Screening intervals for diabetic retinopathy

ISRCTN	ISRCTN62748772
DOI	https://doi.org/10.1186/ISRCTN62748772
Secondary identifying numbers	HTA Project: 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

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

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
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/05/2012
Completion date	01/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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 .
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

England
United Kingdom

Study participating centre

Gloucestershire Diabetic Retinopathy Research Group

Cheltenham
GL53 7AN
United Kingdom

Sponsor information

Gloucestershire Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Mr Mark Walker
Trust Headquarters
1 College Lawn
Gloucestershire
Cheltenham
GL53 7AG
England
United Kingdom

Website	http://www.gloshospitals.org.uk
"ROR"	https://ror.org/04mw34986

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK) ref: 10/66/01

No information available

Results and Publications

Intention to publish date	31/12/2015
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Planned publication in a peer reviewed journal.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2015		Yes	No

Editorial Notes

30/01/2017: Publication reference added.