Health Education England, North West Deanery (Mersey Sector), UK.
Trauma and Orthopaedic Department, Wirral University Hospital Trust, Wirral, UK.
Br J Hosp Med (Lond). 2021 Apr 2;82(4):1-7. doi: 10.12968/hmed.2020.0504. Epub 2021 Apr 21.
AIMS/BACKGROUND: The Montgomery v Lanarkshire Health Board (2015) case set a precedent that has driven the modernisation of consenting practice. Failure to demonstrate informed consent is a common source of litigation. This quality improvement project aimed to provide pragmatic guidance for surgeons on consent and to improve the patient experience during decision making.
Elective orthopaedic patients were assessed and the quality of documented consent was recorded. Data were collected over two discrete cycles, with cycle 1 used as a baseline in practice. The following criteria were reviewed: grade of consenting clinician, alternative treatment options, description of specific risks, place and timing of consent and whether the patient received written information or a copied clinic letter. Cycle 1 results were presented to clinicians; a teaching session was provided for clinicians on the standard of consent expected and implementation of a change in practice was established with a re-audit in cycle 2.
There were 111 patients included in cycle 1, and 96 patients in cycle 2. Consent was undertaken mostly by consultants (54%). Specific patient risks were documented in 50% of patients in cycle 1 and 60% in cycle 2. Risks associated with a specific procedure were documented in 42% in cycle 1 and 76% in cycle 2, alternative options in 48% (cycle 1) and 66% (cycle 2). A total of 14% of patients in cycle 1 and 8% in cycle 2 had documented written information provision. Copied letters to patients was only seen in 12% of all cycles. Documentation from dedicated consenting clinics outperformed standard clinics.
Highlighting poor documentation habits and refining departmental education can lead to improvements in practice. The use of consenting clinics should be considered and clinicians should individually reflect on how to address their own shortcomings. Other units should strongly consider a similar audit. This article provides stepwise advice to improve consent and specifics from which to audit.
目的/背景：蒙哥马利诉拉纳克郡卫生局案（2015 年）开创了先例，推动了同意实践的现代化。未能证明知情同意是诉讼的常见来源。本质量改进项目旨在为外科医生提供关于同意的实用指导，并改善患者在决策过程中的体验。
对择期矫形患者进行评估，并记录书面同意的质量。数据收集分两个阶段进行，第一阶段用于实践的基线。审查了以下标准：同意医生的级别、替代治疗方案、具体风险描述、同意的地点和时间以及患者是否收到书面信息或复印的诊所信件。第一阶段的结果呈现给医生；为医生提供了关于预期同意标准的教学课程，并在第二阶段通过重新审核建立了实践变更的实施。
第一阶段有 111 名患者，第二阶段有 96 名患者。同意主要由顾问医生（54%）进行。第一阶段有 50%的患者记录了具体的患者风险，第二阶段有 60%的患者记录了具体的患者风险。第一阶段有 42%的患者记录了与特定手术相关的风险，第二阶段有 76%的患者记录了与特定手术相关的风险，第一阶段有 48%的患者记录了替代方案，第二阶段有 66%的患者记录了替代方案。第一阶段有 14%的患者和第二阶段有 8%的患者有书面信息提供的记录。只有 12%的所有阶段都有复制给患者的信件。专门同意诊所的记录优于标准诊所。
强调较差的记录习惯和完善部门教育可以改进实践。应考虑使用同意诊所，并且医生应单独反思如何解决自己的不足。其他单位应强烈考虑类似的审核。本文提供了逐步改进同意和审核细节的建议。
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