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