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. 2022 May 6;2022(5):CD014798. doi: 10.1002/14651858.CD014798.pub2

Demirtas 2020.

Study characteristics
Patient Sampling Authors retrospectively reviewed a prospectively collected database of 1261 people with cirrhosis at a tertiary centre between December 2008 and February 2017.
Excluded: people with insufficient data, those lost to follow‐up, with contraindications to MRI, ineligible MRI surveillance periods (< 10 and > 14 months), AFP > 20 ng/mL at entry, and HCC diagnosis within 1 year. Patients with an AFP level 10–20 ng/mL at enrolment were only included if previous imaging confirmed the absence of any suspicious masses within 3 months from enrolment.
Patient characteristics and setting People with cirrhosis were screened for HCC.
Index tests Aim: to determine the performance of a surveillance strategy with annual MRI scans to detect HCCs at earlier curable stages.
HCC was diagnosed radiologically or histologically (or both) using the EASL guidelines.
Radiologists were unaware of the final diagnosis of the lesion.
Target condition and reference standard(s) Reference standards: biopsy or AFP/CT/MRI follow‐up. Further testing was decided on the basis of the index test results.
Flow and timing Time between index test and reference standard not reported. Used multiple reference standards.
Comparative  
Notes Authors declared no COI. 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?     Low concern
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? No    
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? 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