Diabetic retinopathy (a complication of diabetes that affects the eyes), progression of the disease and how it responds to treatment - UK Model validation
| ISRCTN | ISRCTN10956293 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10956293 |
| IRAS number | 253774 |
| Secondary identifying numbers | RG_22-099, IRAS 253774, CPMS 54464 |
- Submission date
- 14/01/2023
- Registration date
- 17/01/2023
- Last edited
- 24/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Patients with diabetes are prone to develop complications at the back of the eye causing blindness, and are therefore screened yearly or two-yearly. If serious disease develops, additional hospital appointments are necessary for monitoring/treatment. Due to increasing pressure on hospital, it would be beneficial to have a system by which patients could be prioritised in terms of risk, and appointments allocated accordingly so the high-risk patients don't come to any harm due to delays. A model has been designed in general practitioner's gathered data.
Aims: Update already developed patient risk assessment model, test it in hospital population and measure its clinical benefit.
Who can participate?
The study will use routine practice data for patients (12 years or over) with diabetic retinopathy under care of hospital eye services.
What does the study involve?
Anonymised data will be gathered anonymously at three participating NHS trusts and analysed by researchers in the University of Birmingham. The benefits to both the patients and the care provider under different scenarios will then be measured. We will then present our findings in an expert meeting including patients where it can be discussed before making a final decision on the model’s efficacy and implementation. It does not involve any interference to the patient's ongoing treatment so there is no chance of harm.
What are the possible benefits and risks of participating?
None
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
July 2022 to December 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Dr Sajjad Haider, s.haider.2@bham.ac.uk
Contact information
Principal Investigator
7 Westfield Rd
Edgbaston
Birmingham
B15 3XA
United Kingdom
 ORCID ID |
0000-0001-8111-8577 |
|---|---|
| Phone | +44 7877879753 |
| s.haider.2@bham.ac.uk |
Study information
| Study design | Mixed methods observational retrospective multicentre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 43055 PIS Poster 10112022.pdf |
| Scientific title | Diabetic Retinopathy Progression in patients under monitoring for Treatment or Vision Loss: external validation, update, and net clinical benefit of a multivariable prediction model |
| Study acronym | DRPTVL-UK Model validation |
| Study objectives | Diabetes mellitus is one of the most common chronic conditions affecting nearly 4.9 million people in UK as of 2021. With the prevalence rising each year, there is an ongoing global and UK wide increase in the number of people with diabetes mellitus and consequently DR. The detection of DR has also improved through wider population screening, further increasing the demand for Hospital Eye Services. There are delays in patients being seen, causing harm especially for the higher risk patients with diabetic retinopathy. Therefore, this bottleneck urgently needs addressing. We propose to mitigate this risk by stratifying these patients and prioritise care for higher risk patients by using a statistical model we developed in primary care data. We now need to assess the model’s performance in a secondary care population to ensure it performs adequately to identify patients at high risk of treatment or vision loss. If this model performs well for predicting risk at different time points in hospital eye services / surveillance clinics data during external validation, we propose that it could be used to prioritise individuals at higher risk of vision loss and potentially inform the length of the follow up intervals after referral to hospital eye services / surveillance clinics. |
| Ethics approval(s) | Approved 24/11/2022, South Central - Hampshire A Research Ethics Committee (Temple Quay House, 2 The Square, Temple Quay, Bristol, BS1 6PN, UK; +44 207 104 8196; hampshirea.rec@hra.nhs.uk), ref: 22/SC/0425 |
| Health condition(s) or problem(s) studied | Diabetic Retinopathy |
| Intervention | Routine practice anonymised data analysis, a retrospective observational cohort study. Enrolment is at referral from diabetic eye screening programme into hospital with diabetic retinopathy. Once they had an outcome whichever comes first (treatment/vision failure/discharge/transfer to another provider/study period end), the data extraction stops (censoring). |
| Intervention type | Other |
| Primary outcome measure | The first of any of these patient outcomes: date of treatment/vision loss of three lines in EDTRS chart/discharge/transfer to another provider/study period end, will be recorded in addition to the specific nature of the outcome like what treatment was given. Data is to be extracted from clinical notes/hospital electronic databases. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2022 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 12 Years |
| Sex | Both |
| Target number of participants | 2400 |
| Total final enrolment | 3659 |
| Key inclusion criteria | Patients with diabetes aged 12 years and over with referable diabetic retinopathy (patients enter the screening programme from age 12) will be identified at referral to the NHS hospital trusts from DESP between 2013 and 2016 for close monitoring and treatment. |
| Key exclusion criteria | Patients with the specific outcome of retinopathy treatment or vision loss at referral or those referred for reasons other than retinopathy will be excluded. Patients objecting to their information being used (through a local or national opt out scheme) will also be excluded. |
| Date of first enrolment | 28/06/2023 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Dudley Road
Birmingham
B18 7QH
United Kingdom
Durham Road
Sunderland
SR3 4AG
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 7877879753 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The dataset generated during the study will be available upon request from s.haider.2@bham.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Recruitment poster | 10/11/2022 | 16/01/2023 | No | Yes |
| Protocol file | version 1 | 19/08/2022 | 16/01/2023 | No | No |
| Protocol article | protocol | 03/04/2023 | 04/04/2023 | Yes | No |
Additional files
- 43055 PIS Poster 10112022.pdf
- Recruitment poster
- 43055 Protocol v1 19Aug2022.pdf
Editorial Notes
24/12/2024: The total final enrolment was added.
28/06/2024: The study participating centre NHS Greater Glasgow and Clyde was added.
13/12/2023: The following changes were made to the study record:
1. The recruitment start date was changed from 01/02/2023 to 28/06/2023.
2. The recruitment end date was changed from 30/06/2023 to 30/06/2024.
3. The overall study end date was changed from 31/12/2023 to 31/12/2024.
4. The intention to publish date was changed from 31/12/2024 to 31/12/2025.
04/04/2023: Publication reference added.
01/02/2023: Internal review.
NHW 16/01/2023: Trial's existence confirmed by NHS HRA.
