Mohamed 2020a.
| Study characteristics | |||
| Patient Sampling | Serum samples were collected from a total number of 200 participants. All patients were recruited from the Department of Gastroenterology and Hepatology, Theodor Bilharz Research Institute, in Egypt, during the period from October 2017 to November 2018.
40 healthy volunteers were involved in the current study as a control group. Participants were divided into 3 categories: Control group (n = 40), liver cirrhosis group without HCC (LC) who had chronic hepatitis C (CHC) more than 6 months of infection (n = 80) and HCC patients who had cirrhosis and were currently infected by HCV, but did not start the treatments (n = 80). Age range not reported. Males 66% |
||
| Patient characteristics and setting | |||
| Index tests | Serum AFP level was determined using sandwich Enzyme Linked Immunosorbent Assay (ELISA). No predefinition of a cut‐off value | ||
| Target condition and reference standard(s) | HCC: CT Control: no specification |
||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | "The authors declare no conflicts of 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) | |||
| 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 | ||