医疗机构中药制剂开发价值评估评价指标体系构建及内容效度评价
Establishment and content validity assessment of evaluation index system for development value of traditional Chinese medicine preparations in medical institutions
唐碧华 1元唯安 2张俊华 3张磊 4唐健元 5陈星源 1李东晓 6郭继华 7张霄潇 7华桦1
作者信息
- 1. 四川省中医药转化医学中心,四川成都 610000
- 2. 上海中医药大学附属曙光医院,上海 201203
- 3. 天津中医药大学,天津 300193
- 4. 上海中医药大学,上海 201203
- 5. 成都中医药大学附属医院,四川 成都 610075
- 6. 四川省中医药科学院,四川 成都 610000
- 7. 中华中医药学会,北京 100029
- 折叠
摘要
医疗机构中药制剂作为新药"孵化器"获得蓬勃发展,尚缺乏综合评价其开发价值的评估体系.该研究通过文献调研法建立条目池,运用德尔菲专家咨询法确定评价指标内容,利用优序图法确定各指标权重,建立一套2级维度的医疗机构中药制剂开发价值评估评价指标体系,包含7个一级条目,36个二级条目,具有科学性.一级条目及权重分别为传承性10.61％、有效性23.22％、安全性22.71％、创新性13.21％、经济性10.00％、适宜性8.57％、可及性11.68％;二级条目权重排名最前的3个指标为开展不良反应监测6.73％、疗效证据5.71％、临床有效率4.75％,排名最后的3个指标为生产优势0.86％、药味剂量0.48％、药品气味(口感)0.18％.进行了内容效度评价,结果证明该指标体系具有可靠性,总体内容效度指数0.47,平均内容效度指数0.90.利用已形成的指标体系对四川省某地级市中医医院的6个院内制剂进行了探索性应用,证明该指标体系具有可操作性.结果表明,该指标体系具有科学性、可靠性和可操作性,可为开发者选择性开发医疗机构中药制剂时提供优选参考.实际应用以该指标体系及权重为基础,根据实际情况做适当调整.
Abstract
The development of traditional Chinese medicine(TCM)preparations as an incubator for new drugs in medical institu-tions has flourished,while an evaluation index system remains to be established for comprehensively assessing the development value of these prescriptions.This study established an item pool through literature research,employed the Delphi method to determine the con-tent of evaluation indexes,and adopted the superiority chart to determine the weight of each index.Two-level evaluation index system for the development value of TCM preparations in medical institutions was established,which included 7 first-level items and 36 se-cond-level items,demonstrating scientific validity.The first-level items(weight)were inheritance(10.61％),effectiveness(23.22％),safety(22.71％),innovation(13.21％),economy(10.00％),suitability(8.57％),and accessibility(11.68％).The top three second-level items in terms of weight distribution were adverse reaction monitoring(6.73％),evidence of therapeutic effect(5.71％),and clinical response rate(4.75％).The bottom three second-level items were production advantages(0.86％),medicinal dosage(0.48％),and medicinal smell or taste(0.18％).The content validity of the established system was assessed,which revealed that the index system was reliable,with the overall and average content validity indexes of 0.47 and 0.90,respectively.Furthermore,the established evaluation index system was used to evaluate six TCM preparations in a city-level hospital of TCM in Si-chuan Province,which demonstrated that the system had operability.The results indicate that the evaluation index system is scientific,reliable,and operable,providing a reference for developers to selectively develop TCM preparations in medical institutions.In practical application,the system can be adjusted regarding the index weights according to actual conditions.
关键词
医疗机构中药制剂/开发价值评估/评价指标体系/德尔菲法/优序图法/内容效度Key words
traditional Chinese medicine preparations in medical institutions/assessment of development value/evaluation index system/Delphi method/superiority chart/content validity引用本文复制引用
基金项目
中华中医药学会求实项目(2023-QSDXWT-02)
四川省中医药产业创新团队项目(2022C009)
出版年
2024
NETL
NSTL
万方数据