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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Other: charging a co-payment for Diabetic Retinopathy screening
* Other: free screening without charging a co-payment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All diabetic patients who attend the clinic during the study period. Exclusion Criteria: Only if not competent to give informed consent
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: free screening group<br>Subjects in this group receive free diabetic retinopathy screening. | Other: free screening without charging a co-payment<br>* The intervention is to provide free screening without charging a co-payment<br>|
| Other: Pay screening group<br>Subjects in this group receive diabetic retinopathy screening with charging a co-payment. | Other: charging a co-payment for Diabetic Retinopathy screening<br>* The intervention is charging a co-payment of HK$60 for the Diabetic Retinopathy screening.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinopathy profile in the two groups | The extent of diabetic retinopathy in two groups were measured in the first year screening. | the first year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects' attendance of the screening | Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the first year screening. | the first year | 
| Retinopathy profile in the two groups | The extent of diabetic retinopathy in two groups were measured in the second year screening. | the second year | 
| Subjects' attendance of the screening | Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the second year screening. | the second year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic retinopathy, screening, co-payment, health service