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Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.
Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin.
Afiliación
  • Klokker L; From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumm
  • Tugwell P; L. Klokker, PT, MSc, PhD Fellow, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Canada Research Chair in Health Equity, Department of Medicine, School of Epidemiology, P
  • Furst DE; From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumm
  • Devoe D; L. Klokker, PT, MSc, PhD Fellow, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Canada Research Chair in Health Equity, Department of Medicine, School of Epidemiology, P
  • Williamson P; From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumm
  • Terwee CB; L. Klokker, PT, MSc, PhD Fellow, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Canada Research Chair in Health Equity, Department of Medicine, School of Epidemiology, P
  • Suarez-Almazor ME; From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumm
  • Strand V; L. Klokker, PT, MSc, PhD Fellow, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Canada Research Chair in Health Equity, Department of Medicine, School of Epidemiology, P
  • Woodworth T; From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumm
  • Leong AL; L. Klokker, PT, MSc, PhD Fellow, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Canada Research Chair in Health Equity, Department of Medicine, School of Epidemiology, P
  • Goel N; From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumm
  • Boers M; L. Klokker, PT, MSc, PhD Fellow, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Canada Research Chair in Health Equity, Department of Medicine, School of Epidemiology, P
  • Brooks PM; From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumm
  • Simon LS; L. Klokker, PT, MSc, PhD Fellow, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Canada Research Chair in Health Equity, Department of Medicine, School of Epidemiology, P
  • Christensen R; From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumm
J Rheumatol ; 44(12): 1916-1919, 2017 Dec.
Article en En | MEDLINE | ID: mdl-27744393
OBJECTIVE: Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. METHODS: The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. RESULTS: Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. CONCLUSION: The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades Reumáticas / Evaluación de Resultado en la Atención de Salud / Antirreumáticos Tipo de estudio: Clinical_trials / Prognostic_studies / Qualitative_research Límite: Humans Idioma: En Revista: J Rheumatol Año: 2017 Tipo del documento: Article Pais de publicación: Canadá
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Enfermedades Reumáticas / Evaluación de Resultado en la Atención de Salud / Antirreumáticos Tipo de estudio: Clinical_trials / Prognostic_studies / Qualitative_research Límite: Humans Idioma: En Revista: J Rheumatol Año: 2017 Tipo del documento: Article Pais de publicación: Canadá