Department of General Surgery, Ulster Hospital, Upper Newtownards Road, Dundonald, Belfast, BT16 1RH, UK.
Centre for Public Health, Institute of Clinical Sciences, Royal Victoria Hospital, Belfast, BT12 6BA, UK.
BMC Med Ethics. 2022 Aug 9;23(1):79. doi: 10.1186/s12910-022-00820-w.
300 million operations and procedures are performed annually across the world, all of which require a patient's informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy.
The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials (COMET) methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars to ratify outcomes for inclusion in the final core outcome set. (Registration- https://www.comet-initiative.org/Studies/Details/1024 ). Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers.
36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the 'consensus in' criteria. 6 met 'consensus in' all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting 'consensus in' were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions.
This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research.
全球每年进行 3 亿次手术和操作，所有这些都需要患者知情同意。目前的临床实践中没有标准化的知情同意过程衡量标准。我们旨在为治疗的知情同意定义一个核心结局集。
核心结局集的制定符合预先设定的研究方案和核心结局在有效性试验（COMET）方法，包括系统评价、定性半结构化访谈、改良 Delphi 流程和共识网络研讨会，以确定纳入最终核心结局集的结果。（注册-https://www.comet-initiative.org/Studies/Details/1024）。来自所有关键利益相关者群体的参与者参与了该过程，包括患者和公众、医疗保健从业者和同意研究人员。
通过系统评价综合了 36 个结局领域，并将其组织成一个同意分类法。对所有同意利益相关者群体进行了 41 次半结构化访谈。来自 8 个国家的所有利益相关者群体的 164 名参与者完成了第一轮 Delphi，125 名参与者完成了第二轮 Delphi。11 项结果符合“共识”标准。6 项符合所有利益相关者群体的“共识”标准，并直接纳入最终核心结局集。其余 5 项符合“共识”标准的结果在两次共识网络研讨会上得到了批准。最终核心结局集中包括 9 项核心结局：对信息质量和数量的满意度、患者感到有选择、患者感到做出同意决定是自己的、对所做决定的信心、对沟通的满意度、对临床医生的信任、患者对同意过程的满意度、患者对提问时间和机会的评价。
这项国际混合方法定性研究是首例定义干预措施知情同意核心结局集的研究。它定义了知情同意过程中关键利益相关者关注的结果，是朝着未来知情同意研究标准化迈出的一步。
