Karine Toupin-April1, Simon Décary2, Maarten de Wit3, Alexa Meara4, Jennifer L Barton5, Liana Fraenkel6, Linda C Li7, Peter Brooks8, Beverly Shea9, Dawn Stacey10, France Légaré11, Anne Lydiatt12, Cathie Hofstetter12, Laurie Proulx13, Robin Christensen14, Marieke Voshaar15, Maria E Suarez-Almazor16, Annelies Boonen17, Tanya Meade18, Lyn March19, Janet Elizabeth Jull20, Willemina Campbell21, Rieke Alten22, Esi M Morgan23, Ayano Kelly24, Jessica Kaufman25, Sophie Hill25, Lara J Maxwell26, Francis Guillemin27, Dorcas Beaton28, Yasser El-Miedany29, Shikha Mittoo30, Tiffany Westrich Robertson31, Susan J Bartlett32, Jasvinder A Singh33, Melissa Mannion34, Samah Ismail Nasef35, Savia de Souza36, Anne Boel37, Adewale Adebajo38, Laurent Arnaud39, Tiffany K Gill40, Ellen Moholt41, Jennifer Burt42, Arundathi Jayatilleke43, Ihsane Hmamouchi44, David Carrott45, Francisco J Blanco46, Kate Mather47, Ajesh Maharaj48, Saurab Sharma49, Francesco Caso50, Christopher Fong51, Anthony P Fernandez52, Sarah Mackie53, Elena Nikiphorou54, Allyson Jones55, Regina Greer-Smith56, Victor S Sloan57, Akpabio Akpabio58, Vibeke Strand59, Valerie Umaefulam60, Sara Monti61, Charmaine Melburn62, Nouran Abaza63, Kirsten Schultz64, Simon Stones65, Sonam Kiwalkar66, Hemalatha Srinivasalu67, Deb Constien68, Lauren K King69, Peter Tugwell70. 1. School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Roger Guindon Hall, Room 3071, 451 Smyth Road, Ottawa, ON K1H 8M5, Canada; Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, Canada; Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada. Electronic address: ktoupina@uottawa.ca. 2. Department of family medicine and emergency medicine, Université Laval, Quebec, Canada. 3. OMERACT patient research partner, OMERACT, Amsterdam, The Netherlands. 4. Division of Rheumatology, The Ohio State University, Columbus, Ohio, United States. 5. VA Portland Health Care System, Oregon Health & Science University, Portland, Oregon, United States. 6. Department of Internal Medicine, Yale University, New Haven, Connecticut, United States. 7. Department of Physical Therapy, University of British Columbia, Vancouver, Canada. 8. School of Population and Global Health, University of Melbourne and Northern Health, Melbourne, Australia. 9. Bruyère Research Institute, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada. 10. School of Nursing, University of Ottawa, The Ottawa Hospital Research Institute, Ottawa, Canada. 11. Department of Family Medicine and Emergency Medicine, Université Laval, Quebec City, Canada. 12. Patient Research Partner, Canada. 13. Patient Research Partner, Canadian Arthritis Patient Alliance, Ottawa, Canada. 14. Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, & Department of Rheumatology, Odense University Hospital, Denmark. 15. Department of Pharmacy, Sint Maartenskliniek, The Netherlands; Department of Pharmacy, Radboudumc, Nijmegen, The Netherlands. 16. Department of General Internal Medicine, Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas, United States. 17. Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht University, Maastricht, Netherlands. 18. Western Sydney University and Faculty of Medicine, University of Sydney, Sydney, Australia. 19. Department of Rheumatology, Royal North Shore Hospital, The University of Sydney, Australia. 20. School of Rehabilitation Therapy, Queen's University, Kingston, Canada. 21. Patient Research Partner, Toronto Western Hospital, University Health Network, Toronto, Canada. 22. Head of Department of Internal Medicine II, Director of Rheumatology Research Center, Rheumatology, Clinical Immunology, Osteology, Physical Therapy and Sports Medicine, Schlosspark-Klinik, Charité, University Medicine Berlin, Berlin, Germany. 23. Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States. 24. Canberra Rheumatology, Department of Rheumatology, Liverpool Hospital, and College of Health and Medicine, Australian National University, Liverpool, Australia. 25. Centre for Health Communication and Participation, School of Psychology and Public Health, La Trobe University, Melbourne, Australia. 26. Ottawa Hospital Research Institute, Centre for Practice Changing Research and University of Ottawa, Ottawa, Canada. 27. School of Public Health, Faculty of Medicine, Université de Lorraine, EA 4360 APEMAC, Nancy, France. 28. Institute for Work & Health, Institute Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada. 29. Canterbury Christ Church University, Honorary Senior Clinical Lecturer, King's College London, London, United Kingdom. 30. Department of Medicine, Division of Rheumatology, University of Toronto, Toronto, Canada. 31. Patient research partner, International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis), United States. 