Identifying Provisional Generic Contextual Factor Domains for Clinical Trials in Rheumatology: Results from an OMERACT Initiative
Sabrina Nielsen
,
Peter Tugwell
(1)
,
Maarten P.T. de Wit
,
Maarten Boers
(2)
,
Dorcas Beaton
(3)
,
Thasia G. Woodworth
(4)
,
Reuben Escorpizo
,
Beverley Shea
,
Karine Toupin-April
,
Francis Guillemin
(5)
,
Vibeke Strand
(6)
,
Jasvinder Singh
,
Margreet Kloppenburg
,
Daniel Furst
(4)
,
George Wells
,
Josef Smolen
(7)
,
Richard Veselý
,
Annelies Boonen
(8)
,
Helene Storgaard
,
Marieke Voshaar
,
Lyn March
(9)
,
Robin Christensen
(10)
1
University of Ottawa [Ottawa]
2 Department of Clinical Epidemiology and Biostatistics
3 IWH - Institute for Work and Health
4 UCLA - University of California [Los Angeles]
5 APEMAC - Maladies chroniques, santé perçue, et processus d'adaptation
6 Stanford School of Medicine [Stanford]
7 Medizinische Universität Wien = Medical University of Vienna
8 MUMC - Maastricht University Medical Centre
9 Institute of Bone & Joint Research
10 The Parker Institute
2 Department of Clinical Epidemiology and Biostatistics
3 IWH - Institute for Work and Health
4 UCLA - University of California [Los Angeles]
5 APEMAC - Maladies chroniques, santé perçue, et processus d'adaptation
6 Stanford School of Medicine [Stanford]
7 Medizinische Universität Wien = Medical University of Vienna
8 MUMC - Maastricht University Medical Centre
9 Institute of Bone & Joint Research
10 The Parker Institute
Sabrina Nielsen
- Function : Author
Peter Tugwell
- Function : Author
- PersonId : 791626
- ORCID : 0000-0001-5062-0556
- IdRef : 081376324
Maarten P.T. de Wit
- Function : Author
Reuben Escorpizo
- Function : Author
Beverley Shea
- Function : Author
Karine Toupin-April
- Function : Author
Francis Guillemin
- Function : Author
- PersonId : 757347
- IdRef : 068536569
Jasvinder Singh
- Function : Author
Margreet Kloppenburg
- Function : Author
George Wells
- Function : Author
Richard Veselý
- Function : Author
Helene Storgaard
- Function : Author
Marieke Voshaar
- Function : Author
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.