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患者权利以及关于术中视听记录的同意书语言。

Patient rights and consent form language about intraoperative audiovisual recording.

作者信息

Habib Daniel R S, Prasad Kavita, Aweeda Marina, Lin George, Bishay Anthony E, Gao Yue, Liu Dandan, Langerman Alexander

机构信息

Vanderbilt University School of Medicine, Nashville, TN, USA.

Department of Otolaryngology - Head and Neck Surgery, Vanderbilt University Medical Center, 1211 Medical Center Dr, Nashville, TN, 37232, USA.

出版信息

Surg Endosc. 2025 Jul 17. doi: 10.1007/s00464-025-12010-x.

Abstract

BACKGROUND

Intraoperative audiovisual recordings offer benefits in quality improvement, education, and research, but challenges hinder their routine use. No comprehensive guidelines exist on how intraoperative recordings should be communicated to patients, and no previous study has examined how informed consent documents (ICDs) address this topic. This study aims to analyze procedural consent forms for themes and readability of disclosures related to intraoperative audiovisual recording.

METHODS

ICDs were collected from 104 high-volume U.S. hospitals identified via the American Hospital Association Annual Survey Database. Measures included hospital demographics (public/private, academic/non-academic, region, and Social Vulnerability Index), Flesch-Kincaid reading level, and audiovisual recording themes labeled by two independent researchers. Analyses examined the distribution of consent themes by hospital type and the association between reading level and the number of themes with U.S. census region, hospital type, and Social Vulnerability Index as covariates using ordinal logistic regressions.

RESULTS

Of 104 ICDs, 70 contained text about procedural recording. All 70 forms discussed modality, 66 (94.3%) discussed recording purpose, 38 (54.3%) discussed patient safeguards, and 10 (14.3%) discussed patient rights. The median reading level was 15.0 (IQR: 12.5-17.7), equivalent to third year of college. Higher reading level (aOR = 1.14, 95% CI 1.04-1.24) and academic hospital status (aOR = 2.83, 95% CI 1.11-7.23) were associated with more subthemes.

CONCLUSION

Most ICDs addressed recording modality and purpose but inadequately covered safeguards and patient rights. The median reading level significantly exceeded the recommended sixth- to eighth-grade standard. These findings will help guide ICD development to include often overlooked themes and use accessible language about intraoperative recording.

摘要

背景

术中视听记录在质量改进、教育和研究方面具有诸多益处,但一些挑战阻碍了其常规使用。目前尚无关于如何向患者传达术中记录的全面指南,且此前也没有研究探讨过知情同意书(ICD)如何阐述这一主题。本研究旨在分析手术同意书中与术中视听记录相关的主题及披露内容的可读性。

方法

通过美国医院协会年度调查数据库确定了104家高容量的美国医院,并收集了它们的ICD。测量指标包括医院人口统计学特征(公立/私立、学术/非学术、地区和社会脆弱性指数)、弗莱什-金凯德阅读水平,以及由两名独立研究人员标注的视听记录主题。分析通过有序逻辑回归,以美国人口普查地区、医院类型和社会脆弱性指数作为协变量,研究同意主题在不同医院类型中的分布情况,以及阅读水平与主题数量之间的关联。

结果

在104份ICD中,70份包含有关手术记录的文本。所有70份表格都讨论了记录方式,66份(94.3%)讨论了记录目的,38份(54.3%)讨论了患者保护措施,10份(14.3%)讨论了患者权利。阅读水平中位数为15.0(四分位间距:[12.5, 17.7]),相当于大学三年级水平。较高的阅读水平(调整后比值比 = 1.14,95%置信区间1.04 - 1.24)和学术医院身份(调整后比值比 = 2.83,95%置信区间1.11 - 第七章:23)与更多的子主题相关。

结论

大多数ICD涉及记录方式和目的,但对保护措施和患者权利的涵盖不足。阅读水平中位数显著超过了推荐标准的六年级至八年级水平。这些发现将有助于指导ICD的制定,使其纳入经常被忽视的主题,并使用通俗易懂的语言阐述术中记录。

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