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追踪未入组患者:未入组临床试验个体的肺癌筛查模式。

Tracking the Nonenrolled: Lung Cancer Screening Patterns Among Individuals not Accrued to a Clinical Trial.

机构信息

Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX; Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX.

Department of Psychology, University of Arizona, Tucson, AZ; Department of Family and Community Medicine, University of Arizona, Tucson, AZ.

出版信息

Clin Lung Cancer. 2020 Jul;21(4):326-332. doi: 10.1016/j.cllc.2020.02.010. Epub 2020 Feb 26.

Abstract

INTRODUCTION

For lung cancer screening, the available data are often derived from patients enrolled prospectively in clinical trials. We, therefore, investigated lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial.

PATIENTS AND METHODS

From February 2017 through February 2019, we enrolled subjects in a trial examining telephone-based navigation during low-dose computed tomography (LDCT) for lung cancer screening. We identified patients for whom LDCT was ordered and who were approached, but not enrolled, in the trial. We categorized nonenrollment as the patient had declined or could not be reached. We compared the characteristics and LDCT completion rates among these groups and the enrolled population using the 2-sample t test and χ test.

RESULTS

Of 900 individuals approached for participation (mean age, 62 years; 45% women, 53% black), 447 were enrolled in the screening clinical trial. No significant demographic differences were found between the enrolled and nonenrolled cohorts. Of the 453 individuals not enrolled, 251 (55%) had declined participation and 202 (45%) could not be reached, despite up to 6 attempts. LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P < .001).

CONCLUSIONS

In the present single-center study, demographic factors did not predict for participation in a lung cancer screening trial. Lung cancer screening adherence rates were substantially lower for those not enrolled in a screening trial, especially for those who could not be contacted. These findings may inform the broader implementation of screening programs.

摘要

简介

对于肺癌筛查,可用数据通常来自前瞻性入组临床试验的患者。因此,我们调查了符合但未入组筛查试验的个体的肺癌筛查模式。

患者和方法

从 2017 年 2 月至 2019 年 2 月,我们入组了一项试验,该试验研究了在肺癌筛查中使用低剂量计算机断层扫描(LDCT)进行电话导航。我们确定了 LDCT 被开具但未入组该试验的患者。我们将未入组归类为患者拒绝或无法联系。我们使用两样本 t 检验和 χ 检验比较了这些组和入组人群的特征和 LDCT 完成率。

结果

在 900 名被邀请参与的个体(平均年龄 62 岁;45%为女性,53%为黑人)中,447 名入组了筛查临床试验。入组和未入组队列之间没有发现显著的人口统计学差异。在未入组的 453 名个体中,251 名(55%)拒绝参与,202 名(45%)尽管进行了多达 6 次尝试但无法联系。LDCT 完成率与入组状态显著相关:入组个体中为 81%,拒绝参与的个体中为 73%,无法联系的个体中为 49%(P <.001)。

结论

在本单中心研究中,人口统计学因素不能预测是否参与肺癌筛查试验。未入组筛查试验的个体的肺癌筛查依从率明显较低,尤其是那些无法联系的个体。这些发现可能为更广泛的筛查计划实施提供信息。

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