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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

Broadbent, Deborah M; Sampson, Christopher J; Wang, Amu; Howard, Lola; Williams, Abigail E; Howlin, Susan U; Appelbe, Duncan; Moitt, Tracy; Cheyne, Christopher P; Rahni, Mehrdad Mobayen; Kelly, John; Collins, John; Garc�a-Fi�ana, Marta; Stratton, Irene M; James, Marilyn; Harding, Simon P

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 Thumbnail


Authors

Deborah M Broadbent

Christopher J Sampson

Amu Wang

Lola Howard

Abigail E Williams

Susan U Howlin

Duncan Appelbe

Tracy Moitt

Christopher P Cheyne

Mehrdad Mobayen Rahni

John Kelly

John Collins

Marta Garc�a-Fi�ana

Irene M Stratton

MARILYN JAMES MARILYN.JAMES@NOTTINGHAM.AC.UK
Professor of Health Economics

Simon P Harding



Abstract

Introduction: Currently, 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.

Citation

Broadbent, D. M., Sampson, C. J., Wang, A., Howard, L., Williams, A. E., Howlin, S. U., …Harding, S. P. (2019). 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. BMJ Open, 9(6), Article e025788. https://doi.org/10.1136/bmjopen-2018-025788

Journal Article Type Article
Acceptance Date May 23, 2019
Online Publication Date Jun 17, 2019
Publication Date 2019-06
Deposit Date Nov 18, 2019
Publicly Available Date Mar 29, 2024
Journal BMJ Open
Electronic ISSN 2044-6055
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
Volume 9
Issue 6
Article Number e025788
DOI https://doi.org/10.1136/bmjopen-2018-025788
Keywords General Medicine
Public URL https://nottingham-repository.worktribe.com/output/2470000
Publisher URL https://bmjopen.bmj.com/content/9/6/e025788