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

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.
Competing Interests: Declaration of Competing Interest Dr. Alten reports personal fees from Abbvie, personal fees from BMS, personal fees from Celltrion, grants from Galapagos, personal fees from Gilead, personal fees from Lilly, grants and personal fees from Pfizer, outside the submitted work. Annelies Boonen received research grants form Celgene and Abbvie and fees for advisory boards from Abbvie, Eli Lilly and Galapagos, all paid to her department. Dr. Furst reports NO stocks, royalties, direct financial holding, expert testimony, board of director. Grant/Research Support Actelion, Amgen, BMS Corbus, Galapagos GSK, NIH, Novartis, Pfizer, Sanofi, Roche/Genentech. Consultant Actelion, Amgen, BMS, Corbus, Galapagos Novartis, Pfizer, Speakers Bureau CME only. Dr. March reports personal fees from Pfizer Australia Ltd, personal fees from Bristol Myer Squibb Australia, personal fees from Elsevier Ltd, personal fees from Up To Date, grants from Janssen Australia, outside the submitted work; and LM is a member of the executive of OMERACT. Dr. Shea reports being the senior methodologist on this project. Dr. Singh reports personal fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Trio health, Adept Field solutions, Medscape, WebMD, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, Practice Point communications, the National Institutes of Health and the American College of Rheumatology, personal fees from Simply Speaking, other from Amarin, Viking, Moderna and Vaxart pharmaceuticals; and Charlotte's Web Holdings, non-financial support from FDA Arthritis Advisory Committee, non-financial support from Steering committee of OMERACT, non-financial support from Veterans Affairs Rheumatology Field Advisory Committee, non-financial support from Editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis, outside the submitted work. Dr. Smolen received grants to his institution from Abbvie, AstraZeneca, Janssen, Lilly, Merck Sharpe & Dohme, Pfizer, and Roche and provided expert advice for, or had symposia speaking engagements with, AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO Pharma, Janssen, Lilly, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, and UCB. V. Strand is a member of the executive of OMERACT. OMERACT, an organization that develops outcome measures in rheumatology, receives arms-length funding from 8 companies. The other authors have no conflict of interest relevant to the content of this study.
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