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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic viral hepatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transient elastography | Diagnostic Test | Transient elastography measures liver stiffness in kPa |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95. | 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). | Assessed at a 30 min visit to the outpatient clinic |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability, estimated using the intra-class correlation | Reliability, for continuous stiffness measurements as well as for different fibrosis stage categories. | Assessed at a 30 min visit to the outpatient clinic |
| Patient and exam characteristics associated with inter-rater differences above our prespecefied threshold. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic viral hepatitis, i.e. chronic hepatitis B (with or without chronic hepatitis D), of chronic hepatitis C.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oskar Ljungquist, M.D, PhD | Contact | +46424061000 | oskar.ljungquist@med.lu.se | |
| Gustav Torisson, M.D, PhD | Contact | +464033 10 00 | gustav.torisson@med.lu.se |
| Name | Affiliation | Role |
|---|---|---|
| Oskar Ljungquist, MD, PhD. | Division of Infection Medicine, Department of Clinical Sciences, Lund University, Lund. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oskar Ljungquist | Recruiting | Helsingborg | Skåne County | 25187 | Sweden |
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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) |
| Assessed at a 30 min visit to the outpatient clinic |