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

Journal article

Toupin-April, K., Décary, S., de Wit, M., Meara, A., Barton, J. L., Fraenkel, L., Li, L. C., Brooks, P., Shea, B., Stacey, D., Légaré, 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., Westrich Robertson, T., Bartlett, S. J., Singh, J. A., Mannion, M., Nasef, S. I., de Souza, S., 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. and Tugwell, P. 2021. Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach. Seminars in Arthritis and Rheumatism. 51 (3). https://doi.org/10.1016/j.semarthrit.2021.03.017
AuthorsToupin-April, K., Décary, S., de Wit, M., Meara, A., Barton, J. L., Fraenkel, L., Li, L. C., Brooks, P., Shea, B., Stacey, D., Légaré, 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., Westrich Robertson, T., Bartlett, S. J., Singh, J. A., Mannion, M., Nasef, S. I., de Souza, S., 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. and Tugwell, P.
AbstractTo gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions. 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. 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. 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. 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. [Abstract copyright: Copyright © 2021 Elsevier Inc. All rights reserved.]
KeywordsCore domain set; OMERACT; Shared decision making
Year2021
JournalSeminars in Arthritis and Rheumatism
Journal citation51 (3)
PublisherElsevier
ISSN1532-866X
Digital Object Identifier (DOI)https://doi.org/10.1016/j.semarthrit.2021.03.017
Official URLhttps://doi.org/10.1016/j.semarthrit.2021.03.017
FunderOMERACT
The Arthritis Society
Canadian Institutes of Health Research
Ontario Ministry of Economic Development
National Institute for Health Research (NIHR)
The Oak Foundation
Publication dates
Online06 Apr 2021
Publication process dates
Accepted26 Mar 2021
Deposited10 May 2021
Output statusIn press
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