| Study characteristics |
| Patient Sampling |
Blood samples were obtained from 34 patients with HCC, 20 patients with hepatitis plus liver cirrhosis.
Age range and % of males not reported |
| Patient characteristics and setting |
|
| Index tests |
AFP measurement in serum. No prespecified cut‐off value |
| Target condition and reference standard(s) |
HCC was diagnosed histologically when a liver biopsy specimen was available or from clinical information following the guidelines of the European Association for the Study of the Liver (EASL). Sera from patients who were diagnosed with nonmalignant liver disease (hepatitis with liver cirrhosis) at the time of serum collection were only included in this study if there was no indication of malignant disease 6 months after such collection. |
| Flow and timing |
No information on interval between index test and reference standard |
| Comparative |
|
| Notes |
The author, M.C, was supported by a fellowship from the Cancer Research Society of Canada. |
| 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? |
Unclear |
|
|
| If a threshold was used, was it pre‐specified? |
Yes |
|
|
| Could the conduct or interpretation of the index test have introduced bias? |
|
Unclear 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? |
No |
|
|
| Were all patients included in the analysis? |
Yes |
|
|
| Could the patient flow have introduced bias? |
|
High risk |
|
