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真实世界数据:科学证据框架中的一个相关组成部分。

Real-world data: A relevant component in the framework of scientific evidence.

作者信息

Canonica Giorgio W, Del Moro Lorenzo, Costanzo Giovanni, Nappi Emanuele, Paoletti Giovanni

机构信息

Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Asthma and Allergy Unit-IRCCS Humanitas Research Hospital, Milan, Italy.

出版信息

Asia Pac Allergy. 2023 Mar;13(1):40-43. doi: 10.5415/apallergy.0000000000000004. Epub 2023 Apr 28.

Abstract

Explanatory randomized controlled clinical trials test hypotheses to see if the intervention causes an outcome of interest in optimal circumstances, that is, established by selecting patients based on inclusion and exclusion criteria and controlled environments. They assess the "efficacy" of an intervention. On the contrary, it is crucial for society to address issues related to real-world clinical practices. This need can be fulfilled by real-world studies. We discuss the challenges in obtaining real-world evidence in asthma, debating the importance of including patients who are typically excluded from randomized controlled clinical trials to ensure the generalizability of the results. We conclude by discussing the integration of real-world evidence in guidelines and the need for standard rules to use real-world evidence in guidelines.

摘要

解释性随机对照临床试验检验假设,以确定干预措施在最佳情况下是否会导致感兴趣的结果,即在通过纳入和排除标准选择患者以及在受控环境中确定的情况下。它们评估干预措施的“疗效”。相反,社会应对与实际临床实践相关的问题至关重要。这一需求可通过真实世界研究来满足。我们讨论了在哮喘领域获取真实世界证据的挑战,探讨了纳入通常被排除在随机对照临床试验之外的患者以确保结果可推广性的重要性。我们通过讨论真实世界证据在指南中的整合以及在指南中使用真实世界证据的标准规则的必要性来得出结论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9329/10166240/49ae73cb9495/pa9-13-40-g001.jpg

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