Development, content validity and cross-cultural adaptation of a Patient-Reported Outcome Measure for Real-time Symptom Assessment in Irritable Bowel Syndrome

Vork, L.; Keszthely, D.; Mujagic, Z.; Kruimel, J.W.; Leue, C.; Pont�n, I.; T�rnblom, H.; Simren, Magnus; Albu-Soda, A.; Aziz, Q.; Corsetti, Maura; Holvoet, L.; Tack, Jan; Rao, S.S.; van Os, J.; Quetglas, E.G.; Drossman, D.A.; Masclee, A.A.M.

Abstract

BACKGROUND: End-of-day questionnaires, which are considered the gold standard for assessing abdominal pain and other gastrointestinal (GI) symptoms in irritable bowel syndrome (IBS), are influenced by recall and ecological bias. The Experience Sampling Method (ESM) is characterized by random and repeated assessments in the natural state and environment of a subject, and herewith overcomes these limitations. This report describes the development of a patient-reported outcome measure (PROM) based on the ESM-principle, taking into account content validity and cross-cultural adaptation.
METHODS: Focus group interviews with IBS patients and expert meetings with international experts in the fields of neurogastroenterology & motility and pain were performed in order to select the items for the PROM. Forward-and-back translation and cognitive interviews were performed to adapt the instrument for the use in different countries and to assure on patients’ understanding with the final items.
KEY RESULTS: Focus group interviews revealed 42 items, categorized into five domains: physical status, defecation, mood and psychological factors, context and environment, and nutrition and drug use. Experts reduced the number of items to 32 and cognitive interviewing after translation resulted in a few slight adjustments regarding linguistic issues, but not regarding content of the items.
CONCLUSIONS AND INFERENCES: An ESM-based PROM, suitable for momentary assessment of IBS symptom patterns was developed, taking into account content validity as well as cross-cultural adaptation. This PROM will be implemented in a specifically designed smartphone application and further validation in a multicenter setting will follow.

Citation

Vork, L., Keszthely, D., Mujagic, Z., Kruimel, J., Leue, C., Pontén, I., Törnblom, H., Simren, M., Albu-Soda, A., Aziz, Q., Corsetti, M., Holvoet, L., Tack, J., Rao, S., van Os, J., Quetglas, E., Drossman, D., & Masclee, A. (in press). Development, content validity and cross-cultural adaptation of a Patient-Reported Outcome Measure for Real-time Symptom Assessment in Irritable Bowel Syndrome. Neurogastroenterology and Motility, 30(3), Article e13244. https://doi.org/10.1111/nmo.13244

• Journal Article Type: Article
• Acceptance Date: Oct 9, 2017
• Online Publication Date: Nov 6, 2017
• Deposit Date: Oct 17, 2017
• Publicly Available Date: Nov 7, 2018
• Journal: Neurogastroenterology and Motility
• Print ISSN: 1350-1925
• Electronic ISSN: 1365-2982
• Publisher: Wiley
• Peer Reviewed: Peer Reviewed
• Volume: 30
• Issue: 3
• Article Number: e13244
• DOI: https://doi.org/10.1111/nmo.13244
• Keywords: Irritable bowel syndrome, abdominal pain, GI symptoms, experience sampling method, momentary symptom assessment
• Public URL: https://nottingham-repository.worktribe.com/output/893027
• Publisher URL: http://onlinelibrary.wiley.com/doi/10.1111/nmo.13244/abstract
• Additional Information: This is the peer reviewed version of the following article: Vork L, Keszthelyi D, Mujagic Z, et al. Development, content validity, and cross-cultural adaptation of a patient-reported outcome measure for real-time symptom assessment in irritable bowel syndrome. Neurogastroenterol Motil. 2017;e13244. https://doi.org/10.1111/nmo.13244 which has been published in final form at http://onlinelibrary.wiley.com/doi/10.1111/nmo.13244/full This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
• Contract Date: Oct 17, 2017