臺灣博碩士論文加值系統

「遠距醫療」泛指應用媒體科技系統、突破時間與空間的控制、以從事互動式的醫療專業顧問與諮詢。遠距醫療的優點在於「打破時空限制」和「資源分享，節省成本」。臺大醫院遠距照護中心設立於2009年，採用互動式資料蒐集與分析系統，且即時反應的遠距照護模式，提供病患遠距式的持續性醫療照護。
植入式電子儀器旨在植入在病人體內多年，可間歇地、長時間地監測追蹤關於可植入系統的性能或病人的健康的信息。現今置入式心臟電子儀器的技術發展，心臟電子儀器已可記錄許多和儀器本身功能及病人心律不整或心臟功能變化指標的資訊，並可藉由遠距監測自動取得且通知病人及醫師，遠距監測心臟電子儀器的發展，將使心臟電子儀器置入病人其臨床照護及追蹤產生結構性的改變。關於心血管疾病之遠距醫療照護之臨床實證，在隨機分派的大型臨床試驗中並未證實對於「沒有植入式心臟電子儀器」之病人可以顯著減少有關病人之死亡率和心臟衰竭相關住院率。
就台大醫院本身而言，期望藉由遠距醫療照護的特點，克服龐大的臨床服務量壓力，在人力、空間、就醫流程的困境上，改善醫療品質，也利用植入式電子儀器遠距監測突破台大醫院遠距照護中心的發展瓶頸。植入式電子儀器遠距監測的導入，在病人端、醫療從業人員以及機構端三方面均有可預期的障礙與困難，我們透過必要的措施盡力消除克服，期能在醫療照護、臨床研究及產學合作構面上為組織帶來優勢與競爭力。
為此，我們建立了台大醫院心臟電子儀器置入病人之遠距監測的營運模式，透過心臟電子儀器之記錄電子化，將心臟電子儀器之記錄自動無線傳輸至雲端，雲端記錄可跨平台讀取，並導入台大醫院電子病歷，可電子簽章認證，永久儲存。未來將整合不同廠家的心臟電子儀器記錄之 HL7 database，建立屬於台大醫療體系之心臟電子儀器病人資料庫。我們進行了一項病例對照研究，發現植入式心臟電子儀器病人在台灣之環境下，無線傳輸的可靠性高達99％。因臨床事件或儀器異常所產生的警訊傳輸約佔27.8％；臨床事件中又以心房心律不整(主要是心房顫動)居多，發生比率佔研究人群50％以上。此外，遠距監測對心房顫動事件臨床決策時間平均可提前14天，有助於心房顫動的即早治療及中風預防，惟遠距監測組有較多的診間隨訪次數，且最後影響臨床決策的比例與傳統診間隨訪組並無差異。植入式心臟電子儀器病人的生活品質方面，兩組無顯著不同，這可能是追蹤時間過短、植入式心臟電子儀器病人遠距監測照護初建立或台灣地區傳統診間就診十分方便等因素所造成。但因遠距監測無線傳輸造成的植入式心臟電子儀器電池壽命減少，則是技術上待克服的課題。
根據臺大醫院對於植入式心臟電子儀器病人的遠距照護經驗，遠距照護的確可改善植入式心臟電子儀器病人的就醫可近性及可負擔性，提升醫療照護品質。植入式心臟電子儀器病人的遠距照護是一種以「不一樣的遠距監測方式」、對「特定醫療需求的病人族群」，進行「長時間、連續性的監測」。國外經由隨機分派的臨床試驗以及大型世代觀察型研究，發現接受遠距監測可有效降低植入式心臟電子儀器病人的全因總死亡率，改善病人預後。台灣的遠距監測尚屬建置初期，臨床經驗有限，雖有初步成效，但尚未觀察到病人預後的改變。期能透過克服法律與監管、科技技術及財務層面上的障礙與挑戰，結合政府與民間的力量，將台灣作為植入式心臟電子儀器置入病人遠距醫療照護研發基地，建立有競爭力的商業模式，藉由中國市場的經濟規模，開創植入式心臟電子儀器置入病人遠距醫療照護中國市場的藍海策略；並以此照護模式為借鏡，提供台灣資訊科技產業及生技醫療產業轉型的可能方向。

Telemedicine refers to the application of media technology, breaking the limitation of time and space to engage in interactive medical professional consultants. The Telemedicine Center of National Taiwan University was established in 2009 to provide remote, continuous medical care to patients using an interactive data collecting and analyzing system that responds instantaneously.
