- Questions to Evaluate a Study Whose Primary Objective is to Evaluate a Diagnostic Test
Methods Evaluation
- Was there an independent, blind comparison with a reference "*gold" standard of diagnosis?
- Were the patients well enough described: could you understand who was being tested and for what?
- Were the sites doing the testing described so that you could know why the patients presented and who were the doctors doing the testing?
- Was the diagnostic test evaluated in patients with an adequate or representative spectrum of disease?
- Were those who read the tests (for example, the radiologists and pathologists) *blinded to the clinical findings and the group to which the patient was assigned?
- Was the reference standard applied in every case?
- Was the test described in sufficient detail?
- Was more than one expert asked to review the test and the *gold standard?
- Did the experts agree, and how were conflicts resolved?
- Was the test result reproducible?
- Were confidence intervals given?
- Were likelihood ratios calculated for levels of outcome?
- Who funded the research?
Outcomes Evaluation
- What was the contribution of the test to the total diagnostic process assessed: did the test make a difference?
