Study on clinical application evaluation of patient monitor based on real world data / 医疗卫生装备

ABSTRACT

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 X1 series for mid-end products and X2 series for high-end products)and a foreign brand Y(including Y1 series for mid-end products and Y2 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.Conchision 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.[Chinese Medical Equipment Journal,2023,44(11):71-78]