ADaPT to Engage: Assessing for Disparities and Potential Targets for Intervention to Engage Acutely Ill Children in Research

项目总结：临床研究必须招募不同背景的人才能取得成果 可概括的知识，并确保公平分配研究的利益和负担。在- 不同群体的代表可能：(1)导致招生不佳，导致延迟和/或学习失败，(2) 阻止不同群体体验研究的好处，以及(3)导致调查人员失踪 在疾病和治疗方面基于多样性的重要差异。儿科文献尚未产生 关于研究中不同群体招生不足/超额的共识，而且还不充分 理解为什么可能存在差异。在急诊和重症监护(ECC)环境中注册 带来了独特的挑战。这些因素，再加上健康结果与 支持医学干预的证据，激励拟议的研究。这项提议的目标是 描述儿科ECC研究中健康差异风险(CRHD)儿童参与研究的特征 并确定可修改和潜在可修改的因素与参与相关的程度。这个 核心假设--CRHD的代表性不足(失去研究效益)和代表性过高 (冒险利用)，以及可修改的因素是差异研究的主要驱动因素 招生-将以混合方法进行评估，有3个相互关联但不同的目标：目标1：至 前瞻性地描述CRHD在儿科ECC研究中的登记特征并确定相关因素 注册和保留。目标2：阐明对可修改和不可修改的定性理解 影响儿科ECC研究登记/保留的因素。目标3：确定哪些因素是最重要的 与成功注册CRHD相关。目标1将通过前瞻性跟踪实现 同一地点预计18项研究的研究登记/保留数据以及与以下因素相关的因素 招生。目标2将通过对家长和研究团队工作人员的半结构化访谈来实现。目标 3结合前瞻性调查和访谈方法，为最重要的因素制定优先顺序 与父母参与相关的决定，以计划未来的干预研究。 该项目将推进候选人从事跨学科研究的长期目标，并 使用循证、利益相关者知情和道德敏感的做法制定政策，以 缩小健康差距，解决偏见，促进儿童健康公平。具有以下专业知识的导师 儿科伦理、差异、临床试验、决策和健康沟通 机构支持将允许候选人扩大与决策相关的研究方法的知识- 制定、发展健康差距研究方面的专门知识，并培养传播和实施 有效改善治疗病情最严重儿童所依赖的证据基础的技能。提议的计划是 有助于成功过渡到独立并成为该领域的领导者。

PROJECT SUMMARY: Clinical research must enroll individuals from diverse backgrounds to yield generalizable knowledge and ensure that the benefits and burdens of research are fairly distributed. Under- representation of diverse groups may: (1) lead to poor enrollment leading to delays and/or study failure, (2) prevent diverse groups from experiencing the benefits of research and (3) result in investigators missing important diversity based differences in illness and treatment. The pediatric literature has not produced consensus regarding under/over enrollment of diverse groups in research and there is inadequate understanding as to why disparities may exist. Enrollment in emergency and critical care (ECC) settings presents unique challenges. These factors, coupled with knowledge that health outcomes are strongly tied to evidence supporting medical interventions, motivate the proposed research. The goal of this proposal is to characterize research participation by children at risk for health disparities (CRHDs) in pediatric ECC research and to determine the degree to which modifiable and potentially modifiable factors relate to participation. The central hypothesis—that CRHDs are underrepresented (losing research benefit) and overrepresented (risking exploitation) in others and that modifiable factors are the primary drivers of differential study enrollment—will be evaluated in a mixed-methods study with 3 interrelated but distinct aims: Aim 1: To prospectively characterize enrollment by CRHDs in pediatric ECC research and to identify factors associated with enrollment and retention. Aim 2: To elucidate qualitative insights into modifiable and non-modifiable factors impacting enrollment/retention in pediatric ECC research. Aim 3: To determine which factors are most associated with successful enrollment of CRHDs. Aim 1 will be addressed through prospective tracking of study enrollment/retention data in an anticipated 18 studies at a single site and factors associated with enrollment. Aim 2 will be accomplished through semi-structured interviews of parents and study team staff. Aim 3 combines prospective survey and interview methods to develop a priority order for the most important factors related to parental decisions to participate to plan future intervention studies. This project will advance the candidate’s long-term goal to engage in interdisciplinary research and policy development using evidence-based, stakeholder-informed, and ethically-sensitive practices to reduce health disparities, address bias, and promote health equity for children. Mentors with expertise in pediatric ethics, disparities, clinical trials, decision-making, and health communication augmented by essential institutional support will permit the candidate to expand knowledge of research methods relevant to decision- making, develop expertise in health disparities research, and cultivate dissemination and implementation skills to effectively improve the evidence base relied upon to treat the sickest children. The proposed plan is instrumental to a successful transition to independence and becoming a leader in the field.