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体外膜肺氧合动物实验平台质量评价指标体系的构建与验证

王硕 吕昀徽 王小康 张朕豪 崔永春

实验动物与比较医学2023,Vol.43Issue(6):604-611,8.
实验动物与比较医学2023,Vol.43Issue(6):604-611,8.DOI:10.12300/j.issn.1674-5817.2023.107

体外膜肺氧合动物实验平台质量评价指标体系的构建与验证

Construction and Verification of Quality Evaluation Indicator System for Extracorporeal Membrane Oxygenation Animal Experimental Platform

王硕 1吕昀徽 1王小康 1张朕豪 1崔永春1

作者信息

  • 1. 北京协和医学院中国医学科学院阜外医院动物实验中心,国家心血管病中心心血管疾病国家重点实验室,心血管植入材料临床前研究评价北京市重点实验室,北京 102800
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摘要

Abstract

Objective To establish a standardized and professional service quality evaluation index system for extracorporeal membrane oxygenation(ECMO)animal experimental platform.Methods The literature research and expert consultation were used to establish a factor set for the quality evaluation of ECMO animal experimental platform.Then,experts used the 1/9-9 scale method to compare and score pair-two indicators.Based on the principles of fuzzy analytic hierarchy process and expert scoring results,the ECMO animal experimental platform quality evaluation system was constructed.In order to verify the actual efficacy of this system,a case study was carried out on the ECMO animal experiment platform of FW Animal Experimental Center(FAEC)laboratory.Results A total of 10 experts were included in this study,the questionnaire recovery rate was 100%,the judgment coefficient(Ca)and familiarity coefficient(Cs)were both greater than 0.50,the expert authority was high(Cr>0.80),the validity test was P<0.01,and the coordination was good.The quality evaluation system of ECMO animal experiment platform includes two levels.There are 4 first-level indicators,with professionalism,safety,functionality,and stability ranked from high to low in terms of their weights.There are 15 second-level indicators,and the top 5 weights are personnel's technical expertise,attractiveness of hardware facility,auditability of data,confidentiality capabilities of data,and professionalism in service process.To facilitate the popularization and application of the system,this study also proposed a"star"system to represent the evaluation results of an ECMO animal experimental platform quality.The quality evaluation system established in this study was used to evaluate the FAEC laboratory as a case study,and the evaluation result was five-star.The actual potency value of FAEC laboratory was 0.910,reaching the five-star level,but the average actual appraisal values of"service continuity"and"sufficiency of project completion"were lower than 0.80,which needs to be improved.Conclusion A standardized and professional ECMO animal experimental platform quality evaluation system was established in this study,which would provide a measurable basis for the demander to select the supplier and a method for the supplier to complete the animal experiment of ECMO research and development with high quality.

关键词

体外膜肺氧合/动物实验平台/质量评价

Key words

Extracorporeal membrane oxygenation/Animal experimental platform/Quality evaluation

分类

医药卫生

引用本文复制引用

王硕,吕昀徽,王小康,张朕豪,崔永春..体外膜肺氧合动物实验平台质量评价指标体系的构建与验证[J].实验动物与比较医学,2023,43(6):604-611,8.

基金项目

北京市西城区财政科技专项科技创新项目"体外心肺支持辅助设备临床前研究评价服务平台建设"(XCSTS-TI2022-29) (XCSTS-TI2022-29)

实验动物与比较医学

OACSTPCD

1674-5817

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