Scott I A, Attia J
Department of Internal Medicine and Clinical Epidemiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
School of Clinical Medicine, University of Queensland, Brisbane, Queensland, Australia.
Intern Med J. 2017 Feb;47(2):144-157. doi: 10.1111/imj.13167.
Observational studies of the effectiveness of clinical interventions are proliferating as more 'real-world' clinical data (so called 'big data') are gathered from clinical registries, administrative datasets and electronic health records. While well-conducted randomised controlled trials (RCT) remain the scientific standard in assessing the efficacy of clinical interventions, well-designed observational studies may add to the evidence base of effectiveness in situations where RCT are of limited value or very difficult to perform. Rather than dismissing observational studies, we need to determine what circumstances may justify doing an observational study and when the study is sufficiently rigorous to be considered reasonably trustworthy. This article proposes criteria by which users of the literature might make such determinations.
随着从临床登记处、行政数据集和电子健康记录中收集到越来越多“真实世界”的临床数据（即所谓的“大数据”），关于临床干预效果的观察性研究正在激增。虽然精心设计的随机对照试验（RCT）仍然是评估临床干预疗效的科学标准，但在RCT价值有限或很难实施的情况下，精心设计的观察性研究可能会为有效性证据库增添内容。我们不应摒弃观察性研究，而是需要确定哪些情况可能证明进行观察性研究是合理的，以及该研究何时足够严谨从而被认为具有合理的可信度。本文提出了一些标准，文献使用者可据此做出此类判断。
