用于真实世界证据的结构化模板和报告工具(STaRT-RWE)的解读
Structured template for planning and reporting on the implementation of real world evidence studies(STaRT-RWE):an interpretation
曹雪 1孟祥然 1王馨 1秦宇宁 1王梦琪 1刘佳1
作者信息
- 1. 中国中医科学院中医临床基础医学研究所(北京 100700)
- 折叠
摘要
真实世界证据的结构化模板和报告工具(structured template and reporting tool for real world evidence,STaRT-RWE)是由哈佛医学院布莱根妇女医院Shirley V Wang教授带领的团队制订的用于规划和报告关于治疗安全性和有效性的真实世界证据研究的实施情况,并于2021年1月发表在BMJ杂志,该模板已得到国际药物流行病学学会以及国际药物经济学和结局研究学会的透明度倡议的认可.本文对其条目进行解读,以促进国内从事真实世界研究的学者对STaRT-RWE的理解和应用,有助于提高RWE研究的透明度、可重复性和准确性.
Abstract
Structured template and reporting tool for real world evidence(STaRT-RWE)was developed by a team led by professor Shirley V Wang of Brigham and Women's Hospital,Harvard Medical School,which is to plan and report on the implementation of real world evidence(RWE)studies on the safety and efficacy of treatments.The template,published in the journal BMJ in January 2021,has been endorsed by the International Society of PharmacoEpidemiology and the Transparency Initiative promoted by the International Society of Pharmacoeconomics and Outcome Research.This article interprets its entries to promote the understanding and application of STaRT-RWE by domestic scholars engaged in real world study,and help to improve the transparency,repeatability,and accuracy of RWE research.
关键词
真实世界/结构化数据/报告规范/STaRT-RWEKey words
Real world/Structured data/Reporting guidance/STaRT-RWE引用本文复制引用
基金项目
中国中医科学院科技创新工程项目(CI2021A05408)
中国中医科学院科技创新工程项目(CI2021A00702-2)
国家重点研发计划(2019YFC1712200)
国际针灸临床研究服务标准研制项目(2019YFC1712205)
出版年
2024
NETL
NSTL
万方数据