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多中心医学影像装备临床应用评价平台构建方法探讨OACSTPCD

Discussion on the Construction Method of Clinical Application Evaluation Platform for Multi-Center Medical Imaging Equipment

中文摘要英文摘要

目的 通过搭建一级和二级信息中心,构建多中心医学影像装备临床应用评价平台.方法 采用二级信息中心获取医学影像装备临床应用数据,利用数据采集、数据治理及指标设计等方法对原始数据脱敏,通过数据空间管理和数据空间测试验证技术,将脱敏数据传输至一级信息中心;一级信息中心依据医学影像装备临床应用评价标准设计分析算法对设备进行临床应用评价.结果 多家二级信息中心通过数据空间管理技术向一级信息中心传输标准化数据列表,可对医学影像装备可靠性、可用性、功能效果、设备性能、运行效率等方面进行分析评价.用户可通过一级信息中心展示的结果,了解各类医学影像装备不同品牌间的临床适用性评价.以PET/MR为例,从单台评分来看,A品牌设备的可靠性评价为99.69%,B品牌设备的可靠性评价为98.37%,A品牌设备的可靠性略高于B品牌.以MRI为例,2024年8月3种品牌的高级功能应用率分别为61%、47%和38%,通过秩和检验,3种品牌MRI的高级功能应用率差异没有统计学意义(P=0.53).结论 多平台医学影像装备临床应用评价平台的构建可为医疗机构选用并验证医学影像装备提供系统技术解决方案与平台支撑,为推进国产医学影像装备质量提升提供数据支撑,为建立健全国产医学影像装备可靠性、临床应用验证、维护维修等有关标准规范、标准体系提供研究数据及基础共享服务平台支撑.

Objective To establish a clinical application evaluation platform for multi-center medical imaging equipment by building primary and secondary information centers.Methods The clinical application data of medical imaging equipment was obtained through a secondary information center.The raw data was desensitized using methods such as data collection,data governance,and indicator design.Through data space management and data space testing verification techniques,the desensitized data was transmitted to the primary information center.The primary information center designed analysis algorithms based on the clinical application evaluation criteria for medical imaging equipment to evaluate the clinical application of the equipment.Results A number of secondary information centers transmitted standardized data listed to the primary information center through data space management technology,and was able to analyze and evaluate the reliability,availability,functional effect,equipment performance and operating efficiency of medical imaging equipment.Users could intuitively understand the clinical applicability evaluation results of various medical imaging equipment brands through the results displayed on the primary information platform.Taking PET/MR as an example,from the perspective of individual ratings,the reliability evaluation of A brand equipment was 99.69%,and the reliability evaluation of B brand equipment was 98.37%,the reliability of A brand equipment was slightly higher than that of B brand equipment.Taking MRI as an example,the advanced function application rates among the three brands in August 2024 was 61%,47%,and 38%,respectively.According to the rank sum test,there was no significant difference in the advanced function application rates among the three brands of MRI(P=0.53).Conclusion The construction of clinical application evaluation platform for multi-center medical imaging equipment can provide systematic technical solutions and platform-wise support for medical institutions to select and verify medical imaging equipment,can provide data support for promoting the quality improvement of domestic-made medical imaging equipment,and can provide research data and basic sharing service platform-wise support for establishing and improving standards and standardized systems on the reliability,clinical application verification and maintenance of domestic-made medical imaging equipment.

荣瑶;花城;董硕;吴萍;李东;张文龙;吴航

首都医科大学宣武医院 医学工程处,北京 100053

预防医学

影像装备临床应用评价可靠性可用性医院信息系统影像归档与通信系统放射科信息系统

imaging equipmentclinical application evaluationreliabilityavailabilityhospital information system(HIS)picture archiving and communication system(PACS)radiation information system(RIS)

《中国医疗设备》 2024 (012)

1-7 / 7

工业和信息化部产业技术基础公共服务平台项目(2021-0179-1-1);国家卫生健康委医院管理研究所2024医学工程研究项目(2024MEA102).

10.3969/j.issn.1674-1633.2024.12.001

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