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

Publication type
Journal article
Authors
Nielsen SM Tugwell P de Wit MPT Boers M Beaton DE Woodworth TG Escorpizo R Shea B Toupin-April K Guillemin F Strand V Singh JA Kloppenburg M Furst DE Wells GA Smolen JS VeselĂ˝ R Boonen A Storgaard H Voshaar M March L Christensen R
Date published
2019 Sep 01
Journal
Journal of Rheumatology
Volume
46
Issue
9
Pages
1159-1163
Open Access?
No
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