国际临床研究相关报告标准概述

An Overview of Reporting Standards for a Series of Systematic Reviews of International Clinical Trials

设计合理并执行正确的临床研究,无论哪种证据级别,都可以为临床实践的干预措施提供有效的证据。但如果是设计和报告质量低的临床研究会得出偏倚的结果,从而误导临床医生的决策。因此,研究者只有准确、充分地报告临床试验的设计、实施和分析,才可经得起研究质量的严格评价,才能得出令人信服的研究结果。本文旨在简析目前国际临床研究范围里针对各种临床研究或系统综述的报告标准,为中医药临床研究实践提供参考标准。

Any kind of clinical study can supply clinical decision-making with useful information when they are designed and reported properly. However, results with bias or mistake can misguide doctors′ decisions, if trials with poor design quality were reported wrongly. Therefore, researchers should report trials accurately and critically, so that the quality of trials could reach a high level and get trustworthy results. This article made an overview of many kinds of reporting standards about systematic reviews and all kinds of trials. We hope these international published standards could be helpful for Chinese medicine researchers in their practice.