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Patient, Family, and Center-Based Factors Associated with Attrition in Neonatal Clinical Research: A Prospective
Sara B DeMauro1,2, Scarlett L Bellamy3,4, Melissa Fernando3
1Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA, demauro@email.chop.edu.
Insights
Lower maternal education and larger households predict attrition in neonatal research. Strategies to reduce study burden and reinforce goals are needed for families with lower educational levels to decrease attrition bias.
Area of Science:
- Neonatal Research
- Clinical Study Design
Background:
- Attrition (loss to follow-up) threatens longitudinal clinical research validity.
- Predictors of attrition in neonatal research are poorly understood.
- The impact of family experiences on study compliance in infant research is unknown.
Purpose of the Study:
- Identify factors associated with attrition in preterm infants over one year.
- Examine predictors of attrition in the Prematurity and Respiratory Outcomes Program (PROP) study.
Main Methods:
- Coordinators estimated attrition likelihood at discharge.
- Parents completed surveys on study experience at discharge and 1-year corrected age.
- Logistic models analyzed associations between infant, family, and site characteristics and attrition.
Main Results:
- 89% of 318 infants completed the primary endpoint (4 PROP interviews).
- Bivariate analysis: lower maternal education, more people in household, public insurance, and site associated with attrition.
- Multivariable analysis: lower maternal education and more people in household most strongly predicted attrition.
Conclusions:
- Lower maternal education and larger household size are key predictors of attrition.
- Neonatal research should develop strategies to reduce study burden for at-risk families.
- Reinforcing study goals can improve participation and decrease attrition bias in vulnerable populations.
Background:
Attrition, or loss to follow-up, presents a significant threat to the integrity and validity of longitudinal clinical research. Little is known about predictors of attrition in neonatal clinical research, and no prior studies have examined how families' experiences participating in research with their infants influences study compliance.
Objective:
To identify novel factors that were associated with attrition over 1 year of study follow-up among preterm infants enrolled in the multicenter Prematurity and Respiratory Outcomes Program (PROP) observational study.
Methods:
At discharge, research coordinators estimated the likelihood of attrition. The parents completed questionnaires about their experience with the study at discharge and at 1 year corrected age. The primary endpoint was completion of 4 PROP interviews during the first year. Logistic models were used to evaluate the associations between infant, family, and center-based characteristics and attrition.
Results:
Among 318 children, 283 (89%) met the primary endpoint. In bivariate analyses, lower maternal education, more people in the household, public insurance, and site were associated with attrition (p < 0.05). Parent survey responses, infant characteristics, and site characteristics were unrelated to attrition. Coordinators' prediction of attrition was associated with completion of early study interviews; this effect waned over time. In multivariable analyses, lower maternal education and more people in the household were the factors most strongly associated with attrition.
Conclusion:
Future neonatal research should evaluate novel strategies to decrease the burden associated with study participation and reinforcement of study goals with families who have lower educational levels to facilitate participation and decrease attrition bias.
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