Institute of Psychology, Health and Society, University of Liverpool, Liverpool, United Kingdom.
PLoS One. 2011;6(7):e21604. doi: 10.1371/journal.pone.0021604. Epub 2011 Jul 12.
Recruiting children to clinical trials is perceived to be challenging. To identify ways to optimise recruitment and its conduct, we compared how parents and practitioners described their experiences of recruitment to clinical trials.
This qualitative study ran alongside four children's clinical trials in 11 UK research sites. It compared analyses of semi-structured interviews with analyses of audio-recordings of practitioner-family dialogue during trial recruitment discussions. Parents from 59 families were interviewed; 41 had participated in audio-recorded recruitment discussions. 31 practitioners were interviewed. Parents said little in the recruitment discussions contributing a median 16% of the total dialogue and asking a median of one question. Despite this, parents reported a positive experience of the trial approach describing a sense of comfort and safety. Even if they declined or if the discussion took place at a difficult time, parents understood the need to approach them and spoke of the value of research. Some parents viewed participation as an 'exciting' opportunity. By contrast, practitioners often worried that approaching families about research burdened families. Some practitioners implied that recruiting to clinical trials was something which they found aversive. Many were also concerned about the amount of information they had to provide and believed this overwhelmed families. Whilst some practitioners thought the trial information leaflets were of little use to families, parents reported that they used and valued the leaflets. However, both parties agreed that the leaflets were too long and wanted them to be more reader-friendly.
Parents were more positive about being approached to enter their child into a clinical trial than practitioners anticipated. The concerns of some practitioners, that parents would be overburdened, were unfounded. Educating practitioners about how families perceive clinical trials and providing them with 'moral' support in approaching families may benefit paediatric research and, ultimately, patients.
招募儿童参与临床试验被认为具有挑战性。为了确定优化招募及其实施的方法，我们比较了家长和从业者如何描述他们在临床试验招募方面的经验。
这项定性研究与四项英国研究机构的儿童临床试验同时进行。它比较了对家长参与的半结构化访谈的分析与在试验招募讨论期间记录的从业者与家长对话的音频分析。59 个家庭的家长接受了访谈；41 个家庭参与了录音的招募讨论。31 名从业者接受了访谈。家长在招募讨论中发言很少，仅占总对话的中位数 16%，并提出了中位数为一个问题。尽管如此，家长们还是对试验方法的体验评价为正面，描述了一种舒适和安全感。即使他们拒绝了或者讨论是在困难的时候进行的，家长们理解了接近他们的必要性，并谈到了研究的价值。一些家长认为参与是一个“令人兴奋”的机会。相比之下，从业者往往担心接近家庭进行研究会给家庭带来负担。一些从业者暗示，招募儿童参与临床试验是他们觉得不愉快的事情。许多人还担心他们必须提供的信息量，并认为这让家庭感到不知所措。虽然一些从业者认为临床试验信息传单对家庭没有用处，但家长们报告说他们使用并重视这些传单。然而，双方都认为传单太长了，希望它们更便于阅读。
家长对被邀请让孩子参加临床试验比从业者预期的更为积极。一些从业者担心家长会负担过重，这种担心是没有根据的。教育从业者了解家庭如何看待临床试验，并为他们在接近家庭时提供“道德”支持，可能会有益于儿科研究，并最终有益于患者。
