Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 601-606 |
| Number of pages | 6 |
| Journal | Seminars in Arthritis and Rheumatism |
| Volume | 51 |
| Issue number | 3 |
| Early online date | 2021 |
| DOIs | |
| Publication status | Published - 1 Jun 2021 |
Keywords
- Consensus
- Contextual factors
- Delphi survey
- Effect modifying contextual factors
- Humans
- Measurement affecting contextual factors
- OMERACT
- Outcome Assessment, Health Care
- Outcome explaining contextual factors
- Research Design
- Rheumatology
- Surveys and Questionnaires
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}
In: Seminars in Arthritis and Rheumatism, Vol. 51, No. 3, 01.06.2021, p. 601-606.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study
T2 - A mixed methods study
AU - Nielsen, Sabrina Mai
AU - Boers, Maarten
AU - de Wit, Maarten
AU - Shea, Beverly
AU - van der Windt, Danielle A.
AU - Reeves, Barnaby C.
AU - Beaton, Dorcas
AU - Alten, Rieke
AU - Toupin April, Karine
AU - Boonen, Annelies
AU - Escorpizo, Reuben
AU - Flurey, Caroline
AU - Furst, Daniel E.
AU - Guillemin, Francis
AU - Leong, Amye
AU - Pohl, Christoph
AU - Rasmussen, Marianne Uggen
AU - Singh, Jasvinder A.
AU - Smolen, Josef S.
AU - Strand, Vibeke
AU - Verstappen, Suzanne M. M.
AU - Voshaar, Marieke
AU - Woodworth, Thasia G.
AU - Ellingsen, Torkell
AU - March, Lyn
AU - Wells, George A.
AU - Tugwell, Peter
AU - Christensen, Robin
N1 - Funding Information: Amye Leong: Conceptualization, Writing - Review & Editing; Annelies Boonen: Conceptualization, Resources, Writing - Review & Editing; Barney Reeves: Conceptualization, Methodology, Validation, Writing - Review & Editing; Beverley Shea: Conceptualization, Methodology, Writing - Review & Editing, Supervision; Caroline Flurey: Conceptualization, Methodology, Writing - Review & Editing; Christoph Pohl: Conceptualization, Writing - Review & Editing, Supervision; Daniel E Furst: Conceptualization, Validation, Writing - Review & Editing; Danielle van der Windt: Conceptualization, Methodology, Writing - Review & Editing; Dorcas Beaton: Conceptualization, Methodology, Writing - Review & Editing, Supervision; Francis Guillemin: Conceptualization, Writing - Review & Editing; George A Wells: Conceptualization, Methodology, Validation, Writing - Review & Editing, Supervision; Jasvinder Singh: Conceptualization, Writing - Review & Editing; Josef Smolen: Conceptualization, Methodology, Writing - Review & Editing; Karine Toupin-April: Conceptualization, Writing - Review & Editing; Lyn March: Conceptualization, Methodology, Writing - Review & Editing, Supervision; Maarten Boers: Conceptualization, Methodology, Validation, Writing - Review & Editing; Maarten de Wit: Conceptualization, Methodology, Investigation, Writing - Review & Editing; Marianne Uggen Rasmussen: Conceptualization, Methodology, Writing - Review & Editing, Supervision; Marieke Voshaar: Conceptualization, Writing - Review & Editing; Peter Tugwell: Conceptualization, Methodology, Writing - Review & Editing, Supervision; Rieke Alten: Conceptualization, Writing - Review & Editing; Reuben Escorpizo: Conceptualization, Validation, Writing - Review & Editing; Robin Christensen: Conceptualization, Methodology, Writing - Review & Editing, Supervision, Funding acquisition; Sabrina Mai Nielsen: Conceptualization, Methodology, Formal analysis, Investigation, Writing - Original Draft, Writing - Review & Editing, Visualization, Project administration Funding acquisition; Suzanne Verstappen: Conceptualization, Validation, Writing - Review & Editing; Thasia G Woodworth: Conceptualization, Writing - Review & Editing; Torkell Ellingsen: Conceptualization, Writing - Review & Editing, Supervision, Funding acquisition; Vibeke Strand: Conceptualization, Methodology, Writing - Review & Editing. The Parker Institute is grateful for the financial support received from public and private foundations, companies, and private individuals over the years. The Parker Institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18?774-OFIL); The Oak Foundation is a group of philanthropic organisations that, since its establishment in 1983, has given grants to not-for-profit organisations around the world. SMN has received PhD Scholarships from the Faculty of Health Sciences, University of Southern Denmark, and Odense