Working Teams and Committees

Rome Foundation Committee on Outcomes/Endpoints in IBS

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 has 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 is 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 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:

1. global assessment of relief
2. adequate or satisfactory relief of IBS pain or discomfort
3. integrative symptom severity scores

The analyses will answer the following questions:

1. Are global response criteria, including adequate relief and satisfactory relief, superior to scales measuring symptom reduction for discriminating active treatment from placebo (i.e., which endpoints show the largest effect sizes)?
2. What are the placebo rates for global response criteria relative to symptom reduction criteria?
3. Are response rates associated with global response criteria confounded with baseline symptom severity such that patients with more severe IBS show the smallest global response rates but the largest symptom reductions compared to patients with mild symptom severity at baseline?

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

Committee Composition:

Michael Camilleri, MD, Chair
Mayo Medical Center
Rochester, MN, USA

Viola Andresen, MD
Israelitic Hospital
Hamburg, Germany

Hashem B. el-Serag, MD, MPH
Baylor College of Medicine
Houston, TX, USA

Allen Mangel, MD, PhD
RTI Health Solutions, RTI International
Research Triangle Park, NC, USA

Brennan M. R. Spiegel, MD, MSHS
VA Greater Los Angeles Healthcare System
David Geffen School of Medicine at UCLA
Los Angeles, CA, USA

William Whitehead, PhD
Co-Director of the Center for Functional GI & Motility Disorders
University of NC at Chapel Hill
Chapel Hill, NC, USA

 

William D. Chey, MD, AGAF, F ACG
University of Michigan
Ann Arbor, MI, USA

Sheri Fehnel, PhD
RTI Health Solutions, RTI International
Research Triangle Park, NC, USA

Emeran A. Mayer, MD
David Geffen School of Medicine
at UCLA
Center for Neurovisceral Sciences & Women's Health
UCLA, Los Angeles, CA, USA

Nicholas J. Talley, MD, PhD
Mayo Clinic
Jacksonville, FL, USA