1. Was the spectrum of patients representative of the patients who will receive the test in practice?
|
No
|
No
|
No
|
2. Were selection criteria clearly described?
|
No
|
No
|
No
|
3. Is the reference standard likely to correctly classify the target condition?
|
No
|
No
|
No
|
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?
|
Yes
|
Yes
|
Yes
|
5. Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis?
|
Yes
|
No
|
No
|
6. Did patients receive the same reference standard regardless of the index test result?
|
Yes
|
No
|
No
|
7. Was the reference standard independent of the index test (i.e. the index test did not form part of the reference standard)?
|
No
|
No
|
No
|
8. Was the execution of the index test described in sufficient detail to permit replication of the test?
|
No
|
No
|
No
|
9. Was the execution of the reference standard described in sufficient detail to permit its replication?
|
Yes
|
No
|
No
|
10. Were the index test results interpreted without knowledge of the results of the reference standard?
|
No
|
No
|
No
|
11. Were the reference standard results interpreted without knowledge of the results of the index test?
|
Yes
|
No
|
No
|
12. Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?
|
n/a
|
n/a
|
n/a
|
13. Were uninterpretable/ intermediate test results reported?
|
No
|
No
|
No
|
14. Were withdrawals from the study explained? |
No |
No |
No |