Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial
Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial
复制标题
DOI：
10.1136/bmj.317.7167.1177
复制
发表时间：
1998-10-31
影响因子：
105.7
通讯作者：
Donovan, JL
中科院分区：
文献类型：
--
作者：
Featherstone, K;Donovan, JL
目的 探讨试验参与者对随机化的理解。设计 在这项探索性研究中，使用定性研究方法，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。采访内容被录制在录音带上并进行了完整转录。通过比较成绩单和描述新出现的主题，使用扎根理论方法对数据进行分析。 设置 CLasP 研究包括三项相互关联的多中心、实用性随机对照试验，评估激光治疗标准手术和保守治疗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兼有的男性的有效性和成本效益。 CLasP 研究的受试者接受了 20 名参与者的采访。抽样是有目的的：每个治疗组、两个主要中心以及试验中不同阶段的男性都被纳入。干预措施和结果衡量访谈使用主题清单来鼓励参与者描述他们的经历。对有关随机化的叙述进行比较，以确定共同主题，保留讨论的背景，以便进行详细解释。结果大多数参与者回忆并描述了随机化的各个方面，例如机会、比较和隐藏分配的参与。然而，许多人发现随机化的概念很困难，并提出了替代的外行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简单解释造成了混乱。结论 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化等概念的解释一致。患者可能需要讨论随机化的目的，以便充分理解它们并给予埋葬知情同意书
Objectives To explore trial participants' understandings of randomisation.Design 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.Setting 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.Subjects 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.Interventions and outcome measures 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.Results 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.Conclusions 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 bury informed consent