Takimoto Yoshiyuki, Maeda Shoichi, Slingsby Brian Taylor, Harada Kenji, Nagase Takahide, Nagawa Hirokazu, Nagai Ryozo, Akabayashi Akira
Center for Biomedical Ethics and Law, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.
Med Sci Monit. 2007 Aug;13(8):PH15-8.
There are few studies to use a template to ensure that information provided to the patient in the process of informed consent is consistent. To examine the differences between informed consent forms based on a template and those not based on a template.
MATERIAL/METHODS: An intervention study using a template for informed consent forms that could be modified according to test/treatment, specialty, setting and patient. Our sample included 22 departments at the University of Tokyo Hospital, a 1100-bed care referral center. Twelve items in each informed consent form were scored. Items included diagnosis and current condition, purpose of procedure, details and nature of procedure, effectiveness, patient specific information, changing one's mind, and the use of illustrations and figures. The 36 possible points for each form were summed for a total possible score of 108 points. Total scores and scores for each item were then compared between pre- and post-test forms.
Total number of points significantly increased from 70.9 to 96.9 between pre- and post intervention (p<0.001, paired t test). Internal medicine (pre: 68.6 to post: 101.9) showed a more significant increase in score than surgery (71.9 to 95.2) (ANOVA, pre-post: F(1,106)=324.8 p<0.001; interaction: F(1,106)=11.2, p<0.01). There was no difference in the rate of improvement between treatment and examination forms (ANOVA, pre-post: F(1, 106)=253.3, p<0.001; interaction: F(1,106)=2.8, p=0.1).
A template can increase the number of items described and the thoroughness in which they are described.
很少有研究使用模板来确保在知情同意过程中向患者提供的信息是一致的。本研究旨在探讨基于模板的知情同意书与非基于模板的知情同意书之间的差异。
材料/方法：采用一项干预研究，使用可根据检查/治疗、专业、环境和患者情况进行修改的知情同意书模板。我们的样本包括东京大学医院的22个科室，这是一家拥有1100张床位的护理转诊中心。对每份知情同意书中的12项内容进行评分。项目包括诊断和当前病情、手术目的、手术细节和性质、有效性、患者特定信息、改变主意以及插图和图表的使用。每份表格的36个可能得分相加，总可能得分为108分。然后比较测试前和测试后表格的总分以及各项目得分。
干预前后总分显著从70.9分提高到96.9分（p<0.001，配对t检验）。内科（术前：68.6分至术后：101.9分）的得分增幅比外科（71.9分至95.2分）更显著（方差分析，术前-术后：F(1,106)=324.8，p<0.001；交互作用：F(1,106)=11.2，p<0.01）。治疗表格和检查表格的改善率没有差异（方差分析，术前-术后：F(1, 106)=253.3，p<0.001；交互作用：F(1,106)=2.8，p=0.1）。
模板可以增加所描述项目的数量及其描述的详尽程度。
