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我们是否符合脊柱手术中规定的知情同意标准?

Are we meeting the standards set for informed consent in spinal surgery?

机构信息

St George's Hospital, UK.

出版信息

Ann R Coll Surg Engl. 2023 Apr;105(4):372-377. doi: 10.1308/rcsann.2022.0049. Epub 2022 Jul 29.

Abstract

INTRODUCTION

Informed consent empowers patients to exercise their autonomy and actively participate in their medical care. Guidance published by the British Association of Spine Surgeons (BASS) lists three components of consent: provision of information booklets, patient-centred dialogue and completion of appropriate consent forms. The aim of the study was to review the quality of the spinal surgery consent process against the BASS guidance in a single tertiary neurosurgery centre in London.

METHODS

Retrospective review of clinic letters and consent forms was performed for 100 consecutive cases of elective, non-instrumented spinal decompression surgeries performed in 2019. Documentation was graded for inclusion of the intended benefit (improvement of pain/prevention of neurological deterioration), alternative management options (including no treatment), surgical options and risks (infection, bleeding, paralysis, sphincter disturbances, dural tear and recurrence). Provision of supplementary information booklets was recorded. Two-tailed Fisher exact test was used to calculate statistical significance where appropriate.

RESULTS

Documentation of indications and risks of elective spinal surgery, specifically risk of recurrence (62%) and sphincter disturbance (85%), was suboptimal on the consent forms. Documentation of these risks was also poor in clinic letters (<50%). Alternative treatment options were explained in less than half of the clinic letters, and there was no documentation of information booklet provision prior to elective surgeries.

CONCLUSION

Lack of informed consent plays a major role in medical malpractice claims in spinal surgery. Poor documentation puts the surgeon in a liable position. BASS guidance could be implemented to create a more standardised process of consent in spinal surgery.

摘要

简介

知情同意使患者能够行使自主权并积极参与他们的医疗护理。英国脊柱外科医师协会 (BASS) 发布的指南列出了同意书的三个组成部分:提供信息手册、以患者为中心的对话和填写适当的同意书。本研究的目的是在伦敦的一家三级神经外科中心,根据 BASS 指南审查脊柱手术同意书的质量。

方法

对 2019 年 100 例择期非器械性脊柱减压手术的门诊信件和同意书进行回顾性审查。对纳入的预期益处(改善疼痛/预防神经功能恶化)、替代管理选项(包括不治疗)、手术选项和风险(感染、出血、瘫痪、括约肌功能障碍、硬脊膜撕裂和复发)的文件进行了评分。记录补充信息手册的提供情况。在适当的情况下,使用双尾 Fisher 精确检验计算统计学意义。

结果

在同意书中,择期脊柱手术的适应证和风险(特别是复发风险[62%]和括约肌功能障碍风险[85%])的记录并不完善。门诊信件中对这些风险的记录也很差(<50%)。不到一半的门诊信件中解释了替代治疗方案,并且在择期手术之前没有记录提供信息手册的情况。

结论

缺乏知情同意是脊柱手术医疗事故索赔的主要原因。记录不佳使外科医生处于责任位置。可以实施 BASS 指南,以在脊柱手术中创建更标准化的同意书流程。

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本文引用的文献

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Informed consent in spinal surgery.脊髓手术中的知情同意。
Bone Joint J. 2019 Apr;101-B(4):355-360. doi: 10.1302/0301-620X.101B4.BJJ-2018-1045.R2.
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Informed consent: where are we in 2015?知情同意:2015年我们处于什么状况?
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