Lüderitz B, Wolpert C
Dept. of Medicine-Cardiology, University of Bonn, Sigmund-Freud-Str. 25, 53105 Bonn, Germany.
Z Kardiol. 2003 May;92(5):377-83. doi: 10.1007/s00392-003-0931-6.
Written informed consent for pacemaker and ICD patients should be easy to understand and provided in written form in the patient's language. Comprehensiveness is required. It is essential to address driving and running machines, complication rates, benefits in appropriate hierarchical order and future necessary interventions. Eventually potential risks, e.g., flying, sports, sexual activity should be mentioned. It is important to explain pacemaker systems and ICD devices in details including cardiac resynchronization therapy (CRT) for heart failure. One of the main aspects concerns protection of human subjects participating in clinical studies. Informed consent necessitates a statement that the study involves research. This statement should include explanation of the purposes of the study, expected duration, description of the procedures, identification of experimental procedures, description of foreseeable risks or discomforts, and disclosure of alternative procedures. Further information should be given on psychological concerns, sexual activity, driving and quality of life in pacemaker and ICD patients.
对于起搏器和植入式心脏除颤器（ICD）患者，书面知情同意书应易于理解，并以患者的语言提供书面形式。需要全面性。必须按适当的层次顺序说明驾驶和操作机器、并发症发生率、益处以及未来必要的干预措施。最终应提及潜在风险，例如飞行、运动、性行为。详细解释起搏器系统和ICD设备（包括用于心力衰竭的心脏再同步治疗（CRT））非常重要。主要方面之一涉及对参与临床研究的人类受试者的保护。知情同意需要声明该研究涉及研究。该声明应包括对研究目的、预期持续时间、程序描述、实验程序识别、可预见风险或不适描述以及替代程序披露的解释。还应提供有关起搏器和ICD患者心理问题、性行为、驾驶和生活质量的进一步信息。
