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 StrandSuzanne M. M. Verstappen, Marieke Voshaar, Thasia G. Woodworth, Torkell Ellingsen, Lyn March, George A. Wells, Peter Tugwell, Robin Christensen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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.
Original languageEnglish
Pages (from-to)601-606
Number of pages6
JournalSeminars in Arthritis and Rheumatism
Issue number3
Publication statusPublished - 1 Jun 2021

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