Wang 2013a.
| Study characteristics | |||
| Patient Sampling | Blood samples were collected under informed consent from 55 HCC patients in the infectious department of our hospital from 2009 to 2010 (Union Hospital, Wuhan, China). For comparison, 40 patients with liver cirrhosis we encountered during the same period were also included. Age range: 39‐65. Males 79% |
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| Patient characteristics and setting | |||
| Index tests | AFP: taking both sensitivity and specificity into account, the cut‐off point was selected according to maximum number of sensitivity and specificity. AFP showed 85.71% specificity and 40.00% sensitivity at the cut‐off value of 20 ng/mL. | ||
| Target condition and reference standard(s) | HCC: the diagnosis of HCC was based on typical findings in three‐phase dynamic CT or MRI, and the diagnosis was confirmed by histopathology. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | "The authors declare that there is no conflict 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? | 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? | 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 | ||