Basis: The identification of the methodological limitations of diagnostic research on laboratory tests is the basis in order to guide its enhancement and facilitate the application of the results to the clinical decisions.
Methods: Seventeen articles published in Revista Clínica Española and Medicina Clínica from 1997 to 2000 were analyzed, in which the sensitivity and specificity of a diagnostic laboratory test were determined. Some standardized criteria of methodological quality were independently applied by three investigators.
Results: A high frequency in the fulfillment of some key methodological aspects was observed: adequate description of the standard of reference (88%), of the test investigated (88%), of the clinical sample evaluated (71%), and of the prevention of the sequence bias (82%). The assessment of indeterminate results (12%), the test reproducibility (12%), or the description of the origin of the evaluated population (6%) were infrequent.
Conclusion: The methodological defects of diagnostic laboratory research could be prevented through the collaboration with clinical services and with simple modifications of the trial's designs.