Wong 2014b.
| Study characteristics | |||
| Patient Sampling | A historical control cohort of 424 treatment‐naive patients was recruited from December 1997 to July 2000 from the hepatitis clinic at the Prince of Wales Hospital, Hong Kong. These patients underwent routine clinical care until the mid to late 2000s, when antiviral treatments were not readily available or reimbursable. Patients suffering from chronic hepatitis C (CHC), preexisting HCC, or HCC diagnosed within the first year of entecavir treatment were excluded. Age range: 28‐54. Males 65% |
||
| Patient characteristics and setting | |||
| Index tests | AFP: cut‐off predefined at 6 ng/mL | ||
| Target condition and reference standard(s) | HCC: the diagnosis of HCC was established based on histopathological confirmation detection of a positive lesion with at least two imaging techniques (trans‐abdominal USG, triphasic CT, magnetic resonance imaging, or hepatic angiogram), or detection with one imaging technique coupled with an AFP concentration greater than 400 lg/L. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | "Potential conflicts of interest: Grace L.H. Wong has served as an advisory committee member for Otsuka and Gilead; she is also on the speakers’ bureau for Echosens, Furui, and Otsuka. Henry L.Y. Chan is a consultant for Abbott, Bristol‐Myers Squibb, Furui, Gilead, Merck, Novartis, and Roche, has received honoraria for lecturing for Abbott, Bristol‐Myers Squibb, Echosens, Gilead, GlaxoSmithKline, Merck, Novartis, and Roche, and has received an unrestricted grant from Roche for hepatitis B research. He is on the speakers’ bureau for Abbott, Bristol‐Myers Squibb, Echosens, Gilead, GlaxoSmithKline, Merck, Novartis, and Roche. Vincent W.S. Wong has served as an advisory committee member for Roche, Novartis, Gilead, and Otsuka; he is also on the speakers’ bureau for Bristol‐Myers Squibb, Roche, Novartis, Abbott Diagnostics, and Echosens." | ||
| 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? | 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? | 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? | Yes | ||
| Could the conduct or interpretation of the index test have introduced bias? | Low 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? | Yes | ||
| Could the patient flow have introduced bias? | High risk | ||