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Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.
With the drive to practice evidence-based medicine, the need for robust clinical research in pediatrics is more important than ever, but it can still be a struggle to get parents to enroll their children. An investigation offers insight into some factors that can influence the decision to enroll.
The urgent need for more research in children has been a cause for concern for quite some time, particularly research into infants. However, it can be difficult to enroll children from this population. An investigation in JAMA Network Open examines the differences between parents who enroll their infant in clinical trials versus parents who decide to not enroll.1
The investigators used a survey in 12 US level 3 and 4 neonatal intensive care units to assess the parents of infants who had enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial as well as the parents who had infants who were eligible to be in the study, but had declined to be involved. The questions in the survey were created with the belief that parents who enrolled in the study versus those who didn’t were different in 4 different categories: trust in the clinicians and researchers, how the parent perceived the infant’s illness, the parent’s understanding of the study, and characteristics of the infant as well as the parent’s demographic information.
A total of 387 parents were eligible and 269 completed the survey, which included 183 parents who enrolled their child in HEAL and 86 parents who did not enroll their child. The researchers found that parents who enrolled in the study had a higher rate of having an annual income greater than $55,000 (94 [52.8%] vs 30 [37.5%]; P = .03) as well as lower rates of being a Medicaid participant (74 [41.1%] vs 47 [55.3%]; P = .04) than the parents who chose to decline. Additionally, Black parents had a lower enrollment rate than white parents (odds ratio [OR], 0.35; 95% CI, 0.17-0.73). Those who said that their child’s condition was more serious also had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Trust in the medical researchers was also greater in parents who enrolled than in those who declined (mean difference, 5.3 [0.3-10.3]). Parental understanding of the study was not found to have any link to enrollment.
The reviewers concluded that a variety of factors impacted a parent’s decision to participate in clinical research. They believed that further research should be done to offer more confirmation of the results and understand the reasons behind the groups that declined, especially because these groups have often been underrepresented in clinical researcher.
1. Weiss E, Olszewski A, Guttmann K, et al. Parental factors associated with the decision to participate in a neonatal clinical trial. JAMA Netw Open. 2021;4(1):e2032106. doi:10.1001/jamanetworkopen.2020.32106