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