中国循证医学杂志2024,Vol.24Issue(10) :1156-1161.DOI:10.7507/1672-2531.202402025

基于德尔菲法构建真实世界证据评价体系

Constructing a real-world evidence evaluation system based on Delphi method

姚振阁 周佳薇 陆梦依 尤东方 赵杨
中国循证医学杂志2024,Vol.24Issue(10) :1156-1161.DOI:10.7507/1672-2531.202402025

基于德尔菲法构建真实世界证据评价体系

Constructing a real-world evidence evaluation system based on Delphi method

姚振阁 1周佳薇 1陆梦依 2尤东方 1赵杨3
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作者信息

  • 1. 南京医科大学公共卫生学院生物统计学系(南京 211166)
  • 2. 南京医科大学公共卫生学院生物统计学系(南京 211166);南京医科大学国家疫苗研发创新平台(南京 211166)
  • 3. 南京医科大学公共卫生学院生物统计学系(南京 211166);南京医科大学国家疫苗研发创新平台(南京 211166);江苏省恶性肿瘤生物标志物与防治重点实验室,肿瘤个体化医学省部共建协同创新中心(南京 211166)
  • 折叠

摘要

目的 构建真实世界证据评价体系,为获得高质量的循证医学证据提供参考.方法 通过调研、分析影响真实世界研究证据的关键因素,结合国内外文献和评估工具,初步确定真实世界证据评价体系的指标,采用德尔菲法对相关领域专家进行征询,修改并确定最终评价指标.结果 最终构建的真实世界证据评价体系的指标包括40个条目.两轮专家征询的有效回收率为88.2%和100%;专家协调系数为0.174(P<0.001)和0.189(P<0.001).第2轮征询后专家意见的均数集中在3.73~4.93,变异系数变化范围为0.05~0.21.结论 本研究构建的真实世界证据评价体系具有一定的可靠性和科学性,能够为真实世界研究转化为高质量的证据提供依据和帮助.

Abstract

Objective We constructed a real-world evidence evaluation system to provide reference for obtaining high-quality evidence in evidence-based medicine.Methods Through the investigation and analysis of the key factors influencing the real-world research evidence,combined with domestic and foreign literature and evaluation tools,we preliminarily constructed the indicators of the real-world evidence evaluation system,then consulted experts in related fields by the Delphi method,modified and determined the final evaluation indicators.Results The indicators of the final real-world evidence evaluation system included 40 items.The recovery efficiencies of the two rounds of expert consultation were 88.2%and 100%;The expert coordination coefficients were 0.174(P<0.001)and 0.189(P<0.001).After the second round of consultation,the mean of Likert scale in the range of 3.73~4.93,and the coefficient of variation varied in the range of 0.05~0.21.Conclusion The real-world evidence evaluation system constructed in this study has certain reliability and scientificity,which can provide a basis and help for the transformation of real-world research into high-quality evidence.

关键词

真实世界证据/德尔菲法/质量评价/偏倚识别

Key words

Real-world evidence/Delphi/Quality evaluation/Identification of bias

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基金项目

国家自然科学基金项目(82173620)

国家自然科学基金项目(82373690)

国家自然科学基金项目(82204156)

国家重点研发计划项目(2022YFC3702702)

出版年

2024
中国循证医学杂志
四川大学

中国循证医学杂志

CSTPCD北大核心
影响因子:1.761
ISSN:1672-2531
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