title: 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. The relationship among multiple patient-reported outcomes measures for patients with ulcerative colitis receiving treatment with MMX® formulated delayed-release mesalamine Measurement of health status. Ascertaining the minimal clinically important difference. Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA Ulcerative Colitis Remission Status After Induction With Mesalazine Predicts Maintenance Outcomes: the MOMENTUM Trial Validity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn's disease. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. A new validation of the Spanish Work Productivity and Activity Impairment Questionnaire-Crohn's disease version. The Validity and Reproducibility of a Work Productivity and Activity Impairment Instrument Response and remission are associated with improved quality of life, employment and disability status, hours worked, and productivity of patients with ulcerative colitis Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study.
abstract: The efficacy and safety of 4-g 5-aminosalicylic acid enemas were assessed in 153 patients with ulcerative colitis involving up to 50 cm of distal colon . Seventy-six patients received active medication and 77 received a placebo .  There were 20 dropouts ( 6 in the active group and 14 in the placebo group ) during the study because of insufficient efficacy . After 6 wk of therapy , 48 of the 76 patients ( 63 % ) receiving 5-aminosalicylic acid were considered to be " much improved " by the study physician compared to 22 of the 77 patients ( 29 % ) on placebo ( p = 0.001 ) . A disease activity index based on patient symptoms and sigmoidoscopic appearance was used to assess efficacy . Mean disease activity index declined 55 % for patients on 5-aminosalicylic acid and 24 % for patients on placebo ( p = 0.0001 ) . Analysis of subgroups indicated that patients most likely to respond were those with disease confined to the 20 - 40 cm from the anus . Response was not affected by concurrent sulfasalazine , but patients requiring concurrent oral steroids had a diminished response . Rapid onset of efficacy was shown by a significant reduction in rectal bleeding within 3 days of treatment initiation . 5-Aminosalicylic acid enemas are well tolerated and are of benefit in the treatment of ulcerative colitis confined to the distal colon 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 Abstract Background and Aims R and omised trials have described the benefits of adalimumab [ ADA ] for ulcerative colitis [ UC ] ; however , few data are available on health-related quality of life [ HRQL ] and health care costs in clinical practice . Methods InspirADA , a multicentre , prospect i ve study , evaluated the effect of ADA in patients with moderate to severe UC treated according to usual clinical practice . Outcomes assessed were : Simple Clinical Colitis Activity Index [ SCCAI ] response/remission rates ; changes in HRQL ; all-cause direct costs ; and UC-related direct and indirect costs from baseline to Week 26 . Results Data from 463 patients were analysed . At Week 26 , 67 % ( 95 % confidence interval [ CI ] : 62 % , 71 % ) of patients achieved response ; 48 % [ 95 % CI : 44 % , 53 % ] were in remission . For the overall population , significant [ all p < 0.001 ] improvements from baseline to Week 26 were observed for the Short Inflammatory Bowel Disease Question naire [ SIBDQ ] ( mean change ± st and ard deviation [ SD ] : 17.4 ± 14.5 ) and the European Quality of Life—5 Dimensions—5 Level [ EQ-5D-5L ] ( index : 0.1 ± 0.2 ; visual analogue scale [ VAS ] : 19.5 ± 25.8 ) . Parallel improvements were seen in work productivity [ 11 % absolute decrease in absenteeism ; 25 % absolute decrease in impairment while working ; and 27 % absolute decrease in impairment of ability to perform daily activities , all p < 0.001 ] . Among study completers , cumulative all-cause medical costs and UC-related medical costs were significantly [ both p < 0.001 ] reduced by 59 % and 77 % , respectively , 6 months after initiation of therapy compared with the preceding 6 months . The safety profile  of ADA was consistent with that observed in previous clinical trials . Conclusions ADA therapy in usual clinical practice is effective at improving and maintaining symptomatic control , improving HRQL , and decreasing costs of medical care among patients with UC Background and Aims : This study assessed the efficacy of maintenance treatment with multimatrix mesalazine following achievement of complete or partial remission after induction treatment with high-dose multimatrix mesalazine . Methods : In this phase 3b/4 , open-label , multicentre , prospect i ve , single-arm study , patients with