Consensus of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic and musculoskeletal diseases

Suellen A. Lyne, Kevin Yip, Vasilis S. Vasiliou, David A. Katz, Pamela Richards, Joanna Tieu, Rachel J. Black, Susan Bridgewater, Andriko Palmowski, Dorcas Beaton, Lara J. Maxwell, Joanna C. Robson, Sarah L. Mackie, Susan M Goodman, Catherine L Hill

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Group
has been working to develop a core domain set to measure the impact of GCs on patients living with rheumatic
and musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trials
measuring the GC effects include infection, bone fragility, mood disturbance, hypertension, diabetes, weight,
fatigue, and mortality. Before progressing to instrument selection, the Working Group sought to establish precise
definitions of all mandatory domains within the core domain set.
Methods: OMERACT methodology was applied with the use of evidence and consensus-based decision making of
all stakeholder groups (patient research partners, health care professionals, clinician researchers, industry
members and methodologists) to develop detailed definitions for the broad domain, target domain and domain
components, taking into consideration sources of variability that could affect measurement of the domain. The
working group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, to
develop a rich definition of ‘what’ is to be measured.
Results: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings to
establish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains were
primarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which was
primarily Life Impact and Weight which spanned both Core Areas. Sources of variability included cultural factors, age, gender, education level, socioeconomic status, personal experiences, emotional state, and language
barriers. The domain definitions will form the foundation for instrument selection and the initial step of domain /
concept match and content validity in the OMERACT pillar of ‘truth’ before moving on to feasibility and
discrimination.
Conclusion: The OMERACT GC Impact Working Group has developed and agreed upon detailed domain definitions for core domains. Future steps of the working group are to select instruments and develop the core outcome
Original languageEnglish
Article number152338
Number of pages7
JournalSeminars in Arthritis and Rheumatism
Volume64
Early online date21 Dec 2023
DOIs
Publication statusPublished - Feb 2024

Keywords

  • OMERACT
  • Glucocorticoids
  • domain definitions
  • patient perspectives
  • adverse effects
  • core set

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