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