title: Designing studies of diagnostic tests for low back pain or radiculopathy.
abstract: New diagnostic tests for the evaluation of patients with low back pain are constantly emerging, but are often not completely evaluated before they become used. Many published studies have a number of biases that tend to exaggerate the estimated accuracy of a diagnostic test. Several key study design features should be considered in such studies: independent comparison of the diagnostic test results with an appropriate "gold standard"; blinded assessment of the new test and the gold standard or competing tests; the reproducibility of interpretation of the test being examined; and the sensitivity and specificity of the test for the final gold standard diagnosis. In addition, evaluations of test accuracy should include patients with a wide spectrum of illness from mild to severe, and the study setting and patient characteristics should be described in detail. Finally, the contribution of a diagnostic test to the overall validity of a full group or sequence of tests should be considered, and, ideally, the effect of the test on actual patient outcomes should be determined.
authors: Department of Medicine, University of Washington, Seattle.
authors: R A
authors: RA
authors: Deyo
authors: J
authors: J
authors: Haselkorn
authors: R
authors: R
authors: Hoffman
authors: D L
authors: DL
authors: Kent
mesh_terms: D005069:Evaluation Studies as Topic; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis* / Q000453:epidemiology; D017063:Outcome Assessment, Health Care; D010043:Outcome and Process Assessment, Health Care; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D012107:Research Design; D012680:Sensitivity and Specificity