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An OMERACT initiative toward consensus to identify and characterize candidate contextual factors: Report from the contextual factors working group

Finger, Monika E.; Woodworth, Thasia G.; Nielsen, Sabrina M.; Verstappen, Suzanne M.; Beaton, Dorcas E.; Tugwell, Peter S.; March, Lyn M.; Leong, Amye L; Flurey, Caroline A; Boonen, Annelies; Escorpizo, Reuben; Christensen, Robin; Voshaar, Marieke Scholte; Furst, Daniel E; Milman, Nataliya; Alten, Rieke; Guillemin, Francis; Kloppenburg, Margreet; Pohl, Christoph

Authors

Monika E. Finger

Thasia G. Woodworth

Sabrina M. Nielsen

Suzanne M. Verstappen

Dorcas E. Beaton

Peter S. Tugwell

Lyn M. March

Amye L Leong

Profile Image

Caroline Flurey Caroline2.Flurey@uwe.ac.uk
Associate Professor in Men's Health and Long-term Conditions

Annelies Boonen

Reuben Escorpizo

Robin Christensen

Marieke Scholte Voshaar

Daniel E Furst

Nataliya Milman

Rieke Alten

Francis Guillemin

Margreet Kloppenburg

Christoph Pohl



Abstract

Copyright © 2017. All rights reserved. Objective: The importance of contextual factors (CF) for appropriate patient-specific care is widely acknowledged. However, evidence in clinical trials on how CF influence outcomes remains sparse. The 2014 Outcome Measures in Rheumatology (OMERACT) Handbook introduced the role of CF in outcome assessment and defined them as "potential confounders and/or effect modifiers of outcomes in randomized controlled trials." Subsequently, the CF Methods Group (CFMG) was formed to develop guidance on how to address CF in clinical trials. Methods: First, the CFMG conducted an e-mail survey of OMERACT working groups (WG) to analyze how they had addressed CF in outcome measurement so far. The results facilitated an informed discussion at the OMERACT 2016 CFMG Special Interest Group (SIG) session, with the aim of gaining preliminary consensus regarding an operational definition of CF and to make a first selection of potentially relevant CF. Results: The survey revealed that the WG had mostly used the OMERACT Handbook and/or the International Classification of Functioning, Disability and Health (ICF) definition. However, significant heterogeneity was found in the methods used to identify, refine, and categorize CF candidates. The SIG participants agreed on using the ICF as a framework along with the OMERACT Handbook definition. A list with 28 variables was collected including person-related factors and physical and social environments. Recommendations from the SIG guided the CFMG to formulate 3 preliminary projects on how to identify and analyze CF. Conclusion: New methods are urgently needed to assist researchers to identify and characterize CF that significantly influence the interpretation of results in clinical trials. The CFMG defined first steps to develop further guidance. The Journal of Rheumatology

Citation

March, L. M., Tugwell, P. S., Beaton, D. E., Verstappen, S. M., Nielsen, S. M., Woodworth, T. G., …Pohl, C. (2017). An OMERACT initiative toward consensus to identify and characterize candidate contextual factors: Report from the contextual factors working group. Journal of Rheumatology, 44(11), 1734-1739. https://doi.org/10.3899/jrheum.161200

Journal Article Type Article
Acceptance Date Mar 27, 2017
Publication Date Nov 1, 2017
Deposit Date May 16, 2017
Publicly Available Date Mar 28, 2024
Journal Journal of Rheumatology
Print ISSN 0315-162X
Electronic ISSN 1499-2752
Publisher Journal of Rheumatology
Peer Reviewed Peer Reviewed
Volume 44
Issue 11
Pages 1734-1739
DOI https://doi.org/10.3899/jrheum.161200
Public URL https://uwe-repository.worktribe.com/output/887619
Publisher URL http://dx.doi.org/10.3899/jrheum.161200