Evaluating diagnostic tests
- Neal G Mahutte, MD
Neal G Mahutte, MD
- Medical Director
- The Montreal Fertility Center
- Antoni J Duleba, MD
Antoni J Duleba, MD
- University of California San Diego
The introduction of new diagnostic tests that claim to improve screening or provide definitive diagnosis is a major dilemma for all clinicians. The decision to embrace or reject these tests is often made individually with incomplete information and without thoughtful reflection.
In this topic review we will outline a simple seven-step process that can be used to evaluate the utility of any diagnostic test:
●Can the test be reliably performed?
●Was the test evaluated on an appropriate population?
●Was an appropriate gold standard used?
- CAN THE TEST BE PERFORMED RELIABLY?
- Accuracy and precision
- WAS THE TEST EVALUATED ON AN APPROPRIATE POPULATION?
- Sample size
- WAS AN APPROPRIATE REFERENCE-STANDARD USED?
- Defining normal
- WAS AN APPROPRIATE CUT-OFF VALUE CHOSEN TO OPTIMIZE SENSITIVITY AND SPECIFICITY?
- Balancing sensitivity and specificity
- Two by two tables
- Receiver operating characteristic curves
- WHAT ARE THE POSITIVE AND NEGATIVE LIKELIHOOD RATIOS?
- HOW WELL DOES THE TEST PERFORM IN SPECIFIC POPULATIONS?
- Disease prevalence
- WHAT IS THE BALANCE BETWEEN COST OF THE DISEASE AND COST OF THE TEST?
- SUMMARY AND RECOMMENDATIONS