Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
10.13422/j.cnki.syfjx.20260894
- VernacularTitle:EtD框架要点解读及在《中成药药物警戒指南》编制中的应用
- Author:
Hongyan ZHANG
1
;
Xin CUI
1
;
Yuanyuan LI
1
;
Zhifei WANG
1
;
Mengmeng WANG
1
;
Shuo YANG
1
;
Xiaoxiao ZHAO
1
;
Fumei LIU
1
;
Yaxin WANG
1
;
Rui MA
1
;
Yanming XIE
1
;
Lianxin WANG
1
Author Information
1. Institute of Basic Clinical Medicine，China Academy of Chinese Medical Sciences， Beijing 100700，China
- Publication Type:Journal Article
- Keywords:
evidence-to-decision framework;
pharmacovigilance;
guideline;
evidence;
decision
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(8):220-228
- CountryChina
- Language:Chinese
-
Abstract:
To interpret the evidence-to-decision （EtD） framework and to illustrate its application in traditional Chinese medicine （TCM） guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine， thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework （formulating the question， making an assessment of the evidence， and drawing conclusions）， critical decision points and evaluation evidence within the evidence-translation process were systematically addressed， aligning with the purpose， scope， and key questions of the guideline. Qualitative research methods， such as the nominal group technique， were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation， the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified， focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment， multi-source evidence was integrated， including policy documents， literature research， and expert consensus， completing the evidence evaluation. Finally， in recommendation-forming， dispersed research evidence and expert experience were synthesized into consensus， culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development， effectively enhancing the transparency and scientific rigor of the process. Therefore， it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
