Featherstone K, Donovan J L
Department of Social Medicine, University of Bristol BS8 2PR.
BMJ. 1998 Oct 31;317(7167):1177-80. doi: 10.1136/bmj.317.7167.1177.
To explore trial participants' understandings of randomisation.
In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews were carried out with 20 participants from the CLasP randomised controlled trial. Interviews were recorded on audio tape and fully transcribed. Data were analysed by comparing transcripts and describing emergent themes, using a grounded theory approach.
The CLasP study comprises three linked multicentre, pragmatic randomised controlled trials evaluating the effectiveness and cost effectiveness of laser therapy, standard surgery, and conservative management for men with lower urinary tract symptoms or urinary retention, or both, related to benign prostatic disease.
20 participants in the CLasP study were interviewed. Sampling was purposeful: men were included from each of the treatment arms, the two major centres, and at different points in the trial.
Interviews used a checklist of topics to encourage participants to describe their experiences. Narratives concerning randomisation were compared to identify common themes, retaining the context of the discussion to allow detailed interpretation.
Most participants recalled and described aspects of randomisation, such as the involvement of chance, comparison, and concealed allocation. Many found the concept of randomisation difficult, however, and developed alternative lay explanations to make sense of their experiences. Inaccurate patient information and lay interpretations of common trial terms caused confusion.
The provision of clear and accurate patient information is important, but this alone will not ensure consistent interpretation of concepts such as randomisation. Patients may need to discuss the purposes of randomisation in order to understand them fully enough to give truly informed consent.
探讨试验参与者对随机分组的理解。
在这项采用定性研究方法的探索性研究中，对来自CLasP随机对照试验的20名参与者进行了深入的半结构化访谈。访谈通过录音并进行了完整转录。采用扎根理论方法，通过比较转录本并描述新出现的主题来分析数据。
CLasP研究包括三项相互关联的多中心实用随机对照试验，评估激光治疗、标准手术以及针对患有与良性前列腺疾病相关的下尿路症状或尿潴留或两者皆有的男性的保守治疗的有效性和成本效益。
对CLasP研究中的20名参与者进行了访谈。抽样是有目的的：从每个治疗组、两个主要中心以及试验的不同阶段纳入男性。
访谈使用了一个主题清单，以鼓励参与者描述他们的经历。比较有关随机分组的叙述以确定共同主题，保留讨论背景以进行详细解读。
大多数参与者回忆并描述了随机分组的各个方面，例如机会的参与、比较和隐蔽分配。然而，许多人发现随机分组的概念难以理解，并形成了替代的通俗解释来理解他们的经历。不准确的患者信息和对常见试验术语的通俗解释导致了困惑。
提供清晰准确的患者信息很重要，但仅此一点并不能确保对随机分组等概念的一致理解。患者可能需要讨论随机分组的目的，以便充分理解它们，从而给予真正知情的同意。
