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Recruiting children and their families for clinical trials: a case study
W M Vollmer1, S Hertert, M J Allison
1Kaiser Permanente Center for Health Research, Portland, Oregon 97227.
Insights
Recruiting families for pediatric asthma trials is challenging. Emergency room and hospital records yielded higher participation than outpatient records for this randomized controlled trial.
Area of Science:
- Pediatric pulmonology
- Clinical trial methodology
- Health services research
Background:
- Pediatric asthma management requires effective treatment strategies.
- Recruitment is a critical step in conducting clinical trials for pediatric asthma.
- Health maintenance organizations (HMOs) offer a population for asthma research.
Purpose of the Study:
- To describe the recruitment process for a randomized trial on pediatric asthma management.
- To identify factors influencing family participation in pediatric asthma research.
- To compare recruitment success rates across different identification methods within an HMO.
Main Methods:
- Recruitment of 226 families for a randomized trial.
- Utilizing emergency room, hospital admission, and outpatient prescription records for identification.
- Comparing participation likelihood based on the source of child's health records.
Main Results:
- Families identified via emergency room and hospital admissions showed significantly higher participation rates.
- Recruitment success varied considerably depending on the identification method used.
- The study successfully enrolled a cohort for evaluating pediatric asthma management strategies.
Conclusions:
- The method of identifying potential participants significantly impacts recruitment success in pediatric asthma trials.
- Emergency room and hospital admission records are more effective for recruiting families into asthma management studies.
- Understanding recruitment dynamics is crucial for designing future pediatric clinical trials within managed care settings.
Abstract:
We describe the recruitment of 226 families for participation in a randomized trial examining the effectiveness of alternative strategies for the management of pediatric asthma. All families were members of a large health maintenance organization. Families of children identified through emergency room and hospital admission records were much more likely to participate in the study than were families of children identified only through outpatient prescription records. Specific details of the recruitment process are described.