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

J Crohns Colitis. 2020 Mar 25;jjaa057. doi: 10.1093/ecco-jcc/jjaa057. Online ahead of print.

Emma M van Andel 1, Brechtje D M Koopmann 1, Femke Crouwel 1, Casper G Noomen 1, Nanne K H de Boer 2 3, Dirk P van Asseldonk 1, Lidwine B Mokkink 4


Author information

1Noordwest Ziekenhuisgroep, Wilhelminalaan, Netherlands.

2Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam.

3Gastroenterology and Metabolism Research Institute, De Boelelaan, HV Amsterdam, Netherlands.

4Amsterdam UMC, Vrije Universiteit Amsterdam, dept of Epidemiology and Biostatistics Amsterdam Public Health research institute, De Boelelaan, BV Amsterdam, Netherlands.

PMID: 32211749

DOI: 10.1093/ecco-jcc/jjaa057


Background and aimsPatient-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 synthesized 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 organized 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 for sufficient relevance, comprehensiveness and comprehensibility, ranging from moderate to very low evidence. 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.

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