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.
Department of family medicine and emergency medicine, Université Laval, Quebec, Canada.
Semin Arthritis Rheum. 2021 Jun;51(3):593-600. doi: 10.1016/j.semarthrit.2021.03.017. Epub 2021 Apr 6.
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.
就风湿病共同决策（SDM）干预措施的风湿病试验的 OMERACT 核心领域集达成共识。
该过程遵循 OMERACT Filter 2.1 方法，并使用自始至终都有患者参与的共识建立方法。在之前的研究中制定了核心领域草案后，我们进行了五个步骤：（i）改进核心领域草案；（ii）制定和传播白板视频以促进理解；（iii）进行电子调查以收集对核心领域草案的反馈；（iv）确定核心领域集并制定摘要、全体会议视频和讨论板以促进理解；（v）进行虚拟研讨会并投票支持核心领域集。
共有来自 28 个国家的 167 名参与者回答了调查（62%为患者/照顾者）。大多数参与者认为各领域具有相关性（81%-95%）和清晰度（82%-93%）。共有 149 名参与者（n=48 名患者/照顾者，101 名临床医生/研究人员）参加了虚拟研讨会，并对拟议的核心领域集进行了投票，该领域集获得了 95%的支持。支持的领域包括：1-对选择的了解，其潜在的好处和危害；2-选择的选项与每个患者的价值观和偏好一致；3-对选择的信心；4-对决策过程的满意度；5-对选择的遵守；6-SDM 干预的潜在负面影响。
我们在国际利益相关者群体中就风湿病 SDM 干预试验的 OMERACT 核心领域集达成了共识。未来的研究将开发核心结局测量集。
在这项研究之前，SDM 干预措施的 OMERACT 核心领域集尚未达成共识。本研究表明，OMERACT 核心领域集得到了包括患者/照顾者、临床医生和研究人员在内的主要利益相关者的高度支持。
