Table 1.
Step | Description |
---|---|
1 | Choose statistical metric for performance |
2 | Determine patient and/or tumor characteristics that can degrade performance for the quantitative imaging biomarker |
3 | Identify plausible set of values for performance |
4 | Consider clinical requirements for performance |
5 | Consider the sample size requirements for actors to test their imaging procedure against the claim value |
6 | Choose the performance value from the plausible set of values in step 3, taking into consideration steps 4–5. |