survey the nurses ' stress perception and their coping mechanisms in a post-graduate educational program . RESULTS Nurses ' BO risk is within the normal range , although the BPI highlighted three borderline subscales : poor team work , work overload and poor feedback . Post-graduate education had a positive effect on the stress perception , but it is not sufficient to improve coping mechanisms . CONCLUSIONS The study revealed the more stressful work situations and the effect of post-graduate education to prevent the effects of stress . This topic needs further investigation in the light of the result of this study CONTEXT Low literacy is an important barrier for patients with diabetes , but interventions to address low literacy have not been well examined . OBJECTIVE To examine the role of literacy on the effectiveness of a comprehensive disease management program for patients with diabetes . DESIGN , SETTING , AND PARTICIPANTS Analysis of the influence of literacy on glycemic control and systolic blood pressure using data from a r and omized controlled trial ( conducted from February 2001 through April 2003 ) of a comprehensive diabetes management program . Participants were 217 patients aged 18 years or older with type 2 diabetes and poor glycemic control ( glycosylated hemoglobin [ HbA1c ] levels > or = 8. OUTPUT: Areas of consensus are HL definition , HL measurement tools , and the relationship between T2DM patient knowledge ( or literacy ) and his/her HL . The gaps in knowledge were the assessment of the relations between HL and health outcomes and self-efficacy , the gender differences , the effectiveness of interventions to improve HL , the cost-effectiveness study of interventions to improve HL , and the underst and ing of the influence of organizational environment on HL . INPUT: OBJECTIVES Diabetes self-management is a key element in the overall management of diabetes . Identifying barriers to disease self-management is a critical step in achieving optimal health outcomes . Our goal was to explore patients ' perceptions about barriers to self-management of diabetes that could possibly help explain poor health outcomes among minority patients . STUDY DESIGN Four focus groups were conducted among 31 predominately African American patients with diabetes who were enrolled in the Baltimore Cardiovascular Partnership Study , a NIH-funded multiyear prospect i ve partnership study . The topic guide consisted of a series of open-ended questions about knowledge of current health status , medication use , continuity of care , blood glucose level and nutrition . RESULTS The focus groups confirmed that previously reported barriers to self-management persisted and identified new concerns that could be associated with poor health outcomes among minority patients with diabetes . Attitudes , perceptions and behaviors surrounding diabetes and self-management of the condition did vary across individuals , however , the variation appeared to reflect the individual 's knowledge and opinions rather than patient 's age , sex , or culture . The primary barrier to diabetes self-management result ed from lack of knowledge of target blood glucose and blood pressure . Several participants found some of the health information to be quite confusing . CONCLUSIONS Diabetes is a major public health concern and the lack of awareness of target blood glucose and blood pressure further complicates the problem . The limited health literacy seen in this study could help explain several of the barriers to self-management . The barriers to self-management identified in this qualitative study are amenable to intervention that could improve health outcomes OBJECTIVES Persons with concomitant heart failure ( HF ) and diabetes mellitus ( DM ) have complicated , often competing , self-care expectations and treatment regimens that may reduce quality of life ( QOL ) . This r and omized controlled trial tested an integrated self-care intervention on outcomes of HF and DM QOL , physical function , and physical activity ( PA ) . METHODS AND RESULTS Participants with HF and DM ( n = 134 ; mean age 57.4 ± 11 years , 66 % men , 69 % minority ) were r and omized to usual care ( control ) or intervention . The control group received st and ard HF and DM educational brochures with follow-up telephone contact . The intervention group received education and counseling on combined HF and DM self-care ( diet , medications , self-monitoring , symptoms , and PA ) with follow-up home visit and telephone counseling . Measures included question naires for HF- and DM-specific and overall QOL , PA frequency , and physical function ( 6-min walk test [ 6MWT ] ) and were obtained at baseline and 3 and 6 months . Analysis included mixed models with a priori post hoc tests . Adjusting for age , body mass index , and comorbidity , the intervention group improved in HF total ( P = .002 ) and physical ( P < .001 ) QOL scores at 3 months with retention of improvements at 6 months , improved in emotional QOL scores compared with control at 3 months ( P = .04 ) , and improved in health status ratings ( P = .04 ) at 6 months compared with baseline . The intervention group improved in 6MWT distance ( 924 ft to 952 ft ; P = .03 ) whereas the control group declined ( 834 ft to 775 ft ; F1,63 = 6.86 ; P = .01 ) . The intervention group increased self-reported PA between baseline and 6 months ( P = .01 ) . CONCLUSIONS An integrated HF and DM self-care intervention improved perceived HF and general QOL but not DM QOL . Improved physical functioning and self-reported PA were also observed with the integrated self-care intervention . Further study of the HF and DM integrated self-care intervention on other outcomes , such as hospitalization and cost , is warranted Aim . This study compares the usefulness of Montreal Cognitive Assessment ( MoCA ) to St and ardized Mini-Mental Status Exam ( SMMSE ) for diagnosing mild cognitive impairment ( MCI ) in Type 2 diabetes mellitus ( DM ) population . Methods . This prospect i ve pilot study enrolled 30 community dwelling adults with Type 2 DM aged 50 years and above . Subjects were assessed using both the SMMSE and MoCA for MCI . In all subjects , depression and dementia were ruled out using the DSM IV criteria , and a functional assessment was done . MCI was diagnosed using the st and ard test , the European consortium criteria . Sensitivity and specificity analysis , positive and negative predictive values , likelihood ratios and Kappa statistic were calculated . Results . In comparison to consortium criteria , the sensitivity and specificity of MoCA were 67 % and 93 % in identifying individuals with MCI , and SMMSE were 13 % and 93 % , respectively . The positive and negative predictive values for MoCA were 84 % and 56 % , and for SMMSE were 66 % and 51 % , respectively . Kappa statistics showed moderate agreement between MoCA and consortium criteria ( kappa = 0.4 ) and a low agreement between SMMSE and consortium criteria ( kappa = 0.07 ) . Conclusion . In this pilot study , MoCA appears to be a better screening tool than SMMSE for MCI in the diabetic population OBJECTIVE To examine the prevalence and predictors of foot disease , self-care and clinical monitoring in adults with type 2 diabetes in Alberta , Canada . METHOD Baseline data from a prospect i ve cohort of adults with type 2 diabetes were used . Assessment of foot disease included self-reported peripheral neuropathy , peripheral vasculopathy , foot or leg ulcer/infection or gangrene/amputation . Foot self-care was assessed using the Summary of Diabetes Self-Care Activities , and clinical monitoring using patients ' reports of having OUTPUT:

The most common concordant comorbidity was hypertension while depression was the most common discordant condition . Adherence to medications was the most frequent diabetes self-care behavior reported and tended to be higher among concordant comorbidities . The findings showed mixed results concerning the effect of some concordant comorbidities such as hypertension , hyperlipidemia , retinopathy , and heart failure on diabetes self-care behaviors . But , there is agreement across studies that diabetes-discordant comorbidities have a more detrimental effect on self-care behaviors . Conclusions : Concordant comorbidities may improve diabetes self-care , but the evidence is inconclusive .

MS2_dynamic_1_shot650

***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: Background This study aim ed to evaluate the associations of selected demographic , individual , social , and environmental factors with moderate-to-vigorous physical activity ( MVPA ) in a sample of children and adolescents . Methods MVPA was assessed among youth ( n = 294 ) 10 - 17-years-old using the ActiGraph accelerometer . Youth completed measures of demographic and individual variables related to physical activity ( PA ) , perceived social support by parents and peers , and perceived neighborhood characteristics . Parents completed the long-form of the International Physical Activity Question naire . The Physical Activity and Media Inventory was used to measure the home environment and Geographical Information Systems software was used to measure the physical neighborhood environment . Bivariate correlations and hierarchical multiple regression were conducted stratified by gender . Results Boys participated in significantly more MVPA than girls . In hierarchical analyses , peer support , home PA equipment , and temperature were significantly associated with MVPA among boys whereas distance to the school they attended was associated with MVPA among girls . The final models accounted for 25 % and 15 % of the variance in MVPA among boys and girls , respectively . Conclusions Important differences exist among the individual , social , and environmental factors related to MVPA between boys and girls . Boys ' levels of activity appear to be influenced by factors closely linked to unstructured and social types of activities whereas girls ' activities relate to internal and external barriers as well as their proximity to their schools . The prospect i ve contribution of these important individual , social , and environmental factors to changes in MVPA among children and adolescents remains to be determined PURPOSE This study examined the association of objective and perceived neighborhood environmental characteristics and parent concerns with active commuting to school , investigated whether parental concerns varied by environmental characteristics , and compared the association of the perceived environment , parental concerns , and objective environment on the outcome active commuting to school . METHODS R and omly selected parents of children ( aged 5 - 18 yr ) , in neighborhoods chosen for their variability in objective ly measured walkability and income , completed question naires about their neighborhood environment , concerns about children walking to school , and children 's behavior ( N = 259 ) . Objective measures of the environment were available for each participant and each neighborhood . Logistic regression analyses were used to investigate the relationships among environment , parental concerns , and walking or biking to or from school at least once a week . RESULTS A parental concerns scale was most strongly associated with child active commuting ( odds ratio : 5.2 , 95 % CI : 2.71 - 9.96 ) . In high-income neighborhoods , more children actively commuted in high-walkable ( 34 % ) than in low-walkable neighborhoods ( 23 % ) ( odds ratio : 2.1 , 95 % CI : 1.12 - 3.97 ) , but no differences were noted in low-income neighborhoods . Parent concerns and neighborhood aesthetics were independently associated with active commuting . Perceived access to local stores and biking or walking facilities accounted for some of the effect of walkability on active commuting . CONCLUSION Both parent concerns and the built environment were associated with children 's active commuting to school . To increase active commuting to school , interventions that include both environmental change and education campaigns may be needed PURPOSE To evaluate the reliability and validity of the CSA ( model 7164 ) accelerometer ( MTI ) in a wide walking-running speed range in laboratory and field . METHOD Twelve male subjects performed three treadmill walking/running sessions and one field trial with the same continuous protocol involving progressively increasing velocities at 5 min per interval from 3 to 6 km x h(-1 ) ( walking ) and 8 to 20 km x h(-1 ) ( running ) . In the field trial , this protocol was terminated after 35 min ( 14 km.h(-1 ) ) , but the trial then extended with 5-km running at a freely chosen velocity . In both scenarios , two CSAs were mounted on each hip and the step frequency measured at each velocity . Oxygen uptake VO(2 ) x kg(-1 ) was measured on the last two treadmill sessions . Correlation analyses were performed for mean CSA output relationship with speed , VO(2 ) per kilogram , and step frequency . RESULTS In all trials , CSA output rose linearly ( R2 = 0.92 , P < 0.001 ) with increasing speed until 9 km.h-1 but remained at approximately 10000 counts.min-1 during running , thus underestimating VO(2 ) per kilogram at speeds > 9 km x h(-1 ) . Estimation errors increased with speed from 11 % ( P < 0.01 ) at 10 km x h(-1 ) to 48 % ( P < 0.001 ) at 16 km x h(-1 ) , when assuming a linear relationship . Freely chosen velocities in the field trial ranged from 10.9 to 16.3 km.h-1 . No difference in the CSA-speed relationship was observed between the two scenarios . Differences in CSA output between subjects could partially be attributed to differences in step frequency ( R = -0.34 ( P = 0.02 ) for walking and R = -0.63 ( P < 0.001 ) for running ) . CONCLUSION CSA output increases linearly with speed in the walking range but not in running , presumably due to relatively constant vertical acceleration in running . Between-subject reliability was related to step frequency because CSA data are filtered most at higher movement frequencies . Epidemiological CSA data should thus be interpreted with these limitations in mind PURPOSE To derive a regression equation that estimates metabolic equivalent ( MET ) from accelerometer counts , and to define thresholds of accelerometer counts that can be used to delineate sedentary , light , moderate , and vigorous activity in adolescent girls . METHODS Seventy-four healthy 8th grade girls , age 13 - 14 yr , were recruited from urban areas of Baltimore , MD , Minneapolis/St . Paul , MN , and Columbia , SC , to participate in the study . Accelerometer and oxygen consumption (.-)VO(2 ) ) data for 10 activities that varied in OUTPUT: Conclusions Children do not benefit to the same extent as adolescents from built-environment features that encourage walking and those design ed or used for neighbourhood play INPUT: OBJECTIVES To determine whether participation in usual moderate-intensity or more-vigorous physical activity ( MVPA ) is associated with physical function performance and to identify sociodemographic , psychosocial , and disease-related covariates that may also compromise physical function performance . DESIGN Cross-sectional analysis of baseline variables of a r and omized controlled intervention trial . SETTING Four academic research centers . PARTICIPANTS Four hundred twenty-four older adults aged 70 to 89 at risk for mobility disability ( scoring < 10 on the Short Physical Performance Battery ( SPPB ) ) and able to complete the 400-m walk test within 15 minutes . MEASUREMENTS Minutes of MVPA ( dichotomized according to above or below 150 min/wk of MVPA ) assessed according to the Community Healthy Activities Model Program for Seniors question naire , SPPB score , 400-m walk test , sex , body mass index ( BMI ) , depressive symptoms , age , and number of medications . RESULTS The SPPB summary score was associated with minutes of MVPA ( ρ=0.16 , P=.001 ) . In multiple regression analyses , age , minutes of MVPA , number of medications , and depressive symptoms were associated with performance on the composite SPPB ( P<.05 ) . There was an association between 400-m walk time and minutes of MVPA ( ρ=-0.18 ; P<.001 ) . In multiple regression analyses , age , sex , minutes of MVPA , BMI , and number of medications were associated with performance on the 400-m walk test ( P<.05 ) . CONCLUSION Minutes of MVPA , sex , BMI , depressive symptoms , age , and number of medications are associated with physical function performance and should all be taken into consideration in the prevention of mobility disability INTRODUCTION AND PURPOSE Physical inactivity in postmenopausal women contributes to a rise in atherogenic risk factors associated with the metabolic syndrome . Although regular physical activity positively contributes to health , inactivity progressively increases with age . The Dose Response to Exercise in Women aged 45 - 75 yr ( DREW ) study is design ed to investigate the effect of different amounts of exercise training on cardiorespiratory fitness and risk factors for cardiovascular disease ( CVD ) in postmenopausal women at moderately increased risk of CVD . METHODS DREW will recruit 450 sedentary , healthy , postmenopausal women with a body mass index of 25 - 40 kg.m-2 , resting systolic blood pressure ( BP ) of 120 - 159 mm Hg , and a resting diastolic BP of < or = 99 mm Hg . Laboratory and self-report measures completed at baseline and 6 months include maximal oxygen consumption ( .VO2max ) , resting BP , anthropometry , dietary habits , physical activity history , medication use , menstrual history , personal and family medical history , and fasting HDL cholesterol , LDL cholesterol , triglycerides , and glucose . Eligible participants are r and omly assigned to a nonexercise group or one of three exercise groups . Participants exercise 3 to 4x wk-1 at a heart rate equivalent to 50 % of .VO2max expending 4 , 8 , or 12 kcal.kg-1.wk-1 , depending on group assignment . This study will allow quantification of possible dose-response relations ( 50 % , 100 % , and 150 % of the consensus physical activity recommendation ) between exercise training and study outcomes . CONCLUSION DREW can make important contributions to our underst and ing of the effects of physical activity in postmenopausal women and help refine public health and clinical recommendations for this group Background Previous research has mainly targeted older people with high risk of falling . The effectiveness of exercise interventions in older people with mild levels of balance dysfunction remains unexplored . Objective This study evaluated the effectiveness of a home balance and strength exercise intervention in older people systematic ally screened as having mild balance dysfunction . Design This was a community-based , r and omized controlled trial with assessors blinded to group allocation . Participants Study participants were older people who reported concerns about their balance but remained community ambulant ( n=225 ) . After a comprehensive balance assessment , those classified as having mild balance dysfunction ( n=165 ) were r and omized into the trial . Intervention Participants in the intervention group ( n=83 ) received a 6-month physical therapist – prescribed balance and strength home exercise program , based on the Otago Exercise Program and the Visual Health Information Balance and Vestibular Exercise Kit . Participants in the control group ( n=82 ) continued with their usual activities . Outcome Measures Laboratory and clinical measures of balance , mobility , and strength were assessed at baseline and at a 6-month re assessment . Results After 6 months , the intervention group ( n=59 ) significantly improved relative to the control group ( n=62 ) for : the Functional Reach Test ( mean difference=2.95 cm , 95 % confidence interval [CI]=1.75 to 4.15 ) , the Step Test ( 2.10 steps/15 seconds , 95 % CI=1.17 to 3.02 ) , hip abductor strength ( 0.02 , 95 % CI=0.01 to 0.03 ) , and gait step width ( 2.17 cm , 95 % CI=1.23 to 3.11 ) . There were nonsignificant trends for improvement on most other measures . Fourteen participants in the intervention group ( 23.7 % ) achieved balance performance within the normative range following the exercise program , compared with 3 participants ( 4.8 % ) in the control group . Limitations Loss to follow-up ( 26.6 % ) was slightly higher than in some similar studies but was unlikely OUTPUT:

In this review we found that exercise interventions ( or lifestyle activities ) that improved cardiorespiratory exercise capacity showed the most positive impact on physical health . CONCLUSIONS Findings suggest that programs should facilitate and support women to participate in regular exercise by embedding physical activity programs in public health initiatives , by developing home-based exercise programs that require few re sources and by creating interventions that can incorporate physical activity within a healthy lifestyle . The review also suggests that clinicians should consider prescribing exercise in a tailored manner for older women to ensure that it is of a high enough intensity to obtain the positive sustained effects of exercise

MS2_dynamic_1_shot651

***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: OBJECTIVE To determine contraceptive efficacy of hormonally induced sperm suppression to severe oligozoospermia or azoospermia . DESIGN Prospect i ve , noncomparative contraceptive efficacy study . SETTING Multicenter study in 15 centers in nine countries . PARTICIPANTS Three hundred ninety-nine normal , healthy , fertile men requesting a male contraceptive method . INTERVENTION Weekly IM injection of 200 mg T enanthate . MAIN OUTCOME MEASURE Incidence of pregnancies in efficacy when couples relied on T injections alone for contraception . RESULTS Four pregnancies occurred during 49.5 person-years involving men with oligozoospermia ( 0.1 to 3 x 10(6)/mL ) and none during 230.4 person-years in azoospermic men : pregnancy rates 8.1 ( 95 percent confidence interval [ CI ] 2.2 to 20.7 ) and 0.0 ( 95 percent CI , 0.0 to 1.6 ) per 100 person-years , respectively , or 1.4 ( 95 percent CI , 0.4 to 3.7 ) per 100 person-years for oligozoospermia and azoospermia ( O to 3 x 10(6)/mL ) combined . Pregnancy rates were related to sperm concentration . Inadequate suppression of spermatogenesis occurred in eight men and escape from suppression occurred in four . Discontinuations were due to personal reasons ( 50 men , cumulative annual life-table rate 12.2 percent [ 95 percent CI , 9.1 percent to 16.1 percent ] ) and dislike of the injection schedule ( 21 men , 5.1 percent [ 95 percent CI , 3.2 percent to 7.9 percent ] ) . Thirty-five men discontinued for medical reasons ( 9.4 percent [ 95 percent CI , 6.7 percent to 13.2 percent ] ) , with no serious treatment-related side effects . After stopping injections , sperm output recovered ; additionally , fertility was demonstrated in 33 couples . CONCLUSION Suppression of spermatogenesis to azoospermia or severe oligozoospermia ( < or = 3 x 10(6)/mL ) induced by weekly T enanthate injections results in sustained , reversible contraception with good efficacy and minimal short-term side effects . New hormonal regimens with more convenient delivery and improved spermatogenic suppression would provide practical male contraception Following the intravasal injection of a new male contraceptive RISUG ( reversible inhibition of sperm under guidance ) in volunteers , routine semen analysis , semen biochemistry and germ cell morphology were evaluated in comparison with the corresponding preinjection sample s for a maximum period of 6 months . Sperm counts in all 25 subjects before injection varied from 45 to 120 x 10(6)/ml . Out of 25 subjects , 6 became azoospermic after 1 month , 15 after 2 months , 3 after 3 months and 1 after 4 months of contraceptive injection . The mean volume of the ejaculates was found to be less as compared to preinjection sample s. Occasional sperm or sperm heads and immature germ cells were identified in only a few postinjected subjects . However , no pregnancy was reported in these subjects during the study period . Abnormal morphology found in most of the sperm , but not in the accompanying immature germ cells , may be due to a charge-related effect on the former but not on the latter cells . Neutral alpha-glucosidase , the biochemical marker for epididymis , was estimated to be significantly lower in the seminal plasma of all the postinjected subjects . On the other h and , acid phosphatase activity and fructose levels in the seminal plasma were found to be in the normal range . Based on the above findings , it is concluded that at least for the present study period , RISUG , a new male contraceptive , is effective as a partially occluding agent in the vas deferens Following up on an earlier clinical trial demonstrating the safety of an intra-vas deferens injection of a contraceptive drug named Risug , comprised of styrene maleic anhydride ( SMA ) in a solvent vehicle of dimethylsulphoxide ( DMSO ) , a study to assess the contraceptive effectiveness of a specific dose ( 60 mg ) of SMA bilaterally was planned and implemented . Male subjects and their wives with normal reproductive profiles were the volunteer subjects . The wives were not using any contraceptives . The results reconfirm the safety and show that for a period of at least 1 year , the treatment leads to azoospermia in the male and gives pregnancy protection The safety and efficacy of gossypol continues to be controversial . The aim of this study was to evaluate gossypol as a contraceptive pill for men at doses lower than those previously prescribed and in men from various ethnic origin . A total of 151 men from Brazil , Nigeria , Kenya , and China were divided into two groups . Both groups received 15 mg gossypol/day for 12 or 16 weeks to reach spermatogenesis suppression . Subjects were then r and omized to either 7.5 or 10 mg/day for 40 weeks . In addition , 51 men were enrolled as a control group . In all , 81 subjects attained spermatogenesis suppression . Only one man discontinued treatment because of tiredness . Potassium levels fluctuated within the normal range . FSH increased consistently . Testicular volume decreased , but after discontinuation , values returned to levels not statistically different from admission . Of 19 subjects on the 7.5 mg/day dose group , 12 recovered sperm counts > 20 million/mL within 12 months of discontinuing gossypol . In the 10 mg/day group , sperm counts recovered in only 10 of 2 OUTPUT: Gossypol had problems with low efficacy and toxicity . Although sperm density was lower among those taking Tripterygium , later reports indicated some toxicity . At this time , no safe and effective nonhormonal drug is available for contraception in men . INPUT: Abuse of anabolic and rogenic steroids ( AASs ) may be an aetiological factor in male infertility among recreational power athletes . They try to avoid AAS-induced deterioration in spermatogenesis by combining doses of human chorionic gonadotrophin ( HCG ) and /or antiestrogens with their AAS abuse . Eighteen healthy male power athletes using massive doses of AASs were recruited for the study . Semen sample s were collected during AAS abuse and 1.5 and 6 months after cessation of the abuse . They were also asked about their reproductive activity six years after the study . At the end of the AAS cycle , the sperm count was 33 + /- 49 x 10 ( 6 ) /ml ( mean + /- SD ) , and only one subject had azoospermia . At 1.5 months after cessation of the AAS cycles , the mean sperm concentration was 30 + /- 42 x 10 ( 6 ) /ml , and after six months 77 + /- 70 x 10 ( 6 ) /ml . There were significant differences between the sample drawn six months after cessation of AAS abuse and both sample s drawn during and 1.5 months after the abuse ( p < /= 0.05 , repeated measures of ANOVA ) . There was a significant positive correlation between HCG dose during the cycle and the relative amount of morphologically abnormal spermatozoa ( r = 0.60 , p < 0.01 ) . The concomitant abuse of HCG and supraphysiological AAS dose cause transient impairment on semen quality in males , although spermatogenesis is maintained with this regimen despite prolonged abuse of massive doses of AAS 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 After failure to confirm an anabolic action of testosterone and its derivatives in rats , meth and ienone ( ' Dianabol ' , an " anabolic steroid " used by athletes ) has been given to 11 athletic men during a course of weight-training , in a double-blind , crossover experiment . The dose of meth and ienone was 100 mg/day for 6 wk . Body weight and composition , muscular strength and performance , and indices of endocrine function were studied . Compared with the placebo period , on meth and ienone the subjects gained weight ( mean 3 - 3 kg + /- 0 - 6 kg ) and accumulated a disproportionately large amount of potassium ( 420+/-68 mmol ) ; the increase in weight was confined to the lean part of the body , and the muscles increased in size . Strength and performance improved over each training period , but not significantly differently on drug and placebo . On the drug , plasma-cortisol concentration and urinary cortisol excretion increased , and plasma-testosterone decreased . Although the weight and body-composition changes may demonstrate an anabolic action of meth and ienone in man , they may alternatively have been caused by an increase in intracellular fluid , and the question of anabolic action therefore remains open The effects of a one-month course of treatment with a potent anabolic steroid , meth and ienone ( 5 and 10 mg daily ) , and a very weak and rogen and hormone precursor , dehydroepi and rosterone sulphate ( DHEAS , 20 and 40 mg daily ) and placebo on plasma testosterone , LH and FSH levels , red cell volume and red cell 2,3-diphosphoglycerate ( 2,3-DPG ) concentration in endurance sportsmen were studied using a double-blind test system . A highly significant decrease in mean plasma testosterone was observed after the 5 and 10 mg meth and ienone regimen ( 66 and 73 % ) . Treatment with 40 mg of DHEAS decreased mean testosterone levels by 41 % ( not statistically significant ) . Pre-test testosterone levels were reattained about 10 days after the end of the treatment period with the higher doses of both compounds , while 2–6 weeks afterwards a significant over-compensation in mean plasma testosterone levels was observed . No significant changes in plasma gonadotropins were seen immediately after treatment with either of these steroids bu The effect of mesterolone ( 1 alpha-methyl-5 alpha-dihydrotestosterone ) administration to 10 normal men aged 24 - 27 years on the pituitary-testicular function was investigated . No effect on the plasma levels of interstitial cell-stimulating hormone ( ICSH ) and follicle stimulating hormone could be detected . After 4 weeks on 75 mg mesterolone/day a significant ( p < .01 ) drop in the mean level of testosterone was observed 5.2 to 4 ng/ml . After another 4 weeks on 150 mg/day a further decrease to 3.5 ng/ml was found . During mesterolone administration the protein binding of testosterone was significantly ( p < .0025 ) reduced and it appeared that the level of free ( nonprotein bound ) testosterone in diluted plasma remained unchanged .37 and .41 ng/ml before and after mesterolone administration respectively . These results suggest that mesterolone given in doses of 75 and 150 mg/day to normal men does not suppress the pituitary ICSH production or the testicular testosterone production The effects of an anabolic steroid on male physical education students at Brigham Young University were studied . 31 subjects were trained with weights for 7 weeks . At the end of week 4 24 subjects were r and omly placed in a treatment-placebo group which took 2 capsules daily from 24 numbered bottles for 21 days . 12 of the bott OUTPUT:

In addition , AAS abuse result ed in structural and functional sperm changes , a reduction in testicular volume , gynecomastia , as well as clitoromegaly , menstrual irregularities , and subfertility . Conclusion The majority of AAS users demonstrated hypogonadism with persistently low gonadotropin and testosterone levels , lasting for several weeks to months after AAS withdrawal . Anabolic and rogenic steroid use results in profound and prolonged effects on the reproductive system of athletes and recreational users and potentially on fertility

MS2_dynamic_1_shot652

***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: Objective To evaluate the clinical effectiveness of low-frequency pulsed electromagnetic field ( PEMF ) therapy for women with fibromyalgia ( FM ) . Methods Fifty-six women with FM , aged 18 to 60 years , were r and omly assigned to either PEMF or sham therapy . Both the PEMF group ( n=28 ) and the sham group ( n=28 ) participated in therapy , 30 minutes per session , twice a day for 3 weeks . Treatment outcomes were assessed by the fibromyalgia Impact question naire ( FIQ ) , visual analog scale ( VAS ) , patient global assessment of response to therapy , Beck Depression Inventory ( BDI ) , and Short-Form 36 health survey ( SF-36 ) , after treatment ( at 4 wk ) and follow-up ( at 12 wk ) . Results The PEMF group showed significant improvements in FIQ , VAS pain , BDI score , and SF-36 scale in all domains at the end of therapy . These improvements in FIQ , VAS pain , and SF-36 pain score during follow-up . The sham group also showed improvement were maintained on all outcome measures except total FIQ scores after treatment . At 12 weeks follow-up , only improvements in the BDI and SF-36 scores were present in the sham group . Conclusion Low-frequency PEMF therapy might improve function , pain , fatigue , and global status in FM patients The aim of this r and omized controlled single-blind study is to explore whether addition of mud-pack and hot pool treatments to patient education make a significant difference in short and mild term outcomes of the patients with fibromyalgia . Seventy women with fibromyalgia syndrome were r and omly assigned to either balneotherapy with mud-pack and hot pool treatments ( 35 ) or control ( 35 ) groups . After r and omization , five patients from balneotherapy group and five patients from control group were dropped out from the study with different excuses . All patients had 6-h patient education programme about fibromyalgia syndrome and were given a home exercise programme . The patients in balneotherapy group had heated pool treatment at 38 ° C for 20 min a day , and mud-pack treatment afterwards on back region at 45 ° C . Balneotherapy was applied on weekdays for 2 weeks . All patients continued to take their medical treatment . An investigator who was blinded to the intervention assessed all the patients before and after the treatment , at the first and the third months of follow-up . Outcome measures were FIQ , BDI and both patient ’s and physician ’s global assessment s. Balneotherapy group was significantly better than control group at after the treatment and at the end of the first month follow-up assessment s in terms of patient ’s and physician ’s global assessment , total FIQ score , and pain intensity , fatigue , non-refreshed awaking , stiffness , anxiety and depression subscales of FIQ . No significant difference was found between the groups in terms of BDI scores . It is concluded that patient education combined with 2 weeks balneotherapy application has more beneficial effects in patients with fibromyalgia syndrome as compared to patient education alone Low energy lasers are widely used to treat a variety of musculoskeletal conditions including fibromyalgia , despite the lack of scientific evidence to support its efficacy . A r and omised , single-blind , placebo-controlled study was conducted to evaluate the efficacy of low-energy laser therapy in 40 female patients with fibromyalgia . Patients with fibromyalgia were r and omly allocated to active ( Ga-As ) laser or placebo laser treatment daily for two weeks except weekends . Both the laser and placebo laser groups were evaluated for the improvement in pain , number of tender points , skinfold tenderness , stiffness , sleep disturbance , fatigue , and muscular spasm . In both groups , significant improvements were achieved in all parameters ( p<0.05 ) except sleep disturbance , fatigue and skinfold tenderness in the placebo laser group ( p>0.05 ) . It was found that there was no significant difference between the two groups with respect to all parameters before therapy whereas a significant difference was observed in parameters as pain , muscle spasm , morning stiffness and tender point numbers in favour of laser group after therapy ( p<0.05 ) . None of the participants reported any side effects . Our study suggests that laser therapy is effective on pain , muscle spasm , morning stiffness , and total tender point number in fibromyalgia and suggests that this therapy method is a safe and effective way of treatment in the cases with fibromyalgia Fibromyalgia is characterized by a range of symptoms that include muscle pain , fatigue and sleep disorders . Transcutaneous electrical nerve stimulation ( TENS ) is an established method for pain relief . The purpose of the study was to evaluate the effectiveness and safety of the use of two simultaneously new TENS devices for fibromyalgia pain . After Ethics approval and informed consent , 39 patients were prospect ively divided into three groups to evaluate TENS device , applied simultaneously in each patient : ( 1 ) at the lower back ( perpendicular to the vertebrae canal , at the level of the 5th lumbar vertebrae ) and ( 2 ) central ly above and below the space between the C7 and T1 spinous processes . The devices were applied for 20 min at 12-h interval during 7 consecutive days . For the placebo group ( PG ) , the devices did not transmitted electrical stimulus . The single-TENS group ( STG ) ( n = 13 ) had one active and one placebo TENS . The DTG applied both active TENS devices at the low back and cervical areas . Diclofenac was used as rescue analgesic . The efficacy measures were pain relief , reduction in use of daily analgesic tablets , quality of sleep and fatigue . The evaluation within groups revealed that patients from DPG refereed no pain relief when compared to their previous VAS pain score ( 8 cm , p > 0.05 ) , while patients from the STG refereed improvement of 2.5 cm in the pain VAS ( previous 8.5 cm compared to 6 cm after treatment ) ( p < 0.05 ) , and the DPG refereed OUTPUT: LLLT did not reduce VAS scores , but it significantly reduced both the number of tender points and FIQ score . Thermal therapy was associated with significantly reduced VAS scores , tender points , and FIQ scores . Electromagnetic field therapy was associated with significantly reduced VAS score and FIQ score . TENS significantly reduced VAS scores . Conclusion Our analyses revealed that thermal therapy and LLLT had a partial effect on pain relief in FM patients , and this beneficial effect may have a positive influence on FM patients ' health status INPUT: The purpose of this study was to investigate the clinical effects of balneotherapy in the treatment of Fibromyalgia Syndrome ( FMS ) and to determine if balneotherapy influences serum levels of inflammation markers , IL-1 , PGE2 and LTB4 . 24 primary fibromyalgia female patients diagnosed according to American College of Rheumatology criteria were included to the study . Their ages ranged between 33 and 55 years . FMS patients were r and omly assigned in two groups as , group 1 ( n = 12 ) and group 2 ( n = 12 ) . Group 1 received 20-min bathing , once in a day for five days per week . Patients participated in the study for 3 weeks ( total of 15 sessions ) in Denizli . Group 2 did not receive balneotherapy . FMS patients were evaluated by tenderness measurements ( tender point count and algometry ) , Visual Analogue Scale , Beck ’s Depression Index , Fibromyalgia Impact Question naire . Ten healthy women recruited group three as the controls . Serum PGE2 , LTB4 and IL1-α levels were measured in all three groups . The biochemical measurements and clinical assessment s were performed before and at the end of general period of therapy . Statistically significant alterations in algometric score , Visual Analogue score , Beck ’s Depression Index and PGE2 levels ( P < 0.001 ) , numbers of tender points ( P < 0.01 ) and Fibromyalgia Impact Question naire score ( P < 0.05 ) were found after the balneotherapy between group 1 and 2 . Mean PGE2 level of FMS patients were higher compared to healthy control group ( P < 0.0001 ) and decreased after the treatment period , only in group 1 ( P < 0.05 ) . As in the group 2 and 3 , detectable IL-1 and LTB4 measurements were insufficient , statistical analysis was performed , only in group 1 . After balneotherapy IL-1 and LTB4 significantly decreased in group 1 ( P < 0.05 ) . In conclusion , balneotherapy is an effective choice of treatment in patients with FMS relieving the clinical symptoms , and possibly influencing the inflammatory mediators Abstract . The aim of this study was to evaluate the effectiveness of balneotherapy on patients with fibromyalgia ( FM ) at the Dead Sea . Forty-eight patients with FM were r and omly assigned to a treatment group receiving sulfur baths and a control group . All participants stayed for 10 days at a Dead Sea spa . Physical functioning , FM-related symptoms , and tenderness measurements ( point count and dolorimetry ) were assessed at four time points : prior to arrival at the Dead Sea , after 10 days of treatment , and 1 and 3 months after leaving the spa . Physical functioning and tenderness moderately improved in both groups . With the exception of tenderness threshold , the improvement was especially notable in the treatment group and it persisted even after 3 months . Relief in the severity of FM-related symptoms ( pain , fatigue , stiffness , and anxiety ) and reduced frequency of symptoms ( headache , sleep problems , and subjective joint swelling ) were reported in both groups but lasted longer in the treatment group . In conclusion , treatment of FM at the Dead Sea is effective and safe and may become an additional therapeutic modality in FM . Future studies should address the outcome and possible mechanisms of this treatment in FM patients Fibromyalgia ( FM ) is a nonarticular rheumatological syndrome associated with diverse clinical and psychological features . One of the major complaints in FM is reduced pain tolerance , especially in tender points ( TP ) for which patients derive significant benefit from nonsteroidal antiinflammatory drugs or corticosteroids . Patients with FM also have altered reactivity of the hypothalamic pituitary adrenal ( HPA ) axis where the predominant feature is reduced containment of the stress response system through diminished adrenocortical output and feedback resistance . Our results show that mud packs together with antidepressant treatment are able to influence the HPA axis , stimulating increased levels of adrenocorticotropic hormone , cortisol and beta-endorphin serum levels . The discharge of corticoids in the blood and the increase in beta-endorphin serum levels are followed by a reduction in pain symptoms , which is closely related to an improvement in disability , depression and quality of life . It seems that the synergic association between a pharmacological treatment ( trazodone ) and mud packs acts by helping the physiological responses to achieve homeostasis and to rebalance the stress response system . To clarify and optimize the effectiveness of this synergic association , studies involving a larger number of FM patients and a different pharmacological treatment are needed Abstract : Fibromyalgia ( FS ) is an idiopathic chronic pain syndrome defined by widespread non-articular musculoskeletal pain and generalised tender points . As there is no effective treatment , patients with this condition have impaired quality of life ( QoL ) . The aim of this study was to assess the possible effect of balneotherapy at the Dead Sea area on the QoL of patients with FS . Forty-eight subjects participated in the study ; half of them received balneotherapy , and half did not . Their QoL ( using SF-36 ) , psychological well-being and FS-related symptoms were assessed prior to arrival at the spa hotel in the Dead Sea area , at the end of the 10-day stay , and 1 and 3 months later . A significant improvement was reported on most subscales of the SF-36 and on most symptoms . The improvement in physical aspects of QoL lasted usually 3 months , but on psychological measures the improvement was shorter . Subjects in the balneotherapy group reported higher and longer-lasting improvement than subjects in the control group . In conclusion , staying at the Dead Sea spa , in addition to balneotherapy , can transiently improve the QoL of patients with FS . Other studies with longer follow-up are needed to support our findings OBJECTIVE We studied whether whirl baths with plain water or with water containing pine oil or valerian have a OUTPUT:

There is moderate evidence that hydrotherapy has short-term beneficial effects on pain and HRQOL in FMS patients .

MS2_dynamic_1_shot653

***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: BACKGROUND Telehome care has been proposed as a solution to the challenges of providing effective and affordable care for patients with diabetes . METHODS A total of 100 adult patients with type 2 diabetes-divided between insulin and noninsulin requiring-was enrolled in a r and omized , controlled trial aim ed at investigating the effects of telehome monitoring . The experimental group ( n = 50 ) received an in-home wireless glucose monitor and transmitter , whereas the control group ( n = 50 ) was instructed to follow the conventional arrangement . RESULTS There was an overall reduction in HbA1c values in both experimental and control groups after 6 months . A significant difference in HbA1c values between the groups was observed only among the noninsulin-requiring patients ( decline from 6.95 % ± 0.82 % to 6.66 % ± 0.86 % in IB vs. 7.21 % ± 2.02 % to 7.2 % ± 1.86 % in IIB ; p = 0.02 ) . The experimental group reported considerably less hyperglycemic and hypoglycemic events . The profile of the patient who benefited the most from telemonitoring consisted of older , more educated patient who had acquired the disease relatively recently , and who spends most of the time at home . The experimental group had higher overall scores on quality of life measures and sense of control over diabetes . There was a positive association between educational attainment and ability to use the telemonitoring system without help ( p = 0.045 ) . CONCLUSIONS Although not conclusive because of the small sample and short observation period , the study suggests that telehome monitoring is an effective tool in controlling type 2 diabetes in a primary care setting OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P < 0.05 ) when compared with education and usual care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1.2 % ; P = 0.051 ) or education and usual care ( -1.4 % ; P < 0.05 ) . A larger number of website data uploads was associated with a larger decline in A1C ( highest tertile -2.1 % , lowest tertile -1.0 % ; P < 0.02 ) . Hypertensive participants in the web-based group had a greater reduction in systolic blood pressure ( P < 0.01 ) . HDL cholesterol rose and triglycerides fell in the web-based group ( P < 0.05 ) . CONCLUSIONS Web-based care management may be a useful adjunct in the care of patients with poorly controlled diabetes Purpose The purpose of this study is to investigate the impact of a 6-month Web-based intervention on the psychosocial well-being of older adults with diabetes . Methods This study was a r and omized controlled trial ( N = 62 ) comparing the effects of a 6-month Web-based intervention plus usual care with usual care alone among adults aged 60 years or older with diabetes . The outcomes included quality of life , depression , social support , and self-efficacy . Results The intervention group showed significant improvement , F(4.48 ) = 4.03 P = .007 , when compared with the control group on measures of depression , quality of life , social support , and self-efficacy when controlling for all baseline outcome variables ( age , gender , and number of years with diabetes ) . Conclusions These findings provide support for the conclusion that a Web-based intervention is effective in improving the psychosocial well-being of participants at a 6-month follow-up . Future research needs to investigate the long-term effectiveness of Web-based interventions for sustaining psychosocial well-being , including factors that may affect quality of life , such as diabetes-specific beliefs , attitudes , social support , and disease-specific coping skills OBJECTIVE —To test Web-based care management of glycemic control using a shared electronic medical record with patients who have type 2 diabetes . RESEARCH DESIGN AND METHODS —We conducted a trial of 83 adults with type 2 diabetes r and omized to receive usual care plus Web-based care management or usual care alone between August 2002 and May 2004 . All patients had GHb ≥7.0 % , had Web access from home , and could use a computer with English language –based programs . Intervention patients received 12 months of Web-based care management . The Web-based program included patient access to electronic medical records , secure e-mail with providers , feedback on blood glucose readings , an educational Web site , and an interactive online diary for entering information about exercise , diet , and medication . The primary outcome was change in GHb . RESULTS —GHb levels declined by 0.7 % ( 95 % CI 0.2−1.3 ) on average among intervention patients compared with usual-care patients . Systolic blood pressure , diastolic blood pressure , total cholesterol levels , and use of in-person health care services did not differ between the two groups . CONCLUSIONS —Care management delivered through secure patient Web communications improved glycemic control in type 2 diabetes OBJECTIVE To assess the effect OUTPUT: Internet blood glucose monitoring systems ( IBGMS ) are associated with improved glycemic control in patients with type 2 diabetes ( T2D ) who are pharmacologically managed , using oral agents or insulin . IBGMS improves glycemic levels in patients with type 1 diabetes ( T1D ) . IBGMS has not led to increased hypoglycemia . Mechanisms underlying IBGMS-associated glycemic improvement extend beyond optimizing insulin dose titration . The most important effects seem to be associated with increased patient self-motivation and improved patient-physician communication . IBGMS have been recommended in clinical practice guidelines , and their effectiveness and safety in trials suggest that this approach is appropriate for patients with T1D or T2D INPUT: BACKGROUND Telehome care has been proposed as a solution to the challenges of providing effective and affordable care for patients with diabetes . METHODS A total of 100 adult patients with type 2 diabetes-divided between insulin and noninsulin requiring-was enrolled in a r and omized , controlled trial aim ed at investigating the effects of telehome monitoring . The experimental group ( n = 50 ) received an in-home wireless glucose monitor and transmitter , whereas the control group ( n = 50 ) was instructed to follow the conventional arrangement . RESULTS There was an overall reduction in HbA1c values in both experimental and control groups after 6 months . A significant difference in HbA1c values between the groups was observed only among the noninsulin-requiring patients ( decline from 6.95 % ± 0.82 % to 6.66 % ± 0.86 % in IB vs. 7.21 % ± 2.02 % to 7.2 % ± 1.86 % in IIB ; p = 0.02 ) . The experimental group reported considerably less hyperglycemic and hypoglycemic events . The profile of the patient who benefited the most from telemonitoring consisted of older , more educated patient who had acquired the disease relatively recently , and who spends most of the time at home . The experimental group had higher overall scores on quality of life measures and sense of control over diabetes . There was a positive association between educational attainment and ability to use the telemonitoring system without help ( p = 0.045 ) . CONCLUSIONS Although not conclusive because of the small sample and short observation period , the study suggests that telehome monitoring is an effective tool in controlling type 2 diabetes in a primary care setting OBJECTIVE To improve quality and efficiency of care for elderly patients with type 2 diabetes , we introduced elderly-friendly strategies to the clinical decision support system (CDSS)-based ubiquitous healthcare ( u-healthcare ) service , which is an individualized health management system using advanced medical information technology . RESEARCH DESIGN AND METHODS We conducted a 6-month r and omized , controlled clinical trial involving 144 patients aged > 60 years . Participants were r and omly assigned to receive routine care ( control , n = 48 ) , to the self-monitored blood glucose ( SMBG , n = 47 ) group , or to the u-healthcare group ( n = 49 ) . The primary end point was the proportion of patients achieving A1C < 7 % without hypoglycemia at 6 months . U-healthcare system refers to an individualized medical service in which medical instructions are given through the patient ’s mobile phone . Patients receive a glucometer with a public switched telephone network-connected cradle that automatically transfers test results to a hospital-based server . Once the data are transferred to the server , an automated system , the CDSS rule engine , generates and sends patient-specific messages by mobile phone . RESULTS After 6 months of follow-up , the mean A1C level was significantly decreased from 7.8 ± 1.3 % to 7.4 ± 1.0 % ( P < 0.001 ) in the u-healthcare group and from 7.9 ± 1.0 % to 7.7 ± 1.0 % ( P = 0.020 ) in the SMBG group , compared with 7.9 ± 0.8 % to 7.8 ± 1.0 % ( P = 0.274 ) in the control group . The proportion of patients with A1C < 7 % without hypoglycemia was 30.6 % in the u-healthcare group , 23.4 % in the SMBG group ( 23.4 % ) , and 14.0 % in the control group ( P < 0.05 ) . CONCLUSIONS The CDSS-based u-healthcare service achieved better glycemic control with less hypoglycemia than SMBG and routine care and may provide effective and safe diabetes management in the elderly diabetic patients Introduction The role of mobile technology in patient-reported outcomes ( PRO ) and glycemic control in adults with type 1 diabetes ( T1D ) needs further evaluation . Methods The single-center , prospect i ve , 6-month , open-label , investigator-initiated study r and omized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose ( SMBG ) with Accu-Chek Nano ® and an intervention group using SMBG with iPhone plus glucose meter ( iBGStar ® ) . The primary endpoint was the change in PRO ( hypoglycemia fear score , behavior and worry subscores ) . Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values . Results Baseline demographics and glycosylated hemoglobin ( A1c ) values were similar in the two groups . There was a significant decrease in A1c value at 6 months in iBGStar ® group compared to the control group ( −0.16 vs. −0.51 , p = 0.04 ) . The total insulin dose increased significantly in the iBGStar ® group at 3 months but did not change at 6 months . The hypoglycemia fear scale ( PRO ) improved in both groups at 6 months ( −1.4 ± 10.0 vs. −3.9 ± 12.5 , p = 0.32 ) . Conclusion The use of iBGStar ® result ed in better glycemic control and improvement in some PRO ( hypoglycemia fear and behavior scores ) compared to the control group at 6 months with no increased risk of hypoglycemia . Clinical trial registration Clinical Trials.gov : NCT01825382 . Funding Sanofi BACKGROUND Basal insulin titration in the real world is often unsuccessful . LTHome , a web tool , applies a rules engine-based algorithm providing insulin titration advice OUTPUT:

Discussion Compared to usual care , the use of telemedicine was found to improve HbA1c and reduce the risk of moderate hypoglycaemia in diabetic patients , but without significant difference in BMI

MS2_dynamic_1_shot654

***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: Aims /hypothesisThe aim of the present study was to investigate the effect of blood pressure lowering and intensive glucose control on the incidence and progression of retinopathy in type 2 diabetic patients . Methods The Action in Diabetes and Vascular Disease : Preterax and Diamicron MR Controlled Evaluation ( ADVANCE ) Retinal Measurements study , a sub study of ADVANCE , is a r and omised ( using a central , computer-based procedure ) controlled 2 × 2 factorial trial comprising a double-blind comparison of blood pressure lowering with perindopril – indapamide vs placebo , and an open comparison of st and ard vs intensive glucose control targeting a HbA1c of ≤ 6.5 % in 1,602 diabetic patients from ADVANCE centres with access to retinal cameras conducted from 2001 to 2008 . At baseline and the final visit , seven-field stereoscopic retinal photographs were taken and grade d by blinded readers ( grade able baseline and final photographs from 1,241 patients ) . Progression of ≥2 steps in the Early Treatment of Diabetic Retinopathy Study classification ( using the eye with worst grading ) was the primary outcome . Results Retinopathy progressed in 59 ( 4.8 % ) patients and developed in 128 ( 10.3 % ) patients over 4.1 years . Fewer patients on blood pressure-lowering treatment ( n = 623 ) experienced incidence or progression of retinopathy compared with patients on placebo ( n = 618 ) , but the difference was not significant ( OR 0.78 ; 95 % CI 0.57–1.06 ; p = 0.12 ) . Blood pressure-lowering treatment reduced the occurrence of macular oedema ( OR 0.50 ; 95 % CI 0.29–0.88 ; p = 0.016 ) and arteriovenous nicking compared with placebo ( OR 0.60 ; 95 % CI 0.38–0.94 ; p = 0.025 ) . Compared with st and ard glucose control ( n = 611 ) , intensive glucose control ( n = 630 ) did not reduce ( p = 0.27 ) the incidence and progression of retinopathy ( OR 0.84 ; 95 % CI 0.61–1.15 ) . Lower , borderline significant risks of microaneurysms , hard exu date s and macular oedema were observed with intensive glucose control , adjusted for baseline retinal haemorrhages . These effects of the two treatments were independent and additive . Adverse events in the ADVANCE study are reported elsewhere . Conclusions /interpretationBlood pressure lowering or intensive glucose control did not significantly reduce the incidence and progression of retinopathy , although consistent trends towards a benefit were observed , with significant reductions in some lesions observed with both interventions .Trial registration : Clinical Trials.gov ID no. NCT00145925 . Funding : Grants from Servier and the National Health and Medical Research Council of PURPOSE To examine the 4-year incidence and risk factors for diabetic retinopathy ( DR ) among black participants with diabetes in the Barbados Eye Studies ( BES ) . DESIGN Population -based incidence study . SETTING AND PARTICIPANTS Four hundred ten persons with diabetes mellitus ( DM ) from the BES cohort , which was based on a simple r and om sample of Barbadians , 40 to 84 years of age at baseline . MAIN OUTCOME MEASURES Development of DR , assessed by independent gradings of 30 degrees color stereo fundus photographs of the disc and macula . Associations were evaluated by logistic regression analyses . RESULTS After 4 years , DR developed in 92 of 306 ( 30.1 % ; 95 % confidence interval , 25.0 % , 35.5 % ) persons unaffected at baseline . The incidence of DR was 31.9 % in those with known DM at baseline and 20.9 % in newly diagnosed DM . Clinical ly significant macular edema developed in 16 ( 4.5 % ) of 353 individuals at risk . Seven ( 6.9 % ) of the 101 persons with minimum or moderate DR at baseline progressed to proliferative DR . Age-specific incidence declined from 36.2 % at age 40 to 49 years to 28.8 % and 24.2 % over the subsequent two decades , increasing to 38.2 % among those > /=70 years . Risk factors for DR were increased systolic blood pressure ( relative risk [ RR ] , 1.16 [ 1.03 , 1.31]/10 mmHg increase ) ; use of oral hypoglycemics ( RR , 2.4 [ 1.3 , 4.2 ] ) ; and use of insulin ( RR , 6.1 [ 1.7 , 22.1 ] ) ( vs. no treatment or diet only ) ; and elevated glycated hemoglobin ( GHb ; RR , 6.4 [ 2.5 , 16.0 ] ) ; GHb > 11.5 % vs. GHb < /=8 % ) . CONCLUSIONS High rates of incident DR were evident in the black BES population , also known to have high rates of DM . Prevention of visual loss caused by DR in this population has high priority , including optimal glycemic and blood pressure control BACKGROUND Diabetes mellitus is a strong risk factor for cardiovascular and renal disease . We investigated whether the angiotensin-converting-enzyme ( ACE ) inhibitor ramipril can lower these risks in patients with diabetes . METHODS 3577 people with diabetes included in the Heart Outcomes Prevention E OUTPUT: However , the lack of evidence to support such intervention to slow progression of diabetic retinopathy or to prevent other outcomes considered in this review , along with the relatively modest support for the beneficial effect on incidence , weakens the conclusion regarding an overall benefit of intervening on blood pressure solely to prevent diabetic retinopathy INPUT: Aims /hypothesisThe aim of the present study was to investigate the effect of blood pressure lowering and intensive glucose control on the incidence and progression of retinopathy in type 2 diabetic patients . Methods The Action in Diabetes and Vascular Disease : Preterax and Diamicron MR Controlled Evaluation ( ADVANCE ) Retinal Measurements study , a sub study of ADVANCE , is a r and omised ( using a central , computer-based procedure ) controlled 2 × 2 factorial trial comprising a double-blind comparison of blood pressure lowering with perindopril – indapamide vs placebo , and an open comparison of st and ard vs intensive glucose control targeting a HbA1c of ≤ 6.5 % in 1,602 diabetic patients from ADVANCE centres with access to retinal cameras conducted from 2001 to 2008 . At baseline and the final visit , seven-field stereoscopic retinal photographs were taken and grade d by blinded readers ( grade able baseline and final photographs from 1,241 patients ) . Progression of ≥2 steps in the Early Treatment of Diabetic Retinopathy Study classification ( using the eye with worst grading ) was the primary outcome . Results Retinopathy progressed in 59 ( 4.8 % ) patients and developed in 128 ( 10.3 % ) patients over 4.1 years . Fewer patients on blood pressure-lowering treatment ( n = 623 ) experienced incidence or progression of retinopathy compared with patients on placebo ( n = 618 ) , but the difference was not significant ( OR 0.78 ; 95 % CI 0.57–1.06 ; p = 0.12 ) . Blood pressure-lowering treatment reduced the occurrence of macular oedema ( OR 0.50 ; 95 % CI 0.29–0.88 ; p = 0.016 ) and arteriovenous nicking compared with placebo ( OR 0.60 ; 95 % CI 0.38–0.94 ; p = 0.025 ) . Compared with st and ard glucose control ( n = 611 ) , intensive glucose control ( n = 630 ) did not reduce ( p = 0.27 ) the incidence and progression of retinopathy ( OR 0.84 ; 95 % CI 0.61–1.15 ) . Lower , borderline significant risks of microaneurysms , hard exu date s and macular oedema were observed with intensive glucose control , adjusted for baseline retinal haemorrhages . These effects of the two treatments were independent and additive . Adverse events in the ADVANCE study are reported elsewhere . Conclusions /interpretationBlood pressure lowering or intensive glucose control did not significantly reduce the incidence and progression of retinopathy , although consistent trends towards a benefit were observed , with significant reductions in some lesions observed with both interventions .Trial registration : Clinical Trials.gov ID no. NCT00145925 . Funding : Grants from Servier and the National Health and Medical Research Council of Background —This study sought to determine whether tight glycemic control with a modified glucose-insulin-potassium ( GIK ) solution in diabetic coronary artery bypass graft ( CABG ) patients would improve perioperative outcomes . Methods and Results —One hundred forty-one diabetic patients undergoing CABG were prospect ively r and omized to tight glycemic control ( serum glucose , 125 to 200 mg/dL ) with GIK or st and ard therapy ( serum glucose < 250 mg/dL ) using intermittent subcutaneous insulin beginning before anesthesia and continuing for 12 hours after surgery . GIK patients had lower serum glucose levels ( 138±4 versus 260±6 mg/dL ; P < 0.0001 ) , a lower incidence of atrial fibrillation ( 16.6 % versus 42 % ; P = 0.0017 ) , and a shorter postoperative length of stay ( 6.5±0.1 versus 9.2±0.3 days ; P = 0.003 ) . GIK patients also showed a survival advantage over the initial 2 years after surgery ( P = 0.04 ) and decreased episodes of recurrent ischemia ( 5 % versus 19 % ; P = 0.01 ) and developed fewer recurrent wound infections ( 1 % versus 10 % , P = 0.03 ) . Conclusions —Tight glycemic control with GIK in diabetic CABG patients improves perioperative outcomes , enhances survival , and decreases the incidence of ischemic events and wound complications A prospect i ve , stratified , r and omized 3-year clinical trial was conducted on the effect of rigorous versus conventional glucose control on peripheral nerve function in 33 insulin-treated diabetic patients with a duration of diabetes of less than 2 years . The goals for conventional glucose control were the mean of fasting and 80-minute postpr and ial plasma glucose of 150 mg/dl for non-insulin-dependent diabetes and 200 mg/dl for insulin-dependent diabetes . The goal of rigorous glucose control was an approximation of nondiabetic glucose control . No significant difference in glucose control or peripheral nerve function was observed between the rigorously and the conventionally controlled groups . Eight patients in the conventional-control group spontaneously achieved glucose control in the range that was the objective for the rigorous-control group , and five patients in the rigorous-control group never achieved the desired glucose control . In the remaining 20 patients , with similar baseline glucose control and peripheral nerve function characteristics , observed over a median of 2 years OUTPUT:

Intensive glycaemic control does not seem to reduce all cause mortality in patients with type 2 diabetes .

