Yao 2016.
| Study characteristics | |||
| Patient Sampling | A total of 1845 patients diagnosed either with chronic hepatitis, cirrhosis, or HCC with different backgrounds were enrolled between December 2008 and December 2013 at Henan Cancer Hospital in Zhengzhou, and Beijing Hospital. The study included 318 cases of hepatitis, 731 cases of cirrhosis and 796 HCC cases. Age range: 31‐65. Males 79.5% |
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| Patient characteristics and setting | |||
| Index tests | AFP: Receiver operating characteristic (ROC) curves were plotted to identify a cut‐off value that would best distinguish HCC patients from the other two groups of participants. The optimal cut‐off value for AFP was 11.62 ng/mL. The measurement of AFP in the two hospitals were achieved by using same electrochemiluminescence immunoassay system Modular E170 (Roche, Mannheim, Germany). The normal range is 0 ng/mL to 20 ng/mL. |
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| Target condition and reference standard(s) | The diagnosis of HCC was confirmed by pathologic examination of the resected liver specimens. Patients were examined for HCC by abdominal ultrasonography, dynamic CT, and/or MRI every 3‐6 months. |
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| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | No conflict of interest was disclosed in this study. | ||
| 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? | 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? | 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 | ||