| Study characteristics |
| Patient Sampling |
All patients diagnosed with HCC (mean age ± SD, 58 ±10.5 years; male:female ratio, 3.4:1) at TropicalMedicine Unit,Mansoura University hospitals, Mansoura, Egypt between March 2008 to December 2010 were considered eligible for this study.The second group included 100 patients with cirrhosis (mean age ± SD, 50 ± 11.6 years; male:female ratio, 2.8:1). During a 3‐year period (2008–2010), 150 consecutive HCC patients and 100 LC patients and 50 healthy individuals were enrolled in the study. Patients with rheumatoid arthritis, hepatitis B viral infection, alcohol abuse, autoimmune liver diseases and metabolic disorders, or other malignancies were not included.
Age range not reported. Males 75% |
| Patient characteristics and setting |
|
| Index tests |
AFP level was performed by chemiluminescence, with Immulite AFP (1000) kit (Diagnostic Products Corporation; Los Angeles, CA, USA). |
| Target condition and reference standard(s) |
The diagnosis of HCC was based on AFP levels N200 ng/mL, the presence of hepatic focal lesion (s) detected by liver ultrasound and confirmed by computed tomography and/or magnetic resonance as imaging techniques. The final diagnosis was confirmed by histopathological analysis on ultrasound assisted fine‐needle biopsy, when indicated. All the studied participants underwent thorough clinical examination and ultrasonography of the abdomen. |
| Flow and timing |
No information on interval between index test and reference standard |
| Comparative |
|
| Notes |
No information on conflicts of interest or funding |
| 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? |
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? |
Yes |
|
|
| Could the conduct or interpretation of the index test have introduced bias? |
|
Low 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? |
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 |
|
