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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.
Afiliación
  • Lyne SA; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Adelaide Medical School, The University of Adelaide, Adelaide, Australia.
  • Yip K; Division of Rheumatology, Hospital for Special Surgery, New York, NY, USA.
  • Vasiliou VS; Department of Psychology, Royal Holloway, University of London, UK.
  • Katz DA; Sparrow Pharmaceuticals; Portland, OR, USA.
  • Richards P; Patient Research Partner, Bristol, UK.
  • Tieu J; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Adelaide Medical School, The University of Adelaide, Adelaide, Australia.
  • Black RJ; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Adelaide Medical School, The University of Adelaide, Adelaide, Australia.
  • Bridgewater S; Rheumatology Research, Centre for Health and Clinical Research, University of the West of England, Bristol, UK.
  • Palmowski A; Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Germany; Section for Biostatistics and Evidence-based Research, the Parker Institute, Frederiksberg and Bispebjerg Hospital, University of Copenhagen, Frederiksberg, Denmark.
  • Beaton D; Institute for Work & Health, University of Toronto, Canada.
  • Maxwell LJ; Faculty of Medicine, University of Ottawa, Ottawa, Canada.
  • Robson JC; Rheumatology Research, Centre for Health and Clinical Research, University of the West of England, Bristol, UK; Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
  • Mackie SL; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
  • Goodman SM; Division of Rheumatology, Hospital for Special Surgery, New York, NY, USA.
  • Hill CL; Rheumatology Unit, The Queen Elizabeth Hospital, Adelaide, Australia; Adelaide Medical School, The University of Adelaide, Adelaide, Australia. Electronic address: catherine.hill@sa.gov.au.
Semin Arthritis Rheum ; 64: 152338, 2024 Feb.
Article en En | MEDLINE | ID: mdl-38134623
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 measurement set for clinical trials measuring the impact of GC on patients with rheumatic and musculoskeletal diseases.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Reumatología / Enfermedades Reumáticas / Enfermedades Musculoesqueléticas Límite: Humans Idioma: En Revista: Semin Arthritis Rheum Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Reumatología / Enfermedades Reumáticas / Enfermedades Musculoesqueléticas Límite: Humans Idioma: En Revista: Semin Arthritis Rheum Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Estados Unidos