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

作者：Arbuckle Robert A^*; Carson Robyn T; Abetz Webb Linda; Hyams Jeffrey; Di Lorenzo Carlo; Lewis Barbara E; Gargon Elizabeth; Kurtz Caroline; Shiff Steven J; Johnston Jeffrey M

来源：Patient-Patient Centered Outcomes Research, 2014, 7(4): 343-364.

DOI：10.1007/s40271-014-0070-3

Symptom measurement in pediatric chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) trials requires appropriately developed clinical outcome assessments (COAs). %26lt;br%26gt;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. %26lt;br%26gt;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. %26lt;br%26gt;Findings demonstrate consistency in the literature on key CIC/IBS symptoms to measure in pediatric trials, but existing COAs do not meet regulatory standards.

• 出版日期2014-12