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

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

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.

• Journal Article Type: Article
• Acceptance Date: Apr 1, 2021
• Online Publication Date: Apr 2, 2021
• Publication Date: 2021-06
• Deposit Date: Apr 30, 2021
• Publicly Available Date: Jul 7, 2021
• Journal: Seminars in Arthritis and Rheumatism
• Print ISSN: 0049-0172
• Electronic ISSN: 1532-866X
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 51
• Issue: 3
• Pages: 601-606
• DOI: https://doi.org/10.1016/j.semarthrit.2021.03.013
• Keywords: Anesthesiology and Pain Medicine; Rheumatology
• Public URL: https://uwe-repository.worktribe.com/output/7319816