Agreement and Reliability of Transient Elastography

Recruiting

• Conditions: Chronic Viral Hepatitis
• Interventions: Diagnostic Test: Transient elastography

• Registration Number: NCT05686785
• Lead Sponsor: Lund University

Brief 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.

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-17
• Study Start: 2023-06-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04
• Primary Completion: 2026-02-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic viral hepatitis	Transient elastography	-

Primary Outcome Measures

Name	Time	Method
Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95.	Assessed at a 30 min visit to the outpatient clinic	Disagreement, expressed as 1) the proportion of participants with inter-rater differences at or above our prespecified threshold (33%) and 2) the smallest detectable change, representing the difference needed to state with 95% certainty that a change had occurred in the underlying fibrosis (SDC95).

Secondary Outcome Measures

Name	Time	Method
Reliability, estimated using the intra-class correlation	Assessed at a 30 min visit to the outpatient clinic	Reliability, for continuous stiffness measurements as well as for different fibrosis stage categories.
Patient and exam characteristics associated with inter-rater differences above our prespecefied threshold.	Assessed at a 30 min visit to the outpatient clinic	As an exploratory outcome, patient and exam characteristics associated with inter-rater differences above our prespecified threshold of ≥ 33% in liver stiffness will be evaluated. These characteristics include patients age, hepatitis b staging, BMI, biomarkers including Alanine transaminase, probe type, (medium or XL-probe) viral load, alkaline phosphatase, bilirubin, albumin, prothrombin time/international normalized ratio, time since food (hours), time since alcohol (hours), previous liver biopsy (years)

Trial Locations

Locations (1)

Oskar Ljungquist; 🇸🇪 Helsingborg, Skåne, Sweden