24卷4期

• Link 綜論 Review Article
• 醫療品質評估的發展－從專業評鑑到報告卡系統The Evolution of Healthcare Quality Assessment: From Accreditation to Report Card System
• 魏玉容、鍾國彪、鄭守夏
  Yu-Jung Wei, Kuo-Piao Chung, Shou-Hsia Cheng
• 醫療品質 ； 評鑑 ； 評估 ； 報告卡
  quality of care ; accreditation ; assessment ; report card
• 醫療品質向來是醫療服務體系中的核心價值之一，品質的評估、確保與持續改進也是各國政府十分重視的工作。本文主要在整理與比較美國與台灣在醫療品質的確保與品質測量的各種努力。從過去發展的演進來看，醫療品質的確保是由醫院評鑑制度開始，其間持續不斷的發展測量指標，來評估、監測醫療品質。接著是醫療專業在成本控制壓力下的自我提升，包括引進企業管理的制度與技術，並訂定以實證為基礎的臨床作業準則，進一步提升醫療品質。最近則發展到讓醫療消費者參與品質的評估以及醫療品質資訊的公開，希望透過資訊提供讓消費者能做明智的選擇，促使醫療專業可以加速品質改善，更符合病人的期望。最後本文亦提出建議供政策參考。
  Quality of health care is one of the core values in the healthcare delivery system. Many nations have made essential efforts in the assessment, assurance, and improvement of healthcare quality. The purpose of this article is to describe the evolution in healthcare quality improvement and assessment in the United States and in Taiwan. Evidence shows that quality assurance was initially established by implementing a hospital accreditation mechanism; accompanied by continuous development of quality indicators to monitor the quality of healthcare. As the cost-containment pressure increased, health professionals began to adapt industrial management tools and create evidence-based practice guidelines to improve the quality of healthcare. Recent developments include consumer involvement in quality assessment and public disclosure of quality information. It is hoped that the quality information provision will facilitate consumers choice among providers and accelerate the process of professional quality improvement. Finally, the article provides several recommendations for policy consideration.
• 275 - 283
• 10.6288/TJPH2005-24-04-01

• Link 原著 Original Article
• 肝癌患者經導管動脈化學栓塞治療標準流程之建立及其效益評估Evaluation of the Implementation of Clinical Guidelines for Transcatheter Arterial chemo-embolization of Patients with Hepatocellular Carcinoma
• 黃凱琳、蘇維文、 孫茂勝、吳順生、陳洋源、 陳美如
  Kai-Lin Hwang, Wei-Wen Su, Maw-Soan Soon, Shun-Sheng Wu, Yang-Yuan Chen, Mei-Ju Chen
• 化學栓塞治療 ； 標準治療流程 ； 效益評估 ； 滿意度
  transcatheter arterial chemo-embolization ; clinical guidelines ; effectiveness evaluation ; satisfaction
• 目標：本研究之目的?評估肝癌病患經導管動脈化學栓塞治療標準流程建立及其效益。方法：本研究採前後期實驗對照研究法於彰化基督教醫院肝膽胃腸科進行，比較動脈化學栓塞治療標準流程建立前後之各項指標。共分三個階段：流程未實施前?對照期、流程宣導及試行期、與路徑實施後三個月之實驗期。結果：於對照期及實驗期各收錄57名患者進行評估。兩組住院天數雖無顯著差異，但路徑實施後較實施前略降0.4天（3.3比2.9天，p=0.23），患者對大部份項目的服務滿意度在路徑實施後均較實施前有所提升，其中「護理人員對可能發生狀況的說明」(77.4%vs.94.6%, p=0.01)與「對發燒的處理」(78.8% vs.96.8%, p=0.04)之滿意／非常滿意的比例在路徑實施後顯著增加。路徑實施前之平均醫療費用（±標準差）?NT$57,736.1(±11,197.7)，實施後?NT$53,824.3(±10,332.6)，降幅?6.8%(p=0.07)；前後兩次門診總醫療費用由NT$14,135.5(±5,143.9)降?NT$12,2695(±4,670.7)，降幅達13.2%(p=0.05)。除了對減少工作負擔的同意率略低外(63.9%)，醫護人員對各項指標的支持度都在83%以上，尤以對照護品質提升的認同率最高達100%。結論：肝癌病患之肝動脈化學栓塞治療臨床路徑，除了對患者與醫護人員的滿意與支持度略有提升外，亦有減少醫療費用之傾向，值得繼續鼓勵與推動。但在實際應用上，仍需視個案實際情況由主治醫師依醫療專業給予最適當的處置與治療。
  Objectives: To evaluate the effectiveness of clinical guidelines for transcatheter arterial chemo-embolization (TACE) of patients with hepatocellular carcinoma (HCC). Methods: Pre- and post-implementation evaluations were performed at the Division of Gastroenterology and Hepatology, Changhua Christian Hospital. There were three study periods, control (3 months prior to implementation), construction and practice, and trial (3 months after the implementation). Results: Fifty-seven patients were recruited into each of the pre- and post-study periods. The average hospital stay was shortened (0.4 days, 3.3 vs. 2.9 days) for pre- and post-periods, respectively, p=0.23). Patients had a higher satisfaction of most of the services provided after the guidelines had been implemented. Among them, ”instruction of expected events” (77.4% vs. 94.6%, p=0.01) and ”treatment of fever” (78.8% vs. 96.8%, p=0.04) had significant higher rates of ”satisfied/very satisfied” ranking compared with those from the