Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders
Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders
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DOI：
10.1007/s00213-003-1501-3
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发表时间：
2003-12-01
影响因子：
3.4
通讯作者：
Dunn, LB
中科院分区：
文献类型：
--
作者：
Dunn, LB
理由。优化精神疾病患者的能力，为研究提供有意义的知情同意，已成为精神病学研究人员高度关注的问题。目标.我们检查了同意后测试的理解给予老年精神障碍患者，以确定问题领域的理解知情同意的研究。方法. 102名中老年精神分裂症或相关精神障碍门诊患者和20名正常对照受试者接受了20项问卷调查，以评估他们在接受常规（基于纸张）或增强（计算机化，结构化幻灯片，包括更多的审查）同意程序后对低风险研究方案的理解。对个别问题的数据进行了分析。结果在开放式问题上，患者比正常对照受试者更困难，包括询问研究程序、涉及的时间以及潜在的风险和获益。在患者中，与常规手术相比，增强手术在潜在风险和所需时间方面的表现更好。结论.在理解知情同意方面的问题领域，如研究程序和潜在的风险和益处，应该是改善严重精神疾病患者参与者知情同意过程的重点。还应进行研究，以澄清如何最好地评估对同意的理解，因为问题的措辞可能会影响回答。
Rationale. Optimizing the abilities of individuals with psychiatric disorders to provide meaningful informed consent for research has become a heightened concern for psychiatric researchers. Objectives. We examined a post-consent test of comprehension given to older patients with psychotic disorders to identify problem areas in the understanding of informed consent for research. Methods. One hundred and two middle-aged and older outpatients with schizophrenia or related psychotic disorders and twenty normal comparison subjects were administered a 20-item questionnaire to assess their comprehension of consent for a low-risk research protocol after receiving either a routine (paper-based) or an enhanced (computerized, structured slideshow incorporating greater review) consent procedure. Data on individual questions were analyzed. Results. Patients had more difficulty than normal comparison subjects on open-ended questions, including those asking about study procedures, time involved, and potential risks and benefits. Among patients, the enhanced procedure was associated with better performance on questions about potential risks and time required than the routine procedure. Conclusions. Problem areas in the understanding of informed consent, such as study procedures and potential risks and benefits, should be the focus of attempts to improve the consent process for patient participants with severe mental illness. Research also should be done to clarify how best to assess understanding of consent, since the wording of questions likely affects the responses.