1 Section of Criminology and Forensic Psychiatry, University of Bari, Bari, Italy.
2 Department of Psychiatry and Behavioral Neuroscience, Saint Louis University School of Medicine, St. Louis, MO, USA.
Int J Soc Psychiatry. 2018 Feb;64(1):26-36. doi: 10.1177/0020764017739642. Epub 2017 Nov 28.
Informed consent is an essential element in doctor-patient relationship. In particular, obtaining valid informed consent from patients with neurocognitive diseases is a critical issue at present. For this reason, we decided to conduct research on elderly patients with Alzheimer's disease ( Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) to assess their capacity to make treatment decisions.
The experimental group comprised 70 Alzheimer patients who were admitted to the Neurodegenerative Disease Unit of the University of Bari. The control group consisted of 83 elderly patients without neurocognitive disorders who were hospitalized in the Geriatric Unit at the same university. After providing written consent to participate in the research, each subject underwent the following assessments: (a) assessment of comprehension sheet, (b) Neuropsychiatric Inventory (NPI) and Global Functioning Evaluation (GFE), (c) neurological evaluation, (d) neuropsychological assessment with a full battery of tests, (d) The MacArthur Treatment Competence Study (MacArthur Competence Assessment Tool for Treatment (MacCAT-T); understanding, appreciating, reasoning and expressing a choice) and (e) a semi-structured interview administered by the patient's caregiver.
RESULTS/CONCLUSION: The present survey was designed to analyze possible qualitative and quantitative correlations between cognitive functioning and capacity to consent in relation to different degrees of severity of the neurodegenerative disorder. A large portion of the patients in our experimental sample did not appear to have the capacity to provide a valid consent. The authors present initial results of this study and discuss their possible implications.
知情同意是医患关系的一个重要组成部分。特别是，目前从患有神经认知疾病的患者那里获得有效的知情同意是一个关键问题。出于这个原因，我们决定对患有阿尔茨海默病的老年患者（《精神障碍诊断与统计手册》第五版（DSM-5）进行研究，以评估他们做出治疗决策的能力。
实验组由 70 名被诊断为阿尔茨海默病的患者组成，他们被收入巴里大学神经退行性疾病科。对照组由 83 名无神经认知障碍的老年患者组成，他们被收入同一所大学的老年科。在书面同意参与研究后，每位受试者都接受了以下评估：（a）理解表评估，（b）神经精神问卷（NPI）和总体功能评估（GFE），（c）神经学评估，（d）使用全套测试进行神经心理学评估，（d）麦克阿瑟治疗能力研究（麦克阿瑟治疗能力评估工具（MacCAT-T）：理解、欣赏、推理和表达选择）和（e）由患者照顾者进行的半结构化访谈。
结果/结论：本调查旨在分析认知功能与同意能力之间可能存在的定性和定量相关性，以及与神经退行性疾病严重程度不同的关系。我们实验样本中的很大一部分患者似乎没有能力提供有效的同意。作者介绍了这项研究的初步结果，并讨论了它们可能的影响。
