Psychometric Evaluation of Patient-Reported Outcomes in Irritable Bowel Syndrome Randomized Controlled Trials: A Rome Foundation Report

Brennan Spiegel, Michael Camilleri, Roger Bolus, Viola Andresen, William D. Chey, Sheri Fehnel, Allen Mangel, Nicholas J. Talley, William E. Whitehead

Research output: Contribution to journalArticle

52 Scopus citations

Abstract

Background & Aims: There is debate about how best to measure patient-reported outcomes (PROs) in irritable bowel syndrome (IBS). We pooled data to measure the psychometric properties of IBS end points, including binary responses (eg, "adequate relief") and 50% improvement in symptom severity. Methods: We pooled data from 12 IBS drug trials involving 10,066 participants. We tested the properties of binary response and 50% improvement end points, including the impact of baseline severity on performance, and measured construct validity using clinical anchors. Results: There were 9044 evaluable subjects (age, 44 years; 85% female; 58% IBS constipation-prominent [IBS-C]; 31% IBS diarrhea-prominent [IBS-D]). Using the binary end point, the proportion responding in the mild, moderate, and severe groups was 42%, 40%, and 38%, respectively (P = .0008). There was no effect of baseline severity on binary response (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.99-1.0; P = .07). The proportions reaching 50% improvement in pain were 45%, 41%, and 41%, respectively; there was a small, yet significant, impact of baseline severity (OR, 1.04; 95% CI, 1.03-1.05; P < .0001) that did not meet clinical relevance criteria. Both end points revealed strong construct validity and detected "minimally clinically important differences" in symptoms. Both provided better discriminant spread in IBS-D than IBS-C. Conclusions: Both the traditional binary and 50% improvement end points are equivalent in their psychometric properties. Neither is impacted by baseline severity, and both demonstrate excellent construct validity. They are optimized for the IBS-D population but also appear valid in IBS-C.

Original languageEnglish (US)
Pages (from-to)1944-1953.e3
JournalGastroenterology
Volume137
Issue number6
DOIs
StatePublished - Dec 2009

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Fingerprint Dive into the research topics of 'Psychometric Evaluation of Patient-Reported Outcomes in Irritable Bowel Syndrome Randomized Controlled Trials: A Rome Foundation Report'. Together they form a unique fingerprint.

  • Cite this

    Spiegel, B., Camilleri, M., Bolus, R., Andresen, V., Chey, W. D., Fehnel, S., Mangel, A., Talley, N. J., & Whitehead, W. E. (2009). Psychometric Evaluation of Patient-Reported Outcomes in Irritable Bowel Syndrome Randomized Controlled Trials: A Rome Foundation Report. Gastroenterology, 137(6), 1944-1953.e3. https://doi.org/10.1053/j.gastro.2009.08.047