Examining Barriers and Practices to Recruitment and Retention in Stroke Clinical Trials.
Examining Barriers and Practices to Recruitment and Retention in Stroke Clinical Trials.
复制标题
DOI：
10.1161/strokeaha.114.008564
复制
发表时间：
2015-08
期刊：
影响因子：
8.3
通讯作者：
Edwards D
中科院分区：
文献类型：
--
作者：
Boden-Albala B;Carman H;Southwick L;Parikh NS;Roberts E;Waddy S;Edwards D
美国国立卫生研究院（NIH）的政策要求在临床研究中纳入代表性不足的群体，如妇女和少数民族。在卒中临床试验中，少数人群招募和保留率差仍然是限制一般人群安全性和有效性的重大挑战。以前的研究探讨了参与者参与临床试验的障碍，但对研究者的观点知之甚少。本研究解决了这一差距，并审查了研究人员报告的障碍和最佳做法，少数参与中风临床试验。定量和定性的方法，包括调查，焦点小组，和关键的线人访谈。在一项对93名著名卒中研究人员的调查中，n=43（51.2%）（70%的应答率）报告主动设定了少数族裔入选的招募目标; n=29（36.3%）报告需要文化能力工作人员培训，n=44（51.2%）报告了关于试验设计的社区咨询。焦点小组和关键知情人访谈强调了招聘少数群体的结构和体制挑战，包括对研究/医疗企业的不信任，沟通不畅以及对临床试验缺乏了解。研究人员确定的最佳做法包括使用标准化的项目管理程序和协议（例如，（c）制定切合实际的预算，以应对征聘方面的挑战，如参加者的差旅/停车费报销），对研究人员进行文化能力和交流战略方面的培训，以及发展和促进指导研究进程的社区伙伴关系。这项研究的形成性评价为文献提供了一个新的维度，因为它突出了研究人员报告的障碍和提高少数群体参与中风临床试验的最佳实践。
The National Institutes of Health (NIH) policy calls for the inclusion of underrepresented groups, such as women and minorities, in clinical research. Poor minority recruitment and retention in stroke clinical trials remains a significant challenge limiting safety and efficacy in a general population. Previous research examines participant barriers to clinical trial involvement, but little is known about the investigator perspective. This study addresses this gap and examines researcher reported barriers and best practices of minority involvement in stroke clinical trials. Quantitative and qualitative methods, including surveys, focus groups, and key informant interviews were used. In a survey of 93 prominent stroke researchers; n=43 (51.2%) (70% response rate) reported proactively setting recruitment goals for minority inclusion; n=29 (36.3 %) reported requiring cultural competency staff training and n=44 (51.2%) reported community consultation about trial design. Focus groups and key informant interviews highlighted structural and institutional challenges to recruitment of minorities, including mistrust of the research/medical enterprise, poor communication, and lack of understanding of clinical trials. Researcher-identified best practices included using standardized project management procedures and protocols (e.g., realistic budgeting to support challenges in recruitment, such as travel/parking reimbursement for participants), training research staff on cultural competency and communication strategies, and developing and fostering community partnerships that guide the research process. This study’s formative evaluation contributes a new dimension to the literature as it highlights researcher-reported barriers and best practices for enhancing participation of minority populations into stroke clinical trials.