control period. Average (±standard deviation) overall medical expenditure was reduced from NT$57,736.1 (±11,197.7) to NT$53,824.3 (±10, 332.6); a reduction of 6.8% (p=0.07). The average medical expenditure for the outpatient visit prior to and after the TACE hospitalization was reduced from NT$14,135.5 (±5,143.9) to NT$ 12,269.5 (±4,670.7); a reduction rate of 13.2% (p=0.05). All health professionals agreed that the guidelines improved the quality of care, more than 83% supported additional advantages. However, only 63.9% agreed that workload decreased. Conclusions: The clinical pathway of TACE for patients with HCC was effective in terms of both patient's and health-care provider's satisfaction and tended to control medical expenditure. Still, it is strongly recommended that physicians provide the most appropriate treatment to patients based on professional judgment.
• 284 - 295
• 10.6288/TJPH2005-24-04-02

• Link 原著 Original Article
• 市場競爭及其他因素對精神科急性住院病患醫療利用之影響The Effect of Market Competition and Risk Factors on the Utilization of Acute Psychiatric Inpatients
• 李靜玟、吳肖琪
  Ching-Wen Lee, Shiao-Chi Wu
• 市場競爭；精神醫療；醫療利用；急性病床
  ?competition?;?psychiatry?;?utilization?;?acute beds
• 目標：探討台灣急性精神病床住院市場競爭程度及其他因素對精神病患精神科急性住院利用之影響。方法：以民國90年身份證加密之全民健保精神科住院申報資料，主診斷ICD-9-CM介於290-319之急性精神病床住院病患?對象。市場區域以縣市?單位，市場競爭程度採用賀芬達指標，市場佔有率分別以住院費用及住院日計算之。結果：53.89%急性精神住院病患在高競爭地區住院。病患就醫市場之競爭程度愈高，病患住院費用、每人日住院費用、14與30日再住院情形較高，其住院日較中度競爭地區病患短。住在私立醫院之病患住院費用、每人日住院費用、住院日較住公立醫院者低、但再住院情形較高。住在評鑑層級愈高的醫院，住院費用、每人日住院費用、住院日愈高，再住院情形較低。住在精神專科醫院之住院費用、每人日住院費用、住院日較住在綜合醫院精神科高，但30日再住院情形較低。住在醫院規模愈大的醫院，住院費用愈高、住院日愈短、再住院情形愈高。結論：精神醫療市場存在非價格競爭，市場競爭程度愈高，急性住院病患醫療利用愈高，建議政府應注意高度競爭地區的監控，尤其是私立醫院、醫院層級愈低、規模愈大醫院的再住院率，以確保病患照護品質與減少醫療支出。
  Objectives: To investigate the effects of psychiatric market competition and other factors on acute psychiatric inpatients in Taiwan. Methods: The data (with scrambled IDs) of the inpatients from 2001 was derived from the National Health Insurance database. The primary diagnosis code numbers of ICD-9-CM were between 290 and 319. The market area of psychiatric service was based on city or county, and the Herfindahl-Hirschman Indexes were based on the amount of acute inpatient cost and the length of stay. These indexes were used to represent the degree of the competitive psychiatric market. Results: 53.89% of acute inpatients fall into areas with a highly competitive psychiatric market. Patients located in the area of a highly competitive psychiatric market had a higher cost per case and cost per diem as well as a higher rate of 14 & 30 days readmission, however, length of stay was shorter than of medium level competitive market (p<0.05). Regarding the ownership of hospitals where patients were admitted, although the inpatient cost per case, cost per diem, and length of stay in private hospitals were all lower than in public hospitals, 14 & 30 days readmission were actually higher than in public hospitals (p<0.05). The inpatient cost per case, cost per diem and length of stay in medical centers were higher than in regional and district hospitals (p<0.05). Nevertheless the 14 & 30 days readmission of patients in medical centers was lower than in regional and district hospitals. The inpatient cost per case, cost per diem and length of stay at psychiatric hospitals was higher than general hospitals with psychiatric sections, but had lower 30 days readmission rates (p<0.05). On the size of hospitals, the inpatient cost was higher, length of stay was shorter, and 14 & 30 days readmission were higher in larger sized hospitals than in smaller sized hospitals. Conclusions: There is non-price competition in the psychiatry market. The government should pay attention to the market of acute bed care in order to reduce readmission rate. This is especially the case for hospitals in areas with a highly competitive psychiatric market.
