Division of Optometry and Visual Science, School of Health Sciences, City, University of London, London, United Kingdom.
National Institute for Health Research Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and University College London Institute of Ophthalmology, London, United Kingdom.
Ophthalmology. 2019 May;126(5):682-689. doi: 10.1016/j.ophtha.2018.09.034. Epub 2018 Sep 28.
The United Kingdom Glaucoma Treatment Study (UKGTS) demonstrated the effectiveness of an intraocular pressure-lowering drug in patients with glaucoma using visual field progression as a primary outcome. The present study tested the hypothesis that responses on patient-reported outcome measures (PROMs; secondary outcome measure) differ between patients receiving a topical prostaglandin analog (latanoprost) or placebo eye drops in UKGTS.
Multicenter, randomized, triple-masked, placebo-controlled trial.
Newly diagnosed glaucoma patients in the UKGTS with baseline and exit PROMs (n = 182 and n = 168 patients from the treatment and placebo groups, respectively).
In the UKGTS (trial registration number, ISRCTN96423140), patients with open-angle glaucoma were allocated to receive latanoprost (treatment) or placebo; the observation period was 24 months. Patients completed general health PROMs (European Quality of Life in 5 Dimensions [EQ-5D] and 36-item Short Form [SF-36]) and PROMs specific to glaucoma (15-item Glaucoma Quality of Life [GQL-15] and 9-item Glaucoma Activity Limitation [GAL-9]) at baseline and exit from the trial. Percentage changes between measurement on PROMs were calculated for each patient and compared between treatment arms. In addition, differences between stable patients (n = 272) and those with glaucomatous progression (n = 78), as determined by visual field change (primary outcome), were assessed.
PROMs on health-related and vision-related quality of life.
Average percentage change on PROMs was similar for patients in both arms of the trial, with no statistically significant differences between treatment and placebo groups (EQ-5D, P = 0.98; EQ-5D visual analog scale, P = 0.88; SF-36, P = 0.94, GQL-15, P = 0.66; GAL-9, P = 0.87). There were statistically significant differences between stable and progressing patients on glaucoma-specific PROMs (GQL-15, P = 0.02; GAL-9, P = 0.02), but not on general health PROMs (EQ-5D, P = 0.62; EQ-5D visual analog scale, P = 0.23; SF-36, P = 0.65).
Average change in PROMs on health-related and vision-related quality of life was similar for the treatment and placebo groups in the UKGTS. The PROMs used may not be sensitive enough to function as primary end points in clinical trials when participants have newly diagnosed early-stage glaucoma.
英国青光眼治疗研究（UKGTS）使用视野进展作为主要结局，证明了一种降眼压药物在青光眼患者中的有效性。本研究检验了以下假设，即在 UKGTS 中，接受局部前列腺素类似物（拉坦前列素）或安慰剂滴眼的患者，其患者报告结局测量（PROM；次要结局测量）的反应是否存在差异。
多中心、随机、三盲、安慰剂对照试验。
UKGTS 中基线和退出时具有 PROM 的新诊断青光眼患者（治疗组和安慰剂组分别有 n=182 和 n=168 名患者）。
在 UKGTS（试验注册号 ISRCTN96423140）中，开角型青光眼患者被分配接受拉坦前列素（治疗）或安慰剂；观察期为 24 个月。患者在基线和退出试验时完成了一般健康 PROM（欧洲五维健康量表 [EQ-5D] 和 36 项简明健康调查问卷 [SF-36]）和专门针对青光眼的 PROM（15 项青光眼生活质量问卷 [GQL-15] 和 9 项青光眼活动受限问卷 [GAL-9]）。为每位患者计算了 PROM 上测量值之间的百分比变化，并比较了治疗组之间的差异。此外，还评估了根据视野变化（主要结局）确定的稳定患者（n=272）和进展患者（n=78）之间的差异。
健康相关和视力相关生活质量的 PROM。
试验中两个治疗组的 PROM 平均百分比变化相似，治疗组和安慰剂组之间无统计学显著差异（EQ-5D，P=0.98；EQ-5D 视觉模拟评分，P=0.88；SF-36，P=0.94，GQL-15，P=0.66；GAL-9，P=0.87）。在专门针对青光眼的 PROM 上，稳定患者和进展患者之间存在统计学显著差异（GQL-15，P=0.02；GAL-9，P=0.02），但在一般健康 PROM 上没有统计学显著差异（EQ-5D，P=0.62；EQ-5D 视觉模拟评分，P=0.23；SF-36，P=0.65）。
UKGTS 中，治疗组和安慰剂组在健康相关和视力相关生活质量的 PROM 平均变化相似。当参与者患有新诊断的早期青光眼时，用于测量的 PROM 可能不够敏感，无法作为临床试验的主要终点。
