Comparative Study on the Clinical Economy of Domestic and Imported Stapler Based on Real World Data
Objective To analyze and evaluate the relevant cost indicators of domestic and imported staplers in clinical surgery from an economic perspective,and to provide references for statistical analysis and evaluation method selection of clinical evaluation of similar products.Methods Based on the guiding principles of the real world data formulated by the state and combined with the clinical application of staplers,the path and method of the study of the real world data related to staplers was put forward.A total of 2000 surgical procedures using staplers were selected from the Department of Thoracic Surgery and the Department of Surgical Oncology of Shanghai Chest Hospital from 2019 to 2021,of which 1000 cases used domestic staplers and the other 1000 cases used imported staplers.Descriptive statistical analysis and bias score correction were used to analyze the differences in patients,efficiency and economy of the two groups of data.Results The average cost of stapler per operation and hemostatic consumables per operation in the operation group using domestic stapler were significantly lower than those in the operation group using imported stapler(P<0.001).There was no significant difference in operation duration between the two groups(P=0.900).Correlation analysis showed that stapler cost was strongly correlated with operation time(r=0.987,P=0.002).There was no significant difference in the proportion of stapler cost and hemostatic consumables cost between imported stapler and domestic stapler(P>0.05).Conclusion Domestic staplers have a certain positive effect on affecting the cost of surgical direct consumables and related consumables.It is suggested to establish a consensus of domestic stapler experts to provide a certain reference basis for the fine management of domestic medical devices and the development of future innovative technologies.
staplerreal world dataclinical economic evaluation of medical devicesdisease intervention results