Consensus on the definitions and descriptions of the domains of the OMERACT Core Outcome Set for shared decision making interventions in rheumatology trials

Journal article

Décary, Simon, de Wit, Maarten, Naye, Florian, Barton, Jennifer L., Fraenkel, Liana, Li, Linda C., Brooks, Peter, Stacey, Dawn, Maxwell, Lara J., Campbell, Willemina, Hofstetter, Cathie, Voshaar, Marieke, Meara, Alexa, Christensen, Robin, Boonen, Annelies, Suarez-Almazor, Maria E., Meade, Tanya, March, Lyn, Jull, Janet Elizabeth, Alten, Rieke, Morgan, Esi M., Hazlewood, Glen, Barber, Claire, Guillemin, Francis, El-Miedany, Yasser, Mittoo, Shikha, Robertson, Tiffany Westrich, Bartlett, Susan J., Singh, Jasvinder A., Mannion, Melissa, Nasef, Samah Ismail, Boel, Anne, Adebajo, Adewale, Arnaud, Laurent, Gill, Tiffany K., Moholt, Ellen, Burt, Jennifer, Jayatilleke, Arundathi, Hmamouchi, Ihsane, Berthelsen, Dorthe B, Blanco, Francisco J., Mather, Kate, Maharaj, Ajesh, Sharma, Saurab, Caso, Francesco, Beaton, Dorcas, Shea, Beverly, Fong, Christopher, Fernandez, Anthony P., Mackie, Sarah, Nikiphorou, Elena, Jones, Allyson, Greer-Smith, Regina, Sloan, Victor S., Akpabio, Akpabio, Strand, Vibeke, Lee, Rebecca R., Umaefulam, Valerie, Monti, Sara, Abaza, Nouran, Schultz, Grayson, Stones, Simon, Gossec, Laure, Nielsen, Sabrina Mai, Cavallo, Sabrina, Srinivasalu, Hemalatha, Constien, Deb, Evans, Vicki, Tugwell, Peter and Toupin-April, K. 2024. Consensus on the definitions and descriptions of the domains of the OMERACT Core Outcome Set for shared decision making interventions in rheumatology trials. Seminars in Arthritis and Rheumatism. 65, p. 152381. https://doi.org/10.1016/j.semarthrit.2024.152381
AuthorsDécary, Simon, de Wit, Maarten, Naye, Florian, Barton, Jennifer L., Fraenkel, Liana, Li, Linda C., Brooks, Peter, Stacey, Dawn, Maxwell, Lara J., Campbell, Willemina, Hofstetter, Cathie, Voshaar, Marieke, Meara, Alexa, Christensen, Robin, Boonen, Annelies, Suarez-Almazor, Maria E., Meade, Tanya, March, Lyn, Jull, Janet Elizabeth, Alten, Rieke, Morgan, Esi M., Hazlewood, Glen, Barber, Claire, Guillemin, Francis, El-Miedany, Yasser, Mittoo, Shikha, Robertson, Tiffany Westrich, Bartlett, Susan J., Singh, Jasvinder A., Mannion, Melissa, Nasef, Samah Ismail, Boel, Anne, Adebajo, Adewale, Arnaud, Laurent, Gill, Tiffany K., Moholt, Ellen, Burt, Jennifer, Jayatilleke, Arundathi, Hmamouchi, Ihsane, Berthelsen, Dorthe B, Blanco, Francisco J., Mather, Kate, Maharaj, Ajesh, Sharma, Saurab, Caso, Francesco, Beaton, Dorcas, Shea, Beverly, Fong, Christopher, Fernandez, Anthony P., Mackie, Sarah, Nikiphorou, Elena, Jones, Allyson, Greer-Smith, Regina, Sloan, Victor S., Akpabio, Akpabio, Strand, Vibeke, Lee, Rebecca R., Umaefulam, Valerie, Monti, Sara, Abaza, Nouran, Schultz, Grayson, Stones, Simon, Gossec, Laure, Nielsen, Sabrina Mai, Cavallo, Sabrina, Srinivasalu, Hemalatha, Constien, Deb, Evans, Vicki, Tugwell, Peter and Toupin-April, K.
Abstract

Objective
To gain consensus on the definitions and descriptions of the domains of the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials evaluating shared decision making (SDM) interventions.

Methods
Following the OMERACT Handbook methods, our Working Group (WG), comprised of 90 members, including 17 patient research partners (PRPs) and 73 clinicians and researchers, had six virtual meetings in addition to email exchanges to develop draft definitions and descriptions. The WG then conducted an international survey of its members to gain consensus on the definitions and descriptions. Finally, the WG members had virtual meetings and e-mail exchanges to review survey results and finalize names, definitions and descriptions of the domains.

Results
WG members contributed to developing the definitions. Fifty-two members representing four continents and 13 countries completed the survey, including 15 PRPs, 33 clinicians and 37 researchers. PRPs and clinicians/researchers agreed with all definitions and descriptions with agreements ranging from 87% to 100%. Respondents suggested wording changes to the names, definitions and descriptions to better reflect the domains. Discussions led to further simplification and clarification to address common questions/concerns about the domains.

Conclusion
Our WG reached consensus on the definitions and descriptions of the domains of the core domain set for rheumatology trials of SDM interventions. This step is crucial to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set.

Clinical significance
The current study provides consensus-based definitions and descriptions for the domains of the OMERACT core domain set for shared decision making interventions from patients/caregivers, clinicians and researchers. This is a crucial step to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set for trials of SDM interventions.

KeywordsOMERACT; Outcome Measures in Rheumatology ; SDM; Shared decision making; PRPs; Patient research partners; WG; Working group
Year2024
JournalSeminars in Arthritis and Rheumatism
Journal citation65, p. 152381
PublisherElsevier
ISSN00490172
Digital Object Identifier (DOI)https://doi.org/10.1016/j.semarthrit.2024.152381
Official URLhttps://www.sciencedirect.com/science/article/pii/S0049017224000222
Publication dates
PrintApr 2024
Publication process dates
Deposited18 Jan 2024
Output statusPublished
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