Agreement and Reliability of Transient Elastography (HEPSCAN)

Lund University

Status: Enrolling

Conditions: Chronic Viral Hepatitis

Treatments: Diagnostic Test: Transient elastography

Study type: Observational

Funder types: Other

Identifiers

NCT05686785

CIV-22-08-040567

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients at the departments of infectious diseases in Malmö, Lund and Helsingborg with chronic viral hepatitis.
• Adult patients
• Signed informed consent to participate in the study.

Exclusion criteria

• suspected or confirmed pregnancy.
• patients unable to speak Swedish
• inability to sign informed consent.

Trial design

300 participants in 1 patient group

Chronic viral hepatitis

Treatment:

Diagnostic Test: Transient elastography