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.
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.
Authors: Stefan Müller-Lissner; Gary Koch; Nicholas J Talley; Douglas Drossman; Peter Rueegg; Cornelia Dunger-Baldauf; Martin Lefkowitz Journal: J Clin Epidemiol Date: 2003-04 Impact factor: 6.437
Authors: G Di Nardo; G Barbara; S Cucchiara; C Cremon; R J Shulman; S Isoldi; L Zecchi; L Drago; S Oliva; R Saulle; M R Barbaro; L Stronati Journal: Neurogastroenterol Motil Date: 2013-11-07 Impact factor: 3.598
Authors: K Pokusaeva; C Johnson; B Luk; G Uribe; Y Fu; N Oezguen; R K Matsunami; M Lugo; A Major; Y Mori-Akiyama; E B Hollister; S M Dann; X Z Shi; D A Engler; T Savidge; J Versalovic Journal: Neurogastroenterol Motil Date: 2016-07-25 Impact factor: 3.598