Implanted electronic devices are intended to be implanted in a patient for many years to monitor intermittently or continuously tracking information regarding the performance of the implantable system or the patient''s health status. Clinical evidence of telemedicine for cardiovascular disease has not been shown in large randomized clinical trials to significantly reduce heart failure-related hospitalizations and/or mortality for patients without implanted devices.
For National Taiwan University Hospital (NTUH), the introduction of remote monitoring of CIEDs has predictable obstacles and difficulties in terms of patient end, medical practitioner and hospital organization.
We have established a remote monitoring operating system in patients with CIEDs at NTUH. The recording of the CIEDs were wirelessly transmitted to the cloud and integrated with the NTU''s electronic medical records, which can be electronically signed and certified for permanent storage. A prospective, case-control study was conducted at NTUH. During a one-year and four-month follow-up period, the reliability of wireless data transmission of CIEDs in Taiwan is high (99%). Alter- initiated transmission accounts for about 27.8% of all transmission and 57% of alter transmission are arrhythmia-related warning. Although there were more follow-up visits in the remote monitoring group, there was no difference in medication adjustment between the remote monitoring group and the control group. The clinical time to decision for atrial fibrillation was 14 days earlier in patients with remote monitoring, which is helpful for the early treatment of atrial fibrillation and stroke prevention. We also surveyed patients in the remote monitoring group, their quality of life before and after 6-12 months being monitored remotely, and the results showed no significant change.
We believe that telemedicine can indeed improve the accessibility and affordability of patients with CIEDs compared to traditional medical care and also improve the quality of medical care. Remote monitoring for CIEDs is a "long-term, continuous monitoring “ in a patient population with “specific medical needs" using a "different remote monitoring methods". Taiwan is still at an initial stage of establishment, and our clinical experience is limited. Although preliminary results have been obtained, the prognosis of patients has not been observed yet. We look forward to establishing Taiwan as a place of the R&D center for remote medical care for CIED patients by overcoming legal and regulatory, technological and financial barriers.

口試委員會審定書 i
誌 謝 ii
中文摘要 iii
目 錄 vii
圖目錄 viii
表目錄 ix
第一章 緒論 1
第一節、遠距醫療於台灣現況與困境 1
第二節、植入式心臟電子儀器於台灣現況 4
第三節、研究目的 7
第二章　文獻探討 9
第一節、遠距醫療照護之臨床實證 9
第二節、遠距監測於心臟電子儀器置入病人醫療照護之優點 11
第三節、遠距監測於植入式心臟電子儀器病人之臨床照護實證 15
第三章　心臟電子儀器置入病人之遠距監測於台灣及臺大醫院之發展策略分析 22
第一節、外部環境分析: STEP 分析 22
第二節、內部環境分析 28
第三節、預期可能遭遇的障礙及消除這些障礙的可能措施 29
第四節、可能為組織帶來的優勢或競爭力 31
第四章　研究設計及方法 34
第一節、心臟電子儀器置入病人之遠距監測的營運模式 34
第二節、研究設計及方法 36
第五章　研究結果 40
第六章　討論與展望 45
第一節、遠距醫療對傳統醫療照護的影響 45
第二節、心臟電子儀器置入病人之遠距監測的現況與挑戰 47
第三節、展望 52
參考文獻 57

圖目錄
圖 1 遠距醫療臨床相關研究之研究對象分布 9
圖 2 遠距醫療臨床相關研究之遠距照護方式分布 10
圖 3 ALTITTUDE研究中不同族病人之存活率 18
圖 4 MERLIN研究中不同族病人之遠程監測使用率和存活率 19
圖 5 植入式心臟電子儀器檢查記錄整合入台大醫院電子病歷之實例 35
圖 6 遠距監測組及對照組之每人平均診間追蹤隨訪次數及有藥調整的診間隨訪比率 41
圖 7 遠距監測組及對照組之臨床事件發生到臨床決策的平均時間 42
圖 8 遠距監測組植入式電子儀器於追蹤期間之電池容量 43
圖 9 科技接受模型（Technology Acceptance Model，TAM） 52





















