Core Outcome Measures in Effectiveness Trials

Defining a Core Outcome Set for Efficacy Trials in Adult Patients with Posterior Segment-Involving Uveitis

General Information

Summary:
Aims:
To define a consensus-based COS that has value to all stakeholders for use in all clinical trials of posterior-segment involving uveitis.
Previous work:
There is currently no agreed COS for uveitis. In 2005, Jabs et al published the results of the First International Workshop for the Standardization of Uveitis Nomenclature (SUN) which sought to ‘begin a process of standardizing the methods for reporting clinical data in the field of uveitis’. Whilst this provided some comments on the use of outcomes - notably recommending a preferred scoring system for key parameters such as visual acuity and vitreous haze, the group fell short of defining a COS for use in all trials. Additionally it should be noted that the group was entirely composed of expert clinicians in the field of uveitis, with no representation from patients, carers or policy makers. Furthermore our study of the outcome measures in registered trials of uveitis show that even the limited recommendations of the SUN group have not been generally adopted. Our pilot data underlines the degree of outcome heterogeneity present within both published and ongoing uveitis studies, and the pressing need for a COS to be defined.
Plan of investigation:
1) Identification of potential outcomes to be included in the core outcome set through key respondent focus groups and interviews
2) Systematic review of efficacy trials in posterior segment-involving uveitis to identify the outcome measures actually used
3) Development of a comprehensive list of potential outcomes for inclusion in the ‘core set’ (based on (1) and (2))
4) Delphi methodology will be used to reduce the range of potential outcomes to a core set.
5) Stakeholder Meeting to discuss the Delphi results and ratify the final outcome set.
Potential impact:
There is currently no consensus as to what outcome measures should be collected in uveitis trials. The development of a core outcome set for uveitis would provide for the first time a standardized set of outcome measures that has value to all stake-holders and can be used in all efficacy trials in uveitis. This has the potential to profoundly enhance evidence synthesis by ensuring consistency in the outcomes measured, reducing outcome-reporting bias as the whole COS is reported and improving the statistical power of any meta-analysis as more studies can be included.

Link to protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2294-8

Contributors:
Prof Alastair Denniston (University of Birmingham and University Hospitals Birmingham NHSFT) – Principal Investigator
Prof Melanie Calvert (University of Birmingham) – Co-Investigator
Prof Philip Murray (University of Birmingham) – Co-Investigator
Dr David Moore (University of Birmingham) – Co-Investigator
Dr Jonathan Mathers (University of Birmingham) – Co-Investigator
Prof Jane Blazeby (University of Bristol) - Collaborator
Dr Jennifer Burr (University of St Andrew's and BRC Ophthalmology, University College London) - Collaborator
Mr Mohammad Tallouzi (University of Birmingham) – Research Associate

Further Study Information

Current Stage:
Ongoing
Date:
August 2015 - August 2019
Funding source(s):
National Institute of Health Research (NIHR, UK)

Health Area

Disease Category
Eyes & vision

Disease Name
Uveitis

Target Population

Age Range
16 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

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

1) Key respondent focus groups and interviews of stakeholders to identify potential outcomes to be included in the core outcome
2) Systematic review of efficacy trials in posterior segment-involving uveitis to identify the outcome measures actually used
3) Development of a comprehensive list of potential outcomes for inclusion in the ‘core set’ (based on (1) and (2))
3) Delphi methodology to reduce the range of potential outcomes to a core set.
4) Stakeholder Meeting to discuss the Delphi results and ratify the final outcome set.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Governmental agencies
Policy makers

Study Type

COS for clinical trials or clinical research

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