METHODOLOGIC STANDARDS FOR DIAGNOSTIC-TEST RESEARCH IN PULMONARY MEDICINE

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.