Core Outcome Measures in Effectiveness Trials

CHronic Rhinosinusitis Outcome MEasures (CHROME) – developing a core outcome set for trials of interventions in chronic rhinosinusitis

General Information

Abstract:
Statement of problem: Evaluating the effectiveness of treatments in chronic rhinosinusitis (CRS) have been limited by both a
paucity of high quality randomised trials, and the heterogeneity of outcomes in those that have been reported.
Core outcome sets (COS) are an agreed, standardized set of outcomes that should be measured and reported by future trials as a minimum and will facilitate future meta-analysis of trial results in systematic reviews (SRs). We set out to develop a core outcome set for interventions for adults with CRS.

Method(s) of study: A long-list of potential outcomes was identified by a steering group utilising a literature review, thematic
analysis of a wide range of stakeholders’ views and systematic analysis of currently available Patient Reported Outcome Measures
(PROMs). A subsequent e-Delphi process allowed 110 patients and healthcare practitioners to individually rate the outcomes in
terms of importance, on a Likert scale.

Main results: After 2 rounds of the iterative Delphi process, the 54 initial outcomes were distilled down to a final core-outcome
set of 15 items, over 4 domains.

Principal conclusions: The authors hope inclusion of these core outcomes in future trials will increase the value of research on
interventions for CRS in adults. It was felt important to make recommendations regarding how these outcomes should be measured, although additional work is now required to further develop and revalidate existing outcome measures.

Authors:
Claire Hopkins1, Roland Hettige2, Archana Soni-Jaiswal3, Raj Lakhani4, Sean Carrie5, Anders Cervin6, Richard Douglas7, Wytske Fokkens8, Richard Harvey9, Peter Hellings10, Andreas Leunig11, Valerie Lund12, Carl Philpott13, Tim Smith14, De-Yun Wang15, Luke Rudmik16

Publication

Journal:
Rhinology
Volume:
56
Issue:
3
Pages:
-
Year:
2018
DOI:
Further Study Information

Date:
September 2015 - July 2016
Funding source(s):
British Rhinologic Society

Health Area

Disease Category
Ear, nose, & throat

Disease Name
Rhinosinusitis
Sinusitis (chronic rhinosinusitis)

Target Population

Age Range
16 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Literature review
Systematic review

Stakeholders Involved

Clinical experts
Consumers (patients)
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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.