Moriyama 2000.
| Study characteristics | |||
| Patient Sampling | This study included 39 patients with HCC based on chronic liver disease (CLD) and 50 CLD patients without HCC. CLD included clinicopathologically‐proven chronic hepatitis (CH) and compensated liver cirrhosis (LC). In order to avoid the overestimation of the markers, they excluded cases with advanced HCC. Therefore, they selected 39 HCC patients with the tumour size < 3 cm and the number of tumours that were < 3. Age range: 21‐78. Males 60% |
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| Patient characteristics and setting | |||
| Index tests | AFP: serum AFP concentrations were assayed using a solid phase immunoassay analyzer (ARC 1000, Aloka, Tokyo) with a detection limit of 1.0 ng/mL. According to the ROC curve analysis, the optimal cut‐off value for AFP was 18.0 ng/mL. | ||
| Target condition and reference standard(s) | HCC: HCC was diagnosed by characteristic findings from ultrasonography, computed tomography, and hepatic angiography which are compatible with HCC or in combination with the histological examinations of a tumour biopsy. No information on diagnosis of control group |
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| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | No information on 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? | 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 | ||