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美国新生血管性年龄相关性黄斑变性临床试验的地理可及性差异。

Geographic Access Disparities of Clinical Trials in Neovascular Age-Related Macular Degeneration in the United States.

机构信息

From Wills Eye Hospital, Mid Atlantic Retina, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.

Biostatistics Consulting Core, Vickie and Jack Farber Vision Research Center, Wills Eye Hospital, Philadelphia, Pennsylvania, USA.

出版信息

Am J Ophthalmol. 2021 Sep;229:160-168. doi: 10.1016/j.ajo.2021.04.001. Epub 2021 Apr 20.

Abstract

UNLABELLED

To identify geographic and socioeconomic variables predictive of residential proximity to neovascular age-related macular degeneration (nAMD) clinical trial locations.

DESIGN

Retrospective, cross-sectional study.

METHODS

Census tract-level data from public datasets and trial-level data from ClinicalTrials.gov were analyzed. We calculated the driving distance (>60 miles) and time (>60 minutes) from the population-weighted US census tract centroid to the nearest clinical trial site.

RESULTS

We identified 42 trials studying nAMD across 829 unique clinical trial sites in the United States. In a multivariable model, driving distance >60 miles had a significant association with rural location (adjusted odds ratio [aOR] 5.54; 95% confidence interval [CI] 3.86-7.96, P < .0001) and with Midwest (aOR 2.30; 95% CI 1.21-4.38, P = .01) and South (aOR 2.43; 95% CI 1.21-4.91, P = .01) as compared to the Northeast region, and with some college or an associate's degree, as compared to a bachelor's degree (aOR 1.02; 95% CI 1.01-1.04, P = .0007, and aOR 1.05; 95% CI 1.00-1.10, P = .04, respectively). Lower odds of traveling >60 miles to the nearest nAMD trial site were associated with census tracts with a higher percentage of blacks (aOR 0.98; 95% CI 0.97-0.99, P < .0001), Hispanics (aOR 0.97; 95% CI 0.95-0.99, P = .002), and Asians (aOR 0.90; 95% CI 0.88-0.93, P < .0001), as compared to whites, and with a lower percentage of the population <200% of the federal poverty level. Similar predictors were found in time traveled >60 minutes.

CONCLUSIONS

There are geographic access disparities of clinical trial sites for nAMD in the United States.

摘要

目的

确定与新生血管性年龄相关性黄斑变性(nAMD)临床试验地点相关的地理位置和社会经济变量。

设计

回顾性、横断面研究。

方法

分析公共数据集的普查区数据和 ClinicalTrials.gov 的试验数据。我们计算了从人口加权美国普查区质心到最近临床试验地点的行车距离(>60 英里)和时间(>60 分钟)。

结果

我们在美国发现了 42 项研究 nAMD 的试验,涉及 829 个独特的临床试验地点。在多变量模型中,行驶距离>60 英里与农村地区(调整后的优势比[aOR]5.54;95%置信区间[CI]3.86-7.96,P<.0001)以及中西部(aOR 2.30;95% CI 1.21-4.38,P=.01)和南部(aOR 2.43;95% CI 1.21-4.91,P=.01)与东北部地区相比,以及与一些大学或副学士学位相比,学士学位(aOR 1.02;95% CI 1.01-1.04,P=.0007,aOR 1.05;95% CI 1.00-1.10,P=.04)分别)。前往最近的 nAMD 试验地点行驶距离超过 60 英里的可能性较低,与黑人比例较高的普查区(aOR 0.98;95% CI 0.97-0.99,P<.0001)、西班牙裔(aOR 0.97;95% CI 0.95-0.99,P=.002)和亚洲人(aOR 0.90;95% CI 0.88-0.93,P<.0001),与白人相比,以及人口比例低于联邦贫困线 200%的普查区。在行驶时间超过 60 分钟的情况下也发现了类似的预测因素。

结论

美国 nAMD 临床试验地点存在地理位置上的差异。

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