Understanding of placebo controls among older people with schizophrenia.
Understanding of placebo controls among older people with schizophrenia.
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了解老年精神分裂症患者的安慰剂对照。
DOI：
10.1093/schbul/sbi069
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发表时间：
2006
期刊：
影响因子：
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通讯作者：
Keehan,Monique
中科院分区：
文献类型：
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作者：
Dunn,LauraB;Palmer,BartonW;Keehan,Monique
研究方案经常需要与常规临床护理中使用的程序或设计元素不同的程序或设计元素。一个例子是在许多随机临床试验中纳入安慰剂组。由于患有精神分裂症等慢性疾病时服用安慰剂存在风险，因此确定患有严重精神疾病的人对安慰剂的理解程度是实证研究伦理学的一项重要任务。我们研究了是否可以通过简短的教育干预来提高精神分裂症患者对安慰剂对照的理解。我们将 49 名患有精神分裂症或分裂情感障碍的中老年患者随机分组，接受以下两种治疗：(1) 在同意假设的双盲安慰剂对照临床试验的情况下对安慰剂进行常规解释，或 (2) 同意假设的试验加上更深入地解释安慰剂的简短教育模块。通过包含 12 项的问卷评估对安慰剂的理解，我们检查了对安慰剂理解的人口统计学、临床、神经认知和决策相关性。与仅接受标准信息的参与者相比，接受干预的参与者在安慰剂后测试中获得了更高的分数。安慰剂后测试的表现与决策能力和神经认知能力的测量呈正相关，与阴性症状的严重程度呈负相关，但与阳性或一般症状没有关系。一些参与者将常用短语“糖丸”解释为与糖尿病有关。我们的结论是，对重要研究设计相关信息的理解水平不是静态的，而是可能受到研究人员如何处理同意过程的影响。
Research protocols frequently necessitate procedures or design elements that differ from those used in routine clinical care. An example is the inclusion of a placebo arm in many randomized clinical trials. Because there are risks to taking a placebo when one has a chronic disorder such as schizophrenia, ascertaining how well people with severe mental illness understand placebos is an important task for empirical research ethics. We investigated whether schizophrenia patients' understanding of placebo controls could be improved with a brief educational intervention. We randomized 49 middle-aged and older patients with schizophrenia or schizoaffective disorder to receive either (1) a routine explanation of placebos in the context of consent for a hypothetical double-blind placebo-controlled clinical trial, or (2) the consent for the hypothetical trial plus a brief educational module explaining placebos in more depth. Understanding of placebos was assessed with a 12-item questionnaire, and we examined demographic, clinical, neurocognitive, and decision-making correlates of understanding of placebos. Those participants who received the intervention obtained higher scores on the placebo post-test compared to those who received the standard information alone. Performance on the placebo post-test was positively correlated with measures of decisional capacity and neurocognitive abilities and negatively correlated with severity of negative symptoms, but it showed no relationship with positive or general symptoms. Some participants interpreted the common phrase “sugar pill” as relating somehow to diabetes. We conclude that the level of understanding of important research design–related information is not static but may be influenced by how investigators approach the consent process.