title: Parents' agendas in paediatric clinical trial recruitment are different from researchers' and often remain unvoiced: a qualitative study.
abstract: Ensuring parents make an informed decision about their child's participation in a clinical trial is a challenge for practitioners as a parent's comprehension of a trial may differ from that intended by the practitioners responsible for recruitment. We explored what issues parents consider important when making a decision about participation in a paediatric clinical trial and their comprehension of these issues to inform future recruitment practice. This qualitative interview and observational study examined recruitment in four placebo-controlled, double-blind randomised clinical trials of medicines for children. Audio-recorded trial recruitment discussions between practitioners and parents (N = 41) were matched with semi-structured interviews with parents (N = 41). When making a decision about trial entry parents considered clinical benefit, child safety, practicalities of participation, research for the common good, access to medication and randomisation. Within these prioritised issues parents had specific misunderstandings, which had the potential to influence their decisions. While parents had many questions and concerns about trial participation which influenced their decision-making, they rarely voiced these during discussions about the trials with practitioners. Those involved in the recruitment of children to clinical trials need to be aware of parents' priorities and the sorts of misunderstandings that can arise with parents. Providing trial information that is tailored to what parents consider important in making a decision about a clinical trial may improve recruitment practice and ultimately benefit evidence-based paediatric medicine.
authors.affiliation: Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom. K.Woolfall@liverpool.ac.uk
authors.forename: Kerry
authors.initials: K
authors.lastname: Woolfall
authors.forename: Valerie
authors.initials: V
authors.lastname: Shilling
authors.forename: Helen
authors.initials: H
authors.lastname: Hickey
authors.forename: Rosalind L
authors.initials: RL
authors.lastname: Smyth
authors.forename: Emma
authors.initials: E
authors.lastname: Sowden
authors.forename: Paula R
authors.initials: PR
authors.lastname: Williamson
authors.forename: Bridget
authors.initials: B
authors.lastname: Young
mesh_terms: D002986:Clinical Trials as Topic; D032882:Comprehension; D034462:Dissent and Disputes; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D010290:Parents; D010372:Pediatrics; D011368:Professional-Family Relations; D036301:Qualitative Research; D012108:Research Personnel