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