title: Measuring the symptoms of pediatric constipation and irritable bowel syndrome with constipation: expert commentary and literature review.
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.
  
  
  CONCLUSIONS
  Findings demonstrate consistency in the literature on key CIC/IBS symptoms to measure in pediatric trials, but existing COAs do not meet regulatory standards.
authors: Adelphi Values Ltd, Bollington, Cheshire, SK10 5JB, UK, rob.arbuckle@adelphivalues.com.
authors: Robert A
authors: RA
authors: Arbuckle
authors: Robyn T
authors: RT
authors: Carson
authors: Linda
authors: L
authors: Abetz-Webb
authors: Jeffrey
authors: J
authors: Hyams
authors: Carlo
authors: C
authors: Di Lorenzo
authors: Barbara E
authors: BE
authors: Lewis
authors: Elizabeth
authors: E
authors: Gargon
authors: Caroline
authors: C
authors: Kurtz
authors: Steven J
authors: SJ
authors: Shiff
authors: Jeffrey M
authors: JM
authors: Johnston
mesh_terms: D015746:Abdominal Pain; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D003248:Constipation / Q000628:therapy*; D006801:Humans; D007223:Infant; D043183:Irritable Bowel Syndrome / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010372:Pediatrics; D012720:Severity of Illness Index; D016896:Treatment Outcome