Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach

Karine Toupin-April, Simon Décary, Maarten de Wit, Alexa Meara, Jennifer L. Barton, Liana Fraenkel, Linda C. Li, Peter Brooks, Beverly Shea, Dawn Stacey, France Légaré, Anne Lydiatt, Cathie Hofstetter, Laurie Proulx, Robin Christensen, Marieke Voshaar, Maria E. Suarez-Almazor, Annelies Boonen, Tanya Meade, Lyn MarchJanet Elizabeth Jull, Willemina Campbell, Rieke Alten, Esi M. Morgan, Ayano Kelly, Jessica Kaufman, Sophie Hill, Lara J. Maxwell, Francis Guillemin, Dorcas Beaton, Yasser El-Miedany, Shikha Mittoo, Tiffany Westrich Robertson, Susan J. Bartlett, Jasvinder A. Singh, Melissa Mannion, Samah Ismail Nasef, Savia de Souza, Anne Boel, Adewale Adebajo, Laurent Arnaud, Tiffany K. Gill, Ellen Moholt, Jennifer Burt, Arundathi Jayatilleke, Ihsane Hmamouchi, David Carrott, Francisco J. Blanco, Kate Mather, Sara Monti

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions. Methods: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating white-board videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set. Results: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1- Knowledge of options, their potential benefits and harms; 2- Chosen option aligned with each patient's values and preferences; 3- Confidence in the chosen option; 4- Satisfaction with the decision-making process; 5- Adherence to the chosen option and 6- Potential negative consequences of the SDM intervention. Conclusion: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set. Clinical significance: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers.

Original languageEnglish
JournalSeminars in Arthritis and Rheumatism
DOIs
Publication statusAccepted/In press - 2021

Keywords

  • Core domain set
  • OMERACT
  • Shared decision making

ASJC Scopus subject areas

  • Rheumatology
  • Anesthesiology and Pain Medicine

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