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Background and Aims Patient-reported outcome measures are increasingly important in daily care and research in inflammatory bowel disease [IBD]. This study provides an overview of the content and content validity of IBD-specific patient-reported outcome measures on three selected constructs. Methods Databases were searched up to May 2019 for development and/or content validity studies on IBD-specific self-report measures on health-related quality of life, disability, and self-report disease activity in adults. Evidence was synthesised on content validity in three aspects: relevance, comprehensiveness, and comprehensibility following the COnsensus-based Standards for the selection of health Measurement INstruments methodology. Questionnaire items were organised in themes to provide an overview of important aspects of these constructs. Results For 14/44 instruments, 25 content validity studies were identified and 25/44 measures had sufficient content validity, the strongest evidence being of moderate quality, though most evidence is of low or very low quality. The Crohn’s Life Impact Questionnaire and IBD questionnaire-32 on quality of life, the IBD-Control on disease activity, and the IBD Disability Index Self-Report and its 8-item version on disability, have the strongest evidence of sufficient relevance, comprehensiveness, and comprehensibility, ranging from moderate to very low quality. A fair number of recurring items themes, possibly important for the selected constructs, was identified. Conclusions The body of evidence for content validity of IBD-specific health-related quality of life, self-report disease activity, and disability self-report measures is limited. More content validity studies should be performed after reaching consensus on the constructs of interest for IBD, and studies should involve patients.

journal of crohn's and colitis

Systematic Review of Development and Content Validity of Patient-reported Outcome Measures in Inflammatory Bowel Disease: Do We Measure What We Measure?