Safety and cost-effectiveness of individualised screening for diabetic retinopathy: the ISDR open-label, equivalence RCT

• DOI: 10.1007/s00125-020-05313-2
• Publication Date: 2020-11-04T07:02:46Z
• Authors: Deborah M. Broadbent; Amu Wang; Christopher P. Ch...; Marilyn James; James Lathe; Irene M. Stratton; John Roberts; Tracy Moitt; Jiten P. Vora; Mark Gabbay; Marta García-Fiñana; Simon P. Harding
• Keywords: Open label; Human physiology

Abstract Aims/hypothesis Using variable diabetic retinopathy screening intervals, informed by personal risk levels, offers improved engagement of people with diabetes and reallocation resources to high-risk groups, while addressing the increasing prevalence diabetes. However, safety data on extending intervals are minimal. The aim this study was evaluate cost-effectiveness individualised, variable-interval, risk-based population compared usual care, wide-ranging input from individuals Methods This a two-arm, parallel-assignment, equivalence RCT (minimum 2 year follow-up) in aged 12 years or older registered single English programme. Participants were randomly allocated 1:1 at baseline individualised 6, 24 months for those high, medium low risk, respectively, as determined each episode risk-calculation engine using local demographic, clinical data, annual (control group). Screening staff investigators observer-masked allocation interval. Data collected within primary outcome attendance (safety). A secondary development sight-threatening retinopathy. Cost-effectiveness evaluated time horizon National Health Service societal perspectives. Results total 4534 participants randomised. After withdrawals, there 2097 arm 2224 control arm. Attendance rates first follow-up equivalent between two arms (individualised 83.6%; 84.7%; difference −1.0 [95% CI −3.2, 1.2]), detection non-inferior 1.4%, 1.7%; −0.3 −1.1, 0.5]). Sensitivity analyses confirmed these findings. No important adverse events observed. Mean differences complete case quality-adjusted life-years (EuroQol Five-Dimension Questionnaire, Utilities Index Mark 3) did not significantly differ zero; multiple imputation supported dominance screening. Incremental cost savings per person £17.34 (95% 17.02, 17.67) perspective £23.11 22.73, 23.53) perspective, representing 21% reduction overall programme costs. Overall, 43.2% fewer appointments required Conclusions/interpretation Stakeholders involved care can be reassured study, which is largest ophthalmic date, that extended feasible safely cost-effectively introduced established systematic programmes. Because trial long frame disease, robust monitoring should included any future implementation. Trial registration ISRCTN 87561257 Funding funded UK Institute Research.