Table 2 Protocol based on the Quadas tool for interpretation of relevant original studies

1

Was the spectrum of patients representative of the patients who will receive the test in practice?

2

Were the selection criteria clearly described?

3

Is there a diagnostic reference standard?

4

If so, is the reference standard likely to correctly classify the target condition?

5

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?

6

Did the whole sample or a random selection of sample, receive verification using a reference standard of diagnosis?

7

Was the execution of the index test described in sufficient detail to permit replication of the test?

8

Was the execution of the reference standard described in sufficient detail to permit replication of the test?

9

Were the index test results interpreted without knowledge of the results of the reference standard?

10

Were the reference standard results interpreted without knowledge of the results of the index test?

11

Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?

12

Were uninterpretable/intermediate results reported?

13

Were withdrawals from the study explained?

14

Are data presented on observer or instrument variation that could affect the estimates of test performance?

15

Were appropriate results presented (percentage of correct diagnoses, sensitivity, specificity, predictive values, measures of ROC, likelihood ratios, or other relevant measures) and were these calculated appropriately?