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 Decary; Maarten de Wit; Alexa Meara; Jennifer L. Barton; Liana Fraenkel; Linda C. Li; Peter Brooks; Beverly Shea; Dawn Stacey; France Legare; Anne Lydiatt; Cathie Hofstetter; Laurie Proulx; Robin Christensen; Marieke Voshaar; Maria E. Suarez-Almazor; Annelies Boonen; Tanya Meade; Lyn March; Janet 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; Ajesh Maharaj; Saurab Sharma; Francesco Caso; Christopher Fong; Anthony P. Fernandez; Sarah Mackie; Elena Nikiphorou; Allyson Jones; Regina Greer-Smith; Victor S. Sloan; Akpabio Akpabio; Vibeke Strand; Valerie Umaefulam; Sara Monti; Charmaine Melburn; Nouran Abaza; Kirsten Schultz; Simon Stones; Sonam Kiwalkar; Hemalatha Srinivasalu; Deb Constien; Lauren K. King; Peter Tugwell

doi:10.1016/j.semarthrit.2021.03.017

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 Decary, Maarten de Wit, Alexa Meara, Jennifer L. Barton, Liana Fraenkel, Linda C. Li, Peter Brooks, Beverly Shea, Dawn Stacey, France Legare, 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, Ajesh Maharaj, Saurab Sharma, Francesco Caso, Christopher Fong, Anthony P. Fernandez, Sarah Mackie, Elena Nikiphorou, Allyson Jones, Regina Greer-Smith, Victor S. Sloan, Akpabio Akpabio, Vibeke Strand, Valerie Umaefulam, Sara Monti, Charmaine Melburn, Nouran Abaza, Kirsten Schultz, Simon Stones, Sonam Kiwalkar, Hemalatha Srinivasalu, Deb Constien, Lauren K. King, Peter Tugwell

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-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 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.

Original language	English
Pages (from-to)	593-600
Number of pages	8
Journal	Seminars in Arthritis and Rheumatism
Volume	51
Issue number	3
DOIs	https://doi.org/10.1016/j.semarthrit.2021.03.017
Publication status	Published - Jun 2021

Keywords

OMERACT
Shared decision making
Core domain set
EULAR RECOMMENDATIONS
ARTHRITIS
MANAGEMENT
FRAMEWORK
AIDS

Access to Document

10.1016/j.semarthrit.2021.03.017

Cite this

Toupin-April, K., Decary, S., Wit, M. D., Meara, A., Barton, J. L., Fraenkel, L., Li, L. 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., ... 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), 593-600. https://doi.org/10.1016/j.semarthrit.2021.03.017

@article{f6227695c52e43c0bfa95372be0ef74a,

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

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 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.",

keywords = "OMERACT, Shared decision making, Core domain set, EULAR RECOMMENDATIONS, ARTHRITIS, MANAGEMENT, FRAMEWORK, AIDS",

author = "Karine Toupin-April and Simon Decary and Wit, {Maarten de} and Alexa Meara and Barton, {Jennifer L.} and Liana Fraenkel and Li, {Linda C.} and Peter Brooks and Beverly Shea and Dawn Stacey and France Legare and Anne Lydiatt and Cathie Hofstetter and Laurie Proulx and Robin Christensen and Marieke Voshaar and Suarez-Almazor, {Maria E.} and Annelies Boonen and Tanya Meade and Lyn March and Jull, {Janet Elizabeth} and Willemina Campbell and Rieke Alten and Morgan, {Esi M.} and Ayano Kelly and Jessica Kaufman and Sophie Hill and Maxwell, {Lara J.} and Francis Guillemin and Dorcas Beaton and Yasser El-Miedany and Shikha Mittoo and Robertson, {Tiffany Westrich} and Bartlett, {Susan J.} and Singh, {Jasvinder A.} and Melissa Mannion and Nasef, {Samah Ismail} and Souza, {Savia de} and Anne Boel and Adewale Adebajo and Laurent Arnaud and Gill, {Tiffany K.} and Ellen Moholt and Jennifer Burt and Arundathi Jayatilleke and Ihsane Hmamouchi and David Carrott and Blanco, {Francisco J.} and Kate Mather and Ajesh Maharaj and Saurab Sharma and Francesco Caso and Christopher Fong and Fernandez, {Anthony P.} and Sarah Mackie and Elena Nikiphorou and Allyson Jones and Regina Greer-Smith and Sloan, {Victor S.} and Akpabio Akpabio and Vibeke Strand and Valerie Umaefulam and Sara Monti and Charmaine Melburn and Nouran Abaza and Kirsten Schultz and Simon Stones and Sonam Kiwalkar and Hemalatha Srinivasalu and Deb Constien and King, {Lauren K.} and Peter Tugwell",

