Dataset Information

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.

SUBMITTER: DeMauro SB

PROVIDER: S-EPMC6657796 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

DeMauro Sara B SB Bellamy Scarlett L SL Fernando Melissa M Hoffmann Julie J Gratton Teresa T Schmidt Barbara B

Neonatology 20190305 4

<h4>Background</h4>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.<h4>Objective</h4>To identify novel factors that were associated with attrition over 1 year of study follow-up among preterm infants enrolled ...[more]

PMID: 30836358

Similar Datasets

Project description:BackgroundOne of the most difficult aspects of conducting clinical research is the ability to successfully recruit participants. Pediatric clinical research presents unique recruitment challenges that relate to the need for parental consent on behalf of a minor, child assent, and school attendance. Yet, this has been less well studied. We conducted a survey of investigators performing human subjects research in a single large academic pediatric hospital to better understand characteristics of studies with successful recruitment.MethodsWe conducted a web-based survey from September 2011 to December 2011 of all principal investigators with an Institutional Review Board approved human subjects protocol at Boston Children's Hospital, a pediatric Academic Medical Center. The survey captured various characteristics of the protocols including study design, staffing, resources, and investigator experience and training as well as respondents' perceived barriers and facilitators to recruitment. We used chi square tests and Mantel-Haenszel test for linear trend to examine the relationship between selected predictor variables and the binary outcome of successful vs. unsuccessful recruitment and multivariable logistic regression analyses to examine the simultaneous influence of potential predictors on each outcome.ResultsAmong the 349 eligible investigators, 52% responded to the survey, and 181 with valid data were included in the analyses. Two-thirds of the 87 protocols closed to enrollment reached 80% or more of their target enrollment, whereas, only one-third of the 94 protocols actively recruiting were meeting 80% of their target. Recruitment method appeared to be the only significant and independent factor associated with achieving 80% or more of target enrollment in closed to enrollment protocols. Closed to enrollment protocols that used recruitment in person were 4.55 times (95% CI 1.30 to 15.93; p = 0.02) more likely to achieve 80% or more of their target enrollment when compared to those that used other recruitment methods. Other potentially modifiable factors such as number of study visits, study duration and investigator experience were suggestive of being meaningfully related to recruitment.ConclusionRecruiting in person may promote reaching an acceptable target enrollment in pediatric as well as adult clinical research. Future research is needed on larger and more diverse samples to gain a better understanding of how the characteristics and qualifications of the individuals who conduct recruitment influence participant enrollment as well as how best to approach patient and families for their participation.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets