Core Outcome Measures in Effectiveness Trials

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

General Information

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.

Authors:
Morgan, E. M. Riebschleger, M. P. Horonjeff, J. Consolaro, A. Munro, J. E. Thornhill, S. Beukelman, T. Brunner, H. I. Creek, E. L. Harris, J. G. Horton, D. B. Lovell, D. J. Mannion, M. L. Olson, J. C. Rahimi, H. Gallo, M. C. Calandra, S. Ravelli, A. Ringold, S. Shenoi, S. Stinson, J. Toupin-April, K. Strand, V. Bingham, C. O., 3rd

Publication

Journal:
J Rheumatol
Volume:
44
Issue:
12
Pages:
1884 - 1888
Year:
2017
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Child health
Rheumatology

Disease Name
Juvenile idiopathic arthritis (JIA)

Target Population

Age Range
0 - 18

Sex
Either


Nature / type of Intervention
Any

Method(s)

Literature review
Semi structured discussion
Survey

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.


Stakeholders Involved

Unknown

Study Type

Recommendations made

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