Development, content validity and cross-cultural adaptation of a Patient-Reported Outcome Measure for Real-time Symptom Assessment in Irritable Bowel Syndrome
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 rep...
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| Format: | Article |
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Wiley
2017
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| Online Access: | https://eprints.nottingham.ac.uk/47322/ |
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| author | Vork, L. Keszthely, D. Mujagic, Z. Kruimel, J.W. Leue, C. Pontén, I. Törnblom, 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. |
| author_facet | Vork, L. Keszthely, D. Mujagic, Z. Kruimel, J.W. Leue, C. Pontén, I. Törnblom, 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. |
| author_sort | Vork, L. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T20:05:07Z |
| format | Article |
| id | nottingham-47322 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:05:07Z |
| publishDate | 2017 |
| publisher | Wiley |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-473222020-05-04T19:16:21Z https://eprints.nottingham.ac.uk/47322/ 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. Pontén, I. Törnblom, 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. 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. Wiley 2017-11-06 Article PeerReviewed Vork, L., Keszthely, D., Mujagic, Z., Kruimel, J.W., Leue, C., Pontén, I., Törnblom, 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. and Masclee, A.A.M. (2017) 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). e13244/1-e13244/10. ISSN 1365-2982 Irritable bowel syndrome abdominal pain GI symptoms experience sampling method momentary symptom assessment http://onlinelibrary.wiley.com/doi/10.1111/nmo.13244/abstract doi:10.1111/nmo.13244 doi:10.1111/nmo.13244 |
| spellingShingle | Irritable bowel syndrome abdominal pain GI symptoms experience sampling method momentary symptom assessment Vork, L. Keszthely, D. Mujagic, Z. Kruimel, J.W. Leue, C. Pontén, I. Törnblom, 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. Development, content validity and cross-cultural adaptation of a Patient-Reported Outcome Measure for Real-time Symptom Assessment in Irritable Bowel Syndrome |
| title | Development, content validity and cross-cultural adaptation of a Patient-Reported Outcome Measure for Real-time Symptom Assessment in Irritable Bowel Syndrome |
| title_full | Development, content validity and cross-cultural adaptation of a Patient-Reported Outcome Measure for Real-time Symptom Assessment in Irritable Bowel Syndrome |
| title_fullStr | Development, content validity and cross-cultural adaptation of a Patient-Reported Outcome Measure for Real-time Symptom Assessment in Irritable Bowel Syndrome |
| title_full_unstemmed | Development, content validity and cross-cultural adaptation of a Patient-Reported Outcome Measure for Real-time Symptom Assessment in Irritable Bowel Syndrome |
| title_short | Development, content validity and cross-cultural adaptation of a Patient-Reported Outcome Measure for Real-time Symptom Assessment in Irritable Bowel Syndrome |
| title_sort | development, content validity and cross-cultural adaptation of a patient-reported outcome measure for real-time symptom assessment in irritable bowel syndrome |
| topic | Irritable bowel syndrome abdominal pain GI symptoms experience sampling method momentary symptom assessment |
| url | https://eprints.nottingham.ac.uk/47322/ https://eprints.nottingham.ac.uk/47322/ https://eprints.nottingham.ac.uk/47322/ |