Kim 2001.
Study characteristics | |||
Patient Sampling | From May 1996 to November 1999, a total of 52 consecutive patients with liver cirrhosis underwent whole liver transplantation at our institution. Age range and % of males not reported |
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Patient characteristics and setting | |||
Index tests | Ultrasound. Quote: "Experienced radiologists (J.H.L. and W.J.L.), retrospectively reviewed pre‐transplantation ultrasonographic studies. ATL HDI‐3000 (Advanced Technology Laboratories, Bothell, WA) and Acuson XP (Acuson Corp, Mountain View, CA) scanners with 2.5‐ or 3.5‐MHz transducers. All nodular lesions—hyperechoic, hypoechoic, isoechoic, and mixed echogenic lesions larger than 1.0 cm not explainable by normal structures and different from general normal echoes of the liver parenchyma—were interpreted as potential HCCs. A hypoechoic or mixed echogenic lesion with or without a peripheral hypoechoic rind or an isoechoic lesion with a peripheral hypoechoic rind was regarded as HCC. A hyperechoic lesion without a peripheral hypoechoic rind was regarded as a dysplastic nodule." | ||
Target condition and reference standard(s) | Explanted livers were serially sectioned in the transverse or coronal plane at 5 mm to 10 mm intervals depending on the location of hepatic masses. All nodular lesions seen at ultrasonography were matched with corresponding lesions based on their segment locations on the ultrasonograms versus their counterparts in the explanted livers. The ultrasonographic diagnosis was considered correct if the mass identified on ultrasonography coincided with the anatomic location in the pathologic specimen. | ||
Flow and timing | The range of duration between ultrasonography and transplantation was 7 to 100 days (mean, 56 days). | ||
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? | Yes | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Could the selection of patients have introduced bias? | Low risk | ||
Are there concerns that the included patients and setting do not match the review question? | High | ||
DOMAIN 2: Index Test (AFP) | |||
DOMAIN 2: Index Test (US+AFP) | |||
DOMAIN 2: Index Test (US) | |||
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 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? | High | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Yes | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Low risk |