Shen 2012a.
| Study characteristics | |||
| Patient Sampling | We recruited consecutive patients with HCC to a test cohort, from the Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China, from December, 2008, to June, 2009. We also recruited consecutive patients with chronic hepatitis B virus (HBV) or liver cirrhosis and healthy controls from the Department of Infectious Disease, First Affiliated Hospital of Soochow University, Suzhou, China, from April to July, 2009. The test cohort included 831 patients (424 HCC patients, 98 with chronic hepatitis B (CHB), 96 patients with liver cirrhosis, and 213 healthy controls). Patients who had a history of other solid tumours were excluded from the study. Age range: 42‐68. Males 80% |
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| Patient characteristics and setting | |||
| Index tests | AFP: AFP concentrations were measured with commercially available ELISA (R&D Systems), according to the manufacturer’s recommendations. Cut‐off value was prespecified at 20 ng/mL. | ||
| Target condition and reference standard(s) | HCC: HCC was defined on the basis of ultrasound, CT, or MRI characteristics and biochemistry (AFP serology and liver function enzymes), and was confirmed by histopathology, according to the American Association for the Study of Liver Diseases guidelines. Control group: patients with cirrhosis who had raised AFP concentrations were required to have undergone imaging by multiple methods (ultrasonography, CT, or MRI) and to have had no evidence of a hepatic mass for at least 3 months before enrolment. | ||
| Flow and timing | No information on interval between index test and reference standard; 98 CHB patients were included in the control group out of which 41 had AFP values available. | ||
| Comparative | |||
| Notes | "The authors declare no 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? | 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? | No | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| 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? | 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? | Unclear | ||
| Did all patients receive the same reference standard? | No | ||
| Were all patients included in the analysis? | No | ||
| Could the patient flow have introduced bias? | High risk | ||