Development of a Core Outcome Set for Clinical Trials in Non-infectious Uveitis of the Posterior Segment

PurposeTo develop an agreed upon set of outcomes known as a “core outcome set” (COS) for noninfectious uveitis the posterior segment (NIU-PS) clinical trials.DesignMixed-methods study design comprising systematic review and qualitative followed by 2-round Delphi exercise face-to-face consensus meeting.ParticipantsKey stakeholders including patients diagnosed with NIU-PS, their caregivers, healthcare professionals involved in decision-making ophthalmologists, nurse practitioners, policymakers/commissioners.MethodsA long list was developed based on results (1) trials NIU-PS (2) key focus groups interviews. The used to generate rating importance 9-point Likert scale. proportion respondents each item calculated, leading recommendations “include,” “exclude,” or “for discussion” that were taken meeting at which they final COS.Main Outcome MeasureItems recommended inclusion COS NIU-PS.ResultsA total 57 grouped 11 domains presented evaluation exercise, resulting 9 directly qualifying 15 being carried forward meeting, 7 inclusion. contained 16 organized into 4 visual function, health-related quality life, treatment side effects, disease control.ConclusionsThis builds international work across community our research construct world’s first NIU-PS. provides represent priorities minimum use all future trials. Adoption this can improve value reduce noninformative research. Some identified do not yet have internationally methods measurement should be subject development. To Mixed-methods meeting. Key policymakers/commissioners. A COS. Items control. This