About the Contextual Factors Working Group
In 2012, ‘contextual factors’ was introduced for the first time in the OMERACT process, but identifying, understanding and approaching contextual factors proved difficult. The Contextual Factors Working Group (CFWG) was formed to provide guidance on how to address these challenges. An essential part of the research plan includes developing an operational definition and guidance on how to address contextual factors in rheumatology trials, when developing core outcome measurement sets
Robin Christensen
Co-Chair
Lyn March
Co-Chair
Peter Tugwell
Co-Chair
Sabrina Mai Nielsen
Emerging Leader
OMERACT consensus-based operational definition of contextual factors:
Overview of the consensus-based operational definition of contextual factors. The three contextual factor types describe different ways that contextual factors can influence the results of a trial. Brief descriptions of each type are shown in the figure. All three types are described in detail in the material below. In short, EM-CFs modify the treatment effect (i.e. some patient subgroups experience greater or less effect from a treatment compared to other subgroups). OI-CFs are prognostic factors (sometimes called risk factors), i.e. factors predicting the course of a patient’s condition and may confound the results of trials that are not randomized. MA-CFs influence the performance of outcome measurement instruments (such as reliability, validity, responsiveness, etc.). To guide which specific factors could be considered contextual factors, the factors must fit within one of the three classification categories, i.e. either personal-, disease-related, or environmental factors. The contextual factor types are not mutually exclusive, so some specific factors, e.g. sex, may both be an EM-CF, OI-CF, and MA-CF. CFs, Contextual Factors. Figure published in Nielsen et al. Semin Arthritis Rheum. 2021 Jun;51(3):601-606.
About Contextual Factors Working Group
What are Contextual Factors?
![Quiz photo[16]](https://omeract.org/wp-content/uploads/2023/03/Quiz-photo16-scaled.jpg "Quiz photo[16]")
Working Group Publications
(Nielsen et al. 2021) OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study
(Nielsen et al. 2020) Towards consensus in defining and handling contextual factors within rheumatology trials: an initial qualitative study from an OMERACT working group
(Nielsen et al. 2019) Identifying Provisional Generic Contextual Factor Domains for Clinical Trials in Rheumatology: Results from an OMERACT Initiative
(Finger et al. 2017) An OMERACT Initiative Toward Consensus to Identify and Characterize Candidate Contextual Factors: Report from the Contextual Factors Working Group
Working Group Members:
Dorcas Beaton
Lyn March
Peter Tugwell
Robin Christensen
Sabrina Mai Nielsen
Farwa Asim
Max Mischkewitz
Midhat Kamal
Marieke Voshaar
Amye Leong
Niti Goel
Esen Cam
Maarten de Wit
Pam Richards
Michael Gill
Gerd Jenny Aanerud
Patricia Hurley
Diana Hollander
Mary Cowern
Catherine Hofstetter
Aidan Cashin
Allyson Jones
Annelies Boonen
Ayano Kelly
Barnaby Reeves
Caroline Flurey
Catherine Hill
Christoph Pohl
Clifton Bingham
Courage Uhunmwangho
Daniel Furst
Danielle van der Windt
Dinesh Khanna
Dorthe B Berthelsen
Ernest Choy
Eva E. Wæhrens
Francesca Ingegnoli
Francis Guillemin
George Wells
Graham Macdonald
Gulen Hatemi
Helene Storgaard
Irene van der Horst-Bruinsma
Jasvinder Singh
Jennifer Petkovic
Joachim Musaus
Josef Smolen
Karine Toupin-April
Kathleen Tymms
Lara Maxwell
Lars Erik Kristensen
Laure Gossec
Lihi Eder
Linda Li
Bev Shea
Lisa Christopher-Stine
Lisa Stamp
Margreet Kloppenburg
Maria A. Lopez-Olivo
Maria E. Suarez-Almazor
Michael G. Lyon
Monika Finger
Maarten Boers
Nataliya Milman
Peter Choong
Peter Merkel
Peter Taylor
Philip Conaghan
Philip J. Mease
Reuben Escorpizo
Richard Veselý
Rieke Alten
Sarah Mackie
Saurab Sharma
Sofia Ramiro
Stanton P. Newman
Suzanne Verstappen
Thasia Woodworth
Torkell Ellingsen
Vibeke Strand
Will Taylor