Patrick D L
Rev Epidemiol Sante Publique. 1981;29(3):245-53.
The classic experiment, the randomised controlled trial, is the best known and most revered of evaluation research methods. Randomization in community-based intervention trials, however, is not always possible because of ethical problems arising from with holding the experimental treatment from the control groups or the difficulties in conducting experiments in field settings which do not approach controlled laboratory conditions. In such circumstances, quasi-experimental or observational designs must be used. Two major principles are involved in using quasi-experimental methods: (1) the logic for establishing causality between treatment and effect is the same as that for randomised experiments, but the problems of assessing causality or internal validity are greater, and (2) assessment of the external validity or generalizability of quasi-experimental findings crucial to the interpretation of results. Selected quasi-experimental designs using time series and comparison groups are described with examples from public health intervention trials where threats to internal validity have been assessed by using different analytic techniques or gathering additional evidence. Quasi-experimental evaluations are most useful when opportunities exist for testing rival hypotheses concerning the internal and external validity, or the findings can be used to complement true experiments.
经典实验,即随机对照试验,是评估研究方法中最为人所知且最受尊崇的。然而,在基于社区的干预试验中,由于不给对照组提供实验性治疗会引发伦理问题,或者在无法接近受控实验室条件的实地环境中进行实验存在困难,随机化并非总是可行的。在这种情况下,必须采用准实验或观察性设计。使用准实验方法涉及两个主要原则:(1)确立治疗与效果之间因果关系的逻辑与随机实验相同,但评估因果关系或内部效度的问题更大;(2)评估准实验结果的外部效度或可推广性对于结果的解释至关重要。文中结合公共卫生干预试验的实例,描述了使用时间序列和对照组的选定准实验设计,其中通过使用不同的分析技术或收集额外证据来评估内部效度的威胁。当有机会检验关于内部和外部效度的对立假设,或者研究结果可用于补充真实实验时,准实验评估最为有用。