Tan 2014.
| Study characteristics | |||
| Patient Sampling | A multi‐stage, case‐control study was designed to identify a serum miRNA profile as a surrogate marker for HCC. A total of 261 HCC patients, 233 patients with cirrhosis and 173 healthy controls were enrolled in our study. Validation set (cohort of interest) included 103 HCC patients, 78 cirrhosis patients and 60 healthy controls serum samples (from The Third Hospital of Zhenjiang Affiliated Jiangsu University). Age range: 32‐63. Males 67% |
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| Patient characteristics and setting | |||
| Index tests | AFP: cut‐off values not predefined or mentioned | ||
| Target condition and reference standard(s) | HCC: the diagnosis of HCC and cirrhosis was histopathologically confirmed. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | "Competing Interests: the authors have declared that no competing interests exist." | ||
| 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? | No | ||
| 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? | High | ||
| 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? | Yes | ||
| Were all patients included in the analysis? | Yes | ||
| Could the patient flow have introduced bias? | Unclear risk | ||