Wang 2019b.
| Study characteristics | |||
| Patient Sampling | The study population consisted of 90 patients with HBV‐associated HCC, 90 patients with HBV‐associated liver cirrhosis (LC), 90 patients with CHB, and 90 healthy people. HCC patients and LC patients were admitted at the Second Affiliated Hospital of Harbin Medical University between January 2017 and December 2017. CHB patients and healthy participants were recruited from the Second Affiliated Hospital of Harbin Medical University. They were matched for age, gender, and body mass index. Age range not reported. Males 61% |
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| Patient characteristics and setting | |||
| Index tests | Serum AFP measurement: no specification. No predefinition of a cut‐off value | ||
| Target condition and reference standard(s) | The diagnosis of HCC was confirmed by histology, and none of HCC patients received any form of treatment before enrolment. Cirrhosis was diagnosed based on a biopsy or on a combination of clinical, endoscopic, and radiological evidence of portal hypertension or cirrhosis. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | "The authors declare that they have no conflicts of interest." | ||
| 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? | Yes | ||
| 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) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | |||
| If a threshold was used, was it pre‐specified? | |||
| Could the conduct or interpretation of the index test have introduced bias? | |||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | |||
| DOMAIN 2: Index Test (US) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | |||
| If a threshold was used, was it pre‐specified? | |||
| Could the conduct or interpretation of the index test have introduced bias? | |||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | |||
| 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? | Unclear | ||
| 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 | ||