The COSUMO study- Defining a Core Outcome Set in patients with Uveitis
Research type
Research Study
Full title
Defining a Core Outcome Set in patients with Uveitis both with and without Uveitic Macular Oedema (COSUMO).
IRAS ID
221333
Contact name
Mohammad Tallouzi
Contact email
Sponsor organisation
Sandwell and West Birmingham NHS Trust
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
Evidence suggests that little attention has been given to the selection of outcomes that can be measured in clinical trials. This issue can be approached through the development and use of an agreed standardised set of outcomes, known as a core outcome set (COS), that should be measured and reported as a minimum in all trials of a specific clinical area.
The use of a COS would increase consistency in clinical trials, improve their quality and help ensure the relevance of outcomes to stakeholders i.e. patients, carers, health professionals and those involved in health policy decisions.
In this study, we wish to identify a COS for adult patients with inflammation inside their eye(s) known as uveitis, specifically those forms of uveitis affecting the back of the eye that tend to be the most sight-threatening.
We will include those who have the serious complication of macular oedema (fluid leakage into the central light-sensitive layer at the back of the eye). When we see uveitis patients in the Eye Clinic we assess their vision on the eye chart and measure how inflamed the eye is by examining it and by doing scans of the back of the eye.What we cannot assess is the effect of the disease on a person’s everyday life. It is important that the way we measure uveitis outcomes includes those aspects of the disease that really matter to the patient, i.e. how do the patients themselves know whether they are getting better or worse over time? Without this happening, it could mean that doctors and other health professionals may underestimate how severely the uveitis is affecting somebody. This study will result in a consensus (agreement) based COS that has value to all stakeholders and would be suitable for all clinical trials of these forms of uveitis.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
17/WM/0111
Date of REC Opinion
25 Apr 2017
REC opinion
Further Information Favourable Opinion