精神卫生科研如何严格遵守试验设计四原则之对照原则

摘要

To elaborate how to develop and implement best practice of the ″control principle″ in the clinical trial design of mental health. In the context of discipline of mental health,the question challenges designers is how to adherence to the ″control principle″,the essence of which includes whether there is a control group and whether the control group is properly set up. By combining the general features with the examples in the discipline of mental health,the five aspects below should be taken into account in the clinical trial design. ①To correctly choose an appropriate type of control. ②To perceive and determine what is a proper control group. ③To make a proper control group to the best of one′s ability. ④To avoid the mistakes of a false control group and an insufficient control group. ⑤To correctly determine the quantity of control groups. Thus,as to adherence to the ″control principle″,the essence of which requires designers to put the above five aspects into practice,and it′s also a pivotal procedure to achieve high - quality findings of clinical trial research.%明确阐释在进行精神卫生临床试验设计时，应正确把握“对照原则”的意义和要领。从基本常识出发，并基于精神卫生科研的特点，寻找和发现在此研究领域中，怎样做才能被称为严格遵守了“对照原则”。通过结合本专业的特点，并结合实例，获得如下的结果，即在进行精神卫生临床试验设计时，必须把握好以下五个方面：①正确选定合适的对照形式；②正确领悟什么是合理的对照组；③必须尽可能设置合理的对照组；④应尽可能避免出现假对照和对照不全等错误；⑤应正确确定对照的组数。在如何严格遵守对照原则问题上，正确把握好前述提及的五个方面，就是抓住了问题的本质，是提高临床试验研究质量的一个重要环节。