Ishii 2000.
| Study characteristics | |||
| Patient Sampling | This prospectively designed, cooperative study was performed from November 1992 to March 1994. Patients previously diagnosed to have chronic hepatitis or liver cirrhosis were registered consecutively in this study if the following criteria were satisfied: 1) HCC was not detected by ultrasonography at the time of entry; and 2) patients agreed to close follow‐up for more and/or equal to 1 year, and had already been followed for 6 months before entry. Patients were excluded if they had lack of sufficient clinical data and because of loss to follow‐ups during the observation period. Age range: 24‐84. % of males not reported |
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| Patient characteristics and setting | |||
| Index tests | AFP. Levels of AFP were measured by an enzyme immunoassay with an anti‐AFP (Abott AFP‐EIA kit, Dainabott Laboratory, Tokyo, Japan). No pre‐specified threshold. | ||
| Target condition and reference standard(s) | HCC: once HCC was suspected through abdominal ultrasonography or by serum AFP and PIVKA‐II levels, CT with contrast medium and/or hepatic angiography were performed to establish the diagnosis of HCC. In a few cases in which the diagnosis of HCC was still equivocal. Despite the CT and hepatic angiography, percutaneous liver biopsy was performed. | ||
| Flow and timing | Out of 918 patients, 184 were excluded for lack of sufficient clinical data (61 patients) and because of loss to follow‐up during the observation period (123 patients with < 1 year of follow‐up). No data on interval between index test and reference standard | ||
| Comparative | |||
| Notes | No conflict of interest disclosure. Only acknowledgment quote: "The authors thank Ezai Industries Inc. (Tokyo, Japan) for measuring PIVKA‐II levels and gratefully acknowledge the help of Mr. N. Magario (Eizai Industries Inc.)." | ||
| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient Selection | |||
| Was a consecutive or random sample of patients enrolled? | Yes | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| Could the selection of patients have introduced bias? | Low risk | ||
| Are there concerns that the included patients and setting do not match the review question? | Low concern | ||
| 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) | |||
| 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? | No | ||
| Were all patients included in the analysis? | No | ||
| Could the patient flow have introduced bias? | High risk | ||