Assessing the Accuracy and Consistency of Liver Stiffness Measurements Using Transient Elastography in Adults with Chronic Viral Hepatitis

What this Trial Is About

Researchers are evaluating the agreement, smallest detectable change, and reliability of repeated liver stiffness measurements using transient elastography in patients with chronic viral hepatitis. The study aims to determine how consistent the test results are when repeated and to identify factors that may cause differences in measurements between operators. This investigation addresses gaps in previous studies that focused on reliability but did not evaluate measurement agreement for this condition. Participants will undergo repeated transient elastography tests, which measure liver stiffness in kilopascals kPa. The study is observational and includes patients with chronic viral hepatitis from infectious disease departments. Measurements will be taken during a single 30-minute visit to the outpatient clinic. The study focuses on test-retest agreement and smallest detectable changes between operators. During the visit, liver stiffness will be measured multiple times to assess agreement and reliability. Researchers will also collect information about patient and exam characteristics that might influence measurement differences. The primary outcome is the level of disagreement between operators defined by a difference of 33% or more in liver stiffness results. Secondary outcomes include the intra-class correlation as a reliability estimate and factors associated with differences. The study is sponsored by Lund University and participation involves one brief clinic visit.

Agreement and Reliability of Transient Elastography