| Study characteristics |
| Patient Sampling |
200 participants admitted to hospital in Rennes or Lyon from December 1974 to June 1976 underwent AFP measurement and a follow‐up (3‐18 months).
Age range: 25‐81. Males 78% |
| Patient characteristics and setting |
137 participants with cirrhosis (115 alcoholic cirrhosis) and 63 with haemochromatosis (30 with cirrhosis) |
| Index tests |
Serum AFP radioimmunoassay, cut‐off value 7.7 ng/mL |
| Target condition and reference standard(s) |
Follow up 3‐18 months; pathology on surgical specimen or autopsy |
| Flow and timing |
Tthe interval between index test and reference standard was at least 270 days. |
| Comparative |
|
| Notes |
The study was funded by the Institut National de la Santé et de la Recherche Médicale (INSERM); no conflicts of interest reported |
| 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? |
Unclear |
|
|
| 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? |
|
|
High |
| DOMAIN 4: Flow and Timing |
| Was there an appropriate interval between index test and reference standard? |
No |
|
|
| 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 |
|
