Ungtrakul 2016.
| Study characteristics | |||
| Patient Sampling | In the present study, we undertook a screening and surveillance program involving treatment‐naïve chronic hepatitis B (CHB) patients using abdominal US and serum AFP assay. We enrolled male and female Thai patients, aged 20‐65 years, who were serologically positive for hepatitis B surface antigen (s‐Ag). The exclusion criteria included: decompensated cirrhosis (Child‐Pugh class C or Model for End‐stage Liver Disease score > 15); a history of any cancer in the last 5 years; previous antiviral treatment for CHB; concurrent infection with hepatitis C virus infection or human immunodeficiency virus infection; a Karnofsky Performance Status score < 60%; or any medical condition preventing eligibility to complete the protocol (e.g., poor renal function, a serum creatinine level > 1.5 mg/dL, or creatinine clearance < 50 mL/minute. Age range: 20‐65. Males 47% |
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| Patient characteristics and setting | |||
| Index tests | AFP: AFP assays were performed with COBAS 6000/e601 Roche Diagnostics, Mannheim, Germany. Cut‐off value prespecified at 20 ng/mL. US: US examinations were performed by experienced radiologists at the initial screening and every 6 months thereafter. Diagnostic criteria for further diagnostic evaluation: focal solid liver nodule. |
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| Target condition and reference standard(s) | HCC was diagnosed using the American Association for the Study of Liver Diseases (AASLD) practice guidelines. If the serum AFP was ≥ 20 mg/L or a focal solid liver nodule was detected on US, further diagnostic studies were performed including computerized tomography, magnetic resonance imaging, or biopsy of the liver lesion. AUS examinations were performed by experienced radiologists at the initial screening and every 6 months. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | "The authors of this manuscript declare that they have no conflicts of interest to disclose." | ||
| 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? | Yes | ||
| 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) | |||
| 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) | |||
| 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 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? | 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 | ||