|
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
|
