SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center, Seattle, Washington.
Columbia University Irving Medical Center, Columbia University, New York, New York.
JAMA Oncol. 2023 Oct 1;9(10):1371-1379. doi: 10.1001/jamaoncol.2023.2800.
The Patient Protection and Affordable Care Act (ACA) Medicaid expansion resulted in increased use of Medicaid insurance nationwide. However, the association between Medicaid expansion and access to clinical trials has not been examined to date.
To examine whether the implementation of ACA Medicaid expansion was associated with increased participation of patients with Medicaid insurance in cancer clinical trials.
DESIGN, SETTING, AND PARTICIPANTS: Data for this cohort study of 51 751 patients were from the SWOG Cancer Research Network. All patients aged 18 to 64 years and enrolled in treatment trials with Medicaid or private insurance between April 1, 1992, and February 29, 2020, were included. Interrupted time-series analysis with segmented logistic regression was used. The monthly unemployment rate and presidential administration were adjusted to reflect potential differences in Medicaid use associated with economic conditions and national administrative policies, respectively. Data analysis was conducted between June 22, 2021, and August 5, 2022.
Implementation of Medicaid expansion on January 1, 2014, was the independent exposure variable.
The number and proportion of patients by insurance type enrolled in cancer clinical trials over time were analyzed.
Overall, data for 51 751 patients were analyzed. Mean (SD) age was 50.6 (9.8) years, 67.3% of patients were female, 41.1% were younger than 50 years, and 9.1% used Medicaid. A 19% annual increase (odds ratio [OR], 1.19; 95% CI, 1.11-1.28; P < .001) was identified in the odds of patients using Medicaid after the ACA Medicaid expansion, resulting in a 52% increase (OR, 1.52; 95% CI, 1.29-1.78; P < .001) compared with what was expected in the number of Medicaid patients enrolled over time. The association was greater in states that adopted Medicaid expansion in 2014 to 2015 (OR, 1.26; 95% CI, 1.15-1.38; P < .001) compared with other states (OR, 1.08; 95% CI, 0.96-1.21; P = .20; P = .04 for interaction). By February 2020, the proportion of patients with Medicaid insurance was 17.8% (95% CI, 15.0%-20.8%; P < .001), whereas the expected proportion had ACA Medicaid expansion not occurred was 6.9% (95% CI, 4.4%-10.3%; P < .001).
Findings suggest that implementation of ACA Medicaid expansion was associated with increased participation of patients using Medicaid in cancer clinical trials. Improved participation in clinical trials for Medicaid-insured patients is critical for socioeconomically vulnerable patients seeking access to the newest treatments available in trials and for improving confidence that trial findings apply to patients of all backgrounds.
《平价医疗法案》(ACA)的医疗补助扩张导致全美更多人使用医疗补助保险。然而,迄今为止,医疗补助扩张与临床试验参与之间的关联尚未得到研究。
研究 ACA 医疗补助扩张的实施是否与更多使用医疗补助保险的患者参与癌症临床试验有关。
设计、设置和参与者:这项针对 51751 名患者的 SWOG 癌症研究网络队列研究的数据。所有年龄在 18 至 64 岁之间,在 1992 年 4 月 1 日至 2020 年 2 月 29 日期间参加有医疗补助或私人保险的治疗试验的患者均被纳入研究。使用分段逻辑回归进行中断时间序列分析。每月失业率和总统管理部门被调整,以分别反映与经济状况和国家行政政策相关的医疗补助使用的潜在差异。数据分析于 2021 年 6 月 22 日至 2022 年 8 月 5 日进行。
2014 年 1 月 1 日实施医疗补助扩张是独立的暴露变量。
分析了随时间推移按保险类型登记的患者数量和比例。
共分析了 51751 名患者的数据。平均(SD)年龄为 50.6(9.8)岁,67.3%的患者为女性,41.1%的患者年龄小于 50 岁,9.1%的患者使用医疗补助保险。ACA 医疗补助扩张后,使用医疗补助保险的患者比例每年增加 19%(比值比[OR],1.19;95%CI,1.11-1.28;P<0.001),与预期相比,登记的医疗补助患者人数增加了 52%(OR,1.52;95%CI,1.29-1.78;P<0.001)。在 2014 年至 2015 年实施医疗补助扩张的州,这种关联更大(OR,1.26;95%CI,1.15-1.38;P<0.001),而其他州则更小(OR,1.08;95%CI,0.96-1.21;P=0.20;P=0.04 用于交互)。到 2020 年 2 月,有医疗补助保险的患者比例为 17.8%(95%CI,15.0%-20.8%;P<0.001),而没有发生 ACA 医疗补助扩张的预期比例为 6.9%(95%CI,4.4%-10.3%;P<0.001)。
研究结果表明,ACA 医疗补助扩张的实施与更多使用医疗补助保险的患者参与癌症临床试验有关。改善医疗补助保险患者参与临床试验对于寻求获得试验中最新治疗方法的社会经济弱势群体患者以及提高对试验结果适用于所有背景患者的信心至关重要。