Patient, Family, and Center-Based Factors Associated with Attrition in Neonatal Clinical Research: A Prospective Study

Abstract

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.

External barriers for including parents of preterm infants in a randomised clinical trial in the neonatal intensive care unit in Sweden: a descriptive study

“…Furthermore, that low maternal education, larger families, site and public insurance affect attrition rate. 23 Due to ethical restrictions, we have no data on families who declined participation and can therefore only relate to the factor of public insurance. As public insurance applies to all families in Sweden it is not suggested to be a factor that explains attrition rate in the present study.…”

“…In different hospital structures, there might be other internal or external factors hindering consent. 14 15 However, studies within an NICU context are few and focus on withdrawal and attrition rather than barriers for inclusion, 23 27 which warrant more research within this field.…”

Evaluation of the Quality of Perinatal Trials: Making the GRADE

“…Masking (blinding) of investigators to reduce detection bias is more important if the outcome of interest is subjective, such as a pain score, rather than objective, such as death [12]. Attrition or loss to follow-up in neonatal trials is an important source of bias because infant trial participants who are followed-up with ease may not have the same characteristics and outcomes as those who are followed-up with difficulty [13]. Attrition is more likely to bias estimates of effect if there is a substantial difference in the level of attrition between trial groups.…”

Seguimento do recém-nascido de risco: revisão integrativa da literatura

“…Nessa lógica, os esforços para identificar e apoiar essas famílias devem ser feitos desde a hospitalização (Swearingen, Research, Society and Development, v. 9, n. 11, e579119515, 2020(CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v9i11.9515 Simpson, Cabacungan & Cohen, 2020. O rastreio permitirá que eventuais desencadeadores de evasão sejam antecipadamente trabalhados pela equipe com vistas a viabilizar o acesso desses neonatos ao acompanhamento ambulatorial (DeMauro et al, 2019).…”