Carol Davila University of Medicine and Pharmacy, Sos.Vitan Barzesti 9, 042122 Sector 4, Bucuresti, Romania.
National Institute of Legal Medicine, Bucharest, Romania.
BMC Psychiatry. 2018 Jan 5;18(1):2. doi: 10.1186/s12888-017-1580-z.
The process of assessing the decision-making capacity of potential subjects before their inclusion in clinical trials is a legal requirement and a moral obligation, as it is essential for respecting their autonomy. This issue is especially important in psychiatry patients (such as those diagnosed with schizophrenia). The primary purpose of this article was to evaluate the degree of impairment in each dimension of decision-making capacity in schizophrenia patients compared to non-mentally-ill controls, as quantified by the (MacCAT-CR) instrument. Secondary objectives were (1) to see whether enhanced consent forms are associated with a significant increase in decision-making capacity in schizophrenia patients, and (2) if decision-making capacity in schizophrenia subjects is dependent on the age, gender, or the inpatient status of the subjects.
We systematically reviewed the results obtained from three databases: ISI Web of Science, Pubmed, Scopus. Each database was scrutinised using the following keywords: "MacCAT-CR + schizophrenia", "decision-making capacity + schizophrenia", and "informed consent + schizophrenia."
We included 13 studies in the analysis. The effect size between the schizophrenia and the control group was significant, with a difference in means of -4.43 (-5.76; -3.1, p < 0.001) for understanding, -1.17 (-1.49, -0.84, p < 0.001) for appreciation, -1.29 (-1.79, -0.79, p < 0.001) for reasoning, and -0.05 (-0.9, -0.01, p = 0.022) for expressing a choice.
Even if schizophrenia patients have a significantly decreased decision-making capacity compared to non-mentally-ill controls, they should be considered as competent unless very severe changes are identifiable during clinical examination. Enhanced informed consent forms decrease the differences between schizophrenia patients and non-mentally-ill controls (except for the reasoning dimension) and should be used whenever the investigators want to include more ill patients in their clinical trials. Increased age, men gender and an increased percentage of inpatients might increase the differential of decision-making incompetence compared to non-mentally-ill subjects in various dimensions of the decision-making competence as analysed by the MacCAT-CR scale, but the small number of subjects did not allow us (except for one instance) to reach statistical significance.
在将潜在受试者纳入临床试验之前，评估其决策能力的过程是法律要求和道德义务，因为这对于尊重他们的自主权至关重要。这个问题在精神病患者（例如被诊断为精神分裂症的患者）中尤为重要。本文的主要目的是评估精神分裂症患者在决策能力的每个维度上相对于非精神疾病对照组的受损程度，这是通过（MacCAT-CR）工具来量化的。次要目的是（1）了解增强的同意书是否会导致精神分裂症患者的决策能力显著提高，以及（2）如果精神分裂症患者的决策能力取决于患者的年龄、性别或住院状态。
我们系统地审查了来自三个数据库的结果：ISI Web of Science、Pubmed 和 Scopus。每个数据库都使用以下关键字进行了详细检查：“MacCAT-CR + 精神分裂症”、“决策能力 + 精神分裂症”和“知情同意 + 精神分裂症”。
我们纳入了 13 项研究进行分析。精神分裂症组和对照组之间的效应大小具有统计学意义，理解方面的平均值差异为-4.43（-5.76；-3.1，p < 0.001），欣赏方面为-1.17（-1.49，-0.84，p < 0.001），推理方面为-1.29（-1.79，-0.79，p < 0.001），表达选择方面为-0.05（-0.9，-0.01，p = 0.022）。
即使精神分裂症患者的决策能力明显低于非精神疾病对照组，除非在临床检查中发现非常严重的变化，否则应将其视为有能力。增强的知情同意书减少了精神分裂症患者和非精神疾病对照组之间的差异（推理维度除外），并且只要研究人员希望将更多的患者纳入临床试验，就应使用这些同意书。年龄增加、男性性别和住院患者比例增加可能会导致决策能力的差异增加，与 MacCAT-CR 量表分析的决策能力各个维度的非精神疾病对照组相比，精神分裂症患者在决策能力方面表现出无能力，但由于研究对象数量较少，除了一个实例之外，我们无法达到统计学意义。
