Guan 2020.
| Study characteristics | |||
| Patient Sampling | A total of 581 cases of serum samples including 302 cases of HCC, 105 cases of liver cirrhosis, 59 cases of chronic hepatitis B (CHB), and 115 cases of healthy controls. Age range not reported. Males 63% |
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| Patient characteristics and setting | |||
| Index tests | Alpha‐foetoprotein (AFP) was measured using standard methods and matched reagents (HITACHI 7600, Hitachi Koki Co. Ltd., Hitachinaka City, Japan. No pre‐definition of cut‐off value | ||
| Target condition and reference standard(s) | HCC was confirmed by histological study after surgical resection. The diagnosis of each patient was confirmed by laboratory, pathological, and imageological examination. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | The authors declared that there were 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? | 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? | Unclear | ||
| 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? | No | ||
| Could the patient flow have introduced bias? | High risk | ||