Department of Pediatrics, Obstetrics, and Gynecology, University of Valencia, Valencia, Spain; Igenomix Foundation-Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain; Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Harvard University, Boston, Massachusetts.
Fertil Steril. 2020 Jun;113(6):1091-1092. doi: 10.1016/j.fertnstert.2020.03.018.
Randomized-controlled trials (RCTs) and meta-analyses are the pinnacle of evidence-based medicine, enabling identification of the best available diagnostic, interventional, and therapeutic options. These tools help clinicians and policy-makers to set clinical guidelines, but they also represent a double-edged sword: the meaningfulness of RCTs and meta-analyses relies on their quality, performance, and integrity. The present Views and Reviews collection prepared by 18 renowned experts and coordinated by Ben Mol aims to inform and educate our readers about RCTs and meta-analyses in reproductive medicine. The collection begins with the basic features that guarantee the quality of a trial, including protocols, registrations and monitoring, study design and analysis, and reporting standards. Next are discussed the status of planning and coordination of RCTs in different global settings, current unmet needs, and how future studies can better meet these needs, as well as methodologic issues facing different types of RCTs. Finally, insight is provided into the issue of data fabrication and falsification, offering possible solutions to ensure the integrity of RCTs. The challenges and benefits of these crucial evidence-generating tools deserve our attention and education because the findings of RCTs and meta-analyses can directly affect the health of our patients, and when performance and integrity problems exist, the "magic" of these tools disappears-with harmful consequences.
随机对照试验（RCTs）和荟萃分析是循证医学的巅峰，能够确定最佳的诊断、干预和治疗选择。这些工具帮助临床医生和决策者制定临床指南，但它们也代表了一把双刃剑：RCTs 和荟萃分析的意义取决于其质量、表现和完整性。本观点与评论集由 18 位知名专家编写，由 Ben Mol 协调，旨在为读者提供生殖医学中 RCTs 和荟萃分析的信息和教育。该文集首先介绍了保证试验质量的基本特征，包括方案、注册和监测、研究设计和分析以及报告标准。接下来讨论了不同全球环境下 RCT 规划和协调的现状、当前未满足的需求以及未来研究如何更好地满足这些需求，以及不同类型 RCTs 面临的方法学问题。最后，深入探讨了数据捏造和伪造问题，提供了确保 RCT 完整性的可能解决方案。这些关键的证据生成工具的挑战和益处值得我们关注和教育，因为 RCTs 和荟萃分析的发现可能直接影响我们患者的健康，而当存在表现和完整性问题时，这些工具的“魔力”就会消失，带来有害的后果。
