Broadbent, Deborah, Wang, Amu, Cheyne, Christopher, James, Marilyn, Lathe, James, Stratton, Irene, Roberts, John, Moitt, Tracy ORCID: 0000-0002-5579-996X, Vora, Jiten, Gabbay, Mark ORCID: 0000-0002-0126-8485 et al (show 2 more authors)
(2021)
Safety and cost-effectiveness of individualised screening for diabetic retinopathy: the ISDR open-label, equivalence RCT.
Diabetologia, 64 (1).
pp. 56-69.
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Abstract
Aims/hypothesis Using variable diabetic retinopathy screening intervals, informed by personal risk levels, offers improved engagement of people with diabetes and reallocation of resources to high-risk groups, while addressing the increasing prevalence of diabetes. However, safety data on extending screening intervals are minimal. The aim of this study was to evaluate the safety and cost-effectiveness of individualised, variable-interval, risk-based population screening compared with usual care, with wide-ranging input from individuals with diabetes. Methods This was a two-arm, parallel-assignment, equivalence RCT (minimum 2 year follow-up) in individuals with diabetes aged 12 years or older registered with a single English screening programme. Participants were randomly allocated 1:1 at baseline to individualised screening at 6, 12 or 24 months for those at high, medium and low risk, respectively, as determined at each screening episode by a risk-calculation engine using local demographic, screening and clinical data, or to annual screening (control group). Screening staff and investigators were observer-masked to allocation and interval. Data were collected within the screening programme. The primary outcome was attendance (safety). A secondary safety outcome was the development of sight-threatening diabetic retinopathy. Cost-effectiveness was evaluated within a 2 year time horizon from National Health Service and societal perspectives. Results A total of 4534 participants were randomised. After withdrawals, there were 2097 participants in the individualised screening arm and 2224 in the control arm. Attendance rates at first follow-up were equivalent between the two arms (individualised screening 83.6%; control arm 84.7%; difference −1.0 [95% CI −3.2, 1.2]), while sight-threatening diabetic retinopathy detection rates were non-inferior in the individualised screening arm (individualised screening 1.4%, control arm 1.7%; difference −0.3 [95% CI −1.1, 0.5]). Sensitivity analyses confirmed these findings. No important adverse events were observed. Mean differences in complete case quality-adjusted life-years (EuroQol Five-Dimension Questionnaire, Health Utilities Index Mark 3) did not significantly differ from zero; multiple imputation supported the dominance of individualised screening. Incremental cost savings per person with individualised screening were £17.34 (95% CI 17.02, 17.67) from the National Health Service perspective and £23.11 (95% CI 22.73, 23.53) from the societal perspective, representing a 21% reduction in overall programme costs. Overall, 43.2% fewer screening appointments were required in the individualised arm. Conclusions/interpretation Stakeholders involved in diabetes care can be reassured by this study, which is the largest ophthalmic RCT in diabetic retinopathy screening to date, that extended and individualised, variable-interval, risk-based screening is feasible and can be safely and cost-effectively introduced in established systematic programmes. Because of the 2 year time horizon of the trial and the long time frame of the disease, robust monitoring of attendance and retinopathy rates should be included in any future implementation.
Item Type: | Article |
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Uncontrolled Keywords: | diabetic retinopathy, individualised, personalised, risk-based, screening, systematic, variable interval |
Depositing User: | Symplectic Admin |
Date Deposited: | 06 Nov 2020 08:18 |
Last Modified: | 18 Jan 2023 23:23 |
DOI: | 10.1007/s00125-020-05313-2 |
Related URLs: | |
URI: | https://livrepository.liverpool.ac.uk/id/eprint/3106121 |
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Safety and cost effectiveness of individualised screening for diabetic retinopathy: the ISDR open-label, equivalence randomised controlled trial. (deposited 14 Sep 2020 09:22)
- Safety and cost-effectiveness of individualised screening for diabetic retinopathy: the ISDR open-label, equivalence RCT. (deposited 06 Nov 2020 08:18) [Currently Displayed]