Item | Yes | No | Unclear |
1. Was the spectrum of patients representative of the patients who will receive the test in practice? | |||
2. Were selection criteria clearly described? | |||
3. Is the reference standard likely to classify the target condition correctly? | |||
4. Is the period between reference standard and index test short enough to be reasonably sure that the target condition did not change between the two tests? | |||
5. Did the whole sample or a random selection of the sample receive verification using a reference standard of diagnosis? | |||
6. Did patients receive the same reference standard regardless of the index test result? | |||
7. Was the reference standard independent of the index test (ie, the index test did not form part of the reference standard)? | |||
8. Was the execution of the index test described in sufficient detail to permit replication of the test? | |||
9. Was the execution of the reference standard described in sufficient detail to permit its replication? | |||
10. Were the index test results interpreted without knowledge of the results of the reference standard? | |||
11. Were the reference standard results interpreted without knowledge of the results of the index test? | |||
12. Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? | |||
13. Were uninterpretable/intermediate test results reported? | |||
14. Were withdrawals from the study explained? |
Reproduced with permission from Whiting P, Rutjes AW, Dinnes J, et al. Development and validation of methods for assessing the quality of diagnostic accuracy studies. Health Technol Assess 2004;8(25):iii, 1–234.14