• 296 - 305
• 10.6288/TJPH2005-24-04-03

• Link 原著 Original Article
• 模擬DRGs實施對我國醫院的財務衝擊Simulating the Financial Impact of DRGs on Hospitals in Taiwan
• 陳婉茗、 吳肖琪
  Wan-Ming Chen, Shiao-Chi Wu
• 疾病診斷關係群 ； 財務衛擊 ； 醫院 ； 模擬
  DRGs ; Financial Impact ; Hospital ; Simulation
• 目標：模擬若住院費用由論量計酬制度改採疾病診斷關係群(diagnosis rolated group; DRGs)制度，對不同特質醫院財務表現之影響。方法：以健保局1998年至2002年身份證字號加密的全民健保「住院醫療費用清單明細檔」，利用該局提供之第二代醫療資訊服務系統，轉出DRGs代碼；進而模擬平均每住院人次收益差?平均之各年度各醫院每住院人次在DRGs支付制度費用減去論量計酬制度下之費用（以下簡稱收益差），以廣義估計方程式模式(generalized estimating equation; GEE)，探討年度效應、醫院特質（權屬層級別、平均編碼個數、平均住院日數、病例組合指標）、區域特質（縣市別醫療市場競爭程度、人口密度、每萬人口醫師數）與醫院收益差之關聯性。結果：若住院申報費用由論量計酬改採DRGs支付住院費用時，對地區醫院較有利，其各年整體收益差呈現正值。區域以上醫院則呈負值。就權屬別而言（除2002年未有評鑑等級醫院外），各層級醫院的平均收益差皆?公立高於私立；年度效應達統計上顯著差異，從1999年開始，醫院受益有逐年增加（受益差分別?-406元、-268元、-125元、46元）；而醫院特質中平均編碼個數每增加一個、收益差增加1640元，平均住院日數每增加l天、收益差減少1460元，病例組合指標值每上升1單位、收益差增加5055元。結論：模擬過去五年住院費用改採DRGs制度，呈現各年度的收益差有逐年改善，這可能與相關單位宣示實施DRGs效產生年度效應有關，而不同特質的醫院其收益差會有不同；建議健保局在全面實施DRGs前應注意DRGs支付制度對不同特質醫院所造成之財務衝擊。
  Objectives: To simulate the financial impact of different kinds of hospitals after the payment system changed to DRGs from fee-for-service. Methods: Data of inpatients from 1998 to 2002, who had their ID scrambed, were grouped into DRGs by the 2nd version software of medical information service system released from BNHI. The difference in the average revenue of per admission per hospital per year between the DRG and fee-for-service payment system was simulated in this study. The association factors with the difference in revenue, such as the year effect, hospital characteristics (ownership-accreditation, average of coding numbers, average length of stay and case-mix index) and regional characteristics (medical competitive level of county, population density and number of physicians) were investigated by the generalized estimating equation model. Results: If payment system was changed from fee-for-service to DRGs, the difference in revenue was positive for district hospitals every year, but negative for regional hospitals and medical centers. The difference in revenue for all of the public hospitals was more than private hospitals (except the hospitals without accreditation in 2002). The year effect for the difference in revenue was also statistically significant. The difference in revenue went from negative to positive compared to 1998 in the past 4 years (NT$ -406 in 1999, NT$ -268 in 2000, NT$ -125 in 2001 and NT$ 46 in 2002). The difference in revenue was increased NT$ 1640 per coding number added and decreased NT$ 1460 per day of length of stay increased. The difference in revenue was decreased NT$ 5055 per case-mix index increased. Conclusion: When the payment system changed from fee-for-service to DRGs, the difference in revenue became better year by year in this simulated study. This year effect was likely related to the announcement of DRG implemented by BNHI. The financial impact was different for different kinds of hospitals.
