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OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study.
Nielsen, Sabrina Mai; Boers, Maarten; de Wit, Maarten; Shea, Beverly; van der Windt, Danielle A; Reeves, Barnaby C; Beaton, Dorcas; Alten, Rieke; Toupin April, Karine; Boonen, Annelies; Escorpizo, Reuben; Flurey, Caroline; Furst, Daniel E; Guillemin, Francis; Leong, Amye; Pohl, Christoph; Rasmussen, Marianne Uggen; Singh, Jasvinder A; Smolen, Josef S; Strand, Vibeke; Verstappen, Suzanne M M; Voshaar, Marieke; Woodworth, Thasia G; Ellingsen, Torkell; March, Lyn; Wells, George A; Tugwell, Peter; Christensen, Robin.
  • Nielsen SM; Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denma
  • Boers M; Department of Epidemiology & Data Science, and Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.
  • de Wit M; OMERACT Patient Research Partner, Amsterdam, the Netherlands.
  • Shea B; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
  • van der Windt DA; School of Medicine, Keele University, Staffordshire, United Kingdom.
  • Reeves BC; Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
  • Beaton D; Institute for Work and Health, and Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute and the Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
  • Alten R; Rheumatology, Clinical Immunology, Osteology, Physical Therapy and Sports Medicine, Schlosspark-Klinik Charité, University Medicine Berlin, Germany.
  • Toupin April K; Children's Hospital of Eastern Ontario Research Institute, Department of Pediatrics and School of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada.
  • Boonen A; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre+, Maastricht, the Netherlands; Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.
  • Escorpizo R; Department of Rehabilitation and Movement Science, College of Nursing and Health Sciences, University of Vermont, Burlington, VT, United States; Swiss Paraplegic Research, Nottwil, Switzerland.
  • Flurey C; Department of Health and Social Sciences, Faculty of Health and Applied Sciences, University of the West of England, Bristol, United Kingdom.
  • Furst DE; Division of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles, CA, United States; University of Washington, Seattle, California, United States; University of Florence, Florence, Italy.
  • Guillemin F; Université de Lorraine, APEMAC, 54000 Nancy, France.
  • Leong A; Healthy Motivation, and Bone and Joint Decade, the Global Alliance for Musculoskeletal Health, Santa Barbara, CA, United States.
  • Pohl C; Rheumatology, Clinical Immunology, Osteology, Physical Therapy and Sports Medicine, Schlosspark-Klinik Charité, University Medicine Berlin, Germany.
  • Rasmussen MU; Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
  • Singh JA; Medicine Service, VA Medical Center, 700 19th St S, Birmingham 35233, AL United States; Department of Medicine at the School of Medicine, University of Alabama at Birmingham (UAB), 1720 Second Ave. South, Birmingham, AL 35294-0022, United States; Department of Epidemiology at the UAB School of Publi
  • Smolen JS; Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.
  • Strand V; Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, United States.
  • Verstappen SMM; Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Tr
  • Voshaar M; Department of Pharmacy, Sint Maartenskliniek, The Netherlands. Department of Pharmacy, Radboudumc, Nijmegen, the Netherlands.
  • Woodworth TG; Division of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles, CA, United States.
  • Ellingsen T; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark.
  • March L; Florance and Cope Professorial Department of Rheumatology, Royal North Shore Hospital and Institute of Bone and Joint Research, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
  • Wells GA; School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
  • Tugwell P; Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
  • Christensen R; Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denma
Semin Arthritis Rheum ; 51(3): 601-606, 2021 06.
Article en En | MEDLINE | ID: mdl-33875246
ABSTRACT

OBJECTIVES:

To develop an operational definition of contextual factors (CF) [1].

METHODS:

Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs.

RESULTS:

Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive.

CONCLUSION:

Through consensus we developed an operational definition of CFs, which was well received by OMERACT members.
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Texto completo: 1 Ejes tematicos: Pesquisa_clinica Banco de datos: MEDLINE Asunto principal: Reumatología Tipo de estudio: Guideline / Qualitative_research Límite: Humans Idioma: En Año: 2021 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Search on Google

Texto completo: 1 Ejes tematicos: Pesquisa_clinica Banco de datos: MEDLINE Asunto principal: Reumatología Tipo de estudio: Guideline / Qualitative_research Límite: Humans Idioma: En Año: 2021 Tipo del documento: Article