University Hospital, and an introductory scholarship from the BFH Research Foundation. Furthermore, The Danish Rheumatism Association covered costs related to the fees of the OMERACT meeting. The funders had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all data of the study and had final responsibility for the decision to submit for publication. We would like to thank the pilot testers of the Delphi survey, including the patient research partners, Catherine Hofstetter, Mary Cowern, and Thomas Buttel, and the clinicians/researchers, Margreet Kloppenburg, Sofia Ramiro, Richard Holland, Ayano Kelly, Peter Wong. The feedback from the pilot tests has played an important role in shaping the final version of the survey. We would like to thank all who participated in our Delphi survey. In particular, we would like to thank those completing both Delphi rounds including (but not limited to): Dr. Allyson Jones, Dr. Ana-Maria ORBAI, Dr. Andrea Delle Sedie, Ms. Anne Boel, Emeritus Professor Anne E Ashford, Doctor Anne-Priscille Trouvin, Dr. Antonio Manzo, Mr. Ben Horgan, Ms. Catherine Hofstetter, Dr. C?sar D?az-Torn?, Emeritus Professor Charles H Goldsmith, Mr. CHAU Sze Ngai Jeffrey, Professor D?sir?e van der Heijde, Professor Dirkjan van Schaardenburg, Professor Ernest Choy, Ms. Esen Cam, Dr. F?line Kroon, Professor Francesca Ingegnoli, Professor Francis Berenbaum, Ms. Georgia Lanier, Ms. Gerd Jenny Aanerud, Mrs Heidi Nugent, Program Director Heiyoung Park, Dr. Hemalatha Srinivasalu, Ms. Ingrid de Groot, Professor J.A.P. da Silva, Dr. James R. Seibold, Dr. Kaitlin A. Quinn, Dr. Kathleen Tymms, Professor Leigh F Callahan, Professor Lene Terslev, Dr. Loreto Carmona, Mrs. Lorna Neill, Professor Margreet Kloppenburg, Professor Marian T. Hannan, Dr. Maria A. Lopez-Olivo, Dr. Marion A.J. van Rossum, Dr. Marion C. Kortekaas, Ms. Mary Cowern, Dr. Matthew Page, Professor Merete Lund Hetland, Associate professor Mihir D Wechalekar, Mr. Michael Gill, Dr. Mike Backhouse, Dr. Mitali Sen, Dr. Monique A. M. Gignac, Professor Nicola Dalbeth, Dr. Niti Goel, Dr. Owen Hensey, Professor Peter A. Merkel, Dr. Polina Putrik, Professor Randall M. Stevens, Assistant Professor Raouf Hajji, Dr. Ricardo J. O. Ferreira. Dr. Richard Vesel?, Professor Dr. Ruth Wittoek, Dr. Sara Tedeschi, Dr. Serena Carville, Ms. Shannon E. Kelly, Ms. Sharon Lee, Dr. Simon Otter, Dr. Sofia Ramiro, Professor Dr. Sule Yavuz, Professor Susan Bartlett, Professor Susanna Proudman, Dr. Tarimobo Michael Otobo, Mr. Thomas W Buttel, Dr. Tiffany K Gill, Professor Till Uhlig, Dr. Toby Smith, Dr. Ulrike Kaiser, Dr. Victoria Navarro-Comp?n, Dr. Violeta Vlad, Associate Professor William J. Taylor, Ms. Zabalan Minisoara Codruta, Mr. Zoltan Harsanyi. We would like to thank Richard Crew for continuous and rapid support for DelphiManager. We would like to thank all who participated in our virtual SIG session, including (but not limited to) Professor Adewale Adebajo MBE, Ms. Ingrid de Groot, Dr. Mike Backhouse, Dr. Richard Vesel?, Dr. Saurab Sharma, Ms. Shannon Kelly, Dr. Sofia Ramiro, Mr Thomas Buttel, Dr. Uta Kiltz, Dr. Win Min Oo. We would like to give a special thanks to Dr. Francesca Ingegnoli and Dr. Mike Backhouse for reviewing the manuscript, improving readability, and to Dr. Saurab Sharma for reviewing the manuscript, improving language and readability. An enormous thanks to the OMERACT secretary, Shawna Grosskleg, for continuous support, circulating invitations for our SIG meeting, ensuring easy access to our preparatory material through our website, setting up and managing all technical aspects of the Zoom call and much more. And finally, we would like to thank everyone in our working group not mentioned here. We are thankful for the interest and engagement in our working group and in the concept ?contextual factors?. Funding Information: Dr. Alten reports personal fees from Abbvie, personal fees from BMS, personal fees from Celltrion, grants from Galapagos, personal fees from Gilead, personal fees from Lilly, grants and personal fees from Pfizer, outside the submitted work. Annelies Boonen received research grants form Celgene and Abbvie and fees for advisory boards from Abbvie, Eli Lilly and Galapagos, all paid to her department. Dr. Furst reports NO stocks, royalties, direct financial holding, expert testimony, board