| Study characteristics |
| Patient Sampling |
The study population included 164 people with cirrhosis, referred to the Department of Turin from January 1981 to July 1986. The patients were prospectively followed as out patients for at least 12 months.
Age range: 36‐79. Males 66% |
| Patient characteristics and setting |
|
| Index tests |
AFP with commercial Kit (alpha fetoprotein Riabead, Dainabot Co. Ltd Tokyo Japan) |
| Target condition and reference standard(s) |
HCC histology; chronic liver disease: US, AFP, CT |
| 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? |
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? |
|
|
Low concern |
| 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 |
|
