Establishing an updated core domain set for studies in juvenile idiopathic arthritis: a report from the OMERACT 2018 JIA Workshop

Objective The current Juvenile Idiopathic Arthritis (JIA) Core Set used in randomized controlled trials (RCTs) and longitudinal observational studies (LOS) was developed without input of patients/parents. At OMERACT 2016, a special interest groupvoted to reconsider the core set incorporating broader stakeholder 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 discussionboards ( ODBs) held with JIA patients and parents in Australia, Italy, and the USA. A Delphi process with parents, patients, health care providers, researchers and regulators served to edit the domain list and prioritize candidate domains. After presentation of results, OMERACT workshop participants voted with consensus set at > 70%. Results Participants in ODBswere 53 JIA patients (ages 15-24 years) and 55 parents. Three rounds of Delphi considering 27 domains were completed by 190 (response rate 85%), 201 (84%) and 182 (77%) stakeholders, respectively, from 50 countries. There was discordance noted between domains prioritized by patient/parents compared to other stakeholders. OMERACT conference voting approved domains for JIA RCTs and LOS with 83% endorsement. Mandatory domains are: pain, joint inflammatory signs, activity limitation/physical function, patient perception of disease activity (overall well-being), and adverse events. Mandatory in specific circumstances: Inflammation/other features relevant to specific JIA categories. Conclusion Following OMERACT methodology we developed an updated JIA Core Domain Set. Next steps are to identify and systematically evaluate best outcome measures for these domains.