Luo 2018b.
| Study characteristics | |||
| Patient Sampling | In the present study, a total of 1448 participants, including normal controls (NC) (healthy volunteers) and patients with chronic hepatitis B (CHB) infections, liver cirrhosis, HCC, gastric cancer or intrahepatic cholangiocarcinoma were enrolled between September 2008 and May 2014. The exclusion criteria were abnormal liver biochemistry, a history of liver disease or other systematic diseases for the healthy controls, and a history of acute diseases or other types of malignant diseases for patients with liver disease. The discovery cohort consisted of 108 participants. Fasting serum samples were collected. The test cohort consisted of 684 participants. The validation cohort 1 consisted of 572 participants. Age range: 43‐65. Males 72% |
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| Patient characteristics and setting | |||
| Index tests | AFP with a cut‐off value of 20 ng/mL | ||
| Target condition and reference standard(s) | HCC: the HCC diagnosis was confirmed with ultrasound, computed tomography, or magnetic resonance imaging; and most cases were further diagnosed by histopathology according to the American Association for the Study of Liver Diseases (AASLD) practice guidelines. Cirrhosis was diagnosed based on clinical evidence of portal hypertension or hepatic decompensation according to the same guidelines. Chronic hepatitis B was defined as the presence of hepatitis B surface antigen for > 6 months, concentrations of hepatitis B virus DNA > 105 copies/ mL, and elevated aspartate aminotransferase or alanine aminotransferase levels. |
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| 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? | 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? | No | ||
| 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? | 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 | ||