CARRYOVER BIAS IN CLINICAL INVESTIGATIONS
CARRYOVER BIAS IN CLINICAL INVESTIGATIONS
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DOI：
10.1002/j.1552-4604.1993.tb01954.x
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发表时间：
1993-09-01
影响因子：
2.9
通讯作者：
CLEOPHAS, TJM
中科院分区：
文献类型：
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作者：
CLEOPHAS, TJM
如果治疗的效果在停止治疗后继续存在，那么对第二次治疗的反应很可能部分是由于先前的治疗。这种所谓的遗留效应可能会使任何类型的研究产生偏差，在这些研究中，受试者被测试了不止一次。交叉研究可常规检查该偏倚。然而，在其他研究设计中，常识和对数据中异常模式的警觉是唯一的防御措施。剂量反应研究、剂量滴定研究和开放性评价研究应要求在两次给药之间有足够的洗脱期。使用重复标准差估计试验的个体内重现性时，应始终结合重复数据之间差异的统计学检验。主观变量经常受到心理遗留效应的影响，应尽可能与客观变量一起进行验证。尽管采取了这些措施，但许多遗留效应的情况仍然无法预防。我们只能接受他们。
If the effect of a treatment continues after the treatment is withdrawn then the response to a second treatment may well be due in part to the previous treatment. This, so called, carryover effect may bias any type of study in which subjects ore tested more than once. Crossover studies can be routinely checked for this bias. In other study designs, however, common sense and alertness for unusual patterns in the data are the only defenses against it. The amount of carryover bias can be somewhat minimized by the following measures. Dose-response studies, dose-titration studies, and open-evaluation studies should require a sufficient washout period between the administrations of drugs. The use of duplicate standard deviations for the estimation of intraindividual reproducibility of a test should always be combined with a statistical test for differences between the duplicate data. Subjective variables, which are frequently influenced by psychologic carryover effects, should be validated together with objective variables whenever possible. In spite of these measures, many cases of carryover effect remain unpreventable. We shall simply have to accept them.