Omar 2017.
| Study characteristics | |||
| Patient Sampling | Data of 2363 Egyptian patients with HCV‐related chronic liver disease were reviewed. 1291 patients were diagnosed with HCC, while 1072 had HCV‐related liver cirrhosis with no HCC on top. Focal hepatic lesions detected on US and/or rising levels of AFP were evaluated by CT or MRI. Age range and % of males not reported |
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| Patient characteristics and setting | |||
| Index tests | AFP: it was found that serum AFP was able to diagnose HCC at the cut‐off level of 11.9 ng/mL with sensitivity 68% and specificity 80.6%. | ||
| Target condition and reference standard(s) | HCC: diagnosed by CT or MRI. Lesions showing hyperenhancement in arterial phase were diagnosed as HCC. Rising AFP assays were further evaluated by CT or MRI. | ||
| Flow and timing | No information on timing between index test and reference standard | ||
| Comparative | |||
| Notes | All authors declared no 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? | 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? | 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? | 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 | ||