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OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

Authors :
Josef S Smolen
Marieke Voshaar
Robin Christensen
Dorcas E. Beaton
Maarten Boers
Maarten de Wit
Christoph Pohl
Barnaby C Reeves
Beverly Shea
Vibeke Strand
Annelies Boonen
Daniƫlle A W M van der Windt
Marianne Uggen Rasmussen
Suzanne M M Verstappen
Sabrina Mai Nielsen
Lyn March
Francis Guillemin
George A. Wells
Reuben Escorpizo
Rieke Alten
Peter Tugwell
Daniel E. Furst
Jasvinder A. Singh
Caroline A Flurey
Torkell Ellingsen
Thasia G. Woodworth
Amye Leong
Karine Toupin April
Epidemiology and Data Science
AII - Inflammatory diseases
APH - Methodology
RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation
Interne Geneeskunde
MUMC+: MA Reumatologie (9)
Source :
Seminars in Arthritis and Rheumatism, 51(3), 601-606. W.B. Saunders Ltd, Nielsen, S M, Boers, M, de Wit, M, Shea, B, van der Windt, D A, Reeves, B C, Beaton, D, Alten, R, Toupin April, K, Boonen, A, Escorpizo, R, Flurey, C, Furst, D E, Guillemin, F, Leong, A, Pohl, C, Rasmussen, M U, Singh, J A, Smolen, J S, Strand, V, Verstappen, S M M, Voshaar, M, Woodworth, T G, Ellingsen, T, March, L, Wells, G A, Tugwell, P & Christensen, R 2021, ' OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials : A mixed methods study ', Seminars in Arthritis and Rheumatism, vol. 51, no. 3, pp. 601-606 . https://doi.org/10.1016/j.semarthrit.2021.03.013, Nielsen, S M, Boers, M, De Wit, M, Shea, B, Van Der Windt, D A, Reeves, B C, Beaton, D, Alten, R, Toupin April, K, Boonen, A, Escorpizo, R, Flurey, C, Furst, D E, Guillemin, F, Leong, A, Pohl, C, Rasmussen, M U, Singh, J A, Smolen, J S, Strand, V, Verstappen, S M M, Voshaar, M, Woodworth, T G, Ellingsen, T, March, L, Wells, G A, Tugwell, P & Christensen, R 2021, ' OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study ', Seminars in arthritis and rheumatism . https://doi.org/10.1016/j.semarthrit.2021.03.013, Seminars in Arthritis and Rheumatism, 51(3), 601-606. W B Saunders Co-Elsevier Inc
Publication Year :
2021

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 consen-sus (>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. (c) 2021 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)

Details

Language :
English
ISSN :
00490172 and 1532866X
Database :
OpenAIRE
Journal :
Seminars in Arthritis and Rheumatism, 51(3), 601-606. W.B. Saunders Ltd, Nielsen, S M, Boers, M, de Wit, M, Shea, B, van der Windt, D A, Reeves, B C, Beaton, D, Alten, R, Toupin April, K, Boonen, A, Escorpizo, R, Flurey, C, Furst, D E, Guillemin, F, Leong, A, Pohl, C, Rasmussen, M U, Singh, J A, Smolen, J S, Strand, V, Verstappen, S M M, Voshaar, M, Woodworth, T G, Ellingsen, T, March, L, Wells, G A, Tugwell, P & Christensen, R 2021, ' OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials : A mixed methods study ', Seminars in Arthritis and Rheumatism, vol. 51, no. 3, pp. 601-606 . https://doi.org/10.1016/j.semarthrit.2021.03.013, Nielsen, S M, Boers, M, De Wit, M, Shea, B, Van Der Windt, D A, Reeves, B C, Beaton, D, Alten, R, Toupin April, K, Boonen, A, Escorpizo, R, Flurey, C, Furst, D E, Guillemin, F, Leong, A, Pohl, C, Rasmussen, M U, Singh, J A, Smolen, J S, Strand, V, Verstappen, S M M, Voshaar, M, Woodworth, T G, Ellingsen, T, March, L, Wells, G A, Tugwell, P & Christensen, R 2021, ' OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study ', Seminars in arthritis and rheumatism . https://doi.org/10.1016/j.semarthrit.2021.03.013, Seminars in Arthritis and Rheumatism, 51(3), 601-606. W B Saunders Co-Elsevier Inc
Accession number :
edsair.doi.dedup.....fc0f5a5753547842bdf5157d7e6bfdd6
Full Text :
https://doi.org/10.1016/j.semarthrit.2021.03.013