基于真实世界数据的彩色超声诊断仪临床应用评价  

Clinical Application Evaluation of Color Ultrasound Diagnostic Instrument Based on Real World Data

作　　者：竺明月 何伟 崔志刚 杨春花 钱英 李鑫 ZHU Mingyue;HE Wei;CUI Zhigang;YANG Chunhua;QIAN Ying;LI Xin(Department of Clinical Medical Engineering,The First Affiliated Hospital with Nanjing Medical University/Jiangsu Province Hospital,Nanjing Jiangsu 210029,China)

机构地区：[1]南京医科大学第一附属医院/江苏省人民医院、临床医学工程处,江苏南京210029

出　　处：《中国医疗设备》2024年第2期130-135,178,共7页China Medical Devices

基　　金：国家卫生健康委医院管理研究所合作项目(20210218)。

摘　　要：目的建立一套可行可信的彩色超声诊断仪评价指标体系,为彩色超声诊断仪的购置与应用提供参考依据。方法通过收集医院医疗设备信息系统、资产管理系统的数据,调取近3年的彩色超声诊断仪质控报告,从临床应用学、卫生经济学以及可靠性3方面进行分析,生成真实世界证据,总结各品牌彩色超声诊断仪之间的优劣差异,形成该类设备的评价体系;统计不同品牌的彩色超声诊断仪中凸阵和线阵探头的输出声强、探测深度、轴(纵)向几何位置示值误差、侧(横)向几何位置示值误差、多普勒血液流速测量误差,并进行统计学分析;结果品牌C在临床常规超声检查中使用次数较多,血管超声检查中倾向于使用品牌A、D,在造影超声检查中基本选择使用品牌B,常规浅表超声检查主要由品牌E完成。品牌B的净利率在5种品牌中最高,为31.32%,但其更换探头的数量明显高于其他品牌。可靠性分析中品牌E在检查量最少的情况下,探头更换数量较多,表明其探头使用寿命短;品牌A、D的探头更换数量明显少于其他品牌。凸阵和线阵探头参数数据的H检验结果显示,两种探头在不同品牌中的性能表现均没有显著差异(P>0.05)。结论本文通过分析彩色超声诊断仪的真实世界数据,建立了一套科学完善的彩色超声诊断仪评价体系,可指导彩色超声诊断仪采购工作,提高彩色超声诊断仪的利用率,提升医院资源的利用效率和配置合理性。Objective To establish a feasible and reliable evaluation index system for color ultrasound diagnostic instrument,and to provide references for its procurement and application.Methods By collecting data from the hospital’s medical equipment information system and asset management system,and retrieving quality control reports of color ultrasound diagnostic instruments from the past three years,an analysis was conducted from three aspects:clinical application,health economics,and reliability.This analysis aimed to generate real-world evidence,summarize the strengths and weaknesses among different brands of color ultrasound diagnostic instruments,and establish an evaluation system for this type of instrument;statistical analysis was performed on the output sound intensity,detection depth,axial(longitudinal)geometric position indication error,lateral(transverse)geometric position indication error,and Doppler blood flow velocity measurement error of convex array and linear array probes in different brands of color ultrasound diagnostic instruments.Results Brand C was used more frequently in routine clinical ultrasonography examinations,while Brands A and D were more preferred for vascular examinations.Brand B was predominantly chosen for angiographic examinations,and routine superficial examinations were mainly performed by Brand E.The net profit ratio of Brand B was 31.32%,the highest among the five brands,but the number of probe replacements was significantly higher than other brands.In terms of reliability analysis,Brand E had a relatively high number of probe replacements with the least number of uses,indicating a shorter lifespan for its probes;the number of probe replacements for Brands A and D was significantly lower than other brands.The H test results of parameter data for convex array and linear array probes indicated that there was no significant difference in performance among different brands(P>0.05).Conclusion This paper analyzes the real-world data of color ultrasound diagnostic instruments and establ

关 键 词：真实世界数据 彩色超声诊断仪 临床应用评价 可靠性分析 卫生经济学评价 

分 类 号：R197.39[医药卫生—卫生事业管理]