"Decision-making capacity for research participation among addicted people: a cross-sectional study"
"Decision-making capacity for research participation among addicted people: a cross-sectional study"
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DOI：
10.1186/s12910-015-0086-9
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发表时间：
2016-01-13
影响因子：
2.7
通讯作者：
Perez-Carceles, Maria D.
中科院分区：
文献类型：
--
作者：
Moran-Sanchez, Ines;Luna, Aurelio;Perez-Carceles, Maria D.
背景：知情同意是临床研究伦理的关键要素。吸毒人群可能存在同意能力受损的风险。然而，很少有研究关注他们对同意书的理解。本研究的目的是评估成瘾的个人提供同意research.Methods的能力：53个主题与DSM-5诊断的物质使用障碍（SUD）和50个非精神对照科目（NPC）参加了调查，从2014年12月至2015年3月。这项横断面研究是在西班牙的一个社区门诊治疗中心和一个城市健康中心进行的。在临床研究的麦克阿瑟能力评估工具（MacCAT-CR）和临床访谈的指导下，对能力/能力丧失进行了二元判断。人口统计学和临床特征进行了评估的情况下，笔记和简易精神状态检查，全球评估功能量表和临床总体impressionscales.Results：NPC表现最好的MacCAT-CR，和SUD患者有最差的性能，特别是在理解和欣赏分量表。32.7%的SUD人缺乏与研究相关的决策能力。有没有统计学上的显着差异组之间的能力，同意research.Conclusions：我们的研究结果提供的证据表明，一个很大比例的个人与SUD的决定能力同意research. Conclusions。因此，根据SUD诊断得出关于研究决策能力的结论是不合适的。在没有严重认知障碍、急性戒断或中毒的情况下，我们应该假设成瘾者具有决策能力。因此，认为SUD患者会因此失去研究同意的决策权的观点是有缺陷的，也是污名化的。
Background: Informed consent is a key element of ethical clinical research. Addicted population may be at risk for impaired consent capacity. However, very little research has focused on their comprehension of consent forms. The aim of this study is to assess the capacity of addicted individuals to provide consent to research.Methods: 53 subjects with DSM-5 diagnoses of a Substance Use Disorder (SUD) and 50 non psychiatric comparison subjects (NPCs) participated in the survey from December 2014 to March 2015. This cross-sectional study was carried out at a community-based Outpatient Treatment Center and at an urban-located Health Centre in Spain. A binary judgment of capacity/incapacity was made guided by the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and a clinical interview. Demographics and clinical characteristics were assessed by cases notes and the Mini-Mental State Examination, the Global Assessment Functional Scale and the Clinical Global Impression Scale.Results: NPCs performed the best on the MacCAT-CR, and patients with SUD had the worst performance, particularly on the Understanding and Appreciation subscales. 32.7 % SUD people lacked research-related decisional capacity. There were no statistically significant differences between the groups in terms of capacity to consent to research.Conclusions: The findings of our study provide evidence that a large proportion of individuals with SUD had decisional capacity for consent to research. It is therefore inappropriate to draw conclusions about capacity to make research decisions on the basis of a SUD diagnosis. In the absence of advanced cognitive impairment, acute withdrawal or intoxication, we should assume that addicted persons possess decision-making capacity. Thus, the view that people with SUD would ipso facto lose decision-making power for research consent is flawed and stigmatizing.