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About

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. This working team conducted a systematic review and meta-analysis of the psychometric and performance characteristics of primary endpoints used in large multi-center therapeutic trials for irritable bowel syndrome using pharmacological approaches.

Publications

Psychometric Evaluation of Patient-Reported Outcomes in Irritable Bowel Syndrome Randomized Controlled Trials: A Rome Foundation Report
Spiegel, B., Camilleri, M., Bolus, R., Andresen, V., Chey, W. D., Fehnel, S. Mangel, A., Talley, N., Whitehead, W. E.
Gastroenterology, 137(6), 1944-1953.e1943

Abstract

Members of the Working Team

Chair

Michael  Camilleri, MD
Mayo Clinic
Rochester, Minnesota

Viola Andresen, MD
Hamburg, Germany

Roger Bolus, PhD
Department of Medicine, David Geffen School of Medicine at UCLA
UCLA/VA Center for Outcomes Research and Education (CORE)
Los Angeles, California

William Chey, MD, AGAF, FACG
University of Michigan
Ann Arbor, Michigan, USA

Sheri Fehnel, PhD
RTI Health Solutions
Research Triangle Park, North Carolina, USA

Allen Mangel, MD, PhD
RTI Health Solutions
Research Triangle Park, North Carolina, USA

Brennan Spiegel, MD, MSHS
Department of Medicine
VA Greater Los Angeles Healthcare System
Department of Medicine, David Geffen School of Medicine at UCLA
UCLA/VA Center for Outcomes Research and Education (CORE)
Los Angeles, California

Nicholas Talley, MD, PhD
Mayo Clinic
Jacksonville, Florida

William Whitehead, PhD
University of North Carolina
Chapel Hill, North Carolina, USA

 

 

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