CAN OVERALL RESULTS OF CLINICAL-TRIALS BE APPLIED TO ALL PATIENTS
CAN OVERALL RESULTS OF CLINICAL-TRIALS BE APPLIED TO ALL PATIENTS
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DOI：
10.1016/s0140-6736(95)90120-5
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发表时间：
1995-06-24
期刊：
影响因子：
168.9
通讯作者：
ROTHWELL, PM
中科院分区：
文献类型：
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作者：
ROTHWELL, PM
一般认为，临床试验的总体结果适用于试验中的所有患者和未来所有类似的患者；换句话说，个别患者的相对治疗效果与总体试验结果相似。虽然这一假设支持将试验结果应用于临床实践，但很少被测试。通过独立得出的预后模型，对欧洲颈动脉手术试验和UK-TIA阿司匹林试验的结果进行重新分析，以找出相对治疗效果是否随中风绝对基线风险而变化。在两个试验中，相对治疗效果存在显著的异质性，导致绝对治疗效果与预测的基线风险有很大差异。尽管平均而言，将总体试验结果应用于所有患者将利大于弊，但了解相对治疗效果和绝对基线风险之间的关联将通过确定哪些患者治疗无效以及哪些患者最有可能受益，从而增加医疗干预的成本效益。
It is generally assumed that the overall results of a clinical trial are generalisable to all patients in the trial and all similar future patients; in other words, that the relative treatment effect in individual patients is similar to the overall trial result. Although this assumption underpins the application of trial results to clinical practice, it has rarely been tested. By independently derived prognostic models, the results of the European Carotid Surgery Trial and the UK-TIA Aspirin Trial were reanalysed to find out whether relative treatment effect varied with absolute baseline risk of stroke. There was significant heterogeneity of relative treatment effect in both trials, resulting in substantial variation in absolute treatment effect with predicted baseline risk. Although, on average, the application of overall trial results to all patients will do more good than harm, a knowledge of the association between relative treatment effect and absolute baseline risk will increase the cost-effectiveness of healthcare interventions by identifying those patients in whom treatment is ineffective and those patients who are most likely to benefit.