Heffner J E, Feinstein D, Barbieri C
Department of Medicine, University of Arizona Health Sciences Center, St. Joseph's Hospital and Medical Center, Phoenix, USA.
Chest. 1998 Sep;114(3):877-85. doi: 10.1378/chest.114.3.877.
To determine conformance with methodologic standards in the evaluation of diagnostic tests.
MEDLINE database search (1992 to 1997) of nine prominent general medicine and six subspecialty journals for articles that report discriminative properties of diagnostic tests in pulmonary medicine.
Articles were eligible if they reported discriminative properties of diagnostic tests in humans, diagnostic tests were intended for the detection of existing conditions, and the target disorder was relevant to pulmonary medicine.
Each study was critically reviewed independently by two observers.
Of the 1,029 retrieved articles, 41 met study inclusion criteria. The median number of the 12 major standards for design fulfilled by study articles was 6 (range, 1 to 12, 25th to 75th percentile, 5.0 to 8.5) and only 2 articles fulfilled all 12 standards. Seven (17%) articles did not report any standard measures of diagnostic accuracy and 7 (17%) provided data only for sensitivity and specificity. Only 4 of 17 articles (24%) that compared different tests used standard statistical methods.
These results indicate that greater methodologic rigor is needed for studies that evaluate diagnostic tests in pulmonary medicine. Existing deficiencies in methodology risk the introduction of invalid tests into clinical practice.
确定诊断试验评估中与方法学标准的符合情况。
对9种著名的普通医学期刊和6种专科期刊进行MEDLINE数据库检索（1992年至1997年），以查找报告肺部医学诊断试验鉴别特性的文章。
如果文章报告了人类诊断试验的鉴别特性、诊断试验旨在检测现有病症且目标疾病与肺部医学相关，则该文章符合入选标准。
两名观察者分别对每项研究进行严格独立审查。
在检索到的1029篇文章中，41篇符合研究纳入标准。研究文章满足的12项主要设计标准的中位数为6（范围为1至12，第25百分位数至第75百分位数为5.0至8.5），只有2篇文章满足所有12项标准。7篇（17%）文章未报告任何诊断准确性的标准测量指标，7篇（17%）仅提供了敏感性和特异性的数据。在比较不同试验的17篇文章中，只有4篇（24%）使用了标准统计方法。
这些结果表明，评估肺部医学诊断试验的研究需要更高的方法学严谨性。方法学上现有的缺陷可能会导致无效试验被引入临床实践。
