Generating a list of potentially important contextual factors covering randomized trials, cohorts, and measurement property studies: An OMERACT initiative

Max Weinbrecht-Mischkewitz; Midhat Kamal; Farwa Asim; Francis Guillemin; Niti Goel; Marieke Voshaar; Annelies Boonen; Dorthe Bang Berthelsen; Karine Toupin-April; Maria A Lopez-Olivo; Victor S Sloan; Maarten Boers; C Allyson Jones; Irene van der Horst-Bruinsma; Aidan G Cashin; Saurab Sharma; Amye Leong; Rieke Alten; Beverley Shea; Lyn March; Peter Tugwell; Robin Christensen; Sabrina Mai Nielsen; Contextual Factors Working Group

doi:10.1016/j.semarthrit.2024.152370

Generating a list of potentially important contextual factors covering randomized trials, cohorts, and measurement property studies: An OMERACT initiative

Semin Arthritis Rheum. 2024 Apr:65:152370. doi: 10.1016/j.semarthrit.2024.152370. Epub 2024 Jan 10.

Authors

Max Weinbrecht-Mischkewitz¹, Midhat Kamal², Farwa Asim³, Francis Guillemin⁴, Niti Goel⁵, Marieke Voshaar⁶, Annelies Boonen⁷, Dorthe Bang Berthelsen⁸, Karine Toupin-April⁹, Maria A Lopez-Olivo¹⁰, Victor S Sloan¹¹, Maarten Boers¹², C Allyson Jones¹³, Irene van der Horst-Bruinsma¹⁴, Aidan G Cashin¹⁵, Saurab Sharma¹⁵, Amye Leong¹⁶, Rieke Alten¹⁷, Beverley Shea¹⁸, Lyn March¹⁹, Peter Tugwell²⁰, Robin Christensen²¹, Sabrina Mai Nielsen²¹; Contextual Factors Working Group

Affiliations

¹ Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology, Schlosspark-Klinik, University Medicine Berlin, Heubnerweg 2, 14059 Berlin, Germany. Electronic address: max.mischkewitz@charite.de.
² Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Health Services Research and Section of Rheumatology and Clinical Immunology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
³ Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Internal Medicine, Piedmont Hospital, Macon, GA, USA.
⁴ Université de Lorraine, Inserm, INSPIIRE, Nancy, France.
⁵ Division of Rheumatology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
⁶ Department of Pharmacy, Sint Maartenskliniek, Radboudumc, Nijmegen, The Netherlands.
⁷ 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.
⁸ Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Research, Research Unit of Rheumatology, University of Southern Denmark, Odense University Hospital, Odense, Denmark; Department of Rehabilitation, Municipality of Guldborgsund, Nykoebing F, Denmark.
⁹ School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, Canada; Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, Canada; Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada; Institut du savoir Montfort, Ottawa, Canada.
¹⁰ The University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
¹¹ Sheng Consulting, LLC, USA; The Peace Corps, Washington, DC, USA.
¹² Department of Epidemiology and Data Science, Amsterdam University Medical Centers, Vrije Universiteit, Amsterdam, The Netherlands.
¹³ Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada.
¹⁴ Department of Rheumatology, Radboud University Medical Centre, Nijmegen, The Netherlands.
¹⁵ School of Health Sciences, Faculty of Medicine and Health, University of New South Wales, Sydney, New South Wales, Australia; Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.
¹⁶ Healthy Motivation, and Bone and Joint Decade, the Global Alliance for Musculoskeletal Health, Santa Barbara, CA, USA.
¹⁷ Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology, Schlosspark-Klinik, University Medicine Berlin, Heubnerweg 2, 14059 Berlin, Germany.
¹⁸ Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹⁹ Florance and Cope Professorial Department of Rheumatology, Royal North Shore Hospital and Kolling Institute, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
²⁰ Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
²¹ Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Research, Research Unit of Rheumatology, University of Southern Denmark, Odense University Hospital, Odense, Denmark.

PMID: 38290371
DOI: 10.1016/j.semarthrit.2024.152370

Abstract

Objectives: To generate candidates for contextual factors (CFs) for each CF type (i.e., Effect Modifying Contextual Factors (EM-CFs), Outcome Influencing Contextual Factors (OI-CFs), and Measurement Affecting Contextual Factors (MA-CFs)) considered important within rheumatology.

Methods: We surveyed OMERACT working groups and conducted a Special Interest Group (SIG) session at the OMERACT 2023 meeting, where the results were reviewed, and additional CFs suggested.

Results: The working groups suggested 44, 49, and 21 generic EM-CFs, OI-CFs, and MA-CFs, respectively. SIG participants added 49, 44, and 55 factors, respectively.

Conclusion: Candidate CFs were identified, next step is a consensus-based set of endorsed (important) CFs.

Keywords: Arthritis; Contextual factors; Effect modifiers; Measurement instruments; OMERACT; Prognostic factors; Rheumatology.

MeSH terms

Consensus
Humans
Outcome Assessment, Health Care*
Randomized Controlled Trials as Topic
Rheumatology*