human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***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 effect of thiopurine immunomodulators on health-related quality of life ( HRQoL ) in patients with inflammatory bowel disease ( IBD ) has been controversial . The aims were to evaluate the HRQoL in patients with IBD treated with thiopurines  and assess the short- and long-term impacts of the treatment on HRQoL. Methods Ninety-two consecutive patients who started treatment with thiopurines were prospect ively included . Evaluation of HRQoL was performed at months 0 , 6 , and 12 using two question naires , the Short-Form Health Survey ( SF-36 ) and the Inflammatory Bowel Disease Question naire ( IBDQ ) . Results Baseline score of IBDQ was 4,6 , range ( 2,31 - 6,84 ) , with an impairment of the five dimensions of HRQoL compared with inactive patients . Results obtained in 8 dimensions of SF-36 showed worse HRQoL than Spanish general population . At 6 months patients had a significant improvement in overall IBDQ score -5,8 ( 1,58 -6,97)- and also in all IBDQ dimensions . All the 8 dimensions of SF-36 obtained a significant improvement . At twelve months score of IBDQ was 6,1 , range ( 2,7 - 6,98 ) , with improvement in all dimensions compared with baseline and 6 months . SF-36 showed a similar significant improvement in all subscales . Conclusions Thiopurine immunomodulators alone or with other treatments have a positive and long lasting impact on HRQoL of IBD patients Background Ingestion of And oSanTM , based on the mushroom Agaricus blazei Murill , has previously shown an anti-inflammatory effect through reduction of pro-inflammatory cytokines in healthy individuals and patients with Crohn ’s disease ( CD ) . In this r and omized single-blinded placebo-controlled study we examined whether intake of And oSanTM also result ed in clinical effects . Methods and Findings 50 patients with symptomatic CD were r and omized for oral daily consumption of And oSanTM or placebo for a 21-day experimental period , in this per- protocol study . Patients reported vali date d scores for symptoms , fatigue and health related quality of life ( HRQoL ) at days 0 , 14 and 21 . Fecal calprotectin and general blood parameters were also analyzed . In the And oSanTM group ( n = 25 ) symptoms improved from baseline ( day 0 ) to days 14 and 21 , with respective mean scores ( 95 % CI ) of 5.52 ( 4.64–6.40 ) , 4.48 ( 3.69–5.27 ) and 4.08 ( 3.22–4.94 ) ( p<0,001 ) . We found significant improvements in symptom score for both genders in the And oSanTM group , and no significant changes in the placebo ( n = 25 ) group . There were however no significant differences between the groups ( p = 0.106 ) , although a marginal effect in symptom score for men ( p = 0.054 ) . There were comparable improvements in physical , mental and total fatigue for both groups . HRQoL versus baseline were at day 21 improved for bodily pain and vitality in the And oSanTM group and for vitality and social functioning in the placebo group . No crucial changes in general blood sample s and fecal calprotectin were detected . Conclusions The results from this single-blinded r and omized clinical trial shows significant improvement on symptoms , for both genders , in the And oSanTM group , but no significant differences between the study groups . The results on fatigue , HRQoL , fecal calprotectin and blood sample s were quite similar compared with placebo . The patients did not report any harms or unintended effects of And oSanTM . CD patients with mild to moderate symptoms may have beneficiary effects of And oSanTM as a safe supplement in addition to conventional medication . Trial Registration Clinical Trials.gov Purpose Ulcerative colitis ( UC ) is associated with impaired health-related quality of life ( HRQL ) and work-related outcomes ( WRO ) . This analysis examined correspondences among measures of HRQL and WRO in patients with UC , as well as the magnitude of each measure ’s responsiveness to disease activity and treatment . Methods An open-label , prospect i ve trial of delayed-release mesalamine tablets formulated with MMX ® technology included 8 weeks of treatment for patients with active mild-to-moderate UC ( n = 137 ) and 12 months of maintenance treatment for patients with quiescent UC ( n = 206 ) . Spearman correlations ( ρ ) measured inter-domain associations across measures of generic HRQL [ 12-item Short-Form Health Survey ( SF-12v2 ) ] , disease-specific HRQL [ Short Inflammatory Bowel Disease Question naire ( SIBDQ ) ] , and disease-specific WRO [ Work Productivity and Activity Impairment for Specific Health Problems ( WPAI : SHP ) ] . Responsiveness to disease activity and treatment was assessed for each instrument . Results Changes in scores from baseline to week 8 were moderately correlated across all instrument domains : 65 of 80 ( 81 % ) between-instrument inter-domain correlations were of moderate magnitude ( 0.30 < ρ < 0.70 ) , with an average magnitude of 0.42 [ 95 % confidence interval ( CI ) 0.38–0.46 ] . Associations between symptom measures were stronger for SIBDQ ( |average ρ| = 0.41 ; 95 % CI 0.34–0.48 ) and WPAI : SHP ( 0.40 ; 0.30–0.47 ) than SF-12v2 ( 0.30 ; 0.27–0.34 ) . SIBDQ was most sensitive to treatment [ effect size ( dz ) for change from baseline to week 8 = 0.62 ; 95 % CI 0.35–0.89 ] , followed by WPAI : SHP ( dz = 0.43 ; 0.32–0.54 ) and SF-12v2 ( dz = 0.33 ; 0.27–0.39 ) . Conclusion While the SIBDQ showed the greatest overall responsiveness to disease activity and treatment , all three patient-reported outcomes instruments provided complementary interpretive information regarding the impact of UC treatment In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Objective . To analyze the effects of a comprehensive lifestyle modification program on health-related quality -of-life , psychological distress , and clinical parameters in patients with ulcerative colitis ( UC ) 3- and 12 months after completion of the program . Material and methods . Sixty patients with UC in clinical remission or with low disease activity were r and omly assigned to an intervention group or a usual-care control group . Comprehensive lifestyle modification consisted of a structured 60-h training program over a period of 10 weeks which included stress management training , psychoeducational elements , and self-care strategies .  Quality -of-life , psychological distress , and clinical disease activity were assessed with st and ardized question naires ( Inflammatory Bowel Disease Question naire ( IBDQ ) ; the MOS Short-Form 36 ( SF-36 ) ; the Brief Symptom Inventory ( BSI ) , and the Colitis Activity Index ( CAI ) ) at baseline , and 3 months and 12 months after comprehensive lifestyle modification . Results . Three months after comprehensive lifestyle modification , patients in the intervention group showed significantly greater improvement in the SF-36 scale physical function ( p=0.0175 ) , and a significantly greater reduction in anxiety scores , measured with the BSI ( p=0.0294 ) . Use of relaxation techniques was a significant predictor of improvement in the psychological sum score after 3 months of therapy ( p=0.034 ) . Though 80 % of patients with an initial IBDQ score < 170 in the intervention group showed an improvement of > 16 points after 3 months , no significant effects of the intervention were found on the IBDQ scales , or on clinical disease parameters , including CAI scores , self-assessed disease activity , hospitalizations , or medical consultations . Conclusions . These results are consistent with possible short-term benefits of a comprehensive lifestyle modification program on some aspects of quality -of-life and emotional well-being , but no effects were discernable 12 months after completion of therapy . Comprehensive lifestyle modification had no effect on clinical disease variables . The generalizability of these data is limited because of the inclusion of patients with a relatively low disease activity who were interested in integrative medicine OBJECTIVES --To gain population norms for the short form 36 health survey question naire ( SF36 ) in a large community sample and to explore the question naire 's internal consistency and validity . DESIGN --Postal survey by using a booklet containing the SF36 and several other items concerned with lifestyles and illness . SETTING --The sample was drawn from computerised registers of the family health services authorities for Berkshire , Buckinghamshire , Northamptonshire , and Oxfordshire . SAMPLE --13,042 r and omly selected subjects aged 18 - 64 years . MAIN OUTCOME MEASURES --Scores for the eight health dimensions of the SF36 . RESULTS --The survey achieved a response rate of 72 % ( n = 9332 ) . Internal consistency of the different dimensions of the question naire was high . Normative data broken down by age , sex , and social class were consistent with those from previous studies . CONCLUSIONS --The SF36 is a potentially valuable tool in medical research . The normative data provided here may further facilitate its validation and use PURPOSE The principal aim of this study was to assess long-term pouch durability and health-related quality of life in an original series of patients operated on with a continent ileostomy . PATIENTS Data from 68 of 88 patients who had a continent ileostomy performed at Sahlgrenska University Hospital between 1967 and 1974 were analyzed . Median age at follow-up was 60 ( range , 40–89 ) years and median follow-up was 31 ( range , 29–36 ) years . METHODS Patients were sent a question naire on pouch function along with the Short Form-36 Health Survey 2.0 . A r and om age-matched and gender-matched sample was drawn from the Swedish national Short Form-36 Health Survey norm data base to compare with the patient group . RESULTS The majority of the patients reported good physical condition and satisfactory