Randomisation in trials: do potential trial participants understand it and find it acceptable?
Randomisation in trials: do potential trial participants understand it and find it acceptable?
复制标题
DOI：
10.1136/jme.2002.001123
复制
发表时间：
2004-02-01
影响因子：
4.1
通讯作者：
Lilford, R
中科院分区：
文献类型：
--
作者：
Kerr, C;Robinson, E;Lilford, R
目的：研究非专业人员识别随机分配方法的能力以及他们在临床试验中使用随机分配方法的可接受性。设计：传单包含假设的医疗、非医疗和涉及随机分配的临床试验场景，使用试验信息传单指南中的材料。成人继续教育学院（n = 130），涵盖了广泛的年龄，职业，和levelsofeducation.Main措施：判断是否每一个五种方法分配到两个组是随机的医疗或非医疗的情况。判断这些分配方法是否是可接受的随机临床试验的情况下，有或没有一个科学的理由randomisation.Results：我们组的参与者的大多数判断正确，让人们他们的喜好是不是随机的，并认为以下是随机的：使用没有个人信息的计算机（MREC试验传单的推荐措辞），投掷硬币，从帽子里抽出一个名字。对依次分配人员的判断是分裂的（不是随机分配方法，但与随机分配具有共同特征）。在医疗和非医疗情况下，判断没有什么不同。在临床试验场景中，很少有正确识别的随机方法被判定为可接受。包括随机化的科学理由显着增加的可接受性，只有一个随机方法：分配通过computer.Conclusions：目前英国指南的建议描述随机分配计算机似乎是有道理的。然而，尽管潜在的试验参与者可能理解随机分配的含义，但他们可能会发现，除非提供可接受的使用理由，否则随机分配是不可接受的。
Objective: To examine lay persons' ability to identify methods of random allocation and their acceptability of using methods of random allocation in a clinical trial context.Design: Leaflets containing hypothetical medical, non-medical, and clinical trial scenarios involving random allocation, using material from guidelines for trial information leaflets.Setting and participants: Adults attending further education colleges (n = 130), covering a wide range of ages, occupations, and levels of education.Main measures: Judgements of whether each of five methods of allocation to two groups was random in a medical or non-medical scenario. Judgements of whether these allocation methods were acceptable in a randomised clinical trial scenario, with or without a scientific justification for randomisation.Results: The majority of our group of participants judged correctly that allowing people their preference was not random, and that the following were random: using a computer with no information about the individual ( recommended wording for MREC trial leaflets), tossing a coin, drawing a name out of a hat. Judgements were split over allocating people in turn ( not a random allocation method but shares features with randomisation). Judgements were no different in medical and non-medical scenarios. Few of the correctly identified random methods were judged to be acceptable in a clinical trial scenario. Inclusion of a scientific justification for randomising significantly increased the acceptability of only one random method: allocation by computer.Conclusions: Current UK guidelines' recommended description of random allocation by computer seems warranted. However, while potential trial participants may understand what random allocation means, they may find it unacceptable unless offered an acceptable justification for its use.