迈向制定一套核心结局指标以评估风湿病学中共享决策干预措施的发展：来自 OMERACT Delphi 调查和共识会议的结果。
Toward the Development of a Core Set of Outcome Domains to Assess Shared Decision-making Interventions in Rheumatology: Results from an OMERACT Delphi Survey and Consensus Meeting.
机构信息
From the Children's Hospital of Eastern Ontario Research Institute, Ottawa; Department of Pediatrics and School of Rehabilitation Sciences, University of Ottawa, and Department of Epidemiology and Community Medicine, and Department of Medicine, Faculty of Medicine, University of Ottawa; School of Nursing, University of Ottawa; Integrated Knowledge Translation Network and University of Ottawa; Ottawa Hospital Research Institute, Centre for Practice-Changing Research and University of Ottawa; Bruyère Research Institute, Bruyère Continuing Care and School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, Faculty of Medicine, and Institute of Population Health, Centre for Global Health, University of Ottawa, Ottawa; Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital; Institute for Work and Health, Institute Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario; Department of Physical Therapy, University of British Columbia; Arthritis Research Centre of Canada, Vancouver, British, Columbia; Department of Family Medicine and Emergency Medicine, Université Laval, Quebec City, Montreal, Canada; VA Portland Health Care System; Oregon Health and Science University, Portland, Oregon; Department of Internal Medicine, Yale University, New Haven, Connecticut; The Ohio State University, Columbus; Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of General Internal Medicine, Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA; School of Population and Global Health, University of Melbourne; Centre for Health Communication and Participation, School of Psychology and Public Health, La Trobe University, Melbourne; Western Sydney University and Faculty of Medicine, University of Sydney; Department of Medicine, University of Sydney, Institute of Bone and Joint Research and Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia; VU Medical Centre, Amsterdam; Department Psychology, Health and Technology, University of Twente, Enschede; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht University, Maastricht; Access to Medicine Foundation, Haarlem, the Netherlands; Sorbonne Universités, UPMC Univ Paris 06, GRC-08; Pitie-Salpétrière Hospital, AP-HP, Rheumatology Department, Paris, France; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Internal Medicine II Rheumatology, Clinical Immunology, Osteology, Physical Therapy and Sports Medicine, Schlosspark-Klinik, Charité, University Medicine Berlin, Berlin, Germany; Rheumatology and Rehabilitation, Ain Shams University, Cairo, Egypt; King's College London, London, UK.
K. Toupin-April, PhD, Associate Scientist, Children's Hospital of Eastern Ontario Research Institute, and Assistant Professor, Department of Pediatrics and School of Rehabilitation Sciences, University of Ottawa; J. Barton, MD, VA Portland Health Care System, and Associate Professor, Oregon Health and Science University; L. Fraenkel, MD, Professor of Medicine, Department of Internal Medicine, Yale University; L.C. Li, PT, PhD, Professor, Department of Physical Therapy, University of British Columbia, and Senior Scientist, Arthritis Research Centre of Canada; P. Brooks, MD, Professor, School of Population and Global Health, University of Melbourne; M. De Wit, PhD, Patient Research Partner, VU Medical Centre; D. Stacey, RN, PhD, Full Professor, School of Nursing, University of Ottawa, and Senior Scientist, The Ottawa Hospital Research Institute; F. Légaré, MD, PhD, Full Professor, Department of Family Medicine and Emergency Medicine, Université Laval; A. Meara, MD, The Ohio State University; B. Shea, PhD, Clinical Scientist, Bruyère Research Institute, and Senior Methodologist, Ottawa Health Research Institute, and Adjunct Professor, Department of Epidemiology and Community Medicine, University of Ottawa; A. Lyddiatt, Patient Research Partner; C. Hofstetter, Patient Research Partner; L. Gossec, MD, PhD, Sorbonne Universités, UPMC Univ Paris 06, GRC-08, and Pitie-Salpétrière Hospital, AP-HP, Rheumatology Department; R. Christensen, PhD, Professor, Senior Biostatistician, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; M. Scholte-Voshaar, MSc, Patient Research Partner, Department Psychology, Health and Technology, University of Twente; M.E. Suarez-Almazor MD, PhD, Professor, Department of General Internal Medicine, Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center; A. Boonen, MD, PhD, Professor