note = "Funding Information: Funding for travel awards to the OMERACT conference were provided by OMERACT . This funding was reported to OMERACT 2022 because of the Covid-19 pandemic. K. Toupin-April is funded by The Arthritis Society , the Chronic Pain Network (a Network funded by the Canadian Institutes of Health Research (CIHR) Strategy for Patient Oriented Research (SPOR), the Ontario Ministry of Economic Development , Job Creation and Trade and the Children's Hospital of Eastern Ontario Research Institute. S. D{\'e}cary received a Banting postdoctoral salary award from Canadian Institutes for Health Research. J. L. Barton's research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health , under Award Number K23AR-064372 . L. Fraenkel's research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health , under Award Number AR060231– 01 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. L. C. Li holds the Harold Robinson/Arthritis Society Chair in Arthritic Diseases, and is supported by the Canada Research Chair Program. D. Stacey holds a University of Ottawa Research Chair in Knowledge Translation to Patients. F. L{\'e}gar{\'e} holds a Tier 1 Canada Research Chair in Shared Decision Making and Knowledge Translation. R. Christensen's research at the Parker Institute is supported by grants from The Oak Foundation ( OCAY-13–309 ). L. March's research is supported by the Northern Sydney Local Health District. S. Hill is supported by La Trobe University. P. Tugwell holds a Canada Research Chair. Funding Information: The authors would like to thank Shawna Grosskleg, Laure Gossec, Sarah Collins, Thomas Chong, Pamela Richards, Ailsa Bosworth, Pamela Montie, Jennifer Petkovic, Vicki Evans, C?cile Gaujoux-Viala, Anne Stiggelbout, Suvi Karuranga, Ian M. Disend and Andrea Boyd. We would like to thank the Canadian Arthritis Patient Alliance (CAPA), the EULAR PARE (People with Arthritis and Rheumatism) network and EULAR PRPs, GRAPPA (Group for Research of Psoriasis and Psoriatic Arthritis) PRPs, the International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis), Creaky Joints, Joint Health, SAVVY Coop, S.T.A.R Initiative, the Childhood Arthritis and Rheumatology Research Alliance (CARRA), the Cochrane Musculoskeletal consumer group, Versus Arthritis UK, Arthritis Care Netherlands, Vasculitis UK, Osteoarthritis Research Society International (OARSI), Dragon Claw and the Canadian Rheumatology Association. Funding for travel awards to the OMERACT conference were provided by OMERACT. This funding was reported to OMERACT 2022 because of the Covid-19 pandemic. K. Toupin-April is funded by The Arthritis Society, the Chronic Pain Network (a Network funded by the Canadian Institutes of Health Research (CIHR) Strategy for Patient Oriented Research (SPOR), the Ontario Ministry of Economic Development, Job Creation and Trade and the Children's Hospital of Eastern Ontario Research Institute. S. D?cary received a Banting postdoctoral salary award from Canadian Institutes for Health Research. J. L. Barton's research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health, under Award Number K23AR-064372. L. Fraenkel's research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health, under Award Number AR060231? 01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. L. C. Li holds the Harold Robinson/Arthritis Society Chair in Arthritic Diseases, and is supported by the Canada Research Chair Program. D. Stacey holds a University of Ottawa Research Chair in Knowledge Translation to Patients. F. L?gar? holds a Tier 1 Canada Research Chair in Shared Decision Making and Knowledge Translation. R. Christensen's research at the Parker Institute is supported by grants from The Oak Foundation (OCAY-13?309). L. March's research is supported by the Northern Sydney Local Health District. S. Hill is supported by La Trobe University. P. Tugwell holds a Canada Research Chair. Publisher Copyright: {\textcopyright} 2021 Elsevier Inc.",

