Study objectives: To determine conformance with methodologic standards
in the evaluation of diagnostic tests. Data sources: MEDLINE database
search (1992 to 1997) of nine prominent general medicine and six subs
pecialty journals for articles that report discriminative properties o
f diagnostic tests in pulmonary medicine. Study selection: Articles we
re eligible if they reported discriminative properties of diagnostic t
ests in humans, diagnostic tests were intended for the detection of ex
isting conditions, and the target disorder was relevant to pulmonary m
edicine. Data extraction: Each study was critically reviewed independe
ntly by two observers. Data synthesis: Of the 1,029 retrieved articles
, 41 met study inclusion criteria. The median number of the 12 major s
tandards 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 al
l 12 standards. Seven (17%) articles did not report any standard measu
res of diagnostic accuracy and 7 (17%) provided data only for sensitiv
ity and specificity. Only 4 of 17 articles (24%) that compared differe
nt tests used standard statistical methods. Conclusion: These results
indicate that greater methodologic rigor is needed for studies that ev
aluate diagnostic tests in pulmonary medicine. Existing deficiencies i
n methodology risk the introduction of invalid tests into clinical pra
ctice.