Department of General Surgery, Ulster Hospital Dundonald, Belfast, UK.
Centre for Public Health, Queen's University Belfast, Belfast, UK.
BMC Med Ethics. 2020 Jul 11;21(1):58. doi: 10.1186/s12910-020-00501-6.
Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set (COS) to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the informed consent process.
This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies.
Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making.
This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery.
The study protocol was registered on the international prospective register for systematic reviews (PROSPERO ID: CRD42017077101).
知情同意是良好医疗实践的一个组成部分。许多研究人员已经研究了提高知情同意质量的措施，但尚不清楚哪些技术最有效，以及为什么。为了解决这个问题，我们建议制定一个核心结局集（COS）来评估旨在改善有能力的成年患者手术同意过程的干预措施。该过程的一部分包括审查已经报告了患者和医生在知情同意过程中重要内容的现有研究。
本定性综合分析包括四个阶段：确定已发表的论文并确定其相关性；评估论文的质量；从每篇论文中确定并总结关键发现，同时根据原始数据确定每个发现的确定性；比较论文之间的关键主题，以便将研究结果联系起来。
对文献数据库的搜索返回了 11073 个标题。其中，有 16 项研究符合纳入标准。这些研究发表于 1996 年至 2016 年之间，共纳入 367 名患者和 74 名医疗保健提供者。13 项研究使用深入访谈收集数据，最常见的定性分析方法是不断比较。从主要论文中提取了 94 项发现，并分为 17 类，最终综合出 6 项与以下内容相关的发现：患者特征、知识、沟通、理想患者、信任和决策。
这是首次对手术知情同意问题进行定性综合分析，揭示了患者和临床医生在评估同意过程质量时认为重要的一些结果。其中一些结果以前在比较知情同意方法的研究中没有被检查过。本综述是制定评估旨在改善手术同意过程的干预措施的 COS 的重要步骤。
研究方案已在国际前瞻性系统评价注册库（PROSPERO 编号：CRD42017077101）中进行了登记。
