Agreement and Reliability of Transient Elastography in Patients With Chronic Viral Hepatitis - a Cross-sectional Test-retest Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •suspected or confirmed pregnancy.
- •patients unable to speak Swedish
- •inability to sign informed consent.
结局指标
主要结局
Disagreement defined as a difference in TE results between operators in KPa of ≥ 33%, as well as the smallest detectable change, SDC95.
时间窗: 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).
次要结局
- Reliability, estimated using the intra-class correlation(Assessed at a 30 min visit to the outpatient clinic)
- Patient and exam characteristics associated with inter-rater differences above our prespecefied threshold.(Assessed at a 30 min visit to the outpatient clinic)