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

Abstract

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 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.