Contact information
Type
Scientific
Primary contact
Prof Peter Scanlon
ORCID ID
http://orcid.org/0000-0001-8513-710X
Contact details
Gloucestershire Diabetic Retinopathy Research Group
Office above Oakley Ward
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA Project: 10/66/01
Study information
Scientific title
Development of a cost-effectiveness model for optimization of the screening interval in diabetic retinopathy screening
Acronym
CODES
Study hypothesis
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
Not provided at time of registration
Study design
A primary research study using routinely collected clinical data to model the clinical efficacy and cost-effectiveness of variable screening intervals.
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
A risk-based algorithm for screening interval
Secondary outcome measures
1. Years of sight saved
2. Quality-Adjusted Life Years (QALYs) gained
3. Key recommendations for further research
Overall trial start date
01/05/2012
Overall trial end date
01/05/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total 24,000 -15,000 in Gloucestershire, 7000 from Coventry including 2000 Asians and 2000 from South London including 700 people of Afro-Caribbean origin .
Participant 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.
Recruitment start date
01/05/2012
Recruitment end date
01/05/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gloucestershire Diabetic Retinopathy Research Group
Cheltenham
GL53 7AN
United Kingdom
Sponsor information
Organisation
Gloucestershire Hospitals NHS Foundation Trust (UK)
Sponsor details
c/o Mr Mark Walker
Trust Headquarters
1 College Lawn
Gloucestershire
Cheltenham
GL53 7AG
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK) ref: 10/66/01
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
31/12/2015
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26384314