基于真实世界数据的病人监护仪临床应用评价研究  

Study on clinical application evaluation of patient monitor based on real world data

作　　者：柏彭开 储晓阳[1,2] 胡强[1] 李辉 冯喜明 黄河娇 张红远 黎家麟 贾其言 BAI Peng-kai;CHU Xiao-yang;HU Qiang;LI Hui;FENG Xi-ming;HUANG He-jiao;ZHANG Hong-yuan;LI Jia-lin;JIA Qi-yan(The Second Affiliated Hospital of Guangxi Medical University,Nanning 530007,China;Teaching and Research Section of Clinical Engineering,Guangxi Medical University,Nanning 530021,China;The 923rd Hospital of Joint Logistics Force,Nanning 530021,China)

机构地区：[1]广西医科大学第二附属医院,南宁530007 [2]广西医科大学临床工程教研室,南宁530021 [3]联勤保障部队第923医院,南宁530021

出　　处：《医疗卫生装备》2023年第11期71-78,共8页Chinese Medical Equipment Journal

基　　金：广西壮族自治区药品监督管理局2018年食品药品监管科研项目(标段二)(GXZC2018-C3-20716-XYGC)。

摘　　要：目的:基于真实世界数据探索建立病人监护仪(以下简称“监护仪”)临床应用综合性评价体系,为各级医疗机构采购监护仪提供参考依据。方法:运用真实世界数据研究方法从广西壮族自治区14家医疗机构收集监护仪临床应用数据,选出占有率最高的国产品牌X(中端产品代表为X_(1)系列、高端产品代表为X_(2)系列)和进口品牌Y(中端产品代表为Y_(1)系列、高端产品代表为Y_(2)系列),基于临床效果、适用性、可靠性、仪器功能、服务体系5项指标建立监护仪临床应用评价体系。采用Mantel-Haenszel分析、倾向性评分分析、对偶比较法等方法进行数据处理,计算X、Y 2个品牌监护仪的临床应用评价得分。结果:在中端系列监护仪的比较中,X品牌监护仪在临床效果评价、可靠性评价以及适用性评价方面的得分高于Y品牌(P<0.05),X、Y品牌产品服务体系评价得分差异无统计学意义(P>0.05);在高端系列监护仪的比较中,X、Y 2个品牌产品的临床效果评价、适用性评价、可靠性评价、服务体系评价得分差异均无统计学意义(P>0.05)。X、Y 2个品牌产品的基础功能和高级功能配备情况相近。结论:基于真实世界数据建立的评价体系能够对监护仪临床应用情况进行有效评价,可为国内医疗器械的临床应用评价提供参考。Objective To establish a comprehensive evaluation system for the patient monitor clinical application based on real world data(RWD)to provide references for levels of medical institutions to purchase patient monitors.Methods RWD method was used to collect clinical application data of the monitors from 14 medical institutions in Guangxi Zhuang Autonomous Region,and a Chinese brand X(including X_(1) series for mid-end products and X_(2) series for high-end products)and a foreign brand Y(including Y_(1) series for mid-end products and Y_(2) series for high-end products)with the highest market share were selected to construct a monitor clinical application evaluation system involving in five indicators such as clinical efficacy,applicability,reliability,instrument function and service system.Data processing was carried out with Mantel-Haenszel analysis,propensity score analysis and pairwise comparison method to calculate the clinical application evaluation scores of X and Y brands of monitors.Results In the mid-end products,X series gained advantages over Y series in clinical efficacy,reliability and applicability(P<0.05),while the differences between the service systems were not statistically signifi-cantly(P>0.05);in the high-end products,there were no significant differences between the clinical efficacy,applicability,reliability and service systems(P>0.05).Brand X and Y monitors were equipped with similar basic and advanced functions.Conclusion The evaluation system established based on real-world data can be able to effectively evaluate the clinical appli-cation of the monitor,which provides references for clinical application evaluation of medical devices in China.

关 键 词：真实世界数据 病人监护仪 医疗器械 临床应用评价 

分 类 号：R197.39[医药卫生—卫生事业管理]