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. |
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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. |
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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 |