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Development of a Framework for the Enrollment of Children and Families in Emergency Department Research
Aliya Redd1, Rosemarie Fernandez1,2, Diego Maldonado-Puebla1
1Department of Emergency Medicine, University of Florida College of Medicine, Gainesville, Gainesville, Florida, USA.
Insights
Developing ethical pediatric emergency department research requires a framework emphasizing clear communication, avoiding coercion, and adapting to unpredictable clinical environments. This ensures inclusive and effective child and family participation.
Area of Science:
- Pediatric Emergency Medicine
- Clinical Research Ethics
- Health Services Research
Background:
- Establishing best practices for ethical and inclusive enrollment of children in emergency settings is crucial.
- Existing research networks may not adequately cover emergency department (ED) research for pediatric populations.
- A stakeholder-informed framework is needed to guide the enrollment of children and families in ED research.
Purpose of the Study:
- To develop a stakeholder-informed framework for enrolling children and families in emergency department (ED) research.
- To identify key considerations for ethical and inclusive research practices in pediatric ED settings.
Main Methods:
- Cross-sectional mixed-methods study with a convergent parallel design.
- Data collection included questionnaires from 225 caregivers and structured interviews with 19 clinicians and researchers.
- Quantitative data analysis involved descriptive statistics; qualitative data underwent content analysis.
Main Results:
- Caregiver participation likelihood varied by research type, perceived importance, and clinical context.
- Clinicians and researchers identified multilevel barriers and facilitators to research recruitment in the ED.
- A 5-principle framework was developed: high-quality communication, non-coercive discussions, clinical team partnership, adaptability, and viewing participation as an opportunity.
Conclusions:
- The developed framework offers essential considerations for conducting ethical and inclusive research with children and families in the ED.
- Implementation of this framework can improve the recruitment and enrollment process in pediatric emergency research.
Objectives:
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.
Methods:
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.
Results:
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.
Conclusion:
Our framework provides key considerations for conducting ED research with children and families.
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