Trevisani 2001.
| Study characteristics | |||
| Patient Sampling | This case‐control study aimed to identify the best cut‐off value of serum AFP to discriminate chronic liver disease (CLD) patients with and without HCC. Two hundred and ten cases fulfilled these criteria. Among them, we were able to match 170 cases (135 males and 35 females) with 170 controls with CLD seen during the same period according to the following criteria: age (within 6 years), sex, underlying CLD (cirrhosis/chronic hepatitis), HBsAg and HCV status. Patients with liver disease due to genetic and autoimmune disorders, primary biliary cirrhosis and sclerosing cholangitis were excluded. Age range: 50‐70. Male 79% |
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| Patient characteristics and setting | |||
| Index tests | AFP: AFP was measured by conventional assays (radioimmunoassay, Eiken Chemical Co., Tokyo, Japan; LA‐AFP test, Poli, Milan, Italy; immunoenzymatic assay, Abbott Laboratories, Rome, Italy). The analysis was performed using these cut‐off values: the best discriminating value provided by the receiver‐operating characteristic (ROC) curve, the value of 20 ng/mL, and 100, 200 ng/mL and 400 ng/mL. | ||
| Target condition and reference standard(s) | HCC: the diagnosis of HCC was based on histological or cytological findings in 128 patients, while it was confirmed by clinical and imaging data or necropsy in the remainder. Control group: In control patients, the presence of HCC was ruled out by ultrasonography and also by excluding patients who developed HCC during the following 6 months. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | No information on 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? | No | ||
| Was a case‐control design avoided? | 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 (AFP) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | No | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| 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? | 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 | ||