Goals:
(1) to be used in systematic reviews of diagnostic accuracy
(2) to be relevant to all diagnostic studies (can be used to assess the methodologic quality of a diagnostic study in generic terms)
(3) allows consistent and reliable assessment by raters with different backgrounds
(4) relatively short and simple to complete
Items:
(1) spectrum of patients in study representative of patients seen in practice
(2) selection criteria clearly described
(3) reference standard likely to correctly classify the target condition
(4) time interval between reference and diagnostic tests short enough to be reasonably sure that the target condition did not change between the 2 tests
(5) verification of whole sample or a random representative selection using the reference standard
(6) patients received the same reference standard independent of the index test result
(7) the reference standard and index test are independent
(8) index test described in sufficient detail to permit replication by others
(9) reference standard described in sufficient detail to permit replication by others
(10) interpretation of the index test blinded to the results of the reference standard
(11) interpretation of the reference standard blinded to the results of the index test
(12) data used in test evaluation the same as would be available if used in practice
(13) uninterpretable intermediate test results reported
(14) withdrawals form the study explained
Interpretation:
• The ideal study has all 14 items marked as Yes.
