Vorbach Samuel M, Pointner Martin, Lehmann Jens, Mangesius Julian, Hart Tilmann, Gstir Claudia, Rändler Theresa, Seppi Thomas, Ganswindt Ute, Kollotzek Siegfried
Department of Radiation Oncology, Medical University of Innsbruck, 6020 Innsbruck, Austria.
Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology, University Hospital of Psychiatry II, Medical University of Innsbruck, 6020 Innsbruck, Austria.
Cancers (Basel). 2024 Oct 21;16(20):3552. doi: 10.3390/cancers16203552.
BACKGROUND/OBJECTIVES: Informed consent is crucial in medical practice, especially for complex treatments such as postoperative radiotherapy for patients with breast cancer. Conventional consent procedures are often based on verbal declarations with a highly condensed but nevertheless large amount of information, which can exceed the recording capacity of patients and lead to misunderstandings. The aim of this study was to develop and test an educational video on breast cancer patients to enhance the informed consent process by improving patients' understanding and reducing the duration of the subsequent consultation.
The educational video was created after the underlying content was determined by a modified Delphi method in which a panellist of radiation oncologists, nurses, radiation therapists, and former patients participated in successive rounds of topic scoring. After achieving content consent, the video included 19 items to cover key aspects of postoperative radiotherapy in a patient-friendly manner. Fifty breast cancer patients scheduled for postoperative radiotherapy were randomised to watch the video prior to their verbal consultation ( = 25) or to the control group participating in the traditional informed consent process only ( = 25). The duration of the informed consent processes in both arms was recorded. To assess the educational effect of the video, a multiple-choice test was created. In addition, patients' satisfaction was recorded using a separate questionnaire. Both questionnaires were completed by the patients one to two hours after signing the consent form.
The patients in the video group evidenced significantly higher knowledge scores than those who received standard verbal explanations (median number of correct answers 9 vs. 8 out of 10, = 0.0039). The whole informed consent process was also completed faster in the video group (mean duration 34.7 vs. 46.2 min, < 0.001). Median satisfaction scores were high in both groups (34 vs. 33 out of 35 points), with no significant differences observed ( > 0.05).
The educational video effectively improved patient understanding and streamlined the informed consent process without compromising patients' satisfaction. This approach also helps to standardise the delivery of complex medical information, and it can also be adapted to improve the informed consent process for other cancer treatments.
背景/目的：知情同意在医疗实践中至关重要，尤其对于乳腺癌患者术后放疗等复杂治疗而言。传统的同意程序通常基于口头声明，虽信息高度浓缩但数量庞大，可能超出患者的记录能力并导致误解。本研究的目的是开发并测试一部关于乳腺癌患者的教育视频，通过提高患者的理解并缩短后续咨询的时长来加强知情同意过程。
在通过改良德尔菲法确定基本内容后制作教育视频，参与该方法的专家小组成员包括放射肿瘤学家、护士、放射治疗师和既往患者，他们连续几轮对主题进行评分。在达成内容共识后，视频以患者友好的方式涵盖了术后放疗的19个关键方面。50名计划接受术后放疗的乳腺癌患者被随机分为两组，一组（n = 25）在进行口头咨询前观看视频，另一组（n = 25）为仅参与传统知情同意过程的对照组。记录两组知情同意过程的时长。为评估视频的教育效果，编制了一份多项选择题测试。此外，使用一份单独问卷记录患者的满意度。两份问卷均由患者在签署同意书后一到两小时内完成。
视频组患者的知识得分显著高于接受标准口头解释的患者（正确答案中位数为9分对10分中的8分，P = 0.0039）。视频组完成整个知情同意过程也更快（平均时长34.7分钟对46.2分钟，P < 0.001）。两组的满意度中位数得分都很高（35分中的34分对33分），未观察到显著差异（P > 0.05）。
教育视频有效提高了患者的理解并简化了知情同意过程，同时不影响患者满意度。这种方法还有助于规范复杂医疗信息的传递，并且也可进行调整以改善其他癌症治疗的知情同意过程。
