Borello Alessandro, Ferrarese Alessia, Passera Roberto, Surace Alessandra, Marola Silvia, Buccelli Claudio, Niola Massimo, Di Lorenzo Pierpaolo, Amato Maurizio, Di Domenico Lorenza, Solej Mario, Martino Valter
University of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.
Department of Oncology, University of Turin, Section of General Surgery, San Luigi Gonzaga University Hospital, Regione Gonzole 10, 10043 Orbassano, Turin, Italy ,.
Open Med (Wars). 2016 Dec 16;11(1):564-573. doi: 10.1515/med-2016-0092. eCollection 2016.
Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion.
This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed.
Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension.
Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.
手术知情同意书对于患者来说可能难以阅读和理解。我们创建了一份同意书，关键信息以项目符号文本和图表相结合的图形格式呈现，以便在口头同意讨论过程中促进对信息的理解。
这项前瞻性随机研究纳入了70例等待因胆结石行胆囊切除术的成年患者。在使用图形格式的文件（研究组，n = 33）或标准文本文件（对照组，n = 37）进行标准口头解释后获取同意书。在手术前通过一份9项选择题问卷评估理解情况，并分析影响理解的因素。
问卷分数比较显示，年龄、性别、同意与手术之间的时间间隔或文件格式对知情同意理解情况均无影响。教育水平是理解情况的唯一预测因素。
简化的手术同意文件符合健康素养和知情同意的目标。教育水平似乎是理解情况的有力预测因素。
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