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

Toupin-April, K.; Decary, S.; Wit, M. de; Meara, A.; Barton, J.L.; Fraenkel, L.; ... ; Tugwell, P. (2021)

Article / Letter to editor

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 whiteboard 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.(c) 2021 Elsevier Inc. All rights reserved.

• OMERACT
• Shared decision making
• Core domain set

• All authors: Toupin-April, K.; Decary, S.; Wit, M. de; Meara, A.; Barton, J.L.; Fraenkel, L.; Li, L.D.C.; Brooks, P.; Shea, B.; Stacey, D.; Legare, F.; Lydiatt, A.; Hofstetter, C.; Proulx, L.; Christensen, R.; Voshaar, M.; Suarez-Almazor, M.E.; Boonen, A.; Meade, T.; March, L.; Jull, J.E.; Campbell, W.; Alten, R.; Morgan, E.M.; Kelly, A.; Kaufman, J.; Hill, S.; Maxwell, L.J.; Guillemin, F.; Beaton, D.; El-Miedany, Y.; Mittoo, S.; Robertson, T.W.; Bartlett, S.J.; Singh, J.A.; Mannion, M.; Nasef, S.I.; Souza, S. de; Boel, A.; Adebajo, A.; Arnaud, L.; Gill, T.K.; Moholt, E.; Burt, J.; Jayatilleke, A.; Hmamouchi, I.; Carrott, D.; Blanco, F.J.; Mather, K.; Maharaj, A.; Sharma, S.; Caso, F.; Fong, C.; Fernandez, A.P.; Mackie, S.; Nikiphorou, E.; Jones, A.; Greer-Smith, R.; Sloan, V.S.; Akpabio, A.; Strand, V.; Umaefulam, V.; Monti, S.; Melburn, C.; Abaza, N.; Schultz, K.; Stones, S.; Kiwalkar, S.; Srinivasalu, H.; Constien, D.; King, L.K.; Tugwell, P.
• Date: 2021-06-01
• Journal: Seminars in Arthritis and Rheumatism
• Volume: 51
• Issue: 3
• Pages: 593 - 600
• DOI: doi:10.1016/j.semarthrit.2021.03.017