pouch function . Patients evacuated the pouch a median of four times every 24 hours . Twelve patients ( 18 percent ) had leakages . Forty-four patients ( 65 percent ) had had at least one postoperative revision to restore continence . Generally minor peristomal skin irritation occurred in seven patients ( 10 percent ) . Patients with concurrent complaints ( mostly age related ) reported poorer health-related quality of life . Nevertheless , 78 percent of the patients rated their overall health as good , very good , or excellent . The patients ’ Short Form-36 Health Survey scores were comparable to reference values . CONCLUSIONS Although revisional operations may be needed to restore continence , continent ileostomy has a good durability . Pouch function was satisfactory and patients ’ satisfaction was high . Health-related quality of life levels were similar to those of the general population BACKGROUND There has been no new effective drug therapy for patients with severe ulcerative colitis since corticosteroids were introduced almost 40 years ago . In an uncontrolled study , 80 percent of 32 patients with active ulcerative colitis refractory to corticosteroid therapy had a response to cyclosporine therapy . METHODS We conducted a r and omized , double-blind , controlled trial in which cyclosporine ( 4 mg per kilogram of body weight per day ) or placebo was administered by continuous intravenous infusion to 20 patients with severe ulcerative colitis whose condition had not improved after at least 7 days of intravenous corticosteroid therapy .  A response to therapy was defined as an improvement in a numerical symptom score ( 0 indicated no symptoms , and 21 severe symptoms ) leading to discharge from the hospital and treatment with oral medications . Failure to respond to therapy result ed in colectomy , but some patients in the placebo group who had no response and no urgent need for surgery were subsequently treated with cyclosporine . RESULTS Nine of 11 patients ( 82 percent ) treated with cyclosporine had a response within a mean of seven days , as compared with 0 of 9 patients who received placebo ( P < 0.001 ) . The mean clinical -activity score fell from 13 to 6 in the cyclosporine group , as compared with a decrease from 14 to 13 in the placebo group . All five patients in the placebo group who later received cyclosporine therapy had a response . CONCLUSIONS Intravenous cyclosporine therapy is rapidly effective for patients with severe 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***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 effect of thiopurine immunomodulators on health-related quality of life ( HRQoL ) in patients with inflammatory bowel disease ( IBD ) has been controversial . The aims were to evaluate the HRQoL in patients with IBD treated with thiopurines  and assess the short- and long-term impacts of the treatment on HRQoL. Methods Ninety-two consecutive patients who started treatment with thiopurines were prospect ively included . Evaluation of HRQoL was performed at months 0 , 6 , and 12 using two question naires , the Short-Form Health Survey ( SF-36 ) and the Inflammatory Bowel Disease Question naire ( IBDQ ) . Results Baseline score of IBDQ was 4,6 , range ( 2,31 - 6,84 ) , with an impairment of the five dimensions of HRQoL compared with inactive patients . Results obtained in 8 dimensions of SF-36 showed worse HRQoL than Spanish general population . At 6 months patients had a significant improvement in overall IBDQ score -5,8 ( 1,58 -6,97)- and also in all IBDQ dimensions . All the 8 dimensions of SF-36 obtained a significant improvement . At twelve months score of IBDQ was 6,1 , range ( 2,7 - 6,98 ) , with improvement in all dimensions compared with baseline and 6 months . SF-36 showed a similar significant improvement in all subscales . Conclusions Thiopurine immunomodulators alone or with other treatments have a positive and long lasting impact on HRQoL of IBD patients Background Ingestion of And oSanTM , based on the mushroom Agaricus blazei Murill , has previously shown an anti-inflammatory effect through reduction of pro-inflammatory cytokines in healthy individuals and patients with Crohn ’s disease ( CD ) . In this r and omized single-blinded placebo-controlled study we examined whether intake of And oSanTM also result ed in clinical effects . Methods and Findings 50 patients with symptomatic CD were r and omized for oral daily consumption of And oSanTM or placebo for a 21-day experimental period , in this per- protocol study . Patients reported vali date d scores for symptoms , fatigue and health related quality of life ( HRQoL ) at days 0 , 14 and 21 . Fecal calprotectin and general blood parameters were also analyzed . In the And oSanTM group ( n = 25 ) symptoms improved from baseline ( day 0 ) to days 14 and 21 , with respective mean scores ( 95 % CI ) of 5.52 ( 4.64–6.40 ) , 4.48 ( 3.69–5.27 ) and 4.08 ( 3.22–4.94 ) ( p<0,001 ) . We found