| Study characteristics |
| Patient Sampling |
From January 1988 to December 1997, 253 patients diagnosed with hepatic cirrhosis with hepatitis B virus infection were examined with hepatitis B markers, biochemical tests, serum α‐FP, screening tests, and ultrasound.
Age range: 33‐55. Males 68% |
| Patient characteristics and setting |
|
| Index tests |
AFP: serum α‐FP levels were measured using the Medgenix α‐FPIRMA kit (Biosource, Nivelles, Belgium). AFP cut‐off predefined. Quote: "When we defined cut‐off values of serum α‐FP as 20, 100 and 500 ng/mL, the corresponding sensitivity and specificity for HCC were 62.9% and 24.0%, 7.4% and 54.2%, 77.3% and 91.9%, respectively." |
| Target condition and reference standard(s) |
HCC: patients who had elevated serum α‐FP underwent liver ultrasonography (US) and abdominal computed tomography (CT) was performed to confirm the presence of liver cancer. Hepatic angiography and hepatic biopsy were performed if necessary. |
| Flow and timing |
No information in interval between index test and reference standard |
| Comparative |
|
| Notes |
No conflicts of interest declared |
| 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? |
Yes |
|
|
| Could the selection of patients have introduced bias? |
|
Low 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 |
|
