title: Parent perspectives on decisions to participate in a phase I hepatocyte transplant trial.
abstract: We examined factors that affect decision-making for families presented with a phase I clinical trial of hepatocyte transplant as a potential alternative to liver transplant for their children among two groups: (i) families who were actually offered enrollment in the hepatocyte trial and; (ii) families whose children had liver transplants before the trial was available. We conducted semi-structured interviews about actual and hypothetical decision-making regarding trial participation and used grounded theory analysis to identify common themes. The most common motivator for participation was decline in the child's health. The most common deterrent was lack of data from prior hepatocyte transplants, particularly when compared with data available about liver transplant. Interviewees' point of comparison for evaluating relative benefits and risks of hepatocyte transplant oscillated between the alternative of doing nothing while waiting for a liver (the relevant alternative) vs. the alternative of getting a liver. These results suggest that families' reluctance to participate may result from misconceptions about severity of the child's disease, underestimating risks of liver transplant, or confusion about the role of hepatocyte transplant in the treatment pathway. Clarification of available treatment alternatives and associated risks as part of informed consent may improve the quality of decision-making regarding trial enrollment.
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Dreyzin
authors.forename: Amber E
authors.initials: AE
authors.lastname: Barnato
authors.forename: Kyle A
authors.initials: KA
authors.lastname: Soltys
authors.forename: Coreen
authors.initials: C
authors.lastname: Farris
authors.forename: Rachel
authors.initials: R
authors.lastname: Sada
authors.forename: Kimberly
authors.initials: K
authors.lastname: Haberman
authors.forename: Ira J
authors.initials: IJ
authors.lastname: Fox
mesh_terms: D000328:Adult; D001294:Attitude to Health; D002986:Clinical Trials as Topic; D003657:Decision Making; D005260:Female; D022781:Hepatocytes / Q000637:transplantation*; D006801:Humans; D007258:Informed Consent; D017093:Liver Failure / Q000628:therapy*; D008297:Male; D010290:Parents / Q000523:psychology*; D010353:Patient Education as Topic; D010358:Patient Participation; D057240:Patient Preference; D018579:Patient Selection; D012306:Risk
keywords: liver transplantation; parental consent; pediatric clinical trials