正确把握精神卫生临床试验设计三要素的要领（Ⅲ）--观测指标

摘要

To explain clearly that the meanings and essentials of " outcomes" should be grasped correctly,when conducting the clinical trial design of mental health. Starting from the basic common sense,and based on the characteristics of mental health study,in what way it can be considered to correctly grasp the " outcomes" by searching and finding an approach to this research field. By combining the features with some real examples in the specialty of mental health,the following results acquired:Need to master the following five aspects when conducting the clinical trial design of mental health. ①The classification of outcomes;②The selection of outcomes;③ The method for measuring the values of outcomes;④ The determination of measuring time of outcomes;⑤ The determination of measuring times. It is an important link to improve the quality of clinical trials to correctly hold the previous five aspects,which is to seize the essence of the issue on answering the question of how to determine the outcomes.%明确阐释在进行精神卫生临床试验设计时，正确把握“观测指标”的意义和要领。从基本常识出发，基于精神卫生科研的特点，寻找和发现在此研究领域中，怎样做才能被称为正确把握了“观测指标”。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观测指标的分类；②观测指标的选定；③观测指标取值的测定方法；④观测指标测定时间的确定；⑤观测指标测定次数的确定。在如何确定观测指标问题上，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。