Table 1.
Example of new test and reference test or strategy | Putative benefit of new test | Diagnostic accuracy | Patients’ outcomes and expected impact on management | Balance between presumed outcomes, test complications, and cost | ||||
---|---|---|---|---|---|---|---|---|
Sensitivity | Specificity | True positives | True negatives | False positives | False negatives | |||
Shorter version of dementia test compared with original mini mental state exam for diagnosis of dementia | Simpler test, less time | Equal | Equal | Presumed influence on patient-important outcomes: | Evidence of shorter time and similar test accuracy (and thus patients’ outcomes) would generally support new test’s usefulness | |||
Uncertain benefit from earlier diagnosis and treatment | Almost certain benefit from reassurance | Likely anxiety and possible morbidity from additional testing and treatment | Possible detriment from delayed diagnosis | |||||
Directness of evidence (test results) for outcomes important to patients: | ||||||||
Some uncertainty | No uncertainty | Some uncertainty | Major uncertainty | |||||
Helical computed tomography for renal calculus compared with intravenous pyelogram (IVP) | Detection of more (but smaller) calculi | Greater | Equal | Presumed influence on patient-important outcomes: | Fewer complications and downsides compared with IVP would support new test’s usefulness, but balance between desirable and undesirable effects is not clear in view of uncertain consequences of identifying smaller stones | |||
Certain benefit for larger stones; less clear benefit for smaller stones, and unnecessary treatment can result | Almost certain benefit from avoiding unnecessary tests | Likely detriment from unnecessary additional invasive tests | Likely detriment for large stones; less certain for small stones, but possible detriment from unnecessary additional invasive tests for other potential causes of complaints | |||||
Directness of evidence (test results) for patient-important outcomes: | ||||||||
Some uncertainty | No uncertainty | No uncertainty | Major uncertainty | |||||
Computed tomography for coronary artery disease compared with coronary angiography | Less invasive testing, but misses some cases | Slightly less | Less | Presumed influence on patient-important outcomes: | Undesirable consequences of more false positives and false negatives with computed tomography are not acceptable despite higher rate of rare complications (infarction and death) and higher cost of angiography | |||
Benefit from treatment and fewer complications | Benefit from reassurance and fewer complications | Harm from unnecessary treatment | Detriment from delayed diagnosis or myocardial insult | |||||
Directness of evidence (test results) for patient-important outcomes: | ||||||||
No uncertainty | No uncertainty | No uncertainty | Some uncertainty |
See text for explanations of terms.