From: Using patient management as a surrogate for patient health outcomes in diagnostic test evaluation
Test claim | Improved health outcomes | Conclusion | Example | |||
---|---|---|---|---|---|---|
 | Assumption 1 | Assumption 2 |  |  | ||
 | Test accuracy | Supportive evidence | Impact of changed management on health outcomes | Supportive evidence |  |  |
Adds effective treatment by detecting more cases (where new test pos, existing tests neg) | New test is more sensitive than existing tests (more TP cases) | Comparative accuracy study | Benefits for TP Absolute treatment benefits outweigh harms: i) risk of disease events is clinically important, and | i) study measuring prognosis in test-stratified population | Judgement Evidence supports potential benefits of treatment for TP, and these benefits outweigh harms for FP Or Require RCT | Breast MRI added to conventional imaging |
 |  |  | ii) relative treatment effects for TP detected by existing tests also apply to additional TP detected by new test | ii) RCT measuring treatment effectiveness for disease subgroups |  |  |
 |  |  | Harms for FP iii) harms of unnecessary treatment are acceptable | iii) study measuring risk of treatment adverse events |  |  |
Avoids unnecessary treatment or further tests by excluding more non-cases (where new test neg, existing tests pos) | New test is more specific than existing tests (fewer FP cases) | Comparative accuracy study | Benefits for TN i) treatment or further tests carry a risk of adverse events | i) study measuring risk of treatment adverse events | Judgement Evidence supports benefits of avoiding treatment or further tests for TN outweigh potential harms for FN cases Or Require RCT | POC prothrombin time versus clinical judgement |
 |  |  | Harms for FN ii) harms of omitting/delaying treatment in FN cases are acceptable | ii) study measuring prognosis in test negative patients not receiving treatment |  |  |