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

To 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.

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Declaration of Competing Interest Karine Toupin-April, Simon Décary, Maarten de Wit, Alexa Meara, Jennifer L. Barton, Liana Fraenkel, Linda C. Li, Peter Brooks, Beverley Shea, Dawn Stacey, France Légaré, Anne Lyddiatt, Cathie Hofstetter, Laurie Proulx, Marieke Voshaar, Maria E. Suarez-Almazor, Tanya Meade, Janet Elizabeth Jull, Willemina Campbell, Rieke Alten, Esi M. Morgan, Ayano Kelly, Jessica Kaufman, Lara J. Maxwell, Francis Guillemin, Dorcas Beaton, Yasser El-Miedany, Shikha Mittoo, Tiffany Westrich Robertson, Susan J. Bartlett, Melissa Mannion, Samah Ismail Nasef, Savia de Souza, Anne Boel, Adewale Adebajo, Laurent Arnaud, Tiffany Gill, Ellen Moholt, Jennifer Burt, Aruni Jayatilleke, Ihsane Hmamouchi, David Carrott, Kate Mather, Ajesh Maharaj, Saurab Sharma, Francesco Caso, Christopher Fong, Allyson Jones, Regina Greer-Smith, Akpabio Akpabio, Valerie Umaefulam, Sara Monti, Charmaine Melburn, Kirsten Schultz, Simon Stones, Sonam Kiwalkar, Hemalatha Srinivasalu, Deb Constien, Lauren K. King and Peter Tugwell have nothing to disclose. Robin Christensen reports other from Lecture: Research Methods (Pfizer, DK; 2017), other from Lecture: GRADE Lecture (Celgene, DK; 2017), other from Ad Board Lecture: CAM (Orkla Health, DK; 2017), other from Project Grant: "GreenWhistle" (Mundipharma, 2019), other from Lecture: Diet in RMD (Novartis, DK; 2019), other from Consultancy Report: Network MA's (Biogen, DK; 2017), other from Ad Board Lecture: GRADE (Lilly, DK; 2017), other from Consultancy Report: GRADE (Celgene, 2018), other from Lecture: Network MA's (LEO; 2020), outside the submitted work; and Musculoskeletal Statistics Unit, The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation; The Oak Foundation is a group of philanthropic organizations that, since its establishment in 1983, has given grants to not-for-profit organizations around the world. Annelies Boonen reports grants from Abbvie, grants from Celgene, other from UCB, other from Galapagos, other from Eli Lilly, outside the submitted work. Lyn March reports personal fees from Pfizer Australia, personal fees from Abbvie Australia, grants from Janssen Australia, outside the submitted work; Dr March is a member of OMERACT executive that receives arms-length funding from 9 companies. Willemina Campbell received OMERACT funded travel to a conference to attend meetings in regard to this paper. Sophie Hill is the Coordinating Editor of the Cochrane Consumers and Communication Group which publishes reviews of the evidence on shared decision making. Jasvinder Singh reports personal fees from Crealta/Horizon, Medisys, Fidia, UBM LLC, Trio health, Medscape, WebMD, Adept Field Solutions, Clinical Care options, Clearview healthcare partners, Putnam associates, Focus forward, Navigant consulting, Spherix, Practice Point communications, the National Institutes of Health and the American College of Rheumatology, personal fees from Simply Speaking, other from Vaxart pharmaceuticals and Charlotte's Web Holdings (current); Amarin, Viking, and Moderna (previously owned), non-financial support from FDA Arthritis Advisory Committee, non-financial support from Steering committee of OMERACT, an international organization that develops measures for clinical trials and receives arms’ length funding from 12 pharmaceutical companies, non-financial support from Veterans Affairs Rheumatology Field Advisory Committee, non-financial support from Editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis, outside the submitted work. Francisco J. Blanco reports grants from Abbvie, grants and personal fees from Pfizer, grants from UCB, grants from Bristol-Mayers Squibb, grants from Roche, grants from Servier, grants from Bioiberica, grants from Sanofie, grants from Grunenthal, grants from GlaxoSmithKline, grants from Lilly, grants from Janssen, grants from Regeneron, grants from Amgen, grants from TRB Chemedica, outside the submitted work. Anthony P. Fernandez reports personal fees and other from AbbVie, grants, personal fees and other from Novartis, grants, personal fees and other from Mallinkrodt, other from Corbus, other from Pfizer, outside the submitted work. Sarah Mackie reports other from Roche Chugai, non-financial support from Roche, other from Sanofi, outside the submitted work; and Patron of the patient charity PMRGCAuk. Elena Nikiphorou reports personal fees and other from AbbVie, personal fees and other from Eli-Lilly, personal fees and other from Gilead, personal fees and other from Celltrion, personal fees and other from Pfizer, other from Sanofi, outside the submitted work. Victor S. Sloan reports having served as paid consultant to various pharmaceuticalcompanies and healthcare consultancies providing advice on clinicalresearch and advisory committee preparation outside the scope of thesubmitted work. Shareholder in UCB Pharma. Vibeke Strand reports consulting fees from AbbVie, Amgen, Arena, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, CORRONA, Crescendo/Myriad, Equillium, Genentech/Roche, GSK, Horizon, Inmedix, Janssen, Eli Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Samsung, Sandoz, Sanofi, TwoXAR and UCB, outside the submitted work.