of director. Grant/Research Support Actelion, Amgen, BMS Corbus, Galapagos GSK, NIH, Novartis, Pfizer, Sanofi, Roche/Genentech. Consultant Actelion, Amgen, BMS, Corbus, Galapagos Novartis, Pfizer, Speakers Bureau CME only. Dr. March reports personal fees from Pfizer Australia Ltd, personal fees from Bristol Myer Squibb Australia, personal fees from Elsevier Ltd, personal fees from Up To Date, grants from Janssen Australia, outside the submitted work; and LM is a member of the executive of OMERACT. Dr. Shea reports being the senior methodologist on this project. Dr. Singh reports personal fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Trio health, Adept Field solutions, Medscape, WebMD, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, Practice Point communications, the National Institutes of Health and the American College of Rheumatology, personal fees from Simply Speaking, other from Amarin, Viking, Moderna and Vaxart pharmaceuticals; and Charlotte's Web Holdings, non-financial support from FDA Arthritis Advisory Committee, non-financial support from Steering committee of OMERACT, non-financial support from Veterans Affairs Rheumatology Field Advisory Committee, non-financial support from Editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis, outside the submitted work. Dr. Smolen received grants to his institution from Abbvie, AstraZeneca, Janssen, Lilly, Merck Sharpe & Dohme, Pfizer, and Roche and provided expert advice for, or had symposia speaking engagements with, AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO Pharma, Janssen, Lilly, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, and UCB. V. Strand is a member of the executive of OMERACT. OMERACT , an organization that develops outcome measures in rheumatology, receives arms-length funding from 8 companies. The other authors have no conflict of interest relevant to the content of this study. Funding Information: The Parker Institute is grateful for the financial support received from public and private foundations, companies, and private individuals over the years. The Parker Institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OCAY-18–774-OFIL); The Oak Foundation is a group of philanthropic organisations that, since its establishment in 1983, has given grants to not-for-profit organisations around the world. SMN has received PhD Scholarships from the Faculty of Health Sciences, University of Southern Denmark, and Odense University Hospital, and an introductory scholarship from the BFH Research Foundation. Furthermore, The Danish Rheumatism Association covered costs related to the fees of the OMERACT meeting. The funders had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all data of the study and had final responsibility for the decision to submit for publication. Publisher Copyright: © 2021 The Authors Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/6/1
Y1 - 2021/6/1
N2 - Objectives: To develop an operational definition of contextual factors (CF) [1]. Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs. Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive. Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members.
AB - Objectives: To develop an operational definition of contextual factors (CF) [1]. Methods: Based on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs. Results: Of 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive. Conclusion: Through consensus we developed an operational definition of CFs, which was well received by OMERACT members.
KW - Consensus
KW - Contextual factors
KW - Delphi survey
KW - Effect modifying contextual factors
KW - Humans
KW - Measurement affecting contextual factors
KW - OMERACT
KW - Outcome Assessment, Health Care
KW - Outcome explaining contextual factors
KW - Research Design
KW - Rheumatology
KW - Surveys and Questionnaires
UR - http://www.scopus.com/inward/record.url?scp=85104286090&partnerID=8YFLogxK
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85104286090&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/33875246
U2 - https://doi.org/10.1016/j.semarthrit.2021.03.013
DO - https://doi.org/10.1016/j.semarthrit.2021.03.013
M3 - Article
C2 - 33875246
SN - 0049-0172
VL - 51
SP - 601
EP - 606
JO - Seminars in Arthritis and Rheumatism
JF - Seminars in Arthritis and Rheumatism
IS - 3
ER -