發展活體肝臟捐贈決策輔助工具及其效益評估

The development of the decision aid for potential donor of living donor liver transplantation and to appraise its effect

吳丕玉(Pi-Yu Wu)

指導教授 ： 陳端容

國立臺灣大學/公共衛生學院/健康政策與管理研究所/博士(2022年)

https://doi.org/10.6342/NTU202200085

摘要

研究背景
肝臟疾病為我國重要公共衛生議題，慢性肝臟疾病進程到末期的病人而言，肝臟移植是救命的最後希望。我國大體捐贈來源的器官有限，肝臟移植以活體肝臟移植（Living donor liver transplantation,LDLT）為主。LDLT的決策涉及捐贈者、受贈者及家庭中其他關係人的想法，捐贈者是否適合亦需要醫療人員嚴謹的評估，故其決策非僅限於捐贈當事人，是一個需要共享決策（Shared decision making，SDM）的議題。就目前已發表的研究，尚未有以協助活體肝臟潛在捐贈者做出符合個人價值觀知情決定的決策輔助工具(Patient decision aid，PDA)。
研究目的與方法
本研究參照國際病人決策支援標準協會(the International Patient Decision Aid Standards ,IPDAS，以下簡稱IPDAS)，經過界定範圍、組成指導小組、需求評估、決定工具形式及應用計畫、實證綜整等過程產出PDA的原型，再經過初步測試(Alpha test)及臨床應用測試(Beta test)發展出輔助LDLT潛在捐贈者作捐贈決策的PDA。PDA的Beta test係針對接受活體肝臟捐贈評估第二階段住院評估的捐贈者，在其住院評估出院前實施問卷測量，以比較PDA介入組及對照組的潛在捐贈者在與LDLT相關知識、捐贈矛盾、決策衝突、決策滿意度及捐贈意向等結果變項。另因需求評估的對象涵蓋LDLT醫療團隊的各職類人員、有過LDLT評估或實際捐贈經驗的捐贈者，以及接受過LDLT的受贈者，故分析需求評估的質性資料，歸納出影響LDLT潛在捐贈者的決策因素及醫療人員在LDLT中扮演的角色。
研究結果
參照IPDAS發展出的PDA，經自評可符合IPDAS4.0的合格類別、認證類別及大部分的品質類別指標，且在Alpha test階段醫療人員及曾經有過捐贈經驗的捐贈者或正在接受捐贈評估的潛在捐贈者均對PDA有正面的評價。Beta test (對照組27人、介入組26人)，並未發現PDA介入組在捐贈矛盾、決策衝突雖較對照組為低、決策滿意度較對照組為高，但兩組在各結果變項均未達到統計上的顯著差異。透過在PDA需求評估階段對醫療人員、捐贈者及受贈者的需求訪談內容所作的質性分析，可歸納出影響活體肝臟捐贈者決策的影響因素可分為「內在動機」、「決策過程」、「外在脈絡」三個層次，在「內在動機」的層次，可歸納出「責任與義務」、「愛與不愛」及「自我實現」三個主題；在「決策過程」的層次，歸納出「拉扯」、「偕同」及「承擔」三個主題；在「外在脈絡」層次，可歸納出「器捐文化」、「資源拉扯」及「醫療主導」三個主題。醫療團隊在LDLT的角色，扮演受贈者的「支持者」、捐贈者的「保護者」並在LDLT過程間擔任「領航員」。
研究結論與建議
從質性研究的結果可知影響活體肝臟潛在捐贈者的決策因素相當多元，且涉及捐贈者、受贈者及其他關係人的身心社會條件與想法，醫療人員亦扮演相當重要的角色，應全面的考量活體肝臟捐贈者的身心社會條件，及其對個人意願或捐贈決定後果的影響。本研究發展的PDA符合IPDAS建議的發展步驟並符合多數IPDAS建議的PDA品質指標，可考量於臨床進一步的推廣應用，且介入時機可考量提早在受贈者接受移植評估時，或至遲於捐贈者接受第一階段捐贈評估時即介入，以更即時讓潛在捐贈者能了解活體肝臟移植及腦死捐贈者肝臟移植的差異，以及個人捐贈或不捐贈的好處與壞處，及早確認個人的價值觀與意願，作出符合個人意願及知情同意精神的決定。

