Assessment of Factors Associated With Parental Perceptions of Voluntary Decisions About Child Participation in Leukemia Clinical Trials.
Assessment of Factors Associated With Parental Perceptions of Voluntary Decisions About Child Participation in Leukemia Clinical Trials.
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DOI：
10.1001/jamanetworkopen.2021.9038
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发表时间：
2021-05-03
影响因子：
13.8
通讯作者：
Nodora J
中科院分区：
文献类型：
--
作者：
Aristizabal P;Ma AK;Kumar NV;Perdomo BP;Thornburg CD;Martinez ME;Nodora J
健康素养、背景因素或社会人口特征是否与儿童白血病临床试验知情同意期间家长对自愿性的看法相关？在这项纳入 97 名新诊断白血病儿童父母的横断面研究中，较低的自愿性认知与较低的健康素养显着相关。健康素养低可能导致父母无法为孩子参与癌症临床试验做出完整且有意义的明智决定。在参加临床试验之前获得自愿知情同意是一项基本的道德要求。评估健康素养、背景因素或社会人口特征是否与同意孩子参加白血病治疗临床试验的父母的自愿性认知相关。这项横断面研究前瞻性地招募了 2014 年至 2017 年在加州大型三级学术中心圣地亚哥拉迪儿童医院诊断患有白血病的 97 名儿童家长。测量了健康素养、背景因素（文化适应、决策后悔和知情同意满意度）、社会人口特征以及同意治疗性临床试验后的自愿性认知。使用单变量和多变量回归来确定显着关联。本研究的分析于 2019 年 5 月至 2020 年 5 月进行。治疗性白血病临床试验的知情同意书。感兴趣的主要结果是对自愿性的看法及其与健康素养和其他背景因素（文化适应、决策后悔和知情同意的满意度）和社会人口特征（包括年龄、种族/族裔、父母语言、教育水平、保险类型、婚姻状况和社会经济地位）的关系。在 97 名家长中，大多数是女性（65 [67%]）、已婚（71 [73%]）和自我报告的西班牙裔（50 [52%]）。较低的自愿性认知与较低的健康素养（r = 0.30；95% CI，0.11-0.47；P = .004）、西班牙语（x̅ = −4.50，P = .05）、较低的西班牙裔文化适应度显着相关(r = 0.30; 95% CI, 0.02-0.54; P = .05)，更大的决策遗憾(r = −0.54; 95% CI, -0.67至-0.38; P < .001)，以及对知情同意的满意度较低(r = 0.39;单变量分析为 95% CI，0.21-0.54；P < .001）。在调整背景因素和社会人口统计学特征后，在多变量分析中，较低的健康素养仍然与较低的自愿性认知显着相关（β = 4.06；95% CI，1.60-6.53；P = .001）。较低的健康素养与西班牙裔种族（平均值，4.16；95% CI，3.75-4.57；P<0.001）、在家使用西班牙语（平均值，3.17；95% CI，1.94-4.40；P<0.001）、高中或以下教育水平（平均值，3.41；P<0.001）显着相关。 95% CI，2.83-3.99；P < .001）、公共保险（平均值，4.00；95% CI，3.55-4.45；P < .001）和未婚状况（平均值，3.71；95% CI，2.91-4.51；P = .03）。在同意孩子参加治疗性临床试验的新诊断白血病儿童的父母中，较低的自愿性认知与较低的健康素养显着相关。这些结果表明，健康素养较低的父母可能会在他们的孩子参与临床试验的决定中感受到外部影响。这一发现强调了根据参与者的健康素养水平量身定制的招募干预措施对于改善服务不足人群的自愿知情同意的潜在作用。这项横断面研究评估了健康素养、背景因素或社会人口特征是否与同意孩子参加白血病治疗临床试验的父母的自愿性认知相关。
Are health literacy, contextual factors, or sociodemographic characteristics associated with parental perception of voluntariness during informed consent for pediatric leukemia clinical trials? In this cross-sectional study that included 97 parents of children with newly diagnosed leukemia, lower perception of voluntariness was significantly associated with lower health literacy. Low health literacy may have a role in parents not making complete and meaningful informed decisions for their child’s participation in cancer clinical trials. Obtaining voluntary informed consent prior to enrollment in clinical trials is a fundamental ethical requirement. To assess whether health literacy, contextual factors, or sociodemographic characteristics are associated with perception of voluntariness among parents who had consented for their child’s participation in a leukemia therapeutic clinical trial. This cross-sectional study prospectively enrolled 97 parents of children diagnosed as having leukemia at Rady Children’s Hospital San Diego, a large tertiary academic center in California, from 2014 to 2017. Health literacy, contextual factors (acculturation, decisional regret, and satisfaction with informed consent), sociodemographic characteristics, and perception of voluntariness after consenting for a therapeutic clinical trial were measured. Univariable and multivariable regression were used to determine significant associations. The analyses for the present study were conducted from May 2019 to May 2020. Informed consent for a therapeutic leukemia clinical trial. The primary outcome of interest was perception of voluntariness and its associations with health literacy and other contextual factors (acculturation, decisional regret, and satisfaction with informed consent) and sociodemographic characteristics, including age, race/ethnicity, parental language, educational level, insurance type, marital status, and socioeconomic status. Of 97 parents included, the majority were women (65 [67%]), married (71 [73%]), and of self-reported Hispanic ethnicity (50 [52%]). Lower perception of voluntariness was significantly associated with lower health literacy (r = 0.30; 95% CI, 0.11-0.47; P = .004), Spanish language (x̅ = −4.50, P = .05), lower acculturation if of Hispanic ethnicity (r = 0.30; 95% CI, 0.02-0.54; P = .05), greater decisional regret (r = −0.54; 95% CI, −0.67 to −0.38; P < .001), and lower satisfaction with informed consent (r = 0.39; 95% CI, 0.21-0.54; P < .001) in univariable analysis. Lower health literacy remained significantly associated with lower perception of voluntariness in multivariable analysis after adjustment for contextual factors and sociodemographic characteristics (β = 4.06; 95% CI, 1.60-6.53; P = .001). Lower health literacy was significantly associated with Hispanic ethnicity (mean, 4.16; 95% CI, 3.75-4.57; P < .001), Spanish language spoken at home (mean, 3.17; 95% CI, 1.94-4.40; P < .001), high school or less educational level (mean, 3.41; 95% CI, 2.83-3.99; P < .001), public insurance (mean, 4.00; 95% CI, 3.55-4.45; P < .001), and unmarried status (mean, 3.71; 95% CI, 2.91-4.51; P = .03). Among parents of children with newly diagnosed leukemia who had consented for their child’s participation in a therapeutic clinical trial, lower perception of voluntariness was significantly associated with lower health literacy. These results suggest that parents with low health literacy may perceive external influences in their decision for their child’s participation in clinical trials. This finding highlights the potential role of recruitment interventions tailored to the participant’s health literacy level to improve voluntary informed consent in underserved populations. This cross-sectional study assesses whether health literacy, contextual factors, or sociodemographic characteristics are associated with perception of voluntariness among parents who consent for their child’s participation in a leukemia therapeutic clinical trial.
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影响因子：
254.7
作者：
Jemal, Ahmedin;Siegel, Rebecca;Thun, Michael J.
通讯作者：
Thun, Michael J.
DOI：
10.1016/j.pedn.2018.06.002
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3.2
作者：
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影响因子：
2.8
作者：
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通讯作者：
Martinez ME