Population |
Clinical spectrum and other characteristics of the prognostic groups including the observed probabilities of the outcome being predicted |
Intervention |
The prognostic test or assessment including all components, exactly what it measures, how it is done, how clinical specimens are obtained, processed, and stored for testing, exactly what is being predicted and how the test results are to be interpreted and used by test operators |
Comparator |
Standard prognostic tests or assessments for predicting the same outcome |
Outcomes |
Time-dependent probabilities (time-to-event curves) of what is being predicted, changes or differences in predicted outcome probabilities or reclassification of patients into different prognostic groups, changes in patient care, the net effect of using the prognostic test on patient outcomes, and cost effectiveness |
Timing |
At what stage in the natural history of outcome development is the prognostic test to be used? How much follow-up time does the prognostic test cover? The percentage of patients who experience the outcome usually increases with time thereby changing the performance charactersitics of prognostic tests |
Setting |
Who will use prognostic test? How? What is the applicable testing scenario? |