Han 2014.
| Study characteristics | |||
| Patient Sampling | 160 HBV‐infected patients with HCC, 88 CHB patients without HCC from April 2012 to April 2013 in the Department of Hepatology, Qilu Hospital of Shandong University. Exclusion criteria included co‐infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV), alcoholic liver diseases, autoimmune liver diseases, non‐alcoholic fatty liver diseases (NAFLD), and other causes of chronic liver diseases. Age range: 46‐61. Males 77%. |
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| Patient characteristics and setting | The current study enrolled a total of 84 patients with HBV/HCV‑related HCC (69 males and 15 females), 74 patients with HBV/HCV‑associated liver cirrhosis (42 males and 32 females), and 29 patients with chronic hepatitis B/C (14 males and 15 females). | ||
| Index tests | AFP was also measured by an automatic analyser (COBAS e 601, Roche Diagnostics, Germany). Cut‐off value 20 ng/mL | ||
| Target condition and reference standard(s) | HCC patients were diagnosed according to the 2010 update of the American Association for the Study of Liver Diseases (AASLD) Practice Guidelines for Management of hepatocellular carcinoma. Chronic HBV infection was defined as a positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to the beginning of this study. Within all the 88 CHB patients, 33 were accompanied by cirrhosis. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | The authors declared that no competing interest 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? | Unclear | ||
| 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? | Unclear | ||
| 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 | ||