Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records.
Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records.
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DOI：
10.3346/jkms.2018.33.e213
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发表时间：
2018-08-20
影响因子：
4.5
通讯作者：
Kim JH
中科院分区：
文献类型：
--
作者：
Kim HS;Lee S;Kim JH
真实世界证据（RWE）和随机对照试验（RCT）数据被认为是相互补充的。然而，与RCT相比，RWE的结果仍然被赋予较低的可信度。必须强调的是，RWE研究是一种真实世界的实践，不需要像RCT研究那样执行，才能可靠。RWE的优点和缺点必须清楚地认识到，然后可以从研究开始就计划适当的方案，以确保尽可能多的样本。必须注意隐私保护。此外，通过详细细致的数据质量管理减少脱落人数，可以有效减少偏倚。RCT研究具有最高的可靠性，而RWE研究反映了临床的实际情况，可以形成相互补充的关系。事实上，一旦这一点得到证实，这两种方法可能构成医学上最强大的循证研究方法。
Real-world evidence (RWE) and randomized control trial (RCT) data are considered mutually complementary. However, compared with RCT, the outcomes of RWE continue to be assigned lower credibility. It must be emphasized that RWE research is a real-world practice that does not need to be executed as RCT research for it to be reliable. The advantages and disadvantages of RWE must be discerned clearly, and then the proper protocol can be planned from the beginning of the research to secure as many samples as possible. Attention must be paid to privacy protection. Moreover, bias can be reduced meaningfully by reducing the number of dropouts through detailed and meticulous data quality management. RCT research, characterized as having the highest reliability, and RWE research, which reflects the actual clinical aspects, can have a mutually supplementary relationship. Indeed, once this is proven, the two could comprise the most powerful evidence-based research method in medicine.
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