Randomized controlled trials in evidence-based mental health care: Getting the right answer to the right question
Randomized controlled trials in evidence-based mental health care: Getting the right answer to the right question
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DOI：
10.1093/oxfordjournals.schbul.a006981
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发表时间：
2003-01-01
影响因子：
6.6
通讯作者：
McGuire, TG
中科院分区：
文献类型：
--
作者：
Essock, SM;Drake, RE;McGuire, TG
临床研究的目的是回答这个问题：当一种新的治疗方法添加到实践中现有的治疗选择范围中时，会对患者有帮助吗？随机对照试验（RCT），特别是双盲随机对照试验，在解决这个问题方面比观察性研究具有重要的方法学优势。然而，这些优势是有代价的。随机对照试验使用特定的分配规则来比较治疗，将患者分配到不模仿现实世界实践的治疗（随机分配）。随机对照试验的“有利”结果表明新疗法优于现有疗法，这对于对上述问题建立“是”答案既不是必要的也不是充分的。以实验设计为模型的随机对照试验耗费时间和金钱，并且必须比较治疗方法的简单差异。调查结果有a.内部效度高，但可能无法满足该领域的需求，特别是在治疗复杂且快速发展的情况下。临床研究的设计需要考虑实际实践中治疗分配的方式，并包括灵活的设计，以最有效地回答重要问题。
The purpose of clinical research is to answer this question: Would a new treatment, when added to the existing range of treatment options available in practice, help patients? Randomized controlled trials (RCTs)in particular, double-blind RCTs-have important methodological advantages over observational studies for addressing this question. These advantages, however, come at a price. RCTs compare treatments using a particular allocation rule for assigning patients to treatments (random assignment) that does not mimic real-world practice. "Favorable" results from an RCT indicating that a new treatment is superior to existing treatments are neither necessary nor sufficient for establishing a "yes" answer to the question posed above. Modeled on an experimental design, RCTs are expensive in time and money and must compare simple differences in treatments. Findings have a. high internal validity but may not address the needs of the field, particularly where treatment is complex and rapidly evolving. Design of clinical research needs to take account of the way treatments are allocated in actual practice and include flexible designs to answer important questions most effectively.