mild-to-moderate ulcerative colitis were treated with multimatrix mesalazine 4.8g/day once daily for 8 weeks [ induction phase ] . At Week 8 , those who achieved complete or partial remission , based on predefined clinical and endoscopic criteria , were eligible to receive 12 months of multimatrix mesalazine 2.4g/day once daily maintenance therapy . The primary endpoint was the proportion of patients in complete remission at Month 12 . Results : A total of 717 patients received induction treatment ; 25.9 % and 39.3 % of patients achieved complete and partial remission , respectively , at Week 8 . A total of 461 patients entered the maintenance phase . The likelihood of remaining in/achieving complete remission at Month 12 was higher for patients who entered the maintenance phase in complete remission compared with those who began maintenance in partial remission [ 47.8 % vs 26.0 % ; p < 0.001 ] . At Month 12 , mucosal healing [ endoscopy score ≤ 1 ] was demonstrated in 76.4 % [ 139/182 ] and 63.5 % [ 176/277 ] of those who were in complete and partial remission , respectively , at the end of induction . Conclusion : Patients achieving complete remission before dose reduction were more likely to remain in remission at Month 12 BACKGROUND Crohn 's disease ( CD ) is a chronic inflammatory bowel disease usually diagnosed in early adult life and characterized by unpredictable flares and debilitating symptoms such as diarrhea , abdominal pain , and fever , which can interfere with a patient 's ability to work and perform daily activities . OBJECTIVE The aim of this study was to assess the validity , reliability , and responsiveness of the Work Productivity and Activity Impairment question naire in CD ( WPAI : CD ) . METHODS The WPAI : CD was tested in CD patients enrolled in a 26-week r and omized clinical trial of cer-tolizumab pegol versus placebo . Discriminative validity of WPAI : CD absenteeism , presenteeism(reduced on-the-job effectiveness ) , overall work productivity loss ( absenteeism + presenteeism ) , and activity impairment scores was assessed relative to 5 measures of disease severity and health status : CD Activity Index ( CDAI ) , Short Form-36 physical component summary ( PCS ) and mental health component summary ( MCS ) scores , Inflammatory Bowel Disease Question naire ( IBDQ ) , and the 5-dimensional EuroQoL health-related quality -of-life visual analog scale ( EQ-VAS ) . Responsiveness was assessed by comparing changes in WPAI : CD scores from baseline to week 26 for patients in remission ( CDAI < 150 points ) versus no remission . St and ardized Response Means ( SRMs ) were calculated to evaluate the magnitude of the changes . RESULTS A total of 662 patients ( mean [ range ] age , 37.4 [ 18 - 77 ] years ; male , 288 [ 43.5 % ] ; white , 629 [ 95.0 % ] ) were enrolled in the study . Patients with CD of the worst severity ( CDAI > median ) showed significantly higher impairment in work ( + 10.5 % ) and activities ( + 10.4 % ) versus patients with " best health " ( no problems ) ( both , P < or = 0.001 ) . Patients with " worst " IBDQ , PCS , MCS , and EQ-VAS scores also showed significantly higher impairments in work ( IBDQ , VAS -24.2 % ; PCS , -24.1 % ; MCS , -15.9 % ; EQ-VAS , -16.5 % ) and activities ( IBDQ , -23.3 % ; PCS , -21.8 % ; MCS , -16.5 % ; EQ-VAS , -17.2 % ) versus " best " scores ( all , P < 0.05 ) . There were significant differences between WPAI : CD impairment scores for patients in remission versus patients failing to achieve remission ( P < 0.05 ) . SRMs were small ( ie , < 0.5 ) in the nonre-mission group , and moderate to large ( ie , > 0.5 ) for patients in remission . CONCLUSIONS The discriminative validity , reliability , and responsiveness of the WPAI : CD were demonstrated . The WPAI : CD may be useful for evaluating drug impact on CD OBJECTIVE Health-related quality of life ( HRQOL ) affects outcome in chronic diseases such as inflammatory bowel disease ( IBD ) . The inflammatory bowel disease question naire ( IBDQ ) , a disease-specific HRQOL question naire , can define changes in health status in IBD , but simple instruments are needed for daily application . The present study proposed to develop a short version of the IBDQ , the SIBDQ , for community physicians . METHODS Using data from a clinical trial in 149 patients with Crohn 's disease , 10 items were selected ( by forward stepwise regression ) that best explained the variance of the IBDQ or dimensional scores ( bowel , systemic , social , emotional ) . The validity , reliability , and responsiveness of the SIBDQ were then assessed in 150 different patients with Crohn 's disease and 45 with ulcerative colitis . All scores were reported with a 7-point scale ( 1 = poor HRQOL , 7 = optimum HRQOL ) . RESULTS