Ieva Francesca, Gale Chris P, Sharples Linda D
Department of Mathematics, Università degli Studi di Milano, via Saldini 50, 20133 Milano, Italy.
Expert Rev Cardiovasc Ther. 2014 Dec;12(12):1383-6. doi: 10.1586/14779072.2015.982096.
Clinical registries are established as tools for auditing clinical standards and benchmarking quality improvement initiatives. They also have an emerging role (as electronic health records) in cardiovascular research and, in particular, the conduct of RCTs. While the RCT is accepted as the most robust experimental design, observational data from clinical registries has become increasingly valuable for RCTs. Data from clinical registries may be used to augment results from RCTs, identify patients for recruitment and as an alternative when randomization is not practically possible or ethically desirable. Here the authors appraise the advantages and disadvantages of both methodologies, with the aim of clarifying when their joint use may be successful.
临床注册登记作为审核临床标准和衡量质量改进举措的工具而设立。它们在心血管研究中(作为电子健康记录)也正发挥着越来越重要的作用,尤其是在随机对照试验(RCT)的开展方面。虽然随机对照试验被公认为是最有力的实验设计,但来自临床注册登记的观察性数据对随机对照试验而言也变得越来越有价值。临床注册登记的数据可用于增强随机对照试验的结果、识别有待招募的患者,以及在随机化在实际操作上不可行或在伦理上不可取时作为一种替代方法。在此,作者评估了这两种方法的优缺点,目的是阐明何时联合使用这两种方法可能会取得成功。