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农村患者参与多机构学术医疗中心的临床试验。

Participation of rural patients in clinical trials at a multisite academic medical center.

作者信息

Bharucha Adil E, Wi Chung Il, Srinivasan Sushmitha Grama, Choi Hyuckjae, Wheeler Phillip H, Stavlund Jennifer R, Keller Daniel A, Bailey Kent R, Juhn Young J

机构信息

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.

Department of Pediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN, USA.

出版信息

J Clin Transl Sci. 2021 Jul 12;5(1):e190. doi: 10.1017/cts.2021.813. eCollection 2021.

Abstract

OBJECTIVE

Clinical trials, which are mainly conducted in urban medical centers, may be less accessible to rural residents. Our aims were to assess participation and the factors associated with participation of rural residents in clinical trials.

METHODS

Using geocoding, the residential address of participants enrolled into clinical trials at Mayo Clinic locations in Arizona, Florida, and the Midwest between January 1, 2016, and December 31, 2017, was categorized as urban or rural. The distance travelled by participants and trial characteristics was compared between urban and rural participants. Ordinal logistic regression analyses were used to evaluate whether study location and risks were associated with rural participation in trials.

RESULTS

Among 292 trials, including 136 (47%) cancer trials, there were 2313 participants. Of these, 731 (32%) were rural participants, which is greater than the rural population in these 9 states (19%,  < 0.001). Compared to urban participants, rural participants were older (65 ± 12 years vs 64 ± 12 years, = 0.004) and travelled further to the medical center (103 ± 104 vs 68 ± 88 miles,  < 0.001). The proportion of urban and rural participants who were remunerated was comparable. In the multivariable analysis, the proportion of rural participants was lower ( < 0.001) in Arizona (10%) and Florida (18%) than the Midwest (38%) but not significantly associated with the study-related risks.

CONCLUSIONS

Approximately one in three clinical trial participants were rural residents versus one in five in the population. Rural residents travelled further to access clinical trials. The study-associated risks were not associated with the distribution of rural and urban participants in trials.

摘要

目的

主要在城市医疗中心开展的临床试验,农村居民可能较难参与。我们的目的是评估农村居民参与临床试验的情况以及与参与相关的因素。

方法

利用地理编码,将2016年1月1日至2017年12月31日期间在亚利桑那州、佛罗里达州和美国中西部的梅奥诊所各地点参加临床试验的参与者的居住地址分为城市或农村。比较了城市和农村参与者的行程距离以及试验特征。采用有序逻辑回归分析来评估研究地点和风险是否与农村居民参与试验有关。

结果

在292项试验中,包括136项(47%)癌症试验,共有2313名参与者。其中,731名(32%)为农村参与者,这一比例高于这9个州的农村人口比例(19%,P<0.001)。与城市参与者相比,农村参与者年龄更大(65±12岁对64±12岁,P = 0.004),前往医疗中心的路程更远(103±104英里对68±88英里,P<0.001)。获得报酬的城市和农村参与者比例相当。在多变量分析中,亚利桑那州(10%)和佛罗里达州(18%)的农村参与者比例低于美国中西部(38%)(P<0.001),但与研究相关风险无显著关联。

结论

约三分之一的临床试验参与者为农村居民,而农村人口在总人口中占五分之一。农村居民前往参加临床试验的路程更远。与研究相关的风险与试验中农村和城市参与者的分布无关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5edb/8596068/7979b78debd2/S205986612100813X_fig1.jpg

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