Identifying provisional generic contextual factor domains for clinical trials in rheumatology: Results from an OMERACT initiative

Sabrina M. Nielsen, Peter Tugwell, Maarten P.T. De Wit, Maarten Boers, Dorcas E. Beaton, Thasia G. Woodworth, Reuben Escorpizo, Beverley Shea, Karine Toupin-April, Francis Guillemin, Vibeke Strand, Jasvinder A. Singh, Margreet Kloppenburg, Daniel E. Furst, George A. Wells, Josef S. Smolen, Richard Veselý, Annelies Boonen, Helene Storgaard, Marieke VoshaarLyn March, Robin Christensen*, for the Contextual Factors Working Group

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Objective. The Contextual Factors Working Group aims to provide guidance on addressing contextual factors in rheumatology trials within OMERACT. Methods. During the Special Interest Group session at OMERACT 2018, preliminary results were presented from a case scenario survey and semistructured interviews, including contextual factors mentioned in these. A group-based exercise sought to identify and rank important generic contextual factors. Results. A total of 79 candidate factors were listed. Across the 3 groups, gender/sex, comorbidities, and the healthcare system were ranked as most important. Conclusion. The identified important contextual factor domains may be considered a provisional list pending further research.

Original languageEnglish
Pages (from-to)1159-1163
Number of pages5
JournalJournal of Rheumatology
Volume46
Issue number9
DOIs
Publication statusPublished - 1 Sep 2019

Cite this

Nielsen, S. M., Tugwell, P., De Wit, M. P. T., Boers, M., Beaton, D. E., Woodworth, T. G., ... for the Contextual Factors Working Group (2019). Identifying provisional generic contextual factor domains for clinical trials in rheumatology: Results from an OMERACT initiative. Journal of Rheumatology, 46(9), 1159-1163. https://doi.org/10.3899/jrheum.181081