Evidence for Updating the Core Domain Set of Outcome Measures for Juvenile Idiopathic Arthritis: Report from a Special Interest Group at OMERACT 2016

Abstract

Objective The current Juvenile Idiopathic Arthritis (JIA) Core Set was developed in 1997 to identify the outcome measures to be used in JIA clinical trials using statistical and consensus-based techniques, but without patient involvement. The importance of patient/parent input into the research process has increasingly been recognized over the years. An Outcome Measures in Rheumatology (OMERACT) JIA Core Set Working Group was formed to determine whether the outcome domains of the current core set are relevant to those involved or whether the core set domains should be revised. Methods Twenty-four people from the United States, Canada, Australia, and Europe, including patient partners, formed the working group. Guided by the OMERACT Filter 2.0 process, we performed (1) a systematic literature review of outcome domains, (2) a Web-based survey (142 patients, 343 parents), (3) an idea-generation study (120 parents), (4) 4 online discussion boards (24 patients, 20 parents), and (5) a Special Interest Group (SIG) activity at the OMERACT 13 (2016) meeting. Results A MEDLINE search of outcome domains used in studies of JIA yielded 5956 citations, of which 729 citations underwent full-text review, and identified additional domains to those included in the current JIA Core Set. Qualitative studies on the effect of JIA identified multiple additional domains, including pain and participation. Twenty-one participants in the SIG achieved consensus on the need to revise the entire JIA Core Set. Conclusion The results of qualitative studies and literature review support the need to expand the JIA Core Set, considering, among other things, additional patient/parent-centered outcomes, clinical data, and imaging data.

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Shoulder arthroplasty for juvenile idiopathic arthritis

“…47 More recently, an Outcome Measures in Rheumatology (OMERACT) JIA Core Set Working Group has been formed to update this to include more on patient- and parent-reported outcome measures. 48…”

“…47 More recently, an Outcome Measures in Rheumatology (OMERACT) JIA Core Set Working Group has been formed to update this to include more on patient-and parent-reported outcome measures. 48 The authors advocate standardisation for the measurement of functional outcomes to allow greater comparison between publications and to compare the differences in implants used and surgical technique. There appears that there is no single functional scoring system that evaluates all outcomes, and as such maybe an agreed set of multiple systems should be used in conjunction with each other.…”

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“…To continue the exponential trajectory of treatment advances, innovative approaches to testing and authorizing medicines are sorely needed, as current approaches do not meet the needs of stakeholders, including patients, regulators, clinicians, investigators, and industry. Efforts to define patient‐centered outcomes consistently emphasize unmet needs in the patient community . In April 2018 in Denver, CO, a stakeholder meeting of clinicians, researchers, patients/parents, and representatives of the Arthritis Foundation, industry, and regulatory agencies (Food and Drug Administration [FDA] and European Medicines Agency [EMA]) was held to discuss current challenges and potential solutions.…”

“…For all these reasons, it is not optimal for shared decision‐making. A large, international collaboration is currently updating components of the core set to be more meaningful to providers and patients , but any format comparing multiple individual assessments to baseline will continue to be problematic.…”