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Who goes and who stays: subject loss in a multicenter, longitudinal follow-up study
Insights
Understanding subject loss in infant clinical trials is crucial. Factors like environmental quality and medical history predict dropout, aiding future study design and sample size calculations.
Area of Science:
- Pediatric Clinical Trials
- Developmental Psychology
- Biostatistics
Background:
- Subject loss, or dropout, is a significant challenge in longitudinal infant studies.
- Accurate prediction of dropout is essential for maintaining study integrity and generalizability.
- Previous research has identified various demographic and clinical factors influencing participant retention.
Purpose of the Study:
- To identify predictors of subject loss in a multicenter cohort of 645 infants.
- To develop a dropout profile by analyzing factors influencing withdrawal at different study time points.
- To inform future clinical trial design by understanding the drivers of participant attrition.
Main Methods:
- Longitudinal analysis of subject loss in a cohort of 645 infants and families.
- Comparison of withdrawn infants to those who remained throughout the study.
- Evaluation of dropout predictors at four distinct time periods (40 weeks conceptional age to 36 months).
- Statistical modeling to identify factors associated with overall dropout and specific time periods.
Main Results:
- Overall subject loss was predicted by Environmental Quality Index (EQI) score, clinical center, gestational age, and 18-month developmental status.
- Dropout profile included race but excluded 18-month developmental status.
- Medical/biologic variables, environmental quality, race, and clinical center were key predictors at different study phases.
Conclusions:
- Predictive factors for subject loss vary across different stages of infant development in clinical trials.
- Identifying these factors allows for better projection of sample size needs in future research.
- Understanding dropout determinants enhances the validity and efficiency of pediatric clinical trials.
Abstract:
Subject loss in a cohort of 645 infants and their families, enrolled in a multicenter clinical trial, was described. Medical/biologic, socioeconomic and social support (Environmental Quality Index [EQI] composite), and developmental outcome data were obtained. Dropout was evaluated by comparing infants who withdrew at any time throughout the study to those who remained, as well as at four different time periods between 40 weeks conceptional age and 36 months. A dropout profile was also developed. Overall dropout was predicted by EQI score, clinical center, gestational age category, and 18-month developmental status. In addition to these variables, the dropout profile included race, but not 18-month developmental status. Medical/biologic variables, environmental quality, and race and center were most influential in the first, second and third, and fourth time periods, respectively. The identification of factors which are associated with increased subject loss can help researchers project needed sample sizes in future studies.