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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

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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

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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.

Project description:ImportanceIt remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations. Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation.ObjectiveTo assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial.Design, setting, and participantsThis survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020.ExposureParental choice of enrollment in neonatal clinical trial.Main outcomes and measuresPercentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers.ResultsOf a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment.Conclusions and relevanceIn this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and reported income), perception of illness, and trust in medical researchers. Future work to confirm these findings and explore the reasons behind them may lead to strategies for better engaging underrepresented groups in neonatal clinical research to reduce enrollment disparities.

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.

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