Volk 2007.
| Study characteristics | |||
| Patient Sampling | All patients were consecutively enrolled from the liver clinics at the University of Michigan Medical Center between February 2003 and December 2004. Two groups of consecutive patients were enrolled: patients with a diagnosis of HCC, and control individuals with cirrhosis without HCC. A total of 84 patients with HCC and 169 patients with cirrhosis and no HCC were enrolled. Age range: 45‐71. Males 67% |
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| Patient characteristics and setting | |||
| Index tests | AFP: total AFP was tested using commercially available immunometric assays with enhanced chemiluminescence at the University of Michigan Hospital Clinical Diagnostic Laboratory and at Wako Diagnostics (Richmond, Virginia). Receiver‐operating characteristic (ROC) curves were constructed to determine the optimal cutoff for each marker in differentiating between HCC and cirrhosis without HCC. The optimal cut‐off that maximized the sensitivity and specificity for AFP was a total AFP > 23 ng/mL. |
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| Target condition and reference standard(s) | HCC: the diagnosis of HCC was based on the European Association for the Study of the Liver (EASL) criteria. Control group: to ensure that cirrhosis controls did not have HCC, an ultrasound showing no mass was required if the total AFP was < 20 ng/mL, and a triple phase CT or dynamic MRI was required if the AFP was > 20 ng/mL. Additionally, these patients were followed for a median of 14 months (range: 8–37 months) and had at least one follow‐up imaging to assure that none had developed HCC. Computed tomography (CT) and magnetic resonance imaging (MRI) studies of patients with HCC were reviewed by one radiologist who was not aware of the serum marker results. |
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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? | 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? | 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? | 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 | ||