Aurora NCORP, Advocate Aurora Health, 960 N 12th St., Milwaukee, WI 53233, United States of America.
Advocate Aurora Research Institute, Advocate Aurora Health, 960 N 12th St., Milwaukee, WI 53233, United States of America.
Contemp Clin Trials. 2021 Apr;103:106315. doi: 10.1016/j.cct.2021.106315. Epub 2021 Feb 21.
Individual demographic data and socioeconomic status (SES) factors from Census block group data may help define groups with disadvantaged access to clinical trials.
Individual demographic data from the Aurora Cancer Registry and SES factors corresponding to the Census block group of the patient's address were studied for a six-year period ending July 31, 2019.
The final study cohort included 39,968 patients (enrolled = 772, and not enrolled = 39,196). In univariate analysis, significantly fewer patients older than age 65 (p < 0.001) and fewer men (p < 0.001) were enrolled in clinical trials. Socioeconomic factors found to be significant during univariate analysis included: low household income (p < 0.001), percentage below the poverty line (p < 0.001), low percentage home ownership (p = 0.006), unemployment (p = 0.003), absence of a college degree (p = 0.037) and absence of a high school degree (p = 0.007). In multivariate analysis, patients older than age 65 were less likely to participate in a trial (odds ratio 0.574, p < 0.001) and men were less likely to participate (odds ratio = 0.703, p < 0.001). Only 1.4% of the variance in clinical trial participation was accounted for demographic and SES factors.
The only groups with disadvantaged access to clinical trials in our institution were the elderly and men. Whether demographic or SES factors are related to accrual rates of clinical trials in other geographic regions or in other types of research studies warrants further investigation.
个体人口统计学数据和社会经济地位(SES)因素来自普查街区组数据,可以帮助确定获得临床试验机会不足的群体。
从奥罗拉癌症登记处获取个体人口统计学数据,并研究患者地址所在的普查街区组的 SES 因素,研究时间为 2019 年 7 月 31 日结束的六年期间。
最终研究队列包括 39968 名患者(入组=772 人,未入组=39196 人)。在单变量分析中,年龄大于 65 岁的患者(p<0.001)和男性(p<0.001)入组临床试验的比例明显较低。单变量分析中发现具有统计学意义的社会经济因素包括:低收入家庭(p<0.001)、贫困线以下比例(p<0.001)、低住房拥有率(p=0.006)、失业(p=0.003)、无大学学历(p=0.037)和无高中学历(p=0.007)。在多变量分析中,年龄大于 65 岁的患者参与试验的可能性较低(优势比 0.574,p<0.001),男性参与试验的可能性较低(优势比=0.703,p<0.001)。人口统计学和 SES 因素仅解释了临床试验参与度 1.4%的差异。
在我们的机构中,只有老年人和男性这两个群体获得临床试验的机会不足。人口统计学或 SES 因素是否与其他地理区域或其他类型的研究中的临床试验入组率有关,值得进一步研究。