Treatment targets in both randomized controlled trials (RCTs) and daily practice have evolved for patients with ulcerative colitis (UC), motivated by changing regulatory requirements and efforts to alter the disease's natural history. Substantial heterogeneity in outcome definitions has been identified in UC RCTs.(1) To harmonize treatment outcomes that should be reported, we proposed the collaborative development of a core outcome set (COS).(2) A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials to facilitate reporting consistency, reduce selective reporting bias, and improve quality of evidence synthesis.(3).
ContributorsMa, C. Athayde, J. Davies, S. C. Parker, C. E. Nguyen, T. M. Khanna, R. Feagan, B. G. Jairath, V.
Disease Category: Gastroenterology
Disease Name: Pouchitis
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Study investigators
- Systematic review of outcome measures/measurement instruments
- Systematic review
MEDLINE, Embase, and CENTRAL were searched without language restriction from inception to November 3, 2017, to identify placebo-controlled RCTs of adult (age, 18 y) UC patients after colectomy with pouch formation and compared an active drug therapy with placebo for the prevention, induction treatment, or maintenance treatment of pouchitis. The search strategy has been published previously5 and included terms to capture trial randomization, blinding, UC, and pouchitis. Screening and data extraction were performed independently and in duplicate by 2 reviewers (J.A. and S.C.D.). Discrepancies were adjudicated by a third reviewer (C.E.P. or C.M.).