表目錄
表 1 植入式心臟電子儀器之遠距監測於台灣及台大醫院所預期可能遭遇的障礙及消除這些障礙的可能措施 30
表 2 植入式心臟電子儀器之遠距監測於台灣及台大醫院所可能為組織帶來的優勢或競爭力 32
表 3 台大醫院心臟電子儀器置入病人遠距醫療照護之SWOT分析 55

1.陸哲駒、陳恆順、鄭伯壎、賴金鑫，2004，遠距醫療的發展與落實，台灣醫學，8(6)：826-831。
2.衛生福利部遠距健康照護服務: http://mohw.telecare.com.tw/WebPages/Sidebar1/ProjectArea.aspx
3.臺大醫院遠距照護中心: http://www.ntuh.gov.tw/telehealth/default.aspx
4.Children’s Health Insurance Progam (CHIP): https://www.medicaid.gov/chip/index.html
5.電子時報 DIGITIMES企劃，2016，穿戴式技術論壇專輯：智慧醫療需求帶動穿戴裝置技術發展，電子時報 DIGITIMES https://www.digitimes.com.tw/tech/dt/n/shwnws.asp?CnlID=13&cat=70&id=0000487961_14L8UAXU7K2ZQY0XFHPXY&ct=1&PACKAGEID=11494
6.Bazaka K, Jacob MV. Implantable Devices: Issues and Challenges. Electronics 2013, 2, 1-34; doi:10.3390/electronics2010001.
7.Heidbüchel H, Lioen P, Foulon S, Huybrechts W, Ector J, Willems R, Ector H. Potential of remote monitoring for scheduled and unscheduled evaluations of patients with an implantable defibrillator. Europace 2008; 10: 351–357.
8.Totten AM, Womack DM, Eden KB, McDonagh MS, Griffin JC, Grusing S, Hersh WR. Telehealth: Mapping the Evidence for Patient Outcomes From Systematic Reviews [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US) 2016. Report No.: 16-EHC034-EF
9.Hanlon P, Daines L, Campbell C, McKinstry B, Weller D, Pinnock H. Telehealth Interventions to Support Self-Management of Long-Term Conditions: A Systematic Metareview of Diabetes, Heart Failure, Asthma, Chronic Obstructive Pulmonary Disease, and Cancer. J Med Internet Res. 2017; 19(5): e172.
10.Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010; (8): CD007228.
11.Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010; 363: 2301–2309.
12.Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD; Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation 2010; 123(17): 1873-1880.
13.Varma, N., Michalski, J., Epstein, A. E., & Schweikert, E. Automatic remote monitoring of implantable cardioconverterdefibrillator lead and generator performance: The Lumos-T Safely ReduceS Routine Office Device Follow-Up (TRUST) trial. Circulation, Arrhythmia and Electrophysiology 2010; 3(5): 428–436.
14.Medtronic. 2017. 6949 Sprint Fidelis. http://wwwp.medtronic.com/productperformance/model/6949-sprint-fidelis.html
15.Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH; CONNECT Investigators. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol 2011; 57(10): 1181-1189.
16.Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, Anderson KP, Calkins H, Hoch D, Goldberger J, Shalaby A, Sanders WE, Schaechter A, Levine JH; Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. 2004; 350(21): 2151–2158.
17.Guedon-Moreau L, Kouakam C, Klug D, MarquiÉ C, Brigadeau F, BoulÉ S, Blangy H, Lacroix D, ClÉMenty J, Sadoul N, Kacet S, on behalf of the EtI. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOSTtrial. J Cardiovasc Electrophysiol 2014; 25: 763–770.
18.Lazarus A. Remote, wireless, ambulatory monitoring of implantable pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy systems: Analysis of a worldwide database. Pacing Clin Electrophysiol 2007; 30(Suppl 1): S2–S12.
19.Ricci RP, Morichelli L, D’Onofrio A, Calo L, Vaccari D, Zanotto G, Curnis A, Buja G, Rovai N, Gargaro A. Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry. Europace 2013; 15: 970–977.
20.Ricci RP, Morichelli L, Santini M. Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation. Europace 2009; 11: 54–61.
