Endorsement of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic 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

doi:10.1016/j.semarthrit.2023.152338

Endorsement of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic 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

Department of Psychology

Research output: Contribution to journal › Article › peer-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 language	English
Journal	Seminars in Arthritis and Rheumatism
Volume	64
DOIs	https://doi.org/10.1016/j.semarthrit.2023.152338
Publication status	Submitted - Feb 2024

Keywords

OMERACT
Glucocorticoids
domain definitions
patient perspectives
adverse effects
core set

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.semarthrit.2023.152338Licence: CC BY

Cite this

Lyne, S. A., Yip, K., Vasiliou, V. S., Katz, D. A., Richards, P., Tieu, J., Black, R. J., Bridgewater, S., Palmowski, A., Beaton, D., Maxwell, L. J., Robson, J. C., & Mackie, S. L. (2024). Endorsement of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic diseases.. Manuscript submitted for publication. https://doi.org/10.1016/j.semarthrit.2023.152338

@article{f3b1fc3efc274ffeb4cbd80480ba26e6,

title = "Endorsement of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic diseases.",

abstract = "Background: The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Grouphas been working to develop a core domain set to measure the impact of GCs on patients living with rheumaticand musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trialsmeasuring 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 precisedefinitions of all mandatory domains within the core domain set.Methods: OMERACT methodology was applied with the use of evidence and consensus-based decision making ofall stakeholder groups (patient research partners, health care professionals, clinician researchers, industrymembers and methodologists) to develop detailed definitions for the broad domain, target domain and domaincomponents, taking into consideration sources of variability that could affect measurement of the domain. Theworking group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, todevelop a rich definition of {\textquoteleft}what{\textquoteright} is to be measured.Results: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings toestablish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains wereprimarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which wasprimarily 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 languagebarriers. 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 {\textquoteleft}truth{\textquoteright} before moving on to feasibility anddiscrimination.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",

keywords = "OMERACT, Glucocorticoids, domain definitions, patient perspectives, adverse effects, core set",

author = "Lyne, {Suellen A.} and Kevin Yip and Vasiliou, {Vasilis S.} and Katz, {David A.} and Pamela Richards and Joanna Tieu and Black, {Rachel J.} and Susan Bridgewater and Andriko Palmowski and Dorcas Beaton and Maxwell, {Lara J.} and Robson, {Joanna C.} and Mackie, {Sarah L.}",

year = "2024",

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doi = "10.1016/j.semarthrit.2023.152338",

language = "English",

volume = "64",

journal = "Seminars in Arthritis and Rheumatism",

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Lyne, SA, Yip, K, Vasiliou, VS, Katz, DA, Richards, P, Tieu, J, Black, RJ, Bridgewater, S, Palmowski, A, Beaton, D, Maxwell, LJ, Robson, JC & Mackie, SL 2024, 'Endorsement of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic diseases.', Seminars in Arthritis and Rheumatism, vol. 64. https://doi.org/10.1016/j.semarthrit.2023.152338

TY - JOUR

T1 - Endorsement of the definitions of the OMERACT glucocorticoid impact core domain set for people with rheumatic 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.

PY - 2024/2

Y1 - 2024/2

N2 - Background: The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Grouphas been working to develop a core domain set to measure the impact of GCs on patients living with rheumaticand musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trialsmeasuring 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 precisedefinitions of all mandatory domains within the core domain set.Methods: OMERACT methodology was applied with the use of evidence and consensus-based decision making ofall stakeholder groups (patient research partners, health care professionals, clinician researchers, industrymembers and methodologists) to develop detailed definitions for the broad domain, target domain and domaincomponents, taking into consideration sources of variability that could affect measurement of the domain. Theworking group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, todevelop a rich definition of ‘what’ is to be measured.Results: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings toestablish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains wereprimarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which wasprimarily 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 languagebarriers. 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 anddiscrimination.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

AB - Background: The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid (GC) Impact Working Grouphas been working to develop a core domain set to measure the impact of GCs on patients living with rheumaticand musculoskeletal diseases. The mandatory domains previously identified for inclusion in all clinical trialsmeasuring 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 precisedefinitions of all mandatory domains within the core domain set.Methods: OMERACT methodology was applied with the use of evidence and consensus-based decision making ofall stakeholder groups (patient research partners, health care professionals, clinician researchers, industrymembers and methodologists) to develop detailed definitions for the broad domain, target domain and domaincomponents, taking into consideration sources of variability that could affect measurement of the domain. Theworking group synthesized prior qualitative studies, quantitative work, and results from Delphi rounds, todevelop a rich definition of ‘what’ is to be measured.Results: Between 2021 and 2023, the OMERACT Working Group on GC Impact conducted virtual meetings toestablish domain definitions. First, we mapped each domain onto an OMERACT Core Area. All domains wereprimarily represented within the Pathophysiological Manifestations Core Area, except from Fatigue which wasprimarily 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 languagebarriers. 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 anddiscrimination.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

KW - OMERACT

KW - Glucocorticoids

KW - domain definitions

KW - patient perspectives

KW - adverse effects

KW - core set

U2 - 10.1016/j.semarthrit.2023.152338

DO - 10.1016/j.semarthrit.2023.152338

M3 - Article

SN - 0049-0172

VL - 64

JO - Seminars in Arthritis and Rheumatism

JF - Seminars in Arthritis and Rheumatism

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