| Study characteristics |
| Patient Sampling |
The study population was composed of consecutive patients who presented at the study centre with liver lesions from May 1997 to March 2003. All patients were managed in either the hepatobiliary surgical unit or the joint hepatoma clinic in the hospital Prince of Wales Hospital, Chinese University of Hong Kong; Inclusion criteria were: (i) presence of one or more focal liver lesions depicted on ultrasonography or computed
tomography of the abdomen; (ii) availability of a histological diagnosis of the corresponding liver lesion(s) obtained by resection or percutaneous needle biopsy; (iii) availability of data on the serum AFP concentration within 1 month of the histological diagnosis and before the commencement of any treatment for cancer, and (iv) a patient age of 18 years.
Age range not reported. Males 79% |
| Patient characteristics and setting |
|
| Index tests |
Serum AFP concentration was measured by electrochemiluminescence immunoassay (E170 Analytics; Roche Diagnostics Corp., Indianapolis, IN, USA |
| Target condition and reference standard(s) |
Histology of surgical specimen or obtained by US‐guided biopsy. Ultrasound‐guided percutaneous biopsy was performed in single lesions or in the most suspicious of multiple lesions. If a lesion was diagnosed histologically as non‐tumourous or as representing a benign condition, an additional 2‐year period of clinical and radiological follow‐up was initiated. A diagnosis of a benign condition was considered definitive if there was no change in clinical and radiological outcomes in the 2‐year follow‐up. Any results of repeated biopsies during the 2‐year period were reviewed to ensure the hepatic lesion was not malignant. |
| Flow and timing |
Serum AFP measured within 1 month prior to the histological diagnosis was reviewed |
| Comparative |
|
| Notes |
Conflicts of interest: none declared |
| 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? |
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 2: Index Test (US+AFP) |
| DOMAIN 2: Index Test (US) |
| 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? |
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? |
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 |
|
