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

项目总结：临床研究必须招募来自不同背景的个人， 这将有助于促进知识的普遍性，并确保公平分配研究的利益和负担。在- 不同群体的代表性可能：（1）导致入组不佳，导致延迟和/或研究失败，（2） 阻碍不同群体体验研究的益处;（3）导致研究者缺失 基于疾病和治疗的重要差异。儿科文献还没有产生 关于研究中不同群体入组不足/过多的共识， 理解为什么会存在差异。急诊和重症监护（ECC）环境中的入组 提出了独特的挑战。这些因素，再加上健康结果与 支持医疗干预的证据，激励拟议的研究。本提案的目的是 在儿科ECC研究中描述存在健康差异风险的儿童（CRHD）参与研究的特征 并确定可修改和可能修改的因素与参与的关系。的 中心假设-CRHD代表性不足（失去研究利益）和代表性过高 （冒着被剥削的风险），而可改变的因素是差异研究的主要驱动力 入组-将在混合方法研究中进行评估，该研究具有3个相互关联但不同的目标：目标1： 前瞻性描述CRHD在儿科ECC研究中的入组情况，并确定相关因素 入学率和保留率。目标2：阐明对可修改和不可修改的定性见解 儿科ECC研究中影响入组/保留的因素。目标3：确定哪些因素最重要 与CRHD成功入组相关。目标1将通过前瞻性跟踪 预期在单个研究中心进行的18项研究中的研究入组/保留数据以及与 招生目标2将通过对家长和研究小组工作人员的半结构化访谈来实现。目的 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 与父母决定参与计划未来的干预研究有关。 该项目将推进候选人的长期目标，从事跨学科研究， 使用基于证据的、知情的和道德敏感的做法制定政策， 减少健康差距，消除偏见，促进儿童健康公平。具有以下专业知识的导师 儿科伦理学，差异，临床试验，决策，和健康沟通的基本增强 机构的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，并促进传播和实施 技能，以有效地改善所依赖的证据基础，以治疗病情最严重的儿童。拟议的计划是 这对成功过渡到独立和成为该领域的领导者至关重要。

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.