Pater J L, Willan A R
Control Clin Trials. 1984 Jun;5(2):107-13. doi: 10.1016/0197-2456(84)90117-x.
Concepts used in evaluating the results of diagnostic tests have been applied to clinical trials by several authors and each has reached the same conclusion: positive trials are more often falsely positive than would intuitively be expected. This conclusion is, however, based on assumptions that require close examination. First of all, it depends upon equating the power of a clinical trial with the sensitivity of a diagnostic test. Although it is possible to define circumstances in which the two are equivalent, decisions made on the basis of the results of clinical trials usually employ a broader definition of "true positive" than, it is shown, is implied by equating sensitivity with power. Secondly, it is assumed that one can speak meaningfully of the baseline "prevalence" of positive trials. The practical application of this concept can be shown to be extremely difficult. Thus, approaching clinical trials as if they were a type of diagnostic test is superficially appealing. However, this may result in misleading conclusions.
几位作者已将用于评估诊断试验结果的概念应用于临床试验，并且每个人都得出了相同的结论：阳性试验出现假阳性的情况比凭直觉预期的更为常见。然而，这一结论是基于一些需要仔细审视的假设。首先，它取决于将临床试验的效能等同于诊断试验的敏感性。虽然有可能定义两者等效的情况，但基于临床试验结果做出的决策通常采用比将敏感性与效能等同所暗示的更为宽泛的“真阳性”定义。其次，假定可以有意义地谈论阳性试验的基线“患病率”。事实表明，这一概念的实际应用极其困难。因此，将临床试验视为一种诊断试验表面上很有吸引力。然而，这可能会导致误导性的结论。
