Lauenstein 2007.
Study characteristics | |||
Patient Sampling | Between January 2004 and March 2006, 210 patients received a liver transplant at the authors' institution. 130/210 patients underwent MRI of the liver within 90 days before transplantation. The other 80 patients underwent MRI > 90 days before transplantation, had contraindications to MRI, or underwent CT. 15 patients were excluded because they had undergone liver chemoembolisation therapy for tumours (13 people) or were unable to complete MRI (2 people). Final study cohort had 115 participants. | ||
Patient characteristics and setting | All participants underwent OLT, therefore only people with advanced liver disease were included. | ||
Index tests | Aim: to evaluate the accuracy of gadolinium‐enhanced liver MRI in tumour surveillance. Positivity criteria: underlying criteria for the diagnosis of HCC included increased enhancement of the lesion compared with normal liver tissue in the arterial contrast phase; washout of lesions during the later contrast phases with isointensity or hypointensity compared with adjacent liver tissue; and development of peripheral rim enhancement, previously referred to as pseudocapsule enhancement, on delayed phase images. Lesions rated as HCC if ≥ 2 of the 3 features were present. Both reviewers were aware the participants were at high risk before liver transplantation, but they did not have access to the pathology reports. |
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Target condition and reference standard(s) | Reference standard: liver transplantation. Participants had cirrhosis and underwent liver transplantation after MRI. Lesion size and location were described in the manner used for the MRI evaluation and were compared with the findings in the detailed MRI report. |
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Flow and timing | Time between index test and reference standard < 90 days. | ||
Comparative | |||
Notes | Information regarding COI and funding not reported. | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Yes | ||
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 (All tests) | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
Were positivity criteria clearly defined? | 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 |