Table 2.
Review-specific modifications to the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool
| Signalling questions | Modification to QUADAS-2 toola |
|---|---|
| Domain 1: case selection | |
| Was a consecutive or random sample of cases selected? | NC |
| Was a case–control design avoided? | NC |
| Did the study avoid inappropriate exclusions? | NC |
| Was a spectrum of disease severity included in the case selection? | + |
| Was a sample size of 50 or more cases used in the study? | + |
| Domain 2: index test | |
| Were the index test results interpreted without knowledge of the results of reference test? | NC |
| If a threshold was used, was it pre-specified | − |
| Was an entire rating scale rather than a binary scale used to record index text diagnosis? | + |
| Was the instrument used to record their diagnosis calibrated with the instrument used by the gold standard readers? | + |
| Was the study reader selection for the index test representative of a radiologist population (in terms of number of readers and range of experience)? | + |
| Was the study reader for the index test given the same referral information and previous imaging as the reference test reader? | + |
| Was the index test diagnosis not limited to a type(s) of pathology? | + |
| Was the index test read with comparable monitor luminance and ambient lighting to the reference test? | + |
| Was the case order randomized? | + |
| Were all index test outcomes reported? | + |
| Domain 3: reference test | |
| Is the reference standard likely to correctly classify the target condition? | − |
| Were the reference standard results interpreted without the knowledge of the results of the index test? | NC |
| Did all cases have a reference test? | NC |
| Was the gold standard diagnosis validated—for example, by consensus of multiple radiologists or review of clinical notes? | + |
| Domain 4: flow and timing | |
| Was there an appropriate interval between index test and reference standard? | − |
| Was there an appropriate interval between index test reading and reference test reading to address retained information? | + |
| Did all cases receive a reference standard? | NC |
| Was the same reference test used for all cases? | NC |
| Were all cases included in the analysis? | NC |
a
+, signalling question added; −, signalling question removed; NC, no change from default tool.