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Introduction
Fertility and Sterility ( IF 6.6 ) Pub Date : 2020-06-01 , DOI: 10.1016/j.fertnstert.2020.03.018
Carlos Simon 1
Affiliation  

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.

中文翻译:

介绍

随机对照试验 (RCT) 和荟萃分析是循证医学的巅峰之作,能够确定最佳的诊断、介入和治疗选择。这些工具帮助临床医生和政策制定者制定临床指南,但它们也代表着一把双刃剑:随机对照试验和荟萃分析的意义取决于它们的质量、性能和完整性。目前由 18 位知名专家编写并由 Ben Mol 协调的观点和评论集旨在向我们的读者介绍和教育我们的读者关于生殖医学的 RCT 和荟萃分析。该集合从保证试验质量的基本特征开始,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 的规划和协调状况、当前未满足的需求、未来研究如何更好地满足这些需求,以及不同类型 RCT 面临的方法学问题。最后,提供了对数据制造和伪造问题的洞察,提供了可能的解决方案,以确保 RCT 的完整性。这些重要的证据生成工具的挑战和好处值得我们关注和教育,因为 RCT 和荟萃分析的结果可以直接影响我们患者的健康,当性能和完整性问题存在时,这些工具的“魔力”就会消失- 带来有害后果。以及不同类型 RCT 面临的方法学问题。最后,提供了对数据制造和伪造问题的洞察,提供了可能的解决方案,以确保 RCT 的完整性。这些重要的证据生成工具的挑战和好处值得我们关注和教育,因为 RCT 和荟萃分析的结果可以直接影响我们患者的健康,当性能和完整性问题存在时,这些工具的“魔力”就会消失- 带来有害后果。以及不同类型 RCT 面临的方法学问题。最后,提供了对数据制造和伪造问题的洞察,提供了可能的解决方案,以确保 RCT 的完整性。这些重要的证据生成工具的挑战和好处值得我们关注和教育,因为 RCT 和荟萃分析的结果可以直接影响我们患者的健康,当性能和完整性问题存在时,这些工具的“魔力”就会消失- 带来有害后果。
更新日期:2020-06-01
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