Student University of Florida College of Medicine Gainesville, Florida, United States
Background: Research with children and families is essential for improving child health, yet there are unique concerns when enrolling children in research in the pediatric emergency department (PED). Despite the growth of PED research, there remains a need to establish and disseminate best practices for ethical and inclusive enrollment of children in pragmatic settings outside of established research networks. Objective: To develop a pragmatic framework for enrolling children and families in PED research guided by perspectives from key stakeholders. Design/Methods: We used multiple methods (questionnaires, structured interviews) to collect input from key stakeholders. Data collection tools were formulated by a multidisciplinary team using existing literature and pilot-tested before use. We approached parents of PED patients at a single site for a tablet-based questionnaire. The 29-item questionnaire took < 10 minutes to complete. One open-ended item solicited any other input about research in the PED. We then conducted a 4-item structured interview via video conference, email, or in person with 1) staff and physicians in a single PED and 2) PED researchers from multiple institutions across the US. We analyzed quantitative data descriptively and thematically analyzed qualitative data using a framework synthesis approach. Results: The questionnaire was completed by 225 parents (84% response rate, Table 1). Parents identified the best times to discuss research was when they are waiting to see a doctor (40%) or after being evaluated by a doctor (80%). Figure 1 shows parents’ perceptions of factors influencing their decision to enroll in research. Of 26 parents (12%) who responded to the open-ended item, identified themes were: 1) the need to respect parent stress, 2) the importance of understanding the rationale for the research, and 3) the perceived benefit of helping others. PED researchers (n = 8 faculty and 3 research coordinators from 10 institutions) and clinicians (n=8 from our PED) identified barriers to and facilitators of research in the PED at the parent level (stress related to child’s illness, prioritization of child’s care), provider level (prioritization of clinical work, low knowledge of studies), and systems level (unpredictable PED environment, coordinators not consistently available). Table 2 presents a framework developed from the findings.
Conclusion(s): Based on input from experts and key stakeholders, our framework provides key considerations and areas to be further studied for designing ethical and inclusive research studies in the PED. Screenshot 2023-10-26 at 3.46.45 PM.jpeg
