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Pediatric Randomized Clinical Trials in Community Hospitals: Strategies to Enhance Site Participation and Engagement
Corrie E McDaniel1, Eric R Coon1, Natalia Paciorkowski2
1Department of Pediatrics, Division of Hospital Medicine, University of Washington, Seattle, Washington.
Insights
Community hospitals can improve pediatric care by increasing participation in randomized clinical trials (RCTs). Fourteen strategies were identified to overcome barriers and enhance research in these settings.
Area of Science:
- Pediatric Health Research
- Clinical Trial Design
- Health Services Research
Background:
- Community hospitals deliver most US pediatric inpatient care but face research barriers.
- Equitable research participation enhances pediatric care quality and generalizability.
- Strategies are needed to boost community hospital involvement in pediatric clinical trials.
Purpose of the Study:
- Identify strategies to increase community hospital participation in pediatric randomized clinical trials (RCTs).
Main Methods:
- Convened an interdisciplinary panel of 33 experts (clinicians, parents, trialists, hospital staff).
- Utilized a two-round nominal group technique for consensus building and strategy refinement.
- Conducted descriptive and qualitative analyses of identified strategies.
Main Results:
- Generated 119 initial ideas, refined to 14 specific strategies.
- Identified three key domains: policy changes, centralized resources, and tailored research design.
- Strategies focus on funding, review guidelines, resource systems, and adaptable trial planning.
Conclusions:
- Developed 14 actionable strategies to support pediatric RCTs in community hospitals.
- Implementation requires systemic changes in trial design, recruitment, funding, and investigation.
- These changes are crucial for improving pediatric research equity and outcomes.
Objective:
Community hospitals provide the majority of inpatient pediatric care in the United States but face significant barriers to conducting research. More equitable research participation across the spectrum of hospital types that deliver inpatient pediatric care can improve pediatric care quality and generalizability of research findings. Thus, we sought to identify strategies to promote community hospital participation in pediatric randomized clinical trials (RCTs).
Methods:
We convened an interdisciplinary group of 33 panelists with expertise across clinical roles (eg, physicians, nurses), nonclinical partners (eg, parents, clinical trialists), and practice environments (eg, children's and community hospitals). We conducted 2 rounds of consensus building using the nominal group technique. Panelists brainstormed, discussed, and scored strategies in each round. Round 1 was conducted within small groups to broadly identify potential strategies. Round 2 was conducted as a large group to refine and rescore top strategies. We performed descriptive analyses of scores and qualitative content analysis of identified strategies (including member checking).
Results:
Panelists identified 119 ideas in round 1. The 20 highest scoring ideas from round 1 were presented in round 2, where 19 strategies were scored then refined into 14 specific strategies. We identified 3 overarching domains: (1) policy changes in funding prioritization and scientific review guidelines, (2) systems for providing centralized resources, and (3) research design and planning tailored to community hospital participation.
Conclusion:
We identified 14 strategies for supporting the conduct of pediatric RCTs in community hospitals. Implementing these strategies will require structural changes to RCT design and recruitment for hospitals, funders, and investigators.
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