正确把握精神卫生临床试验设计三要素的要领（II）--影响因素

摘要

Definitely elaborating the meanings and essentials of grasping the influential factors correctly in the clinical trial design of mental health. Searching and discovering how to hold the influential factors correctly starting from the basic common sense and based on the characteristics of mental health study. The following results are obtained through combining the features with examples in this specialty,that is to say,we must grasp the following five aspects:①the classification of influential factors;②the principles of determining factors and their levels;③how to make the experimental factors standardization;④how to find non - experimental factors accurately and entirely;⑤how to control important non - experimental factors effectively. Mastering the five aspects mentioned above correctly equals to gripe the innate of the issue and it is an important link to improve the quality of clinical trial study in answering the question of how to ascertain influential factors.%明确阐释在进行精神卫生临床试验设计时，应正确把握“影响因素”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，怎样做才能被称为正确把握了“影响因素”。通过结合本专业的特点和实例，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影响因素的分类；②确定因素及其水平的原则；③如何对试验因素进行标准化；④如何找准找全重要的非试验因素；⑤如何有效控制重要非试验因素。在如何确定影响因素的问题上，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。