Ma 2018.
| Study characteristics | |||
| Patient Sampling | From January 2012 to December 2013, 368 HCC patients were recruited. Enrolment criteria were as follows: (1) definitive HCC diagnosis; (2) no prior anticancer treatment; (3) complete resection of all tumour nodules, with the cut surface being free of cancer by histological examination; TACE treatments targeted intrahepatic lesions; and (4) availability of complete clinicopathologic and follow‐up data. A total of 150 HDs and 152 patients with chronic hepatitis B (CHB) and/or liver cirrhosis (LC) without a history of malignancy were enrolled as negative controls. Age range and % of males not reported |
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| Patient characteristics and setting | |||
| Index tests | AFP: cut‐off 400 ng/mL | ||
| Target condition and reference standard(s) | HCC: for the 295 patients who underwent curative resection, HCC diagnosis was based on histopathology, while for the 73 patients who underwent TACE, HCC diagnosis was based on imaging scans and AFP according to the American Association for the Study of Liver Disease (AASLD) practice guidelines. | ||
| 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 to disclose regarding funding from industrial sources or other disclosures with respect to this study. | ||
| 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? | Unclear | ||
| 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? | 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? | High | ||
| 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 | ||