| Study characteristics |
| Patient Sampling |
Retrospective trial conducted between January 2010 and January 2013. Evaluated 126 people with focal liver lesions. Only patients with available data were included. |
| Patient characteristics and setting |
< 30% of participants had evidence of CLD. |
| Index tests |
Aim: to assess the role of transabdominal CEUS and MRI in characterisation and detection of HCC in people diagnosed with focal liver lesions. MRI positivity criteria were not clearly reported. 1 independent experienced radiologist analysed MR images. |
| Target condition and reference standard(s) |
Reference standards: clinical data, blood analysis, imaging (CT/ MRI), and histopathological information. Histopathology was used in only 15 cases with inconclusive imaging results, in benign cases MRI was considered the reference standard, other cases were unclear. |
| Flow and timing |
Time between index test and reference standard unclear. |
| Comparative |
|
| Notes |
Authors declared no COI. Authors reported a public institution regarding source of funding. |
| Methodological quality |
| Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
| DOMAIN 1: Patient Selection |
| Was a consecutive or random sample of patients enrolled? |
No |
|
|
| Did the study avoid inappropriate exclusions? |
No |
|
|
| Could the selection of patients have introduced bias? |
|
High risk |
|
| Are there concerns that the included patients and setting do not match the review question? |
|
|
High |
| DOMAIN 2: Index Test (All tests) |
| Were the index test results interpreted without knowledge of the results of the reference standard? |
Yes |
|
|
| Were positivity criteria clearly defined? |
No |
|
|
| Could the conduct or interpretation of the index test have introduced bias? |
|
High risk |
|
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
|
|
Low concern |
| DOMAIN 3: Reference Standard |
| Is the reference standards likely to correctly classify the target condition? |
No |
|
|
| Were the reference standard results interpreted without knowledge of the results of the index tests? |
No |
|
|
| Could the reference standard, its conduct, or its interpretation have introduced bias? |
|
High risk |
|
| Are there concerns that the target condition as defined by the reference standard does not match the question? |
|
|
High |
| DOMAIN 4: Flow and Timing |
| Was there an appropriate interval between index test and reference standard? |
Unclear |
|
|
| Did all patients receive the same reference standard? |
No |
|
|
| Were all patients included in the analysis? |
Yes |
|
|
| Could the patient flow have introduced bias? |
|
High risk |
|
