Wang 2009.
| Study characteristics | |||
| Patient Sampling | Consecutive patients with HCC and patients with cirrhosis that were age, gender, and race/ethnicity matched to the HCC patients were enrolled from the Liver Clinic from Saint Louis University School of Medicine or the University of Michigan. The study included 113 patients with cirrhosis, 108 patients with stage I or II HCC, and 56 patients with stage III or IV HCC. Age range: 42‐71. Males 71% |
||
| Patient characteristics and setting | |||
| Index tests | AFP: AFP was tested using commercially‐available immunoassays using enhanced chemiluminescence at the University of Michigan Hospital Clinical Diagnostic Laboratory. The upper limit of normal was 8 ng/mL. | ||
| Target condition and reference standard(s) | HCC: the diagnosis of HCC was made by histopathology, including all T1 lesions, and, if histopathology was not available, by two imaging modalities [ultrasound (US), magnetic resonance imaging (MRI), or computed tomography (CT)] showing a vascular enhancing mass of > 2 cm. Control group: each of the patients with cirrhosis had a normal US and, if serum AFP was elevated, a MRI of the liver within 3 months before enrolment and another one 6 months after enrolment that showed no liver mass. The cirrhotic controls have been followed for a median of 12 months (range, 7‐18 months) after enrolment, and no one has developed HCC. |
||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | No potential conflicts of interest exist | ||
| 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? | 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 | ||