Establishing an Updated Core Domain Set for Studies in Juvenile Idiopathic Arthritis: A Report from the OMERACT 2018 JIA Workshop
| Autor: | Karine Toupin-April, Julia G. Harris, Jelena Vojinovic, Marion A J van Rossum, Silvia Magni-Manzoni, Beverley Shea, Esi M. Morgan, Nicolino Ruperto, Richard Vesely, Angelo Ravelli, Daniel B. Horton, Brian M. Feldman, Clifton O. Bingham, Pamela F. Weiss, Susan Shenoi, Jennifer Horonjeff, Vibeke Strand, Nikolay Tzaribachev, Homaira Rahimi, Jane E Munro, Melissa L. Mannion, Natalie J. Shiff, Daniel J. Lovell, Alessandro Consolaro, Susan Thornhill, Sarah Ringold, Ben Horgan, Alessandra Alongi, M. Suzanne Schrandt, Hermine I. Brunner, Hayyah Clairman |
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| Přispěvatelé: | General Paediatrics, AII - Inflammatory diseases |
| Rok vydání: | 2019 |
| Předmět: |
musculoskeletal diseases
Male medicine.medical_specialty Adolescent Immunology Delphi method ODB++ law.invention Young Adult 03 medical and health sciences 0302 clinical medicine Rheumatology Randomized controlled trial Quality of life law Outcome Assessment Health Care medicine Humans Immunology and Allergy Patient Reported Outcome Measures 030212 general & internal medicine 030203 arthritis & rheumatology Response rate (survey) Clinical Trials as Topic business.industry Australia Special Interest Group Arthritis Juvenile United States Clinical trial Treatment Outcome Italy Antirheumatic Agents Family medicine Female Observational study business |
| Zdroj: | Journal of rheumatology, 46(8), 1006-1013. Journal of Rheumatology |
| ISSN: | 1499-2752 0315-162X |
| DOI: | 10.3899/jrheum.181088 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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