Parental Enrollment Decision-Making for a Neonatal Clinical Trial - 15/11/21
, Katherine F. Guttmann, MD, MBE 3, Aleksandra E. Olszewski, MD 1, 2, Brooke E. Magnus, PhD 4, Sijia Li, BS 5, Scott Y.H. Kim, MD, PhD 6, Anita R. Shah, MD, MPH 7, Sandra E. Juul, MD, PhD 2, Yvonne W. Wu, MD, MPH 8, Kaashif A. Ahmad, MD, MSc 9, Ellen Bendel-Stenzel, MD 10, Natalia A. Isaza, MD 11, Andrea L. Lampland, MD 12, Amit M. Mathur, MBBS, MD, MRCP 13, Rakesh Rao, MD 14, David Riley, MD 15, David G. Russell, JD 16, Zeynep N.I. Salih, MD, MA 17, Carrie B. Torr, MD 18, Joern-Hendrik Weitkamp, MD 19, Uchenna E. Anani, MD 19, Taeun Chang, MD 20, Juanita Dudley, BSN 16, John Flibotte, MD 21, Erin M. Havrilla, MSN 19, Alexandra C. O’Kane, MS 22, Krystle Perez, MD, MPH 2, Brenda J. Stanley, MSN 23, Seema K. Shah, JD 24, Benjamin S. Wilfond, MD 1, 2Abstract |
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.
Le texte complet de cet article est disponible en PDF.Keywords : research participation, decisional conflict, enrollment decision-making
Abbreviations : HEAL, HIE, IRB, NICU
Plan
| Funded by Seattle Children’s Hospital Center for Clinical & Translational Research Clinical Research Scholars Program with additional support from Children’s Minnesota Research Grant Program and University of Washington Neonatal Bioresearch Fund. The funders had no control over design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. J-H.W. reports receiving fees as a consultant for Roche Diagnostics Corporation to help with development of a neonatal sepsis marker. The other authors declare no conflicts of interest. |
Vol 239
P. 143 - décembre 2021 Retour au numéro
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