Mean SIBDQ scores were similar ( p = 0.22 ) in Crohn 's patients among 14 participating centers at study entry . Mean scores were lower in active Crohn 's disease ( range 4.00 - 4.92 ) than inactive disease ( range 4.67 - 5.83 ; p = 0.0015 ) . In active ulcerative colitis , the mean SIBDQ was 4.79 + /- 1.17 compared to 5.90 + /- 0.80 ( p = 0.0006 ) in inactive disease . The SIBDQ explained 92 % and 90 % of the IBDQ variance in Crohn 's disease and ulcerative colitis , respectively . In patients with stable Crohn 's disease , the test-retest reliability coefficient was 0.65 and Crohnbach 's alpha was 0.78 , indicating good reliability . In patients with Crohn 's disease who relapsed during follow-up , the mean SIBDQ decreased by -0.93 + 0.55 ( p = 0.001 ) . CONCLUSION The SIBDQ is valid , reliable , and able to detect meaningful clinical changes in HRQOL that might occur in the office setting OBJECTIVES The Work Productivity and Activity Impairment Question naire ( WPAI ) is an instrument that measures work impairment in the setting of different diseases . One previous study validating the WPAI in Crohn 's disease ( CD ) patients suggested that its reproducibility may be unsatisfactory . This study evaluated the validity and reproducibility of the Spain Spanish version of the WPAI question naire in CD patients . METHODS In a prospect i ve study , convergent validity was tested comparing WPAI with quality of life and CD activity indices . Known-groups validity was assessed by comparing WPAI scores in CD patients with active versus inactive disease . Reproducibility of repeated tests was evaluated by comparing two WPAI measures obtained two to four weeks apart in stable patients . RESULTS One hundred eight patients were included in the various steps of the analysis . The WPAI showed adequate known groups validity and convergent validity . The reproducibility of the test and , specifically , that of the evaluation of presenteeism ( the impairment of productivity while working ) were good . CONCLUSIONS This study confirms the validity of WPAI for measuring work impairment  in CD patients . In contrast to previous studies , the test reproducibility was adequate Summary The construct validity of a quantitative work productivity and activity impairment ( WPAI ) measure of health outcomes was tested for use in clinical trials , along with its reproducibility when administered by 2 different methods . 106 employed individuals affected by a health problem were r and omised to receive either 2 self-administered question naires ( self administration ) or one self-administered question naire followed by a telephone interview ( interviewer administration ) . Construct validity of the WPAI measures of time missed from work , impairment of work and regular activities due to overall health and symptoms , were assessed relative to measures of general health perceptions , role ( physical ) , role ( emotional ) , pain , symptom severity and global measures of work and interference with regular activity . Multivariate linear regression models were used to explain the variance in work productivity and regular activity by validation measures . Data generated by interviewer-administration of the WPAI had higher construct validity and fewer omissions than that obtained by self-administration of the instrument . All measures of work productivity and activity impairment were positively correlated with measures which had proven construct validity . These validation measures explained 54 to 64 % of variance ( p < 0.0001 ) in productivity and activity impairment variables of the WPAI . Overall work productivity ( health and symptom ) was significantly related to general health perceptions and the global measures of interference with regular activity . The self-administered question naire had adequate reproducibility but less construct validity than interviewer administration . Both administration methods of the WPAI warrant further evaluation as a measure of morbidity Background : Impairment of health‐related quality of life , employment , and productivity has been documented in patients with moderate to severe ulcerative colitis . Methods : Using prospect ively collected data from the Active Ulcerative Colitis Trials 1 and 2 , we examined the impact of clinical response or remission , as defined using the Mayo score , on health‐related quality of life , employment , disability , productivity , and hours worked per week . These analyses were based on observed data and included all 728 patients , regardless of their r and omized treatment group ( i.e. ,  placebo and infliximab patients were grouped for analysis ) . Changes in Inflammatory Bowel Disease Question naire ( IBDQ ) and Medical Outcomes Study 36‐Item Short Form ( SF‐36 ) scores among nonresponders , responders , and patients in remission were compared . In addition , changes in employment , disability status , productivity , and hours worked per week of patients in clinical remission and patients not in clinical remission were compared . Results : Ulcerative colitis patients in clinical response or remission had significantly improved IBDQ and SF‐36 scores at week 30 compared with those of nonresponders ( P < 0.001 ) . Among those not employed at baseline , including those receiving disability compensation , greater percentages of patients in remission at week 30 were employed ( 20.6 % ) and not receiving disability compensation ( 58.8 % ) than were those not in remission ( 8.3 % and 20.0 % , respectively ; P < 0.05 for both comparisons ) . At week 30 , improvements from baseline in productivity and both actual and fully productive hours worked per week were greater for patients in remission compared with those not in remission ( P < 0.05 for all three comparisons ) . Conclusions : These results confirm the validity of response and remission as defined using the Mayo score We assessed oral 5-aminosalicylic acid ( 5-ASA ) prepared with a pH-sensitive polymer coating in 87 patients with mildly to moderately active ulcerative colitis in a double-blind , placebo-controlled trial . Patients were r and omly assigned to receive 5-ASA at a dosage of either 4.8 or 1.6 g per day or placebo for six weeks . The outcome was monitored by flexible proctosigmoidoscopic examinations and physicians ' assessment s at three-week intervals and by patients ' recordings of daily symptoms . Results showed 24 percent complete and 50 percent partial responses in those receiving 4.8 g of 5-ASA per day as compared with 5 percent complete and 13 percent partial responses in those receiving placebo ( P less than 0.0001 , rank-sum test ) . At a dosage of 1.6 g per day , the response was twice as good as with placebo , but the difference did not reach statistical significance ( P = 0.51 ) . Age , sex , duration of disease , duration of active symptoms , or extent of disease did not affect the clinical outcome . We conclude that oral 5-ASA administered in a dosage of 4.8 g per day is effective therapy , at least in the short term , for mildly to moderately active ulcerative colitis Needing a single index of degree of illness in Crohn 's disease , the National Cooperative Crohn 's Disease Study group collected data prospect ively from 187 visits of 112 patients with Crohn 's disease of the small bowel , colon , or both . Information on 18 predictor variables was gathered at each visit . In addition , the attending physician rated his over-all evaluation of how well the patient was doing and compared the patient 's status with that at the previous visit . A multiple regression computer program was utilized to derive an equation for prediction of the physician 's over-all ratings from a subset of the predictor variables fulfilling a combination of constraints . This equation , numerically simplified and utilizing eight selected variables , is the Crohn 's Disease Activity Index . Index values of 150 and below are associated with quiescent disease ; values above that indicate active disease , and values above 450 are seen with extremely severe disease
target: The evidence supports the WPAI as having test-retest reliability ( reproducibility ) over time ; convergent validity , as indicated by moderate correlations with measures of quality of life and moderate-to-strong correlations with measures of disease activity ; known-groups validity , as indicated by differences in WPAI scores between patients with active and inactive disease ; ability ( sensitivity ) to detect change , as indicated by substantial improvement in scores for patients who achieve remission , accompanied by substantial worsening of scores for patients who relapse ; and , responsiveness to treatment , with improvements in scores following treatments that reduce disease activity .
background: Patients with ulcerative colitis , a type of inflammatory bowel disease , report negative impacts of disease symptoms on work-related outcomes , including absenteeism and presenteeism .
  As a way to better underst and the impact of this disease and its treatment on work-related outcomes , the current review examines the use of the Work Productivity and Activity Impairment Question naire ( WPAI ) , a patient-reported outcomes measure of absenteeism , presenteeism , and impairment in other activities , in studies of patients with ulcerative colitis .
  This review assesses the measurement properties of the WPAI in this patient population : its reliability , construct validity , ability to detect change , and responsiveness to effective treatments .