Core Outcome Measures in Effectiveness Trials

Identifying Outcomes in Clinical Trials of Pouchitis for the Development of a Core Outcome Set

General Information

Abstract:
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).

Authors:
Ma, C. Athayde, J. Davies, S. C. Parker, C. E. Nguyen, T. M. Khanna, R. Feagan, B. G. Jairath, V.

Publication

Journal:
Clin Gastroenterol Hepatol
Volume:
Issue:
Pages:
-
Year:
2018
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Gastroenterology

Disease Name
Pouchitis

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

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.).


Stakeholders Involved

Study investigators

Study Type

Systematic review of outcome measures/measurement instruments

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.