Skip to main content
Erschienen in: Pediatric Cardiology 3/2007

01.06.2007 | ORIGINAL ARTICLE

Parental Factors Impacting the Enrollment of Children in Cardiac Critical Care Clinical Trials

verfasst von: T.M. Hoffman, R. Taeed, J.P. Niles, M.A. McMillin, L.A. Perkins, T.F. Feltes

Erschienen in: Pediatric Cardiology | Ausgabe 3/2007

Einloggen, um Zugang zu erhalten

Abstract

Clinical trials are abundant in adult cardiovascular medicine; however, they are rare in pediatric cardiology. Pediatric cardiac trial design may be impacted by the heterogeneous nature of the underlying cardiac defects, as well as by a strong emotional response from parents whose child will undergo a surgical intervention. The purpose of this study was to assess factors that may have an impact on parents considering enrollment of their child in a clinical trial at the time of surgical intervention. A voluntary, self-administered questionnaire (14 questions) was provided to parents of children 16 years of age or younger during the preadmission testing period. Demographic and procedure-related variables were collected for each patient. A total of 119 surveys were analyzed over a 1.5-year period. Only 8% of the parents had their child participate in a clinical trial in the past. Fifty-six percent of the parents preferred that their child’s cardiologist or surgeon explain clinical trial details, with 23% preferring the principal investigator and 3% preferring the research coordinator. Fifty percent of the parents were favorably disposed to participate in a clinical trial if the drug or device was currently used by their child’s doctor, and 19% were encouraged to participate if the drug or device was approved for use in adults. The majority of parents (64%) preferred to be asked about participating in a trial within 1 month prior to the planned procedure, and 40% preferred to discuss trial details at a remote time in an outpatient location. Sixty-three percent of parents believed that most of the medications currently used in children were already approved by the Food and Drug Administration. Most parents (91%) believed that clinical trials conducted in children will help improve pediatric health care; 74% believed that their child may receive potential benefit from enrolling in a trial. Finally, 43% believed that funding for trials should come from government and health care agencies, as opposed to pharmaceutical companies (24%). This survey reveals the importance of the attending physician and timing in educating parents regarding a cardiac critical care clinical trial. These data may impact the design and successful conduct of future trials.
Literatur
1.
2.
Zurück zum Zitat Barfield RC, Church C (2005) Informed consent in pediatric clinical trials. Curr Opin Pediatr 17:20–24PubMedCrossRef Barfield RC, Church C (2005) Informed consent in pediatric clinical trials. Curr Opin Pediatr 17:20–24PubMedCrossRef
3.
Zurück zum Zitat Best Pharmaceuticals for Children Act (2002). Public Law 107–109 Best Pharmaceuticals for Children Act (2002). Public Law 107–109
4.
Zurück zum Zitat Caldwell PH, Murphy SB, Butow PN, Craig JC (2004) Clinical trials in children. Lancet 364:803–811PubMedCrossRef Caldwell PH, Murphy SB, Butow PN, Craig JC (2004) Clinical trials in children. Lancet 364:803–811PubMedCrossRef
5.
Zurück zum Zitat Food and Drug Administration Modernization Act of 1997. Public Law 105–115 Food and Drug Administration Modernization Act of 1997. Public Law 105–115
6.
Zurück zum Zitat Hoehn KS, Nelson RM (2004) Advising parents about children’s participation in clinical research. Pediatr Ann 33:778–781PubMed Hoehn KS, Nelson RM (2004) Advising parents about children’s participation in clinical research. Pediatr Ann 33:778–781PubMed
7.
Zurück zum Zitat Hoehn KS, Wernovsky G, Rychik J, et al. (2005) What factors are important to parents making decisions about neonatal research? Arch Dis Childhood Fetal Neonatal Ed 90:F267–F269CrossRef Hoehn KS, Wernovsky G, Rychik J, et al. (2005) What factors are important to parents making decisions about neonatal research? Arch Dis Childhood Fetal Neonatal Ed 90:F267–F269CrossRef
8.
Zurück zum Zitat Pediatric Research Equity Act of 2003. Public Law 108–155 Pediatric Research Equity Act of 2003. Public Law 108–155
9.
Zurück zum Zitat Rothmier JD, Lasley MV, Shapiro GG (2003) Factors influencing parental consent in pediatric clinical research. Pediatrics 111:1037–1041PubMedCrossRef Rothmier JD, Lasley MV, Shapiro GG (2003) Factors influencing parental consent in pediatric clinical research. Pediatrics 111:1037–1041PubMedCrossRef
10.
Zurück zum Zitat Salazar JC (2003) Pediatric clinical trial experience: government, child, parent and physician’s perspective. Pediatr Infect Dis J 22:1124–1127PubMedCrossRef Salazar JC (2003) Pediatric clinical trial experience: government, child, parent and physician’s perspective. Pediatr Infect Dis J 22:1124–1127PubMedCrossRef
11.
Zurück zum Zitat Tait AR, Voepel-Lewis T, Malviya S (2003) Participation of children in clinical research: factors that influence a parent’s decision to consent. Anesthesiology 99:819–825PubMedCrossRef Tait AR, Voepel-Lewis T, Malviya S (2003) Participation of children in clinical research: factors that influence a parent’s decision to consent. Anesthesiology 99:819–825PubMedCrossRef
12.
Zurück zum Zitat Tait AR, Voepel-Lewis T, Siewert M, Malviya S (1998) Factors that influence parents’ decisions to consent to their child’s participation in clinical anesthesia research. Anesth Analg 86:50–53PubMedCrossRef Tait AR, Voepel-Lewis T, Siewert M, Malviya S (1998) Factors that influence parents’ decisions to consent to their child’s participation in clinical anesthesia research. Anesth Analg 86:50–53PubMedCrossRef
Metadaten
Titel
Parental Factors Impacting the Enrollment of Children in Cardiac Critical Care Clinical Trials
verfasst von
T.M. Hoffman
R. Taeed
J.P. Niles
M.A. McMillin
L.A. Perkins
T.F. Feltes
Publikationsdatum
01.06.2007
Erschienen in
Pediatric Cardiology / Ausgabe 3/2007
Print ISSN: 0172-0643
Elektronische ISSN: 1432-1971
DOI
https://doi.org/10.1007/s00246-006-0020-5

Weitere Artikel der Ausgabe 3/2007

Pediatric Cardiology 3/2007 Zur Ausgabe

IMAGES IN PEDIATRIC CARDIOLOGY

Which Diaphragm Is Lower and Why?

Update Kardiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.