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

Robin Christensen

Co-Chair

Lyn March

Lyn March

Co-Chair

Peter Tugwell

Peter Tugwell

Co-Chair

Sabrina Mai Nielsen

Sabrina Mai Nielsen

Emerging Leader

Farwa photo

Farwa Asim

Fellow

Midhat photo

Midhat Kamal

Fellow

Max

Max Mischkewitz

Fellow

niti goel

Niti Goel

Patient Research Partner

amye leong

Amye Leong

Patient Research Partner

Marieke Scholte-Voshaar

Marieke Scholte-Voshaar

Patient Research Partner

OMERACT consensus-based operational definition of contextual factors:

Fig 2 original 2021.01.25

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?

OMERACT 2020 Virtual Contextual Factors Special Interest Group November 12th 2020

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
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
Josef Smolen
Karine Toupin-April
Kathleen Tymms
Lara Maxwell
Lars Erik Kristensen
Laure Gossec
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

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