Ette 2015.
| Study characteristics | |||
| Patient Sampling | This was a cross‐sectional case–control study. Patients were drawn from referrals to the Liver Unit at the Obafemi Awolowo University Teaching Hospitals Complex, Ile‐Ife, from April 2011 to March 2012. The patients were divided into two broad groups: HCC and non‐HCC groups. 62 consecutive patients presenting with untreated primary hepatocellular carcinoma. The controls were 57 patients with benign hepatic diseases which comprised of 34 patients with chronic hepatitis B infection, 1 patient with chronic hepatitis C infection, 21 patients with compensated cirrhosis of the liver, and 1 patient with Non‐alcoholic Fatty Liver Disease. Patients with a history of the use of warfarin or other dicoumarol or total bilirubin level above 20 mg/dL (340 µmol/L) were excluded from the study. Age range not reported. Males 72% |
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| Patient characteristics and setting | |||
| Index tests | AFP was tested using commercially available immunoenzymometric assay kit manufactured by INTECO Diagnostics, UK Ltd., London with no predefined cut‐off value. | ||
| Target condition and reference standard(s) | 62 consecutive patients with HCC were enrolled. Patients presented with untreated primary HCC diagnosed using the European Association for the Study of Liver Diseases (EASL) and American Association for the Study of Liver Diseases (AASLD) criteria. All the cases and controls were subjected to abdominal ultrasound while CT scan was restricted to those shown on ultrasound to have focal lesions in the liver. | ||
| Flow and timing | No information on interval between index test and reference standard | ||
| Comparative | |||
| Notes | Competing interests: the authors declared no conflict 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) | |||
| 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? | Unclear | ||
| Could the reference standard, its conduct, or its interpretation have introduced bias? | Unclear 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 | ||