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.
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
Disease Category: Ear, nose, & throat
Disease Name: Rhinosinusitis , Sinusitis (chronic rhinosinusitis)
Age Range: 16 - 100
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Focus group(s)
- Systematic review
- Literature review