21.Orlov MV, Ghali JK, Araghi-Niknam M, Sherfesee L, Sahr D, Hettrick DA; Atrial High Rate Trial Investigators. Asymptomatic atrial fibrillation in pacemaker recipients: incidence, progression, and determinants based on the atrial high rate trial. Pacing Clin Electrophysiol 2007; 30: 404–411.
22.Cheung JW, Keating RJ, Stein KM, Markowitz SM, Iwai S, Shah BK, Lerman BB, Mittal S. Newly detected atrial fibrillation following dual chamber pacemaker implantation. J Cardiovasc Electrophysiol 2006; 17: 1323–1328.
23.Bunch TJ, Day JD, Olshansky B, Stolen KQ, Mullin CM; INTRINSIC RV Study Investigators. Newly detected atrial fibrillation in patients with an implantable cardioverter-defibrillator is a strong risk marker of increased mortality. Heart Rhythm 2009; 6: 2–8.
24.Crossley GH, Chen J, Choucair W, Cohen TJ, Gohn DC, Johnson WB, Kennedy EE, Mongeon LR, Serwer GA, Qiao H, Wilkoff BL. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers. J Am Coll Cardiol 2009; 54: 2012–2019.
25.Botto GL, Padeletti L, Santini M, Capucci A, Gulizia M, Zolezzi F, Favale S, Molon G, Ricci R, Biffi M, Russo G, Vimercati M, Corbucci G, Boriani G. Presence and duration of atrial fibrillation detected by continuous monitoring: crucial implications for the risk of thromboembolic events. J Cardiovasc Electrophysiol 2009; 20: 241–248.
26.Capucci A, Santini M, Padeletti L, Gulizia M, Botto G, Boriani G, Ricci R, Favale S, Zolezzi F, Di Belardino N, Molon G, Drago F, Villani GQ, Mazzini E, Vimercati M, Grammatico A. Monitored atrial fibrillation duration predicts arterial embolic events in patients suffering from bradycardia and atrial fibrillation implanted with antitachycardia pacemakers. J Am Coll Cardiol 2005; 46: 1913–1920.
27.Glotzer TV, Daoud EG, Wyse DG, Singer DE, Ezekowitz MD, Hilker C, Miller C, Qi D, Ziegler PD. The relationship between daily atrial tachyarrhythmia burden from implantable device diagnostics and stroke risk: the TRENDS study. Circ Arrhythm Electrophysiol 2009; 2: 474–480.
28.Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med 2012; 366: 120–129.
29.Glotzer TV, Hellkamp AS, Zimmerman J, Sweeney MO, Yee R, Marinchak R, Cook J, Paraschos A, Love J, Radoslovich G, Lee KL, Lamas GA; MOST Investigators. Atrial high rate episodes detectedby pacemaker diagnostics predict death and stroke: report of the atrial diagnostics ancillary study of the MOde Selection Trial (MOST). Circulation 2003; 107: 1614–1619.
30.Shanmugam N, Boerdlein A, Proff J, Ong P, Valencia O, Maier SK, Bauer WR, Paul V, Sack S. Detection of atrial high-rate events by continuous home monitoring: clinical significance in the heart failure-cardiac resynchronization therapy population. Europace 2012; 14: 230–237.
31.Brambatti M, Connolly SJ, Gold MR, Morillo CA, Capucci A, Muto C, Lau CP, Van Gelder IC, Hohnloser SH, Carlson M, Fain E, Nakamya J, Mairesse GH, Halytska M, Deng WQ, Israel CW, Healey JS; ASSERT Investigators. Temporal relationship between subclinical atrial fibrillation and embolic events. Circulation 2014; 129: 2094–2099.
32.Martin DT, Bersohn MM, Waldo AL, Wathen MS, Choucair WK, Lip GY, Ip J, Holcomb R, Akar JG, Halperin JL; IMPACT Investigators. Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices. Eur Heart J 2015; 36(26): 1660-1668.
33.Vollmann D, Nägele H, Schauerte P, Wiegand U, Butter C, Zanotto G, Quesada A, Guthmann A, Hill MR, Lamp B; EISOS Investigators. Clinical utility of intrathoracic impedance monitoring to alert patients with an implanted device of deteriorating chronic heart failure. Eur Heart J 2007; 28: 1835–1840.
