Parents' agendas in paediatric clinical trial recruitment are different from researchers' and often remain unvoiced: a qualitative study

Woolfall, Kerry, Shilling, Valerie, Hickey, Helen, Smyth, Rosalind L, Sowden, Emma, Williamson, Paula R and Young, Bridget (2013) Parents' agendas in paediatric clinical trial recruitment are different from researchers' and often remain unvoiced: a qualitative study. PLoS ONE, 8 (7). e67352. ISSN 1932-6203

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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. © 2013 Woolfall et al.

Item Type: Article
Keywords: placebo article audio recording child child safety clinical practice comprehension controlled clinical trial (topic) family decision making female health care access health care personnel human male observational study parental attitude pediatrics pharmaceutical care qualitative research randomized controlled trial (topic) research subject semi structured interview Clinical Trials as Topic Dissent and Disputes Humans Interviews as Topic Parents Professional-Family Relations Research Personnel
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Subjects: R Medicine > RJ Pediatrics > RJ0101 Child health. Child health services
Depositing User: Valerie Shilling
Date Deposited: 15 Aug 2016 06:39
Last Modified: 06 Mar 2017 11:24
URI: http://sro.sussex.ac.uk/id/eprint/62341

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