Jelin Elma, Wisløff Torbjørn, Jørstad Øystein Kalsnes, Heiberg Turid, Moe Morten Carstens
Department of Ophthalmology, Oslo University Hospital, Oslo, Norway.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
BMJ Open Ophthalmol. 2019 Oct 3;4(1):e000353. doi: 10.1136/bmjophth-2019-000353. eCollection 2019.
To prospectively explore the following patient-reported outcome measures (PROMs) in the management of neovascular age-related macular degeneration (nAMD): (1) self-reported visual function, (2) symptom-state, (3) general-health and (4) satisfaction of treatment.
Corresponding to the four PROMs, participants responded to the following questionnaires: (1) National Eye Institute Visual-Functioning-Questionnaire (NEI-VFQ-25), (2) Patient-Acceptable-Symptom-Status (PASS 5), (3) EuroQol-Group-Questionnaire (EQ-5D-3L) and (4) Dimensions of Importance in Treatment of nAMD (DITAMD). Data were collected at baseline and after 3, 6 and 12 months of intravitreal antivascular endothelial growth factor treatment. Results were evaluated with t-tests and mixed linear regression analyses.
The study included 197 patients. At baseline NEI-VFQ-25 (79.53±14.52) and EQ-5D (0.74±0.28) had relatively high scores, whereas PASS 5 was below 'acceptable' (3.30±0.80). At 12 months NEI-VFQ-25 and PASS 5 showed significant improvement, whereas EQ-5D and DITAMD remained unchanged. At baseline patients receiving treatment of the better-seeing eye (BSE) (n=52) reported significantly worse NEI-VFQ-25 and PASS 5 than patients for whom treatment only involved the worse-seeing eye (WSE), (n=145). In contrast to BSE patients, there was no improvement of NEI-VFQ-25 for WSE patients at 12 months, despite a significant improvement in best-corrected visual acuity (BCVA). Two independent variables, treatment including the BSE and BCVA for the treated eye, were found to predict both NEI-VFQ-25 and PASS 5.
After 12 months of nAMD treatment, there was a significant improvement in PASS 5 and NEI-VFQ-25, the latter depending on whether therapy included BSE. EQ-5D and DITAMD remained unaltered.
前瞻性探索以下患者报告结局指标(PROMs)在新生血管性年龄相关性黄斑变性(nAMD)管理中的应用:(1)自我报告的视觉功能,(2)症状状态,(3)总体健康状况,以及(4)治疗满意度。
对应上述四项PROMs,参与者回答以下问卷:(1)美国国立眼科研究所视觉功能问卷(NEI-VFQ-25),(2)患者可接受症状状态问卷(PASS 5),(3)欧洲五维度健康量表(EQ-5D-3L),以及(4)nAMD治疗重要性维度问卷(DITAMD)。在玻璃体内注射抗血管内皮生长因子治疗的基线期、3个月、6个月和12个月后收集数据。结果采用t检验和混合线性回归分析进行评估。
该研究纳入了197例患者。在基线期,NEI-VFQ-25(79.53±14.52)和EQ-5D(0.74±0.28)得分相对较高,而PASS 5低于“可接受”水平(3.30±0.80)。在12个月时,NEI-VFQ-25和PASS 5显示出显著改善,而EQ-5D和DITAMD保持不变。在基线期,接受较好视力眼(BSE)治疗的患者(n = 52)报告的NEI-VFQ-25和PASS 5显著差于仅接受较差视力眼(WSE)治疗的患者(n = 145)。与BSE患者不同,WSE患者在12个月时NEI-VFQ-25没有改善,尽管最佳矫正视力(BCVA)有显著提高。发现两个独立变量,即包括BSE的治疗和治疗眼的BCVA,可预测NEI-VFQ-25和PASS 5。
nAMD治疗12个月后,PASS 5和NEI-VFQ-25有显著改善,后者取决于治疗是否包括BSE。EQ-5D和DITAMD保持不变。