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The Patient - Patient-Centered Outcomes Research

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01-12-2014 | Review Article

Measuring the Symptoms of Pediatric Constipation and Irritable Bowel Syndrome with Constipation: Expert Commentary and Literature Review

Authors: Robert A. Arbuckle, Robyn T. Carson, Linda Abetz-Webb, Jeffrey Hyams, Carlo Di Lorenzo, Barbara E. Lewis, Elizabeth Gargon, Caroline Kurtz, Steven J. Shiff, Jeffrey M. Johnston

Published in: The Patient - Patient-Centered Outcomes Research | Issue 4/2014

Abstract

Background

Symptom measurement in pediatric chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) trials requires appropriately developed clinical outcome assessments (COAs).

Methods

Literature was reviewed to identify symptom COAs meeting regulatory standards. Searches were conducted in Pubmed/Medline, EMBASE, and PsychINFO. Title/abstracts were reviewed to identify qualitative studies and those using COAs to measure pediatric CIC/IBS symptoms. Pediatric functional gastrointestinal experts provided input on relevant symptom-concepts to measure.

Results

Review of 1,105 abstracts identified 1 relevant qualitative article and 113 articles including COAs. Symptoms most frequently measured in CIC studies were frequency of bowel movements, fecal incontinence/encopresis, abdominal pain, stool consistency, and painful defecation. Symptoms most frequently measured in IBS were abdominal pain, abdominal distention/bloating, stool consistency, frequency of bowel movements, and gas. Evidence of development/validity of COAs was limited. Expert feedback was broadly consistent with the literature.

Conclusion

Findings demonstrate consistency in the literature on key CIC/IBS symptoms to measure in pediatric trials, but existing COAs do not meet regulatory standards.

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Title: Measuring the Symptoms of Pediatric Constipation and Irritable Bowel Syndrome with Constipation: Expert Commentary and Literature Review
Authors: Robert A. Arbuckle
Robyn T. Carson
Linda Abetz-Webb
Jeffrey Hyams
Carlo Di Lorenzo
Barbara E. Lewis
Elizabeth Gargon
Caroline Kurtz
Steven J. Shiff
Jeffrey M. Johnston
Publication date: 01-12-2014
Publisher: Springer International Publishing
Published in: The Patient - Patient-Centered Outcomes Research / Issue 4/2014
Print ISSN: 1178-1653
Electronic ISSN: 1178-1661
DOI: https://doi.org/10.1007/s40271-014-0070-3

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