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利用真实世界证据进行亚洲卫生技术评估:建议的类型学与范围综述。

Using Real-World Evidence for Health Technology Assessment in Asia: Suggested Typology and Scoping Review.

作者信息

Nugraha Ryan R, Rahadi Arie, Suharlim Christian

机构信息

Management Sciences for Health, Arlington, VA, USA.

Management Sciences for Health, Arlington, VA, USA.

出版信息

Value Health Reg Issues. 2025 Mar;46:101068. doi: 10.1016/j.vhri.2024.101068. Epub 2024 Dec 15.

DOI:10.1016/j.vhri.2024.101068
PMID:39675183
Abstract

OBJECTIVES

This study aimed to provide the typology of real-world evidence (RWE) and challenges associated with improving the use of RWE in Asian countries.

METHODS

This article is divided into 2 subsections. First, a narrative review was conducted to classify RWE based on available real-world data. This method was also used to develop a typology of RWE, particularly considering the nature of the data, the potential evidence generated, and the integration methods into health technology assessment (HTA). Finally, a scoping review was undertaken to identify and filter studies focusing on the implementation of RWE in Asia.

RESULTS

The use of RWE is associated with many caveats, and therefore, its use in Asia is particularly limited. Based on the narrative review, RWE is divided into 3 broad categories: macro-, meso-, and micro-RWE; each represents a different quality of evidence and range of use as evidence for HTA. Although typology helps with consolidating RWE choices for supporting HTA decision making, challenges still persist in using it for HTA purposes. Institutional support, technical capacity, and infrastructure, including data-related issues, may hinder progress in improving the RWE ecosystem for HTA in Asia.

CONCLUSIONS

RWE is a helpful tool that can assist in decision making, especially in reimbursement-related decisions. Although knowing facets of RWE helps in choosing appropriate evidence to assist in policy making, challenges associated with its implementation, especially in the Asian context, need to be anticipated.

摘要

目的

本研究旨在提供真实世界证据(RWE)的类型学,以及在亚洲国家改善RWE使用过程中所面临的挑战。

方法

本文分为两个部分。首先,进行了一项叙述性综述,以根据现有的真实世界数据对RWE进行分类。该方法还用于构建RWE的类型学,尤其考虑了数据的性质、产生的潜在证据以及纳入卫生技术评估(HTA)的整合方法。最后,进行了一项范围综述,以识别和筛选聚焦于RWE在亚洲实施情况的研究。

结果

RWE的使用存在诸多限制条件,因此其在亚洲的应用尤为有限。基于叙述性综述,RWE被分为三大类:宏观、中观和微观RWE;每一类代表不同质量的证据以及作为HTA证据的使用范围。尽管类型学有助于整合RWE选项以支持HTA决策,但将其用于HTA目的时仍存在挑战。机构支持、技术能力以及包括数据相关问题在内的基础设施,可能会阻碍亚洲改善用于HTA的RWE生态系统的进程。

结论

RWE是一种有助于决策的工具,尤其是在与报销相关的决策中。尽管了解RWE的各个方面有助于选择合适的证据以辅助政策制定,但需要预见其实施过程中所面临的挑战,尤其是在亚洲背景下。

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