Making sense of randomization; Responses of parents of critically ill babies to random allocation of treatment in a clinical trial
Making sense of randomization; Responses of parents of critically ill babies to random allocation of treatment in a clinical trial
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DOI：
10.1016/s0277-9536(97)00063-4
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发表时间：
1997-11-01
影响因子：
5.4
通讯作者：
Elbourne, D
中科院分区：
文献类型：
--
作者：
Snowdon, C;Garcia, J;Elbourne, D
随机对照试验（RCTs）被科学界广泛接受为评估卫生保健干预措施的最严格方法。虽然它们的中心特征——随机分配治疗——通常被认为在方法上是适当的，但其应用在卫生专业人员和伦理学家之间引起了许多争论。这篇论文描述了同意他们的危重新生儿应该参加新生儿试验的父母的观点。通过深度访谈来确定他们对试验和随机化的反应。人们对审判的性质往往知之甚少。治疗分配的随机基础和这种方法背后的理由也是有问题的问题。一些家长根本没有察觉到这一过程中的随机因素。这些发现促进了对试验参与者看法的理解，并为那些关注随机对照试验的人提出了重要的问题。更深入地了解参与者的观点有助于改进对未来试验的管理，从而改善那些同意参加试验的人的经验。1997爱思唯尔科学有限公司
Randomized controlled trials (RCTs) are widely accepted by the scientific community as the most rigorous way of evaluating interventions in health care. Although their central feature, random allocation of treatment, is generally seen as methodologically appropriate, its application has caused much debate amongst health professionals and ethicists. This paper describes the views of parents who consented that their critically ill newborn baby should be enrolled in a neonatal trial. In-depth interviews were used to determine their responses to the trial and randomization. The nature of the trial was often poorly understood. The random basis of the allocation of treatment and the rationale behind this approach were also problematic issues. Some parents did not perceive a random element in the process at all. These findings advance understanding of the perceptions of trial participants and raise important issues for those concerned with RCTs. Greater understanding of participants' views provides the potential to improve the management of future trials and so the experience of those agreeing to take part. (C) 1997 Elsevier Science Ltd.