Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
BMJ Open. 2023 Oct 18;13(10):e067684. doi: 10.1136/bmjopen-2022-067684.
To estimate the economic costs, health-related quality-of-life outcomes and cost-effectiveness of subthreshold micropulse laser (SML) versus standard laser (SL) for the treatment of diabetic macular oedema (DMO) with central retinal thickness (CRT) of <400µ.
An economic evaluation was conducted within a pragmatic, multicentre, randomised clinical trial, DIAbetic Macular Oedema aNd Diode Subthreshold.
18 UK Hospital Eye Services.
Adults with diabetes and centre involving DMO with CRT<400µ.
Participants (n=266) were randomised 1:1 to receive SML or SL.
The base-case used an intention-to-treat approach conducted from a UK National Health Service (NHS) and personal social services (PSS) perspective. Costs (2019-2020 prices) were collected prospectively over the 2-year follow-up period. A bivariate regression of costs and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained and the incremental net monetary benefit of SML in comparison to SL. Sensitivity analyses explored uncertainty and heterogeneity in cost-effectiveness estimates.
One participant in the SL arm withdrew consent for data to be used; data from the remaining 265 participants were included in analyses. Mean (SE) NHS and PSS costs over 24 months were £735.09 (£111.85) in the SML arm vs £1099.70 (£195.40) in the SL arm (p=0.107). Mean (SE) QALY estimates were 1.493 (0.024) vs 1.485 (0.020), respectively (p=0.780), giving an insignificant difference of 0.008 QALYs. The probability SML is cost-effective at a threshold of £20 000 per QALY was 76%.
There were no statistically significant differences in EQ-5D-5L scores or costs between SML and SL. Given these findings and the fact that SML does not burn the retina, unlike SL and has equivalent efficacy to SL, it may be preferred for the treatment of people with DMO with CRT<400µ.
ISRCTN17742985; NCT03690050.
评估亚阈值微脉冲激光（SML）与标准激光（SL）治疗中央视网膜厚度（CRT）<400µ 的糖尿病性黄斑水肿（DMO）的经济成本、健康相关生活质量结果和成本效益。
在一项实用的、多中心、随机临床试验中进行了经济评估，即糖尿病性黄斑水肿和二极管亚阈值。
18 家英国医院眼科服务机构。
患有糖尿病且中心涉及 CRT<400µ 的 DMO 的成年人。
参与者（n=266）按 1:1 随机分配接受 SML 或 SL。
基础案例采用从英国国民保健服务（NHS）和个人社会服务（PSS）角度进行的意向治疗方法。在 2 年的随访期间，前瞻性地收集成本（2019-2020 年价格）。对成本和质量调整生命年（QALY）进行双变量回归，对缺失数据进行多重插补，以估计与 SL 相比，SML 每获得一个 QALY 的增量成本和增量净货币效益。敏感性分析探讨了成本效益估计的不确定性和异质性。
SL 组有 1 名参与者撤回了同意使用数据的意愿；其余 265 名参与者的数据被纳入分析。SML 组 24 个月的 NHS 和 PSS 平均（SE）成本为 735.09 英镑（111.85 英镑），而 SL 组为 1099.70 英镑（195.40 英镑）（p=0.107）。SML 组的平均（SE）QALY 估计值分别为 1.493（0.024）和 1.485（0.020）（p=0.780），差异不显著，为 0.008 QALY。在 20,000 英镑/QALY 的阈值下，SML 具有成本效益的概率为 76%。
在 EQ-5D-5L 评分或 SML 和 SL 之间没有统计学上的显著差异。考虑到这些发现以及 SML 不像 SL 那样灼伤视网膜，并且与 SL 具有等效疗效，因此对于 CRT<400µ 的 DMO 患者的治疗，SML 可能是首选。
ISRCTN85333304；NCT03690050。
