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临床试验/NCT01628289
NCT01628289已完成不适用

The Cost-effectiveness of Screening for Diabetic Retinopathy in Hong Kong

The University of Hong Kong3 个研究点 分布在 1 个国家目标入组 4,644 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,644
试验地点
3
主要终点
Retinopathy profile in the two groups

研究概览

简要总结

Introduction: There is no debate that people with diabetes should be screened for the development of retinopathy which can threaten their sight. However, there is no routine screening for retinopathy in Hong Kong at present. Many overseas countries find that they miss a large proportion of their target population and, with reliance on co-payments for screening, as is the case with the limited opportunistic screening at present, the cost-effectiveness of any routine service in Hong Kong could be reduced as is predicted by Hart's inverse care law.

Aim: This study will determine the potential cost-effectiveness of screening for retinopathy in Hong Kong under a free system and one in which a co-payment is charged.

Methods: Primary care patients attending General Outpatient Clinics on Hong Kong Island for their routine diabetic care will randomly be offered screening either at no charge or with the normal co-payment of $65. Those who are willing and unwilling to be screened will be compared for their clinical, lifestyle and socioeconomic characteristics and those unwilling will be asked their reasons. The uptake of screening at no fee and with a payment will be compared as will the prevalence of retinopathy in the two fee groups. Subsequent screening at one year will be offered at the same fee and uptake again compared.

The principal analyses will (a) identify the characteristics of those willing to be screened and reasons for not being screened (b) the uptake of screening when a co-payment is charged compared to when it is free (c) whether there is a difference in the prevalence of retinopathy between the group willing to pay and those who accept free screening and (d) the uptake of re-screening in year 2.

The resulting cost-effectiveness model will use these data, the cost data collected during the study and overseas data on benefits of treatment to model the cost-effectiveness of screening for retinopathy in Hong Kong if it were to be offered free or with a co-payment. This information will be important to determine the most cost-effective means of implementing this preventative strategy to preserve sight and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • All diabetic patients who attend the clinic during the study period.

排除标准

  • Only if not competent to give informed consent

结局指标

主要结局

Retinopathy profile in the two groups

时间窗: the first year

The extent of diabetic retinopathy in two groups were measured in the first year screening.

次要结局

  • Retinopathy profile in the two groups(the second year)
  • Subjects' attendance of the screening(the second year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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