Because of the complexity of the functional gastrointestinal disorders, it has been difficult over the years to determine which outcome measures and endpoints should be used in clinical trials of pharmaceutical agents. Some trials have used a global relief measure as a primary endpoint, while others have focused on symptom improvement.
The Rome Foundation approved an initiative for a strategic group to explore the behavior of different outcome measures and endpoints that have been used in large clinical trials for irritable bowel syndrome. This effort was consistent with the Rome III Design of Treatment Trials documents that recommend additional research to address outcomes and endpoints in the functional gastrointestinal disorders. The committee produced a report, Psychometric Evaluation of Patient-Reported Outcomes in Irritable Bowel Syndrome Randomized Controlled Trials: A Rome Foundation Report, published in Gastroenterology in 2009.
Brief Summary of Plan
To conduct a systematic review and meta-analysis of the psychometric and performance characteristics of primary endpoints used in large multicenter therapeutic trials for irritable bowel syndrome using pharmacological approaches, specifically:
- global assessment of relief
- adequate or satisfactory relief of IBS pain or discomfort
- integrative symptom severity scores
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, and William E. Whitehead.
Gastroenterology, Volume 137, Issue 6, December 2009, Pages 1944-1953.e3