Quality of Life in the Tube Versus Trabeculectomy Study
Quality of Life in the Tube Versus Trabeculectomy Study
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DOI：
10.1016/j.ajo.2017.01.019
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发表时间：
2017-04-01
影响因子：
4.2
通讯作者：
Gedde, Steven J.
中科院分区：
文献类型：
--
作者：
Kotecha, Aachal;Feuer, William J.;Gedde, Steven J.
目的：报告输卵管与小梁切除术（TVT）研究中视力特异性生活质量（QoL）结果。设计：多中心随机临床试验。方法：环境：17个临床中心。研究人群：18-85岁的青光眼患者，既往有白内障和/或青光眼手术。干预：管分流（350-mm(2) Baerveldt青光眼植入物）或MMC小梁切除术。主要结果测量：使用NEI VFQ-25的视力特异性生活质量和最小重要差异（MID）的估计是主要结果测量。采用基于横截面分布和锚点的方法来估计MID。临床锚点测量包括平均偏差（MD）和logMAR视力（VA）测量。锚定的临床显著变化定义为>= 2 dB MD和>= 0.2 logMAR。结果：治疗组间综合评分无显著差异，评分随时间无显著变化。基线时临床锚点的平均（SD；范围）值在手术眼为16.6(9.3；-32至-0.5)dB，在视力较好的眼为0.2(0.3;-0.1至1.3)logMAR VA。对于基于锚点的横断面分析，较好眼VA的综合评分MID （95% CI）为6.3(4.6-7.9)，手术眼MD的综合评分MID为1.4（0.9-1.9）。基于分布的综合评分MID为6.0。结论：小梁切除术和分流管手术对使用NEI VFQ-25测量的患者报告的视力特异性生活质量有相似的影响。在这组晚期青光眼患者中，MIDs的变化取决于所使用的临床锚点。基于分布的mid与基于VA测量的基于锚点的mid很好地对应。本文报道的MID值可能对其他希望在其晚期青光眼患者队列中解释NEI VFQ-25评分的人有用。(C) 2017爱思唯尔公司版权所有。
PURPOSE: To report the vision-specific quality-of-life (QoL) outcomes in the Tube Versus Trabeculectomy (TVT) Study.DESIGN: Multicenter randomized clinical trial.METHODS: SETTING: Seventeen clinical centers. STUDY POPULATION: Patients 18-85 years of age with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery. INTERVENTIONS: Tube shunt (350-mm(2) Baerveldt glaucoma implant) or trabeculectomy with MMC. MAIN OUTCOME MEASURES: Vision specific QoL using the NEI VFQ-25 and estimation of minimally important differences (MID) were the main outcome measures. Cross-sectional distribution- and anchor-based approaches were used to estimate MID. Clinical anchor measures included the mean deviation (MD) and logMAR visual acuity (VA) measurements. Clinically significant changes in anchor were defined as >= 2 dB MD and >= 0.2 logMAR.RESULTS: No significant differences in composite scores were observed between treatment groups, and no significant change in scores were seen over time. Mean (SD; range) values of clinical anchors at baseline were 16.6 (9.3; -32 to -0.5) dB for the surgical eye and 0.2 (0.3; -0.1 to 1.3) logMAR VA in the better-vision eye. For anchor-based cross-sectional analysis, composite score MID (95% CI) was 6.3 (4.6-7.9) for better-eye VA and 1.4 (0.9-1.9) for surgical eye MD. Distribution-based MID for the composite score was 6.0.CONCLUSIONS: Trabeculectomy and tube shunt surgery had similar impact on patient-reported vision-specific QoL measured using the NEI VFQ-25. In this cohort of patients with advanced glaucoma, MIDs varied depending on the clinical anchor used. Distribution-based MIDs corresponded well with anchor-based MIDs based on VA measures. The MID values reported here may be useful for others wishing to interpret NEI VFQ-25 scores in their advanced glaucoma patient cohort. (C) 2017 Elsevier Inc. All rights reserved.