da Costa 2015a.
| Study characteristics | |||
| Patient Sampling | In Thailand, specimens were obtained from patients and hospital‐based controls recruited at the cancer control unit of the National Cancer Institute of Thailand, Bangkok (TLCS, Thailand liver cancer study, Case‐control 1). The study was conducted from April 2008 to December 2009. All cases of PLC were recruited and matched controls were obtained from outpatient clinics. Age range and % of males not reported |
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| Patient characteristics and setting | |||
| Index tests | Serum AFP measurement, with a cut‐off value > 20 ng/mL | ||
| Target condition and reference standard(s) | Differential diagnosis of HCC versus CC was established by a combination of clinical examination,imaging using ultrasonography, computerised tomography (CT) or MRI, biochemistry (AFP and liver function enzymes testing) and histological confirmation on a small subset of patients from whom needle biopsies were available. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | Grant sponsor: European Union Collaborative Project Prolifica, 7th Framework Programme, FP7‐AFRICA‐2010, Health‐F2‐2011‐265994 | ||
| 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? | Yes | ||
| 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? | 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? | No | ||
| Could the patient flow have introduced bias? | High risk | ||