1. Was the spectrum of patients representative of the patients who will receive the test in practice? |
8 |
0 |
0 |
2. Were selection criteria clearly described? |
8 |
0 |
0 |
3. Is the reference standard likely to correctly classify the target condition? |
8 |
0 |
0 |
4. Is the time period between reference standard and index test short enough to be reasonably sure that the target condition did not change between the two tests? |
6 |
0 |
2 |
5. Did the whole sample or a random selection of the sample receive verification using a reference standard of diagnosis? |
8 |
0 |
0 |
6. Did patients receive the same reference standard regardless of the index test result? |
8 |
0 |
0 |
7. Was the reference standard independent of the index test (ie, the index test did not form part of the reference standard)? |
8 |
0 |
0 |
8. Was the execution of the index test described in sufficient detail to permit replication of the test? |
8 |
0 |
0 |
9. Was the execution of the reference standard described in sufficient detail to permit its replication? |
8 |
0 |
0 |
10. Were the index test results interpreted without knowledge of the results of the reference standard? |
4 |
0 |
4 |
11. Were the reference standard results interpreted without knowledge of the results of the index test? |
4 |
0 |
4 |
12. Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? |
8 |
0 |
0 |
13. Were non-interpretable/intermediate test results reported? |
0 |
8 |
0 |
14. Were withdrawals from the study explained? |
8 |
0 |
0 |