Yang 2013a.
| Study characteristics | |||
| Patient Sampling | Plasma was collected from 179 HCC patients (35 females and 144 males, with a mean age of 54.0 years) before hepatectomy at the Cancer Hospital in China. All HCC patients were chronically infected with HBV. Cirrhosis plasma was obtained from 80 liver cirrhosis patients (24 females and 56 males, with a mean age of 53.5 years) with chronic HBV infection at Beijing You’an Hospital, Capital Medical University. Age range not reported. Males 77% |
||
| Patient characteristics and setting | |||
| Index tests | AFP levels were tested using a commercial immunoassay with enhanced chemiluminescence at the Clinical Diagnostic Laboratories of the Cancer Hospital, Chinese Academy of Medical Sciences. Cut‐off value 20 ng/mL | ||
| Target condition and reference standard(s) | The histological diagnosis of the tissue samples was confirmed by experienced pathologists. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | "This work was supported by the National Natural Science Foundation of China (81172035, 30973388), the National Excellent Doctoral Dissertation of China (2007B68), the National High Technology Research and Development Program of China (2012AA020206), and the Basic Research Program of the Cancer Hospital, PUMC & CAMS (JK2009B08, LC2009B45). The authors declare no competing financial interest." | ||
| 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? | 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? | Unclear | ||
| 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? | Unclear 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? | 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 | ||