%0 Journal Article
%T OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study.
%A Nielsen SM
%A Boers M
%A de Wit M
%A Shea B
%A van der Windt DA
%A Reeves BC
%A Beaton D
%A Alten R
%A Toupin April K
%A Boonen A
%A Escorpizo R
%A Flurey C
%A Furst DE
%A Guillemin F
%A Leong A
%A Pohl C
%A Rasmussen MU
%A Singh JA
%A Smolen JS
%A Strand V
%A Verstappen SMM
%A Voshaar M
%A Woodworth TG
%A Ellingsen T
%A March L
%A Wells GA
%A Tugwell P
%A Christensen R
%J Semin Arthritis Rheum
%V 51
%N 3
%D 06 2021
%M 33875246
%F 5.431
%R 10.1016/j.semarthrit.2021.03.013
%X To develop an operational definition of contextual factors (CF) [1].<BR>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.<BR>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.<BR>Through consensus we developed an operational definition of CFs, which was well received by OMERACT members.