Screening intervals for diabetic retinopathy
| ISRCTN | ISRCTN62748772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62748772 |
| Protocol serial number | HTA Project: 10/66/01 |
| Sponsor | Gloucestershire Hospitals NHS Foundation Trust (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) ref: 10/66/01 |
- Submission date
- 06/04/2012
- Registration date
- 12/04/2012
- Last edited
- 30/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Scanlon
Scientific
Scientific
Gloucestershire Diabetic Retinopathy Research Group
Office above Oakley Ward
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
 ORCID ID |
0000-0001-8513-710X |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | A primary research study using routinely collected clinical data to model the clinical efficacy and cost-effectiveness of variable screening intervals. |
| Secondary study design | Cross-section survey |
| Study type | Participant information sheet |
| Scientific title | Development of a cost-effectiveness model for optimization of the screening interval in diabetic retinopathy screening |
| Study acronym | CODES |
| Study objectives | Study aims: 1. Use demographic and routinely collected clinical information from 15000 patients in 85 Gloucestershire GP practices to develop a risk score for each patient and to identify patient groups whose risk of retinopathy progression is low and whose screening interval can be safely extended 2. Model what the influence of the grading classification error is on over referrals and under referrals and how that influence changes over time, taking into account sequential grading results and hospital outcome results, comparing screening intervals that vary according to risk score against current standard practice (annual screening intervals for all patients) and other fixed-interval approaches. 3. Extend our results to multi-ethnic populations using a dataset of 2000 Asians and 5000 Caucasians from Coventry and Warwickshire and a South London dataset of 2000 people with diabetes including 700 people of African Caribbean origin. Grading results can be made available from these datasets for at least a 3 year period. The risk score and algorithm will be tested against retinopathy grades in the two datasets where follow-up data is available 4. Determine if assigning diabetic patients to differing diabetic retinopathy screening intervals using a risk estimation model is cost-effective when compared to current practice, which is annual screening of all eligible patients with diabetes 5. Estimate the economic benefits if personalised screening intervals were to be applied to the National Screening Programme in England |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Diabetic Retinopathy |
| Intervention | The Health Technology being assessed is a variable screening interval based on risk of diabetic retinopathy (DR) assessed using two field digital photographs after pupil dilation as used in the English National Screening Programme (ENSPDR) and other available clinical data. |
| Intervention type | Other |
| Primary outcome measure(s) |
A risk-based algorithm for screening interval |
| Key secondary outcome measure(s) |
1. Years of sight saved |
| Completion date | 01/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 24000 |
| Key inclusion criteria | 1. Participants over the age of 12 years 2. Diagnosed with diabetes and have attended a diabetic retinopathy screening programme in one of the study areas of Gloucestershire, Coventry and Warwickshire, South London and Nottingham. 3. Have been sent the required information about transfer of risk factor data as advised by the Department of Health funded GP2DRS (General Practice to Diabetic Retinopathy Screening) Project and they would have been given the opportunity to inform their General Practice or Screening Programme that they did not want their risk factor data transferred. 4. The participants in this study are pseudoanonymised data on those people who have attended for screening and risk factor data has been transferred according to the recommended guidelines of the GP2DRS project. |
| Key exclusion criteria | 1. People with diabetes under 12 years 2. Those who have not attended for screening 3. Those people who have indicated that they do not want their risk factor data transferred to the screening services. |
| Date of first enrolment | 01/05/2012 |
| Date of final enrolment | 01/05/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Gloucestershire Diabetic Retinopathy Research Group
Cheltenham
GL53 7AN
United Kingdom
GL53 7AN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/01/2017: Publication reference added.
