Darnell 2021.
Study characteristics | |||
Patient Sampling | Aim: to evaluate the diagnostic accuracy of each LI‐RADS category by MRI according to LI‐RADS v2018 in a cohort of people with cirrhosis in whom a solitary nodule ≤ 20 mm was detected during screening US. 315 people with cirrhosis with a single nodule ≤ 20 mm detected by surveillance US were included. 2 participants were excluded due to non‐evaluable results. | ||
Patient characteristics and setting | Patients at risk were screened with US, and suspected cases were referred to MRI. | ||
Index tests | Used the positivity criteria from LI‐RADS v2018, extracted data for the case of LI‐RADS 5 category. Radiologists were unaware of the final diagnosis of the lesion. | ||
Target condition and reference standard(s) | Reference standards: US‐guided biopsy with histology, specific vascular profile (arterial phase hyperenhancement with washout) by MRI and follow‐up. The index test was used as a reference standard and it represents incorporation bias. Further testing was decided based on the index test results. |
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Flow and timing | Time between index test and reference standard > 90 days. Used different reference standards. | ||
Comparative | |||
Notes | Authors disclosed potential COI and funding was provided by a public institution. | ||
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? | Low concern | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | No | ||
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 |