Sheps S B, Schechter M T
JAMA. 1984 Nov 2;252(17):2418-22.
To study current diagnostic test evaluation, 129 recent articles were assessed against several well-known methodological criteria. Only 68% employed a well-defined "gold standard." Test interpretation was clearly described in only 68% and was stated to be "blind" in only 40%. Approximately 20% used the terms sensitivity and specificity incorrectly. Predictive values were considered in only 31% and the influence of disease prevalence and study setting was considered in only 19%. Overall, 74% failed to demonstrate more than four of seven important characteristics and there was an increased proportion of high specificities reported in this group. Articles assessing new tests reported high sensitivities and specificities significantly more often than articles assessing existing tests. These results indicate a clear need for greater attention to accepted methodological standards on the part of researchers, reviewers, and editors.
为研究当前诊断试验的评估情况,依据若干知名方法学标准对129篇近期文章进行了评估。仅有68%的文章采用了明确界定的“金标准”。仅68%的文章清晰描述了试验解读,且仅40%称其为“盲法”。约20%的文章错误使用了敏感性和特异性这两个术语。仅31%的文章考虑了预测值,仅19%的文章考虑了疾病患病率和研究背景的影响。总体而言,74%的文章未能展现出七个重要特征中的四个以上,且该组报告的高特异性比例有所增加。评估新试验的文章比评估现有试验的文章更频繁地显著报告高敏感性和特异性。这些结果表明,研究人员、审稿人和编辑显然需要更加关注公认的方法学标准。