Kumada 2014.
| Study characteristics | |||
| Patient Sampling | Out of 2830 patients positive for hepatitis B surface antigen (HBsAg) or anti‐hepatitis C virus (HCV) antibody, who visited the Department of Gastroenterology and Hepatology, 1214 patients met the eligibility criteria: HBsAg‐ or HCV RNA‐positive for more than 6 months, follow‐up period of > 3 years before HCC diagnosis, availability of sera sampled at least twice at 12‐month intervals, maximal tumour diameter < 3 cm, and 3 nodules or less at diagnosis, and no oral intake of warfarin which is a DCP‐inducing agent. Of these 1214 patients, 114 patients had HCC and 1100 patients had no evidence of HCC during the follow‐up period. To reduce the confounding effects of covariates between HCC and control patients, we selected patients using propensity score matching. We were able to match 104 patients with developed HCC to 104 non‐HCC developing patients. Age range: 14‐84. Males 56% |
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| Patient characteristics and setting | |||
| Index tests | AFP. No explicit info on AFP cut‐off being predefined | ||
| Target condition and reference standard(s) | HCC: 45 patients were diagnosed as HCC histologically (surgical specimen, 39 patients; US‐guided needle biopsy specimens, 6 patients). The remaining 59 patients were diagnosed as patients with HCC, showing typical findings of dynamic MRI including hypervascular in the arterial phase with washout in the portal venous or delayed phase. Patients with liver cirrhosis (LC): US, MRI. |
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| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | All 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? | No | ||
| 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? | Yes | ||
| 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? | Low 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 | ||