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

Esi M. Morgan, Jane E. Munro, Jennifer Horonjeff, Ben Horgan, Beverley Shea, Brian M. Feldman, Hayyah Clairman, Clifton O. Bingham, Susan Thornhill, Vibeke Strand, Alessandra Alongi, Silvia Magni-Manzoni, Marion A.J. Van Rossum, Richard Vesely, Jelena Vojinovic, Hermine I. Brunner, Julia G. Harris, Daniel B. Horton, Daniel J. Lovell, Melissa MannionHomaira Rahimi, Angelo Ravelli, Sarah Ringold, Nicolino Ruperto, M. Suzanne Schrandt, Susan Shenoi, Natalie J. Shiff, Karine Toupin-April, Nikolay Tzaribachev, Pamela Weiss, Alessandro Consolaro

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1006-1013
Number of pages8
JournalJournal of Rheumatology
Volume46
Issue number8
DOIs
StatePublished - Aug 1 2019

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Juvenile Arthritis
Education
Parents
Politics
Observational Studies
Longitudinal Studies
Consensus
Randomized Controlled Trials
Outcome Assessment (Health Care)
Public Opinion
Arthralgia
Rheumatology
Health Personnel
Italy
Research Personnel
Exercise
Inflammation

Keywords

  • Clinical trials
  • Juvenile idiopathic arthritis
  • OMERACT
  • Outcome assessment
  • Quality of life

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Morgan, E. M., Munro, J. E., Horonjeff, J., Horgan, B., Shea, B., Feldman, B. M., ... Consolaro, A. (2019). Establishing an updated core domain set for studies in juvenile idiopathic arthritis: A report from the OMERACT 2018 JIA workshop. Journal of Rheumatology, 46(8), 1006-1013. https://doi.org/10.3899/jrheum.181088

Establishing an updated core domain set for studies in juvenile idiopathic arthritis : A report from the OMERACT 2018 JIA workshop. / Morgan, Esi M.; Munro, Jane E.; Horonjeff, Jennifer; Horgan, Ben; Shea, Beverley; Feldman, Brian M.; Clairman, Hayyah; Bingham, Clifton O.; Thornhill, Susan; Strand, Vibeke; Alongi, Alessandra; Magni-Manzoni, Silvia; Van Rossum, Marion A.J.; Vesely, Richard; Vojinovic, Jelena; Brunner, Hermine I.; Harris, Julia G.; Horton, Daniel B.; Lovell, Daniel J.; Mannion, Melissa; Rahimi, Homaira; Ravelli, Angelo; Ringold, Sarah; Ruperto, Nicolino; Schrandt, M. Suzanne; Shenoi, Susan; Shiff, Natalie J.; Toupin-April, Karine; Tzaribachev, Nikolay; Weiss, Pamela; Consolaro, Alessandro.

In: Journal of Rheumatology, Vol. 46, No. 8, 01.08.2019, p. 1006-1013.

Research output: Contribution to journalArticle

Morgan, EM, Munro, JE, Horonjeff, J, Horgan, B, Shea, B, Feldman, BM, Clairman, H, Bingham, CO, Thornhill, S, Strand, V, Alongi, A, Magni-Manzoni, S, Van Rossum, MAJ, Vesely, R, Vojinovic, J, Brunner, HI, Harris, JG, Horton, DB, Lovell, DJ, Mannion, M, Rahimi, H, Ravelli, A, Ringold, S, Ruperto, N, Schrandt, MS, Shenoi, S, Shiff, NJ, Toupin-April, K, Tzaribachev, N, Weiss, P & Consolaro, A 2019, 'Establishing an updated core domain set for studies in juvenile idiopathic arthritis: A report from the OMERACT 2018 JIA workshop', Journal of Rheumatology, vol. 46, no. 8, pp. 1006-1013. https://doi.org/10.3899/jrheum.181088
Morgan, Esi M. ; Munro, Jane E. ; Horonjeff, Jennifer ; Horgan, Ben ; Shea, Beverley ; Feldman, Brian M. ; Clairman, Hayyah ; Bingham, Clifton O. ; Thornhill, Susan ; Strand, Vibeke ; Alongi, Alessandra ; Magni-Manzoni, Silvia ; Van Rossum, Marion A.J. ; Vesely, Richard ; Vojinovic, Jelena ; Brunner, Hermine I. ; Harris, Julia G. ; Horton, Daniel B. ; Lovell, Daniel J. ; Mannion, Melissa ; Rahimi, Homaira ; Ravelli, Angelo ; Ringold, Sarah ; Ruperto, Nicolino ; Schrandt, M. Suzanne ; Shenoi, Susan ; Shiff, Natalie J. ; Toupin-April, Karine ; Tzaribachev, Nikolay ; Weiss, Pamela ; Consolaro, Alessandro. / Establishing an updated core domain set for studies in juvenile idiopathic arthritis : A report from the OMERACT 2018 JIA workshop. In: Journal of Rheumatology. 2019 ; Vol. 46, No. 8. pp. 1006-1013.
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abstract = "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.",
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T1 - Establishing an updated core domain set for studies in juvenile idiopathic arthritis

T2 - A report from the OMERACT 2018 JIA workshop

AU - Morgan, Esi M.

AU - Munro, Jane E.

AU - Horonjeff, Jennifer

AU - Horgan, Ben

AU - Shea, Beverley

AU - Feldman, Brian M.

AU - Clairman, Hayyah

AU - Bingham, Clifton O.

AU - Thornhill, Susan

AU - Strand, Vibeke

AU - Alongi, Alessandra

AU - Magni-Manzoni, Silvia

AU - Van Rossum, Marion A.J.

AU - Vesely, Richard

AU - Vojinovic, Jelena

AU - Brunner, Hermine I.

AU - Harris, Julia G.

AU - Horton, Daniel B.

AU - Lovell, Daniel J.

AU - Mannion, Melissa

AU - Rahimi, Homaira

AU - Ravelli, Angelo

AU - Ringold, Sarah

AU - Ruperto, Nicolino

AU - Schrandt, M. Suzanne

AU - Shenoi, Susan

AU - Shiff, Natalie J.

AU - Toupin-April, Karine

AU - Tzaribachev, Nikolay

AU - Weiss, Pamela

AU - Consolaro, Alessandro

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N2 - 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.

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KW - Clinical trials

KW - Juvenile idiopathic arthritis

KW - OMERACT

KW - Outcome assessment

KW - Quality of life

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