Jenkins V, Leach L, Fallowfield L, Nicholls K, Newsham A
Cancer Research (UK) Psychosocial Oncology Group, Brighton & Susssex Medical School, University of Sussex, Falmer, Sussex BN1 9QG, UK.
Br J Cancer. 2002 Oct 7;87(8):854-8. doi: 10.1038/sj.bjc.6600527.
Explaining the concept of randomisation in simple terms to patients during the discussion of randomised clinical trials can be a difficult task for many health care professionals. We report the results of a questionnaire-based survey, using seven descriptions of randomisation taken from Corbett's study. We examined the preferences of the general public and patients towards the descriptions and compared the results with the clinicians' choice. Participants in the survey were 341 lay people without cancer, 200 patients with cancer and 200 oncologists from cancer centres throughout the UK. It was difficult to identify 'the best' way to describe the process of randomisation. The two most favoured statements for patients and members of the public included a very explicit statement that mentioned 'a computer', 'chance' and 'not the doctor's or patient's decision' and a succinct statement that played down the role of 'chance'. Clinicians chose neither of these statements as closely resembling their own practice. Patients and members of the public most disliked the statement 'a computer will perform the equivalent of tossing a coin to allocate you to one of two methods of treatment'. This analogy used by 26% of oncologists, was viewed as trivialising and upsetting in the context of determining treatment for life threatening disease.
在讨论随机临床试验时,用简单的术语向患者解释随机化的概念,对许多医疗保健专业人员来说可能是一项艰巨的任务。我们报告了一项基于问卷调查的结果,该调查使用了从科比特研究中选取的七种随机化描述。我们研究了普通公众和患者对这些描述的偏好,并将结果与临床医生的选择进行了比较。调查参与者包括341名无癌症的普通民众、200名癌症患者以及来自英国各地癌症中心的200名肿瘤学家。很难确定描述随机化过程的“最佳”方式。患者和公众最青睐的两种表述,一种是非常明确地提到“计算机”“机会”以及“不是医生或患者的决定”的表述,另一种是淡化“机会”作用的简洁表述。临床医生没有选择这两种与他们自己的做法非常相似的表述。患者和公众最不喜欢的表述是“计算机将执行类似于抛硬币的操作,把你分配到两种治疗方法中的一种”。26%的肿瘤学家使用了这种类比,在确定危及生命疾病的治疗方案时,这种类比被认为是将问题简单化且令人不安的。