Yu 2016.
| Study characteristics | |||
| Patient Sampling | In the Hepatitis Biobank of Southwest Hospital (HBS) cohort at Southwest Hospital, we did a two‐stage nested case‐control study. Totally, 51 HCC cases versus 138 matched controls were enrolled to compare levels of α‐fetoprotein (AFP) and PIVKA‐II in sequential sera at −12, −9, −6, −3 and 0 months before imaging diagnosis. At‐risk controls were randomly selected and matched according to age, gender and liver cirrhosis status. Patients receiving warfarin or vitamin K before haemospasia were screened out for the influence on PIVKA‐II level. Age range: 39‐67. Males 74% |
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| Patient characteristics and setting | |||
| Index tests | AFP: serum levels of AFP were measured by AFP. Reagent kit via chemiluminescent microparticle immunoassay (CMIA) (ARTHITECT i2000, Abbott Laboratories, America). Cut‐off values prespecified at 5, 20, 400, 200 ng/mL | ||
| Target condition and reference standard(s) | HCC: any participants diagnosed as HCC should met two imaging criteria (hepatic ultrasound plus CT or MRI), and then all cases were confirmed by biopsy. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | "The authors declare no competing financial interests." | ||
| 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? | 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? | Low concern | ||
| 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? | 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 | ||