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儿童药物随机对照试验招募过程(RECRUIT):一项定性研究。

Processes in recruitment to randomised controlled trials of medicines for children (RECRUIT): a qualitative study.

机构信息

Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.

出版信息

Health Technol Assess. 2011 Mar;15(15):1-116. doi: 10.3310/hta15150.


DOI:10.3310/hta15150
PMID:21443838
Abstract

OBJECTIVES: To investigate recruitment processes across a range of clinical trials and from the perspective of parents, young people and practitioners to identify strategies to improve recruitment and its conduct across the spectrum of trials of medicines for children. DESIGN: Qualitative interview and observational study. SETTING: Eleven paediatric clinical trial centres recruiting to four trials. PARTICIPANTS: Members of 60 families approached to consider entry to one of the participating trials and 31 practitioners. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Data were verbatim transcripts of (1) audio-recorded trial recruitment discussions between practitioners and families (n = 41) and (2) semi-structured interviews with parents (n = 62), young people (n = 22) and practitioners (19 doctors and 12 research nurses). Analyses were interpretive, following the general principles of the constant comparative method. RESULTS: Practitioners were concerned to avoid overburdening parents and some indicated that they found approaching families about trials to be aversive. By contrast, even in the most difficult situations, parents did not mind being asked about trials and they did not describe the approach as burdensome. Some parents viewed the trial approach as a positive or exciting opportunity. Parents and young people took little active part in the trial discussions and asked few questions. Despite this, they were satisfied with how they had been approached, and spoke of how they had felt involved, valued, cared for and comfortable to interject during the discussion. However, we identified several parents who had important misunderstandings about the trial. There were few differences between parents who consented and those who declined a trial. Regardless of whether they consented or declined, parents' trial decisions were influenced by their perceptions of the trial in relation to their child's safety and well-being, potential benefits to the child and family, potential benefits to others and the practicality of participation. Of these, parents' paramount consideration was safety. Parents', young people's and practitioners' views of what was important when considering a trial were broadly convergent, although families gave greater importance than practitioners to the trial's practical requirements. All parties valued the face-to-face trial discussion highly and wanted shorter and less complex written information. Parents did not feel pressured by the trial team to participate, but some described how their personal values made them reluctant to decline, and several parents who did decline described a passing sense of discomfort. CONCLUSIONS: The concerns of some practitioners that families would be overburdened were unfounded, as parents did not object to being asked about research. Practitioners may benefit from support that helps them feel personally more at ease in approaching families about trials. Parents and young people often described the trial discussions in strongly positive terms and emphasised the importance of the social and emotional aspects of these encounters. Informed consent training could be enhanced if it similarly emphasised these aspects of recruitment; the misunderstandings we identified indicate how this training could also help practitioners to improve the clarity of their trial discussions with families. Guidelines on informed consent documents should take account of findings that all groups thought that these documents should be shorter and more straightforward. FUNDING: This research was commissioned by the National Institute for Health Research Health Technology Assessment programme.

摘要

目的:从不同临床试验的角度调查招募过程,从家长、青少年和从业者的角度,确定在儿童药物试验的各个方面改善招募及其实施的策略。

设计:定性访谈和观察研究。

地点:参与四项试验的 11 个儿科临床试验中心。

参与者:有 60 个家庭参与了其中一项试验,其中 31 名从业者。

干预措施:无。

主要观察指标:数据为从业者与家庭(n=41)之间进行的(1)关于试验招募的音频记录讨论和(2)家长(n=62)、青少年(n=22)和从业者(医生 19 名和研究护士 12 名)半结构式访谈的逐字记录。分析是解释性的,遵循恒定比较法的一般原则。

结果:从业者担心给家长带来负担,一些从业者表示,他们发现与家长讨论试验令人不快。相比之下,即使在最困难的情况下,家长也不介意被问及试验,他们并不认为这种方法是负担。一些家长将试验方法视为积极或令人兴奋的机会。家长和青少年很少主动参与试验讨论,也很少提问。尽管如此,他们对自己的参与方式感到满意,并表示他们感到被重视、被关心、感到舒适,并在讨论中插话。然而,我们发现一些家长对试验存在重要误解。同意和拒绝试验的家长之间几乎没有差异。无论他们是否同意或拒绝,家长的试验决定都受到他们对试验与孩子安全和福祉、对孩子和家庭的潜在益处、对他人的潜在益处以及参与的实际性的看法的影响。其中,家长最关心的是安全。家长、青少年和从业者在考虑试验时对重要因素的看法基本一致,尽管家庭比从业者更看重试验的实际要求。各方都非常重视面对面的试验讨论,并希望获得更简短、更简单的书面信息。家长没有感到试验团队的压力而参与,但有些家长描述了他们的个人价值观如何使他们不愿拒绝,而一些拒绝的家长则表示有过短暂的不适。

结论:一些从业者担心家庭会不堪重负,这种担忧是没有根据的,因为家长并不反对被问及研究。从业者可能会受益于支持,帮助他们在与家庭讨论试验时感到更自在。家长和青少年通常对试验讨论给予强烈的积极评价,并强调这些互动的社会和情感方面的重要性。知情同意培训如果同样强调招募的这些方面,可能会得到加强;我们发现的误解表明,培训还可以帮助从业者提高与家庭讨论试验的清晰度。知情同意文件指南应考虑到所有群体都认为这些文件应该更简短、更直接的事实。

资金:本研究由英国国家卫生研究院卫生技术评估计划委托进行。

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