significant improvements in symptom score for both genders in the And oSanTM group , and no significant changes in the placebo ( n = 25 ) group . There were however no significant differences between the groups ( p = 0.106 ) , although a marginal effect in symptom score for men ( p = 0.054 ) . There were comparable improvements in physical , mental and total fatigue for both groups . HRQoL versus baseline were at day 21 improved for bodily pain and vitality in the And oSanTM group and for vitality and social functioning in the placebo group . No crucial changes in general blood sample s and fecal calprotectin were detected . Conclusions The results from this single-blinded r and omized clinical trial shows significant improvement on symptoms , for both genders , in the And oSanTM group , but no significant differences between the study groups . The results on fatigue , HRQoL , fecal calprotectin and blood sample s were quite similar compared with placebo . The patients did not report any harms or unintended effects of And oSanTM . CD patients with mild to moderate symptoms may have beneficiary effects of And oSanTM as a safe supplement in addition to conventional medication . Trial Registration Clinical Trials.gov Purpose Ulcerative colitis ( UC ) is associated with impaired health-related quality of life ( HRQL ) and work-related outcomes ( WRO ) . This analysis examined correspondences among measures of HRQL and WRO in patients with UC , as well as the magnitude of each measure ’s responsiveness to disease activity and treatment . Methods An open-label , prospect i ve trial of delayed-release mesalamine tablets formulated with MMX ® technology included 8 weeks of treatment for patients with active mild-to-moderate UC ( n = 137 ) and 12 months of maintenance treatment for patients with quiescent UC ( n = 206 ) . Spearman correlations ( ρ ) measured inter-domain associations across measures of generic HRQL [ 12-item Short-Form Health Survey ( SF-12v2 ) ] , disease-specific HRQL [ Short Inflammatory Bowel Disease Question naire ( SIBDQ ) ] , and disease-specific WRO [ Work Productivity and Activity Impairment for Specific Health Problems ( WPAI : SHP ) ] . Responsiveness to disease activity and treatment was assessed for each instrument . Results Changes in scores from baseline to week 8 were moderately correlated across all instrument domains : 65 of 80 ( 81 % ) between-instrument inter-domain correlations were of moderate magnitude ( 0.30 < ρ < 0.70 ) , with an average magnitude of 0.42 [ 95 % confidence interval ( CI ) 0.38–0.46 ] . Associations between symptom measures were stronger for SIBDQ ( |average ρ| = 0.41 ; 95 % CI 0.34–0.48 ) and WPAI : SHP ( 0.40 ; 0.30–0.47 ) than SF-12v2 ( 0.30 ; 0.27–0.34 ) . SIBDQ was most sensitive to treatment [ effect size ( dz ) for change from baseline to week 8 = 0.62 ; 95 % CI 0.35–0.89 ] , followed by WPAI : SHP ( dz = 0.43 ; 0.32–0.54 ) and SF-12v2 ( dz = 0.33 ; 0.27–0.39 ) . Conclusion While the SIBDQ showed the greatest overall responsiveness to disease activity and treatment , all three patient-reported outcomes instruments provided complementary interpretive information regarding the impact of UC treatment In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Objective . To analyze the effects of a comprehensive lifestyle modification program on health-related quality -of-life , psychological distress , and clinical parameters in patients with ulcerative colitis ( UC ) 3- and 12 months after completion of the program . Material and methods . Sixty patients with UC in clinical remission or with low disease activity were r and omly assigned to an intervention group or a usual-care control group . Comprehensive lifestyle modification consisted of a structured 60-h training program over a period of 10 weeks which included stress management training , psychoeducational elements , and self-care strategies .  Quality -of-life , psychological distress , and clinical disease activity were assessed with st and ardized question naires ( Inflammatory Bowel Disease Question naire ( IBDQ ) ; the MOS Short-Form 36 ( SF-36 ) ; the Brief Symptom Inventory ( BSI ) , and the Colitis Activity Index ( CAI ) ) at baseline , and 3 months and 12 months after comprehensive lifestyle modification . Results . Three months after comprehensive lifestyle modification , patients in the intervention group showed significantly greater improvement in the SF-36 scale physical function ( p=0.0175 ) , and a significantly greater reduction in anxiety scores , measured with the BSI ( p=0.0294 ) . Use of relaxation techniques was a significant predictor of improvement in the psychological sum score after 3 months of therapy ( p=0.034 ) . Though 80 % of patients with an initial IBDQ score < 170 in the intervention group showed an improvement of > 16 points after 3 months , no significant effects of the intervention were found on the IBDQ scales , or on clinical disease parameters , including CAI scores , self-assessed disease activity , hospitalizations , or medical consultations . Conclusions . These results are consistent with possible short-term benefits of a comprehensive lifestyle modification program on some aspects of quality -of-life and emotional well-being , but no effects were discernable 12 months after completion of therapy . Comprehensive lifestyle modification had no effect on clinical disease variables . The generalizability of these data is limited because of the inclusion of patients with a relatively low disease activity who were interested in integrative medicine OBJECTIVES --To gain population norms for the short form 36 health survey question naire ( SF36 ) in a large community sample and to explore the question naire 's internal consistency and validity . DESIGN --Postal survey by using a booklet containing the SF36 and several other items concerned with lifestyles and illness . SETTING --The sample was drawn from computerised registers of the family health services authorities for Berkshire , Buckinghamshire , Northamptonshire , and Oxfordshire . SAMPLE --13,042 r and omly selected subjects aged 18 - 64 years . MAIN OUTCOME MEASURES --Scores for the eight health dimensions of the SF36 . RESULTS --The survey achieved a response rate of 72 % ( n = 9332 ) . Internal consistency of the different dimensions of the question naire was high . Normative data broken down by age , sex , and social class were consistent with those from previous studies . CONCLUSIONS --The SF36 is a potentially valuable tool in medical research . The normative data provided here may further facilitate its validation and use PURPOSE The principal aim of this study was to assess long-term pouch durability and health-related quality of life in an original series of patients operated on with a continent ileostomy . PATIENTS Data from 68 of 88 patients who had a continent ileostomy performed at Sahlgrenska University Hospital between 1967 and 1974 were analyzed . Median age at follow-up was 60 ( range , 40–89 ) years and median follow-up was 31 ( range , 29–36 ) years . METHODS Patients were sent a question naire on pouch function along with the Short Form-36 Health Survey 2.0 . A r and om age-matched and gender-matched sample was drawn from the Swedish national Short Form-36 Health Survey norm data base to compare with the patient group . RESULTS The majority of the patients reported good physical condition and satisfactory pouch function . Patients evacuated the pouch a median of four times every 24 hours . Twelve patients ( 18 percent ) had leakages . Forty-four patients ( 65 percent ) had had at least one postoperative revision to restore continence . Generally minor peristomal skin irritation occurred in seven patients ( 10 percent ) . Patients with concurrent complaints ( mostly age related ) reported poorer health-related quality of life . Nevertheless , 78 percent of the patients rated their overall health as good , very good , or excellent . The patients ’ Short Form-36 Health Survey scores were comparable to reference values . CONCLUSIONS Although revisional operations may be needed to restore continence , continent ileostomy has a good durability . Pouch function was satisfactory and patients ’ satisfaction was high . Health-related quality of life levels were similar to those of the general population BACKGROUND There has been no new effective drug therapy for patients with severe ulcerative colitis since corticosteroids were introduced almost 40 years ago . In an uncontrolled study , 80 percent of 32 patients with active ulcerative colitis refractory to corticosteroid therapy had a response to cyclosporine therapy . METHODS We conducted a r and omized , double-blind , controlled trial in which cyclosporine ( 4 mg per kilogram of body weight per day ) or placebo was administered by continuous intravenous infusion to 20 patients with severe ulcerative colitis whose condition had not improved after at least 7 days of intravenous corticosteroid therapy .  A response to therapy was defined as an improvement in a numerical symptom score ( 0 indicated no symptoms , and 21 severe symptoms ) leading to discharge from the hospital and treatment with oral medications . Failure to respond to therapy result ed in colectomy , but some patients in the placebo group who had no response and no urgent need for surgery were subsequently treated with cyclosporine . RESULTS Nine of 11 patients ( 82 percent ) treated with cyclosporine had a response within a mean of seven days , as compared with 0 of 9 patients who received placebo ( P < 0.001 ) . The mean clinical -activity score fell from 13 to 6 in the cyclosporine group , as compared with a decrease from 14 to 13 in the placebo group . All five patients in the placebo group who later received cyclosporine therapy had a response . CONCLUSIONS Intravenous cyclosporine therapy is rapidly effective for patients with severe 
    Output:
    