Ramu Jayashree, Chatziralli Irini, Yang Yit, Menon Geeta, Bailey Clare, Eckstein Michael, Hykin Phil, Sivaprasad Sobha
NIHR Moorfields Biomedical Research Centre, London.
The Royal Wolverhampton Hospitals NHS Trust, Wolverhampton.
Patient Prefer Adherence. 2017 Mar 17;11:579-586. doi: 10.2147/PPA.S132859. eCollection 2017.
The aim of this study was to explore and describe quantitatively patient-reported outcome measures (PROMs), ie, health-related quality of life (QoL), visual function and treatment satisfaction, in patients with diabetic macular edema (DME) receiving two different regimens of Ozurdex (intravitreal dexamethasone implant).
In this multicenter, prospective study, 100 patients with center-involving refractory DME were randomized 1:1 to either five monthly fixed dosing or optical coherence tomography (OCT)-guided pro re nata (PRN) regimen of dexamethasone intravitreal implant therapy. The primary outcome was the difference between arms in change in PROMs and health-related QoL from baseline to 12 months, as measured by the Retinopathy-Dependent Quality of Life (RetDQoL) questionnaire, Visual Function Questionnaire-25 (VFQ-25) and Retinopathy Treatment Satisfaction Questionnaire (RetTSQ).
There was no statistically significant difference in the RetDQoL score and VFQ-25 score at month 12 compared to those at baseline, whereas the total mean RetTSQ score increased significantly at the exit visit. The two treatment arms did not differ significantly regarding the change in PROMs and health-related QoL questionnaires. Logistic regression analysis showed that visual acuity (VA) of ≥55 letters, central foveal thickness <300 μm and macular volume <9.2 mm at the exit visit (month 12) predicted a higher change in RetTSQ.
This study showed that there is a statistically significant improvement in treatment satisfaction, as measured by RetTSQ, in patients with DME treated with dexamethasone intravitreal implant, independent of the dose regimen, namely, fixed or PRN. However, it should be noted that the clinically meaningful change could not be assessed accurately, since no thresholds for clinically meaningful change currently exist for the RetTSQ. On the other hand, there was no significant change in health-related QoL, as measured using VFQ-25 and RetDQoL. Factors affecting the patients' treatment satisfaction were the final VA, the central foveal thickness and the macular volume.
本研究旨在定量探索和描述接受两种不同方案Ozurdex（玻璃体内地塞米松植入物）治疗的糖尿病性黄斑水肿（DME）患者报告的结局指标（PROMs），即健康相关生活质量（QoL）、视觉功能和治疗满意度。
在这项多中心前瞻性研究中，100例累及中心凹的难治性DME患者按1:1随机分为接受每月5次固定剂量或光学相干断层扫描（OCT）引导下按需（PRN）给药方案的玻璃体内地塞米松植入物治疗。主要结局是通过视网膜病变相关生活质量（RetDQoL）问卷、视觉功能问卷-25（VFQ-25）和视网膜病变治疗满意度问卷（RetTSQ）测量的，从基线到12个月时两组在PROMs和健康相关QoL变化方面的差异。
与基线时相比，12个月时RetDQoL评分和VFQ-25评分无统计学显著差异，而在末次随访时RetTSQ总平均分显著增加。在PROMs和健康相关QoL问卷的变化方面，两个治疗组无显著差异。逻辑回归分析显示，末次随访（12个月）时视力（VA）≥55个字母、中心凹厚度<300μm和黄斑体积<9.2mm预测RetTSQ有更高的变化。
本研究表明，通过RetTSQ测量，接受玻璃体内地塞米松植入物治疗的DME患者的治疗满意度有统计学显著提高，与剂量方案无关，即固定剂量或PRN方案。然而，应该注意的是，由于目前RetTSQ尚无临床意义变化的阈值，因此无法准确评估临床意义变化。另一方面，使用VFQ-25和RetDQoL测量的健康相关QoL无显著变化。影响患者治疗满意度的因素是最终视力、中心凹厚度和黄斑体积。
