From: Planning clinically relevant biomarker validation studies using the “number needed to treat” concept
Stepping stone | Question format | |
---|---|---|
0 | Classification rule development | (Outside the scope of this article) |
1 | Defining the clinical scenario | Who are the patients, what are the clinical options? |
2 | Principal goal | What NNT s for the BestToAct and BestToWait groups would make the decision clear-cut? |
3 | Clinical benefit | Specifically how will patients be helped by a test that achieves these NNT’s? |
4 | Classification performance needed | What predictive values do these NNT’s correspond to? |
5 | Prospective study requirements | Given these NNT’s, how large should a prospective study be, and how long the follow-up? |
6 | Retrospective study requirements | Given a prevalence, what sensitivity and specificity do we hope for, and what should the sample sizes be to estimate them sufficiently? |