Monika E. Finger
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
Thasia G. Woodworth
Sabrina M. Nielsen
Suzanne M. Verstappen
Dorcas E. Beaton
Peter S. Tugwell
Lyn M. March
Amye L Leong
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 |
You might also like
Downloadable Citations
About UWE Bristol Research Repository
Administrator e-mail: repository@uwe.ac.uk
This application uses the following open-source libraries:
SheetJS Community Edition
Apache License Version 2.0 (http://www.apache.org/licenses/)
PDF.js
Apache License Version 2.0 (http://www.apache.org/licenses/)
Font Awesome
SIL OFL 1.1 (http://scripts.sil.org/OFL)
MIT License (http://opensource.org/licenses/mit-license.html)
CC BY 3.0 ( http://creativecommons.org/licenses/by/3.0/)
Powered by Worktribe © 2024
Advanced Search