Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.
PLoS One. 2013 Jul 3;8(7):e67352. doi: 10.1371/journal.pone.0067352. Print 2013.
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.
确保家长能够对孩子参与临床试验做出明智的决定，这对从业者来说是一项挑战，因为家长对试验的理解可能与负责招募的从业者的理解不同。我们探讨了家长在决定参与儿科临床试验时考虑的重要问题，以及他们对这些问题的理解，以为未来的招募实践提供信息。这项定性访谈和观察性研究调查了四项针对儿童药物的安慰剂对照、双盲随机临床试验的招募情况。从业者与家长（N=41）之间的试验招募讨论进行了录音，并与家长（N=41）进行了半结构化访谈。当家长决定参与试验时，他们考虑了临床获益、儿童安全、参与的实际性、为共同利益进行的研究、药物的可及性和随机化。在这些优先考虑的问题中，家长有特定的误解，这些误解可能会影响他们的决策。尽管家长对参与试验有很多问题和担忧，这些问题影响了他们的决策过程，但他们很少在与从业者讨论试验时表达这些问题。那些参与招募儿童参与临床试验的人需要了解家长的优先事项以及家长可能产生的误解。提供符合家长在决定参与临床试验时认为重要的信息，可能会改善招募实践，并最终有益于基于证据的儿科医学。
