| Study characteristics |
| Patient Sampling |
This study was conducted on 60 adult patients: 30 patients with CHCV infection and 30 patients with HCC who presented to Tropical, Internal Medicine Department of Al‐Zahraa University Hospital, from March to November 2014.
Exclusion criteria: patients with history or evidence of other malignancies; patients suffering from any other organ failure; and other causes of cirrhosis e.g. alcohol.
Age range: 35‐62. Males 60% |
| Patient characteristics and setting |
|
| Index tests |
Serum alpha‐foetoprotein (AFP) was detected by COBAS e411 chemiluminescence auto‐analyser, using Roche reagents (Roche Diagnostics GmbH, D‐68289 Mannheim, Germany) with no predefined cut‐off value. |
| Target condition and reference standard(s) |
All patients and controls were subjected to the following:
1. Full history and clinical examination.
2. Abdominal ultrasonography.
3. Abdomino‐pelvic triphasic CT scan for suspected cases of HCC.
Liver biopsy and histopathological examination were done when needed for patients with hepatic focal lesions, not fulfilling imaging or AFP diagnostic criteria for HCC. |
| Flow and timing |
No information on interval between index test and reference standard |
| Comparative |
|
| Notes |
No information on funding or 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? |
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? |
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? |
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 |
|
