OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

Sabrina Mai Nielsen; Maarten Boers; Maarten de Wit; Beverly Shea; Danielle A van der Windt; Barnaby C Reeves; Dorcas Beaton; Rieke Alten; Karine Toupin April; Annelies Boonen; Reuben Escorpizo; Caroline Flurey; Daniel E Furst; Francis Guillemin; Amye Leong; Christoph Pohl; Marianne Uggen Rasmussen; Jasvinder A Singh; Josef S Smolen; Vibeke Strand; Suzanne M M Verstappen; Marieke Voshaar; Thasia G Woodworth; Torkell Ellingsen; Lyn March; George A Wells; Peter Tugwell; Robin Christensen

doi:10.1016/j.semarthrit.2021.03.013

OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

Semin Arthritis Rheum. 2021 Jun;51(3):601-606. doi: 10.1016/j.semarthrit.2021.03.013. Epub 2021 Apr 2.

Authors

Sabrina Mai Nielsen¹, Maarten Boers², Maarten de Wit³, Beverly Shea⁴, Danielle A van der Windt⁵, Barnaby C Reeves⁶, Dorcas Beaton⁷, Rieke Alten⁸, Karine Toupin April⁹, Annelies Boonen¹⁰, Reuben Escorpizo¹¹, Caroline Flurey¹², Daniel E Furst¹³, Francis Guillemin¹⁴, Amye Leong¹⁵, Christoph Pohl⁸, Marianne Uggen Rasmussen¹⁶, Jasvinder A Singh¹⁷, Josef S Smolen¹⁸, Vibeke Strand¹⁹, Suzanne M M Verstappen²⁰, Marieke Voshaar²¹, Thasia G Woodworth²², Torkell Ellingsen²³, Lyn March²⁴, George A Wells²⁵, Peter Tugwell²⁶, Robin Christensen²⁷

Affiliations

¹ 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, Denmark.
² Department of Epidemiology & Data Science, and Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, the Netherlands.
³ OMERACT Patient Research Partner, Amsterdam, the Netherlands.
⁴ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁵ School of Medicine, Keele University, Staffordshire, United Kingdom.
⁶ Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
⁷ 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.
⁸ Rheumatology, Clinical Immunology, Osteology, Physical Therapy and Sports Medicine, Schlosspark-Klinik Charité, University Medicine Berlin, Germany.
⁹ Children's Hospital of Eastern Ontario Research Institute, Department of Pediatrics and School of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada.
¹⁰ 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.
¹¹ Department of Rehabilitation and Movement Science, College of Nursing and Health Sciences, University of Vermont, Burlington, VT, United States; Swiss Paraplegic Research, Nottwil, Switzerland.
¹² Department of Health and Social Sciences, Faculty of Health and Applied Sciences, University of the West of England, Bristol, United Kingdom.
¹³ 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.
¹⁴ Université de Lorraine, APEMAC, 54000 Nancy, France.
¹⁵ Healthy Motivation, and Bone and Joint Decade, the Global Alliance for Musculoskeletal Health, Santa Barbara, CA, United States.
¹⁶ Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
¹⁷ 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 Public Health, 1665 University Blvd., Ryals Public Health Building, Room 220, Birmingham, AL 35294-0022, United States.
¹⁸ Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.
¹⁹ Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, United States.
²⁰ 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 Trust, Manchester Academic Health Science Centre, United Kingdom.
²¹ Department of Pharmacy, Sint Maartenskliniek, The Netherlands. Department of Pharmacy, Radboudumc, Nijmegen, the Netherlands.
²² Division of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles, CA, United States.
²³ Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark.
²⁴ 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.
²⁵ School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
²⁶ Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
²⁷ 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, Denmark. Electronic address: robin.christensen@regionh.dk.

PMID: 33875246
DOI: 10.1016/j.semarthrit.2021.03.013

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.

Keywords: Contextual factors; Delphi survey; Effect modifying contextual factors; Measurement affecting contextual factors; OMERACT; Outcome explaining contextual factors.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Consensus
Humans
Outcome Assessment, Health Care
Research Design
Rheumatology*
Surveys and Questionnaires