Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Performance of REACH-B score for eligible antiviral treatment
研究概览
简要总结
International and national guideline for chronic hepatitis B (HBV) infection treatment recommend initiated antiviral in high HBV viral loads patients with significant liver inflammation and significant liver fibrosis. In Thailand, HBV viral loads and liver elastography are limited available in seconds to tertiary care hospital.
Recently, many of simplified scoring system (TREAT-B score, WHO (World Health Organization)-simplified score and REACH-B score) were developed for assessment of antiviral initiation.
This study aim to evaluate the performance of simplified score for chronic HBV treatment compare to Thailand and international standard guideline.
详细描述
According to WHO Global health sector strategy on viral hepatitis 2016- 2021, WHO aim to global eliminate HBV infection within 2030. Main strategies for achievement are effective prevention and treatment.
International and national guideline for HBV infection treatment recommend initiated antiviral in high HBV viral loads patients with significant liver inflammation and significant liver fibrosis. Thus, HBV viral load and liver elastography are required for indication assessment. In low-to-middle income country such as Thailand, HBV viral loads and liver elastography are limited available in seconds to tertiary care hospital.
Recently, many of simplified scoring system (TREAT-B score, WHO-simplified score and REACH-B score) were developed for assessment of antiviral initiation.
This study aim to evaluate the performance of simplified score for chronic HBV treatment compare to Thailand and international standard guideline.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment naive chronic hepatitis B infection patients who visited at liver clinic and internal medicine clinic Siriraj hospital during January 2015-December 2021
- •Age > 18 years
排除标准
- •Treatment experience chronic hepatitis B infection patients
- •HIV co-infection
- •HCV (hepatitis C) co-infection
- •concomitant HCC (hepatocellular carcinoma)
- •Pregnancy
- •Incomplete data
结局指标
主要结局
Performance of REACH-B score for eligible antiviral treatment
时间窗: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
Gold standard: Eligible antiviral treatment according to EASL criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
Performance of TREAT-B score for eligible antiviral treatment
时间窗: at 1st OPD(out patient department) visit through initiation of antivirus or 1 year (if not indication for antivirus)
Gold standard: Eligible antiviral treatment according to EASL (European Association for the Study of the Liver) criteria Description: performance was define by sensitivity(%), specificity(%), PPV(positive predictive value)(%), NPV (negative predictive value)(%), positive LR(likelihood ratio), negative LR
Performance of WHO simplified score for eligible antiviral treatment
时间窗: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
Gold standard: Eligible antiviral treatment according to EASL criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
次要结局
- Performance of TREAT-B score for eligible antiviral treatment(at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus))
- Performance of WHO simplified score for eligible antiviral treatment(at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus))
- Performance of REACH-B score for eligible antiviral treatment(at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus))
研究者
Watcharasak Chotiyaputta
Associate professor, Faculty of Medicine, Siriraj Hospital
Mahidol University