RT Journal Article
SR Electronic
T1 Establishing an Updated Core Domain Set for Studies in Juvenile Idiopathic Arthritis: A Report from the OMERACT 2018 JIA Workshop
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.181088
DO 10.3899/jrheum.181088
A1 Esi M.  Morgan
A1 Jane E.  Munro
A1 Jennifer Horonjeff
A1 Ben Horgan
A1 Beverley Shea
A1 Brian M.  Feldman
A1 Hayyah Clairman
A1 Clifton O.  Bingham III
A1 Susan Thornhill
A1 Vibeke Strand
A1 Alessandra Alongi
A1 Silvia Magni-Manzoni
A1 Marion A.J.  van Rossum
A1 Richard Vesely
A1 Jelena Vojinovic
A1 Hermine I.  Brunner
A1 Julia G.  Harris
A1 Daniel B.  Horton
A1 Daniel J.  Lovell
A1 Melissa Mannion
A1 Homaira Rahimi
A1 Angelo Ravelli
A1 Sarah Ringold
A1 Nicolino Ruperto
A1 M. Suzanne  Schrandt
A1 Susan Shenoi
A1 Natalie J.  Shiff
A1 Karine Toupin-April
A1 Nikolay Tzaribachev
A1 Pamela Weiss
A1 Alessandro Consolaro
YR 2019
UL http://www.jrheum.org/content/early/2019/04/09/jrheum.181088.abstract
AB Objective The current Juvenile Idiopathic Arthritis (JIA) Core Set used in randomized controlled trials (RCT) and longitudinal observational studies (LOS) was developed without the input of patients/parents. At the Outcome Measures in Rheumatology (OMERACT) 2016, a special interest group voted to reconsider the core set, incorporating broader input. We describe subsequent work culminating in an OMERACT 2018 plenary and consensus voting. Methods Candidate domains were identified through literature review, qualitative surveys, and online discussion boards (ODB) held with patients with JIA and parents in Australia, Italy, and the United States. A Delphi process with parents, patients, healthcare providers, researchers, and regulators served to edit the domain list and prioritize candidate domains. After the presentation of results, OMERACT workshop participants voted, with consensus set at > 70%. Results Participants in ODB were 53 patients with JIA (ages 15–24 yrs) and 55 parents. Three rounds of Delphi considering 27 domains were completed by 190 (response rate 85%), 201 (84%), and 182 (77%) people, respectively, from 50 countries. There was discordance noted between domains prioritized by patients/parents compared to others. OMERACT conference voting approved domains for JIA RCT and LOS with 83% endorsement. Mandatory domains are pain, joint inflammatory signs, activity limitation/physical function, patient’s perception of disease activity (overall well-being), and adverse events. Mandatory in specific circumstances: inflammation/other features relevant to specific JIA categories. Conclusion Following the OMERACT methodology, we developed an updated JIA Core Domain Set. Next steps are to identify and systematically evaluate best outcome measures for these domains.