Liu 2007.
| Study characteristics | |||
| Patient Sampling | Patients were recruited from 4 hospitals in Beijing (Youan Hospital, Wujing Hospital, Ditan Hospital, and Beida Hospital), from the Nanjing 2nd Hospital in Nanjing, and from Shanghai Hospital in Shanghai, China. In total, 497 HBV‐infected patients with chronic liver diseases were recruited. The study included 227 cases with HCC and cirrhosis, and 80 cases with cirrhosis. 47 were excluded because of metastasis, autoimmune liver disease, drug related hepatitis, alcoholic hepatitis, or obstructive jaundice. Age range: 39‐64. Males 83% |
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| Patient characteristics and setting | |||
| Index tests | AFP: no explicit data on AFP cut‐off value being prespecified | ||
| Target condition and reference standard(s) | HCC: 227 patients with cirrhosis and HCC were diagnosed histologically by biopsy, autopsy, and surgical specimens, and clinically by ultrasonography and/or computed tomography scanning in a regular examination, and this was combined with the measurement of AFP (cut‐off of 20 ng/mL). | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | Potential conflict of interest: nothing to report | ||
| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient Selection | |||
| Was a consecutive or random sample of patients enrolled? | Unclear | ||
| 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? | 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? | 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 | ||