Bachtiar 2009.
| Study characteristics | |||
| Patient Sampling | Serum samples from 119 patients were collected from the Hepatology Division at the Department Internal Medicine, Cipto Mangunkusumo Hospital, Indonesia. Sera were frozen immediately and stored at −80 °C before use. The group of patients with HCC included 65 patients. The control group of CLD patients comprised 54 patients. Patients displayed CLD related to either hepatitis B virus infection or hepatitis C virus infection (55.6%). Age range: 23‐81. Males 76% |
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| Patient characteristics and setting | |||
| Index tests | The qualitative measurement of serum AFP was performed using enzyme immunoassay method (Diagnostic System Laboratories, Webster, TX). | ||
| Target condition and reference standard(s) | Diagnosis of HCC relied on the presence of a malignant liver nodule, as established on imaging techniques and by pathological analysis of liver biopsies. In total, there were 65 serum samples from patients with primary HCC at different clinical stages and with various AFP concentration (AFP≤ 200, n = 37 and AFPN200, n = 28). The control group consisted of 54 serum samples from patients with CLD only. CLD patients were defined as persons positive for hepatitis B surface antigen (HBsAg) or positive anti‐HCV test for more than 6 months. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | No conflicts of interest. This work was supported by MRIN Funding (Budget no. cc042/2007). | ||
| 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? | Unclear | ||
| If a threshold was used, was it pre‐specified? | Yes | ||
| Could the conduct or interpretation of the index test have introduced bias? | Unclear 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 | ||