书面知情同意书——转化为通俗易懂的语言。一项试点研究。
Written Informed Consent-Translating into Plain Language. A Pilot Study.
作者信息
Zimmermann Agnieszka, Pilarska Anna, Gaworska-Krzemińska Aleksandra, Jankau Jerzy, Cohen Marsha N
机构信息
Department of Medical and Pharmacy Law, Faculty of Health Sciences, Medical University of Gdańsk, 80-210 Gdańsk, Poland.
Department of Nursing Management, Institute of Nursing and Midwifery, Medical University of Gdańsk, 80-211 Gdańsk, Poland.
出版信息
Healthcare (Basel). 2021 Feb 20;9(2):232. doi: 10.3390/healthcare9020232.
BACKGROUND
Informed consent is important in clinical practice, as a person's written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form.
METHODS
Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form's degree of difficulty or readability.
RESULTS
The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4-6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible.
CONCLUSIONS
There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.
背景
在临床实践中，知情同意很重要，因为在许多医疗干预之前都需要获得个人的书面同意。许多知情同意书未能做到简单明了地传达信息。我们研究的目的是创建一份易于理解的表格。
方法
我们对一份波兰语的整形手术知情同意书进行评估，使用波兰语理解分析程序（jasnopis.pl，SWPS大学）来评估为不同教育水平的人编写的文本的可读性；这使我们能够通过缩短句子和简化词汇来修改表格。使用同一软件对该表格进行重新评估，随后将其交给160名成年志愿者，以评估修订后表格的难易程度或可读性。
结果
首次软件分析发现该语言适合大学学历或受过高等教育的人，经过修订和重新评估后，变得适合小学4至6年级及以上学历的人。大多数研究参与者也认为该表格完全可以理解。
结论
提高书面知情同意书的可理解性可能会给患者和从业者带来显著益处。
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