Table 1

Guidelines for Evaluating Studies About a Diagnostic Test

Are the results of the study valid?
Primary guides
 Is there an independent, blind comparison with a reference standard?
 Does the patient sample include an appropriate spectrum of patients to whom the diagnostic test will be applied in clinical practice?
Secondary guides
 Do the results of the test being evaluated influence the decision to perform the reference standard?
 Are the methods for the performing the test described in sufficient detail to permit replication?
What are the results?
 Are likelihood ratios of the test being evaluated or data necessary for their calculation provided?
Will the results help me in caring for my patients?
 Will the reproducibility of the test result and its interpretation be satisfactory in my setting?
 Are the results applicable to my patient?
 Will the results change my management?
 Will patients be better off as a result of the test?