Lubsen J
Eur Heart J. 1983 Jul;4 Suppl D:147-9. doi: 10.1093/eurheartj/4.suppl_d.147.
In general, therapeutic evaluation is based on a comparison between the 'treated' and the 'untreated'. The validity of the inference is based on the methods used in the formation of such groups. Randomized treatment allocation avoids selection bias and leads to interpretable statistical tests of significance. In addition, it defines the point in time at which follow-up starts. The use of placebo in a double-blind manner achieves comparability of information and also makes differences in the use of concomitant medication during follow-up interpretable as effects of the drug under study. Multicenter cooperation may enhance the representativeness of the data for the kind of patient to which the results may apply and makes it possible to check results for consistency between the clinics. These features of the design of recent beta-blocker trials in post-myocardial infarction patients enhance confidence in the results.
一般来说,治疗评估是基于“治疗组”与“未治疗组”之间的比较。这种推断的有效性取决于形成这些组所使用的方法。随机治疗分配可避免选择偏倚,并能进行可解释的显著性统计检验。此外,它还确定了随访开始的时间点。以双盲方式使用安慰剂可实现信息的可比性,并且还能使随访期间伴随用药的差异可解释为所研究药物的效果。多中心合作可提高数据对于结果可能适用的患者类型的代表性,并能够检查各诊所之间结果的一致性。近期心肌梗死后患者β受体阻滞剂试验设计的这些特点增强了对结果的信心。