關鍵字

醫病共享決策 ； 決策輔助工具 ； 活體肝臟移植 ； 活體捐贈者 ； 決策衝突 ； 矛盾

並列摘要

Research Background
Liver disease is an important public health issue in our country. For patients whose chronic liver disease progresses to the end stage, liver transplantation is the last mean of life-saving. Since the resourse of deceased donor organs in our country is very limited, Living Donor Liver Transplantation (LDLT) is the main source of liver transplantation. The stakeholders of the LDLT’s decision-making involves the donors, recipients, and other families and the suitability of donors also requires rigorous evaluation by medical personnel. Therefore, LDLT is a shared decision making (SDM) issue. As far as the published research is concerned, there is no patient decision aid (PDA) to assist LDLT potential donors to make informed decisions in line with personal values.
Methods
This study refered to the International Patient Decision Aid Standards (IPDAS), and prototype of the PDA was created through the process of scoping, forming a steering group, needs assessment, determining format and distribution plan, and synthing empirical evidence, Alpha test and Beta test. The Beta test of PDA is aimed at donors who have undergone the second-stage inpatient evaluation of LDLT evaluation. Questionnaire was implemented before the discharg of potential donor’s inpatient evaluation and to compare potential donors in the PDA intervention group and the control group in terms of knowledge and donation contradictions related to LDLT, decisional conflicts, decision-making satisfaction, and donation intentions. In addition, the qualitative data of the needs assessment was analyzed to explore the determinants of the decision-making of LDLT potential donors and the role of medical staff in LDLT.
Results
With reference to the IPDAS PDA development procedure, after self-assessment, it can meet the qualification elements, certification elements and most of the quality elements of IPDAS4.0, and medical personnel and experienced donors in the Alpha test stage or all have positive comments on PDA. For the Beta test, 27 people in the control group and 26 people in the intervention group. The PDA intervention group had lower donation ambivalence and decisional conflicts than the control group, and higher decision-making satisfaction than the control group, however none of them reached a statistically significant difference. Through the qualitative analysis of interview data of medical personnel, donors and recipients during the PDA needs assessment phase, it can be concluded that the determinants of LDLT potential donors’ decision-making can be divided into three levels："intrinsic motivation", "decision process", and "external context". At the level of "intrinsic motivation", three themes can be summarized: "responsibility and obligation", "love and unlove" and "self-realization"; at the level of "decision-making process", it can be summarized three themes of "be torned", "consistnent" and "bearing" can be summarized; at the level of "external context", three themes of "organ donation culture", "restrainsof social resource " and "medical guiding" can be summarized. The role of the medical team in LDLT is to act as the "supporter" of the recipient, the "protector" of the donor and the "navigator" during the LDLT process.
Conclusion
From the results of qualitative research, we found that the determinants of LDLT dicisions are multi-dimentional and multi-stakeholders invloved. LDLT providers also have a significant role during LDLT decision-making process. Medical staff should fully consider the physical, mental and socilal aspects of donors to help them make informed and value-cohesive decisions. The PDA developed in this study complies with the development steps and meets the PDA quality indicators recommended by IPDAS. It can be considered for further promotion and application. This LDLT-donor PDA can be offered to people whose family are undergone liver transplantation evaluation or to the potential donors who are receiving first-stage evaluation. This PDA is a evidence-based structural instrument to helpthe potential donor efficiently understand the difference between LDLT and DDLT, as well as the pros and cons of being a living donor. This PDA help potential donor to clarify one’s value and will and make informed decision.

並列關鍵字

Shared decision making,SDM ； Patient decion aid,PDA ； Living donor liver transplantation,LDLT ； living donor ； Decisional conflict ； Ambivalence

參考文獻

1. 劉嘉玲, et al., 臺灣B型肝炎防治. 疫情報導, 2016. 32(14): p. 290-300.

2. 林志陵 and 高嘉宏, 肝癌的流行病學. 中華民國癌症醫學會雜誌, 2008. 24(5): p. 277-281.

3. Chen, C.L., C.S. Kabiling, and A.M. Concejero, Why does living donor liver transplantation flourish in Asia? Nature reviews. Gastroenterology amp; hepatology, 2013. 10(12): p. 746-751.

4. Lo, C.M., Deceased donation in Asia: Challenges and opportunities. Liver Transplantation, 2012. 18(SUPPL.2): p. S5-S7.

5. Rela, M. and M.S. Reddy, Living donor liver transplant (LDLT) is the way forward in Asia. Hepatology International, 2017. 11(2): p. 148-151.