Shimizu 2002.
| Study characteristics | |||
| Patient Sampling | This is a case‐control study which included 56 liver cirrhosis patients with HCC and 34 liver cirrhosis patients without HCC. In the liver cirrhosis only group: three of the 39 patients who had developed HCC within one year and 2 patients with warfarin therapy were excluded. Age range: 35‐84. Males 79% |
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| Patient characteristics and setting | |||
| Index tests | AFP: serum AFP levels were measured by EIA (TOSOH, Yamaguchi, Japan). Cut‐off values predefined at 20, 100, and 200 ng/mL | ||
| Target condition and reference standard(s) | HCC: the diagnosis of HCC was based on histological findings in tissue obtained at the time of surgery (n = 6) or ultrasonography guided tumour biopsy (n = 25) in 31 patients. For the remaining 25 patients, the diagnosis was made by imaging modalities, such as ultrasonography, computed tomography, magnetic resonance imaging, and angiography, or was based on elevated serum concentrations of AFP or des‐gamma‐carboxyprothrombin (DCP). Liver cirrhosis control group: all of the patients were regularly checked at 1‐ or 2‐month intervals, at 3‐month intervals for ultrasonography and every 12 months for computed tomography in order to detect HCC. |
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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? | 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 | ||