Agreement and Reliability of Transient Elastography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transient elastography.
- Who it may be relevant to
- Registry conditions: Chronic Viral Hepatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Agreement and Reliability of Transient Elastography in Patients With Chronic Viral Hepatitis - a Cross-sectional Test-retest Study
Overview
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.
Interventions
- Diagnostic test Transient elastography
Transient elastography measures liver stiffness in kPa
Primary outcome measures
- Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95. [Time frame: Assessed at a 30 min visit to the outpatient clinic]
Secondary outcome measures (2)
- Reliability, estimated using the intra-class correlation [Time frame: Assessed at a 30 min visit to the outpatient clinic]
- Patient and exam characteristics associated with inter-rater differences above our prespecefied threshold. [Time frame: Assessed at a 30 min visit to the outpatient clinic]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Oskar Ljungquist — Helsingborg
Identifiers
NCT: NCT05686785 · CIV-22-08-040567