Psychological Ageing Research (PAR), University of Siegen, Siegen, Germany.
Interdisciplinary Ageing Research (IAW), Goethe University Frankfurt, Frankfurt, Germany.
Aging Ment Health. 2023 Feb;27(2):292-300. doi: 10.1080/13607863.2021.2024797. Epub 2022 Jan 6.
As our society ages, the incidence of age-related diseases increases and with it the number of medical treatments that require informed consent. Capacity to consent is often categorically questioned in persons with dementia (PwD) without appropriate assessment, depriving them of their right to autonomous decision-making. Supportive structures for PwD that comply with legal requirements are lacking. The EmMa project tried to overcome this shortcoming by developing and testing possible supportive measures to enhance the informed consent process for PwD. These enhanced consent procedures (ECPs) were tested in a randomized controlled trial with 40 PwD. It was hypothesized that strengths-based ECPs could improve capacity to consent to a drug treatment in PwD as measured with a semi-structured interview. Against the expectations, no effect of the ECPs on capacity to consent could be found, but the ECPs improved understanding of information in PwD. To empower PwD in clinical settings, however, all aspects of capacity to consent should be targeted with specific aids that are implemented carefully and selectively. More research on possible aids for ECPs is urgently needed in order to enable ethically and legally robust informed consent. In particular, effective ways to improve both reasoning and appreciation are yet to be found.
随着社会老龄化，与年龄相关的疾病发病率上升，需要知情同意的医疗治疗数量也随之增加。在没有适当评估的情况下，痴呆症患者（PwD）的同意能力经常被断然质疑，剥夺了他们自主决策的权利。缺乏符合法律要求的支持痴呆症患者的结构。EmMa 项目试图通过开发和测试可能的支持措施来克服这一缺陷，以增强痴呆症患者的知情同意过程。这些增强的同意程序（ECPs）在一项针对 40 名痴呆症患者的随机对照试验中进行了测试。假设基于优势的 ECPs 可以改善用半结构化访谈测量的痴呆症患者对药物治疗的同意能力。出乎意料的是，没有发现 ECPs 对同意能力有影响，但 ECPs 提高了痴呆症患者对信息的理解。然而，为了在临床环境中赋予痴呆症患者权力，应该针对同意能力的所有方面，使用经过精心和有选择性实施的特定辅助工具。为了实现伦理和法律上健全的知情同意，迫切需要对可能的 ECP 辅助工具进行更多研究。特别是，需要找到有效提高推理和欣赏能力的方法。
