| Study characteristics |
| Patient Sampling |
This retrospective study provides a broad survey of the accuracy of US, CT, and MRI for HCC detection in a large population of cirrhotic patients undergoing liver transplantation in a single major USA transplantation centre Query of our database yielded 1097 adults receiving orthotopic liver transplantation at our institution from January 1999 to November 2006. Of these, 638 consecutive patients (407 men, 231 women; age 18–75 years, mean 53.2) with chronic liver disease who underwent unenhanced US, contrast‐enhanced single or multidetector helical CT, and/or dynamic contrast‐enhanced MRI at our institution within 6 months of the transplantation comprised the study population. HCC was confirmed in 638 patients.
Age range: 18‐75. Males 64% |
| Patient characteristics and setting |
|
| Index tests |
AFP: cut‐off values prespecified at 10 ng/mL and 20 ng/mL; US no definition of positivity criteria |
| Target condition and reference standard(s) |
Reference standard: pathology of the explanted liver |
| Flow and timing |
Patients who had imaging modalities performed within 6 months of the transplantation comprised the study population. |
| Comparative |
|
| Notes |
The author discloses the following: "Dr Lu has received educational and research support from Philips and GE Healthcare. The other authors disclose no conflicts of interest." |
| Methodological quality |
| Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
| DOMAIN 1: Patient Selection |
| Was a consecutive or random sample of patients enrolled? |
Yes |
|
|
| Was a case‐control design avoided? |
Yes |
|
|
| 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 (AFP) |
| Were the index test results interpreted without knowledge of the results of the reference standard? |
Yes |
|
|
| If a threshold was used, was it pre‐specified? |
Yes |
|
|
| Could the conduct or interpretation of the index test have introduced bias? |
|
Low risk |
|
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? |
|
|
Low concern |
| DOMAIN 2: Index Test (US+AFP) |
| DOMAIN 2: Index Test (US) |
| Were the index test results interpreted without knowledge of the results of the reference standard? |
Yes |
|
|
| If a threshold was used, was it pre‐specified? |
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? |
Yes |
|
|
| Were the reference standard results interpreted without knowledge of the results of the index tests? |
Yes |
|
|
| Could the reference standard, its conduct, or its interpretation have introduced bias? |
|
Low risk |
|
| Are there concerns that the target condition as defined by the reference standard does not match the question? |
|
|
Low concern |
| DOMAIN 4: Flow and Timing |
| Was there an appropriate interval between index test and reference standard? |
Yes |
|
|
| Did all patients receive the same reference standard? |
Yes |
|
|
| Were all patients included in the analysis? |
Yes |
|
|
| Could the patient flow have introduced bias? |
|
Low risk |
|
