解析温希普癌症研究所骨髓瘤临床试验中非洲裔美国人高参与率的原因。
Accounting for the High Enrollment of African Americans on Winship Cancer Institute's Myeloma Clinical Trials.
作者信息
McClary T S, Blee S M, Avinger A M, Dai Q, Switchenko J, Dixon M D, Pentz R D
机构信息
Emory University, Winship Cancer Institute, 1365, Clifton Road, 30322 Atlanta, GA, USA.
South University Orlando Campus5900 Lake Ellenor Dr, Orlando Fl 32809.
出版信息
Ethics Med Public Health. 2023 Apr;27. doi: 10.1016/j.jemep.2023.100877. Epub 2023 Mar 3.
BACKGROUND
Thirty-four percent of Multiple Myeloma (MM) clinical trial participants at Winship Cancer Institute (Winship) are African American (AA); however, AAs make up only 4.5 percent of myeloma clinical trial participants in the United States. Given our high enrollment, we aimed to measure AAs' trust in providers and identify if clinical trial enrollment barriers exist.
METHODOLOGY
A member of the ethics research team surveyed AA patients who had consented to a MM clinical trial at Winship. Three validated surveys were used: Trust in Medical Research (TMR); Human Connection (THC) which measures how much patients feel they are heard and valued by their physicians; and the Duke Intrinsic Religiosity Scale (DUREL) which measures strength of religious engagement and belief. The survey also included questions about the impact of side effects, distance to the trial center and trial related costs on the decision to participate in clinical trial.
RESULTS
Ninety-two percent (61/67) of patients approached consented. The mean TMR score and the mean THC score were significantly higher (-value < 0.001) than the results obtained in key national surveys (TMR 14.9 compared to 11.65; THC 57.7 compared to 54.6). These two surveys were significantly correlated, meaning trust and human connection increase or decrease in tandem. The 3 religiosity subscale results showed high religiosity (3.84, 4.36, and 4.35 with 5 being the highest score). The mean scores of the importance of the investigational agent's side effects, trial costs, and distance to trial center on the decision to enroll in a clinical trial were also high (8.5, 7.8, and 6.5, respectively, with 10 being the most important).
CONCLUSION
In our study population, high trust and human connection overcame other trial participation barriers: strong religious beliefs and concerns about side effects, costs, and travel distance. We present a roadmap to guide investigators to increase human connection, and hopefully trust.
背景
温希普癌症研究所（Winship）参与多发性骨髓瘤（MM）临床试验的参与者中有34%是非裔美国人（AA）；然而，非裔美国人在美国骨髓瘤临床试验参与者中仅占4.5%。鉴于我们的高入组率，我们旨在衡量非裔美国人对医疗服务提供者的信任度，并确定是否存在临床试验入组障碍。
方法
伦理研究团队的一名成员对已同意在温希普参加MM临床试验的非裔美国患者进行了调查。使用了三项经过验证的调查问卷：医学研究信任度（TMR）；人际联系（THC），用于衡量患者感觉自己被医生倾听和重视的程度；以及杜克内在宗教信仰量表（DUREL），用于衡量宗教参与度和信仰的强度。该调查还包括关于副作用、到试验中心的距离以及试验相关成本对参与临床试验决策的影响的问题。
结果
92%（61/67）的受访患者表示同意。TMR平均得分和THC平均得分显著高于（-值<0.001）在全国关键调查中获得的结果（TMR为14.9，而全国调查结果为11.65；THC为57.7，而全国调查结果为54.6）。这两项调查显著相关，意味着信任和人际联系会同步增加或减少。宗教信仰的三个子量表结果显示宗教信仰程度较高（得分分别为3.84、4.36和4.35，满分5分）。研究药物副作用、试验成本以及到试验中心的距离对参与临床试验决策的重要性平均得分也较高（分别为8.5、7.8和6.5，满分10分，表示最重要）。
结论
在我们的研究人群中，高度的信任和人际联系克服了其他试验参与障碍：强烈的宗教信仰以及对副作用、成本和行程距离的担忧。我们提供了一个路线图，以指导研究人员增强人际联系，并有望提升信任度。
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