Elliott Mark Weiss1, Katherine F Guttmann2, Aleksandra E Olszewski3, Brooke E Magnus4, Sijia Li5, Scott Y H Kim6, Anita R Shah7, Sandra E Juul8, Yvonne W Wu9, Kaashif A Ahmad10, Ellen Bendel-Stenzel11, Natalia A Isaza12, Andrea L Lampland13, Amit M Mathur14, Rakesh Rao15, David Riley16, David G Russell17, Zeynep N I Salih18, Carrie B Torr19, Joern-Hendrik Weitkamp20, Uchenna E Anani20, Taeun Chang21, Juanita Dudley17, John Flibotte22, Erin M Havrilla20, Alexandra C O'Kane23, Krystle Perez8, Brenda J Stanley24, Seema K Shah25, Benjamin S Wilfond3. 1. Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA. Electronic address: emweiss@uw.edu. 2. Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY. 3. Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA. 4. Department of Psychology and Neuroscience, Boston College, Chestnut Hill, MA. 5. Department of Biostatistics, University of Washington School of Public Health, Seattle, WA. 6. Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD. 7. Division of Neonatology, Children's Hospital of Orange County, Orange, CA. 8. Department of Pediatrics, University of Washington School of Medicine, Seattle, WA. 9. Departments of Neurology and Pediatrics, University of California San Francisco School of Medicine, San Francisco, CA. 10. Department of Pediatrics, Baylor College of Medicine, San Antonio, TX. 11. Department of Pediatrics, Mayo Clinic, Rochester, MN. 12. Division of Neonatology, Department of Pediatrics, Children's National Hospital, George Washington University School of Medicine and Health Sciences, Washington, DC. 13. Department of Neonatology, Children's Minnesota Hospital, Minneapolis, MN. 14. Department of Pediatrics, Saint Louis University School of Medicine, St Louis, MO. 15. Department of Pediatrics, Washington University in St Louis School of Medicine, St Louis, MO. 16. Department of Pediatrics, Cook Children's Medical Center, Texas Christian University and University of North Texas Health Science Center School of Medicine, Fort Worth, TX. 17. Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH. 18. Department of Pediatrics, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN. 19. Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT. 20. Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN. 21. Department of Neurology, Children's National Hospital, George Washington University School of Medicine and Health Sciences, Washington, DC. 22. Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA. 23. Georgetown University School of Medicine, Washington, DC. 24. Pediatrix Medical Group, San Antonio, TX. 25. Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL.
Abstract
OBJECTIVE: To describe the parental experience of recruitment and assess differences between parents who participated and those who declined to enroll in a neonatal clinical trial. STUDY DESIGN: This was a survey conducted at 12 US neonatal intensive care units of parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and encephaLopathy (HEAL) trial or who were eligible but declined enrollment. Questions assessed 6 factors of the parental experience of recruitment: (1) interactions with research staff; (2) the consent experience; (3) perceptions of the study; (4) decisional conflict; (5) reasons for/against participation; and (6) timing of making the enrollment decision. RESULTS: In total, 269 of 387 eligible parents, including 183 of 242 (75.6%) of those who enrolled their children in HEAL and 86 of 145 (59.3%) parents who declined to enroll their children in HEAL, were included in analysis. Parents who declined to enroll more preferred to be approached by clinical team members rather than by research team members (72.9% vs 49.2%, P = .005). Enrolled parents more frequently reported positive initial impressions (54.9% vs 10.5%, P < .001). Many parents in both groups made their decision early in the recruitment process. Considerations of reasons for/against participation differed by enrollment status. CONCLUSIONS: Understanding how parents experience recruitment, and how this differs by enrollment status, may help researchers improve recruitment processes for families and increase enrollment. The parental experience of recruitment varied by enrollment status. These findings can guide future work aiming to inform optimal recruitment strategies for neonatal clinical trials.
OBJECTIVE: To describe the parental experience of recruitment and assess differences between parents who participated and those who declined to enroll in a neonatal clinical trial. STUDY DESIGN: This was a survey conducted at 12 US neonatal intensive care units of parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and encephaLopathy (HEAL) trial or who were eligible but declined enrollment. Questions assessed 6 factors of the parental experience of recruitment: (1) interactions with research staff; (2) the consent experience; (3) perceptions of the study; (4) decisional conflict; (5) reasons for/against participation; and (6) timing of making the enrollment decision. RESULTS: In total, 269 of 387 eligible parents, including 183 of 242 (75.6%) of those who enrolled their children in HEAL and 86 of 145 (59.3%) parents who declined to enroll their children in HEAL, were included in analysis. Parents who declined to enroll more preferred to be approached by clinical team members rather than by research team members (72.9% vs 49.2%, P = .005). Enrolled parents more frequently reported positive initial impressions (54.9% vs 10.5%, P < .001). Many parents in both groups made their decision early in the recruitment process. Considerations of reasons for/against participation differed by enrollment status. CONCLUSIONS: Understanding how parents experience recruitment, and how this differs by enrollment status, may help researchers improve recruitment processes for families and increase enrollment. The parental experience of recruitment varied by enrollment status. These findings can guide future work aiming to inform optimal recruitment strategies for neonatal clinical trials.
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