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Towards consensus in defining and handling contextual factors within rheumatology trials: an initial qualitative study from an OMERACT working group

Nielsen, Sabrina Mai; Uggen Rasmussen, Marianne; Boers, Maarten; A van der Windt, Danielle; de Wit, Maarten; G Woodworth, Thasia; A Flurey, Caroline; Beaton, Dorcas; Shea, Beverley; Escorpizo, Reuben; Furst, Daniel E; Smolen, Josef S; Toupin-April, Karine; Boonen, Annelies; Voshaar, Marieke; Ellingsen, Torkell; Wells, George A; Reeves, Barnaby C; March, Lyn; Tugwell, Peter; Christensen, Robin

Authors

Sabrina Mai Nielsen

Marianne Uggen Rasmussen

Maarten Boers

Maarten de Wit

Thasia G Woodworth

Caroline A Flurey

Dorcas Beaton

Beverley Shea

Reuben Escorpizo

Daniel E Furst

Josef S Smolen

Karine Toupin-April

Annelies Boonen

Marieke Voshaar

Torkell Ellingsen

George A Wells

Barnaby C Reeves

Lyn March

Peter Tugwell

Robin Christensen



Abstract

The Outcome Measures in Rheumatology Initiative established the Contextual Factors Working Group to guide the understanding, identification and handling of contextual factors for clinical trials. In clinical research, different uses of the term ‘contextual factors’ exist. This study explores the perspectives of researchers (including clinicians) and patients in defining 'contextual factor’ and its related terminology, identifying such factors and accounting for them in trials across rheumatology.

Citation

Nielsen, S. M., Uggen Rasmussen, M., Boers, M., A van der Windt, D., de Wit, M., G Woodworth, T., …Christensen, R. (2021). Towards consensus in defining and handling contextual factors within rheumatology trials: an initial qualitative study from an OMERACT working group. Annals of the Rheumatic Diseases, 80(2), 242-249. https://doi.org/10.1136/annrheumdis-2020-217895

Journal Article Type Article
Acceptance Date Sep 4, 2020
Online Publication Date Jan 12, 2021
Publication Date Feb 14, 2021
Deposit Date Jun 2, 2023
Journal Annals of the Rheumatic Diseases
Print ISSN 0003-4967
Electronic ISSN 1468-2060
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 80
Issue 2
Pages 242-249
DOI https://doi.org/10.1136/annrheumdis-2020-217895
Keywords General Biochemistry, Genetics and Molecular Biology; Immunology; Immunology and Allergy; Rheumatology