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

Seminars in arthritis and rheumatism（2021）

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摘要

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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