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.
Structured template for planning and reporting on the implementation of real world evidence studies(STaRT-RWE):an interpretation
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.
Real worldStructured dataReporting guidanceSTaRT-RWE
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