Elliott Mark Weiss1,2, Aleksandra E Olszewski1,2, Katherine F Guttmann3, Brooke E Magnus4, Sijia Li5, Anita R Shah6, Sandra E Juul2, Yvonne W Wu7, Kaashif A Ahmad8, Ellen Bendel-Stenzel9, Natalia A Isaza10, Andrea L Lampland11, Amit M Mathur12, Rakesh Rao13, David Riley14, David G Russell15, Zeynep N I Salih16, Carrie B Torr17, Joern-Hendrik Weitkamp18, Uchenna E Anani18, Taeun Chang19, Juanita Dudley15, John Flibotte20, Erin M Havrilla18, Charmaine M Kathen21, Alexandra C O'Kane19, Krystle Perez2, Brenda J Stanley21, Benjamin S Wilfond1,2, Seema K Shah22. 1. Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington. 2. Department of Pediatrics, University of Washington School of Medicine, Seattle. 3. Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York. 4. Department of Psychology and Neuroscience, Boston College, Chestnut Hill, Massachusetts. 5. Department of Biostatistics, University of Washington School of Public Health, Seattle. 6. Division of Neonatology, Children's Hospital of Orange County, Orange, California. 7. Departments of Neurology and Pediatrics, University of California San Francisco School of Medicine, San Francisco. 8. Department of Pediatrics, Baylor College of Medicine, San Antonio, Texas. 9. Department of Pediatrics, Mayo Clinic, Rochester, Minnesota. 10. Division of Neonatology, Department of Pediatrics, Children's National Hospital, George Washington University School of Medicine and Health Sciences, Washington, DC. 11. Department of Neonatology, Children's Minnesota Hospital, Minneapolis. 12. Department of Pediatrics, St Louis University School of Medicine, St Louis, Missouri. 13. Department of Pediatrics, Washington University School of Medicine in St Louis, St Louis, Missouri. 14. Department of Pediatrics, Cook Children's Medical Center, Fort Worth, Texas. 15. Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. 16. Department of Pediatrics, Indiana University School of Medicine, Indianapolis. 17. Department of Pediatrics, University of Utah School of Medicine, Salt Lake City. 18. Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee. 19. Department of Neurology, Children's National Hospital, George Washington University School of Medicine and Health Sciences, Washington, DC. 20. Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. 21. Pediatrix Medical Group, San Antonio, Texas. 22. Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
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.
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.
Authors: Anita R Shah; Benjamin S Wilfond; Amy Silvia; Kerry Hancuch; David Woodrum; Patrick Heagerty; Robin K Ohls; Sherry E Courtney; Ivan D Frantz; Semsa Gogcu; Christine E Bishop; Kaashif A Ahmad; Charmaine Kathen; Sandra Juul Journal: J Perinatol Date: 2018-05-25 Impact factor: 2.521
Authors: Colm P Travers; Waldemar A Carlo; Scott A McDonald; Abhik Das; Namasivayam Ambalavanan; Edward F Bell; Pablo J Sánchez; Barbara J Stoll; Myra H Wyckoff; Abbot R Laptook; Krisa P Van Meurs; Ronald N Goldberg; Carl T D'Angio; Seetha Shankaran; Sara B DeMauro; Michele C Walsh; Myriam Peralta-Carcelen; Monica V Collins; M Bethany Ball; Ellen C Hale; Nancy S Newman; Jochen Profit; Jeffrey B Gould; Scott A Lorch; Carla M Bann; Margarita Bidegain; Rosemary D Higgins Journal: JAMA Netw Open Date: 2020-06-01
Authors: Marliese Dion Nist; Sharon G Casavant; Robin B Dail; Kayla C Everhart; Stephanie Sealschott; Xiaomei S Cong Journal: Nurs Res Date: 2022 Mar-Apr 01 Impact factor: 2.381
Authors: Elliott Mark Weiss; Katherine F Guttmann; Aleksandra E Olszewski; Brooke E Magnus; Sijia Li; Scott Y H Kim; Anita R Shah; Sandra E Juul; Yvonne W Wu; Kaashif A Ahmad; Ellen Bendel-Stenzel; Natalia A Isaza; Andrea L Lampland; Amit M Mathur; Rakesh Rao; David Riley; David G Russell; Zeynep N I Salih; Carrie B Torr; Joern-Hendrik Weitkamp; Uchenna E Anani; Taeun Chang; Juanita Dudley; John Flibotte; Erin M Havrilla; Alexandra C O'Kane; Krystle Perez; Brenda J Stanley; Seema K Shah; Benjamin S Wilfond Journal: J Pediatr Date: 2021-08-14 Impact factor: 4.406