Department of Eye and Vision Science, Institute of Life Course and Medical Sciences, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.
St Paul's Eye Unit, Liverpool University Hospitals Foundation Trust, Member of Liverpool Health Partners, Liverpool, UK.
Diabetologia. 2021 Jan;64(1):56-69. doi: 10.1007/s00125-020-05313-2. Epub 2020 Nov 4.
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.
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.
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.
ISRCTN 87561257 FUNDING: The study was funded by the UK National Institute for Health Research. Graphical abstract.
目的/假设：根据个人风险水平，使用可变的糖尿病视网膜病变筛查间隔，可以提高糖尿病患者的参与度，并将资源重新分配给高风险人群，同时应对糖尿病患病率的上升。然而，关于延长筛查间隔的安全性数据很少。本研究旨在评估个体化、可变间隔、基于风险的人群筛查与常规护理相比的安全性和成本效益，同时广泛征求糖尿病患者的意见。
这是一项在单一的英国筛查计划中，对年龄在 12 岁或以上的糖尿病患者进行的两臂、平行分配、等效 RCT（至少 2 年随访）。参与者在基线时以 1:1 的比例随机分配到个体化筛查组，分别在高、中、低风险时进行 6、12 或 24 个月的筛查，每个筛查阶段都由一个使用当地人口统计学、筛查和临床数据的风险计算引擎来确定，或者每年进行一次筛查（对照组）。筛查工作人员和调查人员对分配和间隔进行了观察性盲法。数据在筛查计划内收集。主要结局是就诊率（安全性）。次要安全性结局是视力威胁性糖尿病视网膜病变的发生。从国家卫生服务和社会角度评估了 2 年内的成本效益。
共有 4534 名参与者被随机分配。经过退出后，个体化筛查组有 2097 名参与者，对照组有 2224 名参与者。两组的首次随访就诊率相当（个体化筛查组 83.6%；对照组 84.7%；差异-1.0[95%CI-3.2,1.2]），而个体化筛查组的视力威胁性糖尿病视网膜病变检出率非劣效（个体化筛查组 1.4%；对照组 1.7%；差异-0.3[95%CI-1.1,0.5]）。敏感性分析证实了这些发现。没有观察到重要的不良事件。完整病例质量调整生命年（EuroQol 五维问卷、健康效用指数标记 3）的平均差异与零没有显著差异；多重插补支持个体化筛查的优势。从国家卫生服务的角度来看，个体化筛查每例患者的增量成本节约为 17.34 英镑（95%CI 17.02,17.67），从社会角度来看为 23.11 英镑（95%CI 22.73,23.53），代表总体项目成本降低了 21%。总体而言，个体化筛查组需要的筛查预约减少了 43.2%。
结论/解释：参与糖尿病护理的利益相关者可以放心，这是迄今为止在糖尿病视网膜病变筛查方面最大的眼科 RCT，可以证明延长和个体化、可变间隔、基于风险的筛查是可行的，可以在既定的系统计划中安全且具有成本效益地引入。由于试验的 2 年时间范围和疾病的长时间框架，任何未来的实施都应包括对就诊率和视网膜病变率的严格监测。
ISRCTN 87561257 资助：该研究由英国国家卫生研究院资助。
Zotero 插件