PATIENT PREFERENCES AND RANDOMIZED CLINICAL-TRIALS
PATIENT PREFERENCES AND RANDOMIZED CLINICAL-TRIALS
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DOI：
10.1136/bmj.299.6694.313
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发表时间：
1989-07-29
影响因子：
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通讯作者：
BRADLEY, C
中科院分区：
文献类型：
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作者：
BREWIN, CR;BRADLEY, C
在一项对照试验中，通过随机化将患者分配到不同的治疗方案，现在在试验设计中几乎是毫无疑问地被接受了。“随机化可以合理地在评估拨款支持的拟议研究中发挥很大作用。随机化的优点是它减少了某些类型的系统误差，这些误差可能会干扰对试验结果的解释。以系统的非随机方式分配患者接受治疗可能会引入偏见，从而破坏可比性。我们认为，尽管有这样的优势，随机分配并不总是合适的。虽然患者在所有治疗的结果中发挥着积极的作用，但我们建议，需要他们维持努力和要求的角色的临床试验，以及他们可能对一种治疗有强烈偏好的临床试验，需要考虑并以不同的方式进行。在开始对某一特定疗程进行治疗之前，调动患者遵循治疗方案的动机可能会受到任何偏好的影响。参与的需要越大，动机影响结果的空间就越大。这种“参与性”干预措施包括：糖尿病患者的自我监测、饮食、自我用药方案；心肌梗塞恢复期患者的康复方案；癌症患者或那些将疾病遗传给后代的高风险患者的咨询；行为和
Allocating patients to different treatments by randomisation in a controlled trial is now accepted almost without question in accounts of trial design.'Randomisation may reasonably be supposed to play a large part in evaluating proposed studies for grant support. The virtue of randomisation is that it reduces some types of systematic error that may interfere with the interpretation of the results of a trial. Allocating patients to treatments in a systematic non-randomised way may introduce bias which destroys comparability. We argue here that despite this advantage random allocation is not always suitable. Though patients play an active part in the outcome of all treatments, we suggest that clinical trials in which they are required to sustain an effortful and demanding role and those in which they are likely to have strong preferences for one treatment need to be considered and conducted differently.Motivation Patients' motivation to follow treatment regimens is likely to be influenced by any preference before treatment is begun for one particular course of action. The greater the need for participation the greater is the scope for motivation to influence outcome. Such" participative" interventions include self monitoring, diet, ar4d self medication regimens for patients with diabetes; rehabilitation programmes for patients recovering from a myocardial infarction; counselling for patients with cancer or those at high risk of passing disorders to their offspring; behavioural and