Department of Cardiology, TOBB Economy and Technology University School of Medicine, Ankara, Turkey.
Department of History of Medicine and Ethics, TOBB Economy and Technology University School of Medicine, Ankara, Turkey.
Turk Kardiyol Dern Ars. 2021 Sep;49(6):477-487. doi: 10.5543/tkda.2021.55534.
This study aimed to evaluate the content of informed consent forms (ICFs) used during cardiology interventions by the university, research and training (R-T), and private hospitals with regard to ethical standards and compare them with the Turkish Society of Cardiology (TSC) templates and among various institutions.
A total of 185 forms from the university, R-T, and private hospitals and 19 TSC templates were selected and analyzed for 26 criteria. Compliance with TSC templates was also evaluated. Data were presented as the percentage of ICFs satisfying the criteria and compared using the Fisher exact test, and 95% confidence intervals were calculated.
TSC templates were more compatible and included more information to comply with ethical standards than ICFs of all 3 types of healthcare institutions. The areas of improvement for these templates were prospects of treatment and alternative treatments, quality of life, explanation for third-party consent, duration of hospitalization, and time to return to normal life. Among the 3 types of hospitals, R-T-ICFs were more compatible with templates. Private hospital ICFs had the poorest compliance with TSC templates. Separate anesthesia ICFs and detailed information about exposure to radioactivity were lacking.
The current ICFs for cardiology interventions have major ethical deficiencies and need urgent improvement. Professional societies such as TSC are essential institutions to develop and provide guidance and templates for ICFs to meet the ethical standards during the informed consent process and standardization of the process among various institutions.
本研究旨在评估大学、研究与培训（R-T）和私立医院心内科介入治疗中使用的知情同意书（ICF）在伦理标准方面的内容，并将其与土耳其心脏病学会（TSC）模板进行比较，同时比较不同机构之间的差异。
共选取了来自大学、R-T 和私立医院的 185 份表格和 19 份 TSC 模板，对 26 项标准进行了分析。还评估了对 TSC 模板的遵守情况。数据以满足标准的 ICF 百分比表示，并使用 Fisher 确切检验进行比较，计算了 95%置信区间。
与所有 3 种类型医疗机构的 ICF 相比，TSC 模板更符合且包含了更多符合伦理标准的信息。这些模板需要改进的方面包括治疗前景和替代治疗、生活质量、第三方同意的解释、住院时间和恢复正常生活的时间。在 3 种类型的医院中，R-T-ICF 与模板的兼容性更高。私立医院的 ICF 对 TSC 模板的遵守情况最差。缺乏单独的麻醉 ICF 和关于放射性暴露的详细信息。
目前心内科介入治疗的 ICF 存在重大伦理缺陷，急需改进。TSC 等专业协会是制定和提供指导以及 ICF 模板的重要机构，以满足知情同意过程中的伦理标准，并实现不同机构之间流程的标准化。
