Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand
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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Watcharasak Chotiyaputta, Assoc Prof
- 전화번호: 6624197281
- 이메일: watcharasak.cho@mahidol.ac.th
연구 연락처 백업
- 이름: Tawesak Tanwandee, Professor
- 전화번호: 6624197282
- 이메일: tawesak@gmail.com
연구 장소
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Bangkok, 태국, 10700
- Siriraj Hospital
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연락하다:
- Watcharasak Chotiyaputta, Asso Prof
- 전화번호: 6624197281
- 이메일: watcharasak.cho@mahidol.ac.th
-
연락하다:
- Tawesak Tanwandee, Prof
- 전화번호: 6624197282
- 이메일: tawesak@gmail.com
-
수석 연구원:
- Watcharasak Chotiyaputta, Asso Prof
-
부수사관:
- Tawesak Tanwandee, Prof
-
부수사관:
- Tanawat Geeratragool, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- Treatment experience chronic hepatitis B infection patients
- HIV co-infection
- HCV (hepatitis C) co-infection
- concomitant HCC (hepatocellular carcinoma)
- Pregnancy
- Incomplete data
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Patient with chronic hepatitis B infection
Patient with chronic hepatitis B infection visited at liver and internal medicine clinic, Siriraj hospital between January 2015-2020
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TREAT-B score: ALT(alanine transferase), HBeAg REACH-B score: sex, ALT, HBV viral load, age WHO-simplified score: ALT, cirrhosis
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Performance of TREAT-B score for eligible antiviral treatment
기간: at 1st OPD(out patient department) visit through initiation of antivirus or 1 year (if not indication for antivirus)
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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
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at 1st OPD(out patient department) visit through initiation of antivirus or 1 year (if not indication for antivirus)
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Performance of WHO simplified score for eligible antiviral treatment
기간: 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
|
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
기간: 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
|
at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Performance of TREAT-B score for eligible antiviral treatment
기간: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
|
Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
|
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
기간: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
|
Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
|
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
기간: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
|
Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
|
at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Watcharasak Chotiyaputta, Assoc prof, Mahidol university
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Si 745/2021
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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