Abdel‐Razik 2016.
| Study characteristics | |||
| Patient Sampling | 309 participants with chronic hepatitis C were prospectively and consecutively enrolled in a tertiary university centre in Egypt.; 47 excluded according to exclusion criteria (hepatitis B virus (HBV) and HIV, liver transplant, patients who developed HCC in addition to HBV infection, patients with nonalcoholic steatohepatitis and patients receiving certain medications that may increase serotonin levels such as antidepressants or migraine headache medications, patients with hyperlipidaemia, peripheral vascular disease, hypertension, heart failure, and autoimmune diseases). Age range: 29‐70. Males 71% |
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| Patient characteristics and setting | Patients with chronic liver disease at tertiary referral centre in Egypt | ||
| Index tests | Serum total AFP was assayed using the chemiluminescent immunometric technique on an Immulite 2000 system (Siemens Medical Solutions Diagnostics, Los Angeles, California, USA). The cut‐off value of 11.8 ng/mL was derived as the optimal cut‐off. |
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| Target condition and reference standard(s) | Hepatocellular carcinoma. Quote: "All studied patients were subjected to a full assessment of history, clinical examination, abdominal ultrasonography, and computed tomography scan to confirm and/or exclude the presence of small HCC. Liver cirrhosis was diagnosed by abnormal biochemical changes, histological examination of liver biopsy, ultrasonography, or endoscopic results suggesting advanced liver disease with portal hypertension. The diagnosis of HCC was made on the basis of a clinical algorithm, triphasic spiral computed tomography of the abdomen, dynamic contrast enhanced MRI of the abdomen, and measurement of AFP." | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | 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? | Yes | ||
| Was a case‐control design avoided? | Yes | ||
| 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? | 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? | 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? | Yes | ||
| Were all patients included in the analysis? | Yes | ||
| Could the patient flow have introduced bias? | Low risk | ||