Quality item | Positive score |
---|---|
1. Was the spectrum of patients representative of the patients who will receive the test in practice? | Patients with lesions detected at conventional imaging (e.g., CT, US, or anatomical MRI). Conventional imaging could not assess whether those lesions were benign or malignant |
2. Were selection criteria clearly described? | It was clear how patients were selected for inclusion |
3. Is the reference standard likely to correctly classify the target condition? | Histological examination was used as a reference standard |
4. Was the time period between histological assessment and DWI short enough to be reasonably sure that the target condition did not change between the two tests? | Histological assessment was performed within 2Â weeks after DWI |
5. Did the whole sample or a random selection of the sample receive verification using a reference standard of diagnosis? | All patients, or a random sample of patients, received histological examination |
6. Did patients receive the same reference standard regardless of the index test result? | Patients received histological assessment regardless of ADC measured |
7. Was the execution of the index test described in sufficient detail to permit replication of the test? | All of the following MRI parameters are described: field strength, coil type, sequence type, applied b-values, BH/RT/FB, and direction(s) of applied diffusion gradients |
8. Was the execution of the reference test described in sufficient detail to permit replication? | Description of the following points: means of harvesting histological material (biopsy or surgery) given, interpreter of histological assessment mentioned |
9. Were the index test results interpreted without knowledge of the results of the reference standard? | DWI was interpreted without knowledge of the histological assessment findings |
10. Were the reference standard results interpreted without knowledge of the results of the index test? | Histological assessment was interpreted without knowledge of the DWI findings |
11. Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? | Clinical data were available to the interpreter(s) of the DWI |
12. Were withdrawals from the study explained? | Withdrawals from the study after inclusion were explained |