Gutzwiller F
Soz Praventivmed. 1980 Nov;25(5):244-9. doi: 10.1007/BF02078489.
Intervention tricals can principally be classified into community or clinically oriented designs. The clinical approach of the randomized controlled trial (RCT) implies the individual randomization of a volunteer population into a study and a control group. In community-oriented trials, however, the study and control group are not composed of individuals, but rather of total population groups (e.g. communities, factories). The paper gives first an overview over the historial development of epidemiological methods as the basis for both study types. Shortcomings and advantages both of RCT's and of community trials are discussed, using the examples of the "diet-heart" hypothesis and of the National Research Program 1A design, respectively. The two study types uses as primary endpoints for the analysis changes in risk factor distribution, morbidity and/or mortality. A recent alternative is presented, too: advances in angiography allow direct measurements of changes in vessels with atherosclerotic disease. The different study types available complement one another in trying to understand the mechanisms involved in disease of multifactorial origin.
干预试验原则上可分为社区导向型或临床导向型设计。随机对照试验(RCT)的临床方法意味着将志愿者群体个体随机分为研究组和对照组。然而,在社区导向型试验中,研究组和对照组不是由个体组成,而是由总人口群体(如社区、工厂)组成。本文首先概述了作为这两种研究类型基础的流行病学方法的历史发展。分别以“饮食-心脏”假说和国家研究计划1A设计为例,讨论了RCT和社区试验的缺点和优点。这两种研究类型将危险因素分布、发病率和/或死亡率的变化用作分析的主要终点。还介绍了一种最近的替代方法:血管造影技术的进步使得能够直接测量动脉粥样硬化疾病血管的变化。现有的不同研究类型在试图理解多因素起源疾病所涉及的机制方面相互补充。