Reichl 2015.
| Study characteristics | |||
| Patient Sampling | This is a case‐control study which included serum samples from HCC patients (311) as well as healthy (125) and cirrhotic (30) controls from Shanghai, Vienna, Brno, and Hong Kong. The analysis included HCC patients and cirrhotic controls. Exclusion criteria were alterations in liver serology, viral or nonviral liver disease, as well as other malignancies. Age range not reported. Males 82% |
||
| Patient characteristics and setting | |||
| Index tests | AFP: for AFP, the clinically well‐established cut‐off value of 20 ng/mL was used. | ||
| Target condition and reference standard(s) | HCC: all patients were diagnosed by ultrasound, computed tomography or magnetic resonance imaging, AFP and liver enzyme serology, and histopathologically confirmed by two individual board certified pathologists after surgical resection. Controls: people with liver cirrhosis (controls) were histopathologically confirmed and screened for tumour formation by ultrasound, computed tomography, or magnetic resonance imaging. |
||
| Flow and timing | No information on interval between index test and reference standard. Of 311 HCC patients included, 309 had available AFP values. | ||
| Comparative | |||
| Notes | Conflicts of interest: K.S. received travel grants from Roche, MSD and Novartis as well as speaker honorarium from Roche and Biotest. | ||
| 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? | 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? | 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? | High | ||
| 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? | No | ||
| Could the patient flow have introduced bias? | High risk | ||