Kim 2019.
| Study characteristics | |||
| Patient Sampling | A prospective cohort the Seoul National University Hospital (Seoul, Republic of Korea). The training set comprised 53 patients with very early or early HCC based on the Barcelona Clinic Liver Cancer staging system [1], 47 patients with cirrhosis and 50 healthy controls enrolled between January 2014 and August 2017 as part of an ongoing study. Age range and % of males not reported |
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| Patient characteristics and setting | |||
| Index tests | Serum AFP measurement: no specification. No pre‐definition of the cut‐off value | ||
| Target condition and reference standard(s) | HCC was mostly diagnosed based on the noninvasive criteria of an international guideline [1,2]. Cirrhosis was diagnosed based on either histological or clinical findings. | ||
| Flow and timing | No data on interval between index test and reference standard. | ||
| Comparative | |||
| Notes | |||
| 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? | 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? | 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) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | |||
| If a threshold was used, was it pre‐specified? | |||
| Could the conduct or interpretation of the index test have introduced bias? | |||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | |||
| DOMAIN 2: Index Test (US) | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | |||
| If a threshold was used, was it pre‐specified? | |||
| Could the conduct or interpretation of the index test have introduced bias? | |||
| Are there concerns that the index test, its conduct, or interpretation differ from the review question? | |||
| 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 | ||