共病与癌症临床试验的讨论及参与相关：来自健康信息国家趋势调查-监测、流行病学和最终结果计划（2021年）的发现。

Comorbidities were associated with cancer clinical trial discussion and participation: findings from the Health Information National Trends Survey-Surveillance, Epidemiology, and End Results Program (2021).

作者信息

Cho Youmin, Shang Shaomei, Zhou Weijiao

机构信息

College of Nursing, Chungnam National University College of Nursing, Daejeon, South Korea; School of Biomedical Informatics, The University of Texas Health Science Center at Houston School of Biomedical Informatics, Houston, TX, USA.

School of Nursing, Peking University School of Nursing, Beijing, China.

出版信息

J Clin Epidemiol. 2023 Nov;163:62-69. doi: 10.1016/j.jclinepi.2023.09.016. Epub 2023 Sep 30.

DOI:10.1016/j.jclinepi.2023.09.016

PMID:37783400

Abstract

OBJECTIVES

Oncology clinical trials are recommended to better reflect real-world cancer patient populations and to increase patient access to new treatments in trials. The influence of comorbidities on trial participation is unclear. This study examined the association of having comorbidities and patients' experiences with clinical trial discussion or actual participation.

STUDY DESIGN AND SETTING

We included 958 cancer survivors from Health Information National Trends Survey-Surveillance, Epidemiology, and End Results Program. Trial discussion was defined as whether their medical team discussed cancer clinical trials, and trial participation was defined as whether they participated. Comorbidities included diabetes, hypertension, heart condition, chronic lung disease, and depression/anxiety disorder. Design-based logistic regression results were conducted.

RESULTS

Seventy-five percent of patients had one or more comorbidities, commonly having hypertension (56%) and diabetes (26%). Only 15% of participants reported trial discussion and 8% reported trial participation. Having one or more comorbidities was significantly associated with lower rates of trial discussion in univariate analysis (22.9% vs. 12.1%, odds ratio = 0.46, P = 0.001), and such association was pertained in adjusted logistic regression (20.5% vs. 12.8%, adjusted odds ratio = 0.54, P = 0.02).

CONCLUSION

Findings suggest patients with comorbidities were underrepresented in cancer clinical trials, implying a potential lack of representativeness among trial participants.

摘要

目的

推荐进行肿瘤学临床试验，以更好地反映真实世界的癌症患者群体，并增加患者参与试验获得新治疗方法的机会。合并症对试验参与的影响尚不清楚。本研究调查了合并症与患者临床试验讨论经历或实际参与情况之间的关联。

研究设计与背景

我们纳入了来自健康信息国家趋势调查-监测、流行病学和最终结果计划的958名癌症幸存者。试验讨论定义为其医疗团队是否讨论过癌症临床试验，试验参与定义为他们是否参与过。合并症包括糖尿病、高血压、心脏病、慢性肺病以及抑郁/焦虑症。进行了基于设计的逻辑回归分析。

结果

75%的患者有一种或多种合并症，常见的有高血压（56%）和糖尿病（26%）。只有15%的参与者报告有试验讨论，8%报告参与过试验。在单因素分析中，有一种或多种合并症与较低的试验讨论率显著相关（22.9%对12.1%，比值比=0.46，P=0.001），且在调整后的逻辑回归中这种关联依然存在（20.5%对12.8%，调整后比值比=0.54，P=0.02）。