MS2_dynamic_1_shot655

***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: Lowering blood pressure reduces cardiovascular risk , yet hypertension is poorly controlled in diabetic patients . In a pilot study we demonstrated that a home blood pressure telemonitoring system , which provided self-care messages on the smartphone of hypertensive diabetic patients immediately after each reading , improved blood pressure control . Messages were based on care paths defined by running averages of transmitted readings . The present study tests the system 's effectiveness in a r and omized , controlled trial in diabetic patients with uncontrolled systolic hypertension . Of 244 subjects screened for eligibility , 110 ( 45 % ) were r and omly allocated to the intervention ( n=55 ) or control ( n=55 ) group , and 105 ( 95.5 % ) completed the 1-year outcome visit . In the intention-to-treat analysis , mean daytime ambulatory systolic blood pressure , the primary end point , decreased significantly only in the intervention group by 9.1±15.6 mmHg ( SD ; P<0.0001 ) , and the mean between-group difference was 7.1±2.3 mmHg ( SE ; P<0.005 ) . Furthermore , 51 % of intervention subjects achieved the guideline recommended target of < 130/80 mmHg compared with 31 % of control subjects ( P<0.05 ) . These improvements were obtained without the use of more or different antihypertensive medications or additional clinic visits to physicians . Providing self-care support did not affect anxiety but worsened depression on the Hospital Anxiety and Depression Scale ( baseline , 4.1±3.76 ; exit , 5.2±4.30 ; P=0.014 ) . This study demonstrated that home blood pressure telemonitoring combined with automated self-care support reduced the blood pressure of diabetic patients with uncontrolled systolic hypertension and improved hypertension control . Home blood pressure monitoring alone had no effect on blood pressure . Promoting patient self-care may have negative psychological effects BACKGROUND : Adolescents with chronic disease ( ACD ) must develop independent disease self-management and learn to communicate effectively with their health care team to transition from pediatric to adult-oriented health care systems . Disease-specific interventions have been implemented to aid specific ACD groups through transition . A generic approach might be effective and cost-saving . METHODS : Eighty-one ACD , aged 12 to 20 years , were recruited for a r and omized clinical trial evaluating an 8-month transition intervention ( MD2Me ) . MD2Me recipients received a 2-month intensive Web-based and text-delivered disease management and skill-based intervention followed by a 6-month review period . MD2Me recipients also had access to a texting algorithm for disease assessment and health care team contact . The intervention was applicable to adolescents with diverse chronic illnesses . Controls received mailed material s on general health topics . Disease management , health-related self-efficacy , and health assessment s were performed at baseline and at 2 and 8 months . Frequency of patient-initiated communications was recorded over the study period . Outcomes were analyzed according to assigned treatment group over time . RESULTS : MD2Me recipients demonstrated significant improvements in performance of disease management tasks , health-related self-efficacy , and patient-initiated communications compared with controls . CONCLUSIONS : Outcomes in ACD improved significantly among recipients of a generic , technology-based intervention . Technology can deliver transition interventions to adolescents with diverse chronic illnesses , and a generic approach offers a cost-effective means of positively influencing transition outcomes . Further research is needed to determine whether improved short-term outcomes translate into an improved transition for ACD 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 OBJECTIVE To improve quality and efficiency of care for elderly patients with type 2 diabetes , we introduced elderly-friendly strategies to the clinical decision support system (CDSS)-based ubiquitous healthcare ( u-healthcare ) service , which is an individualized health management system using advanced medical information technology . RESEARCH DESIGN AND METHODS We conducted a 6-month r and omized , controlled clinical trial involving OUTPUT: The majority of these interventions showed improvement on primary endpoints , such as HbA1c ; mHealth technologies that interacted with both patients and providers were more likely to be effective . There was little evidence about persistent use by patients , use by a patient ’s health care provider , or long-term effectiveness . INPUT: Lowering blood pressure reduces cardiovascular risk , yet hypertension is poorly controlled in diabetic patients . In a pilot study we demonstrated that a home blood pressure telemonitoring system , which provided self-care messages on the smartphone of hypertensive diabetic patients immediately after each reading , improved blood pressure control . Messages were based on care paths defined by running averages of transmitted readings . The present study tests the system 's effectiveness in a r and omized , controlled trial in diabetic patients with uncontrolled systolic hypertension . Of 244 subjects screened for eligibility , 110 ( 45 % ) were r and omly allocated to the intervention ( n=55 ) or control ( n=55 ) group , and 105 ( 95.5 % ) completed the 1-year outcome visit . In the intention-to-treat analysis , mean daytime ambulatory systolic blood pressure , the primary end point , decreased significantly only in the intervention group by 9.1±15.6 mmHg ( SD ; P<0.0001 ) , and the mean between-group difference was 7.1±2.3 mmHg ( SE ; P<0.005 ) . Furthermore , 51 % of intervention subjects achieved the guideline recommended target of < 130/80 mmHg compared with 31 % of control subjects ( P<0.05 ) . These improvements were obtained without the use of more or different antihypertensive medications or additional clinic visits to physicians . Providing self-care support did not affect anxiety but worsened depression on the Hospital Anxiety and Depression Scale ( baseline , 4.1±3.76 ; exit , 5.2±4.30 ; P=0.014 ) . This study demonstrated that home blood pressure telemonitoring combined with automated self-care support reduced the blood pressure of diabetic patients with uncontrolled systolic hypertension and improved hypertension control . Home blood pressure monitoring alone had no effect on blood pressure . Promoting patient self-care may have negative psychological effects Background Overweight ( Body Mass Index [ BMI ] ≥ 25 kg/m2 ) and obesity ( BMI ≥ 30 kg/m2 ) are associated with increased cardiovascular risk , posing a considerable burden to public health . The main aim of this study was to investigate lifestyle intervention effects on cardiovascular risk factors in healthy overweight employees . Methods Participants were 276 healthy overweight employees ( 69.2 % male ; mean age 44.0 years [ SD 9.2 ] ; mean BMI 29.7 kg/m2 [ SD 3.1 ] ) . They were r and omized to one of two intervention groups receiving a six month lifestyle intervention with behavior counseling by phone ( phone group ) or e-mail ( Internet group ) , or to a control group receiving usual care . Body weight , height , waist circumference , sum of skinfolds , blood pressure , total cholesterol level and predicted aerobic fitness were measured at baseline , at 6 and at 24 months . Regression analyses included the 141 participants with complete data . Results At 6 months a significant favorable effect on total cholesterol level ( -0.2 mmol/l , 95%CI -0.5 to -0.0 ) was observed in the phone group and a trend for improved aerobic fitness ( 1.9 ml/kg/min , 95%CI -0.2 to 3.9 ) in the Internet group . At two years , favorable trends for body weight ( -2.1 kg , 95%CI -4.4 to 0.2 ) and aerobic fitness ( 2.3 ml/kg/min , 95%CI -0.2 to 4.8 ) were observed in the Internet group . Conclusions The intervention effects were independent of the used communication mode . However short-term results were in favor of the phone group and long-term results in favor of the internet group . Thus , we found limited evidence for our lifestyle intervention to be effective in reducing cardiovascular risk in a group of apparently healthy overweight workers . Trial registration IS RCT Background : The CardioFit internet-based expert system was design ed to promote physical activity in patients with coronary heart disease ( CHD ) who were not participating in cardiac rehabilitation . Design : This r and omized controlled trial compared CardioFit to usual care to assess its effects on physical activity following hospitalization for acute coronary syndromes . Methods : A total of 223 participants were recruited at the University of Ottawa Heart Institute or London Health Sciences Centre and r and omly assigned to either CardioFit ( n = 115 ) or usual care ( n = 108 ) . The CardioFit group received a personally tailored physical-activity plan upon discharge from the hospital and access to a secure website for activity planning and tracking . They completed five online tutorials over a 6-month period and were in email contact with an exercise specialist . Usual care consisted of physical activity guidance from an attending cardiologist . Physical activity was measured by pedometer and self-reported over a 7-day period , 6 and 12 months after r and omization . Results : The CardioFit internet-based physical activity expert system significantly increased objective ly measured ( p = 0.023 ) and self-reported physical activity ( p = 0.047 ) compared to usual care . Emotional ( p = 0.038 ) and physical ( p = 0.031 ) dimensions of heart disease health-related quality of life were also higher with CardioFit compared to usual care . Conclusions : Patients with CHD using an internet-based activity prescription with online coaching were more physically active at follow up than those receiving usual care . Use of the CardioFit program could extend the reach of rehabilitation and secondary -prevention services Introduction : A large proportion of the cardiovascular disease ( CVD ) burden can potentially be prevented by primary prevention programs addressing major causal risk factors . A Web-based health risk assessment ( HRA ) with tailored feedback for individual health promotion is a promising strategy . We evaluated the effect on CVD risk of such a program among OUTPUT:

Overall , these aggregations of data provide evidence that DHIs can reduce CVD outcomes and have a positive impact on risk factors for CVD

MS2_dynamic_1_shot656

***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: The efficacy of self-recording of blood pressure in the management of hypertension was assessed in a r and omized clinical trial involving 140 persons who had been receiving antihypertensive therapy for a year or more , but whose diastolic blood pressure had remained at 95 mm Hg or higher . To control for the increased attention implicit in self-recording , which might affect blood pressure , the patients were assigned at r and om to one of the four groups : self-recording and monthly home visits , self-recording only , monthly home visits only , and neither self-recording nor monthly home visits . This design also permitted assessment of the effect of home visits . During the 6-month experiment no significant differences were apparent between the groups in either compliance or diastolic blood pressure . However , both self-recording and monthly home visits produced a reduction in blood pressure among patients who admitted to difficulty remembering to take their pills ; a reduction was not seen among patients who said they had no such difficulty . This confirmed an earlier observation suggesting that this easily identified group of patients may be the most responsive to intervention programs Background —Hypertension is a leading mortality risk factor yet inadequately controlled in most affected subjects . Effective programs to address this problem are lacking . We hypothesized that an information technology – supported management program could help improve blood pressure ( BP ) control . Methods and Results —This r and omized controlled trial included 223 primary care hypertensive subjects with mean 24-hour BP > 130/80 and daytime BP > 135/85 mm Hg measured with ambulatory monitoring ( ABPM ) . Intervention subjects received a BP monitor and access to an information technology – supported adherence and BP monitoring system providing nurses , pharmacists , and physicians with monthly reports . Control subjects received usual care . The mean ( ±SD ) follow-up was 348 ( ±78 ) and 349 ( ±84 ) days in the intervention and control group , respectively . The primary end point of the change in the mean 24-hour ambulatory BP was consistently greater in intervention subjects for both systolic ( −11.9 versus −7.1 mm Hg ; P<0.001 ) and diastolic BP ( −6.6 versus −4.5 mm Hg ; P=0.007 ) . The proportion of subjects that achieved Canadian Guideline target BP ( 46.0 % versus 28.6 % ) was also greater in the intervention group ( P=0.006 ) . We observed similar BP declines for ABPM and self-recorded home BP suggesting the latter could be an alternative for confirming BP control . The intervention was associated with more physician-driven antihypertensive dose adjustments or changes in agents ( P=0.03 ) , more antihypertensive classes at study end ( P=0.007 ) , and a trend toward improved adherence measured by prescription refills ( P=0.07 ) . Conclusions —This multidisciplinary information technology – supported program that provided feedback to patients and healthcare providers significantly improved blood pressure levels in a primary care setting OBJECTIVE : To evaluate the effectiveness of a community pharmacist-based home blood pressure ( BP ) monitoring program . DESIGN : Trial of a high-intensity ( HI ) versus low-intensity ( LI ) intervention r and omized in 12 community pharmacies . The HI intervention comprised 4 face-to-face visits with a trained pharmacist . Pharmacists provided patient-specific education about hypertension . Following the first and third visits , patients were provided with a home BP monitoring device and instructed to measure their BP at least once daily for the next month . Home BP readings were used by the pharmacists to develop treatment recommendations for the patient ’s physician . Recommendations were discussed with the physician and , if approved , implemented by the pharmacist . In the LI intervention , pharmacists measured patients BP in the pharmacy and referred them to their physician for evaluation . PARTICIPANTS : Patients with uncontrolled BP at baseline . MEASUREMENTS : The main outcomes were the differences in systolic and diastolic BP ( SBP and DBP ) from baseline to follow-up between the HI and LI patients . RESULTS : The study enrolled 125 patients , 64 in the HI and 61 in the LI group . From baseline , SBP declined 13.4 mmHg in the HI group and 9.0 mmHg in the LI group . At the final visit , the difference in SBP/DBP change between the HI and LI group was −4.5/−3.2 mmHg ( P=.12 for SBP and P=.03 for DBP ) . CONCLUSIONS : The HI intervention achieved a lower DBP and this model could be a strategy for patients with hypertension Home blood pressure monitoring ( HBPM ) overcomes many of the limitations of traditional office blood pressure ( BP ) measurement and is both cheaper and easier to perform than ambulatory BP monitoring . Monitors that use the oscillometric method are currently available that are accurate , reliable , easy to use , and relatively inexpensive . An increasing number of patients are using them regularly to check their BP at home , but although this has been endorsed by national and international guidelines , detailed recommendations for their use have been lacking . There is a rapidly growing literature showing that measurements taken by patients at home are often lower than readings taken in the office and closer to the average BP recorded by 24-hour ambulatory monitors , which is the BP that best predicts cardiovascular risk . Because of the larger numbers of readings that can be taken by HBPM than in the office and the elimination of the white-coat effect ( the increase of BP during an office visit ) , home readings are more reproducible than office readings and show better correlations with measures of target organ damage . In addition , prospect i ve studies that have used multiple home readings to express the true BP have found that home BP predicts risk better than office BP ( class IIa ; level of evidence A ) . This call-to-action article makes the following recommendations : 1 ) It is recommended that HBPM should become OUTPUT: For SMBP monitoring plus additional support versus SMBP monitoring alone or with less intense additional support ( 13 comparisons ) , low-strength evidence fails to support a difference . Across all comparisons , evidence for clinical outcomes is insufficient . For other surrogate or intermediate outcomes , low-strength evidence fails to show differences . Self-measured BP monitoring with or without additional support lowers BP compared with usual care , but the BP effect beyond 12 months and long-term benefits remain uncertain . Additional support enhances the BP-lowering effect . INPUT: BACKGROUND Because of poor patient compliance and clinical inertia , hypertension control rates remain poor . Home blood-pressure measurements ( HBPM ) improve compliance of patients and achievement of blood pressure ( BP ) targets . However , few studies have evaluated self-BP management by patients . METHODS In a multicenter , prospect i ve , single-group , open-label pilot study of 111 patients whose hypertension was uncontrolled despite monotherapy , we studied satisfaction with , and feasibility of , HBPM and self-titration of antihypertensive treatment using telemedicine for compliance , efficacy , and safety . After education ( protocol , action plan , and use of the HBPM device ) , patients performed a sequence of HBPM every 2 weeks for 8 weeks . Following a stepwise approach , treatment was increased by the patient at weeks 4 and 6 if average HBPM values exceeded predefined limits . For each titration , the patient informed the Core Center by telemedicine , but BP values were transferred automatically . RESULTS Overall , 80 % of patients were satisfied ( 58 % ) or very satisfied ( 23 % ) with the program ( 95 % confidence interval , 73 % to 87 % ) . Regarding compliance , 78 % of patients fully complied with self-measurement , and just over 71 % titrated their treatment adequately . Physicians were satisfied ( 52 % ) or very satisfied ( 22 % ) with the program . Between the first and final visits ( at week 8) , office systolic/diastolic BP ( mean + /- SD ) decreased significantly from 151 + /- 9/91 + /- 6 to 143 + /- 13/84 + /- 11 mmHg . During the trial , HBPM ( mean + /- SD ) decreased significantly from 149 + /- 13/86 + /- 12 to 138 + /- 16/81 + /- 10 mmHg . No significant safety issues were reported . CONCLUSIONS This innovative approach to the management of hypertension , combining self-measurement and self-titration , is feasible , well-accepted by both patients and physicians , and safe In underserved population s , inadequate surveillance and treatment allows hypertension to persist until actual cardiovascular events occur . Thus , we developed an Internet-based telemedicine system to address the suboptimal control of hypertension and other modifiable risk factors . To minimize cost , the subjects used home monitors for blood pressure ( BP ) measurements and entered these values into the telemedicine system . We hypothesized that patients could accurately measure their BP and transmit these values via a telemedicine system . Inner city and rural subjects ( N = 464 ; 42 % African-American or Hispanic ) with 10 % or greater 10-year risk of cardiovascular disease and with treatable risk factors were r and omized into two groups , control group ( CG ) and telemedicine group ( TG ) . Each subject received a home sphygmomanometer with memory . The TG recorded and entered BP at least weekly . During office visits , the BP meters were downloaded and recorded BP compared to BP values transmitted via telemedicine . The telemedicine ( T ) BP values were similar to the meter recorded ( R ) values ( T : systolic/diastolic BP 133.4 + /- 11.1/77.5 + /- 6.8 mm Hg , and R : systolic/diastolic BP 136.4 + /- 11.9.4/79.7 + /- 7.5 mm Hg ) . The percent error was < 1 % for both systolic ( -0.02 + /- 0.04 % ) and diastolic ( -0.03 + /- 0.04 % ) BP . Lastly , the telemedicine BP values were similar to the office ( O ) BP values for systolic and diastolic BP ( T : systolic/diastolic BP 133.4 + /- 11.1/77.5 + /- 6.8 mm Hg , and O : systolic/diastolic BP 136.3 + /- 20.5/78.1 + /- 10.5 mm Hg ) . In underserved population s , this inexpensive approach of patients using a home monitor and entering these values into a telemedicine system provided accurate BP data The purpose of this study was to determine if ambulatory blood pressure measurement predicted total and cardiovascular mortality over and beyond clinic blood pressure measurement and other cardiovascular risk factors ; 5292 untreated hypertensive patients referred to a single blood pressure clinic who had clinic and ambulatory blood pressure measurement at baseline were followed up in a prospect i ve study of mortality outcome . Multiple Cox regression was used to model time to total and cause-specific mortality for ambulatory blood pressure measurement while adjusting for clinic blood pressure measurement and other risk factors at baseline . There were 646 deaths ( of which 389 were cardiovascular ) during a median follow-up period of 8.4 years . With adjustment for gender , age , risk indices , and clinic blood pressure , higher mean values of ambulatory blood pressure were independent predictors for cardiovascular mortality . The relative hazard ratio for each 10-mm Hg increase in systolic blood pressure was 1.12 ( 1.06 to 1.18 ; P<0.001 ) for daytime and 1.21 ( 1.15 to 1.27 ; P<0.001 ) for nighttime systolic blood pressure . The hazard ratios for each 5-mm Hg increase in diastolic blood pressure were 1.02 ( 0.99 to 1.07 ; P = NS ) for daytime and 1.09 ( 1.04 to 1.13 ; P<0.01 ) for nighttime diastolic press OUTPUT:

TC led to a greater decrease in systolic and diastolic BP than UC . The differences between TC and UC for systolic BP tend to become larger when no treatment modification is applied . TC seems a valuable tool for hypertension management

MS2_dynamic_1_shot657

***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: Introduction The aim of this study was to examine the efficacy of transcutaneous electrical tibial nerve stimulation ( TTNS ) to treat urge urinary incontinence ( UUI ) in older women . Material and methods The study design was a r and omized clinical trial conducted on 51 elderly women ( > 60 years ) with UUI . All were treated with 12 weeks of bladder retraining and pelvic floor muscle exercises , and 25 were r and omly selected to receive TTNS in addition to the st and ard therapy . The cases were evaluated at the baseline and after the end of therapy by 3-day bladder diary , quality of life question naires ( QoL ) , and subjective response . Results Of the patients , 68.0 % in TTNS group reported cure or improvement vs. 34.6 % in the control group ( P = 0.017 ) . TTNS showed significant improvement in most areas of QoL and in UUI parameters when compared with the control group . Conclusion TTNS is efficacious to treat UUI in older women Objective To verify whether the combination of transcutaneous electrical neural stimulation ( TENS ) with oxybutynin in the treatment of women with overactive bladder ( OAB ) would be more effective than isolated treatments . Methods We r and omized 75 women with OAB , in three groups : GI—30 min TENS , twice a week ; GII — daily slow release 10 mg oxybutynin ; and GIII — TENS + oxybutynin ( multimodal ) ; all for 12 weeks . Patients were evaluated with vali date d question naires International Consultation on Incontinence-Short Form ( ICIQ-SF ) , International Consultation on Incontinence-OAB ( ICIQ-OAB ) , Symptom bother , and 3-day Voiding diary at weeks 0 , 12 , and 24 . Results The groups were similar before treatment . After treatment , all groups significantly improved in OAB symptoms and quality of life ( QoL ) . At week 12 , ICIQ-OAB scores were 5.9 , 4.6 , and 2.9 , in groups I , II , and III , respectively , p = 0.01 . At week 24 , GI and GIII kept the scores of the end of treatment ( week 12 ) , while GII increased ICIQ-OAB from 4.6 to 9.2 , p = 0.0001 , ICIQ-SF from 9.8 to 13.3 , p = 0.0006 , and Symptom bother score from 3.4 to 7.0 , p = 0.0001 . Conclusions The multimodal treatment was more effective and TENS alone or in association presented longer lasting results for improvement of clinical symptoms of OAB and Purpose To compare the effectiveness of percutaneous tibial nerve stimulation ( PTNS ) using adhesive skin surface electrodes versus solifenacin succinate ( SS ) in patients with neurogenic detrusor overactivity ( NDO ) secondary to spinal cord injury ( SCI ) . Methods A r and omized controlled study involving 100 patients with NDO secondary to SCI was conducted . Patients were r and omized into two groups . In group A , patients received PTNS using adhesive skin surface electrodes for 4 weeks . In group B , patients underwent SS treatment for 4 weeks . Bladder diaries and incontinence quality of life question naire were review ed before treatment and 2 and 4 weeks after treatment . Results Improvement in all bladder diary parameters was statistically significant within each group 2 and 4 weeks after treatment compared to baseline ( p < 0.05 ) , but did not reach statistical significance between the PTNS and SS groups ( p > 0.05 ) . Compared to SS , PTNS was not associated with any unanticipated adverse events . Conclusions PTNS therapy with adhesive skin surface electrodes is an effective method to treat NDO secondary to SCI . This therapy is not only no difference comparing to SS therapy but also noninvasive and easily managed by patients 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 AIMS This is the first study design ed to describe the natural history of stress urinary incontinence ( SUI ) and overactive bladder ( OAB ) , using vali date d symptom syndrome severity scores developed for the purpose . METHODS Two separate but related studies were involved , ( i ) a clinic sample ( N = 2,052 ) from a r and omised controlled trial ( RCT ) and ( ii ) a prospect i ve cohort study ( N = 12,750 ) with 3-year follow-up . Subjects in both studies were women aged 40 or more living in the community , approached using similar postal question naires . Severity scores using st and ardised urinary symptoms were derived for SUI and OAB from weightings obtained from logistic regression models of symptoms in relation to urodynamic diagnosis . Symptom severity scores were plotted for baseline and 3 years of follow-up to demonstrate the natural history of the main categories of SUI and OAB . RESULTS Overactive bladder and SUI syndrome severity scores showed good criterion validity in relation to relevant clinical measures and good test-retest reliability . OAB severity increased progressively with age including a period of accelerated increase in the 60s . In contrast , SUI severity showed two age-related peaks around age 60 and again at age 80 . SUI severity also showed a more fluctuating pattern from year to year compared to OAB . CONCLUSIONS Contrasting patterns of natural history for OAB and SUI syndromes were identified consistent with differences in the patterns of related co-morbidities . Further studies are needed to confirm these findings Objective : Overactive bladder ( OAB ) is characterized by symptoms of urinary frequency and urgency , with and OUTPUT: Limited evidence is provided that TTNS is an effective , safe intervention for idiopathic OAB in adults and may be of benefit in those with neurogenic OAB . INPUT: Forty patients with the unstable bladder syndrome have been treated in a double-blind crossover trial of baclofen 5 mg qds versus placebo . Baclofen significantly improved diurnal and nocturnal frequency of micturition and the severity of incontinence . Considerable improvement was also obtained with placebo Introduction The aim of this study was to examine the efficacy of transcutaneous electrical tibial nerve stimulation ( TTNS ) to treat urge urinary incontinence ( UUI ) in older women . Material and methods The study design was a r and omized clinical trial conducted on 51 elderly women ( > 60 years ) with UUI . All were treated with 12 weeks of bladder retraining and pelvic floor muscle exercises , and 25 were r and omly selected to receive TTNS in addition to the st and ard therapy . The cases were evaluated at the baseline and after the end of therapy by 3-day bladder diary , quality of life question naires ( QoL ) , and subjective response . Results Of the patients , 68.0 % in TTNS group reported cure or improvement vs. 34.6 % in the control group ( P = 0.017 ) . TTNS showed significant improvement in most areas of QoL and in UUI parameters when compared with the control group . Conclusion TTNS is efficacious to treat UUI in older women AIMS To evaluate the clinical outcomes of two different doses of BTX-A in patients with I-OAB . METHODS This investigator initiated , r and omized trial was design ed to evaluate clinical differences in outcomes for 100 versus 150 U BTX-A in patients with I-OAB . Patients with OAB-Wet and OAB-Dry were r and omized to receive 100 or 150 U BTX-A intra-detrusor injection . For patients with OAB-Wet , the primary outcome of interest was change in daily UUI episodes , and for those with OAB-Dry the primary outcome measure was change in number of daily voids as determined by 3-VD . Statistical comparisons were made both pre- and post-injection and also between different treatment groups to assess the superiority of one dose versus the other . RESULTS Forty-four patients enrolled in the study ; 10 OAB-Dry and 12 OAB-Wet patients received 100 U and another 10 OAB-Dry and 12 OAB-Wet patients received 150 U. No significant differences in outcome measure were noted between those receiving 100 versus 150 U. Patients with OAB-Wet tended to be completely dry more frequently if they received the 150 U dose , but this was not statistically significant . No differences in urodynamics outcomes were noted between the groups . QOL was significantly improved in both groups with no difference between the different doses . CONCLUSIONS In patients with I-OAB , preliminary results indicate that 100 U BTX-A and 150 U BTX-A are equivalent in terms of symptom reduction and QOL improvement PURPOSE We studied the effect of surface neuromodulation on cystometric pressure and volume parameters in women with detrusor instability or sensory urgency . Electrical current was delivered to the suprapubic region and third sacral foramina via a transcutaneous electrical nerve stimulator with sham neuromodulation control . MATERIAL S AND METHODS A consecutive series of women with proved detrusor instability or sensory urgency were r and omized to 3 surface neuromodulation groups . Volume and pressure parameters were the main outcomes of transcutaneous electrical nerve stimulation applied during second cystometric fill . RESULTS Sham transcutaneous electrical nerve stimulation did not alter the outcome measures . However , neuromodulation delivered across the suprapubic and sacral skin effected a reduction in mean maximum height of detrusor contraction . A current which inhibits motor activity was not superior to that which inhibits sensory perception in reducing detrusor pressure . Response in sensory urgency was poor . CONCLUSIONS Results from our sham controlled study suggest that short-term surface neuromodulation via transcutaneous electrical nerve stimulation may have a role in the treatment of detrusor instability . Future studies must examine the clinical effect of long-term surface neuromodulation In a prospect i ve , r and omised , double-blind , placebo-controlled study 40 women with sensory urgency or detrusor instability r and omly received either magnesium hydroxide ( group A ) or placebo ( group B ) . Pre- and post-treatment symptoms , frequency-volume charts and cystometry results were compared . Eleven of 20 patients receiving magnesium ( 55 % ) reported a subjective improvement of their urinary symptoms , compared with five patients taking placebo ( 20 % ) . In both study groups there was no statistically significant difference in pre- and post-treatment urodynamic parameters in those reporting symptomatic improvement . Magnesium was well tolerated by patients in group A , and no side effects were reported . These results suggest that magnesium hydroxide may be beneficial for detrusor instability or sensory urgency in women AIMS To assess the hypothesis that resiniferatoxin ( RTX ) can be useful in women with urgency incontinence and idiopathic detrusor overactivity ( IDO ) , we conducted a prospect i ve , double-blind , r and omized , placebo-controlled , parallel trial comparing the effects of RTX and placebo . MATERIAL S AND METHODS Fifty-eight patients were r and omly assigned to receive a single intravesical dose of 100 ml of either RTX 50 nM or placebo . Safety and efficacy were evaluated over 4 weeks . The primary efficacy endpoints were voiding symptoms evaluated through the voiding diary . Secondary efficacy endpoint was urodynamic response . Quality of life was measured by the Kings ' Health Question naire RESULTS Although improving trends were seen in both groups after the instillations , no statistically significant differences were found between the groups in any of the clinical or urodynamic parameters . RTX instillations OUTPUT:

Pelvic floor exercises are more effective in subjective and objective outcomes with biofeedback or verbal feedback . Weight loss with diet and exercise , caffeine reduction , 25 - 50 % reduction in fluid intake , and pelvic floor muscle exercises with verbal instruction and or biofeedback were all efficacious . Botulinum toxin A improves urge incontinence episodes , urgency , frequency , quality of life , nocturia , and urodynamic testing parameters . Acupuncture improves quality of life and urodynamic testing parameters . Extracorporeal magnetic stimulation improves urodynamic parameters . Mirabegron improves daily incontinence episodes , nocturia , number of daily voids , and urine volume per void , whereas solabegron improves daily incontinence episodes . Short-term posterior tibial nerve stimulation is more efficacious than pelvic floor muscle training exercises and behavioral therapy for improving : urgency , urinary incontinence episodes , daily voids , volume per void , and overall quality of life . Sacral neuromodulation is more efficacious than antimuscarinic treatment for subjective improvement of overactive bladder and quality of life . Transvaginal electrical stimulation demonstrates subjective improvement in overactive bladder symptoms and urodynamic parameters . Multiple therapies , including physical therapy , behavioral therapy , botulinum toxin A , acupuncture , magnetic stimulation , mirabegron , posterior tibial nerve stimulation , sacral neuromodulation , and transvaginal electrical stimulation , are efficacious in the treatment of overactive bladder

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: CONTEXT The effects of continuous combined hormone therapy on gynecologic cancers have not been investigated previously in a r and omized trial setting . OBJECTIVE To determine the possible associations of estrogen plus progestin on gynecologic cancers and related diagnostic procedures . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial of 16 608 postmenopausal women , who had not had a hysterectomy at baseline and who had been recruited from 40 US clinical centers between September 1993 and October 1998 ( average follow-up , 5.6 years ) . INTERVENTION One tablet per day containing 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate ( n = 8506 ) or placebo ( n = 8102 ) . MAIN OUTCOME MEASURE Incident invasive cancer of the ovary and endometrium . RESULTS In 5.6 years of follow-up , there were 32 cases of invasive ovarian cancer , 58 cases of endometrial cancer , 1 case of nonendometrial uterine cancer , 13 cases of cervical cancer , and 7 cases of other gynecologic cancers . The hazard ratio ( HR ) for invasive ovarian cancer in women assigned to estrogen plus progestin compared with placebo was 1.58 ( 95 % confidence interval [ CI ] , 0.77 - 3.24 ) . The HR for endometrial cancer was 0.81 ( 95 % CI , 0.48 - 1.36 ) . No appreciable differences were found in the distributions of tumor histology , stage , or grade for either cancer site . The incidence of other gynecologic cancers was low and did not differ by r and omization assignment . More women taking estrogen plus progestin required endometrial biopsies ( 33 % vs 6 % ; P<.001 ) . CONCLUSIONS This r and omized trial suggests that continuous combined estrogen plus progestin therapy may increase the risk of ovarian cancer while producing endometrial cancer rates similar to placebo . The increased burden of endometrial biopsies required to assess vaginal bleeding further limits the acceptability of this regimen . These data provide additional support for caution in the use of continuous combined hormones CONTEXT The timing of initiation of hormone therapy may influence its effect on cardiovascular disease . OBJECTIVE To explore whether the effects of hormone therapy on risk of cardiovascular disease vary by age or years since menopause began . DESIGN , SETTING , AND PARTICIPANTS Secondary analysis of the Women 's Health Initiative ( WHI ) r and omized controlled trials of hormone therapy in which 10,739 postmenopausal women who had undergone a hysterectomy were r and omized to conjugated equine estrogens ( CEE ) or placebo and 16,608 postmenopausal women who had not had a hysterectomy were r and omized to CEE plus medroxyprogesterone acetate ( CEE + MPA ) or placebo . Women aged 50 to 79 years were recruited to the study from 40 US clinical centers between September 1993 and October 1998 . MAIN OUTCOME MEASURES Statistical test for trend of the effect of hormone therapy on coronary heart disease ( CHD ) and stroke across categories of age and years since menopause in the combined trials . RESULTS In the combined trials , there were 396 cases of CHD and 327 cases of stroke in the hormone therapy group vs 370 [ corrected ] cases of CHD and 239 cases of stroke in the placebo group . For women with less than 10 years since menopause began , the hazard ratio ( HR ) for CHD was 0.76 ( 95 % confidence interval [ CI ] , 0.50 - 1.16 ) ; 10 to 19 years , 1.10 ( 95 % CI , 0.84 - 1.45 ) ; and 20 or more years , 1.28 ( 95 % CI , 1.03 - 1.58 ) ( P for trend = .02 ) . The estimated absolute excess risk for CHD for women within 10 years of menopause was -6 per 10,000 person-years ; for women 10 to 19 years since menopause began , 4 per 10,000 person-years ; and for women 20 or more years from menopause onset , 17 per 10,000 person-years . For the age group of 50 to 59 years , the HR for CHD was 0.93 ( 95 % CI , 0.65 - 1.33 ) and the absolute excess risk was -2 per 10,000 person-years ; 60 to 69 years , 0.98 ( 95 % CI , 0.79 - 1.21 ) and -1 per 10,000 person-years ; and 70 to 79 years , 1.26 ( 95 % CI , 1.00 - 1.59 ) and 19 per 10,000 person-years ( P for trend = .16 ) . Hormone therapy increased the risk of stroke ( HR , 1.32 ; 95 % CI , 1.12 - 1.56 ) . Risk did not vary significantly by age or time since menopause . There was a nonsignificant tendency for the effects of hormone therapy on total mortality to be more favorable in younger than older women ( HR of 0.70 for 50 - 59 years ; 1.05 for 60 - 69 years , and 1 OUTPUT: Hormone replacement therapy may slightly improve overall survival in women who have undergone surgical treatment for EOC , but the certainty of the evidence is low . There may be little or no effect of HRT use on progression-free survival . Future well- design ed RCTs are required as this is an important area to women experiencing menopausal symptoms following surgical treatment for ovarian cancer , especially as doctors are often reluctant to prescribe HRT in this scenario . The evidence in this review is too limited to support or refute that HRT is very harmful in this population INPUT: Objective To assess the effect of combined hormone replacement therapy ( HRT ) on health related quality of life . Design R and omised placebo controlled double blind trial . Setting General practice s in United Kingdom ( 384 ) , Australia ( 94 ) , and New Zeal and ( 24 ) . Participants Postmenopausal women aged 50 - 69 at r and omisation ; 3721 women with a uterus were r and omised to combined oestrogen and progestogen ( n=1862 ) or placebo ( n=1859 ) . Data on health related quality of life at one year were available from 1043 and 1087 women , respectively . Interventions Conjugated equine oestrogen 0.625 mg plus medroxyprogesterone acetate 2.5/5.0 mg or matched placebo orally daily for one year . Main outcome measures Health related quality of life and psychological wellbeing as measured by the women ’s health question naire . Changes in emotional and physical menopausal symptoms as measured by a symptoms question naire and depression by the Centre for Epidemiological Studies depression scale ( CES-D ) . Overall health related quality of life and overall quality of life as measured by the European quality of life instrument ( EuroQol ) and visual analogue scale , respectively . Results After one year small but significant improvements were observed in three of nine components of the women ’s health question naire for those taking combined HRT compared with those taking placebo : vasomotor symptoms ( P<0.001 ) , sexual functioning ( P<0.001 ) , and sleep problems ( P<0.001 ) . Significantly fewer women in the combined HRT group reported hot flushes ( P<0.001 ) , night sweats ( P<0.001 ) , aching joints and muscles ( P=0.001 ) , insomnia ( P<0.001 ) , and vaginal dryness ( P<0.001 ) than in the placebo group , but greater proportions reported breast tenderness ( P<0.001 ) or vaginal discharge ( P<0.001 ) . Hot flushes were experienced in the combined HRT and placebo groups by 30 % and 29 % at trial entry and 9 % and 25 % at one year , respectively . No significant differences in other menopausal symptoms , depression , or overall quality of life were observed at one year . Conclusions Combined HRT started many years after the menopause can improve health related quality of life . Trial registration IS RCT N 63718836 Gene expression analysis of healthy postmenopausal women in a prospect i ve clinical study indicated that genes encoding for epithelial proliferation markers Ki-67 and progesterone receptor B mRNA are differentially expressed in women using hormone therapy ( HT ) with natural versus synthetic estrogens . Two 28-day cycles of daily estradiol ( E2 ) gel 1.5 mg and oral micronized progesterone ( P ) 200 mg/day for the last 14 days of each cycle did not significantly increase breast epithelial proliferation ( Ki-67 MIB-1 positive cells ) at the cell level nor at the mRNA level ( MKI-67 gene ) . A borderline significant beneficial reduction in anti-apoptotic protein bcl-2 , favouring apoptosis , was also seen followed by a slight numeric decrease of its mRNA . By contrast , two 28-day cycles of daily oral conjugated equine estrogens ( CEE ) 0.625 mg and oral medroxyprogesterone acetate ( MPA ) 5 mg for the last 14 days of each cycle significantly increased proliferation at both the cell level and at the mRNA level , and significantly enhanced mammographic breast density , an important risk factor for breast cancer . In addition , CEE/MPA affected around 2,500 genes compared with just 600 affected by E2/P. These results suggest that HT with natural estrogens affects a much smaller number of genes and has less-adverse effects on the normal breast in vivo than conventional , synthetic therapy The authors further analyzed results from the Women 's Health Initiative r and omized trials ( 1993 - 2004 ) of conjugated equine estrogens , with or without medroxyprogesterone acetate , focusing on health benefits versus risks among women who initiated hormone therapy soon after menopause . Data from the Women 's Health Initiative observational study ( 1993 - 2004 ) were included in some analyses for additional precision . Results are presented here for incident coronary heart disease , stroke , venous thromboembolism , breast cancer , colorectal cancer , endometrial cancer , or hip fracture ; death from other causes ; a summary global index ; total cancer ; and total mortality . Hazard ratios for breast cancer and total cancer were comparatively higher ( P < 0.05 ) among women who initiated hormone therapy soon after menopause , for both regimens . Among these women , use of conjugated equine estrogens appeared to produce elevations in venous thromboembolism and stroke and a reduction in hip fracture . Estrogen plus progestin results among women who initiated use soon after menopause were similar for venous thromboembolism , stroke , and hip fracture but also included evidence of longer-term elevations in breast cancer , total cancer , and the global index . These analyses provide little support for the hypothesis of favorable effects among women who initiate postmenopausal estrogen use soon after menopause , either for coronary heart disease or for health benefits versus risk indices considered The efficacy of estrogen replacement therapy ( ERT ) for mood disturbances associated with menopause has yet to be firmly established . The objective of this study was to investigate the efficacy of ERT for improving mood and anxiety of non-depressive postmenopausal women . This double-blind , r and omized , placebo-controlled study involved two treatment groups : one receiving conjugated OUTPUT:

This moderate to large effect size , showing lower ratings of depressed mood in treated patients compared with controls , implicated HRT as a potential treatment of or prophylactic for depression in menopausal women . One can generalize from the studies review ed here only with great caution , but there is little evidence to support the use of estradiol to improve mood in nondepressed patients ( not surprisingly ) and some evidence to support the antidepressant efficacy of estradiol in perimenopausal but not postmenopausal women

MS2_dynamic_1_shot659

***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: Background Type 2 diabetes is rapidly growing as a proportion of the disease burden in Australia as elsewhere . This study addresses the cost effectiveness of an integrated approach to assisting general practitioners ( GPs ) with diabetes management . This approach uses a central ized data base of clinical data of an Australian Division of General Practice ( a network of GPs ) to co-ordinate care according to national guidelines . Methods Long term outcomes for patients in the program were derived using clinical parameters after 5 years of program participation , and the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) Outcomes Model , to project outcomes for 40 years from the time of diagnosis and from 5 years post-diagnosis . Cost information was obtained from a range of sources . While program costs are directly available , and costs of complications can be estimated from the UKPDS model , other costs are estimated by comparing costs in the Division with average costs across the state or the nation . The outcome and cost measures are used derive incremental cost-effectiveness ratios . Results The clinical data show that the program is effective in the short term , with improvement or no statistical difference in most clinical measures over 5 years . Average HbA1c levels increased by less than expected over the 5 year period . While the program is estimated to generate treatment cost savings , overall net costs are positive . However , the program led to projected improvements in expected life years and Quality Adjusted Life Expectancy ( QALE ) , with incremental cost effectiveness ratios of $ A8,106 per life-year saved and $ A9,730 per year of QALE gained . Conclusions The combination of an established model of diabetes progression and generally available data has provided an opportunity to establish robust methods of testing the cost effectiveness of a program for which a formal control group was not available . Based on this methodology , integrated health care delivery provided by a network of GPs improved health outcomes of type 2 diabetics with acceptable cost effectiveness , which suggests that similar outcomes may be obtained elsewhere Objectives : To determine the effects of a nurse led intermediate care programme in patients who have been hospitalised with an acute exacerbation of chronic obstructive pulmonary disease ( AE COPD ) . Design : R and omised controlled trial . Setting : Community and hospital care in west London . Participants : 122 patients with COPD . Intervention : A care package incorporating initial pulmonary rehabilitation and self-management education , provision of a written , personalised COPD action plan , monthly telephone calls and 3 monthly home visits by a specialist nurse for a period of 2 years . Main outcome measure : Hospital readmission rate . Secondary outcomes : Unscheduled primary care consultations and quality of life . Results : There were no differences in hospital admission rates or in exacerbation rates between the two groups . Self-management of exacerbations was significantly different and the intervention group were more likely to be treated with oral steroids alone or oral steroids and antibiotics , and the initiators of treatment for exacerbations were statistically more likely to be the patients themselves . 12 patients in the control group died during the 2 year period , eight as a result of COPD , compared with six patients in the intervention group , of whom one died from COPD . This is a significant difference . When the numbers were adjusted to reflect the numbers still alive at 2 years , in the intervention group patients reported a total of 171 unscheduled contacts with their general practitioner ( GP ) and in the control group , 280 contacts . The number needed to treat was 0.558—ie , for every one COPD patient receiving the intervention and self-management advice , there were 1.79 fewer unscheduled contacts with the GP . Conclusions : An intermediate care package incorporating pulmonary rehabilitation , self-management education and the receipt of a written COPD action plan , together with regular nurse contact , is associated with a reduced need for unscheduled primary care consultations and a reduction in deaths due to COPD but did not affect the hospital readmission rate OBJECTIVE To determine the long-term effects on total healthcare costs of the Improving Mood : Promoting Access to Collaborative Treatment ( IMPACT ) program for late-life depression compared with usual care . STUDY DESIGN R and omized controlled trial with enrollment from July 1999 through August 2001 . The IMPACT trial , conducted in primary care practice s in 8 delivery organizations across the United States , enrolled 1801 depressed primary care patients 60 years or older . Data are from the 2 IMPACT sites for which 4-year cost data were available . Trial enrollment across these 2 health maintenance organizations was 551 patients . METHODS Participants were r and omly assigned to the IMPACT intervention ( n = 279 ) or to usual primary care ( n = 272 ) . Intervention patients had access to a depression care manager who provided education , behavioral activation , support of antidepressant medication management prescribed by their regular primary care provider , and problem-solving treatment in primary care for up to 12 months . Care managers were supervised by a psychiatrist and a primary care provider . The main outcome measures were healthcare costs during 4 years . RESULTS IMPACT participants had lower mean total healthcare costs ( $ 29 422 ; 95 % confidence interval , $ 26 479-$32 365 ) than usual care patients ( $ 32 785 ; 95 % confidence interval , $ 27 648-$37 921 ) during 4 years . Results of a bootstrap analysis suggested an 87 % probability that the IMPACT program was associated with lower healthcare costs than usual care . CONCLUSION Compared with usual primary care , the IMPACT program is associated with a high probability of lower total healthcare costs during a 4-year period OBJECTIVE This study explored the cost-effectiveness of quality -improvement interventions for depression in primary care , relative to usual care , among patients with subthreshold depression or depressive disorder . METHODS A total of 746 primary care patients in managed care organizations with 12-month depressive disorder and 502 with current depressive symptoms but no disorder ( sub OUTPUT: Although it is widely believed that disease management programs reduce healthcare expenditures , the present study shows that evidence for this cl aim is still inconclusive . INPUT: Background National and international policy makers have been increasing their focus on developing strategies to enable poor countries achieve the millennium development goals . This requires information on the costs of different types of health interventions and the re sources needed to scale them up , either singly or in combinations . Cost data also guides decisions about the most appropriate mix of interventions in different setting s , in view of the increasing , but still limited , re sources available to improve health . Many cost and cost-effectiveness studies include only the costs incurred at the point of delivery to beneficiaries , omitting those incurred at other levels of the system such as administration , media , training and overall management . The few studies that have measured them directly suggest that they can sometimes account for a substantial proportion of total costs , so that their omission can result in biased estimates of the re sources needed to run a programme or the relative cost-effectiveness of different choices . However , prices of different inputs used in the production of health interventions can vary substantially within a country . Basing cost estimates on a single price observation runs the risk that the results are based on an outlier observation rather than the typical costs of the input . Methods We first explore the determinants of the observed variation in the prices of selected " non-traded " intermediate inputs to health programmes – printed matter and media advertising , and water and electricity – accounting for variation within and across countries . We then use the estimated relationship to impute average prices for countries where limited data are available with uncertainty intervals . Results Prices vary across countries with GDP per capita and a number of determinants of supply and dem and . Media and printing were inelastic with respect to GDP per capita , with a positive correlation , while the utilities had a surprisingly negative relationship . All equations had relatively good fits with the data . Conclusion While the preferred option is to derive costs from a r and om sample of prices in each setting , this option is often not available to analysts . In this case , we suggest that the approach described in this paper could represent a better option than basing policy recommendations on results that are built on the basis of a single , or a few , price observations Aims /hypothesisWe determined the effects of 6 years of lifestyle intervention in persons with impaired glucose tolerance ( IGT ) on the development of retinopathy , nephropathy and neuropathy over a 20 year period . Methods In 1986 , 577 adults with IGT from 33 clinics in Da Qing , China were r and omly assigned by clinic to a control group or one of three lifestyle intervention groups ( diet , exercise , and diet plus exercise ) . Active intervention was carried out from 1986 to 1992 . In 2006 we conducted a 20 year follow-up study of the original participants to compare the incidence of microvascular complications in the combined intervention group vs the control group . Results Follow-up information was obtained on 542 ( 94 % ) of the 577 original participants . The cumulative incidence of severe retinopathy was 9.2 % in the combined intervention group and 16.2 % in the control group ( p = 0.03 , log-rank test ) . After adjusting for clinic and age , the incidence of severe retinopathy was 47 % lower in the intervention group than the control group ( hazard rate ratio 0.53 , 95 % CI 0.29–0.99 , p = 0.048 ) . No significant differences were found in the incidence of severe nephropathy ( hazard rate ratio 1.05 , 95 % CI 0.16–7.05 , intervention vs control , p = 0.96 ) or in the prevalence of neuropathy ( 8.6 % vs 9.1 % , p = 0.89 ) among the 20 year survivors . Conclusions /interpretationLifestyle intervention for 6 years in IGT was associated with a 47 % reduction in the incidence of severe , vision-threatening retinopathy over a 20 year interval , primarily due to the reduced incidence of diabetes in the intervention group . However , similar benefits were not seen for nephropathy or neuropathy Background Cost-effectiveness studies of lifestyle interventions in people at risk for lifestyle-related diseases , addressing ‘ real-world ’ implementation , are needed . This study examines the cost-effectiveness of a primary care intervention from a societal perspective , compared with provision of health brochures , alongside a r and omized controlled trial . Methods Adults aged 30 - 50 years , at risk of type 2 diabetes ( T2DM ) and /or cardiovascular disease ( CVD ) , were recruited from twelve general practice s in The Netherl and s. They were r and omized to the intervention ( n = 314 ) or control group ( n = 308 ) . The intervention consisted of up to six face-to-face counseling sessions with a trained practice nurse , followed by three-monthly sessions by phone . Costs were collected using three-monthly retrospective question naires . Quality of life was measured with the EuroQol-5D-3L , at baseline , 6 , 12 and 24 months . Nine-year risk of developing T2DM and ten-year risk of CVD mortality were estimated using the ARIC and SCORE formulae , respectively , based on measurements at baseline and 24 months while applying a fixed age of 60 years at both time points . Results Small , statistically non-significant differences in effects were found between the intervention and control group with regard to risk scores and Quality Adjusted Life Years ( QALYs ) gained . The mean difference in costs between the intervention and control group was € -866 ( 95 % confidence interval -2372 ; 370 ) . The probability that the intervention was cost-effective varied from 93 % at € 8000/QALY to 88 % at € 80,000/QALY . Conclusion A primary care lifestyle intervention aim ed at adults at increased risk of T2DM and /or CVD could result in cost savings over a two-year period . However , due to method ological OUTPUT:

T2D prevention by physical activity or diet or both proved cost-effective according to accepted thresholds , except for five inconclusive studies , three on diabetes prevention and two on obesity control . This confirms that lifestyle interventions for the primary prevention of diabetes are cost-effective .

MS2_dynamic_1_shot660

***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: Background Preliminary studies suggest that physical exercise interventions can improve physical fitness , fatigue and quality of life in cancer patients after completion of chemotherapy . Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly . The present paper presents the design of a r and omized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes . Methods After baseline measurements , cancer patients who completed chemotherapy are r and omly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme . Next , patients from both groups are r and omly assigned to immediate training or a waiting list ( i.e. waiting list control group ) . After 12 weeks , patients of the waiting list control group start with the exercise programme they have been allocated to . Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration , but differ in training intensity . Additionally , patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle , tailored to their individual preferences and capabilities . Measurements will be performed at baseline ( t = 0 ) , 12 weeks after r and omization ( t = 1 ) , and 64 weeks after r and omization ( t = 2 ) . The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators , and self-reported fatigue . Secondary outcome measures include health-related quality of life , self-reported physical activity , daily functioning , body composition , mood and sleep disturbances , and return to work . In addition , compliance and satisfaction with the interventions will be evaluated . Potential moderation by pre- and post-illness lifestyle , health and exercise-related attitudes , beliefs and motivation will also be assessed . Finally , the cost-effectiveness of both exercise interventions will be evaluated . Discussion This r and omized controlled trial will be a rigorous test of effects of exercise programmes for cancer patients after chemotherapy , aim ing to contribute to evidence -based practice in cancer rehabilitation programmes . Trial registration This study is registered at the Netherl and s Trial Register ( NTR2153 Background : Substantial numbers of cancer patients use complementary medicine therapies , even without a supportive evidence base . This study aim ed to evaluate in a r and omized controlled trial , the use of Medical Qigong ( MQ ) compared with usual care to improve the quality of life ( QOL ) of cancer patients . Patients and methods : One hundred and sixty-two patients with a range of cancers were recruited . QOL and fatigue were measured by Functional Assessment of Cancer Therapy — General and Functional Assessment of Cancer Therapy — Fatigue , respectively , and mood status by Profile of Mood State . The inflammatory marker serum C-reactive protein ( CRP ) was monitored serially . Results : Regression analysis indicated that the MQ group significantly improved overall QOL ( t144 = −5.761 , P < 0.001 ) , fatigue ( t153 = −5.621 , P < 0.001 ) , mood disturbance ( t122 = 2.346 , P = 0.021 ) and inflammation ( CRP ) ( t99 = 2.042 , P < 0.044 ) compared with usual care after controlling for baseline variables . Conclusions : This study indicates that MQ can improve cancer patients ’ overall QOL and mood status and reduce specific side-effects of treatment . It may also produce physical benefits in the long term through reduced inflammation Introduction Numerous primary studies and several review papers have highlighted delayed physical and psychological recovery for survivors of critical illness , often beyond 6 months after discharge . This r and omized controlled trial with blinded assessment aims to test the effects of an 8-week , home-based , individually tailored physical rehabilitation programme on physical and psychological recovery for survivors of a critical illness after discharge from hospital . Method Participants are survivors of a critical illness discharged from nine intensive care units ( ICUs ) in Australia , who are aged 18 years or older , in an ICU longer than 48 hours , discharged home to self-care or carer ( non-institutional care ) , able to participate in physical rehabilitation , and within the hospitals ' local geographical areas for home visits . The study is based in participants ' home environments . Blinded assessment s at weeks 1 , 8 and 26 after hospital discharge examine physical functioning , exercise capacity , health-related quality of life and psychological well being . The intervention is grade d , individualized endurance and strength training prescribed by a pulmonary rehabilitation physiotherapist over an 8-week period , with three home visits , five follow-up phone calls , and a printed exercise manual supporting the training . Initial focus is on lower limb exercises and walking , with warm-up stretches , and progresses to the addition of core stabilization and upper limb exercises . Results The burden of a critical illness is well documented . This novel study will determine whether a home-based physical rehabilitation programme improves the recovery trajectory for survivors of critical illness . The projected sample size of 200 patients aims to detect a clinical ly important 10 % improvement in physical functioning . The study will also examine whether other important physical and psychological measures are improved . Conclusion This multicentre , r and omized controlled trial will examine outcomes that are meaningful to patients , their family and society , namely functional ability and well being . The study will also target a health problem that is likely to increase as the population ages . If the programme is effective , it will provide a model that can be easily adapted and adopted by existing primary care or community services to improve the recovery of individuals following critical illness BACKGROUND Anemia in patients with solid tumors is a common problem that is associated with impaired exercise capacity , increased fatigue , and lower quality of life ( QoL ) . Erythropoiesis-stimulating agents ( ESAs ) have been shown to improve these outcomes ; however , OUTPUT: HRQoL and its domains were measured using a wide range of measures .The results suggested that exercise compared with control has a positive impact on HRQoL and certain HRQoL domains . No conclusions can be drawn regarding the effects of exercise interventions on HRQoL domains of cognitive function , physical functioning , general health perspective , role function , and spirituality . This systematic review indicates that exercise may have beneficial effects on HRQoL and certain HRQoL domains including cancer-specific concerns ( e.g. breast cancer ) , body image/self-esteem , emotional well-being , sexuality , sleep disturbance , social functioning , anxiety , fatigue , and pain at varying follow-up periods . INPUT: Background In the United Kingdom , patients with locally advanced rectal cancer routinely receive neoadjuvant chemoradiotherapy . However , the effects of this on physical fitness are unclear . This pilot study is aim ed to investigate the effect of neoadjuvant chemoradiotherapy on objective ly measured in vivo muscle mitochondrial function and whole-body physical fitness . Methods We prospect ively studied 12 patients with rectal cancer who completed st and ardized neoadjuvant chemoradiotherapy , recruited from a large tertiary cancer centre , between October 2012 and July 2013 . All patients underwent a cardiopulmonary exercise test and a phosphorus magnetic resonance spectroscopy quadriceps muscle exercise-recovery study before and after neoadjuvant chemoradiotherapy . Data were analysed and reported blind to patient identity and clinical course . Primary variables of interest were the two physical fitness measures ; oxygen uptake at estimated anaerobic threshold and oxygen uptake at Peak exercise ( ml.kg−1.min−1 ) , and the post-exercise phosphocreatine recovery rate constant ( min−1 ) , a measure of muscle mitochondrial capacity in vivo . Results Median age was 67 years ( IQR 64–75 ) . Differences ( 95%CI ) in all three primary variables were significantly negative post-NACRT : Oxygen uptake at estimated anaerobic threshold −2.4 ml.kg−1.min−1 ( −3.8 , −0.9 ) , p = 0.004 ; Oxygen uptake at Peak −4.0 ml.kg−1.min−1 ( −6.8 , −1.1 ) , p = 0.011 ; and post-exercise phosphocreatine recovery rate constant −0.34 min−1 ( −0.51 , −0.17 ) , p<0.001 . Conclusion The significant decrease in both whole-body physical fitness and in vivo muscle mitochondrial function raises the possibility that muscle mitochondrial mechanisms , no doubt multifactorial , may be important in deterioration of physical fitness following neoadjuvant chemoradiotherapy . This may have implication s for targeted interventions to improve physical fitness pre-surgery . Trial Registration Clinical trials.gov registration Abstract Background : Colorectal cancer ( CRC ) is the second most prevalent type of cancer in the world . Surgery is the most common therapeutic intervention , and associated with 20–40 % reduction in physiological and functional capacity . Postoperative complications occur in up to 50 % of patients result ing in higher mortality rates and greater hospital costs . The number and severity of complications is closely related to patients ’ preoperative performance status . The aim of this study was to identify the most important preoperative modifiable risk factors that could be part of a multimodal prehabilitation program . Methods : Prospect ively collected data of a consecutive series of Dutch CRC patients undergoing colorectal surgery were analyzed . Modifiable risk factors were correlated to the Comprehensive Complication Index ( CCI ) and compared within two groups : none or mild complications ( CCI < 20 ) , and severe complications ( CCI ≥20 ) . Multivariate logistic regression analysis was done to explore the combined effect of individual risk factors . Results : In this 139 patient cohort , smoking , malnutrition , alcohol consumption , neoadjuvant therapy , higher age , and male sex , were seen more frequently in the severe complications group ( CCI ≥20 ) . Patients with severe complications had significantly longer hospital stay ( 16 vs. 6 days , p < 0.001 ) . The risk for severe complications was increased in patients with ASA score III [ adjusted odds ratio ( OR ) 4.4 , 95 % CI 1.04–18.6 ] , and hemoglobin level < 7 mmol/l ( adjusted OR 3.3 , 95 % CI 1.3–8.2 ) . Compared to having no risk factors , more than one risk factor increased OR of severe complications ( crude OR 5.2 , 95 % CI 1.8–15 ) . Conclusion : This study revealed that the risk of getting severe complications increases with the number of risk factors present preoperatively . Several preoperative patient-related risk factors are modifiable . Multimodal prehabilitation may improve patients ’ preoperative status and should be tested in a multicenter r and omized controlled trial . With an international consortium ( Copenhagen , Montreal , Paris , Eindhoven ) we initiated a r and omized controlled trial ( NTR5947 ) BACKGROUND Anastomotic leak is a serious complication of gastrointestinal surgery . Abnormal vital signs are often cited in retrospective peer review and medicolegal setting s as evidence of negligence in the failure to make an early diagnosis . We aim ed to profile the postoperative courses of patients who undergo intestinal anastomosis and determine how reliably abnormal vital signs predict anastomotic leaks . STUDY DESIGN Consecutive patients undergoing bowel resection with anastomosis at an academic medical center from July 2009 through July 2011 were identified from a prospect i ve complication data base . The electronic medical record was queried for postoperative vital signs and laboratory studies , which were digitally abstract ed . Abnormal values were defined as temperature > 38 ° C , white blood cell count ≤4,000 or ≥12,000 cells/uL , systolic blood pressure ≤80 mmHg or diastolic blood pressure ≤50 mmHg , pulse ≥100 beats per minute , and respiratory rate ≥20 breaths per minute . Patients who developed an anastomotic leak were compared with those with an uncomplicated postoperative course . RESULTS Of the 452 patients , 141 ( 31.2 % ) suffered a total of 271 complications , including 19 anastomotic leaks . Even in " OUTPUT:

Endurance training alone was found to increase both lower extremity strength and endurance capacity .

MS2_dynamic_1_shot661

***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: Background : Plasma prolactin levels are sensitive to dopamine and serotonin function , and fatigue . Low cortisol , dopamine and /or serotonin may be involved in burnout and detachment . Methods : In this double-blind within-subject study , we treated 9 female burnout subjects and 9 controls with 35 mg cortisol and placebo orally . We measured state affect and plasma prolactin , oxytocin , cortisol and adrenocorticotropic hormone levels , and administered an attachment question naire . Results : The burnout subjects displayed an extreme distribution of basal prolactin levels , displaying higher or lower levels compared to the controls . The low prolactin burnouts had profoundly low attachment scores and tended to have low oxytocin levels . The high prolactin burnout subjects tended to show cortisol-induced decreased prolactin and fatigue , and increased vigor . Conclusion : Results are consistent with the hypothesis that burnout subjects are either characterized by low serotonergic function or by low dopaminergic function , and that the latter group benefits from cortisol replacement . These preliminary results suggest that differentiating between two syndromes may resolve inconsistencies in research on burnout , and be necessary for selecting the right treatment strategy Burnout is presumed to be the result of chronic stress , and chronic stress is known to affect the HPA-axis . To date , studies on HPA-axis functioning in burnout have showed inconsistent results . In the present study , a large sample ( n=74 ) of clinical ly diagnosed burnout individuals , mostly on sick-leave , were included and compared with 35 healthy controls . Salivary cortisol was sample d on 2 days to determine the cortisol awakening response ( CAR ) and the day-curve . In addition , the dexamethasone suppression test ( DST ) was applied to assess the feedback efficacy of the HPA-axis . There were no differences observed in the CAR , day-curve or CAR after DST in the burnout group as compared to a healthy control group . Burnout shows overlap in symptoms with chronic fatigue syndrome ( CFS ) and depression . Therefore , differential changes in HPA-axis functioning that resemble the hypo-functioning of the HPA-axis in CFS , or rather the hyper-functioning of the HPA-axis in depression , might have obscured the findings . However , no effect of fatigue or depressive mood on HPA-axis functioning was found in the burnout group . We concluded that HPA-axis functioning in clinical ly diagnosed burnout participants as tested in the present study , seems to be normal The authors prospect ively tested the hypothesis that obesity predicts burnout and the reverse-causation hypothesis that burnout predicts obesity . Respondents were 724 men and 340 women , apparently healthy employees , who underwent routine periodic health examinations at 2 points of time about 18 months apart . Obesity was assessed by body mass index , waist-hip ratio , and waist circumference . In regression analyses , done separately for men and women , the authors controlled for depressive symptomatology , sport activity , and Time 1 levels of the criterion . The hypothesis that burnout predicts obesity was not supported . The authors found that Time 1 measures of obesity predicted reductions rather than the hypothesized elevations of Time 2 burnout levels . The authors also found that for male respondents with relatively higher levels of Time 1 burnout , the higher their level of Time 1 obesity measure , the lower their level of T2 burnout The author ’ goal was to document baseline pituitaryadrenal hormonal and related metabolic variables in 16 female patients with burnout . Then , following stress management intervention , to compare the changes with an equal number of untreated control subjects . At monthly intervals for 4 mo , 24-h urine sample s were obtained for determination of free cortisol excretion . In addition , fasting blood sample s were analyzed for levels of cortisol , dehydroepi and rosterone sulfate ( DHEAS ) , ACTH , aldosterone , and catecholamines . Other biochemical measurements included growth hormone , prolactin , insulin , glucose , and lipid components . The Maslach Burnout Inventory , General Health Question naire-28 , and Zung depression rating scale were completed on each consecutive visit . The most striking finding was the reduction of urine free-cortisol excretion in the patients compared with controls . Initial urinary free cortisol was significantly lower in the patients ( mean ± SEM=47.2 ± 11.0 vs 79.0 ± 6.8 nmol/L , P=0.02 ) and remained significantly reduced at 4 mo ( mean ± SEM=44.0 ± 6.1 vs 91.1 ± 8.8 nmol/L , p=0.0001 ) . There were no significant changes in the other hormonal and biochemical data . We conclude that there is functional hypocortisolism in burnout , which is not immediately restored on stress management intervention despite clinical and psychological improvement Several studies have investigated the association between burnout and HPA-axis functioning , but the results are far from consistent . This does not preclude the possibility that within a group of burnout patients a recovery of symptoms in a longitudinal course corresponds to ( changes in ) cortisol parameters . The latter possibility is tested in the present study before and after treatment , and at follow-up . HPA-axis functioning and burnout complaints were assessed in burned-out participants at baseline ( n=74 ) , post-treatment ( n=62 ) and at follow-up ( n=53 ) . Multilevel regression analysis was used to test the hypothesis . Burnout complaints were significantly reduced at 8.5 months post-treatment , but there was no further reduction in complaints at follow-up 6.3 months later . Cortisol after awakening , and after dexamethasone intake showed no changes from baseline to post-treatment and follow-up . There was a small decline in cortisol during the day over the OUTPUT: Meta-analyses showed no differences for cortisol awakening response and cortisol awakening response after administration of dexamethasone , cortisol in blood , and blood pressure . INPUT: Background : Plasma prolactin levels are sensitive to dopamine and serotonin function , and fatigue . Low cortisol , dopamine and /or serotonin may be involved in burnout and detachment . Methods : In this double-blind within-subject study , we treated 9 female burnout subjects and 9 controls with 35 mg cortisol and placebo orally . We measured state affect and plasma prolactin , oxytocin , cortisol and adrenocorticotropic hormone levels , and administered an attachment question naire . Results : The burnout subjects displayed an extreme distribution of basal prolactin levels , displaying higher or lower levels compared to the controls . The low prolactin burnouts had profoundly low attachment scores and tended to have low oxytocin levels . The high prolactin burnout subjects tended to show cortisol-induced decreased prolactin and fatigue , and increased vigor . Conclusion : Results are consistent with the hypothesis that burnout subjects are either characterized by low serotonergic function or by low dopaminergic function , and that the latter group benefits from cortisol replacement . These preliminary results suggest that differentiating between two syndromes may resolve inconsistencies in research on burnout , and be necessary for selecting the right treatment strategy Background Occupational burnout is associated with severe negative health effects . While stress management programs proved to have a positive influence on the well-being of patients suffering from burnout , it remains unclear whether aerobic exercise alleviates burnout severity and other parameters related to occupational burnout . Therefore , the main purpose of this study was to pilot-test the potential outcomes of a 12-week exercise training to generate hypotheses for future larger scale studies . Methods The sample consisted of 12 male participants scoring high on the MBI emotional exhaustion and depersonalization subscales . The training program took place in a private fitness center with a 17.5 kcal/kg minimum requirement of weekly energy expenditure . Results The key findings are that increased exercise reduced overall perceived stress as well as symptoms of burnout and depression . The magnitude of the effects was large , revealing changes of substantial practical relevance . Additionally , profiles of mood states improved considerably after single exercise sessions with a marked shift towards an iceberg profile . Conclusion Among burnout patients , the findings provide preliminary evidence that exercise has the potential to reduce stress and prevent the development of a deeper depression . This has important health implication s given that burnout is considered an antecedent of depressive disorders . Trial registration Clinical Trials.gov Identifier : OBJECTIVE To evaluate the efficacy of Qigong in rehabilitation for patients with burnout . DESIGN Prospect i ve , r and omized controlled trial . SUBJECTS Eighty-two patients ( 68 women and 14 men , mean age 44.3 ( st and ard deviation 9.1 ) years ) diagnosed with burnout . METHODS Basic care was offered to both the intervention and the control group . Patients in the intervention group received basic care and , in addition , performed Qigong twice a week for 12 weeks . Psychological variables , health-related quality of life , perceived relaxation and physical measurements were assessed at baseline and after the intervention period . RESULTS No significant difference in treatment efficacy between the groups was found by either intention-to-treat or per- protocol analyses . Both groups improved significantly over time , with reduced levels of burnout , fatigue , anxiety and depression , and increased dynamic balance and physical capacity . CONCLUSION In this study , a Qigong intervention twice a week for 12 weeks had no additional effect beyond basic care for patients with burnout Conundrums in musculoskeletal research are common . Halliday and colleagues1 demonstrated similar outcomes for patients with chronic low back pain who received two seemingly different interventions : ( 1 ) a McKenzie approach and ( 2 ) motor control exercises . Chmielewski and associates2 reported similar knee function and psychosocial status scores in those who received either low intensity or high intensity plyometric exercise programmes . Finally , van Beijsterveildt et al found no differences in the prevention of injuries among amateur footballers when usual care was compared against an exercise strategy that consisted of core stability , eccentric training of thigh muscles , proprioceptive training , dynamic stabilisation and plyometrics exercises.3 These findings beg the question : Why do we see similar outcomes in r and omised trials , which compare treatment strategies that are ostensibly different ? Our goal is to provide explanations beyond the obvious answers —such as treatments that have similarly effective or ineffective causal mechanisms or failing to account for patient heterogeneity in trial design and consequent insufficient statistical power to detect differences . In this editorial , we present the reader with four additional yet plausible explanations for why trials report similar outcomes . # # # Reason 1 : the type of outcome assessment may bias findings Our first explanation is the most obvious one . Outcome measures that capture direct measurements of strength and /or flexibility , or other indices of physical performance , may yield findings that are notably different from outcome measures that capture self-reports of pain , function , overall health status or quality of life . Therefore , null findings ( no difference among groups ) may be related to the fact that different sets of outcome measures are being used to compare the groups being studied . Examples of variant findings among outcomes are present in the literature . One month after total hip arthroplasty , Dayton and colleagues4 report that performance-based function ( eg , timed up and go , 6 min walk test and stair climbing test ) declined compared with baseline , whereas self-reported Background Patients with stress-related exhaustion suffer from cognitive impairments , which often remain after psychological treatment or work place interventions . It is important to find effective treatments that can address this problem . Therefore , the aim of this study was to investigate the effects on cognitive performance and psychological variables of a 12-week aerobic training program performed at a moderate-vigorous intensity for patients with exhaustion disorder who participated in a multimodal rehabilitation program . Methods In this open-label , parallel , r and omized and controlled trial , 88 patients diagnosed with exhaustion disorder participated in a 24-week multimodal rehabilitation program . After 12 weeks OUTPUT:

It can be concluded that physical activity may be effective in reducing burn-out risk . The few observational studies linking sedentary and dietary behavior with burn-out risk suggest that being more sedentary and eating less healthy are each associated with higher burn-out risk .

