Items |
Assessment |
Questions |
|
Q1 |
Adequate spectrum composition |
Was the spectrum of patient’s representative of the patients who will receive the test in practice? |
Q2 |
Clear description of selection criteria |
Were selection criteria clearly described? |
Q3 |
Adequate reference standard |
Is the reference standard likely to correctly classify the target condition? |
Q4 |
Absence of disease progression bias |
Is the period between reference standard and index test short enough to be reasonably sure that the target condition did not change between the 2 tests? |
Q5 |
Absence of partial verification bias |
Did the whole sample or a random selection of the sample, receive verification using a reference standard of diagnosis? |
Q6 |
Absence of differential verification bias |
Did patients receive the same reference standard regardless of the index test result? |
Q7 |
Absence of incorporation bias |
Was the reference standard independent of the index test (i.e. the index test did not form part of the reference standard)? |
Q8 |
Adequate description of the index test execution |
Was the execution of the index test described in sufficient detail to permit replication of the test? |
Q9 |
Adequate description of the reference test execution |
Was the execution of the reference standard described in sufficient detail to permit its replication? |
Q10 |
Absence of index test review bias |
Were the index test results interpreted without knowledge of the results of the reference standard? |
Q11 |
Absence of reference test review bias |
Were the reference standard results interpreted without knowledge of the results of the index test? |
Q12 |
Absence of clinical review bias |
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? |
Q13 |
Report of uninterpretable results |
Were uninterpretable/intermediate test results reported? |
Q14 |
Description of withdrawals |
Were withdrawals from the study explained? |