Redd Aliya, Fernandez Rosemarie, Maldonado-Puebla Diego, Mortensen Julia, Thompson Meredith, McFarlane Antionette, Gutman Colleen
Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Gainesville, Florida, USA.
Center for Experiential Learning and Simulation, University of Florida College of Medicine, Gainesville, Florida, USA.
J Am Coll Emerg Physicians Open. 2025 Jan 9;6(1):100018. doi: 10.1016/j.acepjo.2024.100018. eCollection 2025 Feb.
There remains a need to establish best practices for ethical and inclusive enrollment of children in emergency settings outside of established research networks. We aimed to develop a stakeholder-informed framework for enrolling children and families in emergency department (ED) research.
We conducted a cross-sectional mixed-methods study using a convergent parallel design. Data collection tools were formulated by a multidisciplinary team. We approached caregivers of pediatric ED patients at a single site to complete a tablet-based questionnaire. We conducted 4-item structured interviews with (1) clinicians in a single pediatric ED and (2) pediatric ED researchers from across the United States. We calculated descriptive statistics for quantitative data and conducted a content analysis of qualitative data. These data were merged to develop a framework to support research recruitment and enrollment in the pediatric ED.
The questionnaire was completed by 225 caregivers (61% response). Caregivers' likelihood of participating in research was high but varied by type of research, perceived importance, and the clinical context. Researchers (n = 11) and clinicians (n = 8) identified barriers to and facilitators of research recruitment in the ED at the caregiver, clinician, and systems level. Merging these data, we developed a framework of 5 principles: (1) high-quality communication is essential; (2) discussions about research participation cannot be coercive; (3) partnership with clinical teams is necessary; (4) research teams must adapt to unpredictability; and (5) participation in research may be viewed as an opportunity by families.
Our framework provides key considerations for conducting ED research with children and families.
在既定研究网络之外的紧急情况下，仍需要建立符合伦理且具有包容性的儿童招募最佳实践。我们旨在制定一个由利益相关者提供信息的框架，用于在急诊科（ED）研究中招募儿童及其家庭。
我们采用了一种聚合平行设计进行横断面混合方法研究。数据收集工具由一个多学科团队制定。我们在一个地点接触儿科急诊科患者的护理人员，让他们完成一份基于平板电脑的问卷。我们对（1）单个儿科急诊科的临床医生和（2）来自美国各地的儿科急诊科研究人员进行了4项结构化访谈。我们计算了定量数据的描述性统计量，并对定性数据进行了内容分析。这些数据被合并起来，以制定一个支持儿科急诊科研究招募和入组的框架。
225名护理人员完成了问卷（回复率61%）。护理人员参与研究的可能性很高，但因研究类型、感知重要性和临床背景而异。研究人员（n = 11）和临床医生（n = 8）在护理人员、临床医生和系统层面确定了急诊科研究招募的障碍和促进因素。合并这些数据后，我们制定了一个包含5项原则的框架：（1）高质量沟通至关重要；（2）关于研究参与的讨论不能具有强制性；（3）与临床团队建立伙伴关系是必要的；（4）研究团队必须适应不可预测性；（5）家庭可能会将参与研究视为一个机会。
我们的框架为与儿童及其家庭进行急诊科研究提供了关键考虑因素。
