Core Outcome Measures in Effectiveness Trials

The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica

General Information

Abstract:
OBJECTIVE: To inform development of a core domain set for outcome measures for clinical trials in polymyalgia rheumatica (PMR), we conducted patient consultations, a systematic review, a Delphi study, and 2 qualitative studies. METHODS: Domains identified by 70% or more of physicians and/or patients in the Delphi study were selected. The conceptual framework derived from the 2 qualitative research studies helped inform the meaning of each domain and its relationship to the others. The draft core domain set was refined by further discussion with patients and physicians who had participated in the Delphi study. At the Outcome Measures in Rheumatology (OMERACT) 2016, the domains were discussed and prioritized by 8 breakout groups. Formal voting took place at the end of the workshop and in the final plenary. RESULTS: Ninety-three percent of voters in the final plenary agreed that the inner core of domains considered mandatory for clinical trials of PMR should consist the following: laboratory markers of systemic inflammation, pain, stiffness, and physical function. Patient's global and fatigue were considered important but not mandatory (outer core). The research agenda included psychological impact, weakness, physical activity, participation, sleep, imaging, and health-related quality of life. CONCLUSION: This core domain set was considered sufficiently well-defined that the next step will be to apply the OMERACT Filter 2.0 Instrument Selection Algorithm to select candidate instruments for a subsequent "deeper dive" into the data. This will allow instruments to be mapped onto each of our core domains to derive a core outcome set for PMR.

Authors:
Mackie, S. L. Twohig, H. Neill, L. M. Harrison, E. Shea, B. Black, R. J. Kermani, T. A. Merkel, P. A. Mallen, C. D. Buttgereit, F. Mukhtyar, C. Simon, L. S. Hill, C. L. Omeract Pmr Working Group

Publication

Journal:
J Rheumatol
Volume:
44
Issue:
10
Pages:
1515 - 1521
Year:
2017
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Rheumatology

Disease Name
Polymyalgia rheumatica

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consultations
Delphi process
Focus group(s)
Interview
Nominal group technique (NGT)
Semi structured discussion
Systematic review

(1) Systematic review of domains and instruments in 35 PMR trials and longitudinal observational studies; (2) Patient-driven consultation exercise using modified NGT; (3) Comparing outcome of patient consultations with SR findings; (4) 3 round Delphi study; (5) qualitative research (focus groups) on core PMR symptoms of pain and stiffness; (6) qualitative research (interviews) on the broader experience in PMR.


Stakeholders Involved

Clinical experts
Consumers (patients)
Epidemiologists
Researchers

Study Type

COS for clinical trials or clinical research

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