Measuring symptoms in the irritable bowel syndrome: Development of a framework for clinical trials

B. M R Spiegel, R. Bolus, N. Agarwal, G. Sayuk, L. A. Harris, S. Lucak, E. Esrailian, W. D. Chey, A. Lembo, H. Karsan, K. Tillisch, J. Talley, L. Chang

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

There is uncertainty about how to measure patient-reported outcomes (PROs) in IBS. The Food and Drug Administration (FDA) emphasizes that PROs must be couched in a conceptual framework, yet existing IBS PROs were not based on such a framework. Aim To perform qualitative analyses to inform a new conceptual framework for IBS symptoms. Methods Following FDA guidance, we searched the literature for extant IBS questionnaires. We then performed interviews in IBS patients to learn about the illness experience in their own words. We cultivated vocabulary to inform a conceptual framework depicted with domains, sub-domains, and item categories, per FDA guidance. Results We identified 13 questionnaires with items encompassing 18 symptoms. We recruited 123 IBS patients for cognitive interviews. Major themes included: pain and discomfort are different-asking about discomfort is nonspecific and should be avoided in future PROs; bowel urgency is multifaceted-PROs should measure bowel immediacy, controllability, and predictability; and PROs should divide bloating into how it feels vs. how it looks. Symptom experience may be determined by 35-item categories within five domains: (i) pain; (ii) gas/bloat; (iii) diarrhoea; (iv) constipation; and (v) extraintestinal symptoms. Conclusions We applied FDA guidance to develop a framework that can serve as the foundation for developing a PRO for IBS clinical trials.

Original languageEnglish (US)
Pages (from-to)1275-1291
Number of pages17
JournalAlimentary Pharmacology and Therapeutics
Volume32
Issue number10
DOIs
StatePublished - Nov 2010

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Irritable Bowel Syndrome
Clinical Trials
United States Food and Drug Administration
Interviews
Pain
Vocabulary
Constipation
Patient Reported Outcome Measures
Uncertainty
Diarrhea
Gases

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Spiegel, B. M. R., Bolus, R., Agarwal, N., Sayuk, G., Harris, L. A., Lucak, S., ... Chang, L. (2010). Measuring symptoms in the irritable bowel syndrome: Development of a framework for clinical trials. Alimentary Pharmacology and Therapeutics, 32(10), 1275-1291. https://doi.org/10.1111/j.1365-2036.2010.04464.x

Measuring symptoms in the irritable bowel syndrome : Development of a framework for clinical trials. / Spiegel, B. M R; Bolus, R.; Agarwal, N.; Sayuk, G.; Harris, L. A.; Lucak, S.; Esrailian, E.; Chey, W. D.; Lembo, A.; Karsan, H.; Tillisch, K.; Talley, J.; Chang, L.

In: Alimentary Pharmacology and Therapeutics, Vol. 32, No. 10, 11.2010, p. 1275-1291.

Research output: Contribution to journalArticle

Spiegel, BMR, Bolus, R, Agarwal, N, Sayuk, G, Harris, LA, Lucak, S, Esrailian, E, Chey, WD, Lembo, A, Karsan, H, Tillisch, K, Talley, J & Chang, L 2010, 'Measuring symptoms in the irritable bowel syndrome: Development of a framework for clinical trials', Alimentary Pharmacology and Therapeutics, vol. 32, no. 10, pp. 1275-1291. https://doi.org/10.1111/j.1365-2036.2010.04464.x
Spiegel, B. M R ; Bolus, R. ; Agarwal, N. ; Sayuk, G. ; Harris, L. A. ; Lucak, S. ; Esrailian, E. ; Chey, W. D. ; Lembo, A. ; Karsan, H. ; Tillisch, K. ; Talley, J. ; Chang, L. / Measuring symptoms in the irritable bowel syndrome : Development of a framework for clinical trials. In: Alimentary Pharmacology and Therapeutics. 2010 ; Vol. 32, No. 10. pp. 1275-1291.
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