Lin 2016.
| Study characteristics | |||
| Patient Sampling | 335 participants including early‐stage HCC, liver cirrhosis (LC), chronic hepatitis B (CHB), and healthy people as controls (HC) were enrolled in two cohorts. Age range not reported. Males 70% |
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| Patient characteristics and setting | Cohort I: 26 patients with early‐stage HCC, 22 with liver cirrhosis (LC), 23 with chronic hepatitis B (CHB), and 22 healthy controls Cohort II: 96 patients with early‐stage HCC, 39 with LC, 51 with CHB, and 56 healthy controls In both cohorts, HCC patients were complicated with both cirrhosis and HBV infection, and LC patients were also HBV‐positive. | ||
| Index tests | Serum samples were collected from all participants in both cohorts. | ||
| Target condition and reference standard(s) | HCC: histopathology | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | No conflicts of interest declared | ||
| 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? | 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) | |||
| 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? | No | ||
| Were all patients included in the analysis? | Yes | ||
| Could the patient flow have introduced bias? | High risk | ||