MS2_dynamic_1_shot662

***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: A total of 105 “ high‐risk ” infants born in 1988 were studied prospect ively from birth to 18 months of age . The infants were recommended breastfeeding and /or hypoallergenic formula ( Nutramigen or Profylac ) combined with avoidance of solid foods during the first 6 months of life . All mothers had unrestricted diet . Avoidance of daily exposure to tobacco smoke , furred pets and dust‐collecting material s in the bedroom were advised . This prevention group was compared with a control group consisting of 54 identically defined “ high‐risk ” infants born in 1985 in the same area . All infants had either severe single atopic predisposition combined with cord blood IgE ≥ 0.5 KU/1 or biparental atopic predisposition . The control group had unrestricted diet and was not advised about environmental factors . Apart from the prevention programme and year of birth the prevention group and the control group were comparable . The parents were highly motivated and compliance was good . The rate of participation was 97 % , and 85 % followed the dietary measures strictly . The cumulative prevalence of atopic symptoms was significantly lower at 18 months in the prevention group ( 32 % ) , as compared with the control group ( 74 % ) ( p<0.01 ) , due to reduced prevalence of recurrent wheezing ( 13 % , versus 37 % ; p<0.01 ) , atopic dermatitis ( 14 % versus 31 % ; p<0.01 ) , vomiting/diarrhoea ( 5 % versus 20 % ; p<0.01 ) and infantile colic ( 9 % versus 24 % ; p<0.01 ) . The cumulative prevalence of food allergy was significantly lower in the prevention group ( 6 % versus 17 % ; p<0.05 ) . In both high‐risk groups daily exposure to tobacco smoke increased the risk of recurrent wheezing significantly ( p<0.01 ) . The main difference between the prevention group and the control group was the diet . Thus , feeding with breastmilk and /or hypoallergenic formula combined with avoidance of solid foods until the age of 6 months appeared to reduce the cumulative prevalence of atopic symptoms during the first 18 months of life We have previously reported a protective effect of maternal omega-3 long-chain polyunsaturated fatty acids ( ω-3 LCPUFA ) supplementation in pregnancy and lactation on IgE-associated eczema and food allergy in the infant during the first year of life . Here we investigate whether the effects of the LCPUFA supplementation on IgE-associated diseases last up to 2 yr of age and assess the relationship between plasma proportions of ω-3 PUFAs and the frequency and severity of infant allergic disease . 145 pregnant women , at risk of having an allergic infant , were r and omized to daily supplementation with 1.6 g eicosapentaenoic acid ( EPA ) and 1.1 g docosahexaenoic acid ( DHA ) or placebo starting in the 25th gestational week and continuing through 3.5 months of breastfeeding . Clinical examinations , skin prick tests and analysis of maternal and infant plasma phospholipid fatty acids and infant specific IgE were performed . No difference in the prevalence of allergic symptoms was found between the intervention groups . The cumulative incidence of IgE-associated disease was lower in the ω-3-supplemented group ( 6/54 , 13 % ) compared with the placebo group ( 19/62 , 30 % , p=0.01 ) . Higher maternal and infant proportions of DHA and EPA were associated with lower prevalence of IgE associated disease ( p=0.01 - 0.05 ) in a dose-dependent manner . Higher maternal and infant proportions of DHA and EPA were found if the infants presented none , when compared with multiple allergic symptoms , ( p<0.05 ) regardless of sensitization . In summary , the ω-3 supplementation offered no obvious preventive effect on the prevalence of clinical symptoms of allergic disease , but the decrease in cumulative incidence of IgE-associated disease seen during the first year still remained until 2 yr of age . Furthermore , high proportions of DHA and EPA in maternal and infant plasma phospholipids were associated with less IgE-associated disease and a reduced severity of the allergic phenotype BACKGROUND Partially hydrolyzed whey formula ( pHWF ) has been recommended for infants with a family history of allergic disease at the cessation of exclusive breast-feeding to promote oral tolerance and prevent allergic diseases . OBJECTIVE To determine whether feeding infants pHWF reduces their risk of allergic disease . METHODS A single-blind ( participant ) r and omized controlled trial was conducted to compare allergic outcomes between infants fed a conventional cow 's milk formula , a pHWF , or a soy formula . Before birth , 620 infants with a family history of allergic disease were recruited and r and omized to receive the allocated formula at cessation of breast-feeding . Skin prick tests to 6 common allergens ( milk , egg , peanut , dust mite , rye grass , and cat d and er ) were performed at 6 , 12 , and 24 months . The primary outcome was development of allergic manifestations ( eczema and food reactions ) measured 18 times in the first 2 years of life . RESULTS Follow-up was complete for 93 % ( 575/620 ) at 2 years and 80 % ( 495/620 ) at 6 or 7 years of age . There was no evidence that infants allocated to the pHWF ( odds ratio , 1.21 ; 95 % CI , 0.81 - 1.80 ) or the soy OUTPUT: There was no good evidence to recommend that pregnant or breastfeeding women should change their diet or take supplements to prevent allergies in infants at high or normal risk . There were mixed findings about the preventive benefits of breastfeeding for infants at high or normal risk , but there was evidence to recommend avoiding cow 's milk and substituting with extensively or partially hydrolyzed whey or casein formulas for infants at high risk for the first 4 months . Soy milk and delaying the introduction of solid foods beyond 4 months did not have preventive benefits in those at high or normal risk . There was very little evidence about strategies for preventing food allergy in older children or adults . INPUT: OBJECTIVE --To study the effect of early diet on the development of allergic reactions in infants born preterm . DESIGN --Two r and omised prospect i ve trails . In trail A infants were r and omly allocated banked donor milk or preterm formula as their sole diet or ( separately r and omised ) as a supplement to their mother 's expressed breast milk . In trial B infants were allocated term or preterm formula . A blind follow up examination was done 18 months after the expected date of birth . SETTING --Neonatal units of hospitals in Cambridge , Ipswich , King 's Lynn , Norwich , and Sheffield . Outpatient follow up . PARTICIPANTS --777 Infants with a birth weight less than 1850 g born during 1982 to 1984 . MAIN OUTCOME MEASURES --Development of eczema , allergic reactions to food or drugs , and asthma or wheezing by nine and 18 months after term . Whenever possible the observations were confirmed by rechallenge or clinical examination . RESULTS --At 18 months after term there was no difference in the incidence of allergic reactions between dietary groups in either trial . In the subgroup of infants with a family history of atopy , however , those in trial A who received preterm formula rather than human milk had a significantly greater risk of developing one or more allergic reactions ( notably eczema ) by 18 months ( odds ratio 3.6 ; 95 % confidence interval 1.4 to 9.1 ) . CONCLUSIONS --Feeding neonates on formulas based on cows ' milk , including those with a high protein content , did not increase the overall risk of allergy . Nevertheless , in the subgroup with a family history of atopy early exposure to cows ' milk increased the risk of a wide range of allergic reactions , especially eczema BACKGROUND The gastrointestinal microflora is an important constituent of the gut mucosal defense barrier . We have previously shown that a human intestinal floral strain , Lactobacillus GG ( ATCC 53103 ) , promotes local antigen-specific immune responses ( particularly in the IgA class ) , prevents permeability defects , and confers controlled antigen absorption . OBJECTIVE The aim of this study was to evaluate the clinical and immunologic effects of cow 's milk elimination without ( n = 14 ) and with ( n = 13 ) the addition of Lactobacillus GG ( 5 x 10(8 ) colony-forming units/gm formula ) in an extensively hydrolyzed whey formula in infants with atopic eczema and cow 's milk allergy . The second part of the study involved 10 breast-fed infants who had atopic eczema and cow 's milk allergy . In this group Lactobacillus GG was given to nursing mothers . METHODS The severity of atopic eczema was assessed by clinical scoring . The concentrations of fecal alpha 1- antitrypsin , tumor necrosis factor-alpha , and eosinophil cationic protein were determined as markers of intestinal inflammation before and after dietary intervention . RESULTS The clinical score of atopic dermatitis improved significantly during the 1-month study period in infants treated with the extensively hydrolyzed whey formula fortified with Lactobacillus GG . The concentration of alpha 1-antitrypsin decreased significantly in this group ( p = 0.03 ) but not in the group receiving the whey formula without Lactobacillus GG ( p = 0.68 ) . In parallel , the median ( lower quartile to upper quartile ) concentration of fecal tumor necrosis factor-alpha decreased significantly in this group , from 709 pg/gm ( 91 to 1131 pg/gm ) to 34 pg/gm ( 19 to 103 pg/gm ) ( p = 0.003 ) , but not in those receiving the extensively hydrolyzed whey formula only ( p = 0.38 ) . The concentration of fecal eosinophil cationic protein remained unaltered during therapy . CONCLUSION These results suggest that probiotic bacteria may promote endogenous barrier mechanisms in patients with atopic dermatitis and food allergy , and by alleviating intestinal inflammation , may act as a useful tool in the treatment of food allergy A total of 105 “ high‐risk ” infants born in 1988 were studied prospect ively from birth to 18 months of age . The infants were recommended breastfeeding and /or hypoallergenic formula ( Nutramigen or Profylac ) combined with avoidance of solid foods during the first 6 months of life . All mothers had unrestricted diet . Avoidance of daily exposure to tobacco smoke , furred pets and dust‐collecting material s in the bedroom were advised . This prevention group was compared with a control group consisting of 54 identically defined “ high‐risk ” infants born in 1985 in the same area . All infants had either severe single atopic predisposition combined with cord blood IgE ≥ 0.5 KU/1 or biparental atopic predisposition . The control group had unrestricted diet and was not advised about environmental factors . Apart from the prevention programme and year of birth the prevention group and the control group were comparable . The parents were highly motivated and compliance was good . The rate of participation was 97 % , and 85 % followed the dietary measures strictly . The cumulative prevalence of atopic symptoms was significantly lower at 18 months in the prevention group ( 32 % ) , as compared with the control group ( 74 % ) ( p<0.01 ) , due to reduced prevalence of recurrent wheezing ( 13 % , versus 37 % ; p<0.01 ) , atopic dermatitis ( 14 % versus 31 % ; p<0.01 ) , vom OUTPUT:

Feeding soya-based formula as opposed to st and ard cow 's milk formula did not reduce the risk of having asthma or wheeze at any age . In infants with at least one first degree relative with atopy , hydrolysed formula for a minimum of 4 months combined with dietary restrictions and environment measures may reduce the risk of developing asthma or wheeze in the first year of life . There is insufficient evidence to suggest that soya-based milk formula has any benefit

MS2_dynamic_1_shot663

***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: OBJECTIVES This study was design ed to define more completely the clinical spectrum and consequences of stress cardiomyopathy ( SC ) beyond the acute event . BACKGROUND Stress cardiomyopathy is a recently recognized condition characterized by transient cardiac dysfunction with ventricular ballooning . METHODS Clinical profile and outcome were prospect ively assessed in 136 consecutive SC patients . RESULTS Patients were predominantly women ( n = 130 ; 96 % ) , but 6 were men ( 4 % ) . Ages were 32 to 94 years ( mean age 68 + /- 13 years ) ; 13 ( 10 % ) were < or=50 years of age . In 121 patients ( 89 % ) , SC was precipitated by intensely stressful emotional ( n = 64 ) or physical ( n = 57 ) events , including 22 associated with sympathomimetic drugs or medical/surgical procedures ; 15 other patients ( 11 % ) had no evident stress trigger . Twenty-five patients ( 18 % ) were taking beta-blockers at the time of SC events . Three diverse ventricular contraction patterns were defined by cardiovascular magnetic resonance ( CMR ) imaging , usually with rapid return to normal systolic function , although delayed > 2 months in 5 % . Right and /or left ventricular thrombi were identified in 5 patients ( predominantly by CMR imaging ) , including 2 with embolic events . Three patients ( 2 % ) died in-hospital and 116 ( 85 % ) have survived , including 5 % with nonfatal recurrent SC events . All-cause mortality during follow-up exceeded a matched general population ( p = 0.016 ) with most deaths occurring in the first year . CONCLUSIONS In this large SC cohort , the clinical spectrum was heterogeneous with about one-third either male , < or=50 years of age , without a stress trigger , or with in-hospital death , nonfatal recurrence , embolic stroke , or delayed normalization of ejection fraction . Beta-blocking drugs were not absolutely protective and SC was a marker for increased noncardiac mortality . These data support exp and ed management and surveillance strategies including CMR imaging and consideration for anticoagulation OBJECTIVE To compare left ventricular ( LV ) systolic and diastolic function in patients with apical ballooning syndrome ( ABS ) and those with acute myocardial infa rct ion ( AMI ) using 2-dimensional Doppler echocardiography and strain rate imaging ( SRI ) . PATIENTS AND METHODS We prospect ively enrolled patients with newly diagnosed AMI and ABS who had akinetic apical walls . Both 2-dimensional Doppler echocardiography and SRI were performed on hospital day 1 or within 24 hours of primary percutaneous coronary intervention . RESULTS Twenty-four patients with AMI and 13 patients with ABS ( mean + /- SD age , 63+/-15 vs 73+/-12 years ; P=.03 ) were prospect ively enrolled in the study from October 3 , 2005 through July 12 , 2006 . The mean + /- SD LV end-diastolic volume was larger ( 58.1+/-9.1 vs 45.2+/-10.6 mL/m(2 ) ; P<.001 ) and the mean + /- SD LV ejection fraction was lower ( 35%+/-6 % vs 43%+/-9 % ; P=.006 ) in patients with ABS compared with patients with AMI . The early diastolic mitral annular velocity was similar ( 0.06+/-0.02 vs 0.06+/-0.02 m/s ; P=.85 ) in both groups , but the ratio of early diastolic mitral valve inflow velocity to early diastolic mitral annulus velocity was higher in patients with AMI than in patients with ABS ( 16.3+/-6.9 vs 12.2+/-3.2 ; P=.05 ) . The systolic strain rate was decreased at the apex in both groups ( P=.98 ) . Both the early diastolic strain rate of the apex ( 0.64+/-0.24 vs 0.48+/-0.30 s(-1 ) ; P=.04 ) and the postsystolic shortening index of the apex ( 61%+/-15 % vs 45%+/-23 % ; P=.006 ) were higher in the patients with ABS than in those with AMI . However , early diastolic SR was higher in the akinetic apical walls of patients with AMI with recovery than those with no recovery ( 0.64+/-0.35 vs 0.43+/-0.25 s(-1 ) ; P=.04 ) and was similar between akinetic apical walls of patients with AMI with recovery and the akinetic apical walls of ABS . CONCLUSION Compared with patients with AMI , those with ABS showed the functional paradox of worse initial LV systolic function with larger LV size but better LV diastolic function . The early systolic strain rate and postsystolic shortening were greater in patients with ABS than in those with AMI ; hence , these measurements can be helpful in distinguishing ABS from AMI and in detecting myocardial viability Objectives : To determine the incidence , clinical characteristics , and the coronary angiographic features of patients with apical ballooning syndrome ( ABS ) among those recruited into a large , prospect i ve , international , multicenter trial . Background : ABS is an important entity in the differential diagnosis of ST‐elevation myocardial infa rct ion ( STEMI ) . Current data regarding ABS are limited to single center registries . Methods : Patients with ABS were identified , based on the Mayo Clinic diagnostic criteria , from those enrolled into the HORIZONS‐AMI trial . OUTPUT: In conclusion , TTS has significantly different clinical characteristics than ACS . However , the in-hospital and long-term overall mortality rates are not trivial for TTS patients , and some presenting features ( underlying diseases , male sex , advanced age , low LVEF and shock ) were significantly associated with all-cause mortality INPUT: BACKGROUND Takotsubo syndrome is a stress cardiomyopathy , characterized by reversible left ventricle ( LV ) apical ballooning in the absence of significant angiographic coronary artery stenosis . The frequent association with emotional stress suggests in this disease an autonomic nervous system involvement . We could think that a therapeutic treatment targeting heart sympathetic dysfunction could be of crucial importance . METHODS From January 2010 to June 2012 , 886 patients were consecutively evaluated at Cardarelli Hospital , Naples , Italy . Among these , 48 patients met takotsubo cardiomyopathy ( TCM ) criteria . Each patient was assessed with history and physical examination , 12-lead electrocardiogram , serum troponin , coronary arteriography , and left ventricular angiogram , perfusion myocardial scintigraphy with technetium 99 m , with echocardiography and 123I-metaiodobenzylguanidine ( MIBG ) myocardial scintigraphy . At discharge , the surviving patients were r and omly assigned to α-lipoic acid ( ALA ) treatment ( 600 mg once daily ) or placebo . Following discharge , after the initial TCM event , patients returned to our outpatient clinic at Internal Medicine of the Second University Naples for the follow-up evaluation quarterly until 12 months . Routine analysis , myocardial damage serum markers , oxidative stress serum markers , pro-inflammatory cytokines , and sympathetic tone activity were evaluated in all patients . RESULTS ALA administration improved MIBG defect size at 12 months compared to placebo . CONCLUSIONS Adrenergic cardiac innervation dysfunction in TCM patients persists after previous experience of transient stress-induced cardiac dysfunction . ALA treatment improves the adrenergic cardiac innervation . This study evaluates whether sympatho-vagal alterations are TCM event-related CONTEXT Inflammation is hypothesized to play a role in development of type 2 diabetes mellitus ( DM ) ; however , clinical data addressing this issue are limited . OBJECTIVE To determine whether elevated levels of the inflammatory markers interleukin 6 ( IL-6 ) and C-reactive protein ( CRP ) are associated with development of type 2 DM in healthy middle-aged women . DESIGN Prospect i ve , nested case-control study . SETTING The Women 's Health Study , an ongoing US primary prevention , r and omized clinical trial initiated in 1992 . PARTICIPANTS From a nationwide cohort of 27 628 women free of diagnosed DM , cardiovascular disease , and cancer at baseline , 188 women who developed diagnosed DM over a 4-year follow-up period were defined as cases and matched by age and fasting status with 362 disease-free controls . MAIN OUTCOME MEASURES Incidence of confirmed clinical ly diagnosed type 2 DM by baseline levels of IL-6 and CRP . RESULTS Baseline levels of IL-6 ( P<.001 ) and CRP ( P<.001 ) were significantly higher among cases than among controls . The relative risks of future DM for women in the highest vs lowest quartile of these inflammatory markers were 7.5 for IL-6 ( 95 % confidence interval [ CI ] , 3.7 - 15.4 ) and 15.7 for CRP ( 95 % CI , 6.5 - 37.9 ) . Positive associations persisted after adjustment for body mass index , family history of diabetes , smoking , exercise , use of alcohol , and hormone replacement therapy ; multivariate relative risks for the highest vs lowest quartiles were 2.3 for IL-6 ( 95 % CI , 0.9 - 5.6 ; P for trend = .07 ) and 4.2 for CRP ( 95 % CI , 1.5 - 12.0 ; P for trend = .001 ) . Similar results were observed in analyses limited to women with a baseline hemoglobin A(1c ) of 6.0 % or less and after adjustment for fasting insulin level . CONCLUSIONS Elevated levels of CRP and IL-6 predict the development of type 2 DM . These data support a possible role for inflammation in diabetogenesis Introduction Anemia associated with chronic kidney disease is a serious complication necessitating expenditure of huge medical efforts and re sources . This study investigates the role of alpha-lipoic acid ( ALA ) in end stage renal disease patients undergoing hemodialysis . By the virtue of its antioxidative effects , ALA is expected to act as an erythropoietin ( EPO ) adjuvant , and also has extended beneficial effects on endothelial dysfunction . Methods Forty-four patients undergoing hemodialysis and receiving EPO were r and omized into two groups : the first group received ALA 600 mg once daily for 3 months ; while the other group represented the control group . Parameters measured at baseline and at end of study were hemoglobin , EPO doses , EPO resistance index ( ERI ) , iron store indices , malondialdehyde , oxidized low-density lipoprotein ( ox-LDL ) , interleukin-6 ( IL-6 ) , tumor necrosis factor-α ( TNF-α ) , and asymmetric dimethylarginine ( ADMA ) , as well as routine laboratory follow-up . Results EPO doses and ERI were significantly decreased in the treatment group , while they did not change in the control group . Hemoglobin , iron store indices , malondialdehyde , oxidized ox-LDL , IL-6 , TNF-α , and ADMA were similar in both treatment and control groups at baseline , and did not change by the end of study period . Likewise , routine laboratory measures were not affected by the treatment . Conclusion ALA could be used in hemodialysis patients to reduce requirements for EPO . However , larger and longer term studies are required to OUTPUT:

Conclusion In summary , the current meta- analysis demonstrated the promising impact of ALA administration on decreasing inflammatory markers such as CRP , IL-6 and TNF-α among patients with MetS and related disorders

MS2_dynamic_1_shot664

***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: OBJECTIVE Antipsychotics , such as aripiprazole and risperidone , are often used to treat individuals with schizophrenia . The efficacy as well as safety of aripiprazole in Western population s has been described . The objective of this study is to investigate the efficacy , safety , and tolerability of aripiprazole and risperidone in Chinese Han schizophrenia subjects in mainl and China . METHOD The 6-week , double-blind , r and omized , parallel study was conducted in 5 medical centers in mainl and China from November 2007 to March 2011 . A total of 279 subjects with a primary DSM-IV diagnosis of schizophrenia were r and omly assigned ( with a r and omization ratio of 1:1 ) to aripiprazole ( n=139 ) or risperidone ( n=140 ) . Efficacy measurements included the Positive and Negative Syndrome Scale ( PANSS ) total , positive , negative and general psychopathology subscale scores , and Clinical Global Impressions-Severity of Illness ( CGI-S ) , and Improvement scale scores . Extrapyramidal symptoms ( EPS ) , weight gain , serum prolactin level , QTc interval , and self-reported adverse events were also assessed as measures of safety and tolerability . RESULTS Both the aripiprazole and risperidone groups showed statistically significant improvement of PANSS total , positive , negative , general psychopathology subscale scores , and CGI-S scores from baseline to the endpoint ( all p<0.01 ) . Significant improvement was noted in the first week for both treatment groups . There were no significant differences in efficacy measurements between the two treatment groups . Mean change of PANSS total scores from baseline to the endpoint was -26.8±18.1 for aripiprazole and -30.0±17.7 for risperidone , ( p=0.1475 ) . The responder rate was 71 % ( n=99 ) and 76 % ( n=107 ) for aripiprazole and risperidone , respectively , ( p=0.323 ) . The incidences of EPS were similar in the aripiprazole ( 25 % , n=35 ) and risperidone groups ( 24 % , n=34 ) , respectively ( p=0.757 ) . No clinical ly meaningful effects on QTc interval , QRS duration , or PR interval were observed in either treatment groups . However , the incidence of clinical ly significant weight gain ( p=0.0118 ) and hyperprolactinemia ( p<0.001 ) in the aripiprazole group was significantly lower than in the risperidone group . CONCLUSION The study demonstrated that aripiprazole , as well as risperidone , had rapid and persistent efficacy for psychotic symptoms from the first week of therapy . There may be poor efficacy for aripiprazole compared with risperidone for overall improvement , but there were no significant differences in this study . Aripiprazole showed good tolerability with less weight gain and hyperprolactinemia compared with risperidone . The overall efficacy and safety of aripiprazole in Chinese Han schizophrenia subjects were similar to that reported in Western population OBJECTIVE The objective of this multicenter , international study was to evaluate safety and tolerability of paliperidone extended-release ( ER ) tablets in elderly ( age > or = 65 years ) patients with schizophrenia . The authors conducted a 6-week , double-blind , r and omized , placebo-controlled , optional 24-week open-label extension study . Interventions consisted of flexible , once-daily doses of paliperidone ER ( 3 - 12 mg/day ; 6-mg starting dose , adjusted in 3-mg dose increments ) or placebo ( 2:1 ) during double-blind treatment and paliperidone ER only during open-label treatment . Measurements included adverse events , laboratory tests , physical examinations , 12-lead electrocardiograms , movement disorder rating scales , Positive and Negative Syndrome Scale , and Clinical Global Impression scale . The study was not powered to show statistical differences . RESULTS Patients ( N = 114 ) were predominantly female ( 73 % ) ; mean age was 70 years ( double-blind phase ) . Concomitant disease presence was consistent with that of an older population . During the double-blind phase , discontinuation rates result ing from adverse events were similar between groups ( paliperidone ER : 7 % , placebo : 8 % ) as were incidences of treatment-emergent adverse events ( paliperidone ER : 67 % , placebo : 71 % ) . Serious adverse events occurred in 3 % of the paliperidone ER- and 8 % of the placebo-treated patients . Elevated prolactin levels occurred in approximately one half of patients . No prolactin- or glucose treatment-related adverse events or noteworthy mean changes in body weight ( 0 kg [ st and ard deviation : 2.1 ] and 0 kg [ st and ard deviation : 2.3 ] for paliperidone ER and placebo , respectively ) were observed . Safety and tolerability results in the extension were consistent with the shorter-term results . Efficacy measures did not show consistent statistical improvement between treatment groups . CONCLUSION Paliperidone ER ( 3 - 12 mg/day ) treatment over a 30-week period was generally well-tolerated and may improve symptom severity in elderly patients with schizophrenia OBJECTIVE To evaluate aripiprazole once-monthly ( AOM ) , a long-acting injectable suspension of aripiprazole , as acute treatment in patients with schizophrenia ( DSM-IV-TR ) . METHOD Adults experiencing an acute psychotic episode were r and omized to 12 weeks of double-blind treatment with AOM 400 mg or OUTPUT: Interpretation Marked differences exist between antipsychotics in terms of metabolic side-effects , with olanzapine and clozapine exhibiting the worst profiles and aripiprazole , brexpiprazole , cariprazine , lurasidone , and ziprasidone the most benign profiles . Increased baseline weight , male sex , and non-white ethnicity are predictors of susceptibility to antipsychotic-induced metabolic change , and improvements in psychopathology are associated with metabolic disturbance . INPUT: OBJECTIVE The purpose of this study was to evaluate the impact of prior antipsychotic exposure ( PAE ) on safety and tolerability outcomes in pediatric subjects receiving aripiprazole treatment . METHODS This study was a post-hoc analysis of pooled data from two 8-week , double-blind , r and omized , placebo-controlled studies evaluating aripiprazole for the treatment of irritability in pediatric subjects with autistic disorder , aged 6 - 17 years . Subjects were stratified by PAE ; adverse events ( AEs ) , and changes in weight , and metabolic measures were evaluated . For subjects receiving aripiprazole , regardless of PAE , baseline weight , age , gender , and symptom severity were evaluated in a regression model predicting body weight change . RESULTS Of 316 r and omized subjects , 259 ( 82.0 % ) were antipsychotic naïve ( AN ) and 57 ( 18.0 % ) had a PAE . Aripiprazole-treated AN subjects were more likely than PAE subjects to report somnolence ( 11.9 % vs. 2.8 % ) , sedation ( 22.7 % vs. 11.1 % ) , or fatigue ( 17.0 % vs. 13.9 % ) . Rates of extrapyramidal disorder and drooling , but not akathisia or tremor , were marginally higher in AN subjects . Overall , 10.8 % of aripiprazole-treated AN subjects had at least one AE leading to discontinuation compared with 8.3 % of aripiprazole-treated PAE subjects . AN subjects receiving aripiprazole had a larger change in weight from baseline to endpoint compared with those receiving placebo ( 1.9 vs. 0.7 kg ; treatment difference 1.2 kg , 95 % CI : 0.5 , 1.9 ) than PAE subjects receiving aripiprazole compared with subjects receiving placebo ( 0.4 vs. -0.4 kg ; treatment difference 0.9 kg , 95 % CI : -0.6 , 2.4 ) . Regression analysis identified that younger subjects with higher baseline weight z-score were at highest risk for weight gain . There were no significant changes in metabolic measures compared with placebo in either group . CONCLUSIONS Weight gain was more pronounced in AN subjects and more likely to occur in younger subjects with a higher baseline weight z-score . AN subjects were more likely to experience AEs related to somnolence . However , based on discontinuations rates from AEs , overall tolerability was good for both AN and PAE groups . CLINICAL TRIAL REGISTRATION Study of aripiprazole in the treatment of children and adolescents with autistic disorder . Registry : www . clinical trials.gov . Identifiers : NCT00332241 and NCT00337571 We evaluated the efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents ( 6–17 years ) with autism spectrum disorder ( ASD ) in a r and omized , double-blind , placebo-controlled 8-week study in Japan . Patients received flexibly dosed aripiprazole ( 1–15 mg/day ) or placebo . Ninety-two patients were r and omized to placebo ( n = 45 ) or aripiprazole ( n = 47 ) . Aripiprazole produced a significant improvement in the mean parent/caregiver-rated Aberrant Behavior Checklist Japanese Version irritability subscale score relative to placebo from week 3 through week 8 . Administration of aripiprazole provided significantly greater improvement in the mean clinician-rated Clinical Global Impression-Improvement scores than placebo from week 2 through week 8 . All patients r and omized to aripiprazole completed the study , and no serious adverse events were reported . Three patients in placebo group discontinued . Aripiprazole was effective and generally safe and well-tolerated in the treatment of irritability associated with ASD in Japanese children and adolescents Some open-label studies suggest that risperidone can be useful in the treatment of certain target symptoms in children with autism . We aim ed to study whether the use of risperidone in comparison with placebo improved functioning in children with autism with regard to behavior ( aggressiveness , hyperactivity , irritability ) , social and emotional responsiveness , and communication skills . We conducted a r and omized , double-blind , placebo-controlled trial with 40 consecutive children with autism , whose ages ranged from 2 to 9 years , who were receiving either risperidone or placebo given orally at a dose of 1 mg/day for 6 months . Autism symptoms were monitored periodically . The outcome variables were total scores on the Childhood Autism Rating Scale ( CARS ) and the Children 's Global Assessment Scale ( CGAS ) after 6 months . Of the 40 children enrolled , 39 completed the trial over a period of 18 months ; 19 received risperidone , and 20 received placebo . In the risperidone group , 12 of 19 children showed improvement in the total Childhood Autism Rating Scale score and 17 of 19 children in the Children 's Global Assessment Scale score compared with 0 of 20 children for the Childhood Autism Rating Scale score and 2 of 20 children for the Children 's Global Assessment Scale score in the placebo group ( P < .001 and P = .035 , respectively ) . Risperidone also improved social responsiveness and nonverbal communication and reduced the symptoms of hyperactivity and aggression . Risperidone was associated with increased appetite and a mild weight gain , mild sedation in 20 % , and transient dyskinesias in three children . Risperidone improved global functioning and social responsiveness while reducing hyperactivity and aggression in children with autism and was well tolerated . ( J Child Neurol 2006;21:450—455 ; DOI 10.231 OUTPUT:

The pooled mean change scores in aripiprazole-treated group for the Aberrant Behavior Checklist (ABC)-Irritability , ABC-Hyperactivity/noncompliance , ABC-Inappropriate speech and ABC-Stereotypic behavior were significantly greater than those of the placebo-treated group . Unfortunately , the significant difference between two groups was not found for ABC-Lethargy/social withdrawal . The pooled overall discontinuation rate in aripiprazole-treated group was significantly better than that of placebo-treated group . Conclusion Aripiprazole has efficacy in the treatment of behavioral disturbances , including irritability , hyperactivity/noncompliance , inappropriate speech and stereotypic behavior found in ASD children and adolescents ; however , it could not improve the lethargy/social withdrawal in such patients . The present evidence also indicates that it is safe , acceptable and tolerable in such treatment .

MS2_dynamic_1_shot665

***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: Objectives : To evaluate the effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain . Design : A cluster r and omised controlled trial comparing an active strategy with st and ard dissemination . Setting : Primary care physiotherapy practice s. Participants : 113 physiotherapists were r and omly allocated to receive the guidelines by mail ( control group ) or to receive an additional active strategy ( intervention group ) which consisted of a multifaceted programme including education , discussion , role playing , feedback , and reminders . Main outcome measures : Adherence to the guidelines was measured by means of individual patients ’ forms recording the treatment completed by the physiotherapist . The forms were assessed using an algorithm based on the number of treatment sessions , treatment goals , interventions , and patient education . Results : Physiotherapists in the intervention group more often correctly limited the number of treatment sessions for patients with a normal course of back pain ( OR 2.39 ; 95 % CI 1.12 to 5.12 ) , more often set functional treatment goals ( OR 1.99 ; 95 % CI 1.06 to 3.72 ) , more often used mainly active interventions ( OR 2.79 ; 95 % CI 1.19 to 6.55 ) , and more often gave adequate patient education ( OR 3.59 ; 95 % CI 1.35 to 9.55 ) . They also adhered more to all four criteria ( OR 2.05 ; 95 % CI 1.15 to 3.65 ) . Conclusions : The active strategy moderately improved adherence to the guidelines . Active strategies are recommended to implement the clinical guidelines on physiotherapy for low back pain 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 The effects of the electronic display of guideline -based , patient-specific treatment suggestions on pharmacist work patterns were studied . A total of 28 pharmacists at a hospital-based ambulatory care pharmacy were r and omly assigned to intervention and control groups . The intervention group had access to electronic treatment suggestions for heart failure , ischemic heart disease , reactive airways disease , and uncomplicated hypertension , while the control group did not . Starting 9 and 19 months after the initial display of treatment suggestions , all pharmacists recorded the time they spent on a variety of activities , the purpose of each activity , and persons contacted during the activity ; these observations were recorded in response to a pager-like device that r and omly buzzed four times an hour . A total of 11,102 observations were recorded . Pharmacists in the intervention group spent significantly more of their time discussing information , advising and informing , and solving problems than pharmacists in the control group but significantly less of their time checking and filling prescriptions . Pharmacists in both groups completed a majority of their work alone , but pharmacists in the intervention group worked significantly less by themselves and significantly more with other pharmacy personnel , patients , and physicians and nurses than control-group pharmacists . The delivery of patient-specific information to pharmacists at the time of dispensing had a significant positive impact on pharmacist work patterns The choice of study design for guideline implementation studies will determine the confidence with which the observed effects can be attributed to the interventions under study . In general , cluster r and omized trials , of which there are different types , provide the most robust design . However , the use of these design s has implication s for the power , conduct and analysis of studies . Wherever possible , design s allowing head-to-head comparisons , which incorporate baseline measures of performance , should be used ABSTRACT Studies have shown benefits to patients from improved interventions involving antimicrobial therapy . The purpose of the present study was to evaluate prospect ively the impact of improved interventions by ( i ) the use of TheraTrac 2 , a computer software program which electronically links susceptibility testing results immediately to the pharmacy and alerts pharmacists of potential interventions , and ( ii ) the education of pharmacists involving microbiologic topics . The study group had the new intervention program . The control group had interventions performed the way that they had previously been done by manually review ing hard copies of susceptibility testing data . In a 5-month period , all in patients whose last names began with A to K were the study group ; in patients whose last names began with L to Z were controls . Three analyses were done ; one analysis ( analysis A ) involved only patients with interventions , one analysis ( analysis B ) involved all patients for whom antimicrobial testing was done and who were matched for diagnosis-related groups ( DRGs ) , regardless of whether an intervention occurred , and one analysis ( analysis C ) involved these DRG-matched patients by using severity-adjusted data . In analysis A , the study group had a 4.8 % decreased rate of mortality , an average of a 16.5-day decreased length of stay per patient , and $ 20,88 OUTPUT: Multi-faceted interventions were no more effective than single intervention strategies and effects of the same strategy varied across trials . There is no evidence to support a set guideline implementation strategy for allied health professionals . INPUT: OBJECTIVE To provide access to professional development opportunities for health care professionals , especially in rural Australian regions , consistent with recommendations in the Australian National Pain Strategy and state government policy . DESIGN AND SETTING A preliminary prospect i ve , single-cohort study design , which aligned health policy with evidence -informed clinical practice , evaluated the implementation and effectiveness of an interprofessional , health care provider pain education program ( hPEP ) for management of nonspecific low back pain ( nsLBP ) in rural Western Australia . INTERVENTION The 6.5-hour hPEP intervention was delivered to 60 care providers ( caseload nsLBP 19.8 % ± 22.5 ) at four rural WA regions . OUTCOME MEASURES Outcomes were recorded at baseline and 2 months post-intervention regarding attitudes , beliefs ( modified Health Care Providers Pain and Impairment Relationship Scale [ HC-PAIRS ] ) , Back Pain Beliefs Question naire [ BBQ ] ) , and self-reported evidence -based clinical practice ( knowledge and skills regarding nsLBP , rated on a 5-point Likert scale with 1 = nil and 5 = excellent ) . RESULTS hPEP was feasible to implement . At 2 months post-hPEP , responders ' ( response rate 53 % ) improved evidence -based beliefs were indicated by HC-PAIRS scores : baseline mean ( SD ) [ 43.2 ( 9.3 ) ] ; mean difference ( 95 % CI ) [ -5.9 ( -8.6 to -3.1 ) ] ; and BBQ baseline [ 34.3 ( 6.8 ) ] ; mean difference [ 2.1 ( 0.5 to 3.6 ) ] . Positive shifts were observed for all measures of clinical knowledge and skills ( P < 0.001 ) and increased assistance with planning lifestyle changes ( P < 0.001 ) , advice on self-management ( P = 0.010 ) , and for decreased referrals for spinal imaging ( P = 0.03 ) . CONCLUSIONS This policy-into- practice educational program is feasible to implement in rural Western Australia ( WA ) . While preliminary data are encouraging , a further r and omized controlled trial is recommended Objectives : To evaluate the effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain . Design : A cluster r and omised controlled trial comparing an active strategy with st and ard dissemination . Setting : Primary care physiotherapy practice s. Participants : 113 physiotherapists were r and omly allocated to receive the guidelines by mail ( control group ) or to receive an additional active strategy ( intervention group ) which consisted of a multifaceted programme including education , discussion , role playing , feedback , and reminders . Main outcome measures : Adherence to the guidelines was measured by means of individual patients ’ forms recording the treatment completed by the physiotherapist . The forms were assessed using an algorithm based on the number of treatment sessions , treatment goals , interventions , and patient education . Results : Physiotherapists in the intervention group more often correctly limited the number of treatment sessions for patients with a normal course of back pain ( OR 2.39 ; 95 % CI 1.12 to 5.12 ) , more often set functional treatment goals ( OR 1.99 ; 95 % CI 1.06 to 3.72 ) , more often used mainly active interventions ( OR 2.79 ; 95 % CI 1.19 to 6.55 ) , and more often gave adequate patient education ( OR 3.59 ; 95 % CI 1.35 to 9.55 ) . They also adhered more to all four criteria ( OR 2.05 ; 95 % CI 1.15 to 3.65 ) . Conclusions : The active strategy moderately improved adherence to the guidelines . Active strategies are recommended to implement the clinical guidelines on physiotherapy for low back pain 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 Study Design . Cost-effectiveness analysis alongside a cluster r and omized controlled trial . Objective . To study the cost-effectiveness of 2 low back pain guideline implementation ( GI ) strategies . Summary of Background Data . Several evidence -based guidelines on management of low back pain have been published . However , there is still no consensus on the effective implementation strategy . Especially studies on the economic impact of different implementation strategies are lacking . Methods . This analysis was performed alongside a cluster r and omized controlled trial on the effectiveness of 2 GI strategies ( physician education alone [ GI ] or physician education in combination with motivational counseling [ MC ] by practice nurses)-–both compared with the postal dissemination of the guideline ( control group , C ) . Sociodemographic data , pain characteristics , and cost data were collected by interview at baseline and after 6 OUTPUT:

Meta-analyses did not reveal any differences in effect between multifaceted strategies and controls . Conclusion This review showed that multifaceted strategies for the implementation of neck and /or back pain guidelines in health care do not significantly improve professional behaviour outcomes . No effects on patient outcomes or cost of care could be found .

MS2_dynamic_1_shot666

***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: Objective : To compare the effects of behavioral interventions targeting decreased sedentary behavior versus increased moderate-to-vigorous intensity physical activity ( MVPA ) in older adults . Method : Inactive older adults ( N = 38 , 68 ± 7 years old , 71 % female ) were r and omized to 12-week interventions targeting decreased sedentary behavior ( Sit Less ) or increased MVPA ( Get Active ) . The SenseWear armb and was used to objective ly assess activity in real time . Assessment s included a blinded armb and , the Community Health Activites Model Program for Senior ( CHAMPS ) question naire , 400-meter walk , and the Short Physical Performance Battery ( SPPB ) . Results : Objective ly measured MVPA increased in Get Active ( 75 ± 22 min/week , p < .001 ) ; self-reported MVPA increased in both groups ( p < .05 ) . Sedentary behavior did not change in either group ( all p > .05 ) . Only the Sit Less group improved the SPPB score ( 0.5 ± 0.3 , p = .046 ) . Discussion : Targeting reduced sedentary behavior had a greater effect on physical function among inactive but high functioning older adults over 12 weeks . Future studies of longer duration and combining increased MVPA with reduced sedentary behavior are needed PURPOSE Although moderate-to-vigorous physical activity is related to premature mortality , the relationship between sedentary behaviors and mortality has not been fully explored and may represent a different paradigm than that associated with lack of exercise . We prospect ively examined sitting time and mortality in a representative sample of 17,013 Canadians 18 - 90 yr of age . METHODS Evaluation of daily sitting time ( almost none of the time , one fourth of the time , half of the time , three fourths of the time , almost all of the time ) , leisure time physical activity , smoking status , and alcohol consumption was conducted at baseline . Participants were followed prospect ively for an average of 12.0 yr for the ascertainment of mortality status . RESULTS There were 1832 deaths ( 759 of cardiovascular disease ( CVD ) and 547 of cancer ) during 204,732 person-yr of follow-up . After adjustment for potential confounders , there was a progressively higher risk of mortality across higher levels of sitting time from all causes ( hazard ratios ( HR ) : 1.00 , 1.00 , 1.11 , 1.36 , 1.54 ; P for trend < 0.0001 ) and CVD ( HR:1.00 , 1.01 , 1.22 , 1.47 , 1.54 ; P for trend < 0.0001 ) but not cancer . Similar results were obtained when stratified by sex , age , smoking status , and body mass index . Age-adjusted all-cause mortality rates per 10,000 person-yr of follow-up were 87 , 86 , 105 , 130 , and 161 ( P for trend < 0.0001 ) in physically inactive participants and 75 , 69 , 76 , 98 , 105 ( P for trend = 0.008 ) in active participants across sitting time categories . CONCLUSIONS These data demonstrate a dose-response association between sitting time and mortality from all causes and CVD , independent of leisure time physical activity . In addition to the promotion of moderate-to-vigorous physical activity and a healthy weight , physicians should discourage sitting for extended periods AIM To compare the effect of 7 h of prolonged sitting on resting blood pressure with a similar duration of sitting combined with intermittent brief bouts of light-intensity or moderate-intensity physical activity . METHODS AND RESULTS Overweight/obese adults ( n = 19 ; aged 45 - 65 years ) were recruited for a r and omized three-treatment crossover trial with a one-week washout between treatments : 1 ) uninterrupted sitting ; 2 ) sitting with 2 min bouts of light-intensity walking at 3.2 km/h every 20 min ; and , 3 ) sitting with 2 min bouts of moderate-intensity walking at between 5.8 and 6.4 km/h every 20 min . After an initial 2 h period seated , participants consumed a test meal ( 75 g carbohydrate , 50 g fat ) and completed each condition over the next 5 h. Resting blood pressure was assessed oscillometrically every hour as a single measurement , 5 min prior to each activity bout . GEE models were adjusted for sex , age , BMI , fasting blood pressure and treatment order . After adjustment for potential confounding variables , breaking up prolonged sitting with light and moderate-intensity activity breaks was associated with lower systolic blood pressure [ light : 120 ± 1 mmHg ( estimated marginal mean ± SEM ) , P = 0.002 ; moderate : 121 ± 1 mmHg , P = 0.02 ] , compared to uninterrupted sitting ( 123 ± 1 mmHg ) . Diastolic blood pressure was also significantly lower during both of the activity conditions ( light : 76 ± 1 mmHg , P = 0.006 ; moderate : 77 ± 1 mmHg , P = 0.03 ) compared to uninterrupted sitting ( 79 ± 1 mmHg ) . No significant between-condition differences were observed in mean arterial pressure or heart rate . CONCLUSION Regularly breaking up prolonged sitting may reduce systolic and diastolic blood pressure . TRIAL REGISTRATION NUMBER ACTRN12609000656235 ( http://www.anzctr.org.au ) TRI OUTPUT: The narrative synthesis suggested that interventions have the potential to reduce sitting time in non-working older adults . INPUT: PURPOSE Although moderate-to-vigorous physical activity is related to premature mortality , the relationship between sedentary behaviors and mortality has not been fully explored and may represent a different paradigm than that associated with lack of exercise . We prospect ively examined sitting time and mortality in a representative sample of 17,013 Canadians 18 - 90 yr of age . METHODS Evaluation of daily sitting time ( almost none of the time , one fourth of the time , half of the time , three fourths of the time , almost all of the time ) , leisure time physical activity , smoking status , and alcohol consumption was conducted at baseline . Participants were followed prospect ively for an average of 12.0 yr for the ascertainment of mortality status . RESULTS There were 1832 deaths ( 759 of cardiovascular disease ( CVD ) and 547 of cancer ) during 204,732 person-yr of follow-up . After adjustment for potential confounders , there was a progressively higher risk of mortality across higher levels of sitting time from all causes ( hazard ratios ( HR ) : 1.00 , 1.00 , 1.11 , 1.36 , 1.54 ; P for trend < 0.0001 ) and CVD ( HR:1.00 , 1.01 , 1.22 , 1.47 , 1.54 ; P for trend < 0.0001 ) but not cancer . Similar results were obtained when stratified by sex , age , smoking status , and body mass index . Age-adjusted all-cause mortality rates per 10,000 person-yr of follow-up were 87 , 86 , 105 , 130 , and 161 ( P for trend < 0.0001 ) in physically inactive participants and 75 , 69 , 76 , 98 , 105 ( P for trend = 0.008 ) in active participants across sitting time categories . CONCLUSIONS These data demonstrate a dose-response association between sitting time and mortality from all causes and CVD , independent of leisure time physical activity . In addition to the promotion of moderate-to-vigorous physical activity and a healthy weight , physicians should discourage sitting for extended periods OBJECTIVES To examine whether different sedentary behaviours are associated with the risk of low bone mineral content in adolescents , and if so , whether extracurricular physical-sporting activity influences this association . MATERIAL S AND METHODS A total of 277 adolescents from Zaragoza ( 168 females and 109 males ) aged 13.0 - 18.5 yr within frame work of the multicentre AVENA study participated in this study . Bone mineral content ( BMC ) , lean mass , and fat mass were measured with DXA . Physical activity and sedentary independent variables : participation in extracurricular physical-sporting activity ( PA ) , h/d of television watching , playing video/computer games during school days and on weekend days and doing homework/ study ing . They all were assessed by question naire . The main outcome was low BMC , as defined by BMC Z-score for age and sex < percentile 10 . Logistic regression was used to test the interaction and association of PA and sedentary variables with low BMC , after controlling for confounders like height , maturational status or lean mass . RESULTS Among the sedentary variables studied , only television watching > or =3 h/d was associated with an increased risk for low BMC in males ( OR , 95 % CI : 7.01 , 1.73 to 28.40 ) , after controlling for sexual maturation . When PA was in the models , television watching was not any longer associated with low BMC , while PA was so ( OR , 95 % CI : 0.23 , 0.09 to 0.55 ) . Involvement in such activity reduced the risk of low bone mass by 76 % ( P<0.01 ) independently of body mass , height and fat mass , but not of the lean mass . CONCLUSION Watching television for 3 or more h/d seems to be associated with an increased risk for low BMC in male adolescents . However , this association is mediated by participation in PA , suggesting that negative consequences of excessive television watching on adolescent bone health could be counteracted by sport participation . Longitudinal data and r and omized controlled trials will confirm or contrast our findings UNLABELLED Peak adolescent fracture incidence at the distal end of the radius coincides with a decline in size-corrected BMD in both boys and girls . Peak gains in bone area preceded peak gains in BMC in a longitudinal sample of boys and girls , supporting the theory that the dissociation between skeletal expansion and skeletal mineralization results in a period of relative bone weakness . INTRODUCTION The high incidence of fracture in adolescence may be related to a period of relative skeletal fragility result ing from dissociation between bone expansion and bone mineralization during the growing years . The aim of this study was to examine the relationship between changes in size-corrected BMD ( BMDsc ) and peak distal radius fracture incidence in boys and girls . MATERIAL S AND METHODS Subjects were 41 boys and 46 girls measured annually ( DXA ; Hologic 2000 ) over the adolescent growth period and again in young adulthood . Ages of peak height velocity ( PHV ) , peak BMC velocity ( P BMC V ) , and peak bone area ( BA ) velocity ( PBAV ) were determined for each child . To control for maturational differences , subjects were aligned on PHV . BMDsc was calculated by first regressing the natural logarithms of BMC and BA . The power coefficient ( pc ) values from this analysis were used as follows : BMDsc = BMC /BA(pc ) . RESULTS BMDsc decreased significantly OUTPUT:

Several studies that used DXA or quantitative ultrasound suggested that objective ly measured SB was negatively associated with lower extremity bone outcomes , such as femoral neck bone mineral density . The magnitude of this negative association was small and independent of moderate-to-vigorous physical activity . In contrast to the lower extremities , there was insufficient evidence for an association of lumbar spine bone outcomes with objective ly measured SB . In high- quality studies that used DXA , no association was observed between objective ly measured SB and total body bone outcomes . In studies using question naires , none of these relationships were observed .

MS2_dynamic_1_shot667

***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: Background : Mobile-bearing ankle replacements have become popular outside of the United States over the past two decades . The goal of the present study was to perform a prospect i ve evaluation of the safety and efficacy of a mobile-bearing prosthesis to treat end stage ankle arthritis . We report the results of three separate cohorts of patients : a group of Sc and anavian Total Ankle Replacement ( STAR ) patients and a control group of ankle fusion patients ( the Pivotal Study Groups ) and another group of STAR total ankle patients ( Continued Access Group ) whose surgery was performed following the completion of enrollment in the Pivotal Study . Material s and Methods : The Pivotal Study design was a non-inferiority study using ankle fusion as the control . A non-r and omized multi-centered design with concurrent fusion controls was used . We report the initial perioperative findings up to 24 months following surgery . For an individual patient to be considered an overall success , all of the following criteria needed to be met : a ) a 40-point improvement in total Buechel-Pappas ankle score , b ) no device failures , revisions , or removals , c ) radiographic success , and d ) no major complications . In the Pivotal Study ( 9/00 to 12/01 ) , 158 ankle replacement and 66 arthrodesis procedures were performed ; in the Continued Access Study ( 4/02 to 10/06 ) , 448 ankle replacements were performed , of which 416 were at minimum 24 months post-surgery at time of the data base closure . Results : Major complications and need for secondary surgical intervention were more common in the Pivotal Study arthroplasty group than the Pivotal Study ankle fusion group . In the Continued Access Group , secondary procedures performed on these arthroplasty patients decreased by half when compared with the Pivotal Arthroplasty Group . When the Pivotal Groups were compared , treatment efficacy was higher for the ankle replacement group due to improvement in functional scores . Pain relief was equivalent between fusion and replacement patients . The hypothesis of non-inferiority of ankle replacement was met for overall patient success . Conclusion : By 24 months , ankles treated with STAR ankle replacement ( in both the Pivotal and Continued Access Groups ) had better function and equivalent pain relief as ankles treated with fusion . Level of Evidence : II , Prospect i ve Controlled Comparative Surgical We describe the medium-term results of a prospect i ve study of 200 total ankle replacements at a single-centre using the Sc and inavian Total Ankle Replacement . A total of 24 ankles ( 12 % ) have been revised , 20 by fusion and four by further replacement and 27 patients ( 33 ankles ) have died . All the surviving patients were seen at a minimum of five years after operation . The five-year survival was 93.3 % ( 95 % confidence interval ( CI ) 89.8 to 96.8 ) and the ten-year survival 80.3 % ( 95 % CI 71.0 to 89.6 ) . Anterior subluxation of the talus , often seen on the lateral radiograph in osteoarthritic ankles , was corrected and , in most instances , the anatomical alignment was restored by total ankle replacement . The orientation of the tibial component , as seen on the lateral radiograph , also affects the position of the talus and if not correct can hold the talus in an abnormal anterior position . Subtalar arthritis may continue to progress after total ankle replacement . Our results are similar to those published previously We describe the results of a r and omised , prospect i ve study of 200 ankle replacements carried out between March 2000 and July 2003 at a single centre to compare the Buechel-Pappas ( BP ) and the Sc and inavian Total Ankle Replacement ( STAR ) implant with a minimum follow-up of 36 months . The two prostheses were similar in design consisting of three components with a meniscal polyethylene bearing which was highly congruent on its planar tibial surface and on its curved talar surface . However , the design s were markedly different with respect to the geometry of the articular surface of the talus and its overall shape . A total of 16 ankles ( 18 % ) was revised , of which 12 were from the BP group and four of the STAR group . The six-year survivorship of the BP design was 79 % ( 95 % confidence interval ( CI ) 63.4 to 88.5 and of the STAR 95 % ( 95 % CI 87.2 to 98.1 ) . The difference did not reach statistical significance ( p = 0.09 ) . However , varus or valgus deformity before surgery did have a significant effect ) ( p = 0.02 ) on survivorship in both groups , with the likelihood of revision being directly proportional to the size of the angular deformity . Our findings support previous studies which suggested that total ankle replacement should be undertaken with extreme caution in the presence of marked varus or valgus deformity The purpose of the current prospect i ve study was to determine the midterm results of 68 total ankle replacements with the Sc and inavian Total Ankle Replacement ( S.T.A.R. ) prosthesis . The 65 patients ( 34 women and 31 men ; mean age at surgery , 56.1 years [ range , 22 - 85 years ] ) were assessed clinical ly and radiologically after 3.7 years ( range , 2.4 - 6.2 years ) . Thirty-five patients ( 54 % ) were totally pain-free . The overall clinical score was grade d as excellent or good in 67 ankles . The American Orthopaedic Foot and Ankle Society hindfoot score improved from 24.7 points ( range , 3 - 44 points ) preoperatively to OUTPUT: Conclusions We found that STAR prosthesis achieved encouraging results in terms of intermediate to long-term outcome . The major reasons for implant failure were aseptic loosening and malalignment . Maybe the increase of surgeons ’ experience and patient selection could improve outcomes and decrease failure rate INPUT: Background : Mobile-bearing ankle replacements have become popular outside of the United States over the past two decades . The goal of the present study was to perform a prospect i ve evaluation of the safety and efficacy of a mobile-bearing prosthesis to treat end stage ankle arthritis . We report the results of three separate cohorts of patients : a group of Sc and anavian Total Ankle Replacement ( STAR ) patients and a control group of ankle fusion patients ( the Pivotal Study Groups ) and another group of STAR total ankle patients ( Continued Access Group ) whose surgery was performed following the completion of enrollment in the Pivotal Study . Material s and Methods : The Pivotal Study design was a non-inferiority study using ankle fusion as the control . A non-r and omized multi-centered design with concurrent fusion controls was used . We report the initial perioperative findings up to 24 months following surgery . For an individual patient to be considered an overall success , all of the following criteria needed to be met : a ) a 40-point improvement in total Buechel-Pappas ankle score , b ) no device failures , revisions , or removals , c ) radiographic success , and d ) no major complications . In the Pivotal Study ( 9/00 to 12/01 ) , 158 ankle replacement and 66 arthrodesis procedures were performed ; in the Continued Access Study ( 4/02 to 10/06 ) , 448 ankle replacements were performed , of which 416 were at minimum 24 months post-surgery at time of the data base closure . Results : Major complications and need for secondary surgical intervention were more common in the Pivotal Study arthroplasty group than the Pivotal Study ankle fusion group . In the Continued Access Group , secondary procedures performed on these arthroplasty patients decreased by half when compared with the Pivotal Arthroplasty Group . When the Pivotal Groups were compared , treatment efficacy was higher for the ankle replacement group due to improvement in functional scores . Pain relief was equivalent between fusion and replacement patients . The hypothesis of non-inferiority of ankle replacement was met for overall patient success . Conclusion : By 24 months , ankles treated with STAR ankle replacement ( in both the Pivotal and Continued Access Groups ) had better function and equivalent pain relief as ankles treated with fusion . Level of Evidence : II , Prospect i ve Controlled Comparative Surgical BACKGROUND Interest in mobile-bearing total ankle arthroplasty has increased in recent years . However , to our knowledge , no study has focused exclusively on patients with the diagnosis of inflammatory joint disease or has provided a detailed analysis of the risk factors for failure . METHODS A prospect i ve observational study of the results of cementless mobile-bearing total ankle arthroplasty in patients with inflammatory joint disease ( mainly rheumatoid arthritis ) was conducted at two centers . Ninety-three total ankle arthroplasties were performed . The LCS ( low contact stress ) prosthesis was used initially , in nineteen ankles , between 1988 and 1992 , and a modification of the LCS prosthesis , the Buechel-Pappas design , was used in seventy-four ankles between 1993 and 1999 . Clinical and radiographic follow-up was performed at yearly intervals . Three clinical scoring systems were used , and any complication was recorded throughout follow-up . Actuarial survival ( with revision as the end point ) , multivariate analysis , and a competing risk approach were used to describe the long-term outcome . RESULTS The clinical result at one year after surgery showed a significant improvement in the scores on all three scoring systems ( p < 0.05 ) . Ankle dorsiflexion ( mean , 7 degrees ) also improved significantly ( p < 0.05 ) compared with the preoperative state . The most frequent complication was a malleolar fracture , which occurred in twenty ankles . Only when it occurred in combination with a deformity in the frontal plane did this complication have an adverse effect on the end result . At a mean follow-up of eight years , seventeen patients ( twenty-one ankles ) had died and fifteen ankles had been revised because of aseptic loosening ( six ankles ) , primary or secondary axial deformity with edge-loading ( six ankles ) , deep infection ( two ankles ) , and a severe wound-healing problem ( one ankle ) , leaving fifty-seven ankles ( 61 % ) that were evaluated . The mean overall survival rate at eight years was 84 % . An increased failure rate was encountered in ankles with a preoperative deformity in the frontal plane of > 10 degrees ( p = 0.03 ) and in ankles in which an undersized tibial component had been implanted ( p = 0.02 ) . CONCLUSIONS Mobile-bearing total ankle arthroplasty is a valid treatment option for the rheumatoid ankle if proper indications are used . Aseptic loosening and persistent deformity are the most important modes of failure Interest in mobile-bearing total ankle arthroplasty has increased in recent years . Clinical studies show favorable but varying results , with survival rates between 70 % and 90 % at 10-year followup . Design -specific differences in early migration patterns might explain variations in the results and modes of failure . Using radiostereometric analysis ( RSA ) we prospect ively followed 15 RA patients with a cementless mobile-bearing total ankle arthroplasty . The American Orthopaedic Foot and Ankle Society ankle score and radiostereometric radiographs were evaluated immediately postoperatively , 6 weeks postoperatively , 3 months , 6 months , and 12 months postoperatively and yearly thereafter . The postoperative clinical results improved . We observed increased migration of the tibial component during the first 3 months , but this stabilized OUTPUT:

Regardless of the method ological limitations it can be concluded that both interventions show clinical improvement and in line with current literature neither procedure is superior to the other

MS2_dynamic_1_shot668

***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: Dysfunction in the hypothalamic-pituitary-adrenal ( HPA ) axis has been proposed as a biological endophenotype for affective disorders . In the present study the hypothesis that a high genetic liability to affective disorder is associated with higher cortisol levels was tested in a cross-sectional high-risk study . Healthy monozygotic ( MZ ) and dizygotic ( DZ ) twins with ( High-Risk twins ) and without ( Low-Risk twins ) a co-twin history of affective disorder were identified through nationwide registers . Awakening and evening salivary cortisol levels were compared between the 190 High- and Low-Risk twins . The 109 High-Risk twins had significantly higher evening cortisol levels than the 81 Low-Risk MZ twins , also after adjustment for age , sex , and the level of sub clinical depressive symptoms . No significant difference was found in awakening cortisol levels between High-Risk and Low-Risk twins . In conclusion , a high genetic liability to affective disorder was associated with a higher evening cortisol level , but not with awakening cortisol level . Future prospect i ve family , high-risk and twin studies are needed to decide whether abnormalities in the HPA axis can be identified as an endophenotype of affective disorder BACKGROUND Persistent impairments in neurocognitive function have been described in patients with bipolar disorder whose disease is in remission . However , method ological issues such as the effect of residual mood symptoms and hypercortisolaemia may confound such studies . AIMS To assess neurocognitive functioning in prospect ively verified euthymic patients with bipolar disorder . METHOD Sixty-three patients with bipolar disorder and a matched control group completed a comprehensive neurocognitive test battery . Euthymia was confirmed in the patient group by prospect i ve clinical ratings over 1 month prior to testing . Saliva sample s were collected to profile basal cortisol secretion . RESULTS Patients were significantly impaired across a broad range of cognitive domains . Across the domains tested , clinical ly significant impairment was observed in 3 % to 42 % of patients . Deficits were not causally associated with residual mood symptoms or hypercortisolaemia . CONCLUSIONS Neurocognitive impairment persists in patients whose bipolar disorder is in remission . This may represent a trait abnormality and be a marker of underlying neurobiological dysfunction Rationale Several previous neuroendocrine studies have demonstrated reduced 5-HT1A receptor function in major depressive disorder ( MDD ) . However , hypercortisolaemia or previous drug treatment may have been significant confounds . Objectives To replicate previous studies in subjects with MDD who had been drug free for at least 8 weeks and to relate the findings to measures of HPA axis function . Methods Hormonal responses to l-tryptophan infusion were measured in patients with MDD ( n=20 ) and healthy controls ( n=20 ) . Basal salivary cortisol and DHEA were also profiled . Results No attenuation of 5-HT1A receptor-dependent neuroendocrine responses ( growth hormone , prolactin ) was observed in patients with MDD . The prolactin response to l-tryptophan was significantly greater in MDD patients than in healthy controls ( P=0.008 ) . There was a significant negative correlation between prolactin response and basal salivary cortisol secretion over the 3 days prior to the test . Conclusions These data do not support previous findings of reduced 5-HT1A function in MDD and suggest that hypercortisolaemia or psychotropic medication may have accounted for the attenuation . Basal cortisol , DHEA and the cortisol-DHEA ratio did not differ between patients and controls , and all patients were psychotropic medication-free . The greater prolactin response to l-tryptophan infusion in depressed subjects may be the result of an increase in dopamine receptor sensitivity , secondary to reduced dopamine levels Rationale Patients with major depression show hypothalamic – pituitary – adrenal ( HPA ) axis hyperactivity , but the mechanisms underlying this abnormality are still unclear . Objectives We have compared two synthetic glucorticoids , dexamethasone and prednisolone , in their ability to suppress the hypothalamic – pituitary – adrenal ( HPA ) axis in depressed patients . Dexamethasone probes glucocorticoid receptor ( GR ) function , while prednisolone probes both GR and mineralocorticoid receptor ( MR ) function . Material s and methods We used a single-blind , repeated-measure design . We administered placebo , prednisolone ( 5 mg ) or dexamethasone ( 0.5 mg ) , at 22:00 , to 18 severe , treatment-resistant depressed in patients ( 15 of them with a history of childhood trauma ) and 14 healthy volunteers . On the following days , we collected salivary cortisol from 9:00 to 22:00 . Results Depressed patients had higher salivary cortisol levels compared with controls , at baseline and after both prednisolone and dexamethasone ( p<0.001 ) . Consistent with previous studies , depressed in patients showed impaired suppression by dexamethasone : based on the analysis of the areas under the curve ( AUCs ) , suppression by dexamethasone ( 0.5 mg ) was −85 % in controls vs −46 % in depressed patients ( p=0.018 ) . However , the same depressed patients showed normal suppression by prednisolone ( 5 mg ) : suppression was −41 % in controls and −36 % in depressed patients ( p=0.6 ) . Conclusions We suggest that the additional effects of prednisolone on the MR explain the different responses to these glucocorticoids in the same depressed patients OUTPUT: Further , in meta-regression analyses higher intra-assay coefficients of variation in cortisol kits ( p=0.07 ) and mean age ( p=0.08 ) were associated with a higher mean difference of morning salivary cortisol between depressed and controls , while gender and depression severity were not . Based on the available studies there is not firm evidence for a difference of salivary cortisol in depressed patients and control persons and salivary cortisol is unable to discriminate between persons with and without depression INPUT: The mechanism of the formation of a self-aligned hydroxyapatite ( HAP ) nanocrystallite structure was examined . It is found that the highly ordered HAP nanocrystallite assembly is attributed to the so-called self-(homo)epitaxial nucleation and growth . On the other h and , according to this mechanism , a high supersaturation will give rise to a r and om assembly of HAP crystallites . The effects of ions , biosubstrate , and supersaturation on the micro/nanostructure correlation between substrate and biominerals as well as their implication s in hard tissue formation were examined . Surprisingly , some biomolecules are found to be able to suppress the supersaturation-driven interfacial structure mismatch and hence promote the well aligned HAP pattern formation OUTPUT:

Experimental methacrylate-based adhesives , either when incorporating calcium/sodium phosphate-phyllosilicates or calcium silicate cements , demonstrated to promote therapeutic/protective effects on the micro-mechanical and ultramorphological properties of resin bonded-dentine interfaces associated with mineral deposition over time .

