1Department of Neurological Surgery, Northwestern University Feinberg School of Medicine, Division of Pediatric Neurosurgery, Anne and Robert H. Lurie Children's Hospital, Chicago.
2Department of Philosophy, Northwestern University, Evanston; and.
Neurosurg Focus. 2020 Nov;49(5):E6. doi: 10.3171/2020.8.FOCUS20611.
Informed consent has served as a main principle of medical ethics and laws in the United States. The 1986 American Association of Neurological Surgeons Code of Ethics implied medicolegal liability for the failure to obtain informed consent without providing practical guidance regarding the application of informed consent to individual patient encounters in a medicolegal environment. Here, the authors aimed to identify baseline patient recall after discussions with neurosurgeons and their capacity to provide informed consent, describe the effects of interventions to improve patient comprehension, and elucidate the role of informed consent in malpractice litigation in neurosurgery. Their findings may guide neurosurgeons in discussions to properly inform patients and reduce the risk of litigation.
A systematic review was conducted to explore informed consent within neurosurgery and its application to medicolegal liability using the PubMed, Embase, and Scopus databases. Titles and abstracts from articles identified in the search were read and selected for full-text review. Studies meeting prespecified inclusion criteria were reviewed in full and analyzed for study design, aim, population, interventions, and outcomes.
Of 1428 resultant articles, 21 were included in the review. Baseline patient recall was low, particularly for risks and alternatives of treatments, and even decreased over time. Cognitive impairment was noted as a factor limiting the ability to provide informed consent. Interventions incorporating a combination of modalities in informed consent discussions, a specialized consent form with points for neurosurgeons to check off upon discussion, interactive websites, question prompt lists, and illustrations were found to be effective in improving patient knowledge. Lack of informed consent was a common factor for malpractice litigation. Spine surgery was particularly prone to costly lawsuits. Payments were generally greater for plaintiff verdicts than for settlements.
The application of informed consent to patient encounters is an important facet of clinical practice. Neurosurgeons have a duty to provide patients with all pertinent information to allow them to make decisions about their care. The authors examined baseline patient comprehension and capacity, interventions to improve informed consent, and malpractice litigation; it appears that determining the proper capacity to provide informed consent and considering informed consent as a process that depends on the setting are important. There is room to improve the informed consent process centered on baseline patient health literacy and understanding as well as clear communication using multiple modalities.
知情同意在美国是医学伦理和法律的主要原则。1986 年美国神经外科学会伦理准则暗示，如果未能获得知情同意，将承担医疗法律责任，但并未就如何在医疗法律环境下将知情同意应用于个别患者提供实际指导。在这里，作者旨在确定与神经外科医生讨论后患者的基本记忆，并评估他们提供知情同意的能力，描述改善患者理解的干预措施的效果，并阐明知情同意在神经外科医疗事故诉讼中的作用。他们的发现可以指导神经外科医生进行适当的讨论，以告知患者并降低诉讼风险。
使用 PubMed、Embase 和 Scopus 数据库进行系统评价，探讨神经外科中的知情同意及其在医疗法律责任中的应用。阅读搜索中确定的文章的标题和摘要，并选择全文进行审查。对符合预定纳入标准的研究进行全面审查，并对研究设计、目的、人群、干预措施和结果进行分析。
在 1428 篇文章中，有 21 篇被纳入综述。患者的基本记忆较低，特别是对治疗的风险和替代方案，甚至随着时间的推移而降低。认知障碍被认为是限制提供知情同意能力的因素。在知情同意讨论中结合多种模式的干预措施、带有神经外科医生在讨论时检查的要点的专门同意书、互动网站、问题提示列表和插图被发现可有效提高患者的知识。缺乏知情同意是医疗事故诉讼的常见因素。脊柱手术特别容易引起昂贵的诉讼。原告胜诉的赔偿金通常高于和解金。
将知情同意应用于患者就诊是临床实践的一个重要方面。神经外科医生有责任向患者提供所有相关信息，以便他们能够做出关于自己治疗的决定。作者检查了患者基本的理解和能力、改善知情同意的干预措施以及医疗事故诉讼；似乎确定适当的提供知情同意的能力并将知情同意视为取决于环境的过程很重要。在以患者的基本健康素养和理解为中心以及使用多种模式进行清晰沟通的基础上，还有改进知情同意过程的空间。
