Item | Fritz et al. [ 24 ] | Kasai et al. [ 25 ] | |
---|---|---|---|
1. | Was the spectrum of patients representative of the patients who will receive the test in practice? | Y | U |
2. | Were selection criteria clearly described? | Y | N |
3. | Is the reference standard likely to correctly classify the target condition? | Y | Y |
4. | Is the time period between reference standard and index test short enough to the reasonably sure that the target condition did not change between the two tests? | Y | U |
5. | Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis? | Y | Y |
6. | Did patients receive the same reference standard regardless of the index result? | Y | Y |
7. | Was the reference standard independent of the index (i.e. The index test did not form part of the reference standard)? | Y | Y |
8. | Was the execution of the index described in sufficient detail to permit replication of the test? | Y | Y |
9. | Was the execution of the reference standard described in sufficient detail to permit its replication? | Y | U |
10. | Were the index test results interpreted without knowledge of the result of the reference standard? | Y | Y |
11. | Were the reference standard results interpreted without knowledge of the results of the index test? | Y | Y |
12. | Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? | Y | Y |
13. | Were uninterpretable/intermediate test results reported? | Y | Y |
14. | Were withdrawals from the study explained? | Y | Y |