MS2_dynamic_1_shot669

***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: Background — Dabigatran , an oral thrombin inhibitor , and rivaroxaban and apixaban , oral factor Xa inhibitors , have been found to be safe and effective in reducing stroke risk in patients with atrial fibrillation . We sought to compare the efficacy and safety of the 3 new agents based on data from their published warfarin-controlled r and omized trials , using the method of adjusted indirect comparisons . Methods and Results — We included findings from 44 535 patients enrolled in 3 trials of the efficacy of dabigatran ( R and omized Evaluation of Long-Term Anticoagulation Therapy [ RELY ] ) , apixaban ( Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation [ ARISTOTLE ] ) , and rivaroxaban ( Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation [ ROCKET-AF ] ) , each compared with warfarin . The primary efficacy end point was stroke or systemic embolism ; the safety end point we studied was major hemorrhage . To address a lack of comparability between trial population s caused by the restriction of ROCKET-AF to high-risk patients , we conducted a subgroup analysis in patients with a CHADS2 score ≥3 . We found no statistically significant efficacy differences among the 3 drugs , although apixaban and dabigatran were numerically superior to rivaroxaban . Apixaban produced significantly fewer major hemorrhages than dabigatran and rivaroxaban . Conclusions — An indirect comparison of new anticoagulants based on existing trial data indicates that in patients with a CHADS2 score ≥3 dabigatran 150 mg , apixaban 5 mg , and rivaroxaban 20 mg result ed in statistically similar rates of stroke and systemic embolism , but apixaban had a lower risk of major hemorrhage compared with dabigatran and rivaroxaban . Until head-to-head trials or large-scale observational studies that reflect routine use of these agents are available , such adjusted indirect comparisons based on trial data are one tool to guide initial therapeutic choices Background — Rivaroxaban and dabigatran are new oral anticoagulants that specifically inhibit factor Xa and thrombin , respectively . Clinical studies on the prevention and treatment of venous and arterial thromboembolism show promising results . A major disadvantage of these anticoagulants is the absence of an antidote in case of serious bleeding or when an emergency intervention needs immediate correction of coagulation . This study evaluated the potential of prothrombin complex concentrate ( PCC ) to reverse the anticoagulant effect of these drugs . Methods and Results — In a r and omized , double-blind , placebo-controlled study , 12 healthy male volunteers received rivaroxaban 20 mg twice daily ( n=6 ) or dabigatran 150 mg twice daily ( n=6 ) for 2½ days , followed by either a single bolus of 50 IU/kg PCC ( Cofact ) or a similar volume of saline . After a washout period , this procedure was repeated with the other anticoagulant treatment . Rivaroxaban induced a significant prolongation of the prothrombin time ( 15.8±1.3 versus 12.3±0.7 seconds at baseline ; P<0.001 ) that was immediately and completely reversed by PCC ( 12.8±1.0 ; P<0.001 ) . The endogenous thrombin potential was inhibited by rivaroxaban ( 51±22 % ; baseline , 92±22 % ; P=0.002 ) and normalized with PCC ( 114±26 % ; P<0.001 ) , whereas saline had no effect . Dabigatran increased the activated partial thromboplastin time , ecarin clotting time ( ECT ) , and thrombin time . Administration of PCC did not restore these coagulation tests . Conclusion — Prothrombin complex concentrate immediately and completely reverses the anticoagulant effect of rivaroxaban in healthy subjects but has no influence on the anticoagulant action of dabigatran at the PCC dose used in this study . Clinical Trial Registration — URL : http://www.trialregister.nl . Unique identifier : NTR2272 Background — Oral anticoagulation ( OAC ) therapy is effective in atrial fibrillation but requires vigilance to maintain the international normalized ratio in the therapeutic range . This report examines how differences in time in therapeutic range ( TTR ) between centers and between countries affect the outcomes of OAC therapy . Methods and Results — In a posthoc analysis , the TTRs of patients on OAC in a r and omized trial of OAC versus clopidogrel plus aspirin ( Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events [ ACTIVE W ] ) were used to calculate the mean TTR for each of 526 centers and 15 countries . Proportional-hazards analysis , with and without adjustment for baseline variables , was performed , with patients stratified by TTR quartile and country . A wide variation in TTRs was found between centers , with mean TTRs for centers in the 4 quartiles of 44 % , 60 % , 69 % , and 78 % . For patients at centers below the median TTR ( 65 % ) , no treatment benefit was demonstrated as measured by relative risk for vascular events of clopidogrel plus aspirin versus OAC ( relative risk , 0.93 ; 95 % confidence interval , 0.70 to 1.24 ; P=0.61 ) . However , for patients at centers with a TTR above the study median , OAC had a marked benefit , reducing vascular events by > 2- OUTPUT: Data from r and omized , Phase III clinical trials of the novel oral anticoagulants , dabigatran , a direct thrombin inhibitor , and rivaroxaban and apixaban , both factor Xa inhibitors , indicate these drugs are at least noninferior to warfarin for the prevention of stroke and systemic embolism . They are easier to administer , and have an equivalent or lower risk of bleeding versus warfarin . INPUT: Importance The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial reported that apixaban therapy was superior to warfarin therapy in preventing stroke and all-cause death while causing significantly fewer major bleeds . To establish the value proposition of substituting apixiban therapy for warfarin therapy in patients with atrial fibrillation , we performed a cost-effectiveness analysis using patient-level data from the ARISTOTLE trial . Objective To assess the cost and cost-effectiveness of apixaban therapy compared with warfarin therapy in patients with atrial fibrillation from the perspective of the US health care system . Design , Setting , and Participants This economic analysis uses patient-level re source use and clinical data collected in the ARISTOTLE trial , a multinational r and omized clinical trial that observed 18 201 patients ( 3417 US patients ) for a median of 1.8 years between 2006 and 2011 . Interventions Apixaban therapy vs warfarin therapy . Main Outcomes and Measures Within-trial re source use and cost were compared between treatments , using externally derived US cost weights . Life expectancies for US patients were estimated according to their baseline risk and treatment using time-based and age-based survival models developed using the overall ARISTOTLE population . Quality -of-life adjustment factors were obtained from external sources . Cost-effectiveness ( incremental cost per quality -adjusted life-year gained ) was evaluated from a US perspective , and extensive sensitivity analyses were performed . Results Of the 3417 US patients enrolled in ARISTOTLE , the mean ( SD ) age was 71 ( 10 ) years ; 2329 ( 68.2 % ) were male and 3264 ( 95.5 % ) were white . After 2 years of anticoagulation therapy , health care costs ( excluding the study drug ) of patients treated with apixaban therapy and warfarin therapy were not statistically different ( difference , −$60 ; 95 % CI , −$2728 to $ 2608 ) . Life expectancy , modeled from ARISTOTLE outcomes , was significantly longer with apixaban therapy vs warfarin therapy ( 7.94 vs 7.54 quality -adjusted life years ) . The incremental cost , including cost of anticoagulant and monitoring , of achieving these benefits was within accepted US norms ( $ 53 925 per quality -adjusted life year , with 98 % likelihood of meeting a $ 100 000 willingness-to-pay threshold ) . Results were generally consistent when model assumptions were varied , with lifetime cost-effectiveness most affected by the price of apixaban and the time horizon . Conclusions and Relevance Apixaban therapy for ARISTOTLE-eligible patients with atrial fibrillation provides clinical benefits at an incremental cost that represents reasonable value for money judged using US benchmarks for cost-effectiveness . Trial Registration clinical trials.gov Identifier : Abstract Aim We tested the hypothesis that left ventricular hypertrophy ( LVH ) interferes with the antithrombotic effects of dabigatran and warfarin in patients with atrial fibrillation ( AF ) . Methods and results This is a post-hoc analysis of the R and omized Evaluation of Long-term anticoagulation therapY ( RE-LY ) Study . We defined LVH by electrocardiography ( ECG ) and included patients with AF on the ECG tracing at entry . Hazard ratios ( HR ) for each dabigatran dose vs. warfarin were calculated in relation to LVH . LVH was present in 2353 ( 22.7 % ) out of 10 372 patients . In patients without LVH , the rates of primary outcome were 1.59%/year with warfarin , 1.60 % with dabigatran 110 mg ( HR vs. warfarin 1.01 , 95 % confidence interval ( CI ) 0.75–1.36 ) and 1.08 % with dabigatran 150 mg ( HR vs. warfarin 0.68 , 95 % CI 0.49–0.95 ) . In patients with LVH , the rates of primary outcome were 3.21%/year with warfarin , 1.69 % with dabigatran 110 mg ( HR vs. warfarin 0.52 , 95 % CI 0.32–0.84 ) and 1.55 % with 150 mg ( HR vs. warfarin 0.48 , 95 % CI 0.29–0.78 ) . The interaction between LVH status and dabigatran 110 mg vs. warfarin was significant for the primary outcome ( P = 0.021 ) and stroke ( P = 0.016 ) . LVH was associated with a higher event rate with warfarin , not with dabigatran . In the warfarin group , the time in therapeutic range was significantly lower in the presence than in the absence of LVH . Conclusions LVH was associated with a lower antithrombotic efficacy of warfarin , but not of dabigatran , in patients with AF . Consequently , the relative benefit of the lower dose of dabigatran compared to warfarin was enhanced in patients with LVH . The higher dose of dabigatran was superior to warfarin regardless of LVH status . Clinical trial registration http : www . clinical trials.gov . Unique identifier : NCT00262600 BACKGROUND Comorbid chronic obstructive pulmonary disease ( COPD ) is associated with poor outcomes among patients with cardiovascular disease . The risks of stroke and mortality associated with COPD among patients with atrial fibrillation are not well understood . METHODS We analyzed patients from ARISTOTLE , a OUTPUT:

Warfarin Versus Thrombin Inhibitor ( Dabigatran ) The RE-LY trial ( 9 , 18 ) showed that treatment with dabigatran , 150 mg , is superior to warfarin in reducing the incidence of the composite outcome of stroke or systemic embolism . No statistically significant difference was observed between the 2 therapies with regard to major bleeding , myocardial infa rct ion , or

MS2_dynamic_1_shot670

***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: Background : Despite thous and s of papers , the value of quality of life ( QoL ) in curing disease remains uncertain . Until now , we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building , modelling , an exploratory trial and now a definitive r and omised controlled trial ( RCT ) in breast cancer , whose results we report here . Methods : In all , 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals . Patients were r and omised to either ( 1 ) a novel care pathway including diagnosis of ‘ diseased ’ QoL ( any QoL measure below 50 points ) using a QoL profile and expert report sent to the patient 's coordinating practitioner , who arranged QoL therapy consisting of up to five st and ardised treatments for specific QoL defects or ( 2 ) st and ard postoperative care adhering to the German national guideline for breast cancer . The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery . Patients were blinded to their allocated group . Results : At 0 and 3 months after surgery , diseased QoL was diagnosed in 70 % of patients . The QoL pathway reduced rates of diseased QoL to 56 % at 6 months , especially in emotion and coping , compared with 71 % in controls ( P=0.048 ) . Relative risk reduction was 21 % ( 95 % confidence interval ( CI ) : 0–37 ) , absolute risk reduction 15 % ( 95 % CI : 0.3–29 ) , number needed to treat (NNT)=7 ( 95 % CI : 3–37 ) . When QoL therapy finished after successful treatment , diseased QoL often returned again , indicating good responsiveness of the QoL pathway . Conclusion : A three-component outcome system including clinician-derived objective , patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention . A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based , pragmatic , definitive RCT . While the pathway was active , it was effective with an NNT of 7 PURPOSE To examine the effect of weekly completion of a patient-held quality -of-life ( QOL ) diary in routine oncology practice for palliative care patients . PATIENTS AND METHODS In a pragmatic r and omized controlled trial , 115 patients with inoperable lung cancer were r and omly assigned to receive either st and ard care or a structured QOL diary ( European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 and the related lung cancer module LC13 ) that they completed at home each week for 16 weeks . Patients were encouraged to share the QOL information with health professionals involved in their care . Changes in QOL over time ( measured by the Functional Assessment of Cancer Therapy-Lung question naire and the Palliative Care Quality of Life Index ) , discussion of patient problems , and satisfaction with communication and general care were assessed at baseline and at 2 and 4 months after baseline . RESULTS Analysis of QOL indicated a small but consistent difference between patients in the diary group and the st and ard care group . The diary group had a poorer QOL in many domains . Two different QOL summary scores ( total and overall QOL ) indicated a statistically significant between-group difference . No effects were found in relation to satisfaction with care , communication , or the discussion of patient problems . CONCLUSION The regular completion of a QOL question naire without appropriate feedback to health care professionals and without the provision of appropriate support may have a negative impact on inoperable lung cancer patients . Further research should focus on identifying features such as feedback loops that are required for the successful and meaningful use of QOL question naires in routine patient care PURPOSE Radiation Therapy Oncology Group trial 0525 tested whether dose-intensifying temozolomide versus st and ard chemoradiotherapy improves overall survival ( OS ) or progression-free survival ( PFS ) in newly diagnosed glioblastoma . Tests of neurocognitive function ( NCF ) and symptoms ( using the MD And erson Symptom Inventory-Brain Tumor module ; MDASI-BT ) and of quality of life ( European Organisation for the Research and Treatment of Cancer Quality of Life Question naire [ EORTC QLQ ] -C30/BN20 ) examined the net clinical benefit ( NCB ) of therapy . PATIENTS AND METHODS NCF tests ( Hopkins Verbal Learning Test-Revised , Trail Making Test , and Controlled Oral Word Association ) , MDASI-BT , and EORTC QLQ-C30/BN20 were completed in a subset of patients . Multivariate Cox proportional hazard regression modeling determined the prognostic value of baseline and early change from baseline to cycle 1 for OS and PFS . Two- sample proportional test statistic was used to evaluate differences between treatments ( dose-dense v st and ard-dose ) on NCB measures from baseline to cycle 4 in stable patients . RESULTS Overall , 182 patients participated in the study . Baseline NCF tests and the physical functioning quality of life scale were associated with OS and PFS . Baseline to cycle 1 in all NCB components were associated with OS and PFS . There was greater deterioration in the dose-dense arm from baseline to cycle 4 in the Global Health and Motor Function subscales ( EORTC QLQ-C30/BN20 ) as well as in overall symptom burden , overall symptom interference , and activity-related symptom interference subscales ( MDASI-BT ) . There were no between-arm differences in NCF . CONCLUSION Longitudinal collection of NCB measures is feasible in cooperative group studies and provides an added dimension to st and ard outcome measures . Greater adverse symptom burden and functional OUTPUT: The evidence on the effectiveness of using QoL tools was inconsistent for patient management , but somewhat more consistent in favour of improving patient – physician communication . Interviews identified unharnessed potential and growing interest in QoL tool use and associated challenges to address . INPUT: Background Quality of life ( QoL ) is now established as an important outcome for evaluating the impact of disease , and for assessing the efficacy of treatments . However , individuals change with time and the basis on which they make a QoL judgement may also change , a phenomenon increasingly referred to as response shift . Here , the individual may change his or her internal st and ards , values , and /or conceptualization on the target construct as a result of external factors such as a treatment or a change in health status . This has important implication s for assessing the effects of treatments as a change in QoL may reflect a response shift , a treatment effect , or a complex combination of both . In this study , we used an individualised quality of life ( IQoL ) measure , the SEIQoL , together with a then-test to determine whether response shift would influence the measurement of treatment efficacy in edentulous patients . Methods Data are reported here for the first phase of a r and omised controlled clinical trial design ed to assess the impact , on IQoL , of implant supported dentures compared with high quality conventional dentures . IQoL was measured using the SEIQoL-DW in 117 patients ( mean age 64.8 ; 32 % male ) at baseline ( T1 ) and 3 months ( T2 ) after receiving high quality conventional dentures . The work was carried out in dental teaching hospitals in Dublin and Belfast . Results Unadjusted SEIQoL index scores revealed no significant impact of treatment at three months ( baseline : 75.0 ; 3 months : 73.2 , p = .33 , n.s . ) . However , the then-test at 3 months revealed that patients retrospectively rated their baseline IQoL as significantly lower ( P < .001 ) than they had rated it at the time ( then-test baseline : 69.2 ) . Comparison of the 3 month scores with this readjusted baseline indicated a significant treatment effect ( then-test baseline : 69.2 ; 3 months : 73.2 , p = 0.016 ) . 81 % of patients nominated at least one different IQoL domain at 3 months . Conclusion The positive impact of denture treatment for edentulous patients on IQoL was seen only when response shifts were taken into consideration . The nature of the response shifts was highly complex but the data indicated a degree of re-conceptualisation and reprioritisation . Assessment of the impact of treatments using patient-generated reports must take account of the adaptive nature of patients Quality of Life is a broad construct used in health planning , health economics , and medical decision-making . It is also a term that has a long currency in social and sociological literature s. This paper considers the assumptions underlying prospect i ve QL instruments in an historical and contemporary context . It argues that as a tool in health planning and in clinical decision making life quality as a measurement has its origins in the early eugenics literature and the social policies that derived from it in first North America , the primary focus of this paper , and later in Europe . Reference to narrative and social literature s , as well as those involving coping and adaptation , are then used to critique the assumptions underlying this class of QL instruments . It concludes that to the degree now current prospect i ve instruments reflect a purely physical perspective of " disease burden " irrespective of social conditions they create a context that works against life quality , and in some cases , the continuance of persons with physical differences UNLABELLED Quality of life scales are being increasingly used to evaluate patients . The earliest scales were st and ardized question naire that did not necessarily provide an optimal evaluation of the quality of life of each individual patient . A number of personalized scales are now available , including the SEIQoL , in which the patients nominate the five quality of life areas most important to them . The SEIQoL has been vali date d. We tested the SEIQoL in patients treated by total hip arthroplasty , a procedure that is expected to improve quality of life . OBJECTIVE To compare two methods of administration of the SEIQoL several months after total hip arthroplasty . METHODS The SEIQoL was administered before and after the arthroplasty . During the postoperative test session , the SEIQoL was administered twice , once using the items nominated preoperatively and once after allowing the patient to repeat the nomination procedure . RESULTS With both methods , significant improvements in quality of life were demonstrated ( P < 0.05 ) . There was no significant difference between the two methods . CONCLUSION Changing the items of the SEIQoL during prospect i ve studies does not modify the overall quality of life score . Keeping the same items throughout the study is nevertheless warranted We compared the change over time of individual quality of life ( QOL ) versus health-related QOL ( HRQOL ) and functional status in palliative care patients with amyotrophic lateral sclerosis ( ALS ) . Forty-two patients with ALS performed the following assessment s : the ALS functional rating scale ( ALSFRS ) , the Sickness Impact Profile ( SIP ) , the Short Form 36 ( SF-36 ) , and the Schedule for the Evaluation of Individual QOL-Direct Weighting ( SEIQOL-DW ) . The SF-36 and the SEIQOL-DW were assigned at r and om . Patients were examined at least three times at 2-month intervals . There was a significant decrease from visit 1 to 3 ( 4-month period ) in the function-based values of the SIP , SF-36 , and ALSFRS . Despite this progressive decline of physical function and HRQOL , individual QOL as assessed by the SEIQOL-DW remained stable throughout the observation period . Correspondingly , there was a clear correlation between the ALSFRS , the SIP , and the SF-36 , but no correlation between these scales and the SEIQOL-DW . The QOL domains most often named in the SEIQOL-DW were family , friends/social life , health , and profession . Thus , individual QOL appears to be largely independent from physical function in severely ill patients with ALS . Because of the characteristics of the scale , assessment of individual QOL may have an interventional value in pal OUTPUT:

The results of convergent and discriminant validity support our hypotheses in which SEIQoL-DW was expected to correlate moderately to high with measures of global QoL , life satisfaction and mental health and weakly with measures of functional status and health . Conclusion The SEIQoL-DW appears to be a feasible and valid instrument . The lack of association between the Index score and health , functional status , demographic and clinical parameters may be explained by the instrument ’s focus on global QoL and by that of the idiographic measurement approach reflecting the capacity of a patient to value domains other than health in life , despite having health problems .

MS2_dynamic_1_shot671

***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: Bipolar disorders ( BD ) are mainly characterized by emotional and cognitive processing impairment . The cerebral substrate explaining BD impairment and the action mechanisms of therapies are not completely understood , especially for psychosocial interventions . This fMRI study aims at assessing cerebral correlates of euthymic bipolar patients ( EBP ) before and after psychoeducation therapy . Sixteen EBP and 16 matched healthy subjects ( HS ) performed a word-face emotional Stroop task in two separate fMRI sessions at 3-month interval . Between fMRI sessions , EBP underwent psychoeducation . Before psychoeducation , the comparison of EBP vs. HS in fMRI data revealed ( a ) significant decreased activity of cognitive control regions such as bilateral inferior and left superior frontal gyri , right insula , right fusiform gyrus and bilateral occipital gyri and ( b ) significant increased activity of emotion-related processing regions such as bilateral hippocampus , parahippocampal gyri and the left middle temporal gyrus . After psychoeducation , EBP showed significant clinical improvement , increased activity of inferior frontal gyri and a tendency toward decreased activity of right hippocampus and parahippocampal gyrus . These results suggest that the imbalance between cognitive control and emotion processing systems characterizing BD acute episodes may persist during euthymic periods . Moreover , this imbalance may be improved by psychoeducation , which enhances the cognitive control and modulates emotional fluctuations in EBP The main objective of this structural magnetic resonance imaging ( MRI ) study was to investigate , using diffusion tensor imaging , whether a neurofeedback training ( NFT ) protocol design ed to improve sustained attention might induce structural changes in white matter ( WM ) pathways , purportedly implicated in this cognitive ability . Another goal was to examine whether gray matter ( GM ) volume ( GMV ) might be altered following NFT in frontal and parietal cortical areas connected by these WM fiber pathways . Healthy university students were r and omly assigned to an experimental group ( EXP ) , a sham group , or a control group . Participants in the EXP group were trained to enhance the amplitude of their β1 waves at F4 and P4 . Measures of attentional performance and MRI data were acquired one week before ( Time 1 ) and one week after ( Time 2 ) NFT . Higher scores on visual and auditory sustained attention were noted in the EXP group at Time 2 ( relative to Time 1 ) . As for structural MRI data , increased fractional anisotropy was measured in WM pathways implicated in sustained attention , and GMV increases were detected in cerebral structures involved in this type of attention . After 50 years of research in the field of neurofeedback , our study constitutes the first empirical demonstration that NFT can lead to microstructural changes in white and gray matter Patients with anxiety disorders exhibit excessive neural reactivity in the amygdala , which can be normalized by effective treatment like cognitive behavior therapy ( CBT ) . Mechanisms underlying the brain ’s adaptation to anxiolytic treatments are likely related both to structural plasticity and functional response alterations , but multimodal neuroimaging studies addressing structure – function interactions are currently missing . Here , we examined treatment-related changes in brain structure ( gray matter ( GM ) volume ) and function ( blood – oxygen level dependent , BOLD response to self-referential criticism ) in 26 participants with social anxiety disorder r and omly assigned either to CBT or an attention bias modification control treatment . Also , 26 matched healthy controls were included . Significant time × treatment interactions were found in the amygdala with decreases both in GM volume ( family-wise error ( FWE ) corrected PFWE=0.02 ) and BOLD responsivity ( PFWE=0.01 ) after successful CBT . Before treatment , amygdala GM volume correlated positively with anticipatory speech anxiety ( PFWE=0.04 ) , and CBT-induced reduction of amygdala GM volume ( pre – post ) correlated positively with reduced anticipatory anxiety after treatment ( PFWE⩽0.05 ) . In addition , we observed greater amygdala neural responsivity to self-referential criticism in socially anxious participants , as compared with controls ( PFWE=0.029 ) , before but not after CBT . Further analysis indicated that diminished amygdala GM volume mediated the relationship between decreased neural responsivity and reduced social anxiety after treatment ( P=0.007 ) . Thus , our results suggest that improvement-related structural plasticity impacts neural responsiveness within the amygdala , which could be essential for achieving anxiety reduction with CBT Mindfulness has been suggested to impact emotional learning , but research on these processes is scarce . The classical fear conditioning/extinction/extinction retention paradigm is a well-known method for assessing emotional learning . The present study tested the impact of mindfulness training on fear conditioning and extinction memory and further investigated whether changes in white matter fiber tracts might support such changes . The uncinate fasciculus ( UNC ) was of particular interest in the context of emotional learning . In this pilot study , 46 healthy participants were quasi-r and omized to a Mindfulness-Based Stress Reduction ( MBSR , N = 23 ) or waitlist control ( N = 23 ) group and underwent a two-day fear conditioning , extinction learning , and extinction memory protocol before and after the course or control period . Skin conductance response ( SCR ) data served to measure the physiological response during conditioning and extinction memory phases . Diffusion tensor imaging ( DTI ) data were analyzed with probabilistic tractography and analyzed for changes of fractional anisotropy in the UNC . During conditioning , participants were able to maintain a differential response to conditioned vs. not conditioned stimuli following the MBSR course ( i.e. , higher sensitivity to the conditioned stimuli ) , while controls dropped the response . Extinction memory results were not interpretable due to bas OUTPUT: Conclusions : Non‐pharmacological interventions can induce changes in WM . DWI is a relevant correlate of e.g. cognitive training in prospect i ve , long‐term RCTs of psychiatric patients . HIGHLIGHTSNon‐pharmacological interventions can induce changes in white matter . Minimal intervention duration of 8 weeks is required to induce consistent WM‐changes . Associations between cognitive interventions and WM is substantiated . DWI is a relevant correlate of cognitive training in RCTs of psychiatric patients INPUT: BACKGROUND Functional neurological symptoms ( FNS ) are considered non-volitional and often very disabling , but are not explainable by neurological disease or structural abnormalities . Brief Augmented Psychodynamic Interpersonal Therapy ( BAPIT ) was adapted to treat the putative emotion processing deficits thought to be central to FNS aetiology and maintenance . BAPIT for FNS has previously been shown to improve levels of distress and functioning , but it is unknown whether improvements on such measures correlate with changes in emotion processing ‒ which this treatment focuses on . AIM To determine ( a ) whether the recently developed Emotional Processing Scale-25 can be used to demonstrate BAPIT-associated changes in patients with FNS , and ( b ) whether changes in the EPS-25 are associated with changes in previously vali date d outcome measures . METHOD 44 patients with FNS completed question naires including the EPS-25 and measures of clinical symptomology ( health-related quality of life ( SF-36 ) , somatic symptoms ( PHQ-15 ) , psychological distress ( CORE-10 ) and illness underst and ing ( BIPQ ) ) pre- and post-therapy . RESULTS At group level , emotion processing improved following therapy ( p = .049 ) . Some measures of clinical symptomology also improved , namely health-related quality of life ( p = .02 ) and illness underst and ing ( p = .01 ) . Improvements in the EPS-25 correlated with improvements in mental health-related quality of life and psychological distress . CONCLUSIONS Emotion processing and some measures of clinical symptomology improved in patients with FNS following BAPIT . The EPS-25 demonstrated changes that correlated with previously vali date d outcome measures . The EPS-25 is a suitable measure of psychotherapy-associated change in the FNS patient population Background The evidence base for the effectiveness of psychological interventions for patients with dissociative non-epileptic seizures ( DS ) is currently extremely limited , although data from two small pilot r and omised controlled trials ( RCTs ) , including from our group , suggest that Cognitive Behavioural Therapy ( CBT ) may be effective in reducing DS occurrence and may improve aspects of psychological status and psychosocial functioning . Methods / Design The study is a multicentre , pragmatic parallel group RCT to evaluate the clinical and cost-effectiveness of specifically-tailored CBT plus st and ardised medical care ( SMC ) vs SMC alone in reducing DS frequency and improving psychological and health-related outcomes . In the initial screening phase , patients with DS will receive their diagnosis from a neurologist/epilepsy specialist . If patients are eligible and interested following the provision of study information and a booklet about DS , they will consent to provide demographic information and fortnightly data about their seizures , and agree to see a psychiatrist three months later . We aim to recruit ~500 patients to this screening stage . After a review three months later by a psychiatrist , those patients who have continued to have DS in the previous eight weeks and who meet further eligibility criteria will be told about the trial comparing CBT + SMC vs SMC alone . If they are interested in participating , they will be given a further booklet on DS and study information . A research worker will see them to obtain their informed consent to take part in the RCT . We aim to r and omise 298 people ( 149 to each arm ) . In addition to a baseline assessment , data will be collected at 6 and 12 months post r and omisation . Our primary outcome is monthly seizure frequency in the preceding month . Secondary outcomes include seizure severity , measures of seizure freedom and reduction , psychological distress and psychosocial functioning , quality of life , health service use , cost effectiveness and adverse events . We will include a nested qualitative study to evaluate participants ’ views of the intervention and factors that acted as facilitators and barriers to participation . Discussion This study will be the first adequately powered evaluation of CBT for this patient group and offers the potential to provide an evidence base for treating this patient group . Trial registration Current Controlled Trials IS RCT N05681227 Clinical Trials.gov INTRODUCTION Psychogenic nonepileptic seizures ( PNES ) are episodic alterations in behavior presumed to reflect a physical manifestation of underlying psychological distress . St and ardized treatment approaches for PNES care are lacking . We evaluated common approaches to PNES management that do not require significant commitment of time and re sources . METHODOLOGY Patients with PNES established with video-EEG monitoring were r and omized to one of the following three groups : 1 ) PNES diagnosis delivered per the discretion of the attending physician with advice to seek mental health assistance in the community ( n=12 ) , 2 ) scripted PNES diagnosis provided and inpatient psychiatry consult obtained ( n=10 ) , and 3 ) weekly follow-up phone calls made in addition to scripted diagnosis and inpatient psychiatry consultation ( n=15 ) . Reduction in event frequency measured at 8weeks following hospital discharge represented the primary outcome variable . Secondary variables analyzed included exploration of change in self-reported mood , quality of life , and healthcare utilization . RESULTS No significant improvements were noted in patients simply given a PNES diagnosis and advised to seek outside care on any measure . In contrast , patients receiving a scripted diagnosis and psychiatric consultation demonstrated decreased PNES frequency accompanied by improved quality of life ( QOL ) . Patients also receiving weekly phone calls not only demonstrated decreased PNES frequency and improvements in QOL but also exhibited improved mood . DISCUSSION These findings demonstrate that providing diagnostic information regarding PNES is insufficient by itself to meaningfully affect patient outcome . Structured feedback and psychiatric consultation appeared adequate to significantly reduce PNES frequency and improve aspects of quality of life , while the addition of a weekly phone contact also led to improved mood Background Somatoform disorders are an important factor in functional disability and role impairment , though their independent contribution to disability has been unclear because of pre OUTPUT:

No single measure was identified for use across the range of FND symptoms in adults . Across r and omised controlled trials ( k=40 ) and observational treatment studies ( k=40 ) , outcome measures most often assessed core FND symptom change . Other domains measured commonly were additional physical and psychological symptoms , life impact ( ie , quality of life , disability and general functioning ) and health economics/cost-utility ( eg , healthcare re source use and quality -adjusted life years ) . CONCLUSIONS There are few well-vali date d FND-specific outcome measures .

MS2_dynamic_1_shot672

***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: Background The treatment of children with attention deficit hyperactivity disorder ( ADHD ) and Tourette syndrome ( TS ) has been problematic because methylpheni date (MPH)—the most commonly used drug to treat ADHD — has been reported to worsen tics and because clonidine (CLON)—the most commonly prescribed alternative — has unproven efficacy . Methods The authors conducted a multicenter , r and omized , double-blind clinical trial in which 136 children with ADHD and a chronic tic disorder were r and omly administered CLON alone , MPH alone , combined CLON + MPH , or placebo ( 2 × 2 factorial design ) . Each subject participated for 16 weeks ( weeks 1–4 CLON/placebo dose titration , weeks 5–8 added MPH/placebo dose titration , weeks 9–16 maintenance therapy ) . Results Thirty-seven children were administered MPH alone , 34 were administered CLON alone , 33 were administered CLON + MPH , and 32 were administered placebo . For our primary outcome measure of ADHD ( Conners Abbreviated Symptom Question naire – Teacher ) , significant improvement occurred for subjects assigned to CLON ( p < 0.002 ) and those assigned to MPH ( p < 0.003 ) . Compared with placebo , the greatest benefit occurred with combined CLON + MPH ( p < 0.0001 ) . CLON appeared to be most helpful for impulsivity and hyperactivity ; MPH appeared to be most helpful for inattention . The proportion of individual subjects reporting a worsening of tics as an adverse effect was no higher in those treated with MPH ( 20 % ) than those being administered CLON alone ( 26 % ) or placebo ( 22 % ) . Compared with placebo , measured tic severity lessened in all active treatment groups in the following order : CLON + MPH , CLON alone , MPH alone . Sedation was common with CLON treatment ( 28 % reported moderate or severe sedation ) , but otherwise the drugs were tolerated well , including absence of any evident cardiac toxicity . Conclusions Methylpheni date and clonidine ( particularly in combination ) are effective for ADHD in children with comorbid tics . Prior recommendations to avoid methylpheni date in these children because of concerns of worsening tics are unsupported by this trial Objective : To test the hypothesis that atomoxetine does not significantly worsen tic severity relative to placebo in children and adolescents with attention deficit/hyperactivity disorder ( ADHD ) and comorbid tic disorders . Methods : Study subjects were 7 to 17 years old , met Diagnostic and Statistical Manual of Mental Disorders – IV criteria for ADHD , and had concurrent Tourette syndrome or chronic motor tic disorder . Patients were r and omly assigned to double-blind treatment with placebo ( n = 72 ) or atomoxetine ( 0.5 to 1.5 mg/kg/day , n = 76 ) for up to 18 weeks . Results : Atomoxetine treatment was associated with greater reduction of tic severity at endpoint relative to placebo , approaching significance on the Yale Global Tic Severity Scale total score ( –5.5 ± 6.9 vs –3.0 ± 8.7 , p = 0.063 ) and Tic Symptom Self-Report total score ( –4.7 ± 6.5 vs –2.9 ± 5.2 , p = 0.095 ) and achieving significance on the Clinical Global Impressions ( CGI ) tic/neurologic severity scale score ( –0.7 ± 1.2 vs –0.1 ± 1.0 , p = 0.002 ) . Atomoxetine patients also showed greater improvement on the ADHD Rating Scale total score ( –10.9 ± 10.9 vs –4.9 ± 10.3 , p < 0.001 ) and CGI severity of ADHD/psychiatric symptoms scale score ( –0.8 ± 1.1 vs –0.3 ± 1.0 , p = 0.015 ) . Discontinuation rates were not significantly different between treatment groups . Atomoxetine patients had greater increases in heart rate and decreases of body weight , and rates of treatment-emergent decreased appetite and nausea were higher . No other clinical ly relevant treatment differences were seen in any other vital sign , adverse event , or electrocardiographic or laboratory measures . Conclusions : Atomoxetine did not exacerbate tic symptoms . Rather , there was some evidence of reduction in tic severity with a significant reduction of attention deficit/hyperactivity disorder symptoms . Atomoxetine treatment appeared safe and well tolerated BACKGROUND Current pharmacological treatments for Tourette Syndrome ( TS ) , such as antipsychotic agents and α-2 agonists , are moderately effective in the treatment of tics , but have substantial side effects that limit their use . N-acetylcysteine ( NAC ) modulates glutamatergic systems , and has been used safely as an antioxidant agent with minimal side effects for decades . NAC has been increasingly studied for the treatment of other obsessive-compulsive spectrum disorders . We aim to examine the efficacy of NAC for the treatment of pediatric TS in a double-blind , placebo-controlled , add-on study . METHODS Thirty-one children and adolescents 8 - 17 years of age with TS were r and omly assigned to receive NAC or matching placebo for 12 weeks . Our primary outcome was change in severity of tics as measured by the Yale Global Tic Severity Scale ( YGTSS ) , Total tic score . Secondary measures assessed comorbid obsessive-compulsive disorder ( OCD ) , depression , anxiety , and attention-deficit/hyperactivity disorder ( ADHD ) . Linear mixed models in SAS were used to examine differences between NAC and placebo . OUTPUT: Typical antipsychotic agents were associated with severer side-effects than alpha-2 adrenergic agonist agents . In summary , alpha-2 adrenergic agonist agents were associated with the optimal weigh between efficacy and safety . INPUT: Background The treatment of children with attention deficit hyperactivity disorder ( ADHD ) and Tourette syndrome ( TS ) has been problematic because methylpheni date (MPH)—the most commonly used drug to treat ADHD — has been reported to worsen tics and because clonidine (CLON)—the most commonly prescribed alternative — has unproven efficacy . Methods The authors conducted a multicenter , r and omized , double-blind clinical trial in which 136 children with ADHD and a chronic tic disorder were r and omly administered CLON alone , MPH alone , combined CLON + MPH , or placebo ( 2 × 2 factorial design ) . Each subject participated for 16 weeks ( weeks 1–4 CLON/placebo dose titration , weeks 5–8 added MPH/placebo dose titration , weeks 9–16 maintenance therapy ) . Results Thirty-seven children were administered MPH alone , 34 were administered CLON alone , 33 were administered CLON + MPH , and 32 were administered placebo . For our primary outcome measure of ADHD ( Conners Abbreviated Symptom Question naire – Teacher ) , significant improvement occurred for subjects assigned to CLON ( p < 0.002 ) and those assigned to MPH ( p < 0.003 ) . Compared with placebo , the greatest benefit occurred with combined CLON + MPH ( p < 0.0001 ) . CLON appeared to be most helpful for impulsivity and hyperactivity ; MPH appeared to be most helpful for inattention . The proportion of individual subjects reporting a worsening of tics as an adverse effect was no higher in those treated with MPH ( 20 % ) than those being administered CLON alone ( 26 % ) or placebo ( 22 % ) . Compared with placebo , measured tic severity lessened in all active treatment groups in the following order : CLON + MPH , CLON alone , MPH alone . Sedation was common with CLON treatment ( 28 % reported moderate or severe sedation ) , but otherwise the drugs were tolerated well , including absence of any evident cardiac toxicity . Conclusions Methylpheni date and clonidine ( particularly in combination ) are effective for ADHD in children with comorbid tics . Prior recommendations to avoid methylpheni date in these children because of concerns of worsening tics are unsupported by this trial BACKGROUND Despite the persistence of attention-deficit/hyperactivity disorder ( ADHD ) into adolescence , little is known about the efficacy and tolerability of stimulant medications in this age group . OBJECTIVE To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system ( OROS ) methylpheni date . DESIGN Adolescents ( N = 220 ) having a confirmed Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylpheni date that improved symptoms to predefined criteria . Subjects successfully completing the dose titration phase ( n = 177 ) ( ie , tolerated and responded to treatment and adhered to the protocol ) were r and omized to receive 2 weeks ' treatment with their individualized dosage of OROS methylpheni date ( 18 , 36 , 54 , or 72 mg once daily ) or placebo . Treatment effectiveness was measured using investigator , parent , and adolescent assessment s of ADHD . RESULTS A significant reduction from baseline in the investigator-rated ADHD Rating Scale , the primary efficacy measure , was found with OROS methylpheni date treatment compared with placebo . Similar findings were noted with parent- and adolescent-report measures . Based on a Clinical Global Impression improvement subscale score of much or very much improved , 52 % of subjects in the OROS methylpheni date group improved compared with 31 % receiving placebo . Thirty-seven percent of subjects required the maximum dosage of 72 mg/d . The incidence of drug-related adverse events was similar between the 2 study groups . CONCLUSION In adolescents , once-daily OROS methylpheni date significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d The effects of methylpheni date on the academic performance and classroom behavior of 45 adolescents with attention deficit hyperactivity disorder were studied . During a 6-week , placebo-controlled medication assessment in the context of a summer treatment program , participants received a double-blind , crossover trial of 3 doses of methylpheni date . Dependent measures included note-taking quality , quiz and worksheet scores , written language usage and productivity , teacher ratings , on-task and disruptive behavior , and homework completion . Group data showed positive effects of methylpheni date on academic measures ; however , the greatest benefit came with the lowest dose . Although additional benefit did occur for some participants with higher doses , the largest increment of change usually occurred between the placebo and 10-mg dose . Many adolescents did not experience added benefit with increased dosages , and in some cases they experienced deterioration . Guidelines for assessment of medication effects are discussed OBJECTIVE The effects of stimulant medication treatment were investigated in children with mental retardation ( MR ) and attention-deficit/hyperactivity disorder ( ADHD ) . METHOD Parent and teacher behavioral ratings and reports of side effects were obtained for children ( N = 24 , mean age = 10.9 years , SD = 2.4 ) during a placebo-controlled , double-blind , crossover treatment trial with 0.15 mg/kg , 0.30 mg/kg , and 0.60 mg/kg b.i.d . dosages of methylpheni date . RESULTS The most significant improvements occurred at the 0.60 mg/kg methylpheni date dose for teacher ratings OUTPUT:

There is very-low- quality evidence that clonidine has a small effect on oppositional behaviour and conduct problems in youth with ADHD , with and without ODD or CD . There is moderate- quality evidence that guanfacine has a small-to-moderate effect on oppositional behaviour in youth with ADHD , with and without ODD . There is high- quality evidence that atomoxetine has a small effect on oppositional behaviour in youth with ADHD , with and without ODD or CD . Conclusions : Evidence indicates that psychostimulants , alpha-2 agonists , and atomoxetine can be beneficial for disruptive and aggressive behaviours in addition to core ADHD symptoms ; however , psychostimulants generally provide the most benefit

MS2_dynamic_1_shot673

***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: OBJECTIVE Effects of pump treatment vs. four times daily injections were explored in children with diabetes with regard to quality of life and impact of disease as well as adverse effects and parameters of metabolic control . METHODS An open , parallel , r and omized controlled prospect i ve comparative study lasting 14 months was completed by 38 type 1 children with diabetes ( age 4 - 16 yr ) following a 3.5-months run-in phase . St and ardized quality -of-life Pediatric Quality of life Inventory ( PedsQL ) and impact of disease scores were obtained every 3.5 months as well as regular medical parameters . Parallel treatment group data and longitudinal within-patient data were analysed for each treatment modality . RESULTS Within-patient comparisons of the two treatment modalities showed significant improvement in PedsQL and impact scores after pump treatment . Treatment group comparisons did not show significant improvement . Pump treatment result ed in decreased symptomatic hypoglycaemia and lowered haemoglobin A1c by 0.22 % after run in . CONCLUSIONS Within-patient comparison suggests that metabolic control , frequency of severe hypoglycaemia ( a threefold decrease ) , quality of life and impact of disease scores are improved by pump treatment in comparison to regular treatment with four daily insulin injections BACKGROUND The management of diabetes in preschool children poses unique difficulties for both the families and the medical team . OBJECTIVE To test the feasibility and safety of insulin pump therapy in the 1 - 6 year age group in order to improve quality of life and metabolic control . METHODS The study group comprised 15 type 1 diabetic children aged 1 - 6 years old ( mean + /- SD , 3.8 + /- 1.2 years ) from three diabetes centers . Insulin pump therapy was applied for 12 months . Data , including insulin dose , hemoglobin A1c , hypoglycemic events , as well as scores on the Diabetes Quality of Life Measure Question naire and the Diabetes Treatment Satisfaction Question naire , were collected and compared with the multiple daily injection treatment prior to entry into the study , RESULTS HbA1c was measured at the beginning of the study and at 2 , 4 , 8 and 12 months later ; the respective levels ( mean + /- SD ) were 8.82 + /- 0.98 , 8.45 + /- 1.05 , 8.37 + /- 0.85 , 8.32 + /- 0.71 , 8.18 + /- 0.90 % . HbA1c measurements after 12 months were significantly lower than at the beginning of the study ( P < 0.05 ) . There were no significant differences in insulin dose and the total number of hypoglycemic events . In both the DQOL and DTSQ scales there were significant differences in scores in favor of the insulin pump period ( 43.7 + /- 8.0 versus 33.7 + /- 7.9 , P < 0.001 ; and 10.9 + /- 2.3 versus 14.5 + /- 2.3 , P < 0.001 ) , respectively . CONCLUSIONS For very young diabetic children , insulin pump therapy improves quality of life and is feasible and safe . It should be considered as an optional mode of therapy for this age group OBJECTIVE Our goals were to determine if continuous subcutaneous insulin infusion ( CSII ) , compared with those continuing multiple daily injections ( MDIs ) , can be safely used in young children , if those on CSII will have superior glycemic control , if subjects using CSII will have less hypoglycemia for their level of control , and if families using CSII will report an improved quality of life . RESEARCH DESIGN AND METHODS We conducted a r and omized 1-year feasibility trial comparing CSII with continuing MDIs in preschool children with a history of type 1 diabetes for at least 6 months ' duration . Prospect i ve outcomes included measures of overall glycemic control ( HbA1c and continuous glucose monitoring system ) , the incidence of severe hypoglycemia and diabetic ketoacidosis , the percent of glucose values below 3.9 mmol/l , and the parents ' report of quality of life . RESULTS The 19 subjects ' ages ranged from 1.7 to 6.1 ( mean 3.6 ) years , duration of diabetes ranged from 0.6 to 2.6 ( mean 1.4 ) years , and baseline HbA1c ranged from 6.7 to 9.6 % ( mean 7.9 % ) . Seven subjects were male . Nine subjects were r and omized to start CSII and 10 to continue on MDI . All baseline characteristics were well balanced . Overall metabolic control , diabetes quality of life , and the incidence of hypoglycemia were similar in the two groups . No subject had diabetic ketoacidosis , while one subject in each group had an episode of severe hypoglycemia . No CSII subject discontinued using the pump during or after the study . CONCLUSIONS CSII can be a safe and effective method to deliver insulin in young children BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain . Each study assessment was completed independently by two OUTPUT: RESULTS QoL and glycaemic control was significantly better in CSII subjects at baseline and follow-up . No significant differences in adverse events were found between study groups . No significant changes over time could be shown for either QoL or glycaemic control . CONCLUSION CSII proved to provide similar or slightly better outcomes in all analysed fields . This is consistent with previous research . INPUT: OBJECTIVE To investigate the effects of continuous intraperitoneal insulin infusion ( CIPII ) compared with subcutaneous insulin on health-related quality of life ( HRQOL ) and treatment satisfaction , and to perform a cost analysis in type 1 diabetes . RESEARCH DESIGN AND METHODS We used an open-label , prospect i ve , crossover , r and omized , 16-month study ( N = 24 ) . HRQOL and patient satisfaction were assessed with question naires ( the 36-item short-form health survey [ SF-36 ] , the World Health Organization-Five Well-Being Index [ WHO-5 ] , and the Diabetes Treatment Satisfaction Question naire [ DTSQ ] ) . Direct costs of CIPII and continuous subcutaneous insulin infusion ( CSII ) were compared . RESULTS Question naire scores were higher with CIPII than with subcutaneous therapy . Yearly direct pump- and procedure-associated costs for CIPII were estimated at € 10,910 compared with € 4,810 for CSII . CONCLUSIONS Apart from improving glycemic control , CIPII improved HRQOL and treatment satisfaction compared with subcutaneous insulin . Direct pump- and procedure-associated costs are considerably higher for CIPII , however BACKGROUND In a European trial in 8 countries , the subjective well-being of patients on alternative forms of treatment for insulin-dependent diabetes was compared using the 28-item WHO Well-Being Question naire , covering four dimensions of depression , anxiety , energy and positive well-being . The objective of the analysis reported here has been to identify the items of the WHO question naire which belong to an overall index of negative and positive well-being . METHODS Adult patients at 10 study centres in 8 countries who had been on insulin for at least 2 years were invited to participate in a r and omised , cross-over trial to compare insulin pump treatment with injection therapy . At each phase , patients completed questions on well-being and general health . Internal validity of the well-being index was evaluated by Cronbach 's alpha and Loevinger 's and Mokken 's homogeneity coefficients , as well as factor analysis . External validity was evaluated by comparisons with results of the general assessment questions and by the ability to discriminate between the alternative forms of treatment . RESULTS 358 patients had sufficient data for analysis . Ten items were found to constitute a valid index of well-being with respect to internal and external validity . Coefficients of homogeneity were acceptable and there was evidence for both concurrent and discriminant validity . CONCLUSIONS The WHO ( Ten ) well-being index includes negative and positive aspects of well-being in a single uni-dimensional scale . Its advantage lies in its ability to show overall change along the continuum of well-being , thus facilitating comparisons between patient groups and treatments . It is not specific to diabetes , and therefore may be useful as a disease-independent index of well-being in a broad range of health care studies AIMS Because of the high patient load in Thail and , we need a practical measurement to help primary physicians detect depression . This study aim ed to examine the reliability and validity of the Thai version of the World Health Organization-Five Well-Being Index ( WHO-5-T ) , which is short and easy to use as a screening tool for major depression in primary care patients . METHODS The English version of the WHO-Five Well-Being Index was translated into Thai . Back-translations , cross-cultural adaptation and field testing of the pre-final version with final adjustments were performed accordingly . The WHO-5-T was administered r and omly to 300 patients in our primary care clinic . Then the patients were further assessed using the Mini International Neuropsychiatric Interview and the Hamilton Rating Scale for Depression as the gold st and ard of diagnosis and symptom severity , respectively . RESULTS Completed data were obtained from 274 respondents . Their mean age was 44.6 years [ st and ard deviation ( SD ) = 14.7 ] and 73.7 % of them were female . The mean WHO-5-T score was 14.32 ( SD = 5.26 ) . The WHO-5-T had a satisfactory internal consistency ( Cronbach 's alpha = 0.87 ) and showed moderate convergent validity with the Hamilton Rating Scale for Depression ( r = -0.54 ; P < 0.001 ) . The optimal cut-off score of the WHO-5-T < 12 revealed a sensitivity of 0.89 and a specificity of 0.71 in detecting depression . The area under the curve in this study was 0.86 ( SD = 0.03 , 95 % confidence interval 0.81 to 0.89 ) . CONCLUSIONS The Thai version of the WHO-Five Well-Being Index was found to be a reliable and valid self- assessment to screen for major depression in primary care setting at a cut-off point of < 12 AIMS To estimate harmful alcohol habits in a sample of incident sick-listed individuals compared with a r and om sample from the general population taking social background , health and work-related factors into account . METHODS Data for this cross-sectional question naire study were collected in 2008 in the Västra Götal and region , Sweden . The study population ( 19 - 64 year olds ) consisted of 2888 consecutive incident sick-leave sample ( ISS ) and 3567 individuals from a r and om population sample ( RPS ) . The mailed question naire included Alcohol Use Disorder Identification Test and vali date d instruments on health and work-related factors . Socio-demographic data came from register data . Analyses were made with χ(2 ) tests and logistic regression analyses . RESULTS No differences in prevalence of harmful alcohol habits were found between men in the ISS ( 22 % ) and the R OUTPUT:

The review demonstrated that the WHO-5 has high clinimetric validity , can be used as an outcome measure balancing the wanted and unwanted effects of treatments , is a sensitive and specific screening tool for depression and its applicability across study fields is very high . Conclusions : The WHO-5 is a short question naire consisting of 5 simple and non-invasive questions , which tap into the subjective well-being of the respondents . The scale has adequate validity both as a screening tool for depression and as an outcome measure in clinical trials and has been applied successfully across a wide range of study fields

MS2_dynamic_1_shot674

***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: Background . There is controversy regarding whether hypersensitivity to food proteins contributes to colic among breastfed infants . Methods . A r and omized , controlled trial of a low-allergen maternal diet was conducted among exclusively breastfed infants presenting with colic . In the active arm , mothers excluded cow 's milk , eggs , peanuts , tree nuts , wheat , soy , and fish from their diet ; mothers in the control group continued to consume these foods . Outcomes were assessed after 7 days , as the change in cry/fuss duration over 48 hours , with vali date d charts . The primary end point was a reduction in cry/fuss duration of ≥25 % from baseline . Mothers also assessed the responses to diet with categorical and visual analog scales . Results . Of 107 infants , 90 completed the trial ( mean age : 5.7 weeks ; range : 2.9–8.6 weeks ; 54 male infants ) . Infants in both groups presented with significant distress ( geometric mean : low-allergen group : 690 minutes per 48 hours ; control group : 631 minutes per 48 hours ) . In follow-up assessment s on days 8 and 9 , there were significantly more responders in the low-allergen group ( 74 % vs 37 % ) , ie , an absolute risk reduction of 37 % ( 95 % confidence interval : 18–56 % ) . Cry/fuss duration per 48 hours was reduced by a substantially greater amount in the low-allergen group ; the adjusted geometric mean ratio was 0.79 ( 95 % confidence interval : 0.63–0.97 ) , ie , an average reduction of 21 % ( 95 % confidence interval : 3–37 % ) . Mothers ' subjective assessment s of the responses to diet indicated little difference between the groups . Conclusion . Exclusion of allergenic foods from the maternal diet was associated with a reduction in distressed behavior among breastfed infants with colic presenting in the first 6 weeks of life OBJECTIVE To determine the effect of brief early exposure to cows ’ milk on atopy in the first 2 years of life . DESIGN Double blind , placebo controlled , r and omised feeding intervention trial ( Bokaal study ) . SETTING Dutch midwifery practice s. PARTICIPANTS 1533 breast fed neonates . INTERVENTION Exposure to cows ’ milk protein ( n = 758 ) or a protein free placebo ( n = 775 ) during the first 3 days of life . MAIN OUTCOME MEASURES Clinical atopic disease and any positive radioallergosorbent ( RAST ) tests at 1 year of age . RESULTS Atopic disease in the first year was found in 10.0 % ( cows ’ milk)v 9.3 % ( placebo ) of the children , with a relative risk of 1.07 ; in the second year , atopic disease was found in 9.6 % v 10.2 % , respectively , with a relative risk of 0.94 . Per protocol analysis showed similar results . Any RAST positive test was found in 9.4 % ( cows ’ milk)v 7.9 % ( placebo ) of children , with a relative risk of 1.19 . Stratified analysis for high family risk of allergy showed a doubled incidence of atopic disease but no effect from the intervention . CONCLUSION Early and brief exposure to cows ’ milk in breast fed children does not increase the risk of atopic disease in the first 2 years Background : Little is known about the diagnostic accuracy of atopy patch tests ( APT ) in the clinical practice of pediatric gastroenterology . Moreover , APTs containing purified food extracts have recently become available , but their diagnostic accuracy is largely undefined Thirty seven breast fed infants with eczema were studied to see whether changes in their mothers ' diets affected their skin condition . Nineteen mothers and babies took part in a double blind crossover trial of exclusion of egg and cows ' milk , and 18 took part in open exclusion of 11 foods followed by double blind challenge to those mothers whose infants seemed to respond . Babies were examined at the beginning and end of each dietary period , and the extent and severity of the rash were given a numerical score . The eczema improved in six infants when their mothers avoided egg and cows ' milk and worsened again when these were reintroduced . Two infants suffered gastrointestinal reactions after maternal ingestion of egg and cows ' milk , one developing colitis . Maternal dietary exclusion seems to benefit some breast fed babies with eczema A mixture of neutral short-chain galactooligosaccharides ( scGOS ) and long-chain fructooligosaccharides ( lcFOS ) has been shown to reduce the incidence of atopic dermatitis ( AD ) and infectious episodes during the first 6 mo of life . This dual protection occurred through the intervention period . The present study evaluated if these protective effects were lasting beyond the intervention period . In a prospect i ve , r and omized , double-blind , placebo-controlled design , healthy term infants with a parental history of atopy were fed either a prebiotic-supplemented ( 8 g/L scGOS/lcFOS ) or placebo-supplemented ( 8 g/L maltodextrin ) hypoallergenic formula during the first 6 mo of life . Following this intervention period , blind follow-up continued until 2 y of life . Primary endpoints were cumulative incidence of allergic manifestations . Secondary endpoints were number of infectious episodes and growth . Of 152 participants , 134 infants ( 68 in placebo , 66 in intervention group ) completed the follow-up . During this period , infants in the scGOS/lcFOS group had significantly lower incidence of allergic manifestations . Cumulative incidences for AD , recurrent wheezing , and allergic urticaria were higher in the placebo group , ( 27.9 , 20.6 , and 1 OUTPUT: It is unclear if the prevalence of food allergies is increasing . In high-risk infants , hydrolyzed formulas may prevent cow 's milk allergy but st and ardized definitions of high risk and hydrolyzed formula do not exist . The evidence for the prevalence and management of food allergy is greatly limited by a lack of uniformity for criteria for making a diagnosis INPUT: Background . There is controversy regarding whether hypersensitivity to food proteins contributes to colic among breastfed infants . Methods . A r and omized , controlled trial of a low-allergen maternal diet was conducted among exclusively breastfed infants presenting with colic . In the active arm , mothers excluded cow 's milk , eggs , peanuts , tree nuts , wheat , soy , and fish from their diet ; mothers in the control group continued to consume these foods . Outcomes were assessed after 7 days , as the change in cry/fuss duration over 48 hours , with vali date d charts . The primary end point was a reduction in cry/fuss duration of ≥25 % from baseline . Mothers also assessed the responses to diet with categorical and visual analog scales . Results . Of 107 infants , 90 completed the trial ( mean age : 5.7 weeks ; range : 2.9–8.6 weeks ; 54 male infants ) . Infants in both groups presented with significant distress ( geometric mean : low-allergen group : 690 minutes per 48 hours ; control group : 631 minutes per 48 hours ) . In follow-up assessment s on days 8 and 9 , there were significantly more responders in the low-allergen group ( 74 % vs 37 % ) , ie , an absolute risk reduction of 37 % ( 95 % confidence interval : 18–56 % ) . Cry/fuss duration per 48 hours was reduced by a substantially greater amount in the low-allergen group ; the adjusted geometric mean ratio was 0.79 ( 95 % confidence interval : 0.63–0.97 ) , ie , an average reduction of 21 % ( 95 % confidence interval : 3–37 % ) . Mothers ' subjective assessment s of the responses to diet indicated little difference between the groups . Conclusion . Exclusion of allergenic foods from the maternal diet was associated with a reduction in distressed behavior among breastfed infants with colic presenting in the first 6 weeks of life OBJECTIVE To determine whether administration of Lactobacillus reuteri ( L reuteri ) DSM 17938 is beneficial in breastfed infants with infantile colic . STUDY DESIGN Eighty infants aged < 5 months with infantile colic ( defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 7 days prior to enrollment ) , who were exclusively or predominantly ( > 50 % ) breastfed were r and omly assigned to receive L reuteri DSM 17938 ( 10(8 ) colony-forming units ) ( n = 40 ) or an identically appearing and tasting placebo ( n = 40 ) , both orally , in 5 drops , 1 time daily , for 21 days . The primary outcome measures were the treatment success , defined as the percentage of children achieving a reduction in the daily average crying time ≥ 50 % , and the duration of crying ( minutes per day ) at 7 , 14 , 21 , and 28 days after r and omization . RESULTS The rate of responders to treatment was significantly higher in the probiotic group compared with the placebo group at day 7 ( P = .026 ) , at day 14 ( relative risk ( RR ) 4.3 , 95 % CI 2.3 - 8.7 ) , at day 21 ( RR 2.7 , 95 % CI 1.85 - 4.1 ) , and at day 28 ( RR 2.5 , 95 % CI 1.8 - 3.75 ) . In addition , throughout the study period , the median crying time was significantly reduced in the probiotic group compared with the control group . CONCLUSION Exclusively or predominantly breastfed infants with infantile colic benefit from the administration of L reuteri DSM 17938 compared with placebo The addition of probiotics to infant formula has been shown to be an efficient way to increase the number of beneficial bacteria in the intestine in order to promote a gut flora resembling that of breast-fed infants . The objective of the present study was to evaluate the safety and tolerance of a combination of two probiotic strains in early infancy . A group of 126 newborns were r and omised to receive a prebiotic-containing starter formula supplemented with Lactobacillus paracasei ssp . paracasei and Bifidobacterium animalis ssp . lactis or the same formula without probiotics for the first 3 months of life . A total of eighty infants continued the study until they were aged 6 months . Growth measurements were taken monthly at healthy baby clinics . Diaries were used to monitor behaviour , infections , use of antibiotics , as well as stool characteristics . Normal growth occurred in all infants and no statistically significant differences were detected between the probiotics group and the control group for gain in weight , length and head circumference . Infants in the probiotics group produced softer and more frequent stools during the first 3 months of life . No differences were found in crying and sleeping hours , number of parent-diagnosed infections , antibiotic use , visits to the general practitioner and number of adverse events . The use of a prebiotic-containing starter formula supplemented with L. paracasei ssp . paracasei and B. animalis ssp . lactis in early infancy is safe , well tolerated and has no adverse effects on growth and infant behaviour OBJECTIVE . The goal was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospect i ve r and omized study would improve symptoms of infantile colic . METHODS . Ninety breastfed colicky infants were assigned r and omly to receive either the probiotic L reuteri ( 108 live bacteria per day ) or simethicone ( 60 mg/day ) each day for 28 days . The mothers avoided cow 's milk in their diet . Parents OUTPUT:

AND RELEVANCE Although L reuteri may be effective as treatment for crying in exclusively breastfed infants with colic , there is still insufficient evidence to support probiotic use to manage colic , especially in formula-fed infants , or to prevent infant crying .

