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Strategies to Increase Enrollment and Retention in Pediatric Clinical Research: A Scoping Review
Miguel A Pena1,2,3, Melicia Y Whitley4, Anirudh Sudarshan1,5
1Department of Radiology, Massachusetts General Hospital, Boston, Massachusetts.
Insights
Recruiting diverse pediatric participants requires addressing multiple research stages. Strategies should focus on building trust, offering incentives, and using continuous feedback to improve enrollment and retention in clinical studies.
Area of Science:
- Pediatric Clinical Research
- Health Equity
- Clinical Trial Design
Background:
- Lack of diversity in pediatric clinical research limits generalizability of findings.
- Health inequities can be worsened by non-diverse research participation.
- Identifying effective strategies is crucial for inclusive pediatric research.
Purpose of the Study:
- To identify evidence-based strategies for improving pediatric participant diversity in clinical research.
- To develop a tool guiding pediatric clinical research protocols for better enrollment and retention.
- To address barriers in pediatric clinical research participant recruitment and retention.
Main Methods:
- Scoping review of peer-reviewed literature from 2009-2022.
- Followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews.
- Analyzed quantitative and qualitative outcomes, categorizing findings by attrition steps.
Main Results:
- 31 studies met inclusion criteria, with findings categorized into study design, marketing, participant perceptions, consent, incentives, retention, and follow-up.
- Multiple attrition categories were identified, indicating complex challenges in pediatric participant enrollment and retention.
- Most studies were non-randomized, posing challenges for direct comparison of strategies.
Conclusions:
- Effective recruitment of diverse pediatric cohorts necessitates a comprehensive approach across all research phases.
- Strategies must prioritize building trust, offering appropriate incentives, and integrating ongoing feedback mechanisms.
- A multifaceted strategy is essential for successful pediatric clinical research participant diversity.
Objective:
Lack of participant diversity in pediatric clinical research limits external validity of findings and can exacerbate health inequities. Our objective was to identify evidence-based strategies/interventions that improve enrollment and retention of diversity of pediatric participants in clinical research and provide an evidence-based tool to guide pediatric clinical research protocols.
Methods:
This study comprised a scoping review of peer-reviewed literature that reported methods to increase enrollment and retention of pediatric participants in clinical research (2009-2022). Guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews. Data extraction included quantitative and qualitative outcomes. Eligible studies' findings were analyzed and grouped into specific attrition steps that limit pediatric clinical research participants' enrollment and retention.
Results:
A total of 31 studies met inclusion criteria. Each study's insights were categorized based on attrition steps that limited pediatric participant diversity: study design (n = 1), marketing/outreach strategies (n = 7), participant perceptions (n = 9), consent/enrollment issues (n = 8), incentives/reimbursements mechanisms (n = 4), retention strategies (n = 8), and follow-up/feedback channels (n = 3). Many studies had overlapping attrition categories. Most studies were nonrandomized clinical studies such as retrospective and cohort studies with different strategies/interventions, making comparisons between studies challenging.
Conclusions:
The effectiveness in recruiting a diverse cohort of pediatric clinical research participants requires a multifaceted approach addressing issues at every stage of the clinical research process. Enrollment and retention strategies should focus on building trust, providing effective incentives, and incorporating continuous feedback.
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