The American Journal of Gastroenterology · 2000 · 410 citations · 17 references
PharmacyPharmacotherapyFunctional AssessmentGastroenterologyHealth AssessmentFunctional Gastrointestinal DisordersHealth Status MeasurementHealth-related Quality Of LifeHealth-related Quality Of Life MeasurementIrritable Bowel SyndromeQuality Of LifeConstruct ValidityConstruct Validity AssessmentFunctional Gastrointestinal Disorder AssessmentGastrointestinal Assessment ScalesIrritable Bowel Syndrome TreatmentPatient-reported Bowel Symptoms
OBJECTIVE: There has been growing interest in the investigation of health-related quality of life (HRQOL) among patients with gastrointestinal (GI) disorders. We recently reported on the development and preliminary validation of the IBS-QOL, a specific quality-of-life measure for irritable bowel syndrome (IBS). The aim of this study was to determine the longitudinal construct validity (responsiveness) of the IBS-QOL. METHODS: Female patients enrolled in a multicenter treatment trial for functional bowel disorders were studied pre- and posttreatment with the IBS-QOL and other health status measures. Based on the response to treatment for several variables (pain/14-day score, daily function, and days in bed/3 months), patients were stratified into Responders, Partial Responders, and Nonresponders. Change scores in the IBS-QOL were then statistically compared with changes in the other variables to determine their correlation and whether Responders were significantly different from non- and Partial Responders on the IBS-QOL. RESULTS: There was a significant correlation between change scores on the IBS-QOL and the other measures of treatment effect (Pain/14 days, r = 0.25, p < 0.002; Sickness Impact Profile [SIP] Total Score, r = 0.28, p < 0.0004). In addition, the IBS-QOL scores significantly differentiated Responders from Nonresponders for most of the variables tested (regression trend test for Pain/14 days, p < 0.04; SIP Total, p < 0.0001; SIP Physical, p < 0.0001; SIP Psychosocial, p < 0.002, and SIP Eating, p < 0.04). CONCLUSION: The IBS-QOL is responsive to treatment in a referral-based clinical population of patients with functional bowel disorders.
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Statistical Power Analysis for the Behavioral Sciences
Keith E. Muller, Jacob Cohen · Technometrics · 1989 · 83.9K citations
Quality of life and pharmacoeconomics in clinical trials
Joseph L. Pater · Controlled Clinical Trials · 1996 · 2.4K citations