Abstract：
BACKGROUND: Federal regulations allow exception from informed consent (EFIC) to study emergent conditions when obtaining prospective consent is not feasible. Little is known about public views on including children in EFIC studies. The Pediatric Dose Optimization for Seizures in EMS (PediDOSE) trial implements age-based, standardized midazolam dosing for pediatric seizures. The primary objective of this study was to determine public support for and concerns about the PediDOSE EFIC trial. The secondary objective was to assess how support for PediDOSE varied by demographics.
METHODS: We conducted a mixed-methods study in 20 U.S. communities. Participants reviewed information about PediDOSE before completing an online survey. Descriptive data were generated. Univariable and multivariable logistic regression analysis identified factors associated with support for PediDOSE. Reviewers identified themes from free-text response data regarding participant concerns.
RESULTS: Of 2450 respondents, 79% were parents/guardians, and 20% had a child with previous seizures. A total of 96% of respondents supported PediDOSE being conducted, and 70% approved of children being enrolled without prior consent. Non-Hispanic Black respondents were less likely than non-Hispanic White respondents to support PediDOSE with an adjusted odds ratio (aOR) of 0.57 (95% CI 0.42-0.75). Health care providers were more likely to support PediDOSE, with strongest support among prehospital emergency medicine clinicians (aOR 5.82, 95% CI 3.19-10.62). Age, gender, parental status, and level of education were not associated with support of PediDOSE. Common concerns about PediDOSE included adverse effects, legal and ethical concerns about enrolling without consent, and potential racial bias.
CONCLUSIONS: In communities where this study will occur, most respondents supported PediDOSE being conducted with EFIC and most approved of children being enrolled without prior consent. Support was lowest among non-Hispanic Black respondents and highest among health care providers. Further research is needed to determine optimal ways to address the concerns of specific racial and ethnic groups when conducting EFIC trials.
METHODS: We conducted a mixed-methods study in 20 U.S. communities. Participants reviewed information about PediDOSE before completing an online survey. Descriptive data were generated. Univariable and multivariable logistic regression analysis identified factors associated with support for PediDOSE. Reviewers identified themes from free-text response data regarding participant concerns.
RESULTS: Of 2450 respondents, 79% were parents/guardians, and 20% had a child with previous seizures. A total of 96% of respondents supported PediDOSE being conducted, and 70% approved of children being enrolled without prior consent. Non-Hispanic Black respondents were less likely than non-Hispanic White respondents to support PediDOSE with an adjusted odds ratio (aOR) of 0.57 (95% CI 0.42-0.75). Health care providers were more likely to support PediDOSE, with strongest support among prehospital emergency medicine clinicians (aOR 5.82, 95% CI 3.19-10.62). Age, gender, parental status, and level of education were not associated with support of PediDOSE. Common concerns about PediDOSE included adverse effects, legal and ethical concerns about enrolling without consent, and potential racial bias.
CONCLUSIONS: In communities where this study will occur, most respondents supported PediDOSE being conducted with EFIC and most approved of children being enrolled without prior consent. Support was lowest among non-Hispanic Black respondents and highest among health care providers. Further research is needed to determine optimal ways to address the concerns of specific racial and ethnic groups when conducting EFIC trials.
摘要：
背景：当获得前瞻性同意不可行时，联邦法规允许知情同意（EFIC）例外研究紧急情况。公众对将儿童纳入EFIC研究的看法知之甚少。EMS中癫痫发作的儿科剂量优化（PediDOSE）试验实施基于年龄的，规范咪达唑仑给药治疗小儿癫痫。这项研究的主要目的是确定公众对PediDOSEEFIC试验的支持和关注。次要目标是评估对PediDOSE的支持如何因人口统计学而异。
方法：我们在20个美国社区进行了一项混合方法研究。参与者在完成在线调查之前审查了有关PediDOSE的信息。生成描述性数据。单变量和多变量逻辑回归分析确定了与支持PediDOSE相关的因素。审稿人从自由文本答复数据中确定了有关参与者关切的主题。
结果：在2450名受访者中，79％是父母/监护人，20％的孩子有以前的癫痫发作。共有96％的受访者支持进行PediDOSE，70%的儿童在未经事先同意的情况下注册。非西班牙裔黑人受访者比非西班牙裔白人受访者不太可能支持PediDOSE，调整后的优势比（aOR）为0.57（95％CI0.42-0.75）。医疗保健提供者更有可能支持PediDOSE，院前急诊医学临床医生的支持最强（aOR5.82，95%CI3.19-10.62）。年龄,性别,父母身份,和教育水平与PediDOSE的支持无关。关于PediDOSE的常见担忧包括不良反应，关于未经同意注册的法律和道德问题，和潜在的种族偏见。
结论：在将要进行这项研究的社区中，大多数受访者支持使用EFIC进行PediDOSE,大多数被批准的儿童在未经事先同意的情况下进行注册.非西班牙裔黑人受访者的支持率最低，医疗保健提供者的支持率最高。在进行EFIC试验时，需要进一步研究以确定解决特定种族和族裔群体关注的最佳方法。
方法：我们在20个美国社区进行了一项混合方法研究。参与者在完成在线调查之前审查了有关PediDOSE的信息。生成描述性数据。单变量和多变量逻辑回归分析确定了与支持PediDOSE相关的因素。审稿人从自由文本答复数据中确定了有关参与者关切的主题。
结果：在2450名受访者中，79％是父母/监护人，20％的孩子有以前的癫痫发作。共有96％的受访者支持进行PediDOSE，70%的儿童在未经事先同意的情况下注册。非西班牙裔黑人受访者比非西班牙裔白人受访者不太可能支持PediDOSE，调整后的优势比（aOR）为0.57（95％CI0.42-0.75）。医疗保健提供者更有可能支持PediDOSE，院前急诊医学临床医生的支持最强（aOR5.82，95%CI3.19-10.62）。年龄,性别,父母身份,和教育水平与PediDOSE的支持无关。关于PediDOSE的常见担忧包括不良反应，关于未经同意注册的法律和道德问题，和潜在的种族偏见。
结论：在将要进行这项研究的社区中，大多数受访者支持使用EFIC进行PediDOSE,大多数被批准的儿童在未经事先同意的情况下进行注册.非西班牙裔黑人受访者的支持率最低，医疗保健提供者的支持率最高。在进行EFIC试验时，需要进一步研究以确定解决特定种族和族裔群体关注的最佳方法。
