FINESSE study: core outcome set vitreoretinal surgery
Research type
Research Study
Full title
Development of a new standard set of core outcomes to improve health outcomes for patients receiving vitreoretinal surgery: The Finesse Study.
IRAS ID
322992
Contact name
Maria Teresa Sandinha
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Epiretinal membrane (ERM) or macula pucker are scar tissues that grow as a result of ageing on the surface of the central part of the retina called the macula. They are one of the four most prevalent causes of identifiable visual impairment in the UK and present in about a quarter of all people over 65 years of age.
Surgery, commonly a vitrectomy, is extremely effective at restoring vision, but clinical outcomes can be unpredictable and the surgery itself is not without risk.
This research will bring together UK research interested surgeons, patients, community optometrists and orthoptists managing these patients and UK based clinical trialists to meet face-to-face and on a virtual platform to reach consensus on what outcomes are important to measure. The questions the study aims to answer are:
1) What outcomes are important to patients with macula pucker and health care practitioners (HCPs) managing their care?
2) Do existing validated patient-reported outcome measures (PROMs) adequately capture the patient-reported outcomes identified?
The project will involve two work packages (WPs) and will apply mixed-methods, modified Delphi process (WP1) and qualitative methodology utilising cognitive interviewing and Focus Groups (WP2). An online modified Delphi technique will be used to identify and develop a core outcome set (COS). A two-stage process involving qualitative methodology (cognitive interviews and focus groups) will be used to gain greater insight into the relevance of the validated PROMs to measure the patients outcomes included in the COS and specific items on the questionnaires.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
23/NE/0207
Date of REC Opinion
7 Nov 2023
REC opinion
Favourable Opinion