| Study characteristics |
| Patient Sampling |
The authors presented interim results from a prospective cohort study (8/14‐5/17) at the Houston VAMC.
Quote: "We enrolled consecutive patients with cirrhosis irrespective of aetiology and no past or present HCC in a 6‐monthly surveillance program consisting of liver imaging (mostly ultrasound) combined with AFP. We limited the analysis to 26 HCC cases with complete information on biomarkers before HCC development and 543 controls with consistently negative liver imaging."
Age range not reported. Males 98% |
| Patient characteristics and setting |
|
| Index tests |
Serum AFP measurement; cut‐off value 20 ng/mL |
| Target condition and reference standard(s) |
US, CT, MR, histology; follow‐up 6 months |
| Flow and timing |
No information on interval between index test and reference standard |
| Comparative |
|
| Notes |
Abstract. 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? |
Yes |
|
|
| Was a case‐control design avoided? |
Yes |
|
|
| 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? |
|
|
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 |
|
