Mol Ben W, Li Wentao, Lai Shimona, Stock Sarah
Department of Obstetrics and Gynaecology, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
Department of Obstetrics and Gynaecology, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.
Eur J Obstet Gynecol Reprod Biol. 2021 Jun;261:144-147. doi: 10.1016/j.ejogrb.2021.04.031. Epub 2021 Apr 24.
Randomized controlled trials (RCTs) are a cornerstone for the assessment of the effectiveness of interventions. Appropriate randomization, design, sample size, statistical analyses, and conduct that reduces the risk of bias, enhance the chance they will deliver true research findings. The credibility of RCTs is difficult to assess without objective evidence of compliance with Good Clinical Practice standards. Remarkably, no mechanisms are in place both in the initial peer review process and during meta-analysis to assess these, and little guidance on how to assess data where research integrity cannot be confirmed (e.g. where data originated from a setting without established infrastructure or an era preceding current standards). We describe the case of the use of antenatal steroids. When these drugs are used in early preterm birth, their benefits outweigh the harms. However, later in pregnancy, and specifically at term, this balance is less clear. We describe that the four randomised clinical trials that inform clinical practice through the Cochrane meta-analysis, for various reasons, lack clear governance which makes it difficult to verify provenance and reliability of the data. We conclude that transparency and assessment of data credibility need to be inbuilt both at the time of publication and at the time of meta-analysis. This will drive up standards and encourage appropriate interpretation of results and the context from which they were derived.
随机对照试验（RCTs）是评估干预措施有效性的基石。适当的随机化、设计、样本量、统计分析以及降低偏倚风险的实施方法，能增加得出真实研究结果的机会。如果没有符合《药物临床试验质量管理规范》标准的客观证据，随机对照试验的可信度就很难评估。值得注意的是，在初步同行评审过程和荟萃分析过程中，都没有评估这些标准的机制，对于如何评估无法确认研究完整性的数据（例如数据来自没有既定基础设施的环境或当前标准之前的时代）也几乎没有指导。我们描述了产前使用类固醇的案例。当这些药物用于早产时，其益处大于危害。然而，在妊娠后期，特别是足月时，这种利弊平衡就不那么明确了。我们描述了通过Cochrane荟萃分析为临床实践提供依据的四项随机临床试验，由于各种原因，缺乏明确的管理，这使得难以核实数据的来源和可靠性。我们得出结论，在发表时和荟萃分析时都需要内置数据可信度的透明度和评估。这将提高标准，并鼓励对结果及其得出的背景进行恰当的解读。
