Parental comprehension of the benefits/risks of first-line randomised clinical trials in children with solid tumours: a two-stage cross-sectional interview study
Parental comprehension of the benefits/risks of first-line randomised clinical trials in children with solid tumours: a two-stage cross-sectional interview study
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DOI：
10.1136/bmjopen-2013-002733
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发表时间：
2013-01-01
期刊：
影响因子：
2.9
通讯作者：
Doz, Francois
中科院分区：
文献类型：
--
作者：
Chappuy, Helene;Bouazza, Naim;Doz, Francois
目的：分析一线随机临床试验（RCT）中父母对知情同意信息的理解，包括恶性实体瘤儿童，并评估父母的决策需求。设计：观察性前瞻性研究。设置：法国巴黎地区的3个儿科肿瘤中心。参与者：53名父母被邀请参加一项针对他们患有恶性实体瘤的孩子的RCT，为期1年。主要和次要结果指标：父母对RCT中信息的理解，父母对决策的需求。父母被询问的心理学家，独立的儿科肿瘤学团队，使用半直接采访，1（M1）和6个月（M6）后的同意searched.Results：18父母（45%）不理解的概念随机。一半的父母既不能解释临床试验的目的，也不能解释纳入临床试验对孩子的潜在好处。35名父母（87.5%）表示与试验相关的特定风险很少。大多数人讲法语（p=0.03）和父母阅读信息表（p=0.0025）提高了他们的理解。M1和M6的父母理解没有差异。他们的决定的主要因素是在医疗团队的信心（39%），希望获得最好的治疗（37%）和最好的生活质量（37%）。结论：尽管医学解释，父母有有限的知识，在某些领域的一线随机对照试验和信息处理的改进是必要的。父母低估了随机试验的特定风险，治疗的未经证实的性质不为人所知或理解。
Objectives: To analyse the parental understanding of informed consent information in first-line randomised clinical trials (RCTs) including children with malignant solid tumours and to assess parents' needs for decision-making.Design: Observational prospective study.Setting: 3 paediatric oncology centres in the Parisian region in France.Participants: 53 parents were approached to participate in a RCT for their child with malignant solid tumour, over a 1-year period. 40 parents have been interviewed in our study.Primary and secondary outcome measures: Parental understanding of information in RCTs, parents' needs for decision-making. Parents were questioned by a psychologist, independent of the paediatric oncology teams, using a semidirected interview, 1 (M1) and 6 months (M6) after the consent was sought.Results: 18 parents (45%) did not understand the concept of randomisation. Half of the parents could explain neither the aim of the clinical trial nor the potential benefit to their child of inclusion. 35 parents (87.5%) expressed very few specific risks related to the trial. Being mostly French-speaking (p=0.03) and the reading of the information sheet by the parents (p=0.0025) improved their understanding. The parental comprehension did not differ between M1 and M6. The principal factors underlying their decision were confidence in the medical team (39%), wish to access to the best treatment (37%) and the best quality of life (37%).Conclusions: Despite medical explanations, parents have limited knowledge in some areas in first-line RCTs and improvements of information process are required. The risks specific to the randomised trial are underestimated by parents and the unproven nature of the treatment is not well-known or understood.