32. Divisions of Clinical Epidemiology, Rheumatology and Respiratory Epidemiology and Clinical Trials Unit, McGill University, Research Institute - McGill University Health Centre, Johns Hopkins Medicine Division of Rheumatology, Montreal, Canada. 33. University of Alabama at Birmingham, Birmingham, Alabama, United States. 34. Department of Pediatrics, Division of Pediatric Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, United States. 35. Department of Rheumatology and Rehabilitation, Faculty of Medicine, Suez Canal University, Ismailia, Egypt. 36. Patient Research Partner, Centre for Rheumatic Diseases, King's College London, London, United Kingdom. 37. Department of Rheumatology, Leiden University Medical Centre, Leiden, Netherlands. 38. Faculty of Medicine, Dentistry and Health, University of Sheffield, Sheffield, United Kingdom. 39. Department of Rheumatology, CRMR RESO, University Hospitals of Strasbourg, Strasbourg, France. 40. Faculty of Health and Medical Sciences, Adelaide Medical School, The University of Adelaide, Australia. 41. Division of Rheumatology and Research, Diakonhjemmet Hospital, Oslo, Norway. 42. Eastern Health, St. Clare's Mercy Hospital, St John's, Newfoundland and Labrador, Canada. 43. Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania, United States. 44. Department of Rheumatology, Temara Hospital, Laboratory of Biostatistics and Clinical Epidemiology (LBRCE), Faculty of Medicine and Pharmacy, Mohamed V University, Rabat, Morocco. 45. Patient Research Partner, Polymyalgia Rheumatica and Giant Cell Arteritis Scotland, Nethy Bridge, Scotland, United Kingdom. 46. INIBIC-Instituto de Investigación Biomedica da Coruña, Rheumatologist, Complejo Hospitalario Universitario A Coruña, Universidad de A Coruña, A Coruña, Spain. 47. Patient Research Partner, Toronto, Canada. 48. Department of Internal Medicine, University of KwaZulu Natal, Durban, South Africa. 49. Department of Physiotherapy, Kathmandu University School of Medical Sciences, Dhulikhel, Nepal; Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. 50. Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy. 51. Eastern Clinical Research Unit, Monash University, Melbourne, Australia. 52. Departments of Dermatology and Pathology, Cleveland Clinic, Cleveland, Ohio, United States. 53. Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital, University of Leeds, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom. 54. Centre for Rheumatic Diseases, King's College London, London, UK; Rheumatology Department, King's College Hospital, London, UK. 55. Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Canada. 56. Patient Research Partner, President/CEO, Healthcare Research Associates, LLC/S.T.A.R. Initiative, Ambassador, Patient-Centered Outcomes Research Institute, Apple Valley, CA, United States. 57. Sheng Consulting LLC, Flemington, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey United State. 58. Internal Medicine Department, University of Uyo Teaching Hospital, Uyo, Nigeria. 59. Division of Immunology/Rheumatology, Standford University, California, United States. 60. Cumming School of Medicine, University of Calgary, Calgary, Canada. 61. Department of Rheumatology, Policlinico S. Matteo, IRCCS Fondazione, University of Pavia, Italy. 62. Patient Research Partner, Buckhorn, Ontario, Canada. 63. Ain Shams University, Cairo, Egypt. 64. Patient Research Partner, Madison, Wisconsin, United States. 65. Patient Research Partner, Health Advocate, Consultant and Research, Collaboro Consulting by Simon R. Stones, Manchester, England, United Kingdom. 66. Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, United States. 67. Pediatric Rheumatology, GW University School of Medicine and Health Sciences, Division of Rheumatology, Children's National Hospital, Washington, DC, United States. 68. Patient Research Partner, Central Regional Lead, Advocacy Leadership Board Chair, International Foundation of Autoimmune Autoinflammatory Arthritis (AiArthritis), Madison, Wisconsin, United States. 69. Department of Medicine, University of Toronto, Toronto, Canada. 70. Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
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 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. 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.
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 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. 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.
Authors: Vanesa Ramos-García; Lilisbeth Perestelo-Pérez; Amado Rivero-Santana; Wenceslao Peñate-Castro; Andrea Duarte-Díaz; Yolanda Álvarez-Pérez; María Del Mar Trujillo-Martín; María Isabel Del Cura-González; Pedro Serrano-Aguilar Journal: BMC Med Inform Decis Mak Date: 2022-06-30 Impact factor: 3.298