摘要
真实世界证据(RWE)的形成、评价及等级的划分,是影响真实世界研究方法深入发展和科学使用的重要因素。本文简要回顾临床医学研究设计等级与证据等级,提出真实世界临床研究证据分级的要点,包括强调内部真实性与外部真实性的综合评价、确定真实世界证据的起评点和使用真实世界证据质量评价方法三个方面;基于国际较为认可的“证据推荐评估、开发与评价分级标准(GRADE)”,结合真实世界证据的分类及特点,形成初步的分级方案,并采用示例对该分级建议进行评价说明。
The formation, evaluation and grade division of real-world evidence(RWE) are bottlenecks restricting the in-depth development and scientific application of real-world study methods. This paper briefly reviewed the design grade and evidence grade of clinical medical research, and proposed the key points of evidence grade of real-world clinical research, including emphasizing the comprehensive evaluation of internal authenticity and external authenticity,determining the "starting point" of real-world evidence, and using the real-world evidence quality evaluation method.Based on the internationally recognized "grading of recommendations assessment, development, and evaluation(GRADE)", combined with the classification and characteristics of real-world evidence, a preliminary grading scheme was formed. An example was given to illustrate the grading suggestion.
作者
费宇彤
柴倩云
夏如玉
金雪晶
FEI Yutong;CHAI Qianyun;XIA Ruyu;JIN Xuejing(Centre for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,P.R.China;Institute for Excellence in Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,P.R.China;Beijing GRADE Center,Beijing University of Chinese Medicine,Beijing 100029,P.R.China)
出处
《中国循证医学杂志》
CSCD
北大核心
2022年第10期1206-1211,共6页
Chinese Journal of Evidence-based Medicine
基金
国家自然科学基金项目(编号:82074282)。
