Wang 2016c.
| Study characteristics | |||
| Patient Sampling | The cohort consisted of 870 patients (432 HCC cases and 438 non‐HCC cirrhosis controls). Cases included consecutive adult patients with HCC seen between February 2005 and August 2007 at seven medical centres in the USA. Patients with HCC were excluded if they were younger than 18 years of age, had prior treatment of their tumour, or history of other solid tumours. Age range: 46‐71. Males 74.5% |
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| Patient characteristics and setting | |||
| Index tests | AFP measurement with no predefined cut‐off value | ||
| Target condition and reference standard(s) | HCC: HCC was defined by histological examination or by the appropriate imaging characteristics as defined by accepted guidelines. To assure that controls did not have HCC, all controls were assessed by AFP and an imaging test (US, CT, or MRI) 6 months after enrolment. |
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| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | T. Block reported receiving commercial research grant from Arbutus Bio‐pharma, had ownership interest (including patents) in Glycotest, and was consultant/advisory board member for Glycotest. No potential conflicts of interest were disclosed by the other authors. | ||
| 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? | 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? | 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? | No | ||
| Were all patients included in the analysis? | Yes | ||
| Could the patient flow have introduced bias? | High risk | ||