Abstract Although new diagnostic tests frequently are introduced to hospital laboratories with enthusiasm, many suffer an early demise or gradually fade from use. Two important explanations have been offered for unwarranted optimism about a diagnostic test.1,2 First, the spectrum of patients in whom the test is studied is crucial to obtaining accurate measures of test performance. The ability of the test to make correct classifications must be challenged by a series of patients suspected of having the disease-not simply a group of "normal" and "diseased" individuals. Second, the interpretation of the test must be independent of the establishment of the ultimate diagnosis; the test result itself must not have been used to help establish the true clinical classification. This independent confirmation has been called a "gold standard" or "benchmark" for diagnosis. Even if one meticulously selects the proper population and uses an appropriate diagnostic standard, important problems remain. Any test References 1. Holland WW, Whitehead TP: Value of new laboratory tests in diagnosis and treatment. Lancet 1974;2:391-394.Crossref 2. Ransohoff DF, Feinstein AR: Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med 1978;299:926-930.Crossref 3. Beck JR: A multivariate approach to laboratory practice. J Med Syst 1980;4:237-252.Crossref 4. Sisson JC, Schoomaker EB, Ross JC: Clinical decision analysis: The hazard of using additional data. JAMA 1976;236:1259-1263.Crossref 5. Weinstein MC, Fineberg HV: Clinical Decision Analysis . Philadelphia, WB Saunders Co, 1980, pp 75-167. 6. Pauker SG, Kassirer JP: The threshold approach to clinical decision making. N Engl J Med 1980;302:1109-1117.Crossref 7. Beck JR, Cornwell GG, French EE, et al: The 'iron screen': Modification of standard laboratory practice with data analysis. Hum Pathol 1981;12:118-126.Crossref 8. Kassirer JP, Pauker SG: Should diagnostic testing be regulated? N Engl J Med 1978;299:947-949.Crossref 9. Council for the National Reference System in Clinical Chemistry: Guidelines for the Development of Definitive Methods for Use in Clinical Chemistry . Villanova, Pa, National Committee for Clinical Laboratory Standards, 1979.
Archives of Internal Medicine – American Medical Association
Published: Apr 1, 1982