Feng 2016.
| Study characteristics | |||
| Patient Sampling | A total of 700 patients who were diagnosed with a hepatopancreatobiliary disease and who had undergone surgery were consecutively enrolled from the Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, between September 2008 and September 2011. Participants receiving surgery were divided into two groups: (i) participants with HCC (n = 329); and (ii) participants without HCC, with either benign or malignant hepatopancreatobiliary disease (n = 371). None of the participants were receiving and/or had received vitamin K therapy. Age range not reported. Males 69% |
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| Patient characteristics and setting | |||
| Index tests | Serum AFP was examined, using a commercially available immunometric assay (ST AIA‐PACK AFP, Tosoh, Tokyo, Japan), with enhanced chemiluminescence at the Southwest Hospital Clinical Diagnostic Center with no predefined cut‐off value. | ||
| Target condition and reference standard(s) | HCC was clinically diagnosed, based on international guidelines. Pathologic findings from resected specimens were confirmed for all 329 participants. No person had received any previous therapy to treat HCC such as TACE, RFA, PEI, or resection, and people underwent surgery for the first time at this hospital. A cohort of people with a hepatopancreatobiliary disease other than HCC, based on enhanced imaging findings, who were undergoing surgery at this hospital, were used. All of these people had been diagnosed by clinical findings as well as pathologic findings. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | Competing interests. The authors declared that they had no competing interests. | ||
| 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? | 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? | Yes | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
| 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? | Yes | ||
| Were all patients included in the analysis? | Yes | ||
| Could the patient flow have introduced bias? | Low risk | ||