TY - JOUR
T1 - Identifying provisional generic contextual factor domains for clinical trials in rheumatology
T2 - Results from an OMERACT initiative
AU - Nielsen, Sabrina M.
AU - Tugwell, Peter
AU - De Wit, Maarten P.T.
AU - Boers, Maarten
AU - Beaton, Dorcas E.
AU - Woodworth, Thasia G.
AU - Escorpizo, Reuben
AU - Shea, Beverley
AU - Toupin-April, Karine
AU - Guillemin, Francis
AU - Strand, Vibeke
AU - Singh, Jasvinder A.
AU - Kloppenburg, Margreet
AU - Furst, Daniel E.
AU - Wells, George A.
AU - Smolen, Josef S.
AU - Veselý, Richard
AU - Boonen, Annelies
AU - Storgaard, Helene
AU - Voshaar, Marieke
AU - March, Lyn
AU - Christensen, Robin
AU - for the Contextual Factors Working Group
N1 - Funding Information:
JAS is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 36 companies. AB received research grants to her department from Celgene and AbbVie. The views expressed in this article are personal views and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties. We thank all participants in our session at OMERACT 2018, as well as the chairs who responded to our survey (study 1a) and the experts and PRP who participated in the interviews (study 1b). A special thanks to the PRP for their positive engagement and input.
Publisher Copyright:
© 2019 The Journal of Rheumatology. All rights reserved.
PY - 2019/9/1
Y1 - 2019/9/1
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Omeract
KW - Outcomes
KW - Rheumatic diseases
KW - n/a OA procedure
UR - http://www.scopus.com/inward/record.url?scp=85070395267&partnerID=8YFLogxK
U2 - 10.3899/jrheum.181081
DO - 10.3899/jrheum.181081
M3 - Article
C2 - 30647174
AN - SCOPUS:85070395267
SN - 0315-162X
VL - 46
SP - 1159
EP - 1163
JO - Journal of rheumatology
JF - Journal of rheumatology
IS - 9
ER -