Ozkan 2011.
| Study characteristics | |||
| Patient Sampling | 158 participants were enrolled in the study between May and October 2009. The participants were divided into three groups: Group 1: 75 cirrhotic patients with HCC Group 2; 55 cirrhotic patients without HCC Group 3: 28 healthy controls Age range not reported. Males 67% |
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| Patient characteristics and setting | |||
| Index tests | AFP was tested using commercially available immunoassays utilising enhanced chemiluminescence at our hospital central laboratory. The upper limit of the normal level was 13 ng/mL. | ||
| Target condition and reference standard(s) | The diagnosis of HCC was made by histopathology. If histopathology was not available, the diagnosis was reached by two imaging modalities (ultrasound, magnetic resonance imaging or computed tomography) showing a vascular‐enhancing mass. Diagnosis of cirrhosis was based on liver histology or clinical, laboratory, and imaging evidence of hepatic decompensation or portal hypertension. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | No information on conflicts of interest or 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 | ||
| Was a case‐control design avoided? | No | ||
| Did the study avoid inappropriate exclusions? | Unclear | ||
| 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? | Unclear | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| Could the conduct or interpretation of the index test have introduced bias? | Unclear 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? | Unclear | ||
| 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? | Unclear 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? | 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 | ||