34.Conraads VM, Tavazzi L, Santini M, Oliva F, Gerritse B, Yu CM, Cowie MR. Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial. Eur Heart J 2011; 32: 2266–2273.
35.Catanzariti D, Lunati M, Landolina M, Zanotto G, Lonardi G, Iacopino S, Oliva F, Perego GB, Varbaro A, Denaro A, Valsecchi S, Vergara G; Italian Clinical Service Optivol-CRT Group. Monitoring intrathoracic impedance with an implantable defibrillator reduces hospitalizations in patients with heart failure. Pacing Clin Electrophysiol 2009; 32: 363–370.
36.Maines M, Catanzariti D, Cemin C, Vaccarini C, Vergara G. Usefulness of intrathoracic fluids accumulation monitoring with an implantable biventricular defibrillator in reducing hospitalizations in patients with heart failure: a case-control study. J Interv Card Electrophysiol 2007; 19: 201–207.
37.van Veldhuisen DJ, Braunschweig F, Conraads V, Ford I, Cowie MR, Jondeau G, Kautzner J, Aguilera RM, Lunati M, Yu CM, Gerritse B, Borggrefe M; DOT-HF Investigators. Intrathoracic impedance monitoring, audible patient alerts, and outcome in patients with heart failure. Circulation 2011; 124: 1719–1726.
38.Whellan DJ, Ousdigian KT, Al-Khatib SM, Pu W, Sarkar S, Porter CB, Pavri BB, O’Connor CM. Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. J Am Coll Cardiol 2010; 55: 1803–1810.
39.Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, Brachmann J, Lewalter T, Goette A, Block M, Kautzner J, Sack S, Husser D, Piorkowski C, Søgaard P; IN-TIME study group. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet 2014; 384: 583–590.
40.Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet 2011; 377: 658–666.
41.Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, Binet D, Daubert JC; COMPAS Trial Investigators. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J 2012; 33: 1105–1111.
42.Varma N, Epstein A, Irimpen A, Schweikert R, Love C; TRUST Investigators. The lumos-T safely reduces routine efficacy and safety of automatic remote monitoring for implantable cardioverter defibrillator follow-up. The lumos-T safely reduces routine office device follow-up (TRUST) trial. Circulation 2010; 122: 325–332.
43.Crossley G, Boyle A, Vitense H, Sherfesee L, Mead RH. The clinical evaluation of remote notification to reduce time to clinical decision (CONNECT) trial. Am Heart J 2008; 156: 840–846.
44.Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J 2012; 34: 605–614.
45.Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation 2012; 125: 2985–2992.
46.Hindricks G, Elsner C, Piorkowski C, Taborsky M, Geller JC, Schumacher B, Bytesnik J, Kottkamp H. Quarterly vs. yearly clinical follow-up of remotely monitored recipients of prophylactic implantable cardioverter-defibrillators: results of the REFORM trial. Eur Heart J 2014; 35: 98–105.
47.Calò L, Gargaro A, De Ruvo E, Palozzi G, Sciarra L, Rebecchi M, Guarracini F, Fagagnini A, Piroli E, Lioy E, Chirico A. Economic impact of remote monitoring on ordinary follow-up of implantable cardioverter defibrillators as compared with conventional in-hospital visits: a single-center prospective and randomized study. J Interv Card Electrophysiol 2013: 37: 69–78.
48.Saxon LA, Hayes DL, Gilliam FR, Heidenreich PA, Day J, Seth M, Meyer TE, Jones PW, Boehmer JP. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation 2010; 122: 2359–2367.
49.Varma NPJ, Snell J, Fischer A, Dalal N, Mittal S. The relationship between level of adherence to automatic wireless remote monitoring and survival in pacemaker and defibrillator patients. J Am Coll Cardiol 2015; 65(24): 2601-2610.
50.Hoenig H, Tate L, Dumbleton S, Montgomery C, Morgan M, Landerman LR, Caves K. A quality assurance study on the accuracy of measuring physical function under current conditions for use of clinical video telehealth. Arch Phys Med Rehabil. 2013;94:998 -1002.
51.Holzinger A. Usability engineering methods for software developers. Communications of the ACM. 2005;48:71–74.