AI Article Synopsis
- The study focuses on the need for effective clinical outcome assessments (COAs) in trials regarding pediatric chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C).
- A literature review including 1,105 abstracts identified a limited number of relevant studies and COAs that measure key symptoms such as bowel movement frequency, abdominal pain, and stool consistency in children.
- Although there is general agreement among experts on important symptoms to measure, the existing COAs fall short of regulatory standards for proper evaluation in clinical trials.
Article 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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Source |
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| http://dx.doi.org/10.1007/s40271-014-0070-3 | DOI Listing |
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