year = "2021",

month = jun,

doi = "10.1016/j.semarthrit.2021.03.017",

language = "English",

volume = "51",

pages = "593--600",

journal = "Seminars in Arthritis and Rheumatism",

issn = "0049-0172",

publisher = "W B Saunders Co-Elsevier Inc",

number = "3",

}

Toupin-April, K, Decary, S, Wit, MD, Meara, A, Barton, JL, Fraenkel, L, Li, LC, Brooks, P, Shea, B, Stacey, D, Legare, F, Lydiatt, A, Hofstetter, C, Proulx, L, Christensen, R, Voshaar, M, Suarez-Almazor, ME, Boonen, A, Meade, T, March, L, Jull, JE, Campbell, W, Alten, R, Morgan, EM, Kelly, A, Kaufman, J, Hill, S, Maxwell, LJ, Guillemin, F, Beaton, D, El-Miedany, Y, Mittoo, S, Robertson, TW, Bartlett, SJ, Singh, JA, Mannion, M, Nasef, SI, Souza, SD, Boel, A, Adebajo, A, Arnaud, L, Gill, TK, Moholt, E, Burt, J, Jayatilleke, A, Hmamouchi, I, Carrott, D, Blanco, FJ, Mather, K, Maharaj, A, Sharma, S, Caso, F, Fong, C, Fernandez, AP, Mackie, S, Nikiphorou, E, Jones, A, Greer-Smith, R, Sloan, VS, Akpabio, A, Strand, V, Umaefulam, V, Monti, S, Melburn, C, Abaza, N, Schultz, K, Stones, S, Kiwalkar, S, Srinivasalu, H, Constien, D, King, LK & 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, vol. 51, no. 3, pp. 593-600. https://doi.org/10.1016/j.semarthrit.2021.03.017

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, Karine; Decary, Simon; Wit, Maarten de et al.
In: Seminars in Arthritis and Rheumatism, Vol. 51, No. 3, 06.2021, p. 593-600.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials

T2 - Results from a multi-stepped consensus-building approach

AU - Toupin-April, Karine

AU - Decary, Simon

AU - Wit, Maarten de

AU - Meara, Alexa

AU - Barton, Jennifer L.

AU - Fraenkel, Liana

AU - Li, Linda C.

AU - Brooks, Peter

AU - Shea, Beverly

AU - Stacey, Dawn

AU - Legare, France

AU - Lydiatt, Anne

AU - Hofstetter, Cathie

AU - Proulx, Laurie

AU - Christensen, Robin

AU - Voshaar, Marieke

AU - Suarez-Almazor, Maria E.

AU - Boonen, Annelies

AU - Meade, Tanya

AU - March, Lyn

AU - Jull, Janet Elizabeth

AU - Campbell, Willemina

AU - Alten, Rieke

AU - Morgan, Esi M.

AU - Kelly, Ayano

AU - Kaufman, Jessica

AU - Hill, Sophie

AU - Maxwell, Lara J.

AU - Guillemin, Francis

AU - Beaton, Dorcas

AU - El-Miedany, Yasser

AU - Mittoo, Shikha

AU - Robertson, Tiffany Westrich

AU - Bartlett, Susan J.

AU - Singh, Jasvinder A.

AU - Mannion, Melissa

AU - Nasef, Samah Ismail

AU - Souza, Savia de

AU - Boel, Anne

AU - Adebajo, Adewale

AU - Arnaud, Laurent

AU - Gill, Tiffany K.

AU - Moholt, Ellen

AU - Burt, Jennifer

AU - Jayatilleke, Arundathi

AU - Hmamouchi, Ihsane

AU - Carrott, David

AU - Blanco, Francisco J.

AU - Mather, Kate

AU - Maharaj, Ajesh

AU - Sharma, Saurab

AU - Caso, Francesco

AU - Fong, Christopher

AU - Fernandez, Anthony P.

AU - Mackie, Sarah

AU - Nikiphorou, Elena

AU - Jones, Allyson

AU - Greer-Smith, Regina

AU - Sloan, Victor S.

AU - Akpabio, Akpabio

AU - Strand, Vibeke

AU - Umaefulam, Valerie

AU - Monti, Sara

AU - Melburn, Charmaine

AU - Abaza, Nouran

AU - Schultz, Kirsten

AU - Stones, Simon

AU - Kiwalkar, Sonam

AU - Srinivasalu, Hemalatha

AU - Constien, Deb

AU - King, Lauren K.

