Consensus of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic and musculoskeletal diseases
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Consensus of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic and musculoskeletal diseases. / Lyne, Suellen A.; Yip, Kevin; Vasiliou, Vasilis S.; Katz, David A.; Richards, Pamela; Tieu, Joanna; Black, Rachel J.; Bridgewater, Susan; Palmowski, Andriko; Beaton, Dorcas; Maxwell, Lara J.; Robson, Joanna C.; Mackie, Sarah L.; Goodman, Susan M.; Hill, Catherine L.
In: Seminars in Arthritis and Rheumatism, Vol. 64, 152338, 2024.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Consensus of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic and musculoskeletal diseases
AU - Lyne, Suellen A.
AU - Yip, Kevin
AU - Vasiliou, Vasilis S.
AU - Katz, David A.
AU - Richards, Pamela
AU - Tieu, Joanna
AU - Black, Rachel J.
AU - Bridgewater, Susan
AU - Palmowski, Andriko
AU - Beaton, Dorcas
AU - Maxwell, Lara J.
AU - Robson, Joanna C.
AU - Mackie, Sarah L.
AU - Goodman, Susan M.
AU - Hill, Catherine L.
N1 - Publisher Copyright: © 2023
PY - 2024
Y1 - 2024
N2 - 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 measurement set for clinical trials measuring the impact of GC on patients with rheumatic and musculoskeletal diseases.
AB - 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 measurement set for clinical trials measuring the impact of GC on patients with rheumatic and musculoskeletal diseases.
KW - Adverse effects
KW - Core set
KW - Domain definitions
KW - Glucocorticoids
KW - OMERACT
KW - Patient perspective
U2 - 10.1016/j.semarthrit.2023.152338
DO - 10.1016/j.semarthrit.2023.152338
M3 - Journal article
C2 - 38134623
AN - SCOPUS:85180561344
VL - 64
JO - Seminars in Arthritis and Rheumatism
JF - Seminars in Arthritis and Rheumatism
SN - 0049-0172
M1 - 152338
ER -
ID: 380415231