High: small risk of bias | Prospective study design. Particular emphasis on the following: |
● adequately described patients constituting a representative and clinically relevant sample (QUADAS items 1, 2). | |
● the index test should not form part of the reference standard (item 7). | |
● evaluators should be masked to results of index test and reference test (items 10, 11) | |
● the tests should be described in sufficient detail to permit replication (items 8, 9). | |
● sample size ≥ 5000. | |
● diagnostic accuracy presented as sensitivity and specificity. | |
Moderate: moderate risk of bias | Prospective study design |
Since no prospective studies based on digital mammography could be identified, scanned analogue images were accepted. Otherwise the same criteria as for high quality were required. | |
Low: high risk of selection and/or verification bias | Retrospective study design. Selected or enriched samples |