El‐Sherif 2012.
Study characteristics | |||
Patient Sampling | The present study was carried on 80 participants. Patients with either liver cirrhosis or HCC were selected among patients who were admitted in the Department of Tropical Medicine and Gastroenterology and Internal medicine; Assiut University Hospital from September 2009 ‐ September 2010. They were 30 people with liver cirrhosis (group I) and 30 people with HCC (group II). Age range not reported. Males 70% |
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Patient characteristics and setting | |||
Index tests | Alpha‐foetoprotein was performed on IMMULITE analyser, using chemiluminescent assay (Siemens Healthcare Diagnostics, UK) with no predefined cut‐off value. | ||
Target condition and reference standard(s) | The diagnosis of HCC was ascertained using a histopathologic examination by liver needle biopsy (30 adults were enrolled in the present study; the patients underwent liver needle biopsy under ultrasound guidance). The diagnosis of cirrhosis was confirmed by abdominal ultrasonography and biochemical findings. | ||
Flow and timing | No information on interval between index test and reference standard | ||
Comparative | |||
Notes | No information on funding or conflicts of interest | ||
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? | Unclear | ||
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? | 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 |