MS2_dynamic_1_shot675

***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: PURPOSE Unaccustomed exercise is associated with an elevated plasma creatine kinase ( CK ) , myofibrillar inflammation , and delayed onset muscle soreness ( DOMS ) . Nonsteroidal antiinflammatory drugs ( NSAID ) may attenuate DOMS and indirect indices of inflammation in humans . METHODS We studied the effects of an NSAID ( naproxen sodium ( 500 mg , 2 times a day for 48 h ) ) taken before and after resistance exercise in eight healthy , moderately trained men in a r and omized , double-blind trial . The exercise consisted of unilateral knee concentric/eccentric weight lifting with 6 sets x 10 repetitions at 80 - 85 % of the 1 repetition maximal contraction . Muscle biopsies of each vastus lateralis ( EX = exercised/REST = control ) were taken 24 h after exercise for immunohistochemical staining of inflammatory cells ( leukocyte common antigen ) . At 24 and 48 h postexercise , we also determined DOMS , plasma CK activity , and knee extensor muscle torque . RESULTS Exercise result ed in an increased CK activity at + 24 and + 48 h ( vs preexercise : P < 0.01 ) , with no treatment effect . There were no treatment effects for any of the measured variables except for a return of voluntary knee extension torque to baseline by + 48 h postexercise for NSAID treatment ( P < 0.05 ) . CONCLUSIONS NSAID administration did not alter CK rise , muscle force deficit at 24 h postexercise , nor perceived muscle pain . In addition , the increased CK at 24 h postexercise was not associated with an acute myofibrillar inflammatory cell infiltrate in moderately trained men after resistance exercise Objective : Delayed-onset muscle soreness ( DOMS ) often occurs after unaccustomed eccentric exercise and reduces exercise performance . We aim ed to study the preventive effects of saffron and indomethacin on the biochemical and functional indicators of DOMS after 1-session eccentric exercise . Design : A 10-day , r and omized , double-blind , placebo-controlled , pretest – posttest design . Setting : Controlled research laboratory . Participants : Thirty-nine nonactive male university students r and omly divided into saffron ( n = 12 ) , indomethacin ( n = 12 ) , and control ( n = 15 ) groups . Interventions : Saffron group received 1 capsule containing dried saffron powder ( n = 12 , 300 mg/d ) , indomethacin group received 75 mg indomethacin ( n = 12 , 25 mg thrice a day ) , and control group ( n = 15 ) received placebo capsules , 1 week before and 3 days after eccentric exercise . Ten days before and 24 , 48 , and 72 hours after muscle soreness protocol , the maximum isometric and isotonic forces , plasma creatine kinase ( CK ) , plasma lactate dehydrogenase ( LDH ) , perceived pain , knee range of movement , and thigh circumference were measured . Muscle soreness protocol was performed with a weight load equal to 80 % of the maximum isotonic force in 4 sessions with 20 repetitions and 3-minute rest in between . Main Outcome Measures : This study shows that 10-day supplementation with 300 mg saffron significantly decreased the CK and LDH concentrations ( P < 0.0001 ) . In the saffron group , there was no decline in maximum isometric and isotonic forces after eccentric exercise , but a significant decline in the isometric force was observed in the control group ( P < 0.0001 ) . No pain was reported in the saffron group , whereas the indomethacin group experienced pain before 72 hours ( P < 0.001 ) . Conclusions : Results obtained from the current novel research indicate a strong preventive effect of 10-day supplementation with saffron on the DOMS . Clinical Relevance : The saffron can be used to prevent DOMS and alleviate the DOMS symptoms The effects of two non-steroidal anti-inflammatory drugs ( NSAIDs ) , meclofenamate and diclofenac , in combination with physiotherapy modalities on the rate of healing of acute hamstring muscle tears were studied in a double-blind , placebo-controlled trial . Fourty-four of the 75 patients with this injury recruited were assessed and r and omly allocated to one of three treatment groups : meclofenamate ( 100 mg 3 times a day ) , diclofenac ( 50 mg 3 times a day ) and placebo . All patients received the same intensive physiotherapy treatment over the 7-day treatment period . Patient assessment s were performed on days 1 , 3 and 7 of the 7-day study period and included pain assessment ( visual analogue scale ) , swelling measurement ( thigh circumference measurement at the site of the muscle tear ) and isokinetic muscle performance testing . Treatment produced a significant improvement in all measurements in all groups , but there was no difference in any measurement between groups . However , when only the more severe injuries were analysed , the reported pain score at day 7 was significantly lower in the placebo group than in either the meclofenamate group or the diclofenac group ( P < 0.05 ) . Hence this study did not find any additive effect on the healing of acute muscle injuries when meclofenamate or diclofenac was added to st and ard physiotherapeutic modalities . The study therefore does not support the use of NSAIDs in the treatment of acute hamstring muscle injuries Objective To investigate the effect of epicutaneously applied Diractin ® ( ketoprofen in Trans OUTPUT: Conclusion : Overall , our analysis supports NSAID use for reducing strength loss , soreness , and blood creatine kinase level after an acute muscle injury , at least for humans and in the short term . INPUT: Objective : Delayed-onset muscle soreness ( DOMS ) often occurs after unaccustomed eccentric exercise and reduces exercise performance . We aim ed to study the preventive effects of saffron and indomethacin on the biochemical and functional indicators of DOMS after 1-session eccentric exercise . Design : A 10-day , r and omized , double-blind , placebo-controlled , pretest – posttest design . Setting : Controlled research laboratory . Participants : Thirty-nine nonactive male university students r and omly divided into saffron ( n = 12 ) , indomethacin ( n = 12 ) , and control ( n = 15 ) groups . Interventions : Saffron group received 1 capsule containing dried saffron powder ( n = 12 , 300 mg/d ) , indomethacin group received 75 mg indomethacin ( n = 12 , 25 mg thrice a day ) , and control group ( n = 15 ) received placebo capsules , 1 week before and 3 days after eccentric exercise . Ten days before and 24 , 48 , and 72 hours after muscle soreness protocol , the maximum isometric and isotonic forces , plasma creatine kinase ( CK ) , plasma lactate dehydrogenase ( LDH ) , perceived pain , knee range of movement , and thigh circumference were measured . Muscle soreness protocol was performed with a weight load equal to 80 % of the maximum isotonic force in 4 sessions with 20 repetitions and 3-minute rest in between . Main Outcome Measures : This study shows that 10-day supplementation with 300 mg saffron significantly decreased the CK and LDH concentrations ( P < 0.0001 ) . In the saffron group , there was no decline in maximum isometric and isotonic forces after eccentric exercise , but a significant decline in the isometric force was observed in the control group ( P < 0.0001 ) . No pain was reported in the saffron group , whereas the indomethacin group experienced pain before 72 hours ( P < 0.001 ) . Conclusions : Results obtained from the current novel research indicate a strong preventive effect of 10-day supplementation with saffron on the DOMS . Clinical Relevance : The saffron can be used to prevent DOMS and alleviate the DOMS symptoms Acetylsalicylic acid ( ASA ) is a short-acting oral inhibitor of the cyclooxygenase enzyme . Ingestion of ASA is associated with a decrease in prostagl and ins , including those of the E2 series , as well as prostacyclin , and thromboxane . Consumption of therapeutic doses is associated with decreased pain and inflammation and is therefore used in a variety of inflammatory conditions . Platelet aggregation is also inhibited . Because of these observations , and the fact that platelet aggregation has been noted to be altered during exercise , the effects of ASA on exercise tolerance was of interest . We studied 17 healthy male volunteers who regularly ran as a source of exercise . During the study they ingested either 650 mg of ASA or placebo 30 min before running 2 miles ( 3.2 km ) . Outcome of the double-blind crossover study was measured by the time required to run a 2-mile distance . No differences between ASA or placebo were noted in the subjects . These data suggest that 650 mg of ASA as a premedication has little effect on exercise performance in normal endurance runners . However , whether ASA may affect pain after exercise or whether other dosage intervals would be more beneficial needs further study Hudson , GM , Green , JM , Bishop , PA , and Richardson , MT . Effects of caffeine and aspirin on light resistance training performance , RPE , and pain perception . J Strength Cond Res 22(6 ) : 1950 - 1957 , 2008-This study compared independent effects of caffeine and aspirin on muscular endurance ( repetitions ) , heart rate ( HR ) , perceived exertion ( RPE ) , and perceived pain index ( PPI ) during light resistance training bouts performed to volitional failure . It was hypothesized that the hypoalgesic properties of these ergogenic aids would decrease pain perception and potentially result in enhanced performance . College-aged men ( n = 15 ) participated in a within-subjects , double-blind study with three independent , counterbalanced sessions wherein aspirin ( 10 mg·kg−1 ) , caffeine ( 6 mg·kg−1 ) , or matched placebo were ingested 1 hour before exercise , and RPE , HR , PPI , and repetitions ( per set and total per exercise ) were recorded at 100 % of individual , predetermined , 12-repetition maximum for leg extensions ( LE ) and seated arm curls ( AC ) . Repeated- measures analyses of variance were used for between-trial comparisons . Caffeine result ed in significantly greater ( p < 0.05 ) HR ( LE and AC ) , total repetitions ( LE ) , and repetitions in set 1 ( LE and AC ) compared with aspirin and placebo . Aspirin result ed in significantly higher PPI in set 1 ( LE ) . In LE , 47 % of participants ' performance exceeded the predetermined effect size ( ≥ 5 repetitions ) for total repetitions , with 53 % exceeding the effect size ( ≥ 2 repetitions ) for repetitions in set 1 with caffeine ( vs. placebo ) . In AC , 53 % ( total repetitions ) and 47 % ( set 1 repetitions ) of participants exceeded effect sizes with caffeine ( vs. placebo ) , with only 13 % experiencing decrements in performance ( total repetitions ) . Aspirin also produced a higher PPI and RPE overall and in set 1 ( vs. placebo ) . This study demonstrates that caffeine significantly enhanced resistance training performance in LE OUTPUT:

There was neither significant difference in the maximum performance between NSAIDs and control groups nor in the time until exhaustion nor in self-perceived pain .

MS2_dynamic_1_shot676

***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: Background —In patients with atrial fibrillation ( AF ) undergoing radiofrequency ( RF ) electrical disconnection of multiple pulmonary veins ( PVs ) , the incidence of late conduction recurrences has not been systematic ally determined . Methods and Results —Using a prospect ively design ed , multistep approach , we aim ed at assessing the correlation between acute achievement and chronic maintenance of electrical conduction block across RF lesions disconnecting the distal tract of the PV in 43 patients ( 52.3±8.2 years ) with AF . Forty-one left superior ( LS ) , 42 right superior ( RS ) , 25 left inferior ( LI ) , and 9 right inferior ( RI ) PVs were targeted during 108 EP procedures ( 2.6±0.5 per patient ) . Seventeen patients underwent 2 procedures , 23 patients underwent 3 procedures , and 3 patients underwent 4 procedures . During the first attempt , electrical disconnection was achieved in 112 PVs ( 95.7 % ) . During a next procedure ( time interval , 4.6±1.9 months ) , conduction recurrence was observed in 32 of 39 LSPVs ( 82.1 % ) , 29 of 40 RSPVs ( 72.5 % ) , 20 of 24 LIPVs ( 83.3 % ) , and 7 of 9 RIPV ( 77.8 % ) . After reablation at gap sites , a later procedure ( time interval , 5.1±2.4 months ) revealed a second recurrence in 13 of 22 LSPVs ( 59.1 % ) and 14 of 19 RSPVs ( 73.7 % ) . Conclusions —Conduction recurrence across disconnecting RF lesions can be observed in ≈80 % of cases 4 months after ablation . After reablation , similar recurrence rates are observed 5 months later . This high rate of late conduction recurrence may contribute significantly to AF recurrence in patients undergoing catheter ablation aim ing at disconnection of multiple PVs BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium . OBJECTIVE The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes . METHODS Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter . In 25 patients , ablation was guided by real-time contact force measurements ( CF group ; SmartTouch , Biosense Webster ) . A control group of 50 patients underwent PVI using a st and ard nonforce sensing catheter ( st and ard group ; ThermoCool , Biosense Webster ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed up at 3 , 6 , and 12 months and by transtelephonic monitoring as well . RESULTS Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs ( 8 % ; 16 % of patients ) in the CF group and 35 PV pairs ( 35 % ; 52 % of patients ) in the st and ard group ( P = .0004 per PV pair ; P = .0029 per patient ) . The single-procedure , off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88 % in the CF group vs 66 % in the st and ard group ( P = .047 ) . Procedure duration and fluoroscopy time were significantly longer in the CF group ( P = .0038 and P = .0001 , respectively ) . CONCLUSION The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias . The utility of a contact force-guided approach requires evaluation in a long-term prospect i ve r and omized study BACKGROUND Contact force ( CF ) information may improve the safety and efficacy of ablation for paroxysmal atrial fibrillation ( PAF ) . OBJECTIVE The purpose of this study was to assess the impact of CF data on ablation for PAF . METHODS Patients undergoing first-time PAF ablation were r and omized at 7 UK centers to ablation with ( CF-on ) or without ( CF-off ) CF data available to the operator , using the same ablation catheter and mapping system . An ablation CF of 5 - 40 g was targeted . Pulmonary vein ( PV ) reconnection was assessed with adenosine at 60 minutes . Follow-up for arrhythmia recurrence was for 1 year with 7-day Holter recordings at 6 and 12 months . RESULTS One hundred seventeen patients were studied ( 59 CF-on , 58 CF-off ) . In the CF-on group , a reduction in acute PV reconnection rates ( 22 % vs 32 % , P = .03 ) but no significant difference in 1-year success rates off antiarrhythmic drugs ( 49 % vs 52 % , P = .9 ) was observed . There was no difference in major complication rates : 2 of 59 ( 3 % ) CF-on , 3 of 58 ( 5 % ) CF-off ( P = .7 ) . Procedural and fluoroscopy times were not significantly different ( P>.5 ) . Overall mean CFs per ablation were not different between groups ( 13.4 [9.1 - 19.6]g CF-on , 13.4 [7.4 - 22.4]g CF-off , P = .5 ) , but a greater proportion of readings in the CF-on group were in the target range OUTPUT: Conclusion : CF‐guided RF catheter ablation was associated with a significant AF/atrial tachycardia‐free survival benefit compared with non‐CF‐guided ablation in patients with paroxysmal AF rather than persistent AF . In addition , CF‐guided ablation strategy also reduced the procedure time , fluoroscopy time , as well as RF time despite no distinct effect on the alleviation of procedure‐related complications INPUT: Background — Data regarding the long-term efficacy of atrial fibrillation ( AF ) ablation are still lacking . Methods and Results —Two hundred four consecutive patients symptomatic for paroxysmal or persistent/permanent AF were r and omly assigned to 2 different ablation schemes : pulmonary vein isolation ( PVI ) and PVI plus left linear lesions ( LL ) . Primary end point was to assess the maintenance of sinus rhythm ( SR ) after procedures 1 and 2 in the absence of antiarrhythmic drugs in a long-term follow-up of at least 3 years . Paroxysmal AF — With a single procedure at 12-month follow-up , 46 % of patients treated with PVI maintained SR , whereas at 3-year follow-up , 29 % were in SR ; using the “ PVI plus LL ” at the 12-month follow-up , 57 % of patients were in SR , whereas at the 3-year follow-up , 53 % remained in SR . After a second procedure , the long-term overall success rate without antiarrhythmic drugs was 62 % with PVI and 85 % with PVI plus LL . Persistent/Permanent AF — With a single procedure at the 12-month follow-up , 27 % of patients treated with PVI were in SR , whereas at the 3-year follow-up , 19 % maintained SR ; using the PVI plus LL with a single procedure at the 12-month follow-up 45 % of patients were in SR , whereas at the 3-year follow-up , 41 % remained in SR . After a second procedure , the long-term overall success rate without antiarrhythmic drugs was 39 % with PVI and 75 % with PVI plus LL . Conclusions —A long-term follow-up of AF ablation shows that short-term results can not be considered permanent because AF recurrences are still present after the first year especially in patients who have had “ PVI ” strategy . PVI isolation plus LL is superior to the PVI strategy in maintaining SR without antiarrhythmic drugs after procedures 1 and 2 both in paroxysmal and persistent AF Background — Information on comparative outcome between radiofrequency catheter ablation ( RFA ) and antiarrhythmic drugs ( AADs ) > 1 year after r and omization is important for clinical decision-making . Methods and Results — A total of 198 patients ( age , 56±10 years ) with paroxysmal atrial fibrillation were r and omly assigned to RFA ( 99 patients ) or to AADs ( 99 patients ) . We evaluated efficacy of RFA or AADs in a comparable 48-month follow-up period according to intention-to-treat analysis . Cardiac rhythm was assessed with daily transtelephonic transmissions . Quality of life was also analyzed . At 4 years , among the 99 patients first assigned to RFA , the procedure was repeated because of recurrent atrial fibrillation/atrial tachycardia in 27 patients ( 27.3 % ) . Among the 99 patients r and omly assigned to AADs , 87 ( 87.9 % ) crossed over to undergo RFA and 4 years after r and om assignment only 12 ( 12.1 % ) were in sinus rhythm with AAD alone without ablation . Despite the high level of crossovers , at 4 years the intention-to-treat analysis showed that 72.7 % of patients in the ablation arm and 56.5 % of those initially r and omly assigned to AADs were free of recurrent atrial fibrillation/atrial tachycardia ( P=0.017 ) . During the follow-up , 19.2 % of AAD patients progressed to persistent atrial fibrillation before switching to RFA . RFA significantly improved quality of life ( P<0.001 ) , whereas before crossing over to RFA , patients receiving AADs showed poorer quality of life . Except for new left atrial tachycardia , there were no serious complications caused by RFA . Conclusions — With follow-up extended to 4 years after r and omly assigned , ablation remains superior to antiarrhythmic drug in these patients with paroxysmal atrial fibrillation . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00340314 Small , single-center studies suggest that catheter ablation of atrial fibrillation ( AF ) can improve ventricular function and reduce symptoms in patients with left ventricular ( LV ) dysfunction . However , ablation has not been compared with a pharmacologic strategy for AF . The authors evaluated patients with AF and symptomatic LV dysfunction ( ejection fraction < or = 45 % ) referred for pulmonary vein isolation ( PVI ) . They compared these patients with a matched cohort treated medically for AF and LV dysfunction via a retrospective case-control method . Fifteen patients ( 14 men , 56+/-11 years , 10 [ 67 % ] paroxysmal AF ) with AF for 4+/-3 years underwent PVI . Baseline ejection fraction was 37%+/-6 % and New York Heart Association ( NYHA ) class was 2.0+/-1.0 . Fifteen controls ( 13 men , 63+/-14 years , 11 [ 73 % ] paroxysmal AF ) with AF for 5+/-4 years were treated medically for AF . Baseline ejection fraction was 34%+/-11 % and NYHA class was 2.0+/-0.7 . The groups were similar in all respects . During a follow-up of 16+/-13 months after complete PVI , ejection fraction improved ( P=.001 ) to 50%+/-13 % and normalized in 8 patients ( 53 % ) . NYHA class improved to 1.3+/-0.5 ( P=.01 ) . In the medically treated group , after follow-up of 16+/-12 months , no improvement in ejection fraction ( 36%+/-12 % OUTPUT:

AFCA efficacy in patients with impaired left ventricular systolic function improves when performed early in the natural history of atrial fibrillation and heart failure . AFCA provides long-term benefits on left ventricular function , significantly reducing the number of patients with severely impaired systolic function

MS2_dynamic_1_shot677

***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: OBJECTIVES The Wong-Baker FACES Pain Rating Scale ( WBS ) , used in children to rate pain severity , has been vali date d outside the emergency department ( ED ) , mostly for chronic pain . The authors vali date d the WBS in children presenting to the ED with pain by identifying a corresponding mean value of the visual analog scale ( VAS ) for each face of the WBS and determined the relationship between the WBS and VAS . The hypothesis was that the pain severity ratings on the WBS would be highly correlated ( Spearman 's rho > 0.80 ) with those on a VAS . METHODS This was a prospect i ve , observational study of children ages 8 - 17 years with pain presenting to a suburban , academic pediatric ED . Children rated their pain severity on a six-item ordinal faces scale ( WBS ) from none to worst and a 100-mm VAS from least to most . Analysis of variance ( ANOVA ) was used to compare mean VAS scores across the six ordinal categories . Spearman 's correlation ( rho ) was used to measure agreement between the continuous and ordinal scales . RESULTS A total of 120 patients were assessed : the median age was 13 years ( interquartile range [ IQR ] = 10 - 15 years ) , 50 % were female , 78 % were white , and six patients ( 5 % ) used a language other than English at home . The most commonly specified locations of pain were extremity ( 37 % ) , abdomen ( 19 % ) , and back/neck ( 11 % ) . The mean VAS increased uniformly across WBS categories in increments of about 17 mm . ANOVA demonstrated significant differences in mean VAS across face groups . Post hoc testing demonstrated that each mean VAS was significantly different from every other mean VAS . Agreement between the WBS and VAS was excellent ( rho = 0.90 ; 95 % confidence interval [ CI ] = 0.86 to 0.93 ) . There was no association between age , sex , or pain location with either pain score . CONCLUSIONS The VAS was found to have an excellent correlation in older children with acute pain in the ED and had a uniformly increasing relationship with WBS . This finding has implication s for research on pain management using the WBS as an assessment tool 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 In a r and omized double-blind study of 57 children ( aged 6 months-6 yr ) , pain following lateral thoracotomy was relieved with repeated i.v . doses of morphine 100 or 50 micrograms kg-1 , or buprenorphine 3.0 or 1.5 micrograms kg-1 . The same drug and dosage were continued and cardioventilatory indices , pain intensity and sedation measured for an observation period of 24 h. The sums of the pain intensity differences were equal in all groups . The mean doses for the complete initial analgesia were 230 and 180 micrograms kg-1 with the larger and the smaller bolus doses of morphine and 5.8 and 3.7 micrograms kg-1 with buprenorphine , respectively . The mean duration of action of buprenorphine was slightly but not significantly longer than that of morphine . The total consumption of both morphine and buprenorphine was less when the smaller bolus doses were used . Two patients developed a degree of ventilatory depression following repeated doses of buprenorphine . Buprenorphine was equal to morphine as a postoperative analgesic This study was a prospect i ve , r and omized comparison of the ventilatory effects of equianalgesic single‐doses of morphine , 100 μg/kg , and buprenorphine , 3.0 μg/kg , administered intravenously to 20 children ( 5–8 years of age ) after elective ophthalmic surgery . The decrease in ventilatory rate and acute change in the arteriolar oxygen saturation and the increase in end‐tidal CO2 levels were statistically significantly greater in magnitude and duration after buprenorphine than after morphine . For both drugs , the time , duration and magnitude of ventilatory changes varied appreciably between individuals . No child had apnea or hypoventilation requiring assistance . The authors conclude that acutely administered buprenorphine depresses ventilation to a greater degree than morphine . The maximal ventilatory effect of buprenorphine occurs later than with morphine , and ventilatory depression after buprenorphine may develop late . For safety , all children given opioids intravenously should be observed until they are fully responsive and ventilatory control has stabilized The safety and efficacy of buprenorphine and morphine as postoperative analgesicsfor children were compared in 60 boys and girls 4 to 14 years old having elective orthopedic operations on upper or lower extremities . The drugs were given in a double-blind manner initially intravenously and thereafter by sublingual buprenorphine or intramuscular morphine administered as required to relieve pain until the third postoperative morning . The IV dose needed to achieve complete initial analgesia was 5.2 ± 2.8 μg/kg buprenorphine and 166 ± 100 μg/kg morphine . The duration of effect was significantly longer with buprenorphine than with morphine , 248 ± 314 and 114 ± 109 minutes , respectively ( P = 0.03 ) . The most common side effects were nausea and vomiting ( 28 and 16 % ) and urinary retention ( 21 and 19 % ) in the buprenorphine and morphine groups , respectively . Analgesia with sublingual buprenorphine was as effective and reliable as with intramuscular morphine but a longer duration of action could not be demonstrated The study describes long term ventil OUTPUT: There was no significant difference in the rates of adverse effects . Conclusions Buprenorphine provided a longer duration of analgesia than morphine . This in combination with its unique sublingual preparation could prove particularly advantageous in the paediatric population . INPUT: Objective : To examine the language development at corrected age 4 years of a regionally representative cohort of children born very preterm ( VPT ) . Of particular interest was the identification of biological and socioenvironmental risk and protective factors that influence VPT children 's early language development . Method : Data were collected as part of a prospect i ve longitudinal study of 110 VPT ( VPT : ≤33 weeks gestation ) and 113 full-term children ( full term : 37–41 weeks gestation ) born in Canterbury , New Zeal and from 1998 to 2000 . At corrected age 4 years , all children were assessed with the preschool version of the Clinical Evaluation of Language Fundamentals . Extensive information was also collected about children 's family social background , perinatal health , childrearing environment , education/intervention exposures , and neurodevelopmental progress from birth to age 4 . Results : At the age of 4 years , VPT children were characterized by poorer receptive and expressive language development than full-term children . These differences persisted after exclusion of children with neurosensory impairment as well as statistical adjustment for the effects of social risk . Within the VPT group , the key predictors of children 's overall language development were family social risk at birth ( p = .05 ) , severity of white matter abnormalities on neonatal magnetic resonance imaging ( p = .49 ) , observed parent-child synchrony ( p = .001 ) , and concurrent child cognitive ability ( p = .001 ) . Together , these factors accounted for 45 % of the variance in children 's total Clinical Evaluation of Language Fundamentals — Preschool scores . Conclusion : By preschool age , children born VPT show early emerging mild to moderate language delays that are likely to affect their school success and longer-term developmental progress . Findings highlight the importance of potentially modifiable factors such as early brain injury and parenting quality in predicting the language outcomes of children born VPT OBJECTIVES : The goal was to examine whether indomethacin use , gender , neonatal , and sociodemographic factors predict patterns of receptive language development from 3 to 12 years of age in preterm children . METHODS : A total of 355 children born in 1989–1992 with birth weights of 600 to 1250 g were evaluated at 3 , 4.5 , 6 , 8 , and 12 years with the Peabody Picture Vocabulary Test-Revised . Hierarchical growth modeling was used to explore differences in language trajectories . RESULTS : From 3 to 12 years , preterm children displayed catch-up gains on the Peabody Picture Vocabulary Test-Revised . Preterm children started with an average st and ardized score of 84.1 at 3 years and gained 1.2 points per year across the age period studied . Growth-curve analyses of Peabody Picture Vocabulary Test-Revised raw scores revealed an indomethacin-gender effect on initial scores at 3 years , with preterm boys assigned r and omly to receive indomethacin scoring , on average , 4.2 points higher than placebo-treated boys . However , the velocity of receptive vocabulary development from 3 to 12 years did not differ for the treatment groups . Children with severe brain injury demonstrated slower gains in skills over time , compared with those who did not suffer severe brain injury . Significant differences in language trajectories were predicted by maternal education and minority status . CONCLUSION : Although indomethacin yielded an initial benefit for preterm boys , this intervention did not alter the developmental trajectory of receptive language scores . Severe brain injury leads to long-term sequelae in language development , whereas a socioeconomically advantaged environment supports better language development among preterm children Background : Major neurological h and icaps and neuropsychological disturbances are more common in ex-preterm children than their counterparts born at term . Objective : To establish in a prospect i ve study whether a characteristic neuropsychological profile exists in ex-preterm children who do not exhibit neurodevelopmental deficits on routine clinical examination . Methods : Thirty intellectually normal children born preterm ( 30–34 weeks gestation ) without major neurological disabilities and a control group of term children matched for age , sex , and parental educational and occupational status were assessed at 3–4 years of age to obtain a complete neuropsychological profile . Intellectual ability , language comprehension and expression , perceptual and visual motor function , working memory , and attention and behavioural problems were investigated . Results : Even in the absence of major neurological signs , children born preterm achieved lower mean scores than controls on the Stanford-Binet intelligence scale ( 110.8 v 121 , p<0.001 ) , visual perception test ( 33.8 v 42.7 , p<0.001 ) , visual motor integration test ( 42.6 v 47.4 , p = 0.049 ) , memory for location test ( 8.4 v 9.5 , p = 0.007 ) , sustained attention test ( 41.6 v 51.5 , p = 0.009 ) , and the picture vocabulary test ( 33.3 v 44.7 , p = 0.021 ) . Conclusions : Neuropsychological abnormalities can be detected early in childhood in apparently normal ex-preterm children and are consistent with a growing body of evidence that prematurity may be associated with long term neuropsychological morbidity in childhood and adolescence OUTPUT:

RESULTS : Preterm-born children scored significantly lower compared with term-born children on simple ( d = –0.45 [ 95 % CI : –0.59 to –0.30 ] ; P < .001 ) and on complex ( d = –0.62 [ 95 % CI : –0.82 to –0.43 ] ; P < .001 ) language function tests , even in the absence of major disabilities and independent of social economic status . : While growing up , preterm-born children have increasing difficulties with complex language function

MS2_dynamic_1_shot678

***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: Objective : To prospect ively compare the functional outcome associated with cemented and uncemented hemiarthroplasty . Design : Prospect i ve r and omized control trial . Setting : University-affiliated level 1 trauma center . Patients / Participants : All individuals design ated for hemiarthroplasty , older than 55 years , with a nonpathologic displaced femoral neck fracture and the ability to ambulate 10 feet independently before injury [ 269 patients ( 274 hips ) presented with displaced femoral neck fracture , 130 patients ( 48.3 % ) enrolled , and 5 patients ( 3.8 % ) withdrew ] . Intervention : Hip hemiarthroplasty with a cemented femoral prosthesis ( VerSys LD/Fx ; Zimmer , Warsaw , IN ) or an uncemented component ( VerSys Beaded FullCoat ; Zimmer , Warsaw , IN ) . Main Outcome Measures : Instrumental Activities of Daily Living and Physical Activities of Daily Living scales ( Older Americans Re sources and Services Instrument ) and the Energy/Fatigue Scale . Results : No statistically significant differences were present in the groups ' preoperative or intraoperative characteristics , including American Society of Anesthesiologists grade , operative time , anesthesia time , use of perioperative & bgr;-blockers , estimated blood loss , or the rate of intraoperative fracture . Postoperatively , no difference was found in hemoglobin level , transfusion rate , discharge disposition , or acute complication rate . At 30-day , 60-day , and 1-year follow-ups , no clinical ly or statistically significant differences were found in mortality , disposition , need for assistance with ambulation , Older Americans Re sources and Services Activities of Daily Living subscales , or the Energy/Fatigue Scale . Conclusions : In the treatment of nonpathologic displaced femoral neck fractures , the use of cemented and uncemented femoral components is associated with similar functional outcome at 1 year . Practitioners may inform their clinical decisions using these equally good results . Level of Evidence : Therapeutic Level II . See page 128 for a complete description of levels of evidence Hip hemiarthroplasties are frequently performed for displaced femoral neck fractures . The purpose of this study was to identify the costs associated with cementless and cemented hemiarthroplasties , compare operative times , and identify complications . The hypothesis was that cementless hemiarthroplasties cost less than cemented hemiarthroplasties , require less operative time , and have fewer perioperative complications . A retrospective review was conducted of 2 surgeons ' patients admitted for displaced femoral neck fractures between 2006 and 2010 . Group 1 included 45 patients who underwent monopolar hemiarthroplasties with cementless femoral components via a st and ard posterior approach by a single surgeon . Group 2 included 49 patients who underwent monopolar hemiarthroplasties with cemented femoral components via a modified lateral approach by a single surgeon . Surgical and anesthesia times and the cost of implants and accessories were recorded . The cost for cementless components was $ 3275.60 ( femoral stem , $ 2800 ; monopolar head , $ 400 ; sleeve , $ 75.60 ) , whereas the cost of cemented components was $ 3694.47 ( femoral stem , $ 1800 ; monopolar head , $ 400 ; sleeve , $ 75.60 , 3 Simplex with tobramycin cement packets , $ 1221 ; cement mixer/irrigator with tip/ central izer and plug/pressurizer , $ 197.87 ) , a cost savings of 12.7 % ( $ 418.87 ) . Operative time was significantly reduced in group 1 vs group 2 ( mean , 32.9 vs 56.1 minutes , respectively ; P<.01 ) . Anesthesia time was also significantly reduced in group 1 ( mean , 82.3 vs 102.9 minutes , respectively ; P<.01 ) . The difference in mean anesthetic times demonstrates an overall cost savings of 18.6 % , or $ 1161.30 . No difference in complications was noted between the groups perioperatively . Regional cost variances , vendor-hospital contracts , and surgeons ' operative times are factors that may influence cost savings . This study demonstrates significantly lower operative and anesthetic times and observable cost savings with cementless femoral implants Background Displaced femoral neck fractures usually are treated with hemiarthroplasty . However , the degree to which the design of the implant used ( cemented or uncemented ) affects the outcome is not known and may be therapeutically important . Questions / purpose sIn this r and omized controlled trial , we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of ( 1 ) Harris hip scores ; ( 2 ) femoral fractures ; ( 3 ) overall health outcomes using the Barthel Index and EQ-5D scores ; and ( 4 ) complications , reoperations , and mortality since our earlier report on this cohort at 1-year followup . Methods We present followup at a median of 5 years after surgery ( range , 56–65 months ) from a r and omized trial comparing a cemented hemiarthroplasty ( 112 hips ) with an uncemented , hydroxyapatite-coated hemiarthroplasty ( 108 hips ) , both with a bipolar head . Results were previously reported at 1-year followup . Harris hip scores , Barthel Index , and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon . Complications and reoperations were determined by chart review and radiographs examined by OUTPUT: There was no statistically significant difference for any other outcome between the two methods of fixation . Conclusion In hemiarthroplasty of the hip using current generation stems , cemented stems result in fewer implant‐related complications and similar mortality compared with cementless stems INPUT: We selected r and omly a consecutive series of 162 patients requiring hip replacement to receive either a cementless , hemispherical , modular , titanium acetabular cup or a cemented , all-polyethylene cup . These replacements were performed by two surgeons in four general hospitals . The same surgical technique was used and a 26 mm metal-head femoral component was used in every case . After exclusions , 115 hips were studied for differences in rates of wear and osteolysis . The mean clinical follow-up was eight years and the mean radiological follow-up , 6.5 years . The cementless cups wore at a mean rate of 0.15 mm per year and the cemented cups at 0.07 mm per year . This difference was significant ( p < 0.0001 ) . Our findings in this mid-term study suggest that cementless cups wear more than cemented cups UNLABELLED The current study was performed to determine the status , at a minimum of twenty-five years , of a prospect i ve , single-surgeon series of patients treated with primary Charnley total hip arthroplasty with a contemporary femoral cementing technique that included use of a distal cement plug and a retro grade cement-delivery system . Since our review at a minimum of twenty years postoperatively , two primary total hip prostheses were revised ( one because of acetabular loosening , and one because of femoral loosening ) . Of the original cohort of 357 hips ( 320 patients ) , ten ( 2.8 % ) had revision of the femoral stem because of aseptic loosening . Forty-nine patients ( fifty-two hips , 14.6 % ) who had been in the initial study group were still living at the time of the present review . Five hips ( 10 % ) in living patients had required a femoral revision because of aseptic loosening . Including those that were revised , eight femoral components ( 17 % ) in living patients were seen to be loose radiographically . Although this study demonstrates the remarkable durability of the femoral fixation obtained with the polished flatback Charnley prosthesis and the contemporary cementing technique , there was some deterioration of the results with time . These results provide a st and ard for comparison with cementless fixation after hips treated with that technique have been followed for a similar duration . LEVEL OF EVIDENCE Therapeutic Level IV . See Instructions to Authors for a complete description of levels of evidence OBJECTIVE To determine the prevalence of heterotopic bone formation in cemented versus noncemented total hip joint replacement . DESIGN A prospect i ve r and omized controlled trial . Follow-up ranged from 2 to 6 years ( mean 4 years ) . SETTING A university hospital . PATIENTS Two hundred and twenty-six patients who had primary or secondary osteoarthrosis of the hip were stratified according to type of fixation , surgeon and age . Patients were r and omized within strata : 112 received noncemented total hip prostheses and 114 received cemented prostheses . The 2 groups were similar with respect to age and sex . INTERVENTION Primary total hip arthroplasty . A cemented ( methylmethacrylate ) or noncemented prosthesis was inserted by a lateral surgical approach . MAIN OUTCOME MEASURE The Brooker classification was used to grade heterotopic bone formation from postoperative radiographs . RESULTS Overall , 148 ( 66 % ) hips had no heterotopic ossification , 56 ( 25 % ) were Brooker class I , 14 ( 6 % ) were class II , 8 ( 3 % ) were class III and none were class IV . In the noncemented group of patients , 76 ( 68 % ) hips had no heterotopic ossification , 25 ( 22 % ) were Brooker class I , 7 ( 6 % ) were class II , 4 ( 4 % ) were class III and none were class IV . In the cemented group of patients , 72 ( 63 % ) hips had no heterotopic ossification , 31 ( 27 % ) hips were Brooker class I , 7 ( 6 % ) were class II , 4 ( 4 % ) were class III and none were class IV . CONCLUSION There was no significant difference in the prevalence of heterotopic ossification between cemented and noncemented total hip replacements in patients with osteoarthrosis This study compares cemented ( Charnley ) with noncemented ( Honart Patel-Garches ) total hip arthroplasty . 150 patients with osteoarthritis , rheumatoid arthritis , and miscellaneous conditions were r and omized into either group with 75 in each . Patients were evaluated over 5 postoperative years with examinations at 6 months , at 1 year , and then annually . Each examination involved clinical assessment , objective gait analysis , and radiographic examination . The Charnley group improved faster than the HP-Garches group during the first 2 years . At the last evaluation the results were excellent or good in 79 % in the Charnley group and 70 % in the HP-Garches group . In the HP-Garches group midthigh pain occurred in 64 % . Five patients with Charnley prostheses ( 6.7 % ) and 14 patients with HP-Garches prostheses ( 18.7 % had revision surgery to correct mechanical loosening . St and ard radiography revealed radiolucent zones in both groups , but this could not be related to the clinical outcome despite radiolucency being present in all noncemented replacements on the femoral side . Objective gait analysis confirmed inferior clinical results at 6 months in the HP-Garches group . There was no significant difference between the groups at the most recent evaluation . Our findings are not consistent with earlier optimistic expectations on press-fit noncemented total hip arthroplasties In a r and omized clinical trial of cemented and c OUTPUT:

A best evidence analysis for complications , wear , osteolysis , migration and clinical scores showed no superiority for either cemented or cementless socket in the RCTs . A best evidence analysis for non RCT studies revealed better osteolysis , migration properties and aseptic loosening survival for cementless sockets ; however , wear and overall survival favoured the cemented sockets .

MS2_dynamic_1_shot679

***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: Abstract : To examine the risk of mortality following all clinical fractures , we followed 6459 women age 55–81 years participating in the Fracture Intervention Trial for an average of 3.8 years . All fractures and deaths were confirmed by medical record or death certificate . Clinical fractures were fractures that came to medical attention . Fracture status was used as a time-dependent covariate in proportional hazards models . The 907 women who experienced a fracture were older , had lower bone mineral density and were more likely to report a positive fracture history . A total of 122 women died over the course of the study with 23 of these deaths occurring after a clinical fracture . The age-adjusted relative risk ( 95 % confidence intervals ) of dying following a clinical fracture was 2.15 ( 1.36 , 3.42 ) . This primarily reflected the higher mortality following a hip fracture , 6.68 ( 3.08 , 14.52 ) ; and clinical vertebral fracture , 8.64 ( 4.45 , 16.74 ) . Results were similar after adjusting for treatment assignment , health status and specific common comorbidities . There was no increase in mortality following a forearm or other fracture ( non-hip , non-wrist , non-vertebral fracture ) . In conclusion , clinical vertebral fractures and hip fractures are associated with a substantial increase in mortality among a group of relatively healthy older women We examined the effect of alendronate treatment for 3 - 4 yr on risk of new fracture among 3658 women with osteoporosis enrolled in the Fracture Intervention Trial . This cohort included women with existing vertebral fracture and those with osteoporosis as defined by T score of less than -2.5 at the femoral neck but without vertebral fracture . All analyses were prespecified in the data analysis plan . The magnitudes of reduction of fracture incidence with alendronate were similar in both groups . The two groups were , therefore , pooled to obtain a more precise estimate of the effect of alendronate on relative risk of fracture ( relative risk , 95 % confidence interval ) : hip ( 0.47 , 0.26 - 0.79 ) , radiographic vertebral ( 0.52 , 0.42 - 0.66 ) , clinical vertebral ( 0.55 , 0.36 - 0.82 ) , and all clinical fractures ( 0.70 , 0.59 - 0.82 ) . Reductions in risk of clinical fracture were statistically significant by 12 months into the trial . We conclude that reductions in fracture risk during treatment with alendronate are consistent in women with existing vertebral fractures and those without such fractures but with bone mineral density in the osteoporotic range . Furthermore , reduction in risk is evident early in the course of treatment . This pooled analysis provides a more precise estimate of the antifracture efficacy of alendronate in women with osteoporosis than that in prior reports The present study describes the biological effects of risedronate , a pyridinyl bisphosphonate , on bone and assesses the safety and tolerability of risedronate when given at high doses , with or without calcium , to postmenopausal women with spinal osteoporosis . This single-center descriptive , double-blind , placebo-controlled , r and omized , parallel group study included 32 postmenopausal white women with at least one radiographically confirmed vertebral compression fracture . Patients were r and omized to one of four different dose regimen groups : ( i ) R-P , risedronate 20 mg/day for 14 days , followed by placebo for 42 days ; ( ii ) R-CP-P , risedronate 20 mg/day for 14 days , followed by elemental calcium 1000 mg/day and placebo for 14 days , then by placebo for 28 days ; ( iii ) R-CP-R-CP , risedronate 20 mg/day for 7 days , followed by elemental calcium 1000 mg/day and placebo for 21 days , then risedronate 20 mg/day for 7 days , and finally elemental calcium 1000 mg/day and placebo for 21 days ; and ( iv ) P , placebo for 56 days . The biological response was investigated by measuring serum calcium , parathyroid hormone ( PTH ) , and 2 h urinary pyridinoline/creatinine ( Pyr/Cr ) and deoxypyridinoline/creatinine ( DPyr/Cr ) ratios at baseline and at days 3 , 7 , 14 , 21 , 28 , 35 , 42 , 49 , 56 , and 84 . Overall , there were no consistent trends observed between the active group and placebo for serum calcium . In groups R-P , R-CP-P , and R-CP-R-CP , mean serum PTH levels were elevated above baseline values for the entire 56 day treatment period and remained elevated , although to a lesser extent , at the day 84 follow-up visit . The effect of calcium supplementation on PTH was variable . Urinary Pyr/Cr and DPyr/Cr ratios were decreased from baseline over the entire study period in all groups receiving risedronate . The maximum observed percent decreases from baseline for Pyr/Cr and DPyr/Cr were -46.9 % and -58.8 % , respectively , at day 49 in the R-CP-R-CP group . In conclusion , risedronate given orally at a dose of 20 mg/day , continuously for 7 or 14 days , result ed in the expected biological response in osteoporotic women . The time course of changes in PTH levels following cessation of OUTPUT: However , observational data has led to concerns regarding the potential risk for upper gastrointestinal injury and , less commonly , osteonecrosis of the jaw . AUTHORS ' CONCLUSIONS At 5 mg/day a statistically significant and clinical ly important benefit in the secondary prevention of vertebral , non-vertebral and hip fractures was observed , but not for wrist . There were no statistically significant reductions in the primary prevention of vertebral and non-vertebral fractures . INPUT: OBJECTIVES Roux-en-Y gastric bypass surgery is the most commonly performed procedure for the treatment of morbid obesity . This anatomical alteration may affect the absorption and consequently the bioavailability of oral drugs . This study aims to investigate the oral bioavailability of moxifloxacin in 12 healthy volunteers who underwent gastric bypass surgery . PATIENTS AND METHODS In this r and omized crossover study , each subject received two single st and ard doses of 400 mg of moxifloxacin orally or intravenously administered on two occasions separated by a washout period of 1 week . Serial venous blood sample s were drawn up to 72 h after dosing and moxifloxacin plasma levels were measured by a vali date d HPLC method with fluorescence detection . [ clinical trials.gov data base ( identifier : NCT01130922 ) . ] RESULTS After oral dosing , moxifloxacin plasma concentrations reached a maximum ( C(max ) ) of 3.38 ± 1.41 mg/L after 1.75 h ( 0.75 - 4.00 ) . After intravenous dosing , C(max ) and T(max ) were 4.53 ± 1.43 mg/L and 1.03 h ( 0.75 - 2.50 ) , respectively . The mean areas under the plasma concentration time curve extrapolated to infinity ( AUC(∞ ) ) were 46.2 ± 1.4 mg · h/L after oral dosing and 52.3 ± 1.3 mg · h/L after intravenous dosing , result ing in a mean oral bioavailability of 88.32 % [ 90 % confidence interval ( CI ) 85.64%-91.08 % ] . CONCLUSIONS This study confirms that exposure to moxifloxacin is equivalent for oral and intravenous administration of 400 mg dosages in healthy volunteers who underwent gastric bypass surgery . But these exposures were more than 50 % higher than those described for subjects without gastric bypass . This may suggest a higher enterohepatic recirculation of moxifloxacin after gastric bypass 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 Weight loss is associated with short-term amelioration and prevention of metabolic and cardiovascular risk , but whether these benefits persist over time is unknown . METHODS The prospect i ve , controlled Swedish Obese Subjects Study involved obese subjects who underwent gastric surgery and contemporaneously matched , conventionally treated obese control subjects . We now report follow-up data for subjects ( mean age , 48 years ; mean body-mass index , 41 ) who had been enrolled for at least 2 years ( 4047 subjects ) or 10 years ( 1703 subjects ) before the analysis ( January 1 , 2004 ) . The follow-up rate for laboratory examinations was 86.6 percent at 2 years and 74.5 percent at 10 years . RESULTS After two years , the weight had increased by 0.1 percent in the control group and had decreased by 23.4 percent in the surgery group ( P<0.001 ) . After 10 years , the weight had increased by 1.6 percent and decreased by 16.1 percent , respectively ( P<0.001 ) . Energy intake was lower and the proportion of physically active subjects higher in the surgery group than in the control group throughout the observation period . Two- and 10-year rates of recovery from diabetes , hypertriglyceridemia , low levels of high-density lipoprotein cholesterol , hypertension , and hyperuricemia were more favorable in the surgery group than in the control group , whereas recovery from hypercholesterolemia did not differ between the groups . The surgery group had lower 2- and 10-year incidence rates of diabetes , hypertriglyceridemia , and hyperuricemia than the control group ; differences between the groups in the incidence of hypercholesterolemia and hypertension were undetectable . CONCLUSIONS As compared with conventional therapy , bariatric surgery appears to be a viable option for the treatment of severe obesity , result ing in long-term weight loss , improved lifestyle , and , except for hypercholesterolemia , amelioration in risk factors that were elevated at baseline Background Bariatric surgery leads to several anatomo-physiological modifications that may affect pharmacokinetic parameters and consequently alter the therapeutic effect of drugs , such as antibiotics . The pharmacokinetics of oral amoxicillin after Roux-en-Y gastric bypass ( RYGB ) surgery is unknown . Objectives The objective of this study was to evaluate the impact of bariatric surgery on the pharmacokinetics of amoxicillin . Methods This study was performed as a r and omized , open-label , single-dose clinical trial , with two periods of treatment , in which obese subjects ( n = 8) received an amoxicillin 500 mg capsule orally before and 2 months after the RYGB surgery . The amoxicillin plasma concentration was determined by liquid chromatography coupled to mass spectrometry ( LC-MS/MS ) . Results After the surgery , the mean weight loss was 17.03 ± 5.51 kg , and mean body mass index ( BMI ) decreased from 46.21 ± 2.82 to 38.82 ± 3.32 kg/ OUTPUT:

Patients given oral beta-lactams and macrolides warrant close monitoring due to unpredictable absorption post-bariatric surgery , whereas oral fluoroquinolones and linezolid may not be affected . Several studies also showed decreased absorption following RYGB , as well as lower serum exposure in patients with obesity compared to non-obese controls .

MS2_dynamic_1_shot680

***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: BACKGROUND Optimal alignment of the prosthesis in total knee arthroplasty results in improved patient outcomes . The goal of this study was to determine the most accurate technique for component alignment in total knee arthroplasty by comparing computer-assisted surgery with two conventional techniques involving use of an intramedullary guide for the femur and either an intramedullary or an extramedullary guide for the tibia . METHODS One hundred and seven patients were r and omized prior to surgery to one of three arms : computer-assisted surgery for both the femur and the tibia ( the computer-assisted surgery group ) , intramedullary guides for both the femur and the tibia ( the intramedullary guide group ) , and an intramedullary guide for the femur and an extramedullary guide for the tibia ( the extramedullary guide group ) . Measurements of alignment on hip-to-ankle radiographs and computed tomography ( CT ) scans made three months after surgery were evaluated . The operative times and complications were compared among the three groups . RESULTS The coronal tibiofemoral angle demonstrated , on average , less malalignment in the computer-assisted surgery group ( 1.91 ° ) than in the extramedullary ( 3.22 ° ) and intramedullary ( 2.59 ° ) groups ( p = 0.007 ) . The coronal tibiofemoral angle was > 3 ° of varus or valgus deviation in 19 % ( seven ) of the thirty-six patients treated with computer-assisted surgery compared with 38 % ( thirteen ) of the thirty-four in the extramedullary guide group and 36 % ( thirteen ) of the thirty-six in the intramedullary guide group ( p = 0.022 ) . The increase in accuracy with computer-assisted surgery came at a cost of increased operative time . The operative time for the computer-assisted surgery group averaged 107 minutes compared with eighty-three and eighty minutes , respectively , for the surgery with the extramedullary and intramedullary guides ( p < 0.0001 ) . There was no significant difference in any of the outcomes between the intramedullary and extramedullary guide groups . CONCLUSIONS This study provides evidence that the implant alignment with computer-assisted total knee arthroplasty , as measured with radiography and computed tomography , is significantly improved compared with that associated with conventional surgery with intramedullary or extramedullary guides . This finding adds to the body of evidence showing an improved radiographic outcome with computer-assisted surgery compared with that following conventional total knee arthroplasty Background The Knee injury and Osteoarthritis Outcome Score ( KOOS ) is an extension of the Western Ontario and McMaster Universities Osteoarthrtis Index ( WOMAC ) , the most commonly used outcome instrument for assessment of patient-relevant treatment effects in osteoarthritis . KOOS was developed for younger and /or more active patients with knee injury and knee osteoarthritis and has in previous studies on these groups been the more responsive instrument compared to the WOMAC . Some patients eligible for total knee replacement have expectations of more dem and ing physical functions than required for daily living . This encouraged us to study the use of the Knee injury and Osteoarthritis Outcome Score ( KOOS ) to assess the outcome of total knee replacement . Methods We studied the test-retest reliability , validity and responsiveness of the Swedish version LK 1.0 of the KOOS when used to prospect ively evaluate the outcome of 105 patients ( mean age 71.3 , 66 women ) after total knee replacement . The follow-up rates at 6 and 12 months were 92 % and 86 % , respectively . Results The intraclass correlation coefficients were over 0.75 for all subscales indicating sufficient test-retest reliability . Bl and -Altman plots confirmed this finding . Over 90 % of the patients regarded improvement in the subscales Pain , Symptoms , Activities of Daily Living , and knee-related Quality of Life to be extremely or very important when deciding to have their knee operated on indicating good content validity . The correlations found in comparison to the SF-36 indicated the KOOS measured expected constructs . The most responsive subscale was knee-related Quality of Life . The effect sizes of the five KOOS subscales at 12 months ranged from 1.08 to 3.54 and for the WOMAC from 1.65 to 2.56 . Conclusion The Knee injury and Osteoarthritis Outcome Score ( KOOS ) is a valid , reliable , and responsive outcome measure in total joint replacement . In comparison to the WOMAC , the KOOS improved validity and may be at least as responsive as the WOMAC To compare the alignment after computer-navigated total knee arthroplasty , 52 patients were r and omly allocated to 2 groups . Twenty-seven patients received a total knee arthroplasty with the aid of a kinematic computer-navigation system , and 25 patients received a total knee arthroplasty with the conventional method . Both groups were well balanced concerning demographic data and preoperative scores . At 3-month follow-up , the mechanical alignment of the leg reached the desired straight axis in more cases with the computer-navigated implantation . This difference was statistically significant . The femoral and tibial mechanical anteroposterior axis and the femoral and tibial sagittal tilt ( slope ) measured on sagittal x-rays were not significantly improved in this patient group Purpose This study aim ed to verify if the navigation system used in high tibial osteotomy ( HTO ) adds precision to the procedure regarding mechanical axis correction and prevention of tibial slope increases . Methods In this historically controlled study , patients with medial osteoarthrosis and genuvarum underwent HTO between 2004 and 2012 ; the first 20 were operated with the conventional technique , using pre-planning correction by the Dugdale method and 18 further patients were operated with the navigation system introduced in our hospital . OUTPUT: Postoperative clinical and functional scores were improved by navigated HTO although it is not demonstrated if there is significant improvement compared to conventional HTO . Radiographic outcomes reported commonly were weight-bearing mechanical axis , coronal plane angle , and posterior tibial slope angle in the sagittal plane . Studies have shown HTO gives significant correction of mechanical alignment and navigated HTO produces significantly less change in posterior tibial slope postoperatively compared to conventional . Conclusion Navigation HTO results in improved mechanical axis alignment and demonstrates significantly better control over the tibial slope angle change postoperatively compared to conventional methods ; however , these improvements have not yet been reflected in clinical outcome scores . Overall the studies report HTO does create significantly improved knee scores and functions compared to patients ’ preoperative ratings regardless of technique . INPUT: Two surgical strategies are possible in total knee arthroplasty ( TKA ) : a measured resection technique , in which bone l and marks are used to guide resections equal to the distal and posterior thickness of the femoral component , or a gap-balancing approach , in which equal collateral ligament tension in flexion and extension is sought before and as a guide to final bone cuts . In this study performed with computer assisted system , we compared the 2 different methods in 126 patients followed prospect ively in order to analyze the effect of both the techniques on joint-line ( JL ) maintenance , axial limb restoration and components position . The gap technique showed a statistical increase in the post-operative value when compared with the measured resection technique , ( P = 0.008 ) . When comparing the two groups regarding to the pre-operative deformity , we have found a statistical difference ( P = 0.001 ) in case of moderate pre-operative deformity ( less than 10 ° ) , and the measured resection technique showed a slight superiority in preserving a joint line more faithful to the pre-operative . We found an ideal alignment for the mechanical axis ( 180 ° ± 3 ° ) ( 95 % of cases ) . In six cases ( 5 % ) , the mean post-operative value exceeded ( varus or valgus ) the ideal value by more than 3 ° . In the frontal plane , a good alignment was observed for both femoral and tibial components without a significant difference between the two techniques . In the sagittal plane was found more alignment variability due to the different implants used and their ideal starting slope , from 7 ° to 3 ° . Finally , the surgeon can use the approach with which he has more confidence ; however , as the measured resection technique causes less reduction in the post-operative joint-line position , in case of shortening of patellar tendon or patella infera , this technique is preferable A total knee arthroplasty can be completed using two techniques ; measured resection or gap balancing . A prospect i ve blinded r and omized controlled trial was completed with 103 patients r and omized to measured resection ( n = 52 ) or gap balancing ( n = 51 ) . Primary outcome measure was femoral component rotation . Secondary outcome measures were joint-line change , gap symmetry and function and quality -of-life outcomes . Gap balancing result ed in a significantly raised joint-line compared to measured resection . Gap symmetry was significantly better using gap balancing . Functional outcomes and quality -of-life were not significantly different at 24 months . Using computer navigation , gap balancing significantly raises the joint-line in order to improve gap symmetry . This does not result in a clinical difference in function or quality of life at 24 months Purpose The optimal coronal alignment is still under debate . However , in most of the studies , alignment was only assessed using radiographs , which are not accurate enough for assessment of tibial and femoral TKA position . The primary purpose of this study was to assess the relationship between coronal TKA alignment using 3D-reconstructed CTs and clinical outcome in patients with preoperative varus in comparison with patients with natural or valgus deformity . It was the hypothesis that neutral limb alignment shows a better outcome after TKA . Methods Prospect ively collected data of 38 patients were included . The clinical and radiological follow-up was 24 months . The patients were grouped into two groups with regard to their preoperative limb alignment . Group A ( varus ) consisted of 21 patients with preoperative varus of 3 ° or more , while group B ( non-varus ) consisted of 17 patients with neutral ( − 3 < 0 > + 3 ) or valgus alignment ( > + 3 ) . For assessment of TKA component position and orientation , 3D-reconstructed CT was used . The measurements of the deviation from the whole limb mechanical axis ( HKA angle ) and the joint line alignment in the femoral ( mLDFA ) and the tibial side ( MPTA ) were assessed in the preoperative leg as well as during follow-up after TKA . For clinical outcome assessment , the Knee Society Score ( KSS ) was used at 1 and 2 years postoperatively . Correlation between KSS score and each variable was done using a linear and quadratic regression model ( p < 0.05 ) . Results The mean postoperative HKA angle was − 1.3 ( varus ) in the varus group and + 1.4 ( valgus ) in the non-varus group . Overall , significant correlations between the preoperative and postoperative alignments were found . In the preoperatively non-varus group , a highly significant correlation was found between neutral limb alignment ( HKA = 0 ° ± 3 ° ) and higher KSS ( r2 = 0.74 , p = 0.00 ) . In the varus group , no correlation was found between the postoperative whole limb alignment and the components ’ position in the coronal plane to KSS score . Conclusion A significant correlation was found between neutral limb alignment and higher KSS only in patients with preoperative non-varus alignment . The concept of constitutional varus alignment is still under debate . Moreover , it appears that one should aim for a more individualized , alignment target based on the individual knee morphotype . Level of evidence Diagnostic study , Level II Background Femoral component rotation ( FCR ) is one of the most important factors in total knee arthroplasty . In this prospect i ve study , we used three different techniques for FCR and analyzed their accuracy with postoperative axial computed tomography ( CT ) images . We also evaluated effect of FCR to clinical outcome . Methods One hundred sixty-five patients were r and omly allocated into three groups . In the measured resection group , FCR was set by externally rotating the axis 3 ° off the posterior femoral condylar axis . In the tensor group , a gap-tensioning device set at 20 lbf was used . In the block group , spacer blocks of various thicknesses were used . The FCR angle ( FCRa ) was measured on postoperative axial CT as an angle between the clinical transepicondylar and posterior condylar axes of the femoral component . Outliers were defined as FCRas deviated more than 3 ° either OUTPUT:

The EKA Femoral Rotation Focus Group has not identified a single best reference method to determine femoral component rotation , but surgeons mostly prefer the measured resection technique using at least two l and marks for cross-checking the rotation .

