PDF(Pubmed)
Abstract：
BACKGROUND: Despite the increasing availability of clinical trials in Duchenne muscular dystrophy, racial/ethnic minorities and other populations facing health disparities remain underrepresented in clinical trials evaluating products for Duchenne. We sought to understand the barriers faced by Hispanic/Latino families specifically and underrepresented groups more generally to clinical trial participation in Duchenne.
METHODS: We engaged two participant groups: Hispanic/Latino caregivers of children with Duchenne in the US, including Puerto Rico, and health professionals within the broader US Duchenne community. Caregiver interviews explored attitudes towards and experiences with clinical trials, while professional interviews explored barriers to clinical trial participation among socio-demographically underrepresented families (e.g., low income, rural, racial/ethnic minority, etc.). Interviews were analyzed aggregately and using a thematic analysis approach. An advisory group was engaged throughout the course of the study to inform design, conduct, and interpretation of findings generated from interviews.
RESULTS: Thirty interviews were conducted, including with 12 Hispanic/Latina caregivers and 18 professionals. We identified barriers to clinical trial participation at various stages of the enrollment process. In the initial identification of patients, barriers included lack of awareness about trials and clinical trial locations at clinics that were less likely to serve diverse patients. In the prescreening process, barriers included ineligibility, anticipated non-compliance in clinical trial protocols, and language discrimination. In screening, barriers included concerns about characteristics of the trial, as well as mistrust/lack of trust. In consent and recruitment, barriers included lack of timely decision support, logistical factors (distance, time, money), and lack of translated study materials.
CONCLUSIONS: Numerous barriers hinder participation in Duchenne clinical trials for Hispanic/Latino families and other populations experiencing health disparities. Addressing these barriers necessitates interventions across multiple stages of the clinical trial enrollment process. Recommendations to enhance participation opportunities include developing clinical trial decision support tools, translating prominent clinical trials educational resources such as ClinicalTrials.gov, fostering trusting family-provider relationships, engaging families in clinical trial design, and establishing ethical guidelines for pre-screening potentially non-compliant patients.
METHODS: We engaged two participant groups: Hispanic/Latino caregivers of children with Duchenne in the US, including Puerto Rico, and health professionals within the broader US Duchenne community. Caregiver interviews explored attitudes towards and experiences with clinical trials, while professional interviews explored barriers to clinical trial participation among socio-demographically underrepresented families (e.g., low income, rural, racial/ethnic minority, etc.). Interviews were analyzed aggregately and using a thematic analysis approach. An advisory group was engaged throughout the course of the study to inform design, conduct, and interpretation of findings generated from interviews.
RESULTS: Thirty interviews were conducted, including with 12 Hispanic/Latina caregivers and 18 professionals. We identified barriers to clinical trial participation at various stages of the enrollment process. In the initial identification of patients, barriers included lack of awareness about trials and clinical trial locations at clinics that were less likely to serve diverse patients. In the prescreening process, barriers included ineligibility, anticipated non-compliance in clinical trial protocols, and language discrimination. In screening, barriers included concerns about characteristics of the trial, as well as mistrust/lack of trust. In consent and recruitment, barriers included lack of timely decision support, logistical factors (distance, time, money), and lack of translated study materials.
CONCLUSIONS: Numerous barriers hinder participation in Duchenne clinical trials for Hispanic/Latino families and other populations experiencing health disparities. Addressing these barriers necessitates interventions across multiple stages of the clinical trial enrollment process. Recommendations to enhance participation opportunities include developing clinical trial decision support tools, translating prominent clinical trials educational resources such as ClinicalTrials.gov, fostering trusting family-provider relationships, engaging families in clinical trial design, and establishing ethical guidelines for pre-screening potentially non-compliant patients.
摘要：
背景：尽管杜氏肌营养不良症的临床试验越来越多，在评估Duchenne产品的临床试验中，种族/族裔少数群体和其他面临健康差异的人群的代表性仍然不足。我们试图了解西班牙裔/拉丁裔家庭面临的障碍，特别是代表性不足的群体更普遍地参与Duchenne的临床试验。
方法：我们参与了两个参与者组：美国Duchenne儿童的西班牙裔/拉丁裔照顾者，包括波多黎各,和更广泛的美国Duchenne社区内的卫生专业人员。护理人员访谈探讨了对临床试验的态度和经验，虽然专业访谈探讨了社会人口统计学上代表性不足的家庭参与临床试验的障碍(例如，低收入,农村,种族/少数民族，等。).对访谈进行了综合分析，并采用了专题分析方法。在整个研究过程中，聘请了一个咨询小组为设计提供信息，行为,以及对访谈结果的解释。
结果：进行了30次访谈，包括12名西班牙裔/拉丁裔护理人员和18名专业人员。我们确定了在招募过程的各个阶段参与临床试验的障碍。在最初的患者鉴定中，这些障碍包括缺乏对试验的认识,以及在不太可能为不同患者提供服务的诊所的临床试验地点.在预筛选过程中,障碍包括不合格，临床试验方案的预期不合规，语言歧视。在筛选中,障碍包括对审判特征的担忧，以及不信任/缺乏信任。在同意和招募中，障碍包括缺乏及时的决策支持，后勤因素(距离，时间,money),缺乏翻译的学习材料。
结论：许多障碍阻碍了西班牙裔/拉丁裔家庭和其他健康差异人群参与Duchenne临床试验。解决这些障碍需要在临床试验注册过程的多个阶段进行干预。增加参与机会的建议包括开发临床试验决策支持工具，翻译著名的临床试验教育资源，如ClinicalTrials.gov，培养信任的家庭-提供者关系，让家庭参与临床试验设计，并为潜在不合规患者的预筛查建立伦理指南。
方法：我们参与了两个参与者组：美国Duchenne儿童的西班牙裔/拉丁裔照顾者，包括波多黎各,和更广泛的美国Duchenne社区内的卫生专业人员。护理人员访谈探讨了对临床试验的态度和经验，虽然专业访谈探讨了社会人口统计学上代表性不足的家庭参与临床试验的障碍(例如，低收入,农村,种族/少数民族，等。).对访谈进行了综合分析，并采用了专题分析方法。在整个研究过程中，聘请了一个咨询小组为设计提供信息，行为,以及对访谈结果的解释。
结果：进行了30次访谈，包括12名西班牙裔/拉丁裔护理人员和18名专业人员。我们确定了在招募过程的各个阶段参与临床试验的障碍。在最初的患者鉴定中，这些障碍包括缺乏对试验的认识,以及在不太可能为不同患者提供服务的诊所的临床试验地点.在预筛选过程中,障碍包括不合格，临床试验方案的预期不合规，语言歧视。在筛选中,障碍包括对审判特征的担忧，以及不信任/缺乏信任。在同意和招募中，障碍包括缺乏及时的决策支持，后勤因素(距离，时间,money),缺乏翻译的学习材料。
结论：许多障碍阻碍了西班牙裔/拉丁裔家庭和其他健康差异人群参与Duchenne临床试验。解决这些障碍需要在临床试验注册过程的多个阶段进行干预。增加参与机会的建议包括开发临床试验决策支持工具，翻译著名的临床试验教育资源，如ClinicalTrials.gov，培养信任的家庭-提供者关系，让家庭参与临床试验设计，并为潜在不合规患者的预筛查建立伦理指南。
