Development, content validity, and cross-cultural adaptation of a patient-reported outcome measure for real-time symptom assessment in irritable bowel syndrome

L. Vork, D. Keszthelyi, Z. Mujagic, J. W. Kruimel, C. Leue, I. Pontén, H. Törnblom, M. Simrén, A. Albu-Soda, Q. Aziz, M. Corsetti, L. Holvoet, J. Tack, Satish Sanku Chander Rao, J. van Os, E. G. Quetglas, D. A. Drossman, A. A.M. Masclee

Research output: Contribution to journalArticle

5 Citations (Scopus)

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 and cross-cultural adaptation. This PROM will be implemented in a specifically designed smartphone application and further validation in a multicenter setting will follow.

Original languageEnglish (US)
Article numbere13244
JournalNeurogastroenterology and Motility
Volume30
Issue number3
DOIs
StatePublished - Mar 1 2018

Fingerprint

Symptom Assessment
Irritable Bowel Syndrome
Interviews
Focus Groups
Social Adjustment
Defecation
Linguistics
Abdominal Pain
Psychology
Pain
Patient Reported Outcome Measures
Pharmaceutical Preparations
Ecological Momentary Assessment

Keywords

  • GI symptoms
  • abdominal pain
  • experience sampling method
  • irritable bowel syndrome
  • momentary symptom assessment

ASJC Scopus subject areas

  • Physiology
  • Endocrine and Autonomic Systems
  • Gastroenterology

Cite this

Development, content validity, and cross-cultural adaptation of a patient-reported outcome measure for real-time symptom assessment in irritable bowel syndrome. / Vork, L.; Keszthelyi, D.; Mujagic, Z.; Kruimel, J. W.; Leue, C.; Pontén, I.; Törnblom, H.; Simrén, M.; Albu-Soda, A.; Aziz, Q.; Corsetti, M.; Holvoet, L.; Tack, J.; Rao, Satish Sanku Chander; van Os, J.; Quetglas, E. G.; Drossman, D. A.; Masclee, A. A.M.

In: Neurogastroenterology and Motility, Vol. 30, No. 3, e13244, 01.03.2018.

Research output: Contribution to journalArticle

Vork, L, Keszthelyi, D, Mujagic, Z, Kruimel, JW, Leue, C, Pontén, I, Törnblom, H, Simrén, M, Albu-Soda, A, Aziz, Q, Corsetti, M, Holvoet, L, Tack, J, Rao, SSC, van Os, J, Quetglas, EG, Drossman, DA & Masclee, AAM 2018, '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, vol. 30, no. 3, e13244. https://doi.org/10.1111/nmo.13244
Vork, L. ; Keszthelyi, D. ; Mujagic, Z. ; Kruimel, J. W. ; Leue, C. ; Pontén, I. ; Törnblom, H. ; Simrén, M. ; Albu-Soda, A. ; Aziz, Q. ; Corsetti, M. ; Holvoet, L. ; Tack, J. ; Rao, Satish Sanku Chander ; van Os, J. ; Quetglas, E. G. ; Drossman, D. A. ; Masclee, A. A.M. / Development, content validity, and cross-cultural adaptation of a patient-reported outcome measure for real-time symptom assessment in irritable bowel syndrome. In: Neurogastroenterology and Motility. 2018 ; Vol. 30, No. 3.
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AU - Vork, L.

AU - Keszthelyi, D.

AU - Mujagic, Z.

AU - Kruimel, J. W.

AU - Leue, C.

AU - Pontén, I.

AU - Törnblom, H.

AU - Simrén, M.

AU - Albu-Soda, A.

AU - Aziz, Q.

AU - Corsetti, M.

AU - Holvoet, L.

AU - Tack, J.

AU - Rao, Satish Sanku Chander

AU - van Os, J.

AU - Quetglas, E. G.

AU - Drossman, D. A.

AU - Masclee, A. A.M.

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N2 - 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 and cross-cultural adaptation. This PROM will be implemented in a specifically designed smartphone application and further validation in a multicenter setting will follow.

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