MS2_dynamic_1_shot681

***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: IMPORTANCE Cigarette smoking leads to upregulation of nicotinic acetylcholine receptors ( nAChRs ) in the human brain , including the common α4β2 * nAChR subtype . While subjective aspects of tobacco dependence have been extensively examined as predictors of quitting smoking with treatment , no studies to our knowledge have yet reported the relationship between the extent of pretreatment upregulation of nAChRs and smoking cessation . OBJECTIVE To determine whether the degree of nAChR upregulation in smokers predicts quitting with a st and ard course of treatment . DESIGN , SETTING , AND PARTICIPANTS Eighty-one tobacco-dependent cigarette smokers ( volunteer sample ) underwent positron emission tomographic ( PET ) scanning of the brain with the radiotracer 2-FA followed by 10 weeks of double-blind , placebo-controlled treatment with nicotine patch ( r and om assignment ) . Pretreatment specific binding volume of distribution ( VS/fP ) on PET images ( a value that is proportional to α4β2 * nAChR availability ) was determined for 8 brain regions of interest , and participant-reported ratings of nicotine dependence , craving , and self-efficacy were collected . Relationships between these pretreatment measures , treatment type , and outcome were then determined . The study took place at academic PET and clinical research centers . MAIN OUTCOMES AND MEASURES Posttreatment quit status after treatment , defined as a participant report of 7 or more days of continuous abstinence and an exhaled carbon monoxide level of 3 ppm or less . RESULTS Smokers with lower pretreatment VS/fP values ( a potential marker of less severe nAChR upregulation ) across all brain regions studied were more likely to quit smoking ( multivariate analysis of covariance , F8,69 = 4.5 ; P < .001 ) , regardless of treatment group assignment . Furthermore , pretreatment average VS/fP values provided additional predictive power for likelihood of quitting beyond the self-report measures ( stepwise binary logistic regression , likelihood ratio χ21 = 19.8 ; P < .001 ) . CONCLUSIONS AND RELEVANCE Smokers with less upregulation of available α4β2 * nAChRs have a greater likelihood of quitting with treatment than smokers with more upregulation . In addition , the biological marker studied here provided additional predictive power beyond subjectively rated measures known to be associated with smoking cessation outcome . While the costly , time-consuming PET procedure used here is not likely to be used clinical ly , simpler methods for examining α4β2 * nAChR upregulation could be tested and applied in the future to help determine which smokers need more intensive and /or lengthier treatment . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01526005 INTRODUCTION Ex vivo storage phosphor imaging rat studies reported increased brain dopamine D2/3 receptor ( DRD2/3 ) availability following treatment with varenicline , a nicotinergic drug . However , ex vivo studies can only be performed using cross-sectional design s. Small-animal imaging offers the opportunity to perform serial assessment s. We evaluated whether high-resolution pinhole single photon emission computed tomography ( SPECT ) imaging in rats was able to reproduce previous ex vivo findings . METHODS Rats were imaged for baseline striatal DRD2/3 availability using ultra-high-resolution pinhole SPECT ( U-SPECT-II ) and [123I]IBZM as a radiotracer , and r and omized to varenicline ( n=7 ; 2 mg/kg ) or saline ( n=7 ) . Following 2 weeks of treatment , a second scan was acquired . RESULTS Significantly increased striatal DRD2/3 availability was found following varenicline treatment compared to saline ( time⁎treatment effect ) : posttreatment difference in binding potential between groups corrected for initial baseline differences was 2.039 ( P=.022 ) , indicating a large effect size ( d=1.48 ) . CONCLUSIONS Ultra-high-resolution pinhole SPECT can be used to assess varenicline-induced changes in DRD2/3 availability in small laboratory animals over time . Future small-animal studies should include imaging techniques to enable repeated within-subjects measurements and reduce the amount of animals While the combination therapy of varenicline and sustained release bupropion ( bupropion SR ) for cigarette smoking cessation can increase smoking abstinence rates , it has also been associated with increases in self-reported depressive symptoms . We conducted an analysis of the Beck Depression Inventory , second edition ( BDI-II ) , data completed by 505 patients from a large r and omized clinical trial , evaluating the efficacy of 12 weeks of combination therapy ( varenicline+bupropion SR ) compared to varenicline alone . At medication treatment week 2 ( 1 week after target quit date [ TQD ] ) , increased depressive symptoms were observed in patients receiving combination therapy ( effect estimate=0.61 , 95 % CI [ 0.03 , 1.19 ] , P=.039 ) and those with a history of depression ( effect estimate=0.82 , 95 % CI [ 0.07 , 1.57 ] , P=.033 ) . For treatment weeks 2 to 4 , smokers with a history of depression on combination therapy had a greater decline in depressive symptoms compared to those on varenicline alone ( effect estimate=-1.99 , 95 % CI [ -3.99 , 0.00 ] , P=.050 ) . After treatment week 4 , no significant effects of treatment or depression history on BDI-II scores were observed . A history of depression did not moderate the efficacy of combination therapy for smoking abstinence . Our study suggests that for combination therapy with varenicline OUTPUT: Subgroup analyses suggest that this combination may be more beneficial in males and patients with higher baseline nicotine dependence . CONCLUSION To the authors ' knowledge , this is the first review conducted to compile current literature on this novel pharmacotherapy combination for smoking cessation . INPUT: AIMS Animal studies have shown that nicotine releases dopamine , a neurotransmitter implicated in drug reinforcement . We hypothesized that bromocriptine would decrease smoking behavior in humans . DESIGN The study was conducted double blind and subjects ' order of dose exposure was r and omized . PARTICIPANTS The smoking behavior of 20 heavy smokers was recorded for 5 hours after ingesting placebo or one of two doses of bromocriptine ( 2.50 mg , 3.75 mg ) over three sessions ( one dose per session ) . FINDINGS There was a significant negative linear trend by dosage indicating shorter total puffing time with increasing bromocriptine dosages ( p < 0.02 ) . Other significant negative linear trends by increasing dosage include fewer number of puffs , fewer number of cigarettes smoked and mean latency to smoke after 3 hours ( expected CMAX on the drug ( all ps < 0.05 ) . There was a negative significant linear trend showing decreased plasma nicotine ( p < 0.02 ) and cotinine ( p < 0.005 ) with increasing dosages of bromocriptine . Shiffman/Jarvik Withdrawal Scale ( SJWS ) cigarette craving subscale scores decreased significantly across increasing dosages ( linear trend p < 0.02 ) . There was a significant negative linear trend ( p < 0.05 ) on the Profile of Mood States ( POMS ) Vigor and Depression subscales , with subjects reporting decreased vigor and depression with increasing bromocriptine doses . No other mood effects were observed . CONCLUSION These results support the hypothesis that dopaminergic mechanisms mediate cigarette smoking reinforcement Recent studies have suggested that heterogeneity in the level of dopamine activity and function might be useful for identifying a subgroup of cocaine-dependent patients responding better to dopamine-enhancement pharmacotherapy . Here we hypothesized that response to levodopa/carbidopa treatment would be greater in patients with genetically determined low levels of the dopamine metabolizing enzyme dopamine & bgr;-hydroxylase ( D&bgr;H ) . Seventy-one cocaine-dependent patients who participated in a 12-week r and omized double-blind placebo-controlled trial of levodopa/carbidopa were genotyped for the D&bgr;H gene ( DBH ) polymorphism rs1611115 . Our results showed that for patients with the low D&bgr;H activity genotypes ( CT/TT ) who received levodopa , the odds of having cocaine-positive urine decreased significantly over treatment compared with placebo-treated patients with the CT/TT genotypes ( P=0.004 ) . Individuals with the normal D&bgr;H activity genotype ( CC ) showed no differential response to levodopa . These preliminary results need to be confirmed in a larger sample focusing on the DBH polymorphism Separate investigations have suggested that olanzapine , a D4 antagonist , decreases craving after a priming dose of alcohol and that the DRD4 variable number of t and em repeats ( VNTR ) polymorphism influences the expression of craving after a priming dose of alcohol . The present study tested the hypothesis that olanzapine may be differentially effective at reducing cue-elicited craving based on individual differences in DRD4 VNTR in a sample of heavy social drinkers . Participants were r and omly assigned to receive olanzapine ( 5 mg ) or a control medication ( cyproheptadine , 4 mg ) prior to consuming three alcoholic drinks . Participants completed subjective measures of craving and euphoria after each drink . Participants who were homozygous or heterozygous for the 7 ( or longer ) repeat allele of the DRD4 VNTR were classified as DRD4 L , while the other participants were classified as DRD4 S. The findings indicated that olanzapine reduces craving for alcohol at baseline for both DRD4 S and DRD4 L individuals , but only reduces craving after exposure to alcohol cues and after a priming dose of alcohol for DRD4 L individuals Disulfiram ( Antabuse ) is being used in outpatient clinical trials to determine its efficacy as a treatment for cocaine dependence . This inpatient r and omized , double-blind , placebo-controlled , within-subjects study was conducted to determine whether disulfiram ( placebo , 250 or 500 mg/day ) alters responses to acute intranasal cocaine ( placebo , 1 or 2 mg/kg ) administration . Effects of disulfiram on cocaine pharmacokinetics , physiological , and behavioral responses were determined . Disulfiram treatment increased plasma cocaine concentrations three to six times and significantly increased cocaine-associated cardiovascular responses , but did not significantly alter behavioral responses to cocaine . These interactions should be considered in the decision regarding disulfiram treatment in cocaine dependent patients Objectives To examine survival and long term cessation of injecting in a cohort of drug users and to assess the influence of opiate substitution treatment on these outcomes . Design Prospect i ve open cohort study . Setting A single primary care facility in Edinburgh . Participants 794 patients with a history of injecting drug use presenting between 1980 and 2007 ; 655 ( 82 % ) were followed up by interview or linkage to primary care records and mortality register , or both , and contributed 10 390 person years at risk ; 557 ( 85 % ) had received opiate substitution treatment . Main outcome measures Duration of injecting : years from first injection to long term cessation , defined as last injection before period of five years of non-injecting ; mortality before cessation ; overall survival . Results In the entire cohort 277 participants achieved long term cessation of injecting , and 228 died . Half of the survivors had poor health related OUTPUT:

Polymorphisms of the DRD2 , ANKK1 , DAT1 , DBH , and DRD4 genes have been found to moderate the effects of pharmacotherapy of alcohol , opioid , and cocaine use disorders . The integration of genetic information with clinical data will inform health professionals of the most efficacious pharmacotherapeutic intervention for substance use disorders .

MS2_dynamic_1_shot682

***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: OBJECTIVE To determine the effect of brief early exposure to cows ’ milk on atopy in the first 2 years of life . DESIGN Double blind , placebo controlled , r and omised feeding intervention trial ( Bokaal study ) . SETTING Dutch midwifery practice s. PARTICIPANTS 1533 breast fed neonates . INTERVENTION Exposure to cows ’ milk protein ( n = 758 ) or a protein free placebo ( n = 775 ) during the first 3 days of life . MAIN OUTCOME MEASURES Clinical atopic disease and any positive radioallergosorbent ( RAST ) tests at 1 year of age . RESULTS Atopic disease in the first year was found in 10.0 % ( cows ’ milk)v 9.3 % ( placebo ) of the children , with a relative risk of 1.07 ; in the second year , atopic disease was found in 9.6 % v 10.2 % , respectively , with a relative risk of 0.94 . Per protocol analysis showed similar results . Any RAST positive test was found in 9.4 % ( cows ’ milk)v 7.9 % ( placebo ) of children , with a relative risk of 1.19 . Stratified analysis for high family risk of allergy showed a doubled incidence of atopic disease but no effect from the intervention . CONCLUSION Early and brief exposure to cows ’ milk in breast fed children does not increase the risk of atopic disease in the first 2 years BACKGROUND : Eczema is the most common inflammatory skin disease of childhood , characterized by an itchy red rash that usually involves the face and skin folds . There is currently no curative treatment for eczema , so the reduction of eczema incidence through disease prevention is a desirable goal . Potential interventions for preventing eczema include exclusive breastfeeding , hydrolysed protein formulas and soy formulas when bottle feeding , maternal antigen avoidance , omega oil supplementation , prebiotics and probiotics . OBJECTIVES : This overview of review s aims to present the current body of data from Cochrane and non-Cochrane review s to provide the most up-to- date evidence on the efficacy and safety of interventions to prevent eczema in infants and children at different risk levels for developing allergic disease . METHODS : Our pool of Cochrane and non-Cochrane review s came from the 2010 United Kingdom National Health Service ( NHS ) Evidence Skin Disorders Annual Evidence Up date s Mapping Exercise on Atopic Eczema . This group used a comprehensive search strategy last conducted in August 2010 to identify all systematic review s on eczema prevention . We identified all review s that met our pre-specified inclusion criteria , and data were extracted , analysed , compiled into tables and synthesized using quantitative and qualitative methods . MAIN RESULTS : Seven systematic review s containing 39 relevant trials with 11 897 participants were included in this overview . Overall , there was no clear evidence that any of the main interventions review ed reduced eczema incidence . In subgroup analyses of infants at high risk of allergic disease , an observational study found that exclusive breastfeeding for at least six months compared with introduction of solids at three to six months decreased the incidence of eczema by 60 % ( risk ratio ( RR ) : 0.40 ; 95 % confidence interval ( CI ) : 0.21 , 0.78 ) , and a r and omized controlled trial found that prebiotics compared with no prebiotics decreased incidence by 58 % ( RR : 0.42 ; 95 % CI : 0.21 , 0.84 ) . However , each of these findings was based on the results of a single small trial , and no intervention reduced eczema incidence beyond the first two years of life . Although we pre-specified incidence of atopic eczema ( i.e. eczema associated with immunoglobulin E ( IgE ) sensitization ) as a primary outcome , data on whether participants diagnosed with eczema were truly atopic were largely lacking from systematic review s. Similarly , data on atopy , measured using skin prick tests or specific IgE tests to allergens , were not reported in many review s. No interventions were found to decrease atopy when reported . Adverse events data were generally lacking , but data from a trial of probiotics versus no probiotics showed significantly more spitting up in the first one ( RR : 1.88 ; 95 % CI : 1.03 , 3.45 ) and two ( RR : 1.69 ; 95 % CI : 1.02 , 2.80 ) months of life , but no overall increase in risk of gastrointestinal symptoms in the first year . AUTHORS # ENTITYSTARTX02019 ; CONCLUSIONS : Although there is currently no clear evidence showing that any of the interventions examined in this overview prevent eczema in participants not selected for risk of allergic disease , there is some evidence that exclusive breastfeeding for at least six months and prebiotics might reduce eczema incidence in high-risk participants . However , these conclusions are based on limited evidence with method ological shortcomings . Future research on prevention of eczema is needed and should examine different types of hydrolysed formulas , prebiotics and probiotics , as well as enhancement of the skin barrier and other novel approaches in infants at different risk levels for developing allergic disease A total of 105 “ high‐risk ” infants born in 1988 were studied prospect ively from birth to 18 months of age . The infants were recommended breastfeeding and /or hypoallergenic formula ( Nutramigen or Profylac ) combined with avoidance of solid foods during the first 6 months of life . All mothers had unrestricted diet . Avoidance of daily exposure to tobacco smoke , furred pets and dust‐collecting material s in the bedroom were advised . This prevention group was compared with a control group consisting of 54 OUTPUT: While acceptable for cumulative incidence outcomes , inclusion of disease chronicity precludes the precise measurement of disease onset . INPUT: OBJECTIVE To determine the effect of brief early exposure to cows ’ milk on atopy in the first 2 years of life . DESIGN Double blind , placebo controlled , r and omised feeding intervention trial ( Bokaal study ) . SETTING Dutch midwifery practice s. PARTICIPANTS 1533 breast fed neonates . INTERVENTION Exposure to cows ’ milk protein ( n = 758 ) or a protein free placebo ( n = 775 ) during the first 3 days of life . MAIN OUTCOME MEASURES Clinical atopic disease and any positive radioallergosorbent ( RAST ) tests at 1 year of age . RESULTS Atopic disease in the first year was found in 10.0 % ( cows ’ milk)v 9.3 % ( placebo ) of the children , with a relative risk of 1.07 ; in the second year , atopic disease was found in 9.6 % v 10.2 % , respectively , with a relative risk of 0.94 . Per protocol analysis showed similar results . Any RAST positive test was found in 9.4 % ( cows ’ milk)v 7.9 % ( placebo ) of children , with a relative risk of 1.19 . Stratified analysis for high family risk of allergy showed a doubled incidence of atopic disease but no effect from the intervention . CONCLUSION Early and brief exposure to cows ’ milk in breast fed children does not increase the risk of atopic disease in the first 2 years A total of 105 “ high‐risk ” infants born in 1988 were studied prospect ively from birth to 18 months of age . The infants were recommended breastfeeding and /or hypoallergenic formula ( Nutramigen or Profylac ) combined with avoidance of solid foods during the first 6 months of life . All mothers had unrestricted diet . Avoidance of daily exposure to tobacco smoke , furred pets and dust‐collecting material s in the bedroom were advised . This prevention group was compared with a control group consisting of 54 identically defined “ high‐risk ” infants born in 1985 in the same area . All infants had either severe single atopic predisposition combined with cord blood IgE ≥ 0.5 KU/1 or biparental atopic predisposition . The control group had unrestricted diet and was not advised about environmental factors . Apart from the prevention programme and year of birth the prevention group and the control group were comparable . The parents were highly motivated and compliance was good . The rate of participation was 97 % , and 85 % followed the dietary measures strictly . The cumulative prevalence of atopic symptoms was significantly lower at 18 months in the prevention group ( 32 % ) , as compared with the control group ( 74 % ) ( p<0.01 ) , due to reduced prevalence of recurrent wheezing ( 13 % , versus 37 % ; p<0.01 ) , atopic dermatitis ( 14 % versus 31 % ; p<0.01 ) , vomiting/diarrhoea ( 5 % versus 20 % ; p<0.01 ) and infantile colic ( 9 % versus 24 % ; p<0.01 ) . The cumulative prevalence of food allergy was significantly lower in the prevention group ( 6 % versus 17 % ; p<0.05 ) . In both high‐risk groups daily exposure to tobacco smoke increased the risk of recurrent wheezing significantly ( p<0.01 ) . The main difference between the prevention group and the control group was the diet . Thus , feeding with breastmilk and /or hypoallergenic formula combined with avoidance of solid foods until the age of 6 months appeared to reduce the cumulative prevalence of atopic symptoms during the first 18 months of life Abstract Objectives : To investigate the association between the duration of exclusive breast feeding and the development of asthma related outcomes in children at age 6 years . Design : Prospect i ve cohort study . Setting : Western Australia . Subjects : 2187 children ascertained through antenatal clinics at the major tertiary obstetric hospital in Perth and followed to age 6 years . Main outcome measures : Unconditional logistic regression to model the association between duration of exclusive breast feeding and outcomes related to asthma or atopy at 6 years of age , allowing for several important confounders : sex , gestational age , smoking in the household , and early childcare . Results : After adjustment for confounders , the introduction of milk other than breast milk before 4 months of age was a significant risk factor for all asthma and atopy related outcomes in children aged 6 years : asthma diagnosed by a doctor ( odds ratio 1.25 , 95 % confidence interval 1.02 to 1.52 ) ; wheeze three or more times since 1 year of age ( 1.41 , 1.14 to 1.76 ) ; wheeze in the past year ( 1.31 , 1.05 to 1.64 ) ; sleep disturbance due to wheeze within the past year ( 1.42 , 1.07 to 1.89 ) ; age when doctor diagnosed asthma ( hazard ratio 1.22 , 1.03 to 1.43 ) ; age at first wheeze ( 1.36 , 1.17 to 1.59 ) ; and positive skin prick test reaction to at least one common aeroallergen ( 1.30 , 1.04 to 1.61 ) . Conclusion : A significant reduction in the risk of childhood asthma at age 6 years occurs if exclusive breast feeding is continued for at least the 4 months after birth . These findings are important for our underst and ing of the cause of childhood asthma and suggest that public health interventions to optimise breast feeding may help to reduce the community burden of childhood asthma and its associated traits . Key messages Asthma is the leading cause of admission to hospital in Australian children and its prevalence OUTPUT:

Unlike the conclusions of the revised Cochrane review the export group set up by the Section on Paediatrics , European Academy of Allergology and Clinical Immunology ( SP-EAACI ) do not find that the exclusion of the four trials dem and s a change of the previous recommendations regarding primary dietary prevention of allergic diseases . Based on analysis of published peer- review ed observational and interventional studies the results still indicate that breastfeeding is highly recommended for all infants irrespective of atopic heredity . A dietary regimen is effective in the prevention of allergic diseases in high-risk infants , particularly in early infancy regarding food allergy and eczema . The most effective dietary regimen is exclusively breastfeeding for at least 4 - 6 months or , in absence of breast milk , formulas with documented reduced allergenicity for at least the first 4 months , combined with avoidance of solid food and cow 's milk for the first 4 months

MS2_dynamic_1_shot683

***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: Adults with type 2 diabetes mellitus often struggle with their antihyperglycemic medication regimens . To improve medication management , providers must ensure that their patients underst and potential benefits , harms , and burdens of available options and elicit patients ' preferences and barriers to taking medications . Patients who are actively involved in treatment decision making tend to be more satisfied with their health care , be more adherent to treatment , and have improved clinical outcomes ( 13 ) . Such discussion s , however , can be too time-consuming for clinic visits . For inner-city low-income African American and Latino adults , low health literacy and limited English proficiency are often additional barriers ( 4 ) that reduce the exchange of information and decrease patient participation during primary care visits ( 58 ) . This contributes to less optimal treatment decisions and lower patient satisfaction , leading to poor medication adherence and outcomes ( 3 , 911 ) . There is therefore an urgent need for cost-effective approaches to enable low-re source health systems to help these high-risk population s gain information and decision support so that they can more actively participate in and improve satisfaction with their treatment decision making . Since 2000 , the REACH ( Racial and Ethnic Approaches to Community Health 2010 ) Detroit Partnership , a coalition of community , health system , and academic partners , has used community-based participatory research principles to guide development , implementation , and evaluation of interventions to meet this need among African American and Latino adults with diabetes in Detroit , Michigan . These interventions have built on evidence that community health workers ( CHWs ) are effective in improving diabetes outcomes , particularly among racial and ethnic minority communities ( 12 ) . CHW interventions train community members to work as bridges between their ethnic , cultural , or geographic communities and health care providers ( 13 ) . Two cohorts of participants in our previous CHW-led diabetes self-management support interventions improved hemoglobin A1c ( HbA1c ) levels and diabetes distress compared with usual care ( 14 , 15 ) . An important next step in increasing the potential effect of CHWs and other lay health care workers is to develop and test effective tools they can use to better present evidence -based information to patients and to help patients make better self-management decisions ( 16 ) . Little is known about the effectiveness of different approaches for nontraditional care providers , such as CHWs , to deliver health information to ethnic minority and low-literacy population s ( 17 ) . By definition , CHWs and other lay workers do not have medical expertise and thus rely on effectively sharing printed educational and support material s with patients as part of their coaching and counseling efforts . Decision aids can increase satisfaction with treatment decisions and result in treatments that better reflect patients ' preferences ( 18 , 19 ) . There is also evidence that tailored health messages are more effective than generic group messages ( 20 , 21 ) , including for patients with diabetes ( 22 , 23 ) . Tailoring individualizes information and behavior change strategies to reach each person based on characteristics unique to that person derived from an individual assessment and related to the outcome of interest ( 24 ) . Software programs that are being developed to automatically embed tailored content into portable e-health Web applications show promise in improving health behaviors and outcomes ( 25 , 26 ) . To date , however , most e-health applications have been design ed for use by patients with relatively high literacy and the skills to navigate them ( 27 ) . Do more sophisticated , tailored , interactive e-health tools increase the effectiveness of CHW outreach with underserved patients compared with reliance on printed educational material s alone ? We addressed this question by developing and evaluating a personally tailored , interactive diabetes medication decision aid ( iDecide [ in English ] or iDecido [ in Spanish ] ) design ed for CHWs to deliver on tablet computers with 3 G wireless access to African American and Latino adults with diabetes and low health literacy . We then evaluated the effectiveness of iDecide in improving key diabetes outcomes compared with CHW delivery of the same evidence -based information , without tailoring , through print consumer booklets developed by the Agency for Healthcare Research and Quality ( AHRQ ) . Methods Setting This study was developed and implemented by using community-based participatory research principles ( 28 ) in partnership with the REACH Detroit Partnership and the Community Health and Social Services Center ( CHASS ) , a federally qualified health center in Southwest Detroit serving more than 13000 patients with 47099 visits in 2012 ( 29 ) . The University of Michigan and CHASS institutional review boards approved the study . Content of AHRQ Consumer Guides The AHRQ guides ( Pills for Type 2 Diabetes and Premixed Insulin for Type 2 Diabetes ) ( 30 , 31 ) provide information on diabetes and summarize the effectiveness of currently available medication classes ( oral and insulin ) on HbA1c . They also provide information on administration methods , costs , medication adverse effects , risks for diabetes complications , suggested questions to discuss with health care providers , and prompts to make notes of any questions for the doctor . The booklets include pictures of patients and tables and graphs summarizing information . Content of iDecide The development process and content of the iDecide program have been described in detail elsewhere ( 32 ) . Briefly , we used community-based participatory research and user-centered design ( 33 , 34 ) principles to iteratively develop and refine the iDecide tool . iDecide is available in English and Spanish , can be delivered via tablet computers , and enables navigation by the CHW and participant to selectively explore issues most important to the participant . The iDecide program is organized into 4 main sections and includes the same content as the AHRQ consumer guides . However , its information is presented in a more graphical style suited to patients with low literacy . Table 1 summarizes key differences between the presentation of information in iDecide and the printed material s. The first section illustrates , through animations , how diabetes affects the way glucose is processed in the body and how different medication classes , foods , and physical activity affect blood gl OUTPUT: The effect on depression was small , while there was no effect on health-related quality of life . Exploratory subgroup analyses suggested that interventions using motivational interviewing and individual interventions were associated with incremental effects on DD . Likewise , intensive interventions were associated with significant reductions in both DD and HbA1c INPUT: Adults with type 2 diabetes mellitus often struggle with their antihyperglycemic medication regimens . To improve medication management , providers must ensure that their patients underst and potential benefits , harms , and burdens of available options and elicit patients ' preferences and barriers to taking medications . Patients who are actively involved in treatment decision making tend to be more satisfied with their health care , be more adherent to treatment , and have improved clinical outcomes ( 13 ) . Such discussion s , however , can be too time-consuming for clinic visits . For inner-city low-income African American and Latino adults , low health literacy and limited English proficiency are often additional barriers ( 4 ) that reduce the exchange of information and decrease patient participation during primary care visits ( 58 ) . This contributes to less optimal treatment decisions and lower patient satisfaction , leading to poor medication adherence and outcomes ( 3 , 911 ) . There is therefore an urgent need for cost-effective approaches to enable low-re source health systems to help these high-risk population s gain information and decision support so that they can more actively participate in and improve satisfaction with their treatment decision making . Since 2000 , the REACH ( Racial and Ethnic Approaches to Community Health 2010 ) Detroit Partnership , a coalition of community , health system , and academic partners , has used community-based participatory research principles to guide development , implementation , and evaluation of interventions to meet this need among African American and Latino adults with diabetes in Detroit , Michigan . These interventions have built on evidence that community health workers ( CHWs ) are effective in improving diabetes outcomes , particularly among racial and ethnic minority communities ( 12 ) . CHW interventions train community members to work as bridges between their ethnic , cultural , or geographic communities and health care providers ( 13 ) . Two cohorts of participants in our previous CHW-led diabetes self-management support interventions improved hemoglobin A1c ( HbA1c ) levels and diabetes distress compared with usual care ( 14 , 15 ) . An important next step in increasing the potential effect of CHWs and other lay health care workers is to develop and test effective tools they can use to better present evidence -based information to patients and to help patients make better self-management decisions ( 16 ) . Little is known about the effectiveness of different approaches for nontraditional care providers , such as CHWs , to deliver health information to ethnic minority and low-literacy population s ( 17 ) . By definition , CHWs and other lay workers do not have medical expertise and thus rely on effectively sharing printed educational and support material s with patients as part of their coaching and counseling efforts . Decision aids can increase satisfaction with treatment decisions and result in treatments that better reflect patients ' preferences ( 18 , 19 ) . There is also evidence that tailored health messages are more effective than generic group messages ( 20 , 21 ) , including for patients with diabetes ( 22 , 23 ) . Tailoring individualizes information and behavior change strategies to reach each person based on characteristics unique to that person derived from an individual assessment and related to the outcome of interest ( 24 ) . Software programs that are being developed to automatically embed tailored content into portable e-health Web applications show promise in improving health behaviors and outcomes ( 25 , 26 ) . To date , however , most e-health applications have been design ed for use by patients with relatively high literacy and the skills to navigate them ( 27 ) . Do more sophisticated , tailored , interactive e-health tools increase the effectiveness of CHW outreach with underserved patients compared with reliance on printed educational material s alone ? We addressed this question by developing and evaluating a personally tailored , interactive diabetes medication decision aid ( iDecide [ in English ] or iDecido [ in Spanish ] ) design ed for CHWs to deliver on tablet computers with 3 G wireless access to African American and Latino adults with diabetes and low health literacy . We then evaluated the effectiveness of iDecide in improving key diabetes outcomes compared with CHW delivery of the same evidence -based information , without tailoring , through print consumer booklets developed by the Agency for Healthcare Research and Quality ( AHRQ ) . Methods Setting This study was developed and implemented by using community-based participatory research principles ( 28 ) in partnership with the REACH Detroit Partnership and the Community Health and Social Services Center ( CHASS ) , a federally qualified health center in Southwest Detroit serving more than 13000 patients with 47099 visits in 2012 ( 29 ) . The University of Michigan and CHASS institutional review boards approved the study . Content of AHRQ Consumer Guides The AHRQ guides ( Pills for Type 2 Diabetes and Premixed Insulin for Type 2 Diabetes ) ( 30 , 31 ) provide information on diabetes and summarize the effectiveness of currently available medication classes ( oral and insulin ) on HbA1c . They also provide information on administration methods , costs , medication adverse effects , risks for diabetes complications , suggested questions to discuss with health care providers , and prompts to make notes of any questions for the doctor . The booklets include pictures of patients and tables and graphs summarizing information . Content of iDecide The development process and content of the iDecide program have been described in detail elsewhere ( 32 ) . Briefly , we used community-based participatory research and user-centered design ( 33 , 34 ) principles to iteratively develop and refine the iDecide tool . iDecide is available in English and Spanish , can be delivered via tablet computers , and enables navigation by the CHW and participant to selectively explore issues most important to the participant . The iDecide program is organized into 4 main sections and includes the same content as the AHRQ consumer guides . However , its information is presented in a more graphical style suited to patients with low literacy . Table 1 summarizes key differences between the presentation of information in iDecide and the printed material s. The first section illustrates , through animations , how diabetes affects the way glucose is processed in the body and how different medication classes , foods , and physical activity affect blood gl OUTPUT:

Interventions with a duration of 2 - 6 months providing professional-led support with asynchronous and synchronous communication appeared to be associated with significant well-being outcomes . While the meta-analyses demonstrated nonsignificant results for depression and distress scores , this review has shown that there is a potential for Web-based interventions to improve well-being outcomes in type 2 diabetes .

MS2_dynamic_1_shot684

***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: Background Both low back pain ( LBP ) and neck pain ( NP ) are major occupational health problems . In the workplace , participatory ergonomics ( PE ) is frequently used on musculoskeletal disorders . However , evidence on the effectiveness of PE to prevent LBP and NP obtained from r and omised controlled trials ( RCTs ) is scarce . This study evaluates the process of the Stay@Work participatory ergonomics programme , including the perceived implementation of the prioritised ergonomic measures . Methods This cluster- RCT was conducted at the departments of four Dutch companies ( a railway transportation company , an airline company , a steel company , and a university including its university medical hospital ) . Directly after the r and omisation outcome , intervention departments formed a working group that followed the steps of PE during a six-hour working group meeting . Guided by an ergonomist , working groups identified and prioritised risk factors for LBP and NP , and composed and prioritised ergonomic measures . Within three months after the meeting , working groups had to implement the prioritised ergonomic measures at their department . Data on various process components ( recruitment , reach , fidelity , satisfaction , and implementation components , i.e. , dose delivered and dose received ) were collected and analysed on two levels : department ( i.e. , working group members from intervention departments ) and participant ( i.e. , workers from intervention departments ) . Results A total of 19 intervention departments ( n = 10 with mental workloads , n = 1 with a light physical workload , n = 4 departments with physical and mental workloads , and n = 4 with heavy physical workloads ) were recruited for participation , and the reach among working group members who participated was high ( 87 % ) . Fidelity and satisfaction towards the PE programme rated by the working group members was good ( 7.3 or higher ) . The same was found for the Stay@Work ergocoach training ( 7.5 or higher ) . In total , 66 ergonomic measures were prioritised by the working groups . Altogether , 34 % of all prioritised ergonomic measures were perceived as implemented ( dose delivered ) , while the workers at the intervention departments perceived 26 % as implemented ( dose received ) . Conclusions PE can be a successful method to develop and to prioritise ergonomic measures to prevent LBP and NP . Despite the positive rating of the PE programme the implementation of the prioritised ergonomic measures was lower than expected . Trial registration Current Controlled Trials IS RCT In web-based health promotion programs , large variations in participant engagement are common . The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management . Two versions of the program were offered to r and omly selected departments in IT and media companies . A static version of the program including health screening tool , diary and information about stress was offered to the control group . Additional material s , i.e. interactive , cognitive-based and classical stress management exercises and a chat room , were offered to the intervention group . Baseline data regarding participants ' demographics , health ( self-ratings and biological measures ) , lifestyle , work-related factors and group membership were analyzed to study determinants of employees ' participation in the program during a period of 12 months . Multiple logistic regression analysis was used and found intervention group membership , being a woman , having at most a secondary education , regular physical exercise habits and having positive expectations of the program were significant predictors of high use . The findings demonstrate that the interactivity of a web-based program is an important factor for determining participation in a web-based worksite stress management program . Implication s for those developing and implementing future web-based health promotion activities are discussed OBJECTIVE To evaluate the effectiveness of a lifestyle intervention for male workers in the construction industry at risk of cardiovascular disease ( CVD ) . METHODS In a r and omized controlled trial performed in the Netherl and s between 2007 and 2009 , usual care was compared to 6 months of individual counseling using motivational interviewing techniques , delivered face to face and by telephone . Participants aim ed at improving energy balance-related behavior or smoking cessation . Linear regression analyses were performed to determine the effects . RESULTS Body weight had significantly decreased at 6 ( β=-1.9 , 95 % CI -2.6 ; -1.2 ) and 12 months ( β=-1.8 , 95%CI -2.8 ; -1.1 ) . The intervention effects were also significant for diastolic blood pressure at 6 months ( β=-1.7 , 95 % CI -3.3 ; -0.1 ) . Among participants who had aim ed at energy balance , the intervention had a significant favorable effect on body weight at 6 ( β=-2.1 , 95 % CI -2.9 ; -1.3 ) and 12 months ( β=-2.2 , 95 % CI -3.1 ; -1.3 ) and at HDL cholesterol ( β=0.05 , 95 % CI 0.01 ; 0.10 ) and HbA1c ( β=-0.06 , 95%CI -0.12 ; -0.001 ) at 12 months , although there was no intervention effect on these variables over time . CONCLUSION Individual-based counseling result ed in significant beneficial long-term effects on body weight . This is an important finding for occupational health , considering the rising prevalence of obesity and CVD BACKGROUND This study explored the experiences of university employees recruited to a 10-week r and omized controlled trial ( n = 64 ) . The trial compared " walking routes " with " walking-while-working " on daily step totals , showing that , compared with controls , interventions result ed in around 1000 extra steps per day . METHODS A sub sample of 15 academic and administrative employees from intervention groups completed interviews at the end of intervention . Interviews were transcribed verbatim and subject to inductive coding within the major themes of benefits /positives and problems/barriers . FINDINGS Both interventions benefited employee health and work product OUTPUT: The most frequently reported facilitator was strong management support . Conclusions Process evaluations are not systematic ally performed alongside effectiveness studies for WHPPs . The quality of the process evaluations is mostly poor to average , result ing in a lack of systematic ally measured barriers/facilitators . The narrow focus on implementation makes it difficult to explore the relationship between effectiveness and implementation . INPUT: Background Both low back pain ( LBP ) and neck pain ( NP ) are major occupational health problems . In the workplace , participatory ergonomics ( PE ) is frequently used on musculoskeletal disorders . However , evidence on the effectiveness of PE to prevent LBP and NP obtained from r and omised controlled trials ( RCTs ) is scarce . This study evaluates the process of the Stay@Work participatory ergonomics programme , including the perceived implementation of the prioritised ergonomic measures . Methods This cluster- RCT was conducted at the departments of four Dutch companies ( a railway transportation company , an airline company , a steel company , and a university including its university medical hospital ) . Directly after the r and omisation outcome , intervention departments formed a working group that followed the steps of PE during a six-hour working group meeting . Guided by an ergonomist , working groups identified and prioritised risk factors for LBP and NP , and composed and prioritised ergonomic measures . Within three months after the meeting , working groups had to implement the prioritised ergonomic measures at their department . Data on various process components ( recruitment , reach , fidelity , satisfaction , and implementation components , i.e. , dose delivered and dose received ) were collected and analysed on two levels : department ( i.e. , working group members from intervention departments ) and participant ( i.e. , workers from intervention departments ) . Results A total of 19 intervention departments ( n = 10 with mental workloads , n = 1 with a light physical workload , n = 4 departments with physical and mental workloads , and n = 4 with heavy physical workloads ) were recruited for participation , and the reach among working group members who participated was high ( 87 % ) . Fidelity and satisfaction towards the PE programme rated by the working group members was good ( 7.3 or higher ) . The same was found for the Stay@Work ergocoach training ( 7.5 or higher ) . In total , 66 ergonomic measures were prioritised by the working groups . Altogether , 34 % of all prioritised ergonomic measures were perceived as implemented ( dose delivered ) , while the workers at the intervention departments perceived 26 % as implemented ( dose received ) . Conclusions PE can be a successful method to develop and to prioritise ergonomic measures to prevent LBP and NP . Despite the positive rating of the PE programme the implementation of the prioritised ergonomic measures was lower than expected . Trial registration Current Controlled Trials IS RCT Background Arm , shoulder and neck symptoms are very prevalent among computer workers . In an attempt to reduce these symptoms , a large occupational health service in the Netherl and s developed a preventive programme on exposure to risk factors , prevalence of arm , shoulder and neck symptoms , and sick leave in computer workers . The purpose of this study was to assess the effectiveness of this intervention programme . Methods The study was a r and omised controlled trial . The participants were assigned to either the intervention group or the usual care group by means of cluster r and omisation . At baseline and after 12 months of follow-up , the participants completed the RSI QuickScan question naire on exposure to the risk factors and on the prevalence of arm , shoulder and neck symptoms . A tailor-made intervention programme was proposed to participants with a high risk profile at baseline . Examples of implemented interventions are an individual workstation check , a visit to the occupational health physician and an education programme on the prevention of arm , shoulder and neck symptoms . The primary outcome measure was the prevalence of arm , shoulder and neck symptoms . Secondary outcome measures were the scores on risk factors for arm , shoulder and neck symptoms and the number of days of sick leave . Sick leave data was obtained from the companies . Multilevel analyses were used to test the effectiveness . Results Of the 1,673 persons invited to participate in the study , 1,183 persons ( 71 % ) completed the baseline question naire and 741 persons participated at baseline as well as at 12-month follow-up . At 12-month follow-up , the intervention group showed a significant positive change ( OR = 0.48 ) in receiving information on healthy computer use , as well as a significant positive change regarding risk indicators for work posture and movement , compared to the usual care group . There were no significant differences in changes in the prevalence of arm , shoulder and neck symptoms or sick leave between the intervention and usual care group . Conclusions The effects of the RSI QuickScan intervention programme were small , possibly as a result of difficulties with the implementation process of the proposed interventions . However , some significant positive effects were found as to an increase in receiving education and a decrease in exposure to adverse postures and movements . With regard to symptoms and sick leave , only small and non-significant effects were found . Trial registration Netherl and s National Trial Register BACKGROUND This study exp and ed previous NIOSH-IRS research examining the effects of rest breaks and stretching exercises on symptoms and performance in data -entry workers . METHODS All workers spent 4 weeks with conventional breaks ( two 15 min breaks per day ) and 4 weeks with supplementary breaks ( two 15 min breaks plus four 5 min breaks per day ) . One-half were assigned at r and om to a group instructed to perform brief stretching exercises during breaks . The remainder comprised the " no stretching " ( control ) group . RESULTS 51 workers ( stretch group n = 21 ; no stretch group n = 30 ) completed the study symptom question naires . Discomfort and eyestrain were significantly lower with supplementary breaks , and supplementary breaks attenuated accumulation of discomfort and eyestrain during work sessions . Data -entry speed was significantly faster with supplementary breaks so that work output was maintained , despite replacing 20 min of work time with break time . In the stretch group , workers reported stretching during only 25 % of conventional breaks and 39 % of supplementary breaks , and no significant effects of stretching on discomfort or performance were observed . CONCLUSIONS These results provide further converging evidence that supplementary breaks reliably minimize discomfort and eyestrain without impairing productivity . Low compliance in performing stretches prevented valid assessment OUTPUT:

There was strong evidence for one intervention category , resistance training , leading to the recommendation : Implementing a workplace-based resistance training exercise programme can help prevent and manage UEMSD and symptoms . The synthesis also revealed moderate evidence for stretching programmes , mouse use feedback and forearm supports in preventing UEMSD or symptoms . There was also moderate evidence for no benefit for EMG biofeedback , job stress management training , and office workstation adjustment for UEMSD and symptoms .

MS2_dynamic_1_shot685

***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: Objective : To determine the safety and efficacy of an oral soy isoflavone extract for relief of menopausal hot flushes . Design : This was a double‐blind , r and omized , parallel group , outpatient , multicenter ( 15 sites ) study . A total of 177 postmenopausal women ( mean age = 55 years ) who were experiencing five or more hot flushes per day were r and omized to receive either soy isoflavone extract ( total of 50 mg genistin and daidzin per day ) or placebo . Physical examinations and endometrial and biochemical evaluations were performed upon admission and completion . Body weight , symptoms , and safety were evaluated at all visits . Results : Relief of vasomotor symptoms was observed in both groups . Decreases in the incidence and severity of hot flushes occurred as soon as 2 weeks in the soy group , whereas the placebo group experienced no relief for the first 4 weeks . Differences between evaluable subjects in both groups were statistically significant over 6 weeks ( p = 0.03 ) . Over 12 weeks , between‐group differences approached significance ( p = 0.08 ) . Endometrial thickness evaluated by ultrasound , lipoproteins , bone markers , sex hormone‐binding globulin and follicle‐stimulating hormone , and vaginal cytology did not change in either group . Conclusions : Soy isoflavone extract was effective in reducing frequency and severity of flushes and did not stimulate the endometrium . Soy isoflavone extracts provide an attractive addition to the choices available for relief of hot flushes . ( Menopause 2000;7:236‐242 . © 2000 , The North American Menopause Society . Objective : To evaluate in a 12-month , prospect i ve , r and omized , double-blind , placebo-controlled study whether pure administration of the phytoestrogen genistein ( 54 mg/d ) might reduce the number and severity of hot flushes in postmenopausal women with no adverse effect on the endometrium . Design : A total of 389 participants met the main study criteria and were r and omly assigned to receive the phytoestrogen genistein ( n = 198 ) or placebo ( n = 191 ) . About 40 % of participants in both groups did not suffer from hot flushes , and the evaluation was performed in a subgroup of 247 participants ( genistein , n = 125 ; placebo , n = 122 ) . Reductions from baseline in the frequency and severity of hot flushes were the principal criteria of efficacy . Endometrial thickness was evaluated by ultrasonography . The maturation value was also used to determine hormonal action on the vaginal cells . Results : There were no significant differences in age , time since menopause , body mass index , and vasomotor symptoms between groups at baseline ( 4.4 ± 0.33 hot flushes per day in the genistein group and 4.2 ± 0.35 hot flushes per day in the control group ) . The effect was already evident in the first month and reached its peak after 12 months of genistein therapy ( −56.4 % reduction in the mean number of hot flushes ) . Furthermore , there was a significant difference between the two groups at each evaluation time ( 1 , 3 , 6 , and 12 months ) . No significant difference was found in mean endometrial thickness and maturation value score between the two groups , either at baseline or after 12 months . Conclusions : The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on endometrium Plants contain compounds with oestrogen -- like action called phytoestrogens . Soy contains daidzin , a potent phytoestrogen , and wheat flour contains less potent enterolactones . We aim ed to show in 58 postmenopausal women ( age 54 , range 30 - 70 years ) with at least 14 hot flushes per week , that their daily diet supplemented with soy flour ( n = 28 ) could reduce flushes compared with wheat flour ( n = 30 ) over 12 weeks when r and omised and double blind . Hot flushes significantly decreased in the soy and wheat flour groups ( 40 % and 25 % reduction , respectively < 0.001 for both ) with a significant rapid response in the soy flour group in 6 weeks ( P < 0.001 ) that continued . Menopausal symptom score decreased significantly in both groups ( P < 0.05 ) . Urinary daidzein excretion confirmed compliance . Vaginal cell maturation , plasma lipids and urinary calcium remained unchanged . Serum FSH decreased and urinary hydroxyproline increased in the wheat flour group OBJECTIVE To evaluate the effect of soy isoflavones on menopausal symptoms in women who do and who do not produce equol , a daidzein metabolite . METHOD A r and omized , double-blind , placebo-controlled clinical trial was conducted over 6 months with 96 healthy menopausal women . After taking take 135 mg of isoflavones daily for 1 week , the women in the study group were assigned to the equol-producing ( EP ) or the non-EP group according to the presence or absence of equol in their urine . Menopausal symptoms were evaluated using a modified Kupperman Index . RESULT Compared with the placebo group , the scores for hot flashes and excessive sweating were significantly reduced after 3 months , and the scores for weakness , palpitations , limb paresthesia , and total symptoms after 6 months , in the EP group only . CONCLUSIONS Isoflavone supplementation improves menopausal symptoms only in women with the ability to produce equol Objective : This project was design ed to provide an overview of hot flash studies conducted over the past two decades at the Mayo Clinic and in the North Central Cancer Treatment Group . Design : OUTPUT: Isoflavone supplements providing more than 18.8 mg of genistein ( the median for all studies ) were more than twice as potent at reducing hot flash frequency than lower genistein supplements . Conclusions Soy isoflavone supplements , derived by extraction or chemical synthesis , are significantly more effective than placebo in reducing the frequency and severity of hot flashes . INPUT: The aim of this study was to test the hypothesis that increased dietary intake of phytoestrogens reduces the health impact of the menopause . To test this hypothesis , a double-blind , r and omized , entry-exit , cross-over study was conducted to assess the effects of three dietary manipulations -- soy and linseed diets ( high in phytoestrogens ) and a wheat diet ( low in phytoestrogens ) . Postmenopausal women were recruited and r and omly assigned to one of the three dietary regimens . Urinary phytoestrogen concentrations , hot flush rate , vaginal smears , bone mineral density and bone mineral content were assessed for two 12-week periods . Comparative analysis showed no significant differences , but , when analyzed separately , groups consuming high phytoestrogen diets had between 10 and 30 times higher urinary excretion of phytoestrogens compared to those consuming the low phytoestrogen diet ( p < 0.01 ) . Study participants consuming soy , linseed and wheat diets had a 22 % ( not significant , n.s . ) , 41 % ( p < 0.009 ) and 51 % ( p < 0.001 ) reduction in hot flush rate ; a 103 % ( p < 0.04 ) , 5.5 % ( n.s . ) and 11 % ( n.s . ) increase in vaginal cytology maturation index ; and a 5.2 % ( p < 0.04 ) , 5.2 % ( n.s . ) and 3.8 % ( n.s . ) increase in bone mineral content , respectively . No changes were detected in bone mineral density . The differential effects of high phytoestrogen dietary manipulations on outcomes may represent tissue-specific responses to isoflavones and lignans contained in soy and linseed , respectively . Whilst health outcome measures were not significantly different between groups , the data obtained from separate analysis suggest that phytoestrogens in soy and linseed may be of use in ameliorating some of the symptoms of menopause . Furthermore , the significant decrease in hot flush rate in the wheat group can not be attributable to phytoestrogens measured in this study . Due to subject variability , larger studies are still needed to evaluate population benefit CONTEXT The effects of continuous combined hormone therapy on gynecologic cancers have not been investigated previously in a r and omized trial setting . OBJECTIVE To determine the possible associations of estrogen plus progestin on gynecologic cancers and related diagnostic procedures . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial of 16 608 postmenopausal women , who had not had a hysterectomy at baseline and who had been recruited from 40 US clinical centers between September 1993 and October 1998 ( average follow-up , 5.6 years ) . INTERVENTION One tablet per day containing 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate ( n = 8506 ) or placebo ( n = 8102 ) . MAIN OUTCOME MEASURE Incident invasive cancer of the ovary and endometrium . RESULTS In 5.6 years of follow-up , there were 32 cases of invasive ovarian cancer , 58 cases of endometrial cancer , 1 case of nonendometrial uterine cancer , 13 cases of cervical cancer , and 7 cases of other gynecologic cancers . The hazard ratio ( HR ) for invasive ovarian cancer in women assigned to estrogen plus progestin compared with placebo was 1.58 ( 95 % confidence interval [ CI ] , 0.77 - 3.24 ) . The HR for endometrial cancer was 0.81 ( 95 % CI , 0.48 - 1.36 ) . No appreciable differences were found in the distributions of tumor histology , stage , or grade for either cancer site . The incidence of other gynecologic cancers was low and did not differ by r and omization assignment . More women taking estrogen plus progestin required endometrial biopsies ( 33 % vs 6 % ; P<.001 ) . CONCLUSIONS This r and omized trial suggests that continuous combined estrogen plus progestin therapy may increase the risk of ovarian cancer while producing endometrial cancer rates similar to placebo . The increased burden of endometrial biopsies required to assess vaginal bleeding further limits the acceptability of this regimen . These data provide additional support for caution in the use of continuous combined hormones Objective : To determine the safety and efficacy of an oral soy isoflavone extract for relief of menopausal hot flushes . Design : This was a double‐blind , r and omized , parallel group , outpatient , multicenter ( 15 sites ) study . A total of 177 postmenopausal women ( mean age = 55 years ) who were experiencing five or more hot flushes per day were r and omized to receive either soy isoflavone extract ( total of 50 mg genistin and daidzin per day ) or placebo . Physical examinations and endometrial and biochemical evaluations were performed upon admission and completion . Body weight , symptoms , and safety were evaluated at all visits . Results : Relief of vasomotor symptoms was observed in both groups . Decreases in the incidence and severity of hot flushes occurred as soon as 2 weeks in the soy group , whereas the placebo group experienced no relief for the first 4 weeks . Differences between evaluable subjects in both groups were statistically significant over 6 weeks ( p = 0.03 ) . Over 12 weeks , between‐group differences approached significance ( p = 0.08 ) . Endometrial thickness evaluated by ultrasound , lipoproteins , bone markers , sex hormone‐binding globulin and follicle‐stimulating OUTPUT:

There is no evidence of effectiveness in the alleviation of menopausal symptoms with the use of phytoestrogen treatments

MS2_dynamic_1_shot686

***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: OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas Sixty newly admitted acute schizophrenic patients were r and omly assigned to a double-blind trial of metiapine with a maximum dose of 450 mg per day versus a maximum dose of 450 mg per day versus a maximum daily dose of 900 mg chlorpromazine per day . At the conclusion of the study , 21 patients in each group showed marked to moderate improvement . There were significantly more marked improvers in the metiapine group then the chlorpromazine group on the Physician 's Posttreatment Global Impression . Evaluation by analysis of covariance of the Brief Psychiatric Rating Scale showed a significant difference between treatment groups favoring chlorpromazine on the item of blunted affect . The spectrum of side effects was similar in the two groups , except for six patients treated with metiapine who displayed tachycardia on the EKG . This pulse elevation was reflected in the group data and is probably dose related . In conclusion , both drugs appeared to be equally efficacious in the treatment of newly admitted acute schizophrenic patients OBJECTIVES Clotiapine is a classic neuroleptic with a chemical structure similar to clozapine . It was said that patients unresponsive to other neuroleptics respond to clotiapine although it causes extrapyramidal syndromes ( EPS ) like other typical neuroleptics . We conducted a study of clotiapine vs. chlorpromazine in severe chronic active psychotic hospitalized schizophrenia patients . METHODS The design was double-blind crossover of clotiapine vs chlorpromazine . No washout was necessary from previous neuroleptic treatment , and flexible overlap with the study medication was individualized for each patient . Patients were treated after reaching neuroleptic monotherapy for 3 months with clotiapine and 3 months with chlorpromazine , in r and om order . Medication was supplied in identical capsules of 100 mg chlorpromazine or 40 mg of clotiapine . Positive and Negative Syndrome Scale ( PANSS ) and Clinical Global Impression ( CGI ) were rated every 2 weeks and Nurse 's Observation Scale for Inpatient Evaluation ( NOSIE ) every month . RESULTS Fifty-eight patients were r and omized . Forty-three patients completed at least one phase of the study , and thirty-three completed both phases . Because of the small number of hostel patients and the very high dropout rate in the hostel patients , data analysis was done separately for in patients and hostel patients . Clotiapine was significantly superior to chlorpromazine in 26 in patients completing the crossover , on the PANSS , NOSIE and CGI . Clotiapine was also superior to chlorpromazine in an analysis of the parallel inpatient groups in the first three months before the crossover . CONCLUSION Some classic neuroleptic compounds may have superiority to chlorpromazine in a " clozapine-like " manner , despite OUTPUT: Clinical ly important improvement in global state was measured using the Clinical Global Impression ( CGI ) . INPUT: OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate Limited effective strategies exist to alleviate or treat disruptive behaviors in people with Alzheimer 's disease . Fifty-one residents of a long-term care facility with Alzheimer 's disease were r and omly assigned to one of three intervention groups . A multiple time series , blinded , experimental design was used to compare the effectiveness of therapeutic touch , simulated therapeutic touch , and usual care on disruptive behavior . Three forms of disruptive behavior comprised the dependent variables : physical aggression , physical nonaggression , and verbal agitation . Physical nonaggressive behaviors decreased significantly in those residents who received therapeutic touch compared with those who received the simulated version and the usual care . No significant differences in physically aggressive and verbally agitated behaviors were observed across the three study groups . The study provided preliminary evidence for the potential for therapeutic touch in dealing with agitated behaviors by people with dementia . Research ers and practitioners must consider a broad array of strategies to deal with these behaviors The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas BACKGROUND Acute psychotic illness , especially when associated with agitated or violent behaviour , can require urgent pharmacological tranquillisation or sedation . In several countries , clinicians often use benzodiazepines ( either alone or in combination with antipsychotics ) for this outcome . OBJECTIVES To estimate the effects of benzodiazepines , alone or in combination with antipsychotics , when compared with placebo or antipsychotics , alone or in combination with antihistamines , to control disturbed behaviour and reduce psychotic symptoms . SEARCH METHODS We search ed the Cochrane Schizophrenia Group 's register ( January 2012 ) , inspected reference lists of included and excluded studies and contacted authors of relevant studies . SELECTION CRITERIA We included all r and omised clinical trials ( RCTs ) comparing benzodiazepines alone or in combination with any antipsychotics , versus antipsychotics alone or in combination with any other antipsychotics , benzodiazepines or antihistamines , for people with acute psychotic illnesses . DATA COLLECTION AND ANALYSIS We reliably selected studies , quality assessed them and extracted data . For binary outcomes , we calculated st and ard estimates of relative risk ( RR ) and their 95 % confidence intervals ( CI ) using a fixed-effect model . For continuous outcomes , we calculated the mean difference ( MD ) between groups . If heterogeneity was identified , this was explored using a r and om-effects model . MAIN RESULTS We included 21 trials with a total of n = 1968 participants . There was no significant difference for most outcomes in the one trial that compared benzodiazepines with placebo , although there was a higher risk of no improvement in people receiving placebo in the medium term ( one to 48 hours ) ( n = 102 , 1 RCT , RR 0.62 , 95 % CI 0.40 to 0. OUTPUT:

Using de-escalation techniques for people with psychosis induced aggression or agitation appears to be accepted as good clinical practice but is not supported by evidence from r and omised trials .