AU - Tugwell, Peter

N1 - Funding Information: Funding for travel awards to the OMERACT conference were provided by OMERACT . This funding was reported to OMERACT 2022 because of the Covid-19 pandemic. K. Toupin-April is funded by The Arthritis Society , the Chronic Pain Network (a Network funded by the Canadian Institutes of Health Research (CIHR) Strategy for Patient Oriented Research (SPOR), the Ontario Ministry of Economic Development , Job Creation and Trade and the Children's Hospital of Eastern Ontario Research Institute. S. Décary received a Banting postdoctoral salary award from Canadian Institutes for Health Research. J. L. Barton's research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health , under Award Number K23AR-064372 . L. Fraenkel's research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health , under Award Number AR060231– 01 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. L. C. Li holds the Harold Robinson/Arthritis Society Chair in Arthritic Diseases, and is supported by the Canada Research Chair Program. D. Stacey holds a University of Ottawa Research Chair in Knowledge Translation to Patients. F. Légaré holds a Tier 1 Canada Research Chair in Shared Decision Making and Knowledge Translation. R. Christensen's research at the Parker Institute is supported by grants from The Oak Foundation ( OCAY-13–309 ). L. March's research is supported by the Northern Sydney Local Health District. S. Hill is supported by La Trobe University. P. Tugwell holds a Canada Research Chair. Funding Information: The authors would like to thank Shawna Grosskleg, Laure Gossec, Sarah Collins, Thomas Chong, Pamela Richards, Ailsa Bosworth, Pamela Montie, Jennifer Petkovic, Vicki Evans, C?cile Gaujoux-Viala, Anne Stiggelbout, Suvi Karuranga, Ian M. Disend and Andrea Boyd. We would like to thank the Canadian Arthritis Patient Alliance (CAPA), the EULAR PARE (People with Arthritis and Rheumatism) network and EULAR PRPs, GRAPPA (Group for Research of Psoriasis and Psoriatic Arthritis) PRPs, the International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis), Creaky Joints, Joint Health, SAVVY Coop, S.T.A.R Initiative, the Childhood Arthritis and Rheumatology Research Alliance (CARRA), the Cochrane Musculoskeletal consumer group, Versus Arthritis UK, Arthritis Care Netherlands, Vasculitis UK, Osteoarthritis Research Society International (OARSI), Dragon Claw and the Canadian Rheumatology Association. Funding for travel awards to the OMERACT conference were provided by OMERACT. This funding was reported to OMERACT 2022 because of the Covid-19 pandemic. K. Toupin-April is funded by The Arthritis Society, the Chronic Pain Network (a Network funded by the Canadian Institutes of Health Research (CIHR) Strategy for Patient Oriented Research (SPOR), the Ontario Ministry of Economic Development, Job Creation and Trade and the Children's Hospital of Eastern Ontario Research Institute. S. D?cary received a Banting postdoctoral salary award from Canadian Institutes for Health Research. J. L. Barton's research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health, under Award Number K23AR-064372. L. Fraenkel's research reported in this publication was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health, under Award Number AR060231? 01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. L. C. Li holds the Harold Robinson/Arthritis Society Chair in Arthritic Diseases, and is supported by the Canada Research Chair Program. D. Stacey holds a University of Ottawa Research Chair in Knowledge Translation to Patients. F. L?gar? holds a Tier 1 Canada Research Chair in Shared Decision Making and Knowledge Translation. R. Christensen's research at the Parker Institute is supported by grants from The Oak Foundation (OCAY-13?309). L. March's research is supported by the Northern Sydney Local Health District. S. Hill is supported by La Trobe University. P. Tugwell holds a Canada Research Chair. Publisher Copyright: © 2021 Elsevier Inc.

PY - 2021/6

Y1 - 2021/6

N2 - 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.

AB - 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.

KW - OMERACT

KW - Shared decision making

KW - Core domain set

KW - EULAR RECOMMENDATIONS

KW - ARTHRITIS

KW - MANAGEMENT

KW - FRAMEWORK

KW - AIDS

U2 - 10.1016/j.semarthrit.2021.03.017

DO - 10.1016/j.semarthrit.2021.03.017

M3 - Article

C2 - 33892937

SN - 0049-0172

VL - 51

SP - 593

EP - 600

JO - Seminars in Arthritis and Rheumatism

JF - Seminars in Arthritis and Rheumatism

IS - 3

ER -