Objective:Since 2010,hand,foot and mouth disease has remained the top legally notifiable infectious disease in China.Hand,foot and mouth disease has caused significant economic losses for many families and society,especially severe cases and deaths that impose a heavy economic burden on society.It is of great significance to reduce the incidence and severity of hand,foot and mouth disease and the risk of severe cases and deaths to alleviate the economic burden on families and society.Currently,there has been no systematic economic evaluation of the economic burden of hand,foot and mouth disease in Hubei Province,and the annual economic burden caused by hand,foot and mouth disease is still unknown.In addition,there is little research on the applicability of decision tree-Markov models in predicting economic outcomes of EV71 vaccine immunization.The research team has signed a contract for the Phase IV clinical trial of the EV71 vaccine with the Chinese Academy of Medical Sciences,and thus,we plan to establish a scaled epidemiological field study of hand,foot and mouth disease in Yichang,Xiangyang and Huanggang cities in Hubei Province,laying a good foundation for this epidemiological field study.This study aims to comprehensively and systematically elucidate the economic burden of hand,foot and mouth disease in Hubei Province,based on the economic burden of hand,foot and mouth disease in Yichang,Xiangyang and Huanggang cities in recent years,and provide a basis for decision-makers to rationally allocate health resources and develop reasonable strategies for hand,foot and mouth disease prevention and control.Methods:This study used a multi-stage stratified sampling method to conduct investigations on the implementation costs of immunization planning services(i.e.,vaccination)and the economic burden of hand,foot,and mouth disease(HFMD)in Hubei Province,w ith investigations conducted in Yichang,Xiangyang,and Huanggang cities.A self-des igned survey on the economic burden of HFMD was used to obtain parameters on the implementation costs of vaccination and the economic burden of HFMD.In addition,by establishing a decision tree-Markov model,with the 2020 Hubei Province birth co hort(483,200 people)as the study cohort and a simulated time limit of 10 years,the l ong-term incidence and mortality of the vaccinated and unvaccinated populations for HFMD were compared.The implementation costs of vaccination and the cost of purc hasing the HFMD vaccine were set as the total cost of vaccination for HFMD in the m odel,and the avoided disease burden was set as the benefit,incorporating utility para meters such as DALY and QALY,to predict the long-term cost-benefit/utility/effect of the HFMD vaccine in Hubei Province.All case data were constructed using Epi Data3.1 to build a database,and data description and statistical analysis were performed us ing SPSS26.0.Correlation analysis was conducted using the R software.The Tree Age Pro 2011 decision analysis software was used for model construction and calculation of the main results of the economic burden.Results:The study results showed that the proportion of patients aged 0-3 years old was the highest,with 871 cases(67.7%).Among the patients,1187 cases(92.2%)had mild symptoms,and 1038 cases(80.7%)received initial treatment.Analyzing the onset time of all patients by month,the results showed that the cases were mainly concentrated in April,May,and June,with the highest number of cases(865,67.2%)in June.The hospital treatment costs of 592 cases(46.0%)of hand,foot,and mouth disease patients were between 0-1000 yuan,and the cost of missed work was between 0-500 yuan for1036 cases(80.5%).The economic burden of hand,foot,and mouth disease patients had statistical significance with patient type and duration of treatment.In addition,the direct economic burden of hand,foot,and mouth disease was measured as 1722.50 yuan,and the indirect economic burden was 424.50 yuan.After setting up the simulation cohort,the total investment in vaccination during the simulation period was19.6564 million yuan.When calculating only the direct economic burden of hand,foot,and mouth disease,a net benefit of 60,546.40 million yuan was obtained.When calculating both the direct and indirect economic burden of hand,foot,and mouth disease,a net benefit of 75,465.68 million yuan was obtained.According to the two methods of calculating the burden of hand,foot,and mouth disease,each yuan invested in the vaccination program can obtain a return of 7.16 yuan or 7.52 yuan,respectively.The vaccination program prevented a total of 46,634 cases of hand,foot,and mouth disease and 851 deaths.It can recover one QALY loss with an investment of 2038.43 yuan and one DALY with an investment of 146.53 yuan.Sensitivity analysis results showed that the key factors affecting the hand,foot,and mouth disease vaccine were the vaccination rate and protection rate.Conclusions:During investigations in Yichang,Xiangyang,and Huanggang cities,the hand,foot and mouth disease(HFMD)immunization prevention strategy not only prevented the occurrence of HFMD-related illnesses but also significantly increased life expectancy and improved quality of life,with high net benefits.The protection rate and coverage rate of HFMD vaccination in Hubei Province have considerable economic and social benefits,to some extent avoiding severe HFMD cases and significantly reducing the incidence and death of HFMD.This study conducted a relatively systematic method construction for the health economics evaluation of vaccines in Hubei Province,including immunization planning service implementation costs,disease economic burden estimation,and modeling calculations,providing background information for the cost-benefit evaluation of EV71 vaccines and data support and theoretical basis for future development of medical health-related protection strategies and expanding medical coverage. |