Kim 2014.
| Study characteristics | |||
| Patient Sampling | Liver cirrhosis group (LC): 35 patients with compensated hepatitis B virus (HBV) cirrhosis and no HCC. The cirrhosis group had at least 1 year of follow‐up from the time that serum was obtained for these studies. Patients were diagnosed with cirrhosis, based on established clinical, laboratory, and imaging criteria with ultrasound examination. HCC group: 60 patients before HCC treatment who were infected with HBV were also enrolled, from whom serum samples were collected and defined as the HCC group. To reduce causal heterogeneity, HCC patients who had other types of chronic liver disease, except for chronic hepatitis B, such as chronic hepatitis C and alcoholic hepatitis, were excluded. A subgroup of patients with stage I HCC was compared to the patients in the LC group. Age range and % of males not reported |
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| Patient characteristics and setting | |||
| Index tests | AFP. Predefined cut‐off value of 20 ng/mL | ||
| Target condition and reference standard(s) | HCC: the diagnosis of HCC was made per the AASLD practice guidelines by a hepatologist with more than 20 years of experience. | ||
| Flow and timing | No data on interval between index test and reference standard | ||
| Comparative | |||
| Notes | The authors have declared that no competing interests existed. | ||
| 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? | Yes | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
| 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? | No | ||
| Could the patient flow have introduced bias? | High risk | ||