Woolfall 2013.pdf (163.38 kB)
Parents' agendas in paediatric clinical trial recruitment are different from researchers' and often remain unvoiced: a qualitative study
journal contribution
posted on 2023-06-09, 02:29 authored by Kerry Woolfall, Valerie ShillingValerie Shilling, Helen Hickey, Rosalind L Smyth, Emma Sowden, Paula R Williamson, Bridget YoungEnsuring 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. © 2013 Woolfall et al.
History
Publication status
- Published
File Version
- Published version
Journal
PLoS ONEISSN
1932-6203Publisher
Public Library of ScienceExternal DOI
Issue
7Volume
8Article number
e67352Department affiliated with
- Sussex Health Outcomes Research & Education in Cancer (SHORE-C) Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2016-08-15First Open Access (FOA) Date
2016-08-15First Compliant Deposit (FCD) Date
2016-08-12Usage metrics
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No categories selectedKeywords
placeboarticleaudio recordingchildchild safetyclinical practicecomprehensioncontrolled clinical trial (topic)family decision makingfemalehealth care accesshealth care personnelhumanmaleobservational studyparental attitudepediatricspharmaceutical carequalitative researchrandomized controlled trial (topic)research subjectsemi structured interviewClinical Trials as TopicDissent and DisputesHumansInterviews as TopicParentsProfessional-Family RelationsResearch Personnel
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