Pompili 2003.
| Study characteristics | |||
| Patient Sampling | 131 patients with liver cirrhosis and HCC consecutively observed in our institution between 1995 and 2000 were included in the present study (HCC group). From 1998 to 2000, we also enrolled 59 cirrhotic patients without HCC (CIR group). Age range: 24‐84. Males 68% |
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| Patient characteristics and setting | |||
| Index tests | AFP: serum levels of AFP were assessed by using a microparticle enzyme immunoassay performed with commercially available kits (AxSYM AFP system; Abbott Laboratories, Abbott Park, IL, USA). Normal values for adults ranged from 5 ng/mL to 15 ng/mL. The ROC curve analysis identified 20 ng/mL as the best discriminator between HCC and cirrhotic patients. | ||
| Target condition and reference standard(s) | HCC: the definitive diagnosis of HCC was based on cytology and/ or histology of ultrasound‐guided fine‐needle biopsies in 99 cases, and unequivocal CT findings in 32 cases. Control group: the 59 cirrhotic patients without HCC (CIR group) had been biopsy‐diagnosed in 21 cases; the other 38 had ultrasound signs of cirrhosis and/or ultrasound or endoscopic evidence of portal hypertension with laboratory findings indicative of chronic liver disease. None presented focal hepatic lesions on ultrasound examination. |
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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? | Unclear | ||
| 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? | 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 | ||