of Rheumatology, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht University; T. Meade, PhD, Professor, Western Sydney University and Faculty of Medicine, University of Sydney; L. March, MD, Professor, Department of Medicine, University of Sydney, Institute of Bone and Joint Research and Department of Rheumatology, Royal North Shore Hospital; C. Pohl, MD, Rheumatologist, Department of Internal Medicine II Rheumatology, Clinical Immunology, Osteology, Physical Therapy and Sports Medicine, Schlosspark-Klinik, Charité, University Medicine Berlin; J.E. Jull, OT, PhD, Postdoctoral Fellow, Integrated Knowledge Translation Network and University of Ottawa; S. Sivarajah, BSc, Research Assistant, Children's Hospital of Eastern Ontario Research Institute; W. Campbell, LLB, Patient Research Partner; R. Alten, MD, PhD, Professor of Medicine, 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; S. Karuranga, MPH, Researcher, Access to Medicine Foundation; E. Morgan, MD, Associate Professor, Division of Rheumatology, Cincinnati Children's Hospital Medical Center; J. Kaufman, BSc, Centre for Health Communication and Participation, School of Psychology and Public Health, La Trobe University; S. Hill, PhD, Centre for Health Communication and Participation, School of Psychology and Public Health, La Trobe University; L.J. Maxwell, PhD, Ottawa Hospital Research Institute, Centre for Practice-Changing Research and University of Ottawa; V. Welch, PhD, Scientist, Bruyère Research Institute, Bruyère Continuing Care and School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa; D. Beaton, PhD, Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital, and Senior Scientist, Institute for Work and Health, Associate Professor, Institute Health Policy, Management and Evaluation, University of Toronto; Y. El-Miedany, MD, Professor, Rheumatology and Rehabilitation, Ain Shams University, and Honorary Senior Clinical Lecturer, King's College London; P.S. Tugwell, MD, Professor, Department of Medicine, Faculty of Medicine, University of Ottawa, and Senior Scientist, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, Faculty of Medicine, and Institute of Population Health, Centre for Global Health, University of Ottawa.
出版信息
J Rheumatol. 2017 Oct;44(10):1544-1550. doi: 10.3899/jrheum.161241. Epub 2017 Aug 1.
OBJECTIVE
The aim of this Outcome Measures in Rheumatology (OMERACT) Working Group was to determine the core set of outcome domains and subdomains for measuring the effectiveness of shared decision-making (SDM) interventions in rheumatology clinical trials.
METHODS
Following the OMERACT Filter 2.0, and based on a previous literature review of SDM outcome domains and a nominal group process at OMERACT 2014, (1) an online Delphi survey was conducted to gather feedback on the draft core set and refine its domains and subdomains, and (2) a workshop was held at the OMERACT 2016 meeting to gain consensus on the draft core set.
RESULTS
A total of 170 participants completed Round 1 of the Delphi survey, and 116 completed Round 2. Respondents came from 29 countries, with 49% being patients/caregivers. Results showed that 14 out of the 17 subdomains within the 7 domains exceeded the 70% criterion (endorsement ranged from 83% to 100% of respondents). At OMERACT 2016, only 8% of the 96 attendees were patients/caregivers. Despite initial votes of support in breakout groups, there was insufficient comfort about the conceptualization of these 7 domains and 17 subdomains for these to be endorsed at OMERACT 2016 (endorsement ranged from 17% to 68% of participants).
CONCLUSION
Differences between the Delphi survey and consensus meeting may be explained by the manner in which the outcomes were presented, variations in participant characteristics, and the context of voting. Further efforts are needed to address the limited understanding of SDM and its outcomes among OMERACT participants.
目的
本疗效测量在风湿病学（OMERACT）工作组的目的是确定核心的疗效测量领域和亚领域，以评估在风湿病学临床试验中共享决策（SDM）干预措施的有效性。
方法
根据 OMERACT Filter 2.0，并基于之前对 SDM 疗效测量领域的文献回顾和 OMERACT 2014 年的名义群体过程，（1）进行了在线 Delphi 调查，以收集对核心草案的反馈意见，并对其领域和亚领域进行细化，（2）在 OMERACT 2016 年会议上举行了一次研讨会，以就草案核心达成共识。
结果
共有 170 名参与者完成了 Delphi 调查的第一轮，116 名参与者完成了第二轮。受访者来自 29 个国家，其中 49%是患者/护理人员。结果表明，7 个领域中的 14 个亚领域超过了 70%的标准（赞同率从 83%到 100%不等）。在 OMERACT 2016 年，96 名与会者中只有 8%是患者/护理人员。尽管分组讨论中最初投票支持，但对这 7 个领域和 17 个亚领域的概念化缺乏足够的共识，因此未能在 OMERACT 2016 年获得认可（参与者的赞同率从 17%到 68%不等）。
结论
德尔菲调查和共识会议之间的差异可能可以用疗效的呈现方式、参与者特征的差异以及投票的背景来解释。需要进一步努力来解决 OMERACT 参与者对 SDM 及其疗效的理解有限的问题。
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