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

7 Citationer (Scopus)

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.

OriginalsprogEngelsk
TidsskriftSeminars in Arthritis and Rheumatism
Vol/bind51
Udgave nummer3
Sider (fra-til)601-606
Antal sider6
ISSN0049-0172
DOI
StatusUdgivet - jun. 2021

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