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. Issue 6 (17th June 2019)

• Record Type: Journal Article
• Authors: 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; García-Fiñana, Marta; Stratton, Irene M; James, Marilyn; Harding, Simon P
• Other Names: author non-byline.; Harding Simon P author non-byline.; Broadbent Deborah M author non-byline.; Fisher Anthony C author non-byline.; Gabbay Mark author non-byline.; García-fiñana Marta author non-byline.; James Marilyn author non-byline.; Moitt Tracy author non-byline.; Roberts John R author non-byline.; Seddon Daniel author non-byline.; Stratton Irene M author non-byline.; Williamson Paula author non-byline.; Appelbe Duncan author non-byline.; Ovens Andy author non-byline.; Howard Lola author non-byline.; Howlin Susan U author non-byline.; Alshukri Ayesh author non-byline.; Williams Abigail E author non-byline.; Cheyne Christopher P author non-byline.; Eleuteri Antonio author non-byline.; Grierson Christopher author non-byline.; Mobayen-Rahni Mehrdad author non-byline.; Sampson Christopher J author non-byline.; Szmyt David author non-byline.; Thetford Clare author non-byline.; Vazquez arango Maria Pilar author non-byline.; Wang Amu author non-byline.; Cooper Helen author non-byline.; Collins John author non-byline.; Kelly John author non-byline.; Massat Nathalie author non-byline.; Smith Gideon author non-byline.; Kumar Vineeth author non-byline.; Rogers Chris author non-byline.; West Julia author non-byline.; Younis Naveed author non-byline.; Rowlands Alison author non-byline.; Lees Peter author non-byline.; Lees Sandra author non-byline.; Doncaster Emily author non-byline.; Williams Betty author non-byline.; Criddle Ticiana author non-byline.; Perrett Stephanie author non-byline.;
• Is Part Of: BMJ open. Volume 9:Issue 6(2019)
• Publication Date: 2019-06-17
• Subjects: diabetic retinopathy -- general diabetes -- health economics -- health policy -- medical ophthalmology -- medical retina; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-025788
• Languages: English
• ISSNs: 2044-6055

Abstract

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. Trial registration number: ISRCTN87561257 ; Pre-results.