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P262 Systematic review of development and content validity of patient-reported outcome measures in inflammatory bowel disease: do we measure what we measure?

E. van Andel*1, B. Koopmann1, D. van Asseldonk1, N. de Boer2, L. Mokkink3, C. Noomen1

1Northwest Clinics, Department of Gastroenterology and Hepatology, Alkmaar, The Netherlands, 2Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology and Metabolism Research Institute, Amsterdam, The Netherlands, 3Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, Amsterdam, The Netherlands


Patient-reported outcome measures (PROMs) are increasingly important in IBD-research and daily care. Many commonly used PROMs predate the current standards for development. This review summarises the evidence on development and content validity of IBD-specific PROMs.


MEDLINE, EMBASE and PsycINFO were searched up to July 2017 using the combined concepts: adults, IBD, PROMs, psychometric properties. Articles were included if the PROM is IBD-specific, measures a form of disability, QOL or disease activity and its development and/or content validity was reported. Evidence was synthesised according to the COSMIN methodology for development and content validity (relevance/comprehensiveness/comprehensibility), using a modified GRADE approach.1


From 4673 screened hits, 45 eligible articles were identified representing 32 PROMs. Three PROMs measure a form of disability, 10 disease activity and 19 QOL. The development process was reviewed for 21 PROMs, the remaining 11 are modifications for which the development study of the original was used. The development studies were of doubtful (n = 4) or inadequate quality (n = 17), the latter due to not clearly defined constructs (n = 8) and/or no patient involvement (n = 14). Sixteen content validity studies were found on 9 PROMs, 11 studies were solely on comprehensibility. The studies were of doubtful (n = 15) or inadequate quality (n = 1). Based on the development and content validity studies and our own judgement, 16 PROMs have sufficient content validity. Moderate quality of evidence was found for the comprehensibility and relevance of three IBDQ versions,2–4 the comprehensiveness of the IBDQ-367 and the comprehensibility of two more IBDQ versions.5,6 All other aspects in those 16 were also sufficient, but with low or very low quality of evidence (judgement of reviewer was decisive). The remaining 16 PROMs did not show sufficient content validity in all aspects, most were rated incomprehensive (n = 15) but comprehensible (n = 12) and some relevant (n = 8). Moderate quality of evidence for sufficient comprehensibility was found for 3 of the 12 comprehensible PROMs. Again, the other aspects had low or very low quality of evidence.


Most of the identified IBD-related PROMs do not meet current standards for development. Content validity studies are scarce and poorly described resulting in a limited body of evidence. There is some evidence for comprehensibility in IBD-specific PROMs, future studies should also focus on relevance and comprehensiveness to strengthen content validity.


1. Terwee CB, Prinsen CAC, Chiarotto A, et al. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res 2018;27:1159–70.

2. Guyatt G, Mitchell A, Irvine EJ, et al. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989;96:804–10.

3. Bernklev T, Moum B, Moum T, et al. Quality of life in patients with inflammatory bowel disease: translation, data quality, scaling assumptions, validity, reliability and sensitivity to change of the Norwegian version of IBDQ. Scand J Gastroenterol 2002;37:1164–74.

4. Häuser W, Dietz N, Grandt D, et al. Validation of the inflammatory bowel disease questionnaire IBDQ-D, German version, for patients with ileal pouch anal anastomosis for ulcerative colitis. Z Gastroenterol 2004;42:131–9.

5. de Boer AG, Wijker W, Bartelsman JF, et al. Inflammatory Bowel Disease Questionnaire: cross-cultural adaptation and further validation. Eur J Gastroenterol Hepatol 1995;7:1043–50.

6. Cheung WY, Garratt AM, Russell IT, et al. The UK IBDQ—a British version of the inflammatory bowel disease questionnaire. development and validation. J Clin Epidemiol 2000;53:297–306.

7. Love JR, Irvine EJ, Fedorak RN. Quality of life in inflammatory bowel disease. J Clin Gastroenterol 1992;14:15–9.