MS2_dynamic_1_shot687

***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: PURPOSE To compare by confocal and scanning electron microscopy the post-resin-dentin interfaces of endodontically-treated teeth which had been restored with dentin-bonding systems and composite and needed to be extracted after 6 months to 6 years of clinical service . MATERIAL S AND METHODS Sixteen single rooted teeth showing proximal lesions penetrating the pulp chamber were included in the investigation and divided into two groups . Group 1 teeth were endodontically-treated , restored with carbon fiber posts and resin-based composite . Group 2 teeth were treated in the same way and covered with porcelain fused-to-metal crowns . RESULTS Two thirds of the observed interfaces showed resin penetration of the root dentin in the middle and coronal third of the post space preparation , while only one third of the interface showed resin infiltration in the apical third of the post space preparation . Debonding of the adhesive from the resin infiltrated dentin area and debonding of the composite cement from the adhesive were the most frequently observed failure modes and were observed in one third of the observed interfaces . There was no difference between the post-resin-dentin interfaces of teeth covered and teeth not covered with porcelain-fused to metal crowns . Teeth extracted after longer periods of clinical service showed more abundant areas of debonding of the adhesive from the resin-dentin interdiffusion zone . The presence of bacteria in resin infiltrated dentin tubules was observed in two specimens STATEMENT OF PROBLEM Crowns have been considered the restoration of choice for endodontically treated teeth , but their selection has been based primarily on anecdotal evidence . PURPOSE This study tested the hypothesis that crown placement ( coronal coverage ) is associated with improved survival of endodontically treated teeth when preaccess , endodontic , and restorative factors are controlled . MATERIAL AND METHODS A University of Iowa College of Dentistry treatment data base was used to identify permanent teeth that had undergone initial obturation between July 1 , 1985 , and December 31 , 1987 . Study patients were restricted to persons with at least 1 dental visit in each 2-year interval from 1985 to 1996 ; a simple r and om sample of 280 patients ( n = 400 teeth ) was selected . Dental charts , radiographs , and computerized data bases were examined to ascertain variables of interest and to verify study inclusion criteria . Kaplan-Meier survival estimates were generated for the 203 teeth that satisfied study inclusion criteria . Multivariate Cox proportional hazards regression models were developed , with st and ard errors adjusted to account for clustering of teeth within patients . RESULTS When tooth type and radiographic evidence of caries at access were controlled , the final Cox model showed that endodontically treated teeth not crowned after obturation were lost at a 6.0 times greater rate than teeth crowned after obturation ( 95 % confidence interval : 3.2 to 11.3 ) . CONCLUSION Within the limitations of this study , a strong association between crown placement and the survival of endodontically treated teeth was observed . These results may impact treatment planning if long-term tooth retention is the primary goal STATEMENT OF PROBLEM Little information exists regarding the outcome of crown build-ups on endodontically treated teeth restored with metal-ceramic crowns or with only a direct-placed composite . PURPOSE The aim of this study was to evaluate the clinical success rate of endodontically treated premolars restored with fiber posts and direct composite restorations and compare that treatment with a similar treatment of full-coverage with metal-ceramic crowns . MATERIAL AND METHODS Subjects included in this study had one maxillary or m and ibular premolar for which endodontic treatment and crown build up was indicated and met specific inclusion /exclusion criteria . Only premolars with Class II carious lesions and preserved cusp structure were included . Subjects were r and omly assigned to 1 of the following 2 experimental groups : ( 1 ) teeth endodontically treated and restored with adhesive techniques and composite or ( 2 ) teeth endodontically treated , restored with adhesive techniques and composite , and then restored with full-coverage metal-ceramic crowns . Sixty teeth were included in the first group and 57 in the second . All restorations were performed by one operator . Causes of failure were categorized as root fracture , post fracture , post decementation , clinical and /or radiographic evidence of marginal gap between tooth and restoration , and clinical and /or radiographic evidence of secondary caries contiguous with restoration margins . Subjects were examined for the listed clinical and radiographic causes of failure by 2 calibrated examiners at intervals of 1 , 2 , and 3 years . Exact 95 % confidence intervals for the difference between the 2 experimental groups were calculated . RESULTS At the 1-year recall , no failures were reported . The only failure modes observed at 2 and 3 years were decementations of posts and clinical and /or radiographic evidence of marginal gap between tooth and restoration . There was no difference in the failure frequencies of the 2 groups ( 95 % confidence interval , -17.5 to 12.6 ) . There was no difference between the number of failures caused by post decementations and the presence of marginal gaps observed in the 2 groups ( 95 % confidence intervals , -9.7 to 16.2 and -17.8 to 9.27 ) . CONCLUSION Within the limitations of this study , the results upheld the research hypothesis that the clinical success rates of endodontically treated premolars restored with fiber posts and direct composite restorations after 3 years of service were equivalent to a similar treatment of full coverage with metal-ceramic crowns PURPOSE The aim of this long-term follow-up study was to collect up to 17 years of survival data of endodontically treated single teeth with or without a prefabricated metal post . MATERIAL S AND METHODS Single teeth were provided with direct composite resin core-crown reconstructions with or without posts by 15 operators . Rest OUTPUT: There is insufficient evidence to support or refute the effectiveness of conventional fillings over crowns for the restoration of root filled teeth . INPUT: STATEMENT OF PROBLEM Cements that yield high retentive values are believed to allow use of shorter posts . PURPOSE This study investigated the use of reinforced composite resin cement as compensation for reduced dowel length . MATERIAL AND METHODS The retention values of stainless steel posts ( parallel-sided ParaPost and tapered Dentatus in 5- , 8- , and 10-mm lengths ) luted with Flexi-Flow titanium-reinforced composite resin and zinc phosphate cements were evaluated . Single-rooted extracted human teeth with crowns ( n = 120 ) , removed at the cementoenamel junction , were r and omly divided into 4 groups of 30 sample s each . Different post lengths were luted with either Flexi-Flow or zinc phosphate . Each sample was placed into a specialized jig and on a tensile testing machine with a crosshead speed of 2 mm/min , applied until failure . The effect of different posts and cements on the force required to dislodge the dowels was evaluated with multiple analyses of variance ( ANOVA ) . One-way ANOVA with Scheffé contrast was applied to determine the effect of different post lengths on the retentive failure of posts luted with the 2 agents . RESULTS Flexi-Flow reinforced composite resin cement significantly increased retention of ParaPost and Dentatus dowels ( P<.001 ) compared with zinc phosphate . One-way ANOVA revealed no statistically significant difference ( P>.05 ) between mean retention of both dowels luted with Flexi-Flow for all posts length used ( 5 mm = 8 mm = 10 mm ) . Mean retention values of the groups luted with zinc phosphate showed a statistically significant difference ( P<.001 ) for the different post lengths ( 10 > 8 > 5 mm ) . Parallel-sided ParaPost dowels demonstrated a higher mean retention than tapered Dentatus dowels ( P<.001 ) . CONCLUSION In this study , Flexi-Flow reinforced composite resin cement compensated for the reduced length of shorter parallel-sided ParaPost and tapered Dentatus dowels OBJECTIVES To evaluate the push-out bond strength and the sealing ability of five adhesive cements routinely used for fiber-post bonding . METHODS Fifty extracted single-rooted teeth were r and omly divided in five groups and restored using Parapost FiberLux and the following luting agents : Panavia 21 ( PAN ) , Clearfil Esthetic Cement ( CLF ) , Variolink II ( VAR ) , RelyX Unicem ( UNI ) and experimental GC self-adhesive cement ( EGC ) . After 1 week of water storage at 37 degrees C , three sections ( coronal , middle and apical ) of 2 mm thickness were prepared from each specimen . Sealing ability was quantified with a fluid-filtration system ( Flodec ) during 10 min , after which the push-out bond strength was immediately measured . Data were analyzed with ANOVA ( push-out ) and Kruskal-Wallis ( sealing ability ) . RESULTS The push-out bond strength and sealing ability were not significantly different among the coronal , middle and apical sections for each luting agent . The highest push-out bond strength was measured for CLF ( 14.60+/-3.63 MPa ) , which was not significantly different from PAN ( 12.57+/-2.45 MPa ) , but significantly higher than VAR ( 11.09+/-4.09 MPa ) , UNI ( 11.29+/-4.31 MPa ) and EGC ( 7.65+/-4.79 MPa ) . When evaluating the sealing ability , significant differences were not found among PAN , CLF and VAR , and between UNI and EGC . The latter luting agents scored significantly lower than the former ones . The push-out bond strength was correlated to the sealing ability ( p<0.001 ) . SIGNIFICANCE The self-etching MDP-based cements presented the highest push-out bond strength . Although the bonding effectiveness of self-adhesive cements appears promising , their interaction with root dentin might be too weak to minimize microleakage at the post-cement-dentin interface OBJECTIVES To verify the influence of different etching procedures of the post-surface on microtensile bond strength values between fiber posts and composite core material s. METHODS 60 DT Light Posts were divided into 10 subgroups using five different chemical surface treatments and two composite material s to build-up the abutment . Chemical surface treatments including etching with potassium permanganate ; treatment with 10 % hydrogen peroxide ; treatment with 21 % sodium ethoxide ; etching with potassium permanganate and 10 vol.% HCl ; silanization ( control group ) were performed on the post 's surface . The build-up was performed using ( A ) Core Paste XP ( Dent Mat ) and ( B ) Unifil Flow ( GC ) . Two sample s of each group were r and omly selected to investigate the morphologic aspect of the post/core interface with a scanning electron microscope ( SEM ) . The remaining specimens were cut so as to obtain microtensile sticks that were loaded in tension at a cross-head speed of 1mm/min until failure . The statistical analysis was performed using two-way ANOVA and the Tukey 's test for post-hoc comparisons ( alpha=0.05 ) . RESULTS SEM examination showed an interpenetrating adhesion network between the treated fiber post-surface and the composite material in all the groups tested . The results achieved with potassium permanganate had a significant influence on microtensile interfacial bond strength values with both the tested material s. Post-superficial treatments enhanced the bond strength particularly of Core Paste XP . SIGNIFICANCE Etching procedures showed a similar effect on the post-surface and enhanced the adhesion of composite core build-ups as a result of micromechanical and chemical retention INTRODUCTION OUTPUT:

The available evidence indicated that the coronal region of the root canal bonded better to the glass fiber post than apical regions . Phosphoric acid , hydrogen peroxide , and silane application enhance post ’s retentiveness . In light of the current evidence , surface treatment strategies increase the bond strength of glass fiber post to dentine . However , recommendations for st and ardized testing methods and reporting of future clinical studies are required to maintain clinical ly relevant information and to underst and the effects of various surface treatment of glass fiber post and their bond strength with dentine walls of the root canal

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: 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 OBJECTIVES For millions of disabled older adults each year , postacute care in skilled nursing facilities is a brief window of opportunity to regain enough function to return home and live independently . Too often this goal is not achieved , possibly because of therapy that is inadequately intense or engaging . This study tested Enhanced Medical Rehabilitation , an intervention design ed to increase patient engagement in , and intensity of , daily physical and occupational therapy sessions in postacute-care rehabilitation . DESIGN R and omized controlled trial of Enhanced Medical Rehabilitation versus st and ard-of-care rehabilitation . SETTING Postacute care unit of a skilled nursing facility in St Louis , MO . PARTICIPANTS Twenty-six older adults admitted from a hospital for postacute rehabilitation . INTERVENTION Based on models of motivation and behavior change , Enhanced Medical Rehabilitation is a set of behavioral skills for physical and occupational therapists that increase patient engagement and intensity , with the goal of improving functional outcome , through ( 1 ) a patient-directed , interactive approach , ( 2 ) increased rehabilitation intensity , and ( 3 ) frequent feedback to patients on their effort and progress . MEASUREMENTS Therapy intensity : assessment of patient active time in therapy sessions . Therapy engagement : Rehabilitation Participation Scale . Functional and performance outcomes : Barthel Index , gait speed , and 6-minute walk . RESULTS Participants r and omized to Enhanced Medical Rehabilitation had higher intensity therapy and were more engaged in their rehabilitation sessions ; they had more improvement in gait speed ( improving from 0.08 to 0.38 m/s versus 0.08 to 0.22 in st and ard of care , P = .003 ) and 6-minute walk ( from 73 to 266 feet versus 40 to 94 feet in st and ard of care , P = .026 ) , with a trend for better improvement of Barthel Index ( + 43 points versus 26 points in st and ard of care , P = .087 ) , compared with participants r and omized to st and ard-of-care rehabilitation . CONCLUSION Higher intensity and patient engagement in the postacute rehabilitation setting is achievable , with result ant better functional outcomes for older adults . Findings should be confirmed in a larger r and omized controlled trial OBJECTIVE During hospitalization older people often experience functional decline which impacts on their future independence . The objective of this study was to evaluate a multifaceted transitional care intervention including home-based exercise strategies for at-risk older people on functional status , independence in activities of daily living ( ADLs ) and walking ability . METHODS A r and omized controlled trial was undertaken in a metropolitan hospital in Australia with 128 patients ( 64 intervention , 64 control ) aged over 65 years with an acute medical admission and at least one risk factor for hospital readmission . The intervention group received an individually tailored programme for exercise and follow-up care which was commenced in hospital and included regular visits in hospital by a physiotherapist and a registered nurse , a home visit following discharge and regular telephone follow-up for 24 weeks following discharge . The programme was design ed to improve health-promoting behaviours , strength , stability , endurance and mobility . Data were collected at baseline , then 4 , 12 and 24 weeks following discharge using the Index of ADL , Instrumental Activities of Daily Living ( IADL ) and the Walking Impairment Question naire ( WIQ ; modified ) . RESULTS Significant improvements were found in the intervention group in IADL scores ( P < 0.001 ) , ADL scores ( P < 0.001 ) and WIQ scale scores ( P < 0.001 ) in comparison to the control group . The greatest improvements were found in the first 4 weeks following discharge . CONCLUSIONS Early introduction of a transitional model of care incorporating a tailored exercise programme and regular telephone follow-up for hospitalized at-risk older adults can improve independence and functional ability Background : The CardioFit internet-based expert system was design ed to promote physical activity in patients with coronary heart disease ( CH OUTPUT: OOHS-based multidisciplinary rehabilitation leads to improved mobility in older patients 3 months after they are discharged from hospital following an acute illness and is not associated with a lower risk of unplanned hospital readmission within 3 months of discharge . INPUT: 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 Introduction : Several established tools are available to assess study quality and reporting of r and omized controlled trials ; however , these tools were design ed with clinical intervention trials in mind . In exercise training intervention trials some of the traditional study quality criteria , such as participant or research er blinding , are extremely difficult to implement . Methods : We developed the Tool for the assEssment of Study qualiTy and reporting in EXercise ( TESTEX ) – a study quality and reporting assessment tool , design ed specifically for use in exercise training studies . Our tool is a 15-point scale ( 5 points for study quality and 10 points for reporting ) and addresses previously unmentioned quality assessment criteria specific to exercise training studies . Results : There were no systematic differences between the summated TESTEX scores of each observer [ H(2 ) = 0.392 , P = 0.822 ] . There was a significant association between the summated TESTEX scores of the three observers , with almost perfect agreement between observers 1 and 2 [ intra-class correlation coefficient ( ICC ) = 0.93 , 95 % confidence interval ( CI ) 0.82–0.97 , P < 0.001 ] , observers 1 and 3 ( ICC = 0.96 , 95 % CI 0.89–0.98 , P < 0.001 ) and observers 2 and 3 ( ICC = 0.91 , 95 % CI 0.75–0.96 , P < 0.001 ) . Conclusions : The TESTEX scale is a new , reliable tool , specific to exercise scientists , that facilitates a comprehensive review of exercise training trials Background Self-efficacy has been determined to be a strong predictor of who will engage in physical activity . We aim ed to evaluate the associations between self-efficacy to perform physical activity , self-reported leisure-time physical activity and cardiovascular events in a population -based cohort of middle-aged Swedish men with no previous cardiovascular disease , or treatment with cardiovascular drugs . Methods Analyses are based on 377 men r and omly selected and stratified for weight and insulin sensitivity from a population sample of 58-year-old men ( n = 1728 ) and who had answered a question about their competence to perform exercise ( as an assessment of physical self-efficacy ) . The Saltin-Grimby Physical Activity Level Scale was used to assess self-reported levels of leisure-time physical activity . Cardiovascular events were recorded during 13-years of follow-up . Results The group with poor self-efficacy to perform physical activity had a significantly higher incidence of cardiovascular events compared with the group with good physical self-efficacy ( 32.1 % vs 17.1 % , p < 0.01 ) . Multivariate analyses showed that poor physical self-efficacy was associated with an increased relative risk of 2.0 ( 95 % CI 1.2 to 3.0 ) , of having a cardiovascular event during follow-up also after adjustments for co-variates such as waist to hip ratio , heart rate , fasting plasma glucose , serum triglycerides , systolic blood pressure , apoB/apoA-I ratio and leisure-time physical activity . ConclusionS elf-efficacy to perform physical activity was strongly and independently associated with cardiovascular events and was superior to self-assessed physical activity in predicting cardiovascular events during 13-years of follow-up in a group of middle-aged men , without known CVD or treatment with cardiovascular drugs Background The prevalence of coronary heart disease is increasing worldwide contributing to mortality and morbidity of millions of people . Cardiac rehabilitation is an interdisciplinary activity with the aim of facilitating and improving the physical , psychological and emotional state of the patients with cardiac complications . This study aim ed to evaluate the probable positive effects of continuing cardiac rehabilitation programs at home on self-efficacy of the patients with cardiac complications . Method In a r and omized controlled trial , 80 patients referred to rehabilitation center from Feb 2009 to Jan 2010 were r and omly OUTPUT:

Conclusions HB exercise is slightly more effective than CB rehabilitation in terms of maintaining EC .

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***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: 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 Objective To determine whether the introduction of an intensive care unit-based medical emergency team , responding to hospital-wide preset criteria of physiologic instability , would decrease the rate of predefined adverse outcomes in patients having major surgery . Design Prospect i ve , controlled before- and -after trial . Setting University-affiliated hospital . Patients Consecutive patients admitted to hospital for major surgery during a 4-month control phase and during a 4-month intervention phase . Interventions Introduction of a hospital-wide intensive care unit-based medical emergency team to evaluate and treat in- patients deemed at risk of developing an adverse outcome by nursing , paramedical , and /or medical staff . Measurements and Main Results We measured incidence of serious adverse events , mortality after major surgery , and mean duration of hospital stay . There were 1,369 operations in 1,116 patients during the control period and 1,313 in 1,067 patients during the medical emergency team intervention period . In the control period , there were 336 adverse outcomes in 190 patients ( 301 outcomes /1,000 surgical admissions ) , which decreased to 136 in 105 patients ( 127 outcomes /1,000 surgical admissions ) during the intervention period ( relative risk reduction , 57.8 % ; p < .0001 ) . These changes were due to significant decreases in the number of cases of respiratory failure ( relative risk reduction , 79.1 % ; p < .0001 ) , stroke ( relative risk reduction , 78.2 % ; p = .0026 ) , severe sepsis ( relative risk reduction , 74.3 % ; p = .0044 ) , and acute renal failure requiring renal replacement therapy ( relative risk reduction , 88.5 % ; p < .0001 ) . Emergency intensive care unit admissions were also reduced ( relative risk reduction , 44.4 % ; p = .001 ) . The introduction of the medical emergency team was also associated with a significant decrease in the number of postoperative deaths ( relative risk reduction , 36.6 % ; p = .0178 ) . Duration of hospital stay after major surgery decreased from a mean of 23.8 days to 19.8 days ( p = .0092 ) . Conclusions The introduction of an intensive care unit-based medical emergency team in a teaching hospital was associated with a reduced incidence of postoperative adverse outcomes , postoperative mortality rate , and mean duration of hospital stay Patient injuries are thought to have a substantial financial impact on the health care system , but recent studies have been limited to estimating the costs of adverse drug events in teaching hospitals . This analysis estimated the costs of all types of patient injuries from a representative sample of hospitals in Utah and Colorado . We detected 459 adverse events ( of which 265 were preventable ) by review ing the medical records of 14,732 r and omly selected 1992 discharges from 28 hospitals . The total costs ( all results are discounted 1996 dollars ) were $ 661,889,000 for adverse events , and $ 308,382,000 for preventable adverse events . Health care costs totaled $ 348,081,000 for all adverse events and $ 159,245,000 for the preventable adverse events . Fifty-seven percent of the adverse event health care costs , and 46 % of the preventable adverse event costs were attributed to outpatient medical care . Surgical complications , adverse drug events , and delayed or incorrect diagnoses and therapies were the most expensive types of adverse events . The costs of adverse events were similar to the national costs of caring for people with HIV/AIDS , and totaled OUTPUT: A substantial part of these events are preventable . Since a large proportion of the in-hospital events are operation- or drug-related , interventions aim ed at preventing these events have the potential to make a substantial difference INPUT: 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 BACKGROUND Surgical site infections ( SSIs ) are the most frequent health-care-associated infections in developing countries . Specific prevention measures are highly effective , but are often poorly implemented . We aim ed to establish the effect of a multimodal intervention on SSIs in Africa . METHODS We did a before-after cohort study , between July 1 , 2013 , and Dec 31 , 2015 , at five African hospitals . The multimodal intervention consisted of the implementation or strengthening of multiple SSI prevention measures , combined with an adaptive approach aim ed at the improvement of teamwork and the safety climate . The primary outcome was the first occurrence of SSI , and the secondary outcome was death within 30 days post surgery . Data on adherence to SSI prevention measures were prospect ively collected . The intervention effect on SSI risk and death within 30 days post surgery was assessed in a mixed-effects logistic regression model , after adjustment for key confounders . FINDINGS Four hospitals completed the baseline and follow-up ; three provided suitable ( ie , sufficient number and quality ) data for the sustainability period . 4322 operations were followed up ( 1604 at baseline , 1827 at follow-up , and 891 in the sustainability period ) . SSI cumulative incidence significantly decreased post intervention , from 8·0 % ( 95 % CI 6·8 - 9·5 ; n=129 ) to 3·8 % ( 3·0 - 4·8 ; n=70 ; p<0·0001 ) , and this decrease persisted in the sustainability period ( 3·9 % , 2·8 - 5·4 ; n=35 ) . A substantial improvement in compliance with prevention measures was consistently observed in the follow-up and sustainability periods . The likelihood of SSI during follow-up was significantly lower than pre-intervention ( odds ratio [ OR ] 0·40 , 95 % CI 0·29 - 0·54 ; p<0·0001 ) , but the likelihood of death was not significantly reduced ( 0·72 , 0·42 - 1·24 ; p=0·2360 ) . INTERPRETATION Implementation of our intervention is feasible in African hospitals . Improvement was observed across all perioperative prevention practice s. A significant effect on the overall SSI risk was observed , but with some heterogeneity between sites . Further large-scale experimental studies are needed to confirm these results and to improve the sustainability and long-term effect of such complex programmes . FUNDING US Agency for Healthcare Research and Quality , WHO INTRODUCTION The World Health Organization sets a st and ard to maintain patient core temperature greater than 36 ° C throughout the perioperative period . Normothermia ( defined as > 36 ° C ) in the Operating Room ( OR ) is an important factor to preventing complications in patients ( MI , infection , coagulopathy ) . R and omized studies suggests that maintaining at higher temperatures may further reduce complications in surgery ( less complications for group at 36.4 ° C than the control group at 36.0 ° C ) [ 1,2 ] . Perioperative normothermia is an important but often unrecognized element during anesthesia . Early recognition of hypothermia would allow for appropriate interventions and prevent complications . METHODOLOGY Manual validation of the diagnostic performance a clinical tool ( alert ) that would automatically measure changes in core temperature to identify patients who fail to be in range of normothermia during surgery . RESULTS The clinical tool ( alert ) was found to be 97 % sensitive BACKGROUND Currently , no single U.S. surveillance system can provide estimates of the burden of all types of health care-associated infections across acute care patient population s OUTPUT:

The results of this study suggest that preoperative warming can reduce rates of SSI after surgery .

MS2_dynamic_1_shot690

***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: In Mexico , the potential impact on child malnutrition from a nutritional supplement ( papilla ) delivered through a conditional transfer program ( Oportunidades ) was attenuated by problems of household utilization . A behavioral change through communication intervention was developed to improve supplement utilization . Our study assessed the efficacy of this intervention through the results of a r and omized trial . In 2 states ( Veracruz and Chiapas ) 2 clusters of communities were r and omly assigned to intervention or control groups . Data were obtained from 176 - 198 mothers in intervention and control communities using a survey question naire at preintervention baseline and at a 5-mo follow-up . Concordance between reported and observed behaviors was examined through an observational sub study . The 4 behavioral recommendations were : 1 ) prepare papilla as a pap ; 2 ) administer the preparation every day ; 3 ) administer it between breakfast and dinner ; and 4 ) administer it only to target children . The intervention result ed in a significant increase ( P<0.05 ) in the prevalence of reported correct behaviors in the intervention group compared with the control for 3 of the behaviors : a mean increase of 42.5 % for preparing papilla as pap , 64.4 % for daily administration , and 61.5 % for giving papilla between breakfast and dinner . Administering to a target child increased significantly in Veracruz ( from 51.5 % to 90.6 % ) , but not in Chiapas ( 20.6 % to 33.3 % ) . Reported behaviors agreed with observed behaviors in the sub study . With the exception of the target-child administration in Chiapas , adopting the recommendations was culturally acceptable and feasible . The results indicate that improvements in household utilization of the supplement can be achieved with a communication intervention that is potentially feasible for implementation on a large scale within the Oportunidades Program Background In 2011 , Cameroon and its health partners distributed over eight million free long-lasting insecticide treated nets ( LLINs ) in an effort to reduce the significant morbidity and mortality burden of malaria in the country . A national communications campaign was launched in July 2011 to ensure that as the nets were delivered , they would be used consistently to close a net use gap : only 51.6 % of adults and 63.4 % of their children in households with at least one net were sleeping under nets before the distribution . Even in households with at least one net for every two people , over 35 % of adults were not sleeping under a net . Malaria No More ( MNM ) adapted its signature NightWatch communications programme to fit within the coordinated “ KO Palu ” ( Knock Out Malaria ) national campaign . This study evaluates the impact of KO Palu NightWatch activities ( that is , the subset of KO Palu-br and ed communications that were funded by MNM ’s NightWatch program ) on bed net use . Methods Using national survey data collected at baseline ( in March/April 2011 , before the national LLIN distribution and KO Palu NightWatch launch ) and post-intervention ( March/April 2012 ) , this study evaluates the impact of exposure to KO Palu NightWatch activities on last-night net use by Cameroonian adults and their children under five . First , a plausible case for causality was established by comparing net use in 2011 and 2012 and measuring exposure to KO Palu NightWatch ; next , a propensity score matching ( PSM ) model was used to estimate the impact of exposure on net use by simulating a r and omized control trial ; finally , the model was tested for sensitivity to unmeasured factors . Results The PSM model estimated that among Cameroonians with at least one net in their household , exposure to KO Palu NightWatch activities was associated with a 6.6 percentage point increase in last-night net use among respondents ( 65.7 % vs 59.1 % , p < 0.05 ) and a 12.0 percentage point increase in last-night net use among respondents ’ children under five ( 79.6 % vs 67.6 % , p < 0.025 ) . Sensitivity analysis suggests only a very small risk of bias from omitted factors influencing exposure and net use . Conclusions Extrapolating the results of the PSM model to the population of Cameroonians with access to at least one mosquito net , this analysis estimates that approximately 298,000 adults and over 221,000 of their children under five slept under a bed net because of the knowledge , motivation , and /or timely reminder provided by KO Palu NightWatch activities . The programme cost less than $ 0.16 per adult reached , and less than $ 1.62 per additional person protected by a net . The results suggest a strong role for mass media communication interventions in support of investments in malaria control commodities such as LLINs In this article we examine the cost-effectiveness of the Smiling Sun multichannel media campaign , which was undertaken in Bangladesh from 2001 to 2003 and involved a nationally broadcast television serial drama supported by radio , television , newspaper , and billboard advertisements and local promotion activities . The goal was to encourage the use of a package of family health services at NGO ( nongovernmental organization ) Service Delivery Program ( NSDP ) providers . This analysis relates the costs of the Smiling Sun campaign at the national and local level to measures of change in the use of health services , namely , antenatal care and childhood immunizations . Effectiveness is measured using data from cross-sectional surveys conducted in 2001 and 2003 in NSDP catchment areas in rural Bangladesh . The statistical approach , bivariate probit estimation , controls for nonr and om exposure to the program 's media messages , advertisements , and signs . Using national-level data , we find that the Smiling Sun campaign was both effective and cost-effective , inducing higher levels of service utilization for only $ 0.05 per additional antenatal care ( ANC ) user and only $ 0.30 and $ 0.36 for each additional child vaccinated for measles and DPT3 , respectively OUTPUT: The moderate and stronger evaluations provide evidence that mass media-centric campaigns can positively impact a wide range of child survival health behaviors INPUT: Despite significant global efforts to improve vaccination coverage against major childhood diseases , vaccination rates are below 90 % . To eradicate diseases such as measles , however , vaccination rates close to 95 % are needed . We use a r and omized experiment to investigate the effect of a dem and incentive , a conditional cash transfer program , in improving vaccination coverage in rural Nicaragua . Double-difference estimates show the program led to large increases in vaccination coverage , and these result ed in vaccination levels greater than 95 % for some vaccines . Effects were especially large for children who are typically harder to reach with traditional supply-side interventions OBJECTIVES To evaluate the impact of Mexico 's conditional cash transfer programme on the quality of health care received by poor women . Quality is measured by maternal reports of prenatal care procedures received that correspond with clinical guidelines . METHODS The data describe retrospective reports of care received from 892 women in poor rural communities in seven Mexican states . The women were participating in an effectiveness study and r and omly assigned to incorporation into the programme in 1998 or 1999 . Eligible women accepted cash transfers conditional on obtaining health care and nutritional supplements , and participated in health education sessions . RESULTS Oportunidades beneficiaries received 12.2 % more prenatal procedures compared with non-beneficiaries ( adjusted mean 78.9 , 95 % Confidence Interval ( CI ) : 77.5 - 80.3 ; P < 0.001 ) . CONCLUSION The Oportunidades conditional cash transfer programme is associated with better quality of prenatal care for low-income , rural women in Mexico . This result is probably a manifestation of the programme 's empowerment goal , by encouraging beneficiaries to be informed and active health consumers BACKGROUND Many governments have implemented conditional cash transfer ( CCT ) programmes with the goal of improving options for poor families through interventions in health , nutrition , and education . Families enrolled in CCT programmes receive cash in exchange for complying with certain conditions : preventive health requirements and nutrition supplementation , education , and monitoring design ed to improve health outcomes and promote positive behaviour change . Our aim was to disaggregate the effects of cash transfer from those of other programme components . METHODS In an intervention that began in 1998 in Mexico , low-income communities ( n=506 ) were r and omly assigned to be enrolled in a CCT programme ( Oportunidades , formerly Progresa ) immediately or 18 months later . In 2003 , children ( n=2449 ) aged 24 - 68 months who had been enrolled in the programme their entire lives were assessed for a wide variety of outcomes . We used linear and logistic regression to determine the effect size for each outcome that is associated with a doubling of cash transfers while controlling for a wide range of covariates , including measures of household socioeconomic status . FINDINGS A doubling of cash transfers was associated with higher height-for-age Z score ( beta 0.20 , 95 % CI 0.09 - 0.30 ; p<0.0001 ) , lower prevalence of stunting ( -0.10 , -0.16 to -0.05 ; p<0.0001 ) , lower body-mass index for age percentile ( -2.85 , -5.54 to -0.15 ; p=0.04 ) , and lower prevalence of being overweight ( -0.08 , -0.13 to -0.03 ; p=0.001 ) . A doubling of cash transfers was also associated with children doing better on a scale of motor development , three scales of cognitive development , and with receptive language . INTERPRETATION Our results suggest that the cash transfer component of Oportunidades is associated with better outcomes in child health , growth , and development Summary Background Cash-transfer programmes can improve the wellbeing of vulnerable children , but few studies have rigorously assessed their effectiveness in sub-Saharan Africa . We investigated the effects of unconditional cash transfers ( UCTs ) and conditional cash transfers ( CCTs ) on birth registration , vaccination uptake , and school attendance in children in Zimbabwe . Methods We did a matched , cluster-r and omised controlled trial in ten sites in Manical and , Zimbabwe . We divided each study site into three clusters . After a baseline survey between July , and September , 2009 , clusters in each site were r and omly assigned to UCT , CCT , or control , by drawing of lots from a hat . Eligible households contained children younger than 18 years and satisfied at least one other criteria : head of household was younger than 18 years ; household cared for at least one orphan younger than 18 years , a disabled person , or an individual who was chronically ill ; or household was in poorest wealth quintile . Between January , 2010 , and January , 2011 , households in UCT clusters collected payments every 2 months . Households in CCT clusters could receive the same amount but were monitored for compliance with several conditions related to child wellbeing . Eligible households in all clusters , including control clusters , had access to parenting skills classes and received maize seed and fertiliser in December , 2009 , and August , 2010 . Households and individuals delivering the intervention were not masked , but data analysts were . The primary endpoints were proportion of children younger than 5 years with a birth certificate , proportion younger than 5 years with up-to- date vaccinations , and proportion aged 6–12 years attending school at least 80 % of the time . This trial is registered with Clinical Trials.gov , number NCT00966849 . Findings 1199 eligible households were allocated to the control group , 1525 to the UCT group , and 1319 to the CCT group . Compared with control clusters , the proportion of children aged 0–4 years with birth certificates had increased by 1·5 % ( 95 % CI − OUTPUT:

The quality of evidence on the effect of financial incentives on breastfeeding practice s was low but seems to indicate a potential positive impact on receiving colostrum , early initiation of breastfeeding , exclusive breastfeeding and mean duration of exclusive breastfeeding . There is no effect of financial incentives on immunization coverage although there was moderate quality evidence of conditional cash transfers leading to a small but non-significant increase in coverage of age-appropriate immunization . Conclusions Financial incentives may have potential to promote increased coverage of several important child health interventions , but the quality of evidence available is low . The more pronounced effects seem to be achieved by programs that directly removed user fees for access to health services . Some indication of effect were also observed for programs that conditioned financial incentives on participation in health education and attendance to health care visits . This finding suggest that the measured effect may be less a consequence of the financial incentive and more due to conditionalities addressing important informational barriers

MS2_dynamic_1_shot691

***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: This study investigated the differences in the effect of an angiotensin converting enzyme inhibitor ( ACEI ) compared with an angiotensin receptor blocker ( ARB ) on blood pressure ( BP ) and pulse pressure ( PP ) measured in the clinic ( CBP and CPP , respectively ) , at home ( HBP , HPP ) and with ambulatory monitoring ( ABP , APP ) . Twenty-seven hypertensive patients were r and omised to receive lisinopril ( 20 mg ) or losartan ( 50 mg ) for 5 weeks , and were subsequently crossed-over to the alternative treatment for a second 5-week period . Measurements of CBP , 24-h ABP and 5-days HBP were performed before r and omisation and at the end of each treatment period . All measurement methods showed that lisinopril was more effective than losartan in reducing BP . However , the difference between the two drugs was demonstrated with greater precision using HBP ( P<0.001 ) than 24-h ABP ( P<0.01 ) , whereas the poorest precision for demonstrating this difference was provided by CBP ( P<0.05 ) . Lisinopril was also found more effective than losartan in reducing HPP ( P=0.01 ) and 24-h APP ( P=0.03 ) whereas no such a difference was detected using measurements of CPP . It was concluded that the antihypertensive drugs may differ in their effects not only on BP , but also on PP . HBP monitoring appears to be as reliable as 24-h ABP monitoring in detecting differences in the effect of drugs on both BP and PP . Clinic measurements seem to be the least reliable method , particularly in the detection of differences in PP Objective To compare the predictive powers of self-measurement of blood pressure at home ( home blood pressure measurement ) and casual ( screening ) blood pressure measurement for mortality . Design A prospect i ve cohort study . Subjects and methods We obtained home and screening blood pressure measurements for 1789 subjects aged ≥ 40 years who were followed up for a mean of 6.6 years . The prognostic significance of blood pressure for mortality was determined by the Cox proportional hazards regression model adjusted for age , sex , smoking status , past history of cardiovascular disease , and the use of antihypertensive medication . Results When the home blood pressure values and the screening blood pressure values were simultaneously incorporated into the Cox model as continuous variables , only the average of multiple ( taken more than three times ) home systolic blood pressure values was significantly and strongly related to the cardiovascular mortality risk . The average of the two initial home blood pressure values was also better related to the mortality risk than were the screening blood pressure values . Conclusions Home blood pressure measurement had a stronger predictive power for mortality than did screening blood pressure measurement for a general population . This appears to be the first study in which the prognostic significance s of home and screening blood pressure measurements have been compared It is still uncertain whether one can safely base treatment decisions on self-measurement of blood pressure . In the present study , we investigated whether antihypertensive treatment based on self-measurement of blood pressure leads to the use of less medication without the loss of blood pressure control . We r and omly assigned 430 hypertensive patients to receive treatment either on the basis of self-measured pressures ( n=216 ) or office pressures ( OPs ; n=214 ) . During 1-year follow-up , blood pressure was measured by office measurement ( 10 visits ) , ambulatory monitoring ( start and end ) , and self-measurement ( 8 times , self-pressure group only ) . In addition , drug use , associated costs , and degree of target organ damage ( echocardiography and microalbuminuria ) were assessed . The self-pressure group used less medication than the OP group ( 1.47 versus 2.48 drug steps ; P<0.001 ) with lower costs ( $ 3222 versus $ 4420 per 100 patients per month ; P<0.001 ) but without significant differences in systolic and diastolic OP values ( 1.6/1.0 mm Hg ; P=0.25/0.20 ) , in changes in left ventricular mass index ( -6.5 g/m(2 ) versus -5.6 g/m(2 ) ; P=0.72 ) , or in median urinary microalbumin concentration ( -1.7 versus -1.5 mg per 24 hours ; P=0.87 ) . Nevertheless , 24-hour ambulatory blood pressure values at the end of the trial were higher in the self-pressure than in the OP group : 125.9 versus 123.8 mm Hg ( P<0.05 ) for systolic and 77.2 versus 76.1 mm Hg ( P<0.05 ) for diastolic blood pressure . These data show that self-measurement leads to less medication use than office blood pressure measurement without leading to significant differences in OP values or target organ damage . Ambulatory values , however , remain slightly elevated for the self-pressure group We examined the effects of the addition of low-dose indapamide to antihypertensive drugs of other classes , as well as its duration of action , using blood pressure ( BP ) self-monitoring at home . Seventy-six patients undergoing monotherapy with a calcium channel blocker ( CCB ) , angiotensin converting-enzyme inhibitor ( ACEI ) , or angiotensin AT1-receptor blocker ( ARB ) , but had an average morning home systolic BP ( SBP ) ≥ 135 mmHg or diastolic BP ( DBP ) ≥ 85 mmHg , were studied . Indapamide ( 1 mg ) was added to their existing treatment once daily for 4 weeks . The additional hypotensive effects of indapamide were evaluated by casual and home BPs , and the results were compared among the three groups of subjects classified according to their initial drug treatment classes . The morning/evening ( M/E ) ratio of BP reduction was calculated to assess the duration OUTPUT: In conclusion , HBP falls approximately 20 % less than CBP with antihypertensive treatments . INPUT: This study investigated the differences in the effect of an angiotensin converting enzyme inhibitor ( ACEI ) compared with an angiotensin receptor blocker ( ARB ) on blood pressure ( BP ) and pulse pressure ( PP ) measured in the clinic ( CBP and CPP , respectively ) , at home ( HBP , HPP ) and with ambulatory monitoring ( ABP , APP ) . Twenty-seven hypertensive patients were r and omised to receive lisinopril ( 20 mg ) or losartan ( 50 mg ) for 5 weeks , and were subsequently crossed-over to the alternative treatment for a second 5-week period . Measurements of CBP , 24-h ABP and 5-days HBP were performed before r and omisation and at the end of each treatment period . All measurement methods showed that lisinopril was more effective than losartan in reducing BP . However , the difference between the two drugs was demonstrated with greater precision using HBP ( P<0.001 ) than 24-h ABP ( P<0.01 ) , whereas the poorest precision for demonstrating this difference was provided by CBP ( P<0.05 ) . Lisinopril was also found more effective than losartan in reducing HPP ( P=0.01 ) and 24-h APP ( P=0.03 ) whereas no such a difference was detected using measurements of CPP . It was concluded that the antihypertensive drugs may differ in their effects not only on BP , but also on PP . HBP monitoring appears to be as reliable as 24-h ABP monitoring in detecting differences in the effect of drugs on both BP and PP . Clinic measurements seem to be the least reliable method , particularly in the detection of differences in PP The antihypertensive efficacy of the angiotensin II receptor blocker olmesartan medoxomil has been shown to compare favourably with that of other antihypertensive agents . This r and omized , double-blind study compared the antihypertensive efficacy of the starting dose of olmesartan medoxomil with that of the calcium channel blocker amlodipine besylate ( amlodipine ) in subjects with mild-to-moderate hypertension . Following a 4-week , single-blind , placebo run-in period , 440 subjects aged ⩾18 years were r and omized to the starting dose of olmesartan medoxomil ( 20 mg/day ) , amlodipine ( 5 mg/day ) , or placebo for 8 weeks . Subjects were evaluated by 24-h ambulatory blood pressure monitoring ( ABPM ) and by seated cuff blood pressure ( BP ) measurements at trough . The primary end point was the change from baseline in mean 24-h diastolic blood pressure ( DBP ) by ABPM at Week 8 . Secondary end points included change from baseline in mean 24-h ambulatory systolic blood pressure ( SBP ) at 8 weeks , change from baseline in mean seated trough cuff DBP and SBP measurements , and response and control rates for DBP < 90 and < 85 mmHg . Control rates for SBP < 140 and < 130 mmHg were also calculated . Olmesartan medoxomil and amlodipine produced significantly greater reductions in ambulatory and seated DBP and SBP compared with placebo . Mean reductions in ambulatory and seated BP were similar between the two active agents ; however , in the olmesartan medoxomil group , significantly more patients achieved the SBP goal of < 130 mmHg and the DBP goal of < 85 mmHg . Both drugs were well tolerated at the recommended starting dose . Although amlodipine was associated with a higher incidence of oedema , this did not reach statistical significance . Olmesartan medoxomil is an effective antihypertensive agent , with BP-lowering efficacy at the starting dose similar to that of amlodipine , and is associated with more patients achieving the rigorous BP goals of SBP < 130 mmHg and DBP < 85 mmHg Abstract . Objective : The aim of this study was to measure the time – effect profiles of a once-daily administered valsartan/hydrochlorothiazide combination and amlodipine on blood pressure using various indices derived from 24-h ambulatory blood pressure ( BP ) monitoring . Methods : Of the 310 r and omized out patients with uncomplicated mild-to-moderate primary hypertension , 259 ( 133 on valsartan/hydrochlorothiazide , 126 on amlodipine ) were eligible for analysis . After a 2-week placebo wash-out period , the patients were r and omly allocated to treatment with either valsartan 80 mg once daily ( o.d . ) or amlodipine 5 mg o.d . for 4 weeks ; in the case of an unsatisfactory blood pressure response , the treatments could be respectively changed to the fixed combination of valsartan 80 mg plus hydrochlorothiazide 12.5 mg o.d . or amlodipine 10 mg o.d . for a further 8 weeks . The trough : peak ratio ( global and individualized approaches ) and smoothness index ( i.e. , the ratio between the average of the 24-hourly BP changes after treatment and the corresponding st and ard deviation ) were calculated from 24-h ambulatory blood pressure recordings made after the placebo period and after 4 weeks and 12 weeks of active treatment . Results : Both regimens effectively lowered systolic and diastolic ambulatory pressures after 4 weeks and 12 weeks ( all P<0.001 ) but , among the responders , the valsartan/hydrochlorothiazide combination had a greater antihypertensive effect during the night-time hours after 12 weeks ( P=0.03/0.02 ) . In the responders , the place OUTPUT:

RESULTS The global antihypertensive activity of ARB differs from that observed with amlodipine in the sense that the magnitude of the reduction in the BP values does not essentially depend on the initial BP values nor on the dose used . When only ARB were considered , the drug used was a determinant for systolic BP reduction , whereas for diastolic BP the influence was on the BP reduction and the duration of the antihypertensive activity . The dose used had a particular influence on the duration of the antihypertensive activity for both systolic and diastolic BP . CONCLUSION Among the ARB , the influence is on duration more than on the magnitude of BP reduction . Dose , therefore , is an important factor in the duration of antihypertensive activity

MS2_dynamic_1_shot692

***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: The British Regional Heart Study ( BRHS ) reported in 1986 that much of the inverse relation of high-density lipoprotein cholesterol ( HDLC ) and incidence of coronary heart disease was eliminated by covariance adjustment . Using the proportional hazards model and adjusting for age , blood pressure , smoking , body mass index , and low-density lipoprotein cholesterol , we analyzed this relation separately in the Framingham Heart Study ( FHS ) , Lipid Research Clinics Prevalence Mortality Follow-up Study ( LRCF ) and Coronary Primary Prevention Trial ( CPPT ) , and Multiple Risk Factor Intervention Trial ( MRFIT ) . In CPPT and MRFIT ( both r and omized trials in middle-age high-risk men ) , only the control groups were analyzed . A 1-mg/dl ( 0.026 mM ) increment in HDLC was associated with a significant coronary heart disease risk decrement of 2 % in men ( FHS , CPPT , and MRFIT ) and 3 % in women ( FHS ) . In LRCF , where only fatal outcomes were documented , a 1-mg/dl increment in HDLC was associated with significant 3.7 % ( men ) and 4.7 % ( women ) decrements in cardiovascular disease mortality rates . The 95 % confidence intervals for these decrements in coronary heart and cardiovascular disease risk in the four studies overlapped considerably , and all contained the range 1.9 - 2.9 % . HDLC levels were essentially unrelated to non-cardiovascular disease mortality . When differences in analytic methodology were eliminated , a consistent inverse relation of HDLC levels and coronary heart disease event rates was apparent in BRHS as well as in the four American studies BACKGROUND In observational analyses , higher levels of high-density lipoprotein ( HDL ) cholesterol have been associated with a lower risk of coronary heart disease events . However , whether raising HDL cholesterol levels therapeutically reduces cardiovascular risk remains uncertain . Inhibition of cholesteryl ester transfer protein ( CETP ) raises HDL cholesterol levels and might therefore improve cardiovascular outcomes . METHODS We r and omly assigned 15,871 patients who had had a recent acute coronary syndrome to receive the CETP inhibitor dalcetrapib , at a dose of 600 mg daily , or placebo , in addition to the best available evidence -based care . The primary efficacy end point was a composite of death from coronary heart disease , nonfatal myocardial infa rct ion , ischemic stroke , unstable angina , or cardiac arrest with resuscitation . RESULTS At the time of r and omization , the mean HDL cholesterol level was 42 mg per deciliter ( 1.1 mmol per liter ) , and the mean low-density lipoprotein ( LDL ) cholesterol level was 76 mg per deciliter ( 2.0 mmol per liter ) . Over the course of the trial , HDL cholesterol levels increased from baseline by 4 to 11 % in the placebo group and by 31 to 40 % in the dalcetrapib group . Dalcetrapib had a minimal effect on LDL cholesterol levels . Patients were followed for a median of 31 months . At a prespecified interim analysis that included 1135 primary end-point events ( 71 % of the projected total number ) , the independent data and safety monitoring board recommended termination of the trial for futility . As compared with placebo , dalcetrapib did not alter the risk of the primary end point ( cumulative event rate , 8.0 % and 8.3 % , respectively ; hazard ratio with dalcetrapib , 1.04 ; 95 % confidence interval , 0.93 to 1.16 ; P=0.52 ) and did not have a significant effect on any component of the primary end point or total mortality . The median C-reactive protein level was 0.2 mg per liter higher and the mean systolic blood pressure was 0.6 mm Hg higher with dalcetrapib as compared with placebo ( P<0.001 for both comparisons ) . CONCLUSIONS In patients who had had a recent acute coronary syndrome , dalcetrapib increased HDL cholesterol levels but did not reduce the risk of recurrent cardiovascular events . ( Funded by F. Hoffmann-La Roche ; dal- OUTCOMES Clinical Trials.gov number , NCT00658515 . ) Background — There is no r and omized , double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline -adjusted treatment of acute myocardial infa rct ion . Methods and Results — OMEGA is a r and omized , placebo-controlled , double-blind , multicenter trial testing the effects of omega-3-acid ethyl esters-90 ( 1 g/d for 1 year ) on the rate of sudden cardiac death in survivors of acute myocardial infa rct ion , if given in addition to current guideline -adjusted treatment . Secondary end points were total mortality and nonfatal clinical events . Patients ( n=3851 ; female , 25.6 % ; mean age , 64.0 years ) were r and omized in 104 German centers 3 to 14 days after acute myocardial infa rct ion from October 2003 until June 2007 . Acute coronary angiography was performed in 93.8 % and acute percutaneous coronary intervention in 77.8 % of all patients . During a follow-up of 365 days , the event rates were ( omega and control groups ) as follows : sudden cardiac death , 1.5 % and 1.5 % ( P=0.84 ) ; total mortality , 4.6 % and 3.7 % ( P=0.18 ) ; major adverse OUTPUT: FINDINGS Niacin may reduce cardiovascular events as monotherapy ; however , recent trials in combination with statins have failed to show a benefit . Trials with omega-3 FAs have failed to demonstrate significant reductions in cardiovascular outcomes . Fibrates may improve cardiovascular outcomes as monotherapy ; however , trials in combination with statins have failed to show a benefit , except in those with elevated triglycerides ( > 200 mg/dL ) or low HDL-C ( < 40 mg/dL ) . There is a lack of data that evaluates bile acid sequestrant in combination with statin therapy on reducing cardiovascular events . IMPLICATION S Nonstatin therapies have a limited role in reducing cardiovascular events in those maintained on guideline -directed statin therapy . In certain clinical situations , such as patients who are unable to tolerate statin therapy or recommended intensities of statin therapy , those with persistent severe elevations in triglycerides , or patients with high cardiovascular risk , some nonstatin therapies may be useful in reducing cardiovascular events . INPUT: The British Regional Heart Study ( BRHS ) reported in 1986 that much of the inverse relation of high-density lipoprotein cholesterol ( HDLC ) and incidence of coronary heart disease was eliminated by covariance adjustment . Using the proportional hazards model and adjusting for age , blood pressure , smoking , body mass index , and low-density lipoprotein cholesterol , we analyzed this relation separately in the Framingham Heart Study ( FHS ) , Lipid Research Clinics Prevalence Mortality Follow-up Study ( LRCF ) and Coronary Primary Prevention Trial ( CPPT ) , and Multiple Risk Factor Intervention Trial ( MRFIT ) . In CPPT and MRFIT ( both r and omized trials in middle-age high-risk men ) , only the control groups were analyzed . A 1-mg/dl ( 0.026 mM ) increment in HDLC was associated with a significant coronary heart disease risk decrement of 2 % in men ( FHS , CPPT , and MRFIT ) and 3 % in women ( FHS ) . In LRCF , where only fatal outcomes were documented , a 1-mg/dl increment in HDLC was associated with significant 3.7 % ( men ) and 4.7 % ( women ) decrements in cardiovascular disease mortality rates . The 95 % confidence intervals for these decrements in coronary heart and cardiovascular disease risk in the four studies overlapped considerably , and all contained the range 1.9 - 2.9 % . HDLC levels were essentially unrelated to non-cardiovascular disease mortality . When differences in analytic methodology were eliminated , a consistent inverse relation of HDLC levels and coronary heart disease event rates was apparent in BRHS as well as in the four American studies BACKGROUND In observational analyses , higher levels of high-density lipoprotein ( HDL ) cholesterol have been associated with a lower risk of coronary heart disease events . However , whether raising HDL cholesterol levels therapeutically reduces cardiovascular risk remains uncertain . Inhibition of cholesteryl ester transfer protein ( CETP ) raises HDL cholesterol levels and might therefore improve cardiovascular outcomes . METHODS We r and omly assigned 15,871 patients who had had a recent acute coronary syndrome to receive the CETP inhibitor dalcetrapib , at a dose of 600 mg daily , or placebo , in addition to the best available evidence -based care . The primary efficacy end point was a composite of death from coronary heart disease , nonfatal myocardial infa rct ion , ischemic stroke , unstable angina , or cardiac arrest with resuscitation . RESULTS At the time of r and omization , the mean HDL cholesterol level was 42 mg per deciliter ( 1.1 mmol per liter ) , and the mean low-density lipoprotein ( LDL ) cholesterol level was 76 mg per deciliter ( 2.0 mmol per liter ) . Over the course of the trial , HDL cholesterol levels increased from baseline by 4 to 11 % in the placebo group and by 31 to 40 % in the dalcetrapib group . Dalcetrapib had a minimal effect on LDL cholesterol levels . Patients were followed for a median of 31 months . At a prespecified interim analysis that included 1135 primary end-point events ( 71 % of the projected total number ) , the independent data and safety monitoring board recommended termination of the trial for futility . As compared with placebo , dalcetrapib did not alter the risk of the primary end point ( cumulative event rate , 8.0 % and 8.3 % , respectively ; hazard ratio with dalcetrapib , 1.04 ; 95 % confidence interval , 0.93 to 1.16 ; P=0.52 ) and did not have a significant effect on any component of the primary end point or total mortality . The median C-reactive protein level was 0.2 mg per liter higher and the mean systolic blood pressure was 0.6 mm Hg higher with dalcetrapib as compared with placebo ( P<0.001 for both comparisons ) . CONCLUSIONS In patients who had had a recent acute coronary syndrome , dalcetrapib increased HDL cholesterol levels but did not reduce the risk of recurrent cardiovascular events . ( Funded by F. Hoffmann-La Roche ; dal- OUTCOMES Clinical Trials.gov number , NCT00658515 . ) BACKGROUND Patients with atherosclerotic vascular disease remain at high risk for cardiovascular events despite effective statin‐based treatment of low‐density lipoprotein ( LDL ) cholesterol levels . The inhibition of cholesteryl ester transfer protein ( CETP ) by anacetrapib reduces LDL cholesterol levels and increases high‐density lipoprotein ( HDL ) cholesterol levels . However , trials of other CETP inhibitors have shown neutral or adverse effects on cardiovascular outcomes . METHODS We conducted a r and omized , double‐blind , placebo‐controlled trial involving 30,449 adults with atherosclerotic vascular disease who were receiving intensive atorvastatin therapy and who had a mean LDL cholesterol level of 61 mg per deciliter ( 1.58 mmol per liter ) , a mean non‐HDL cholesterol level of 92 mg per deciliter ( 2.38 mmol per liter ) , and a mean HDL cholesterol level of 40 mg per deciliter ( 1.03 mmol per liter ) . The patients were assigned to receive either 100 mg of anacetrapib once daily ( 15,225 patients ) or matching placebo ( 15,224 patients ) . The primary outcome was the first major coronary event , a composite of coronary death , myocardial infa rct ion , or coron OUTPUT:

This significant effect was derived by the use of fibrates ( RR 0.80 , 95 % CI 0.73–0.87 , P < 0.001 , I2 = 22 % ) and meta-regression analysis showed that this benefit was consistent with an absolute reduction in low-density lipoprotein cholesterol . Meta-regression analyses failed to demonstrate a significant association of pharmacologically increased high-density lipoprotein cholesterol with key endpoints . Conclusion The use of high-density lipoprotein cholesterol modifying treatments had no significant effect on cardiovascular mortality , stroke or all-cause mortality . The beneficial effect on myocardial infa rct ion was lost when drugs were used with statin therapy

MS2_dynamic_1_shot693

***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: AIM To evaluate the effects of a combination probiotic on symptoms and colonic transit in patients with irritable bowel syndrome ( IBS ) and significant bloating . METHODS Forty-eight patients with Rome II IBS were r and omized in a parallel group , double-blind design to placebo or VSL # 3 twice daily ( 31 patients received 4 weeks and 17 patients 8 weeks of treatment ) . Pre- and post-treatment colonic transit measurements were performed using scintigraphy with (111)In charcoal . Symptoms were summarized as an average daily score for the entire period of treatment and separately for the first 4 weeks of treatment . Weekly satisfactory relief of abdominal bloating was assessed . RESULTS Treatment with VSL # 3 was associated with reduced flatulence over the entire treatment period ( placebo 39.5 + /- 2.6 vs VSL # 3 29.7 + /- 2.6 , P = 0.011 ) ; similarly , during the first 4 weeks of treatment , flatulence scores were reduced ( placebo 40.1 + /- 2.5 vs VSL # 3 30.8 + /- 2.5 , P = 0.014 ) . Proportions of responders for satisfactory relief of bloating , stool-related symptoms , abdominal pain and bloating scores were not different . Colonic transit was retarded with VSL # 3 relative to placebo ( colon geometric center 2.27 + /- 0.20 vs 2.83 + /- 0.19 , P = 0.05 respectively ) . CONCLUSION VSL # 3 reduces flatulence scores and retards colonic transit without altering bowel function in patients with IBS and bloating OBJECTIVE Experimental and clinical studies have shown that a novel symbiotic ( known as SCM-III ) exerts a beneficial effect on gut translocation and local and systemic inflammatory and microbial metabolic parameters . The present investigation was a preliminary trial on the effectiveness of SCM-III for irritable bowel syndrome ( IBS ) . METHODS Sixty-eight consecutive adult patients with IBS who were free from lactose malabsorption , abdominal surgery , overt psychiatric disorders and ongoing psychotropic drug therapy or ethanol abuse were studied prospect ively and divided into 2 groups that were comparable for age , gender , body size , education and pattern of presenting symptoms . The 2 groups were blindly given for 12 weeks either SCM-III 10 mL t.i.d or the same dosage of heat-inactivated symbiotic . RESULTS Treatment with SCM-III was ' effective ' or ' very effective ' in more than 80 % of the patients ( P < 0.01 vs baseline values and control ) . Less than 5 % reported ' not effective ' as the final evaluation compared with over 40 % of patients in the control group . After 6 weeks of treatment , a significant improvement of pain and bloating was reported in the treatment group compared with control and baseline values . There was also a benefit for bowel habits , mostly for patients with constipation or alternating bowel habits . No overt clinical or biochemical adverse side-effects were recorded . CONCLUSION Compared with baseline values and the control group , SCM-III result ed in a significant increase in lactobacilla , eubacteria and bifidobacteria , which suggests that some selected IBS patients could benefit substantially from symbiotics , but the treatment may need to be given on a cyclic schedule because of the temporary modification of the fecal flora BACKGROUND & AIMS We have recently documented the efficacy of a highly concentrated probiotic preparation ( VSL#3 ) in the prevention of flare-up in patients with chronic pouchitis . The aim of this study was to compare probiotic therapy with VSL#3 versus placebo in the ability to prevent the onset of acute pouchitis during the first year after ileal pouch-anal anastomosis . METHODS Forty consecutive patients who underwent ileal pouch-anal anastomosis for ulcerative colitis were r and omized to receive either VSL#3 ( 1 packet containing 900 billion bacteria/day ) ( n = 20 ) or an identical placebo ( n = 20 ) immediately after ileostomy closure for 1 year . The patients were assessed clinical ly , endoscopically , and histologically after 1 , 3 , 6 , 9 , and 12 months . Health-related quality of life was assessed using the Inflammatory Bowel Disease Question naire . RESULTS Two of the 20 patients ( 10 % ) treated with VSL#3 had an episode of acute pouchitis compared with 8 of the 20 patients ( 40 % ) treated with placebo ( log-rank test , z = 2.273 ; P < 0.05 ) . Treatment with VSL#3 determined a significant improvement in Inflammatory Bowel Disease Question naire score , whereas this was not the case with placebo . CONCLUSIONS Treatment with VSL#3 is effective in the prevention of the onset of acute pouchitis and improves quality of life of patients with ileal pouch-anal anastomosis Background : Ten to 15 % of patients with pouchitis experience refractory or recurrent disease . The aim of this study was to evaluate the effectiveness of a single daily high dose probiotic preparation ( VSL#3 ) in maintaining antibiotic induced remission , and quality of life ( QOL ) , for one year in such patients . Methods : Patients with pouchitis at least twice in the previous year or requiring continuous antibiotics , associated with a pouchitis disease activity index ( PDAI ) ⩾7 ( 0 = perfect ; 18 = worst ) , in whom remission was induced by four weeks of combined metronidazole and ciprofloxacin , were r and omised to receive VSL#3 6 g or placebo once daily for one year or until relapse . Sym OUTPUT: : B. infantis 35624 has shown efficacy for improvement of IBS symptoms . INPUT: OBJECTIVES : VSL#3 is a high-potency probiotic mixture that has been used successfully in the treatment of pouchitis . The primary end point of the study was to assess the effects of supplementation with VSL#3 in patients affected by relapsing ulcerative colitis ( UC ) who are already under treatment with 5-aminosalicylic acid ( ASA ) and /or immunosuppressants at stable doses . METHODS : A total of 144 consecutive patients were r and omly treated for 8 weeks with VSL#3 at a dose of 3,600 billion CFU/day ( 71 patients ) or with placebo ( 73 patients ) . RESULTS : In all , 65 patients in the VSL#3 group and 66 patients in the placebo group completed the study . The decrease in ulcerative colitis disease activity index ( UCDAI ) scores of 50 % or more was higher in the VSL#3 group than in the placebo group ( 63.1 vs. 40.8 ; per protocol ( PP ) P=0.010 , confidence interval (CI)95 % 0.51–0.74 ; intention to treat ( ITT ) P=0.031 , CI95 % 0.47–0.69 ) . Significant results with VSL#3 were recorded in an improvement of three points or more in the UCDAI score ( 60.5 % vs. 41.4 % ; PP P=0.017 , CI95 % 0.51–0.74 ; ITT P=0.046 , CI95 % 0.47–0.69 ) and in rectal bleeding ( PP P=0.014 , CI95 % 0.46–0.70 ; ITT P=0.036 , CI95 % 0.41–0.65 ) , whereas stool frequency ( PP P=0.202 , CI95 % 0.39–0.63 ; ITT P=0.229 , CI95 % 0.35–0.57 ) , physician 's rate of disease activity ( PP P=0.088 , CI95 % 0.34–0.58 ; ITT P=0.168 , CI95 % 0.31–0.53 ) , and endoscopic scores ( PP P=0.086 , CI95 % 0.74–0.92 ; ITT P=0.366 , CI95 % 0.66–0.86 ) did not show statistical differences . Remission was higher in the VSL#3 group than in the placebo group ( 47.7 % vs. 32.4 % ; PP P=0.069 , CI95 % 0.36–0.60 ; ITT P=0.132 , CI95 % 0.33–0.56 ) . Eight patients on VSL#3 ( 11.2 % ) and nine patients on placebo ( 12.3 % ) reported mild side effects . CONCLUSIONS : VSL#3 supplementation is safe and able to reduce UCDAI scores in patients affected by relapsing mild-to-moderate UC who are under treatment with 5-ASA and /or immunosuppressants . Moreover , VSL#3 improves rectal bleeding and seems to reinduce remission in relapsing UC patients after 8 weeks of treatment , although these parameters do not reach statistical significance 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 AND AIMS : Intestinal bacteria have been implicated in the initiation and perpetuation of IBD ; in contrast , “ probiotic bacteria ” have properties possibly effective in treating and preventing relapse of IBD . We evaluated the safety and efficacy of VSL#3 and the components , and the composition of the biopsy-associated microbiota in patients with active mild to moderate ulcerative colitis ( UC ) . METHODS : Thirty-four ambulatory patients with active UC received open label VSL#3 , 3,600 billion bacteria daily in two divided doses for 6 wk . The presence of biopsy-associated bacteria was detected using a nucleic acid-based method and the presence of VSL#3 species confirmed by DNA sequencing of 16S rRNA . RESULTS : Thirty-two patients completed 6 wk of VSL#3 treatment and 2 patients did not have the final endoscopic assessment . Intent to treat analysis demonstrated remission ( UCDAI ≤ 2 ) in 53 % ( n = 18 ) ; response ( decrease in UCDAI ≥ 3 , but final score ≥3 ) in 24 % ( n = 8) ; no response in 9 % ( n = 3 ) ; worsening in 9 % ( n = 3 ) ; and failure to complete the final sigmoidoscopy assessment in 5 % ( n = 2 ) . There were no biochemical or clinical adverse events related to VSL#3 . Two of the components of VSL#3 were detected by PCR/DGGE in biopsies collected from 3 patients in remission . CONCLUSION : Treatment of patients with mild to moderate UC , not responding to conventional therapy , with VSL#3 result ed in a combined induction of remission/response rate of 77 % with no adverse events . At least some of the bacterial species incorporated in the probiotic product reached the target site in amounts that could be detected OBJECTIVES : Several probiotic compounds have shown promise in the therapy of ulcerative colitis ( UC ) . However , a strong sustained benefit remains to be seen . Uncontrolled pilot studies suggest that a probiotic preparation ( VSL#3 ) maintains remission in mild to moderate UC and reduces active inflammation in OUTPUT:

CONCLUSIONS VSL#3 , when added to conventional therapy at a daily dose of 3.6 × 10 CFU/d , is safe and more effective than conventional therapy alone in achieving higher response and remission rates in mild to moderately active ulcerative colitis

MS2_dynamic_1_shot694

***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: OBJECTIVES The aim of the present split-mouth study is to assess the peri-implant conditions around early-loaded s and blasted and acid-etched ( SLA ) implants , 5 years after abutment connection and to compare , in the same patients , the results obtained with a st and ard protocol using identical implants with a TPS surface . MATERIAL AND METHODS Surgical procedure was performed by the same operator and was identical at test ( SLA ) and control ( TPS ) sites , in 32 healthy patients . Abutment connection was carried out at 35 N cm 6 weeks postsurgery for test sites and 12 weeks for the controls . Patients were seen regularly , for control and professional cleaning . At 60 months , clinical measures and radiographic bone changes were recorded by the same operator , blind to the type of surface of the implant , on 27 patients , as five patients were lost to follow-up . RESULTS A total number of 106 implants were examined . No implant was lost . No significant differences were found with respect to the presence of plaque [ modified plaque index ( mPI ) 0.27+/-0.56 vs. 0.32+/-0.54 ] , bleeding on probing ( 29 % vs. 32 % ) , mean pocket depth ( 3.2+/-1 vs. 3.2+/-1 mm ) or mean marginal bone loss ( 0.32+/-1.04 vs. 0.44+/-1.12 mm ) between test and control . Four implants that presented ' spinning ' at the time of abutment connection presented no significant differences from the rest of the test sites . CONCLUSION The results of this prospect i ve study confirm that SLA implants , under defined conditions , are suitable for early loading at 6 weeks in both the m and ible and the maxilla . Limited implant spinning , occasionally found at abutment connection , produces no detrimental effect on the clinical outcome when properly h and led This paper describes the 5-year results of a comparative study between Astra Tech and Brånemark system implants . The aim was to compare the systems primarily with regard to bone level changes , and also with regard to other variables of interest . Sixty-six patients with edentulous jaws were included in the study . R and omisation schedules were used to allocate the patients to the two implant systems . 184 Astra Tech implants with a titanium-blasted surface and 187 Brånemark implants with a turned surface were used . The implants were inserted with a two-stage technique and the insertion followed the routines for the respective implant system . All patients were provided with full-arch fixed bridges . All patients were followed up with clinical and radiographic examinations from fixture insertion to the 5-year follow-up . The total mean bone level change in the upper jaw between fixture insertion and the 5-year examination was -1.74+/-0.45 mm at the Astra implants and -1.98+/-0.21 at the Brånemark implants . The corresponding values for the lower jaw were -1.06+/-0.19 for Astra and -1.38+/-0.17 for Brånemark . The major postoperative changes of the marginal bone level took place between fixture insertion and baseline . During this period , there was also a different pattern of bone remodelling between the implant systems . Between baseline ( prosthesis connection ) and the 5-year examination , the marginal bone level changes were small , with no difference between the implant systems . The implant stability was examined with the supraconstructions removed . At the 5-year examination , the survival rate for Astra Tech implants was 98.4 % and for the Brånemark implants it was 94.6 % . The difference was not statistically significant The aim of this study was to determine the influence of age on peri-implant tissues in patients treated with implant-supported overdentures in the m and ible . A prospect i ve study was carried out with 2 groups of healthy edentulous patients . The mean age of the younger group ( n = 32 ) was 46 years ( range 35 to 50 years ) ; the mean age of the older group ( n = 26 ) was 68 years ( range 60 to 80 years ) . Two dental implants were placed in the interforaminal region of the m and ible , and after a 3-month healing period , overdentures were fabricated . Clinical and radiographic parameters were evaluated immediately after completion of the prosthetic treatment , after 1 year , and after 3 years . The evaluated clinical parameters were implant loss , Plaque Index , Gingival Index , Bleeding Index , and probing depth . Radiographic evaluation was performed using a st and ardized long-cone technique with a direction device . Statistical analysis was carried out with SPSS software . One implant in the older group was lost during the healing period . After 3 years , the mean scores for Plaque Index , Gingival Index , and Bleeding Index were between 0 and 1 for both groups ( out of possible scores of 0 to 3 ) , and the mean probing depth was 3 mm in both groups . The mean bone loss after 3 years was 1.2 mm in the younger group and 0.8 mm in the older group , but this difference was not significant . It was concluded from this study population that the clinical performance of implant-supported overdentures in the m and ible is equally successful in younger and older patients This report is an up date on a group of 46 clinical trial patients who each received 3 free-st and ing Endopore dental implants placed using a 2-stage surgical approach in the anterior m and ible . After an initial healing interval of 10 weeks , the implants were used in each case to retain an over-denture , and at the time of the report , all patients had passed 5 years of continuous function . The 5-year cumulative " survival " rate based on a life table analysis was 93.4 % and this remained unchanged after 6 years . The 5-year " success rate " was 83.3 % when assessed qualitatively with the published criteria of others using a four-field table analysis categorizing every OUTPUT: FES harboured more plaque at their implants than PES . Modified bleeding index scores were significantly higher in FES , but no differences in bleeding on probing , implant loss and probing pocket depth were observed between FES and PES . CONCLUSION FES and PES show comparable implant survival rates . However , no conclusion can be drawn regarding differences in prevalence of peri-implant mucositis and peri-implantitis between FES and PES INPUT: OBJECTIVES The aim of the present split-mouth study is to assess the peri-implant conditions around early-loaded s and blasted and acid-etched ( SLA ) implants , 5 years after abutment connection and to compare , in the same patients , the results obtained with a st and ard protocol using identical implants with a TPS surface . MATERIAL AND METHODS Surgical procedure was performed by the same operator and was identical at test ( SLA ) and control ( TPS ) sites , in 32 healthy patients . Abutment connection was carried out at 35 N cm 6 weeks postsurgery for test sites and 12 weeks for the controls . Patients were seen regularly , for control and professional cleaning . At 60 months , clinical measures and radiographic bone changes were recorded by the same operator , blind to the type of surface of the implant , on 27 patients , as five patients were lost to follow-up . RESULTS A total number of 106 implants were examined . No implant was lost . No significant differences were found with respect to the presence of plaque [ modified plaque index ( mPI ) 0.27+/-0.56 vs. 0.32+/-0.54 ] , bleeding on probing ( 29 % vs. 32 % ) , mean pocket depth ( 3.2+/-1 vs. 3.2+/-1 mm ) or mean marginal bone loss ( 0.32+/-1.04 vs. 0.44+/-1.12 mm ) between test and control . Four implants that presented ' spinning ' at the time of abutment connection presented no significant differences from the rest of the test sites . CONCLUSION The results of this prospect i ve study confirm that SLA implants , under defined conditions , are suitable for early loading at 6 weeks in both the m and ible and the maxilla . Limited implant spinning , occasionally found at abutment connection , produces no detrimental effect on the clinical outcome when properly h and led The aim of this study was to evaluate the survival and success rates of immediately restored implants with s and blasted , large-grit , acid-etched ( SLA ) surfaces over a period of 5 years . Twenty patients ( mean age , 47.3 years ) received a total of 21 SLA wide-neck implants in healed m and ibular first molar sites after initial periodontal treatment . To be included in the study , the implants had to demonstrate primary stability with an insertion torque value of 35 Ncm . A provisional restoration was fabricated chairside and placed on the day of surgery . Definitive cemented restorations were inserted 8 weeks after surgery . Community Periodontal Index of Treatment Needs ( CPITN ) indices and the radiographic distance between the implant shoulder and the first visible bone-implant contact ( DIB ) were measured and compared over the study period . The initial mean CPITN was 3.24 , and decreased over the study period to 1.43 . At the postoperative radiographic examination , the mean DIB was 1.41 mm for the 21 implants , indicating that part of the machined neck of the implants was placed slightly below the osseous crest . The mean DIB value increased to 1.99 mm at the 5-year examination . This increase proved to be statistically significant ( P < .0001 ) . Between the baseline and 5-year examinations , the mean bone crest level loss was 0.58 mm . Success and survival rates of the 21 implants after 5 years of function were 100 % . This 5-year study confirms that immediate restoration of m and ibular molar wide-neck implants with good primary stability , as noted by insertion torque values of at least 35 Ncm , is a safe and predictable procedure OBJECTIVES The aim of this prospect i ve cohort study was to evaluate the success rate of titanium screw-type implants with the s and blasted and acid-etched ( SLA ) surface loaded early , after 6 weeks of healing . MATERIAL AND METHODS A total of 104 implants were inserted into posterior sites of 51 partially edentulous patients exhibiting bone densities of class I-III . After a healing period of 6 weeks , all implants were functionally loaded with cemented crowns or fixed partial dentures . The patients were recalled at 3 , 12 , 24 , 36 , 48 and 60 months for clinical and radiographic examination . RESULTS One implant failed to integrate during healing , and three implants were lost to follow-up and were considered drop-outs . The remaining 100 implants showed favorable clinical and radiographic findings at the 5-year examination . The peri-implant soft tissues were stable over time ; the mean probing depths and mean attachment levels did not change during the follow-up period . None of the radiographs exhibited signs of continuous peri-implant radiolucency , which confirmed ankylotic stability for all 100 implants . The measurement of the bone crest levels ( DIB values ) indicated stability as well . Based on strict success criteria , all 100 implants were considered successfully integrated , result ing in a 5-year success rate of 99 % . CONCLUSION This prospect i ve study using an early loading protocol with 6 weeks of healing demonstrated that titanium implants with the SLA surface can achieve and maintain successful tissue integration with high predictability for at least 5 years of follow-up in selected patients and sites PROBLEM Several factors influence primary stabilization of dental implants at placement surgery . These include implant design , bone quality , implant jaw location , and the use of a bone tap . PURPOSE This report evaluates clinical data gathered by the Ankylos Implant Clinical Research Group ( AICRG ) to assess ( 1 ) the influence of several variables on primary stability and ( 2 ) the potential for an Ankylos implant ( Friadent GmbH , Mannheim , Germany ) that is mobile at placement to integrate and survive for at least 3 years of clinical function . METHODS The Ankylos implant is a roughened grade -2 titanium screw . OUTPUT:

Despite of the positive findings achieved by the included studies , few RCTs were available for analysis for SLActive implants .

MS2_dynamic_1_shot695

***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: BACKGROUND Intensive statin therapy can lower the risk of recurrence of major cardiac events in patients with acute coronary syndromes . This could be related to the ability of statins to increase levels of Endothelial Progenitor Cells ( EPCs ) , which were demonstrated to be favorably associated with a better prognosis and post-infa rct ion left ventricular remodeling in patients with ischemic heart disease . AIM OF THE STUDY First , to evaluate , in a r and omized clinical trial , the effect of an intensive vs a st and ard treatment with statins on EPC mobilization in patients undergoing a successful primary or rescue percutaneous coronary intervention ; secondary , to evaluate whether left ventricular remodeling could be influenced by statin therapy through EPC mobilization . METHODS Forty ST-segment elevation myocardial infa rct ion ( STEMI ) patients undergoing a successful primary or rescue PCI were r and omized to receive atorvastatin 80 mg immediately after the admission ( Intensive Treatment , IT ) or atorvastatin 20 mg from the day of the discharge ( St and ard Treatment , ST ) . CD34+/KDR+ EPC count by flow cytometry and left ventricular function by 2-D Echo were measured on admission , at discharge and at 4 months follow up . RESULTS We found that EPC count was similar in the two groups of patients both on admission and at discharge . At follow up , however , EPC count was higher in patients r and omized to IT compared to patients r and omized to ST ( 7.59+/-7.30 vs 3.04+/-3.93 , p=0.04 ) . However , LV volumes , ejection fraction and wall motion score index were similar in both groups . CONCLUSIONS An intensive statin treatment after primary or rescue PCI is associated with a higher EPC count at follow up as compared to st and ard treatment . This beneficial effect did not translate in an improvement of LV function Drug therapy for hypercholesterolaemia has remained controversial mainly because of insufficient clinical trial evidence for improved survival . The present trial was design ed to evaluate the effect of cholesterol lowering with simvastatin on mortality and morbidity in patients with coronary heart disease ( CHD ) . 4444 patients with angina pectoris or previous myocardial infa rct ion and serum cholesterol 5.5 - 8.0 mmol/L on a lipid-lowering diet were r and omised to double-blind treatment with simvastatin or placebo . Over the 5.4 years median follow-up period , simvastatin produced mean changes in total cholesterol , low-density-lipoprotein cholesterol , and high-density-lipoprotein cholesterol of -25 % , -35 % , and + 8 % , respectively , with few adverse effects . 256 patients ( 12 % ) in the placebo group died , compared with 182 ( 8 % ) in the simvastatin group . The relative risk of death in the simvastatin group was 0.70 ( 95 % CI 0.58 - 0.85 , p = 0.0003 ) . The 6-year probabilities of survival in the placebo and simvastatin groups were 87.6 % and 91.3 % , respectively . There were 189 coronary deaths in the placebo group and 111 in the simvastatin group ( relative risk 0.58 , 95 % CI 0.46 - 0.73 ) , while noncardiovascular causes accounted for 49 and 46 deaths , respectively . 622 patients ( 28 % ) in the placebo group and 431 ( 19 % ) in the simvastatin group had one or more major coronary events . The relative risk was 0.66 ( 95 % CI 0.59 - 0.75 , p < 0.00001 ) , and the respective probabilities of escaping such events were 70.5 % and 79.6 % . This risk was also significantly reduced in subgroups consisting of women and patients of both sexes aged 60 or more . Other benefits of treatment included a 37 % reduction ( p < 0.00001 ) in the risk of undergoing myocardial revascularisation procedures . This study shows that long-term treatment with simvastatin is safe and improves survival in CHD patients CONTEXT Patients experience the highest rate of death and recurrent ischemic events during the early period after an acute coronary syndrome , but it is not known whether early initiation of treatment with a statin can reduce the occurrence of these early events . OBJECTIVE To determine whether treatment with atorvastatin , 80 mg/d , initiated 24 to 96 hours after an acute coronary syndrome , reduces death and nonfatal ischemic events . DESIGN AND SETTING A r and omized , double-blind trial conducted from May 1997 to September 1999 , with follow-up through 16 weeks at 122 clinical centers in Europe , North America , South Africa , and Australasia . PATIENTS A total of 3086 adults aged 18 years or older with unstable angina or non-Q-wave acute myocardial infa rct ion . INTERVENTIONS Patients were stratified by center and r and omly assigned to receive treatment with atorvastatin ( 80 mg/d ) or matching placebo between 24 and 96 hours after hospital admission . MAIN OUTCOME MEASURES Primary end point event defined as death , nonfatal acute myocardial infa rct ion , cardiac arrest with resuscitation , or recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization . RESULTS A primary end point event occurred in 228 patients ( 14.8 % ) in the atorvastatin group and 269 patients ( 17.4 % ) in the placebo OUTPUT: In conclusion , r and omized studies in humans suggest that statin therapy mobilizes EPCs into the circulation . INPUT: BACKGROUND Intensive statin therapy can lower the risk of recurrence of major cardiac events in patients with acute coronary syndromes . This could be related to the ability of statins to increase levels of Endothelial Progenitor Cells ( EPCs ) , which were demonstrated to be favorably associated with a better prognosis and post-infa rct ion left ventricular remodeling in patients with ischemic heart disease . AIM OF THE STUDY First , to evaluate , in a r and omized clinical trial , the effect of an intensive vs a st and ard treatment with statins on EPC mobilization in patients undergoing a successful primary or rescue percutaneous coronary intervention ; secondary , to evaluate whether left ventricular remodeling could be influenced by statin therapy through EPC mobilization . METHODS Forty ST-segment elevation myocardial infa rct ion ( STEMI ) patients undergoing a successful primary or rescue PCI were r and omized to receive atorvastatin 80 mg immediately after the admission ( Intensive Treatment , IT ) or atorvastatin 20 mg from the day of the discharge ( St and ard Treatment , ST ) . CD34+/KDR+ EPC count by flow cytometry and left ventricular function by 2-D Echo were measured on admission , at discharge and at 4 months follow up . RESULTS We found that EPC count was similar in the two groups of patients both on admission and at discharge . At follow up , however , EPC count was higher in patients r and omized to IT compared to patients r and omized to ST ( 7.59+/-7.30 vs 3.04+/-3.93 , p=0.04 ) . However , LV volumes , ejection fraction and wall motion score index were similar in both groups . CONCLUSIONS An intensive statin treatment after primary or rescue PCI is associated with a higher EPC count at follow up as compared to st and ard treatment . This beneficial effect did not translate in an improvement of LV function CONTEXT Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions . OBJECTIVE To explore whether the association between funding and conclusions in r and omized drug trials reflects treatment effects or adverse events . DESIGN Observational study of 370 r and omized drug trials included in meta-analyses from Cochrane review s selected from the Cochrane Library , May 2001 . From a r and om sample of 167 Cochrane review s , 25 contained eligible meta-analyses ( assessed a binary outcome ; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment ) . The primary binary outcome from each meta- analysis was considered the primary outcome for all trials included in each meta- analysis . The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect , adverse events , and additional confounding factors ( method ological quality , control intervention , sample size , publication year , and place of publication ) . MAIN OUTCOME MEASURE Conclusions in trials , classified into whether the experimental drug was recommended as the treatment of choice or not . RESULTS The experimental drug was recommended as treatment of choice in 16 % of trials funded by nonprofit organizations , 30 % of trials not reporting funding , 35 % of trials funded by both nonprofit and for-profit organizations , and 51 % of trials funded by for-profit organizations ( P<.001 ; chi2 test ) . Logistic regression analyses indicated that funding , treatment effect , and double blinding were the only significant predictors of conclusions . Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice ( odds ratio , 5.3 ; 95 % confidence interval , 2.0 - 14.4 ) compared with trials funded by nonprofit organizations . This association did not appear to reflect treatment effect or adverse events . CONCLUSIONS Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results . Readers should carefully evaluate whether conclusions in r and omized trials are supported by data CONTEXT Percutaneous coronary intervention ( PCI ) is associated with excellent short-term improvements in ischemic symptoms , yet only three fifths of PCI patients at 5 years and one third of patients at 10 years remain free of major adverse cardiac events ( MACE ) . OBJECTIVE To determine whether treatment with fluvastatin reduces MACE in patients who have undergone PCI . DESIGN AND SETTING R and omized , double-blind , placebo-controlled trial conducted at 77 referral centers in Europe , Canada , and Brazil . PATIENTS A total of 1677 patients ( aged 18 - 80 years ) recruited between April 1996 and October 1998 with stable or unstable angina or silent ischemia following successful completion of their first PCI who had baseline total cholesterol levels between 135 and 270 mg/dL ( 3.5 - 7.0 mmol/L ) , with fasting triglyceride levels of less than 400 mg/dL ( 4.5 mmol/L ) . INTERVENTIONS Patients were r and omly assigned to receive treatment with fluvastatin , 80 mg/d ( n = 844 ) , or matching placebo ( n = 833 ) at hospital discharge for 3 to 4 years . MAIN OUTCOME MEASURE Survival time free of MACE , defined as cardiac death , nonfatal myocardial infa rct ion , or reintervention procedure , compared between the treatment and placebo groups . RESULTS Median time between PCI and first dose of study medication was 2.0 days , and median follow-up was 3.9 years . MACE-free survival time was significantly longer in the fluvastatin group ( P = .01 ) . One hundred eighty-one ( 21.4 % ) of 844 patients in the fluvast OUTPUT:

Based on moderate quality evidence , due to concerns about risk of bias and imprecision , initiation of statin therapy within 14 days following ACS does not reduce death , myocardial infa rct ion , or stroke up to four months , but reduces the occurrence of unstable angina at four months following ACS . Serious side effects were rare

MS2_dynamic_1_shot696

***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: BACKGROUND Combination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) and prostatic enlargement . OBJECTIVE To investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention ( AUR ) , BPH-related surgery , and BPH clinical progression over 4 yr in men at increased risk of progression . DESIGN , SETTING , AND PARTICIPANTS The Combination of Avodart and Tamsulosin ( CombAT ) study was a 4-yr , multicenter , r and omised , double-blind , parallel-group study in 4844 men > or = 50 yr of age with a clinical diagnosis of BPH , International Prostate Symptom Score > or = 12 , prostate volume > or = 30 cm(3 ) , prostate-specific antigen 1.5 - 10 ng/ml , and maximum urinary flow rate ( Q(max ) ) > 5 and < or = 15 ml/s with minimum voided volume > or = 125 ml . INTERVENTION Oral daily tamsulosin , 0.4 mg ; dutasteride , 0.5 mg ; or a combination of both . MEASUREMENTS The 4-yr primary end point was time to first AUR or BPH-related surgery . Secondary end points included BPH clinical progression , symptoms , Q(max ) , prostate volume , safety , and tolerability . RESULTS AND LIMITATIONS Combination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery . Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression . Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr . Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies , with the exception of an imbalance in the composite term of cardiac failure among the three study arms . The lack of placebo control is a study limitation . CONCLUSIONS The 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement . CLINICAL TRIALS.GOV IDENTIFIER : NCT00090103 ( http://www . clinical trials.gov/ct2/show/NCT00090103 ) BACKGROUND We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer , as detected on biopsy , among men who are at increased risk for the disease . METHODS In this 4-year , multicenter , r and omized , double-blind , placebo-controlled , parallel-group study , we compared dutasteride , at a dose of 0.5 mg daily , with placebo . Men were eligible for inclusion in the study if they were 50 to 75 years of age , had a prostate-specific antigen ( PSA ) level of 2.5 to 10.0 ng per milliliter , and had had one negative prostate biopsy ( 6 to 12 cores ) within 6 months before enrollment . Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years . RESULTS Among 6729 men who underwent a biopsy or prostate surgery , cancer was detected in 659 of the 3305 men in the dutasteride group , as compared with 858 of the 3424 men in the placebo group , representing a relative risk reduction with dutasteride of 22.8 % ( 95 % confidence interval , 15.2 to 29.8 ) over the 4-year study period ( P<0.001 ) . Overall , in years 1 through 4 , among the 6706 men who underwent a needle biopsy , there were 220 tumors with a Gleason score of 7 to 10 among 3299 men in the dutasteride group and 233 among 3407 men in the placebo group ( P=0.81 ) . During years 3 and 4 , there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group , as compared with only 1 in the placebo group ( P=0.003 ) . Dutasteride therapy , as compared with placebo , result ed in a reduction in the rate of acute urinary retention ( 1.6 % vs. 6.7 % , a 77.3 % relative reduction ) . The incidence of adverse events was similar to that in studies of dutasteride therapy for benign prostatic hyperplasia , except that in our study , as compared with previous studies , the relative incidence of the composite category of cardiac failure was higher in the dutasteride group than in the placebo group ( 0.7 % [ 30 men ] vs. 0.4 % [ 16 men ] , P=0.03 ) . CONCLUSIONS Over the course of the 4-year study period , dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia . ( Clinical Trials.gov number , NCT00056407 . BACKGROUND Benign prostatic hyperplasia is a progressive , and rogen-dependent disease result ing in enlargement of the prostate gl and and urinary obstruction . Preventing the conversion of testosterone to its tissue-active form , dihydrotestosterone , by inhibiting the enzyme 5 alpha-reductase could decrease the action of and rogens in their target tissues ; in the prostate the result might be a decrease OUTPUT: • Incidences of erectile dysfunction , ejaculate volume , decreased libido , and gynaecomastia were greater with 5-α-RI vs placebo . • 5-α-RIs reduce the risk of being diagnosed with prostate cancer among men who are screened regularly for prostate cancer . • Information is inadequate to assess the effect of 5-α-RIs on prostate cancer or all-cause mortality . • 5-α-RIs increase sexual and erectile dysfunction INPUT: Objectives To evaluate the effect of association of tamsulosin/tadalafil taken daily compared with tamsulosin/placebo in the lower urinary tract with urodynamic study ( UDS ) . Methods All patients underwent baseline UDS before r and omization to tamsulosin 0.4 mg/tadalafil 5 mg ( Group 1 ; n = 20 ) or tamsulosin 0.4 mg/placebo ( Group 2 ; n = 20 ) once daily for 30 days . End-of- study UDS were performed on completion of the treatment period . The primary end point was to demonstrate changes in urodynamic variables in the voiding phase , detrusor pressure at maximum flow ( PdetQmax ) , and maximum flow rate ( Qmax ) , from baseline to week four . Results The primary outcome measure of this clinical trial , PdetQmax , showed a significant reduction in tamsulosin/tadalafil group ( 13 ± 17.0 ) compared to tamsulosin/placebo ( −1.2 ± 14.35 ) group ( P = 0.03 ) . Qmax increased in both groups , tamsulosin/tadalafil ( 1.0 ± 2.4 ) and tamsulosin/placebo ( 1.4 ± 2.4 ) , but the difference was not significant between treatment groups ( P = 0.65 ) . Total IPSS , storage , and voiding sub-score improved significantly in tamsulosin/tadalafil compared with tamsulosin/placebo group . Conclusions The association of tamsulosin/tadalafil reduces detrusor pressure at maximum flow without changing the maximum flow rate during micturition and significantly improves lower urinary tract symptoms compared with the isolated use of tamsulosin OBJECTIVE To evaluate the efficacy and tolerability of extended-release oxybutynin in combination with the alpha1-blocker tamsulosin in reducing lower urinary tract symptoms in men . PATIENTS AND METHODS In this multicenter , double-blind trial performed between March 29 , 2004 , and June 22 , 2005 , 420 men aged 45 years or older with a total International Prostate Symptom Score ( IPSS ) of 13 or more and IPSS for storage of 8 or more were r and omized to receive tamsulosin ( 0.4 mg/d ) with either extended-release oxybutynin ( 10 mg/d ) or placebo for 12 weeks . Eligibility requirements included a maximum flow rate of 8 mL/s or more with voided volume of 125 mL or more and a postvoid residual volume of 150 mL or less on 2 occasions . Postvoid residual volume and peak flow rates at weeks 4 , 8 , and 12 were measured . The primary end point was change from baseline in total IPSS after 12 weeks of treatment . Secondary outcomes included change in IPSSs for storage and quality of life . RESULTS Tamsulosin combined with extended-release oxybutynin result ed in significantly greater improvement in total IPSS compared with tamsulosin and placebo after 8 ( P=.03 ) and 12 ( P=.006 ) weeks of treatment , and improved IPSS for storage and quality of life at all assessment points ( P<.01 ) . The incidence of postvoid residual volume higher than 300 mL was 2.9 % ( 6/209 ) in patients receiving combination therapy compared with 0.5 % ( 1/209 ) in patients receiving tamsulosin alone ( P=.12 ) . Occurrence of peak flow rates below 5 mL/s was 3.8 % ( 8/209 ) for combination therapy and 5.7 % ( 12/209 ) for tamsulosin alone ( P=.49 ) . CONCLUSION In men with substantial storage symptoms , combination therapy with tamsulosin and extended-release oxybutynin demonstrated greater efficacy than and comparable safety and tolerability to tamsulosin monotherapy Purpose : To verify the association between lower urinary tract symptoms ( LUTS ) and erectile dysfunction ( ED ) and evaluate the influence of sildenafil and doxazosin either as single agents or combined on both symptoms . Material and Methods : A prospect i ve r and omized study including 150 patients presented with LUTS caused by BPH in association with clinical ly diagnosed ED , with age equal or more than 45 years from April 2010 to April 20011 . They were categorized into three comparative groups each one containing 50 patients . These groups were comparable regarding pretreatment international prostate symptoms score ( IPSS ) and international index of erectile function ( IIEF ) . The patients of the first group were given sildenafil 50 mg as monotherapy , those of the second group were given doxazosin 2 mg and those of the third group were given combination of both drugs for 4 months for each group . The main post-treatment parameters for assessment and comparison include assessment of patient 's symptoms by repeated IPS S and IIEF , uroflowmetry and assessment of PVR . The statistics was done by use of the Qui -- square test . Results : Pre-treatment parameters were assessed and compared between the three groups . After 4 months of treatment , the comparative parameters were applied to all groups and the differences were measured post-treatment regarding IPSS , erectile function score , uroflowmetry , and post-void residual ( PVR ) urine . Sildenafil alone caused mild improvement in IPSS , more improvement in IIEF score , and little effect on flow rate and PVR urine . Doxazosin alone caused more improvement in IPSS , flow rate and PVR urine and less improvement in IIEF score . A combination of both sildenafil and doxazosin caused more improvement in all of the comparative parameters than when each drug was given alone . Conclusions : There is a strong relationship between LUTS and ED . Doxazosin or sidenafil as a single drug could be used in treating mild or mild to moderate symptoms but more severe symptoms may usually OUTPUT:

Based on improvement of mean International Prostate Symptom Score and quality of life scores , the effectiveness of the newer ABs was not different from the older ABs ( moderate strength of evidence [ SOE ] ) , but had more AEs ( low SOE ) . Antimuscarinics/AB combination therapy had similar outcomes as AB monotherapy ( all moderate SOE ) , but often had more AEs . Phosphodiesterase type-5 inhibitors alone or in combination with ABs had similar or inferior outcomes than ABs alone . Evidence was insufficient for the beta-3 adrenoceptor agonist . For all newer agents , the evidence was generally insufficient to assess long-term efficacy , prevention of symptom progression , or AEs . None of the drugs or drug combinations newly used to treat LUTS attributed to BPH showed outcomes superior to traditional AB treatment . Given the lack of superior outcomes , the studies ' short time-horizon , and less assurance of their safety , their current value in treating LUTS attributable to BPH appears low . We found none of the new drugs to be better but there was more concern about side effects

MS2_dynamic_1_shot697

***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: Objective : To prospect ively compare the functional outcome associated with cemented and uncemented hemiarthroplasty . Design : Prospect i ve r and omized control trial . Setting : University-affiliated level 1 trauma center . Patients / Participants : All individuals design ated for hemiarthroplasty , older than 55 years , with a nonpathologic displaced femoral neck fracture and the ability to ambulate 10 feet independently before injury [ 269 patients ( 274 hips ) presented with displaced femoral neck fracture , 130 patients ( 48.3 % ) enrolled , and 5 patients ( 3.8 % ) withdrew ] . Intervention : Hip hemiarthroplasty with a cemented femoral prosthesis ( VerSys LD/Fx ; Zimmer , Warsaw , IN ) or an uncemented component ( VerSys Beaded FullCoat ; Zimmer , Warsaw , IN ) . Main Outcome Measures : Instrumental Activities of Daily Living and Physical Activities of Daily Living scales ( Older Americans Re sources and Services Instrument ) and the Energy/Fatigue Scale . Results : No statistically significant differences were present in the groups ' preoperative or intraoperative characteristics , including American Society of Anesthesiologists grade , operative time , anesthesia time , use of perioperative & bgr;-blockers , estimated blood loss , or the rate of intraoperative fracture . Postoperatively , no difference was found in hemoglobin level , transfusion rate , discharge disposition , or acute complication rate . At 30-day , 60-day , and 1-year follow-ups , no clinical ly or statistically significant differences were found in mortality , disposition , need for assistance with ambulation , Older Americans Re sources and Services Activities of Daily Living subscales , or the Energy/Fatigue Scale . Conclusions : In the treatment of nonpathologic displaced femoral neck fractures , the use of cemented and uncemented femoral components is associated with similar functional outcome at 1 year . Practitioners may inform their clinical decisions using these equally good results . Level of Evidence : Therapeutic Level II . See page 128 for a complete description of levels of evidence Hip hemiarthroplasties are frequently performed for displaced femoral neck fractures . The purpose of this study was to identify the costs associated with cementless and cemented hemiarthroplasties , compare operative times , and identify complications . The hypothesis was that cementless hemiarthroplasties cost less than cemented hemiarthroplasties , require less operative time , and have fewer perioperative complications . A retrospective review was conducted of 2 surgeons ' patients admitted for displaced femoral neck fractures between 2006 and 2010 . Group 1 included 45 patients who underwent monopolar hemiarthroplasties with cementless femoral components via a st and ard posterior approach by a single surgeon . Group 2 included 49 patients who underwent monopolar hemiarthroplasties with cemented femoral components via a modified lateral approach by a single surgeon . Surgical and anesthesia times and the cost of implants and accessories were recorded . The cost for cementless components was $ 3275.60 ( femoral stem , $ 2800 ; monopolar head , $ 400 ; sleeve , $ 75.60 ) , whereas the cost of cemented components was $ 3694.47 ( femoral stem , $ 1800 ; monopolar head , $ 400 ; sleeve , $ 75.60 , 3 Simplex with tobramycin cement packets , $ 1221 ; cement mixer/irrigator with tip/ central izer and plug/pressurizer , $ 197.87 ) , a cost savings of 12.7 % ( $ 418.87 ) . Operative time was significantly reduced in group 1 vs group 2 ( mean , 32.9 vs 56.1 minutes , respectively ; P<.01 ) . Anesthesia time was also significantly reduced in group 1 ( mean , 82.3 vs 102.9 minutes , respectively ; P<.01 ) . The difference in mean anesthetic times demonstrates an overall cost savings of 18.6 % , or $ 1161.30 . No difference in complications was noted between the groups perioperatively . Regional cost variances , vendor-hospital contracts , and surgeons ' operative times are factors that may influence cost savings . This study demonstrates significantly lower operative and anesthetic times and observable cost savings with cementless femoral implants Background Displaced femoral neck fractures usually are treated with hemiarthroplasty . However , the degree to which the design of the implant used ( cemented or uncemented ) affects the outcome is not known and may be therapeutically important . Questions / purpose sIn this r and omized controlled trial , we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of ( 1 ) Harris hip scores ; ( 2 ) femoral fractures ; ( 3 ) overall health outcomes using the Barthel Index and EQ-5D scores ; and ( 4 ) complications , reoperations , and mortality since our earlier report on this cohort at 1-year followup . Methods We present followup at a median of 5 years after surgery ( range , 56–65 months ) from a r and omized trial comparing a cemented hemiarthroplasty ( 112 hips ) with an uncemented , hydroxyapatite-coated hemiarthroplasty ( 108 hips ) , both with a bipolar head . Results were previously reported at 1-year followup . Harris hip scores , Barthel Index , and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon . Complications and reoperations were determined by chart review and radiographs examined by OUTPUT: There was no statistically significant difference for any other outcome between the two methods of fixation . Conclusion In hemiarthroplasty of the hip using current generation stems , cemented stems result in fewer implant‐related complications and similar mortality compared with cementless stems INPUT: Purpose Bone loss around uncemented femoral components is suspected to precede implant loosening and contribute to problems in revision surgery . Short-stemmed cementless femoral components are design ed to preserve proximal femoral bone stock and ultimately the longevity of the prosthesis . Methods With quantitative computed tomography-assisted osteodensitometry , we prospect ively analyzed femoral cortical and cancellous bone density ( BD ) and contact area changes of an uncemented collum femoris preserving stem ( n = 38 ) 10 days , 1 , 3 and 7 years post-operatively . Results Seven years post-operatively , cancellous BD ( mg CaHA/mL ) had decreased by as much as −66 % and cortical BD by up to −27 % at the metaphyseal portion of the femur ; the decrease was progressive between the 1- and 3-year examinations and halted thereafter . Contact area ( in % out of a possible 100 % ) decreased proximally between the 1- and 3-year follow-up . Conclusion Proximal cortical and cancellous bone density loss and decrease of contact area indicate that metaphyseal fixation can not be achieved . The lack of cortical BD loss and increase of contact area values below the trochanter minor suggest diaphyseal fixation Purpose On the basis of positive clinical results with mid- and long-term follow-up using the Mayo short stem , the Metha neck-preserving stem ( BBraun , Aesculap , Tuttlingen , Germany ) was introduced . The purpose of this study was to vali date the implant design by direct acquisition of bone remodelling data from total hip arthroplasty ( THA ) recipients using dual-energy X-ray absorptiometry ( DEXA ) . Methods After power analysis , 25 patients were included in this prospect i ve study . Patients were examined clinical ly and underwent DEXA examinations preoperatively and postoperatively at one week , six months and one and two years after THA . Gruen zones were adapted to the short stem design ( R1–R7 ) . Results The Harris Hip Score ( HHS ) increased significantly by 31 points . No stem had to be revised . Bone mineral density ( BMD ) in the greater trochanter decreased significantly from 0.78 g/cm2 postoperatively to 0.72 g/cm2 two years after surgery . Marginal changes were seen in the lateral distal regions ( R4–R5 ) . In the minor trochanter region , BMD increased significantly after two years by 12.9 % . In the calcar region , BMD exceeded the baseline value by 6.1 % two years after implantation . Conclusions Stress shielding seems to occur at the greater trochanter due to the vast cross-section of the implant . However , the aim of proximal load transfer of the Metha stem seems to be partially achieved . DEXA analysis revealed a concentrated load distribution on the medial portion of the femur , which is an important region to guarantee long-term implant survival Aim Tissue sparing hip prostheses are becoming more and more popular especially for the treatment of younger patients . The objective of this study was to evaluate the clinical and radiological results after insertion of a tissue sparing hip prosthesis . Method In 47 consecutive non-selected patients ( 50 hips ) , the clinical and radiographic results of cementless total hip arthroplasty using a collum femoris preserving stem , a pressfit cup and an alumina – polyethylene pairing were prospect ively evaluated . The mean age at index-surgery was 58 ( 36–82 ) years , there were 38 women and 9 men . After a mean follow-up of 6.8 years ( minimum 6.1 years ) , two patients had died and one patient underwent revision surgery due to aseptic loosening of the stem . Results The overall survival rate of the acetabular component was 100 % and of the femoral component 98 % . The mean Harris hip score at follow-up was 94 points . Conclusion The mid-term survival with this type of total hip arthroplasty is excellent and compares equal with uncemented straight stems in this age group The CFP stem represents a short collared neck-retaining stem with very proximal metaphyseal anchoring along the calcar combined with up-to- date metallurgy . Despite theoretical advantages , the stability and clinical outcome are unknown . We prospect ively measured the migration pattern of this new stem and cup . Twenty-six patients ( 26 hips ) with a mean age of 54 years ( range , 40 - 66 years ) underwent THA and were followed for 2 years with radiostereometry , radiographs , and clinical scores . The stem showed some early retroversion ( mean , SEM 0.6 ° , 0.3 ) , but stabilized before 1 year . Subsidence ( 0.05 mm , 0.06 ) and varus-valgus tilting ( 0.03 ° , 0.01 ) were low . We observed no bone loss in the calcar region . Factors related to patients , implant design , and implantation did not predict migration patterns . The two-dimensional wear of the ceramic/conventional articulation was 0.09 mm at 2 - 24 months . The low migration of this short neck preserving stem suggests a favorable long-term outcome but longer followup is needed to substantiate this prediction . This design might become an alternative to st and ard stems and hip resurfacing . Level of Evidence : Therapeutic Level IV . See The Guidelines for Authors for a complete description of levels of evidence This prospect i ve study reports the clinical and radiological results of a single-surgeon series using the Mayo conservative hip stem in a district hospital . 30 total hip arthroplasties were performed in 26 physically active patients . There were 18 women and 8 men , with a mean age of 57.4 years ( range 36–79 ) . 4 cases were bilateral . The operation was performed for severe primary or secondary osteoarthritis OUTPUT:

These studies did not show a satisfactory overall survival rate

MS2_dynamic_1_shot698

***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: Background R and omised controlled trials demonstrate a 60 % reduction in type 2 diabetes incidence through lifestyle modification programmes . The aim of this study is to determine whether such programmes are feasible in primary health care . Methods An intervention study including 237 individuals 40–75 years of age with moderate or high risk of developing type 2 diabetes . A structured group programme with six 90 minute sessions delivered during an eight month period by trained nurses in Australian primary health care in 2004–2006 . Main outcome measures taken at baseline , three , and 12 months included weight , height , waist circumference , fasting plasma glucose and lipids , plasma glucose two hours after oral glucose challenge , blood pressure , measures of psychological distress and general health outcomes . To test differences between baseline and follow-up , paired t-tests and Wilcoxon rank sum tests were performed . Results At twelve months participants ' mean weight reduced by 2.52 kg ( 95 % confidence interval 1.85 to 3.19 ) and waist circumference by 4.17 cm ( 3.48 to 4.87 ) . Mean fasting glucose reduced by 0.14 mmol/l ( 0.07 to 0.20 ) , plasma glucose two hours after oral glucose challenge by 0.58 mmol/l ( 0.36 to 0.79 ) , total cholesterol by 0.29 mmol/l ( 0.18 to 0.40 ) , low density lipoprotein cholesterol by 0.25 mmol/l ( 0.16 to 0.34 ) , triglycerides by 0.15 mmol/l ( 0.05 to 0.24 ) and diastolic blood pressure by 2.14 mmHg ( 0.94 to 3.33 ) . Significant improvements were also found in most psychological measures . Conclusion This study provides evidence that a type 2 diabetes prevention programme using lifestyle intervention is feasible in primary health care setting s , with reductions in risk factors approaching those observed in clinical trials . Trial NumberCurrent Controlled Trials IS RCT Background Cardiovascular disease is the leading cause of death for adults in Australia . In recent years there has been a shift in health service delivery from institutional to community‐based care for chronic conditions , including cardiovascular disease . The general practice setting is seen to offer greater flexibility , higher levels of efficiency and more client focused healthcare delivery than is possible in the acute care sector . It has been suggested that practice nurses represent a useful adjunct to current models of cardiovascular disease management . To date , significant descriptive research has been conducted exploring the demographics , roles , educational needs and issues facing practice nurses . However , there is a need to evaluate the effectiveness of practice nurse interventions in terms of patient outcomes , clinician satisfaction and cost‐effectiveness . Objectives This review seeks to present the best available evidence regarding the efficacy of general practice nurse interventions for cardiac risk factor reduction in healthy adults , as well as those with established cardiovascular disease or known cardiac risk factors . Search Strategy A systematic literature search was performed using Medline ( 1966 ‐ 2005 ) , CINAHL ( 1982 −2005 ) , Cochrane Controlled Trials Register ( Issue 4 , 2005 ) and the Joanna Briggs Institute Evidence Library . In addition , the reference lists of retrieved papers , conference proceedings and the Internet , were scrutinised for additional trials . Selection Criteria This review considered any English language r and omised trials that investigated interventions conducted by the practice nurse for cardiovascular disease management or reduction of cardiac risk factors . Interventions conducted by specialist cardiac nurses in general practice were excluded . Outcomes measured included blood pressure , smoking cessation , total cholesterol , exercise , body weight/body mass index and cost‐effectiveness . Results Eighteen trials , reported in 33 papers , were included in the review . Ten trials investigated multifaceted interventions , while the remaining eight trials reported targeted interventions . Of the trials that reported multifaceted interventions , three trials investigated risk reduction in those with established cardiovascular disease , four trials focused on those with known cardiovascular disease risk factors and three trials included the general community . The eight trials which examined the efficacy of targeted interventions focused upon dietary intake ( two trials ) , smoking cessation ( three trials ) , weight reduction ( one trial ) and physical activity ( two trials ) . The effect of both the multifaceted and targeted interventions on patient outcomes was variable . However , both the multifaceted and targeted interventions demonstrated similar outcome trends for specific variables . Improvements were demonstrated by most studies in blood pressure , cholesterol level , dietary intake and physical activity . The variation in outcome measures and contradictory findings between some studies makes it difficult to draw definitive conclusions . Conclusions While interventions to reduce cardiovascular disease risk factors have produced variable results , they offer significant potential to assist patients in modifying their personal risk profile and should be developed . The public health importance of these changes is dependant upon the sustainability of the change and its effect on the health outcomes of these individuals . Further well‐ design ed research is required to establish the effectiveness of practice nurse interventions for cardiovascular disease management and risk factor reduction in terms of patient outcomes and cost‐effectiveness Prevention of type 2 diabetes by intensive lifestyle intervention design ed to achieve and maintain ideal body weight was assessed in subjects with impaired glucose tolerance ( IGT ) . Male subjects with IGT recruited from health-screening examinees were r and omly assigned in a 4:1 ratio to a st and ard intervention group ( control group ) and intensive intervention group ( intervention group ) . The final numbers of subjects were 356 and 102 , respectively . The subjects in the control group and in the intervention group were advised to maintain body mass index ( BMI ) of < 24.0 kg OUTPUT: Based on causal analyses , intervention effectiveness was increased by engaging social support , targeting both diet and physical activity , and using well-defined/established behaviour change techniques . Increased effectiveness was also associated with increased contact frequency and using a specific cluster of " self-regulatory " behaviour change techniques ( e.g. goal - setting , self-monitoring ) . No clear relationships were found between effectiveness and intervention setting , delivery mode , study population or delivery provider . Conclusions This comprehensive review of review s identifies specific components which are associated with increased effectiveness in interventions to promote change in diet and /or physical activity . INPUT: OBJECTIVE The objective of this study was to determine whether cinnamon improves blood glucose , triglyceride , total cholesterol , HDL cholesterol , and LDL cholesterol levels in people with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 60 people with type 2 diabetes , 30 men and 30 women aged 52.2 + /- 6.32 years , were divided r and omly into six groups . Groups 1 , 2 , and 3 consumed 1 , 3 , or 6 g of cinnamon daily , respectively , and groups 4 , 5 , and 6 were given placebo capsules corresponding to the number of capsules consumed for the three levels of cinnamon . The cinnamon was consumed for 40 days followed by a 20-day washout period . RESULTS After 40 days , all three levels of cinnamon reduced the mean fasting serum glucose ( 18 - 29 % ) , triglyceride ( 23 - 30 % ) , LDL cholesterol ( 7 - 27 % ) , and total cholesterol ( 12 - 26 % ) levels ; no significant changes were noted in the placebo groups . Changes in HDL cholesterol were not significant . CONCLUSIONS The results of this study demonstrate that intake of 1 , 3 , or 6 g of cinnamon per day reduces serum glucose , triglyceride , LDL cholesterol , and total cholesterol in people with type 2 diabetes and suggest that the inclusion of cinnamon in the diet of people with type 2 diabetes will reduce risk factors associated with diabetes and cardiovascular diseases AIMS Various spices display insulin-potentiating activity in vitro , and in particular , cinnamon spice and its phenolic extracts have been shown to exhibit these capabilities . In vivo study shows that cinnamon may have beneficial effects on glucose homeostasis ; therefore the aim of this study was to further investigate this phenomenon in humans . METHODS Seven lean healthy male volunteers , aged 26 + /- 1 years , body mass index 24.5 + /- 0.3 kg/m(2 ) ( mean + /- s.e.m . ) , underwent three oral glucose tolerance tests ( OGTT ) supplemented with either a 5 g placebo ( OGTT(control ) ) , 5 g of cinnamon ( OGTT(cin ) ) , or 5 g of cinnamon taken 12 h before ( OGTT(cin12hpre ) ) in a r and omized-crossover design . RESULTS Cinnamon ingestion reduced total plasma glucose responses ( AUC ) to oral glucose ingestion [ -13 % and -10 % for OGTT(cin ) ( p < 0.05 ) and OGTT(cin12hpre ) ( p < 0.05 ) , respectively ] , as well as improving insulin sensitivity as assessed by insulin sensitivity index measures based on Matsuda 's model in both OGTT(cin ) ( p < 0.05 ) and OGTT(cin12hpre ) ( p < 0.05 ) trials compared with OGTT(control ) . CONCLUSIONS These data illustrate that cinnamon spice supplementation may be important to in vivo glycaemic control and insulin sensitivity in humans , and not only are its effects immediate , they also appear to be sustained for 12 Cinnamon ( 肉桂 ròu guì ) has in vitro insulin potentiating activity , and proanthocyanidins from cinnamon prevent in vitro formation of advanced glycation end products . Some human studies were equivocal , but several have shown beneficial effects of cinnamon supplementation on circulating glucose , lipids , and /or insulin . This placebo-controlled double-blind trial tested the effects of a dried water extract of cinnamon ( Cinnamomum cassia ) on circulating glucose , lipids , insulin , and insulin resistance . Men and women from Beijing and Dalian , China , were invited to participate if they had fasting serum glucose > 6.1 mmol/L or 2-h glucose > 7.8 mmol/L. Participants , ( 173 were enrolled and 137 completed the study ) were r and omly assigned to receive either a spray-dried , water extract of cinnamon ( CinSulin ® ) , 250 mg/capsule , or a placebo , twice a day for two months . Mean ± SEM age of participants was 61.3 ± 0.8 years , BMI was 25.3 ± 0.3 and M/F ratio was 65/72 . After 2 mo , fasting glucose decreased ( p < 0.001 ) in the cinnamon extract-supplemented group ( 8.85 ± 0.36 to 8.19 ± 0.29 mmol/L ) compared with the placebo group ( 8.57 ± 0.32 to 8.44 ± 0.34 mmol/L , p = 0.45 ) . Glucose 2 h after a 75 g carbohydrate load , fasting insulin , and HOMA-IR also decreased with cinnamon extract compared with placebo . Total and LDL-cholesterol decreased with cinnamon extract and HDL-cholesterol decreased in both the cinnamon-extract and placebo groups . In conclusion , supplementation with 500 mg of water-extract of cinnamon for two months reduced fasting insulin , glucose , total cholesterol , and LDL cholesterol and enhanced insulin sensitivity of subjects with elevated blood glucose For thous and s of years , cinnamon OUTPUT:

No statistically significant association was found between blood HDL-C changes and duration of supplementation . CONCLUSION Cinnamon supplementation significantly reduced blood triglycerides and total cholesterol concentrations without any significant effect on LDL-C and

MS2_dynamic_1_shot699

***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: PURPOSE To evaluate the success of posterior NuSmile ( ® ) and Kinder ™ Krown and to determine the level of parental satisfaction with this treatment option . METHODS Forty-eight crowns were placed in 18 children with a mean age of 5 years . A split mouth design was used . Each participant r and omly received each crown type on 2 or 4 pair matched molars . Two trained operators completed all treatments . Two additional trained and calibrated clinicians blindly re-evaluated crowns according to specified variables . A visual analogue scale was used to determine parental satisfaction . Examiner reliability was determined by Cohen 's kappa scores and results were analysed statistically using Fisher 's exact test . RESULTS All crowns were retained after 12 months with no statistical difference in the clinical and radiographic success of posterior NuSmile ( ® ) and Kinder ™ Krowns . Overall success was high with 81 % of facings intact and 83 % free of gingival inflammation after 12 months . Radiographically , 81 % were successful . Veneer facing wear was significantly more likely to occur with opposing crowns ( P=.02 ) . Parental satisfaction was excellent with a mean score of 9.3 out of 10 . CONCLUSIONS These crowns combine the durability of conventional stainless steel crowns with improved esthetics and are proposed as a suitable alternative where esthetic dem and is increased Background Severe dental caries and the treatment thereof are reported to affect growth and well-being of young children . The objective of this study was to assess the effects of extraction of severely decayed pulpally involved primary teeth on weight and height in underweight preschool Filipino children . Methods Underweight preschool Filipino children with severe dental decay had their pulpally involved primary teeth extracted during a stepped wedge cluster r and omized clinical trial . Day care centers were r and omly divided into two groups ; children from Group A day care centers received treatment as soon as practical , whereas children from Group B day care centers were treated four months after Group A. Clinical oral examinations using WHO criteria and the pufa-index were carried out . Anthropometric measurements were done on both groups immediately before treatment of Group A and at follow-up four months later . Height and weight z-scores were calculated using 2006 and 2007 WHO Growth St and ards . Multilevel analysis was used to assess the effect of dental extraction s on changes in anthropometric measurements after dental treatment . Results Data on 164 children ( 85 in Group A and 79 in Group B ) , mean age 59.9 months , were analyzed . Both groups gained weight and height during the trial period . Children in Group A significantly increased their BMI ( p < 0.001 ) , and their weight-for-age ( p < 0.01 ) and BMI -for-age z-scores ( p < 0.001 ) after dental treatment , whereas untreated children in Group B did not . Children in Group A had significantly more weight gain ( p < 0.01 ) compared to untreated children in Group B. However , children in Group A had an inverse change in height gain ( p < 0.001 ) . Adjustment for the time interval between the two visits had little effect on the results . Conclusions The extraction of severely decayed primary teeth result ed in significant weight gain in underweight Filipino children . Untreated dental decay should be considered an important co-factor affecting child growth and should be considered when planning for interventions to improve child growth . Trial registration IS RCT N90779069 http://www.controlled-trials.com/is rct n/is rct Background Scotl and has high levels of untreated dental caries in primary teeth . The Hall Technique is a simplified method of managing carious primary molars using preformed metal crowns ( PMCs ) cemented with no local anaesthesia , caries removal or tooth preparation . This study compared the acceptability of the Hall Technique for children , their carers , and dentists , and clinical outcomes for the technique , with conventional restorations . Methods General dental practice based , split mouth , r and omized controlled trial ( 132 children , aged 3–10 ) . General dental practitioners ( GDPs , n = 17 ) in Tayside , Scotl and ( dmft 2.7 ) placed conventional ( Control ) restorations in carious primary molars , and Hall Technique PMCs on the contralateral molar ( matched clinical ly and radiographically ) . Dentists ranked the degree of discomfort they felt the child experienced for each procedure ; then children , their carers and dentists stated which technique they preferred . The teeth were followed up clinical ly and radiographically . Results 128 conventional restorations were placed on 132 control teeth , and 128 PMCs on 132 intervention teeth . Using a 5 point scale , 118 Hall PMCs ( 89 % ) were rated as no apparent discomfort up to mild , not significant ; for Control restorations the figure was 103 ( 78 % ) . Significant , unacceptable discomfort was recorded for two Hall PMCs ( 1.5 % ) and six Control restorations ( 4.5 % ) . 77 % of children , 83 % of carers and 81 % of dentists who expressed a preference , preferred the Hall technique , and this was significant ( Chi square , p < 0.0001 ) . There were 124 children ( 94 % of the initial sample ) with a minimum follow-up of 23 months . The Hall PMCs outperformed the Control restorations : a ) ' Major ' failures ( signs and symptoms of irreversible pulpal disease ) : 19 Control restorations ( 15 % ) ; three Hall PMCs ( 2 % ) ( P < 0.000);b ) ' Minor ' failures ( loss of restoration , caries progression ) : 57 Control restorations ( 46 % ) ; six Hall PMCs ( 5 % ) ( P < 0.000)c ) Pain : 13 Control rest OUTPUT: Crowns placed on primary molar teeth with carious lesions , or following pulp treatment , are likely to reduce the risk of major failure or pain in the long term compared to fillings . Crowns fitted using the Hall Technique may reduce discomfort at the time of treatment compared to fillings . INPUT: PURPOSE To evaluate the success of posterior NuSmile ( ® ) and Kinder ™ Krown and to determine the level of parental satisfaction with this treatment option . METHODS Forty-eight crowns were placed in 18 children with a mean age of 5 years . A split mouth design was used . Each participant r and omly received each crown type on 2 or 4 pair matched molars . Two trained operators completed all treatments . Two additional trained and calibrated clinicians blindly re-evaluated crowns according to specified variables . A visual analogue scale was used to determine parental satisfaction . Examiner reliability was determined by Cohen 's kappa scores and results were analysed statistically using Fisher 's exact test . RESULTS All crowns were retained after 12 months with no statistical difference in the clinical and radiographic success of posterior NuSmile ( ® ) and Kinder ™ Krowns . Overall success was high with 81 % of facings intact and 83 % free of gingival inflammation after 12 months . Radiographically , 81 % were successful . Veneer facing wear was significantly more likely to occur with opposing crowns ( P=.02 ) . Parental satisfaction was excellent with a mean score of 9.3 out of 10 . CONCLUSIONS These crowns combine the durability of conventional stainless steel crowns with improved esthetics and are proposed as a suitable alternative where esthetic dem and is increased Dental caries in early childhood can have a very significant effect not only on the oral health of young children but on their quality of life and that of their families . Added to this are the long-term infective risks to the host of untreated caries in primary teeth but also the risk of damage to successor permanent teeth . Traditional restoration of damaged primary teeth has been shown to have only moderate outcomes depending on the techniques and material s used and the ability of children to cooperate because of age or other factors . The Hall technique has outperformed other techniques in r and omised clinical trials . In this Opinion Article I will take a look back at the Innes et al. paper , first published in this Journal in 2006 , that introduced the Hall Technique and the subsequent scientific literature which provided us with high quality scientific evidence of the efficacy of the technique . I will evaluate how this new technique has affected the management of early childhood caries and hence its influence on wider oral and general health Background There is a lack of evidence for effective management of dental caries ( decay ) in children ’s primary ( baby ) teeth and an apparent failure of conventional dental restorations ( fillings ) to prevent dental pain and infection for UK children in Primary Care . UK dental schools ’ teaching has been based on British Society of Paediatric Dentistry guidance which recommends that caries in primary teeth should be removed and a restoration placed . However , the evidence base for this is limited in volume and quality , and comes from studies conducted in either secondary care or specialist practice s. Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been question ed . The FiCTION trial addresses the Health Technology Assessment ( HTA ) Programme ’s commissioning brief and research question “ What is the clinical and cost effectiveness of restoration caries in primary teeth , compared to no treatment ? ” It compares conventional restorations with an intermediate treatment strategy based on the biological ( sealing-in ) management of caries and with no restorations . Methods / Design This is a Primary Care-based multi-centre , three-arm , parallel group , patient-r and omised controlled trial . Practitioners are recruiting 1461 children , ( 3–7 years ) with at least one primary molar tooth where caries extends into dentine . Children are r and omized and treated according to one of three treatment approaches ; conventional caries management with best practice prevention , biological management of caries with best practice prevention or best practice prevention alone . Baseline measures and outcome data ( at review /treatment during three year follow-up ) are assessed through direct reporting , clinical examination including blinded radiograph assessment , and child/parent question naires . The primary outcome measure is the incidence of either pain or infection related to dental caries . Secondary outcomes are ; incidence of caries in primary and permanent teeth , patient quality of life , cost-effectiveness , acceptability of treatment strategies to patients and parents and their experiences , and dentists ’ preferences . Discussion FiCTION will provide evidence for the most clinical ly-effective and cost-effective approach to managing caries in children ’s primary teeth in Primary Care . This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth . The trial is currently recruiting patients .Trial registration Protocol ID : NCTU : IS RCT Aims To prospect ively report on the survival of resin-modified glass ionomer cement ( RMGIC ) , photac-fil and pre-formed stainless steel crown ( SSC ) restorations in primary molar teeth placed over a seven-year period in a specialist paediatric dental practice under private contract of remuneration . Method All primary molar restorations placed by a specialist paediatric dentist over a seven-year period were review ed and the outcome results recorded . Data were recorded at review visits until June 30 , 2003 . Data recorded included Class I restorations , Class II restorations and SSC . The Class II cavities were either mesial or distal , with or without buccal/palatal extensions . If both proximal surfaces were decayed or if after cavity preparation the result ant outline form was significantly larger than the minimal classical form , RMGIC was not used ; an SSC was placed instead . Stainless steel crown preparation followed conventional guidelines . The crowns were cemented with reinforced zinc oxide and eugenol ( Kalzinol ) . The status was recorded as satisfactory restoration , tooth exfoliated , tooth extracted for orthodontic reasons with the date of extraction , or needing replacement . If replaced then the reason for replacement was also recorded . Results A total of 544 Class I RMGICs , 962 Class II RMGICs , and 1,010 SSCs were placed . At the last review of each restoration , 98.3 % of Class I , 9 OUTPUT:

Class I restorations and restorations placed using rubber dam presented better AFR . An elevated number of failures were observed due to recurrent caries , highlighting the need for professionals to work with a health-promoting approach .