随机对照试验研究与观察性研究的系统比较

摘要

OBJECTIVE: To compare randomized controlled trial (RCT) study and observational study systematically, and to provide reference for selecting suitable study design types for clinical researchers. METHODS: RCT study and observational study were compared in respects of study design and study report paradigm. Relevant literatures were retrieved from PubMed database and Chinese Journal Full-text Database. The differences of literature publication of RCT study and observational study were compared at home and abroad. RESULTS: There were differences in design principles, objectives, subjects, interventions and validity between RCT study and observational study. The requirements of CONSORT statemtnt and STROBE statement to the topics, abstracts, introduction, results and discussions of report paradigm of two studies were basically consistent, and main difference of them were in aspects of methods and other information. The number of literatures about RCT study and observational study had little gap at abroad, but had great gap at home, especially in cohort study with high-level evidence of evidence-based medicine. CONCLUSIONS: The observational study has developed rapidly in recent years, but RCT study is still a "gold standard" to evaluate the causal effect of clinical study. The researchers should choose the appropriate type of design according to the actual situation.%目的:对随机对照试验研究与观察性研究进行系统性地比较,为临床研究者选择合适的设计类型提供借鉴和参考.方法:比较随机对照试验研究与观察性研究的研究设计、研究报告范式,并检索PubMed数据库、中国期刊全文数据库中的文献,分析国内外随机对照试验研究与观察性研究文献发表的差异.结果:随机对照试验研究与观察性研究在设计原则、研究目的、研究对象、干预措施、效度等多方面均存在差异.CONSORT声明和STROBE声明对两种研究报告范式的题目和摘要、引言、结果、讨论等内容的要求基本一致,主要差别在于方法和其他信息方面.国外随机对照试验研究与观察性研究的文献数量相差较小,而国内相差较大,特别是在证据等级较高的队列研究方面.结论:观察性研究近年来发展迅速,但随机对照试验研究仍然是临床研究中评价因果效应的"金标准",研究者在进行研究时应根据实际情况选择合适的设计类型.