NCT05686785

Agreement and Reliability of Transient Elastography

Agreement and Reliability of Transient Elastography in Patients With Chronic Viral Hepatitis - a Cross-sectional Test-retest Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Lund University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess agreement, smallest detectable change, and reliability of repeated measurements of liver stiffness of transient elastography in patients with chronic viral hepatitis, and to explore factors associated with disagreement.

Detailed description

Previous studies have reported excellent test-retest reliability for transient elastography (TE) in viral hepatitis. Reliability refers the ability of an instrument to discriminate between study subjects and may be excellent even if considerable measurement-error exists, if the population is heterogenous. Agreement, in contrast, refers to differences of measurements on the original scale (kPa for TE). Whether agreement is acceptable is situation-dependent and can be related to the smallest detectable change (SDC). Agreement metrics or SDC have not been addressed in previous studies for chronic viral hepatitis. The aim of this study is to assess agreement, SDC, and reliability of repeated measurements of liver stiffness of TE in patients with chronic viral hepatitis, and to explore factors associated with disagreement.

Conditions

• Chronic Viral Hepatitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transient elastography	Transient elastography measures liver stiffness in kPa

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-02-01
• Completion: 2026-12-01
• First posted: 2023-01-17
• Last updated: 2023-10-04

Locations

1 site across 1 country: Sweden

Regulatory

• FDA-regulated device study