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泌尿外科知情同意书可读性评估:开放手术、内镜手术和腹腔镜手术的知情同意书是否存在差异?

Evaluation of the readability of informed consent forms used in urology: Is there a difference between open, endoscopic, and laparoscopic surgery?

作者信息

Sönmez Mehmet Giray, Kozanhan Betül, Özkent Mehmet Serkan, Ecer Gökhan, Boğa Mehmet Salih, Demirelli Erhan, Öztürk Ahmet

机构信息

Department of Urology, Necmettin Erbakan University Meram School of Medicine, Konya, Turkey.

Department of Anesthesiology and Reanimation, University of Health Sciences Konya Training and Research Hospital, Konya, Turkey.

出版信息

Turk J Surg. 2018 Aug 28;34(4):295-299. doi: 10.5152/turkjsurg.2017.3973.

DOI:10.5152/turkjsurg.2017.3973
PMID:30216178
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6340652/
Abstract

OBJECTIVE

The aim of this study is to evaluate the readability levels of informed consent forms used in Turkey before urological surgery and to compare the readability levels of open, endoscopic, and laparoscopic surgical informed consent forms.

MATERIAL AND METHODS

A total of 529 informed consent forms used for urological open, endoscopic, and laparoscopic surgical procedures were collected from different hospitals in Turkey. Evaluating informed consent forms that have exactly the same text only once, a total of 69 consent forms were evaluated. The Gunning Fog Index and Flesch-Kincaid test measuring the general readability level were used to calculate the readability level of informed consent forms in addition to the Ateşman and Bezirci-Yılmaz formulas defined to determine the readability level of Turkish texts. Informed consent forms were evaluated and divided into three groups as open, endoscopic, and laparoscopic surgery forms, depending on their content.

RESULTS

Among 69 informed consent forms evaluated, 35 were open, 19 were endoscopic, and 15 were laparoscopic surgery consent forms. The readability level of all informed consent forms was detected as average according to the Ateşman formula, very difficult according to the Flesch-Kincaid test, difficult according to the Gunning Fog Index, and at the high school education level according to the Bezirci-Yılmaz formula. A statistical evaluation of the three groups did not show a significant difference in the readability level.

CONCLUSION

In this study, it was detected that the informed consent form readability levels used for urological surgical procedures in our country were rather low. We think that the cooperation of the concerned institutions is required for the revision of the consent information texts available and the improvement of the texts according to the strategies recommended.

摘要

目的

本研究旨在评估土耳其泌尿外科手术前使用的知情同意书的可读性水平,并比较开放性、内镜和腹腔镜手术知情同意书的可读性水平。

材料与方法

从土耳其不同医院收集了总共529份用于泌尿外科开放性、内镜和腹腔镜手术的知情同意书。仅对文本完全相同的知情同意书评估一次,共评估了69份同意书。除了用于确定土耳其语文本可读性水平的阿泰斯曼公式和贝齐尔西 - 伊尔马兹公式外,还使用了测量一般可读性水平的冈宁雾度指数和弗莱什 - 金凯德测试来计算知情同意书的可读性水平。根据知情同意书的内容,将其评估并分为开放性、内镜和腹腔镜手术同意书三组。

结果

在评估的69份知情同意书中,35份为开放性手术同意书,19份为内镜手术同意书,15份为腹腔镜手术同意书。根据阿泰斯曼公式,所有知情同意书的可读性水平被检测为中等;根据弗莱什 - 金凯德测试,非常困难;根据冈宁雾度指数,困难;根据贝齐尔西 - 伊尔马兹公式,处于高中教育水平。对三组的统计评估未显示可读性水平有显著差异。

结论

在本研究中,发现我国泌尿外科手术使用的知情同意书可读性水平相当低。我们认为,需要相关机构合作,对现有的同意信息文本进行修订,并根据推荐的策略改进文本。

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