TY - JOUR
T1 - OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials
T2 - A mixed methods study
AU - Nielsen, Sabrina Mai
AU - Boers, Maarten
AU - de Wit, Maarten
AU - Shea, Beverly
AU - van der Windt, Danielle A
AU - Reeves, Barnaby C
AU - Beaton, Dorcas
AU - Alten, Rieke
AU - Toupin April, Karine
AU - Boonen, Annelies
AU - Escorpizo, Reuben
AU - Flurey, Caroline
AU - Furst, Daniel E
AU - Guillemin, Francis
AU - Leong, Amye
AU - Pohl, Christoph
AU - Rasmussen, Marianne Uggen
AU - Singh, Jasvinder A
AU - Smolen, Josef S
AU - Strand, Vibeke
AU - Verstappen, Suzanne M M
AU - Voshaar, Marieke
AU - Woodworth, Thasia G
AU - Ellingsen, Torkell
AU - March, Lyn
AU - Wells, George A
AU - Tugwell, Peter
AU - Christensen, Robin
N1 - Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - Contextual factors
KW - Delphi survey
KW - Effect modifying contextual factors
KW - Measurement affecting contextual factors
KW - OMERACT
KW - Outcome explaining contextual factors
UR - http://www.scopus.com/inward/record.url?scp=85104286090&partnerID=8YFLogxK
U2 - 10.1016/j.semarthrit.2021.03.013
DO - 10.1016/j.semarthrit.2021.03.013
M3 - Journal article
C2 - 33875246
SN - 0049-0172
VL - 51
SP - 601
EP - 606
JO - Seminars in Arthritis and Rheumatism
JF - Seminars in Arthritis and Rheumatism
IS - 3
ER -