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青少年与临床试验相关的知识和态度。

Adolescent knowledge and attitudes related to clinical trials.

作者信息

Brown Devin L, Cowdery Joan E, Jones Toni Stokes, Langford Aisha, Gammage Catherine, Jacobs Teresa L

机构信息

Stroke Program, The Cardiovascular Center, University of Michigan, Ann Arbor, MI, USA

School of Health Promotion & Human Performance, Eastern Michigan University, Ypsilanti, MI, USA.

出版信息

Clin Trials. 2015 Jun;12(3):212-4. doi: 10.1177/1740774515571443. Epub 2015 Feb 10.

Abstract

BACKGROUND OR AIMS

Poor enrollment plagues most clinical trials. Furthermore, despite mandates to improve minority representation in clinical trial participation, little progress has been made. We investigated the knowledge and attitudes of adolescents related to clinical trials and made race/ethnicity comparisons in an attempt to identify a possible educational intervention target.

METHODS

Students aged 13-18 years in southeast Michigan were offered participation through a class at one high school or two academic summer enrichment programs that drew from multiple high schools (73% response). Questionnaires previously validated in adults were administered. Non-Hispanic whites were compared with minorities using Wilcoxon rank-sum tests.

RESULTS

Of the 82 respondents, the median age was 16 years (interquartile range: 15-17 years); 22 (28%) were white, 41 (51%) were African American, 11 (14%) were multiracial, 2 (2%) were American Indian or Alaska Native, 1 (1%) was Asian, 3 (4%) were Native Hawaiian or other Pacific Islander, and 2 respondents did not report a race (but did report Hispanic ethnicity). Nine (12%) were Hispanic. Only 27 (33%) had ever heard of a clinical trial. On a scale from 1 (most receptive) to 5 (least receptive) for learning more about a clinical trial for a relevant medical condition, the median score was 2 (interquartile range: 1-3) and for participating in a clinical trial for a relevant medical condition was 2 (interquartile range: 2-3). Overall knowledge was poor, with a median of 46% (interquartile range: 23%-62%) of knowledge answers correct. Knowledge was reduced (p = 0.0006) and attitudes were more negative (p = 0.05) in minorities than non-Hispanic whites, while minorities also endorsed more substantial barriers to trial participation (p = 0.0002). Distrust was similar between minority students and non-Hispanic whites (p = 0.15), and self-efficacy was greater in non-Hispanic whites (p = 0.05).

CONCLUSION

Educational interventions directed toward adolescents that address knowledge, attitudes, and distrust in order to improve clinical trial awareness and receptivity overall are needed and may represent a tool to address disparities in minority enrollment in clinical trials.

摘要

背景或目的

入组率低困扰着大多数临床试验。此外,尽管有提高少数族裔参与临床试验比例的要求,但进展甚微。我们调查了青少年对临床试验的了解和态度,并进行了种族/族裔比较,以确定可能的教育干预目标。

方法

通过一所高中的班级或两个从多所高中招募学生的学术暑期强化项目,邀请密歇根州东南部13 - 18岁的学生参与(回复率73%)。采用先前在成年人中验证过的问卷进行调查。使用Wilcoxon秩和检验对非西班牙裔白人与少数族裔进行比较。

结果

82名受访者的中位年龄为16岁(四分位间距:15 - 17岁);22人(28%)为白人,41人(51%)为非裔美国人,11人(14%)为多种族,2人(2%)为美国印第安人或阿拉斯加原住民,1人(1%)为亚洲人,3人(4%)为夏威夷原住民或其他太平洋岛民,2名受访者未报告种族(但报告了西班牙裔族裔)。9人(12%)为西班牙裔。只有27人(33%)听说过临床试验。在针对相关医疗状况了解更多临床试验的接受程度评分中(从1分(最愿意)到5分(最不愿意)),中位得分为2分(四分位间距:1 - 3分),针对参与相关医疗状况的临床试验的接受程度评分中位得分为2分(四分位间距:2 - 3分)。总体知识水平较差,知识问答的中位正确率为46%(四分位间距:23% - 62%)。与非西班牙裔白人相比,少数族裔的知识水平较低(p = 0.0006),态度更消极(p = 0.05),同时少数族裔也认可参与试验存在更多实质性障碍(p = 0.0002)。少数族裔学生与非西班牙裔白人之间的不信任程度相似(p = 0.15),非西班牙裔白人的自我效能感更强(p = 0.05)。

结论

需要针对青少年开展教育干预,解决知识、态度和不信任问题,以提高整体临床试验意识和接受度,这可能是解决临床试验中少数族裔入组差异的一种手段。

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