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临床试验/NCT07821281
NCT07821281已完成不适用

China Cochlear Implant for 30 Years: Epidemiology, Policy Effects and Health Economics Evaluation of Cochlear Implantation in China

Chinese PLA General Hospital0 个研究点目标入组 180,000 人开始时间: 1995年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180,000
主要终点
Trends in disease burden of severe/very severe deafness in China and provinces

研究概览

简要总结

Cochlear implantation is an effective intervention for patients with severe to very severe sensorineural hearing loss. By the beginning of 2026, the total number of cochlear implants in China was about 180000. According to the World Health Organization (WHO) survey and data released by the National Bureau of Statistics of China, it is estimated that China's population with severe hearing loss is about 11 million, and the penetration rate is only 1.55. Among them, the adult penetration rate is particularly insufficient, which is far lower than the level of developed countries. In recent years, policy dividends have been intensively introduced in various parts of China. With the update of the rehabilitation service catalog, the price of a single set of cochlear implants in China has plummeted, and cochlear implants have progressed rapidly. At this historical turning point, a systematic analysis of the epidemiology of cochlear implants in my country Characteristics, policy effects and health economics benefits are of great significance for optimizing resource allocation and formulating national hearing care strategies.

详细描述

The data of this study mainly include basic demographic information, clinical and surgical information, implant product information, regional information and external macro data of cochlear implant patients. Patient-level data include gender, date of birth, date of operation, age of implantation, place of residence, area of operation, type of implantation, type of implant and manufacturer, etc. Regional-level data include population size, age structure, economic development level, per capita disposable income of residents, allocation of medical resources, medical insurance policy, centralized procurement policy, CDPF subsidy policy and coverage of rehabilitation service catalogue in each province; the burden of disease and health economics parameters include the prevalence of severe/very severe hearing loss, disability weight, quality of life utility value, medical expenses, rehabilitation costs, care costs and productivity losses.

Statistical analysis begins with cleaning, de-duplication, missing value processing and logical verification of the original data, and unifying the coding of variables such as region, age, gender, implant type and product model. Descriptive statistical methods were used to analyze the age, gender, region, implant time, implant type and product source distribution of cochlear implant patients in China and provinces from 1995 to 2026, and to describe the change trend of cochlear implant volume, implant rate and penetration rate.

On this basis, combined with the population data of the National Bureau of Statistics of China and the prevalence of severe/extremely severe hearing loss published by the World Health Organization (WHO) or related studies, the cochlear implant penetration rate of different age groups and different genders in the country and provinces is estimated, and the differences between different regions and different populations are compared. The impact of economic and policy factors on the volume and penetration of cochlear implants is further analyzed, taking into account the economic level, medical resources, medical insurance payment, collection policy, CDPF subsidy and rehabilitation service coverage in each region.

For the impact of important policies and major events, we will compare the changes in the number, regional distribution, age structure and product structure of cochlear implants before and after the event, and assess the impact of policies or public health events on the accessibility of cochlear implant services.

In the aspect of health economics analysis, it is proposed to evaluate the disease burden and health benefits of cochlear implant by combining the direct medical cost, rehabilitation cost, care cost, productivity loss, disability lost life year (YLD), disability adjusted life year (DALY) and quality of life improvement caused by severe/very severe deafness. The Markov model is further constructed to simulate the transfer between different health states of patients with cochlear implant and non-implanted or conventional hearing aid intervention, and to measure the cost, health benefit and cost effect of cochlear implant in the whole life cycle, which provides the basis for medical insurance payment, government health resource allocation and hearing health intervention policy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who received cochlear implants in Chinese medical institutions between 1995 and 2026;
  • Patients with preoperative diagnosis of severe/very severe sensorineural deafness;
  • Implantation age ≥ 6 months;
  • Records containing at least gender, date of birth, date of surgery, domicile, surgical area, type of implant surgery (first unilateral implant/first bilateral implant/first contralateral implant/re-implant) and implant model information.

排除标准

  • Lack of key information;
  • Other devices such as auditory brainstem implants (ABI) or middle ear implants.

研究组 & 干预措施

Chinese cochlear implant patients from 1995 to 2026.

干预措施: Cochlear Implant (Other)

结局指标

主要结局

Trends in disease burden of severe/very severe deafness in China and provinces

时间窗: from 1995 to 2026

Based on the data of Chinese cochlear implants, combined with the population with severe hearing loss, the total penetration rate of cochlear implants in China and the trend of changes over the years were calculated. The patients were grouped according to the age at the time of operation.The proportion of each age group in the total population, the change trend of age distribution and gender distribution characteristics were calculated respectively. To construct the medical flow of patients in the provinces of household registration and surgery, Compare the changes in the provincial retention rate and cross-provincial flow of cochlear surgery in China and provinces before and after the collection and medical insurance policy. Set different cochlear implant coverage scenarios, calculate the new demand for the number of surgeries currently completed under the target, quantify the potential service gap, and provide a preliminary planning reference for future cochlear implant services.

次要结局

未报告次要终点

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shiming Yang, PhD

Professor and Chairman Dept of Otolaryngology Head and Neck Surgery Chinese PLA General Hospital

Chinese PLA General Hospital

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