Developing a Core Outcome Set for trials of intervention in CRS
Research type
Research Study
Full title
Developing a core outcome set for trials of interventions in chronic rhinosinusitis
IRAS ID
200646
Contact name
Claire Hopkins
Contact email
Sponsor organisation
Guys and St Thomas's NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Core outcome sets (COS) are an agreed, standardised set of outcomes that should ideally be measured and reported by clinical trails. They facilitate homogeneity of data across multiple trials, allowing meaningful comparisons about treatments to be made and high standard meta-analysis to be performed. Thus, decreasing research waste and improving quality of evidence based patient care.
This project aims to develop a core outcome set for chronic rhinosinusitis (CRS). It will employ the clear methodology outlined by the COMET initiative. A long list of outcomes will be drawn from a systematic review of the all published randomised control trials looking at treatment of patients with CRS. This long-list will be considered and ranked by healthcare practitioners (HCPs) and patients using an online Delphi technique.
It is essential that treatment outcomes reflect the needs of the patients receiving the treatment. A focus group of patients will be invited to participate in the development of the COS. A group of ten patients will be drawn from across the UK and invited to join us for a one-day focus group. They will provide feedback on the long-list of outcomes obtained from the systematic review and agree definitions of these outcomes from a patient perspective for use in the Delphi Process.
A second group of up to 50 adult patients with CRS will be invited to participate in the online Delphi process and asked to rank the outcomes presented according to importance. The Delphi is repeated over 3 rounds in order to reach consensus.The process will conclude with a face-to-face consensus meeting, to which a patient representative will be invited to attend.
REC name
West of Scotland REC 3
REC reference
16/WS/0097
Date of REC Opinion
26 May 2016
REC opinion
Further Information Favourable Opinion