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临床试验中少数民族、青少年和青年成年人的失随访情况:来自儿童肿瘤学组的报告。

Loss to follow-up of minorities, adolescents, and young adults on clinical trials: A report from the Children's Oncology Group.

机构信息

Section of Pediatric Hematology and Oncology, Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut, USA.

Department of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.

出版信息

Cancer. 2023 May 15;129(10):1547-1556. doi: 10.1002/cncr.34701. Epub 2023 Feb 22.

DOI:10.1002/cncr.34701
PMID:36813754
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10357561/
Abstract

BACKGROUND

The increasing number of childhood cancer survivors necessitates continued follow-up to monitor for long-term complications. Inequities in loss to follow-up for patients enrolled on pediatric clinical trials have not been well studied.

METHODS

This was a retrospective study of 21,084 patients residing in the United States enrolled on phase 2/3 and phase 3 Children's Oncology Group (COG) trials between January 1, 2000 and March 31, 2021. Rates of loss to follow-up to COG were evaluated using log-rank tests and multivariable Cox proportional hazards regression models with adjusted hazard ratios (HRs). Demographic characteristics included age at enrollment, race, ethnicity, and zip code level socioeconomic data.

RESULTS

Adolescent and young adult (AYA) patients 15-39 years old at diagnosis had an increased hazard of loss to follow-up compared to patients 0-14 years old (HR, 1.89; 95% confidence interval (CI), 1.76-2.02). In the overall cohort, non-Hispanic Blacks were found to have an increased hazard of loss to follow-up compared to non-Hispanic Whites (HR, 1.56; 95% CI, 1.43-1.70). Among AYAs, the highest loss to follow-up rates were among non-Hispanic Blacks (69.8% ± 3.1%), patients on germ cell tumor trials (78.2% ± 9.2%), and patients living in zip codes with a median household income ≤150% of the federal poverty line at diagnosis (66.7% ± 2.4%).

CONCLUSIONS

AYAs, racial and ethnic minority patients, and those living in lower socioeconomic status areas had the highest rates of loss to follow-up among clinical trial participants. Targeted interventions are warranted to ensure equitable follow-up and improved assessment of long-term outcomes.

PLAIN LANGUAGE SUMMARY

Little is known about disparities in loss to follow-up for pediatric cancer clinical trial participants. In this study, we found that participants who were adolescents and young adults when treated, those who identified as a racial and/or ethnic minority, or those residing in areas with lower socioeconomic status at diagnosis were associated with higher rates of loss to follow-up. As a result, the ability to assess their long-term survival, treatment-related health conditions, and quality of life is hindered. These findings suggest the need for targeted interventions to improve long-term follow-up among disadvantaged pediatric clinical trial participants.

摘要

背景

儿童癌症幸存者人数不断增加,需要持续进行随访以监测长期并发症。在儿童临床试验中,入组患者的失访率存在不平等现象,这一问题尚未得到充分研究。

方法

这是一项回顾性研究,纳入了 2000 年 1 月 1 日至 2021 年 3 月 31 日期间,在美国参加儿童肿瘤学组(COG)2/3 期和 3 期临床试验的 21084 名患者。使用对数秩检验和多变量 Cox 比例风险回归模型评估 COG 失访率,并进行了调整后的风险比(HR)分析。人口统计学特征包括入组时的年龄、种族、族裔和邮政编码水平的社会经济数据。

结果

诊断时年龄为 15-39 岁的青少年和年轻成人(AYA)患者与 0-14 岁患者相比,失访风险更高(HR,1.89;95%置信区间(CI),1.76-2.02)。在总体队列中,与非西班牙裔白人相比,非西班牙裔黑人的失访风险更高(HR,1.56;95%CI,1.43-1.70)。在 AYA 中,失访率最高的是非西班牙裔黑人(69.8%±3.1%)、生殖细胞瘤试验患者(78.2%±9.2%)和诊断时居住在家庭收入中位数为联邦贫困线 150%以下的邮政编码的患者(66.7%±2.4%)。

结论

在临床试验参与者中,青少年和年轻成人、少数族裔患者和生活在社会经济地位较低地区的患者的失访率最高。需要采取有针对性的干预措施,以确保公平随访并改善长期结局评估。

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