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研究生: Tapiwa Blessing Matanhire
Tapiwa Blessing Matanhire
論文名稱: 基於風險的血液安全決策
Risk Based Approach for Blood Safety Decisions in Taiwan
指導教授: 林希偉
Shi-Woei Lin
口試委員: 林承哲
Cheng-Jhe Lin
王敏
Min Wang
學位類別: 碩士
Master
系所名稱: 管理學院 - 工業管理系
Department of Industrial Management
論文出版年: 2018
畢業學年度: 106
語文別: 英文
論文頁數: 68
中文關鍵詞: 以風險為基礎的決策制定血液風險醫療科技評估B型肝炎病毒
外文關鍵詞: Risk-based decision-making, Health technology assessment, Blood safety, Hepatitis B Virus
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  • 如何建立以風險為基礎的決策制定(risk-based decision making)原則是血液風險管理中的重要議題。由於台灣的B型肝炎病例較其他已開發國家為多,因此從2013年起,對於B型肝炎病毒的篩檢同時採核酸擴大檢驗(nucleic acid amplification testing, NAT)以及酵素免疫分析法(enzyme-linked immunoassay, EIA)進行常規檢測。然而使用兩種篩檢法並行之常規檢測來管理輸血風險的作法存在高機會成本,也可能造成醫療資源的不當使用。本研究採透過風險決策分析方法探討單獨以核酸擴大檢驗(即移除 EIA常規檢驗)替代目前兩種檢驗並行的可能性。本研究使用馬可夫疾病模型,分析在取消 EIA檢驗下之捐血傳染疾病的機率及成本效益,研究結果指出移除 EIA 常規檢測並無法真正提高篩檢之成本效益。此分析結果雖與部分歐美文獻不一致,但卻和在東南亞的血液篩檢研究之結論有相似之處,即在B型肝炎較不盛行的地區,較可能單獨使用 NAT(即取消EIA),但EIA常規檢測在B型肝炎高風險區域仍可能有存在必要。本研究結果可供血液管理單位之重要決策參考。


    Hepatitis B virus (HBV) is a vaccine preventable infectious disease that poses transmission risk by way of blood transfusion. The transfusion transmission risk of HBV infection has tremendously decreased over the past few decades with the advent of increasingly sensitive screening test technologies and procedures. Yet, transfusion recipients can still be infected from the residual risk of an infectious donation in its window period or by an occult hepatitis B infectious donation (OBI) which is hepatitis B surface antigen (HBsAg) unreactive and has exceedingly low levels of viral DNA that is undetectable by sensitive nucleic acid tests (NAT). Taiwan has relatively high prevalence of HBV as compared to other developed countries. It has been implementing a testing algorithm of both mini-pool nucleic acid testing (MP-NAT) and individual-donor nucleic acid testing (ID-NAT) in parallel with HBsAg (EIA) serological tests to screen blood donors for HBV since 2013. However, this testing scheme might have considerably high opportunity costs for managing transfusion risk and some of the healthcare resources could be reallocated to other risk areas where they can be effectively utilized. In this research, we use a risk-based decision analysis approach to explore the possibility of discontinuing the HBsAg (EIA) test in order to remain with MP-NAT and ID-NAT without causing incremental risk. To assure no incremental risk, parallel test results from 2013 to 2017 were analyzed for any discordancy. A proposed Markov disease model was built to project the costs and effects of an infectious donation and perform cost effectiveness analysis for the test discontinuation. The results showed marginal cost effectiveness for the test discontinuation. There were discordant test results that showed a similar pattern to those reported for similar studies in South East Asia. Although discontinuation of serological test might now be imminent in areas with low HBV prevalence, this might not be immediately applicable in high endemic areas. This research can be of impact to blood operators in countries with similar HBV prevalence, who plan to implement NAT screening or discontinue the HBsAg test for their blood supply.

    摘要 i ABSTRACT ii ACKNOWLEDGEMENT iii TABLE OF CONTENTS iv LIST OF FIGURES vi LIST OF TABLES vii GLOSSARY OF TERMS viii CHAPTER 1: INTRODUCTION 1 1.1. Research Background and Motivation 1 1.2. Research Objectives 3 1.3. Research Contribution 4 1.4. Overview 4 CHAPTER 2: LITERATURE REVIEW 5 2.1. Blood Safety and Donor Selection 5 2.2. Hepatitis B Virus (Transfusion Transmissible Infection) 6 2.3. Transfusion Transmission Risk 7 2.4. Testing Technologies 8 2.5. Costs 9 2.6. Ethical Considerations 10 2.7. Methodological Approach 10 2.8. Summary and Critique 12 CHAPTER 3: MATERIALS AND METHODS 14 3.1. Decision Analytic Modeling 14 3.2. Markov Model 16 3.2.1. Markov Model for HBV 16 3.2.2. Markov States 17 3.2.3. State Values 18 3.3. Probability Distributions 19 3.3.1 Beta Distribution 20 3.3.2 Binomial Distribution 20 3.3.3 Multinomial Distribution 20 3.3.4 Gamma Distribution 21 3.4. Evidence Synthesis 21 3.5. Residual Risk 22 3.6. Cost Effectiveness Analysis 24 3.7. Computational Methods 25 3.8. Cohort Study 25 3.9. Sensitivity Analysis 26 CHAPTER 4: RESULTS AND ANALYSIS 28 4.1. Cost Effectiveness Analysis 28 4.1.1 Deterministic Sensitivity Analysis 29 4.1.2 Probabilistic Sensitivity Analysis 32 4.2. Economic Evaluation 34 4.2.1 Net Monetary Benefit 36 4.2.2 Value of Information 38 4.2.3 Test Result Analysis 40 4.2.4 Result Summary 40 CHAPTER 5: DISCUSSION AND CONCLUSION 41 REFERENCES 43 APPENDICES 50

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