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.

Citation

Nielsen, S. M., Boers, M., de Wit, M., Shea, B., van der Windt, D. A., Reeves, B. C., …Christensen, R. (2021). OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study. Seminars in Arthritis and Rheumatism, 51(3), 601-606. https://doi.org/10.1016/j.semarthrit.2021.03.013

• 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