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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Watcharasak Chotiyaputta, Assoc Prof
- 電話番号：6624197281
- メール：watcharasak.cho@mahidol.ac.th
研究連絡先のバックアップ
- 名前：Tawesak Tanwandee, Professor
- 電話番号：6624197282
- メール：tawesak@gmail.com
研究場所
-
-
-
Bangkok、タイ、10700
- Siriraj Hospital
-
コンタクト：
- Watcharasak Chotiyaputta, Asso Prof
- 電話番号：6624197281
- メール：watcharasak.cho@mahidol.ac.th
-
コンタクト：
- Tawesak Tanwandee, Prof
- 電話番号：6624197282
- メール：tawesak@gmail.com
-
主任研究者：
- Watcharasak Chotiyaputta, Asso Prof
-
副調査官：
- Tawesak Tanwandee, Prof
-
副調査官：
- Tanawat Geeratragool, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
TREAT-B score: ALT(alanine transferase), HBeAg REACH-B score: sex, ALT, HBV viral load, age WHO-simplified score: ALT, cirrhosis
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Performance of TREAT-B score for eligible antiviral treatment
時間枠：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
|
at 1st OPD(out patient department) visit through initiation of antivirus or 1 year (if not indication for antivirus)
|
|
Performance of WHO simplified score for eligible antiviral treatment
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Performance of TREAT-B score for eligible antiviral treatment
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Watcharasak Chotiyaputta, Assoc prof、Mahidol university
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Si 745/2021
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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