Date: Sunday, October 21, 2018
Session Title: 3S115 ACR/ARHP Abstract: Pediatric Rheum (976–981)
Session Type: ACR/ARHP Combined Abstract Session
Session Time: 4:30PM-6:00PM
Background/Purpose: The current JIA Core Set (ACR Pediatric 30) to assess efficacy of medications in randomized controlled trials (RCTs) was published in 1997 and developed without input from patients or caregivers. The current core set includes 6 variables: physician global assessment, parent/patient global assessment of overall wellbeing, physical functional ability, count of joints with active arthritis, count of joints with restricted motion, an acute phase reactant and – for systemic JIA – fever in past week. Outcome Measures in Rheumatology (OMERACT) recommends four core areas to include in RCTs and longitudinal observational studies (LOS) – 1) life impact, 2) pathophysiologic manifestations, 3) resource use, 4) adverse events – and conceptualizes domains along three levels of requirements for inclusion: inner circle – mandatory for all RCTs and LOS; middle circle – important, but optional; outer circle – research agenda. Since 2015, the OMERACT JIA Core Set working group has obtained global stakeholder input from JIA patients, caregivers, health care providers and researchers to update the JIA core domain set. At the OMERACT 2016 meeting, a special interest group voted to reconsider the entire core set. This abstract reports subsequent work.
Methods: Online discussion boards (ODBs) were held with JIA patients and parents in Australia and Italy, and results compared to USA ODBs to generate candidate domains. Three rounds of a Delphi process to prioritize these domains were held with stakeholders identified by patient advocacy groups, pediatric rheumatology clinical trials organizations and regulators. In the final Delphi round, domains were rated for inclusion in inner, middle or outer circles. Results were presented at the OMERACT conference in May 2018 for consensus among participants, with level of consensus set at ≥70%.
Results: 53 JIA patients (ages 15-24) and 55 parents participated in ODBs. Three rounds of Delphi considering 27 domains were completed by 196 (response rate 80%), 201 (81%) and 182 (77%) stakeholders, respectively, from 42 countries. Result of the final voting at the OMERACT 2018 conference approved the following core domains for JIA RCTs and LOS with 83% endorsement. Inner circle: pain, activity limitation/physical function, joint inflammatory signs (active joints), patient global assessment, adverse events. Middle circle: extra-articular inflammation (including uveitis), joint damage, labs, physician global assessment, stiffness, growth/maturation, participation restriction, imaging signs of inflammation, fatigue, impact on emotional function/mood/cognition, physical activity. Outer circle: coping with illness, healthcare utilization, sleep, social relationships, personal factors.
Conclusion: We have developed an updated JIA Core Domain Set following OMERACT methodology with qualitative input from patients/parents and broad stakeholders through a Delphi process and consensus voting. A notable change is pain is now recommended as a core domain for all JIA RCTs, LOS. Multiple patient reported domains were also voted as important to consider for inclusion in JIA trials, including fatigue, emotional function, and participation restriction.
To cite this abstract in AMA style:Morgan E, Consolaro A, Munro J, Horonjeff J, Feldman BM, Clairman H, Bingham III CO, Alongi A, Strand V, van Rossum MAJ, Veselý R, Brunner HI, Horton D, Lovell DJ, Ringold S, Ruperto N, Schrandt S, Shiff NJ, Toupin-April K, Shea B. New Consensus on an Updated Core Domain Set for Clinical Trials in Juvenile Idiopathic Arthritis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/new-consensus-on-an-updated-core-domain-set-for-clinical-trials-in-juvenile-idiopathic-arthritis/. Accessed December 8, 2019.
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