Song 2014.
| Study characteristics | |||
| Patient Sampling | This is a case‐control study which included consecutive patients divided into five groups.
The groups of interest are the following.
1) HCC group, which involved HCC patients proved by pathology after hepatic resection (550 cases)
4) Chronic liver disease group (85 cases), which involved patients with hepatitis or liver cirrhosis Age range: 15‐82. Males 87% |
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| Patient characteristics and setting | |||
| Index tests | AFP: serum AFP levels were tested using a commercial ELISA kit in accordance with instructions from the manufacturer (Biocell Biotech, Zhengzhou, China). Youden's index was calculated as an index of sensitivity and specificity. To determine the optimal cut‐off values for DCP and AFP to diagnose HCC, receiver operating characteristic (ROC) curves were created using all possible cutoffs for each assay. The optimal cut‐off value for AFP was 21 ng/mL. | ||
| Target condition and reference standard(s) | HCC: HCC patients proved by pathology after hepatic resection | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | No information on 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? | No | ||
| Did the study avoid inappropriate exclusions? | Unclear | ||
| 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? | No | ||
| If a threshold was used, was it pre‐specified? | No | ||
| Could the conduct or interpretation of the index test have introduced bias? | High 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? | No | ||
| 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? | 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 | ||