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. 2021 Jan 4;4(1):e2032106.
doi: 10.1001/jamanetworkopen.2020.32106.

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

Elliott Mark Weiss  1   2 , Aleksandra E Olszewski  1   2 , Katherine F Guttmann  3 , Brooke E Magnus  4 , Sijia Li  5 , Anita R Shah  6 , Sandra E Juul  2 , Yvonne W Wu  7 , Kaashif A Ahmad  8 , Ellen Bendel-Stenzel  9 , Natalia A Isaza  10 , Andrea L Lampland  11 , Amit M Mathur  12 , Rakesh Rao  13 , David Riley  14 , David G Russell  15 , Zeynep N I Salih  16 , Carrie B Torr  17 , Joern-Hendrik Weitkamp  18 , Uchenna E Anani  18 , Taeun Chang  19 , Juanita Dudley  15 , John Flibotte  20 , Erin M Havrilla  18 , Charmaine M Kathen  21 , Alexandra C O'Kane  19 , Krystle Perez  2 , Brenda J Stanley  21 , Benjamin S Wilfond  1   2 , Seema K Shah  22
Affiliations

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

Elliott Mark Weiss et al. JAMA Netw Open. .

Abstract

Importance: It 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.

Objective: To 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 participants: This 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.

Exposure: Parental choice of enrollment in neonatal clinical trial.

Main outcomes and measures: Percentages 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.

Results: Of 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 relevance: In 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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Weitkamp reports receiving fees in his role as a consultant for Roche Diagnostics Corporation to help with development of a neonatal sepsis marker. Dr Juul reported receiving grants from the National Institutes of Health (NIH), grants from Cerebral Palsy Alliance, and grants from Gates Foundation during the conduct of the study. Dr Weitkamp reported receiving grants from NIH during the conduct of the study; personal fees from Roche Diagnostics Consultant, grants from NIH as coinvestigator or site principle investigator (PI), nonfinancial support from Fresenius Kabi as site PI, nonfinancial support from ONY Biotech as site PI, and grants from Gates Foundation as coinvestigator outside the submitted work. Dr Flibotte reported receiving personal fees from Cipriani and Werner, PC, personal fees from Hunton, Andrews, Kurth LLC, personal fees from St Peter’s University Hospital, personal fees from White and Williams, LLP, and personal fees from Main Line Health outside the submitted work. Dr S. Shah reported receiving grants from Seattle Children’s Hospital Center for Clinical & Translational Research Clinical Research Scholars Program, grants from Children’s Minnesota Research Grant Program, and grants from University of Washington Neonatal Bioresearch Fund during the conduct of the study. No other disclosures were reported.

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References

    1. Laventhal N, Tarini BA, Lantos J. Ethical issues in neonatal and pediatric clinical trials. Pediatr Clin North Am. 2012;59(5):1205-1220. doi:10.1016/j.pcl.2012.07.007 - DOI - PMC - PubMed
    1. Katz AL, Webb SA. Informed consent in decision-making in pediatric practice. Pediatrics. 2016;138(2):e20161485. doi:10.1542/peds.2016-1485 - DOI - PubMed
    1. Nordheim T, Anderzén-Carlsson A, Nakstad B. A qualitative study of the experiences of norwegian parents of very low birthweight infants enrolled in a randomized nutritional trial. J Pediatr Nurs. 2018;43(43):e66-e74. doi:10.1016/j.pedn.2018.07.008 - DOI - PubMed
    1. Al Maghaireh DF, Abdullah KL, Chan CM, Piaw CY, Al Kawafha MM. Systematic review of qualitative studies exploring parental experiences in the neonatal intensive care unit. J Clin Nurs. 2016;25(19-20):2745-2756. doi:10.1111/jocn.13259 - DOI - PubMed
    1. Rich WD, Auten KJ, Gantz MG, et al. ; National Institute of Child Health and Human Development Neonatal Research Network . Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment. Pediatrics. 2010;126(1):e215-e221. doi:10.1542/peds.2009-3353 - DOI - PMC - PubMed

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