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

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., A Flurey, C., Beaton, D., Shea, B., Escorpizo, R., Furst, D. E., Smolen, J. S., Toupin-April, K., Boonen, A., Voshaar, M., Ellingsen, T., Wells, G. A., Reeves, B. C., March, L., Tugwell, P., & 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
• Public URL: https://keele-repository.worktribe.com/output/435344