Kim 2012.
| Study characteristics | |||
| Patient Sampling | Serum AFP levels were collected in 354 patients with liver disease and 196 patients with HCC. Age range and % of males not reported |
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| Patient characteristics and setting | |||
| Index tests | AFP: the serum AFP was measured using a routine automated method in chemiluminescent microparticle immunoassay (ARCHITECT i2000SR, Abbott). The cut‐off value for the AFP level was set at 20 ng/mL according to the manufacturer's instruction. | ||
| Target condition and reference standard(s) | HCC: all cases of HCC were diagnosed by fine‐needle biopsy under the guidance of ultrasonography and surgery. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | No data 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? | Unclear | ||
| Was a case‐control design avoided? | No | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| 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? | Yes | ||
| 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? | 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? | Unclear | ||
| Were all patients included in the analysis? | Yes | ||
| Could the patient flow have introduced bias? | Unclear risk | ||