Assessing and Validating a Model of Study Completion for a Prospective Cohort of Healthy Newborns

Abstract

OBJECTIVES: To identify potentially modifiable or actionable factors related to study completion among healthy mother-infant dyads participating in prospective research. PATIENTS/METHODS: We conducted a secondary analysis of completion data from a prospective study on newborn jaundice in the first week of life at a tertiary-care hospital in Philadelphia, PA, from 2015 to 2019. Participation in the original study involved enrollment before newborn discharge and subsequent follow-up for a jaundice assessment between 2 and 6 days of life. For this study, our primary outcome was completion of all study procedures. Associations between predictor variables and the outcome were assessed using bivariate and multivariable analyses. We fit a predictive model of study completion using logistic regression and validated the model using 5-fold cross-validation. RESULTS: Of 501 mother-infant dyads enrolled in the original study, 304 completed the study. Median maternal age was 28 years and 81.8% of mothers delivered via vaginal birth. Study completion was associated with colocation of the study visit with the initial well-child visit (adjusted odds ratio [aOR], 2.99, 95% confidence interval [CI], 2.01–4.46) and provision of an alternate phone number by the participant (aOR, 1.99; 95% CI, 1.34–2.96). The cross-validated model performed similarly to our final predictive model and had an average area under the receiver operating characteristic curve of 0.67 (range, 0.59-0.72), with a sensitivity of 68% and specificity of 60%. CONCLUSIONS: Findings demonstrate the importance of communication and patient-centric approaches for recruitment and retention in newborn research. Future work should incorporate these approaches while continuing to evaluate study retention strategies.