Proposed outcome measures for prospective clinical trials in juvenile idiopathic arthritis-associated uveitis: A consensus effort from the multinational interdisciplinary working group for uveitis in childhood (MIWGUC)

Abstract

Objective:

To develop a set of core outcome measures for usein randomized controlled trials (RCTs) and longitudinal observational studies (LOS)in juvenile idiopathic arthritis-associated uveitis.

Methods:

Literature relating to outcome measures used in studies of uveitis in childhood and adolescence were reviewed. A set of core outcomes and domains was established using the Delphi process. These were reviewed by a representative,multinational, interdisciplinary working group. Nominal group technique consensus was reached on face and content validity of the range and content of domains. The outcomes and the appropriate instruments for uveitis trials were adapted to the age ranges of patients with JIA-associated uveitis.

Results:

Consensus was reached that data be reported at defined time points in longitudinal studies with patients stratified by prognostic markers.Visual acuity testing should be age-appropriate. Uveitis severity (measured as anterior chamber cell grade) and duration of active inflammation should be documented. Visually significant structural complications should be recorded and quantified with standard measures. Responses to treatment and corticosteroid-sparing effects of treatment should be documented. Patient-reported disease activity and age-specific uveitis-related quality of life should be reported using appropriate questionnaires.

Conclusions:

The proposed outcome measuresin JIA-associated uveitis should aid in standardization and comparison of future RCTs of treatments for this disease. The proposed outcome measures will be verified in a prospective validation study. © 2012 by the American College of Rheumatology