ArticleBMJ open2019
Individualised screening for diabetic retinopathy: the ISDR study-rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening.
Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Safety and cost-effectiveness of individualised screening for diabetic retinopathy: the ISDR open-label, equivalence RCT.Diabetologia · 2021Trial
- Metformin and incidence of age-related macular degeneration in people with diabetes: a population-based 5-year case-control study.BMJ open ophthalmology · 2026Article
- Artificial Intelligence-Based Screening System for Diabetic Retinopathy in Primary Care.Diagnostics (Basel, Switzerland) · 2024Article
- Referable Diabetic Retinopathy Prediction Algorithm Applied to a Population of 120,389 Type 2 Diabetics over 11 Years Follow-Up.Diagnostics (Basel, Switzerland) · 2024Article
- Appropriate design and reporting of superiority, equivalence and non-inferiority clinical trials incorporating a benefit-risk assessment: the BRAINS study including expert workshop.Health technology assessment (Winchester, England) · 2023Article
- Development of an Instrument for the Assessment of Health-Related Multi-sectoral Resource Use in Europe: The PECUNIA RUM.Applied health economics and health policy · 2023Article
- Real-world outcomes of a clinical decision support system for diabetic retinopathy in Spain.BMJ open ophthalmology · 2022Article
- Validation of an Algorithm for the Prediction of Diabetic Retinopathy in Type 1 Diabetic Patients in a Spanish Population.Clinical ophthalmology (Auckland, N.Z.) · 2022Article
- Factors associated with non-attendance in the Irish national diabetic retinopathy screening programme (INDEAR study report no. 2).Acta diabetologica · 2021Article
- Validation of a Diagnostic Support System for Diabetic Retinopathy Based on Clinical Parameters.Translational vision science & technology · 2021Article
- Prevalence of diabetic retinopathy in children and adolescents at an urban tertiary eye care center.Pediatric diabetes · 2020Article
- Personalising screening of sight-threatening diabetic retinopathy - qualitative evidence to inform effective implementation.BMC public health · 2020Article
- European Association for the Study of Diabetes 2019 Conference: Podcast Overview of the Conference.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020Article
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Authors and funding
17 authors.
Funding
Abstract
introductionCurrently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year. We describe the rationale, design and methodology for a randomised controlled trial (RCT) evaluating the safety, acceptability and cost-effectiveness of personalised variable-interval risk-based screening for DR. This is the first randomised trial of personalised screening for DR and the largest ophthalmic RCT in the UK. METHODS AND ANALYSIS: PWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme were recruited into a single site RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals. A risk calculation engine developed for the trial estimates the probability that an individual will develop referable disease (screen positive DR) within the next 6, 12 or 24 months using demographic, retinopathy and systemic risk factor data from primary care and screening programme records. Dynamic, secure, real-time data connections have been developed. The primary outcome is attendance for follow-up screening. We will test for equivalence in attendance rates between the two arms. Secondary outcomes are rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life. The required sample size was 4460 PWD. Recruitment is complete, and the trial is in follow-up. ETHICS AND DISSEMINATION: Ethical approval was obtained from National Research Ethics Service Committee North West - Preston, reference 14/NW/0034. Results will be presented at international meetings and published in peer-reviewed journals. This pragmatic RCT will inform screening policy in the UK and elsewhere. TRIAL REGISTRATION NUMBER: ISRCTN87561257; Pre-results.
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