• 306 - 314
• 10.6288/TJPH2005-24-04-04

• Link 原著 Original Article
• 職場哺乳親善措施對女性員工母乳哺育行爲之影響The Effects of a Workplace breastfeeding-friendly Policy on Female Employees Breastfeeding Behavior
• 陳怡君、丁志音、 劉益宏、郭淑珍
  Yi-Chun Chen, Chih-Yin Lew-Ting, Yi-Hung Liu, Shu-Chen Kuo
• 母乳哺育 ； 職業婦女 ； 哺乳親善措施
  breastfeeding ; female employees ; breastfeeding-friendly policy
• 目標，瞭解職場哺乳親善措施（集乳室的設置與擠奶時間的規定）對職業婦女哺乳示?之影響以及婦女對哺乳措施的感受。方法：本研究在設有集乳室的某半導體公司進行問卷調查，以1999年一月至2000年四月在該公司生育子女的女性員工?研究對象，共獲得998份有效樣本（回收率75.3%）。結果，本研究發現，即使是在設有集乳室並且支持擠奶時間的公司內，上班後持續哺乳的婦女並不多(l3.2%)。在影響婦女哺乳行?因素方面，對哺乳措施的瞭解程度與工作性質是影響婦女上班後持續哺乳的重要因素。對於公司哺乳親善措施較瞭解者與非生產線的工作者，有較高的可能性會在上班後持續哺乳。婦女對於公司哺乳措施方面，有五成的婦女對於公司所設置的集乳室表示滿意或是沒有意見。上班後持續哺乳的媽媽有較高的比例是有意見的，主要的意見是「應該添購擠奶相關設備」。對於擠奶時間的規定，有五成的婦女表示有意見，最有共識的意見是「沒有宣導，不知道有此措施」。結論：集乳室的設置與擠奶時間的規定，這兩項哺乳措施可以提高婦女上班後持續哺乳的可能性。但是兩項措施仍有改善的空間，集乳室的設置應該更符合使用者的需求，對於擠奶時間的規定應該要多多加以宣導。
  Objectives: The objective of this research was to explore the effects of a breastfeeding friendly policy (i.e., pumping room facilities and the rules of breastfeeding breaks) in the workplace on the behavior of female employees and to describe their perception of this policy. Methods: The survey was conducted in a large semiconductor company with a pumping room. Our subjects were employees who gave birth between January 1999 and April 2000. A total of 998 valid questionnaires were collected, giving a survey return rate of 75.3%. Results: The research found that, despite the provision of a pumping room and milk expression time, few employed mothers (13.2% of the valid sample) continued to breastfeed after returning to work. The key factors affecting the decision of female employees to continue breastfeeding after returning to the workplace were their perception of the company's breastfeeding policy and the nature of their work. Office workers rather than fab workers favored continuing to breastfeed. Female employees who were aware of their company's breastfeeding-friendly policy were more likely to continue to breastfeed. A half of the survey subjects were satisfied or had no comment on the pumping room facilities provided by the company, and a greater percentage of the survey subjects held the opinion that ”the company needed to buy equipment related to milk expression.” Regarding the period set aside for milk expression, 50% of the survey subjects opined that they ”did not know about the policy.” Conclusions: Pumping room facilities and time periods set aside for milk expression increase the likelihood that female employees continue to breastfeed after returning to the workplace. Nonetheless, these two key factors still need to be improved upon, such as enhancing pumping room facilities to better match users' requirements and better promotion of the period set aside for milk expression.
• 315 - 324
• 10.6288/TJPH2005-24-04-05

• Link 原著 Original Article
• 社會階層、社會心理因素對大學生運動行爲之影響The Influences of Socioeconomic Status and Psychosocial Factors in Exercise Behaviors among Undergraduates
• 張淑紅
  Shu-Hung Chang
• 社會階層 ； 社會心理因素 ； 運動行 ； 大學生
  Socioeconomic status ; Psychosocial ; Exercise behaviors ; Undergraduates
• 目標：探討台大學生運動行?，並進一步分析社會階層與社會心理因素對運動行?之影響。方法：本研究?橫斷式研究，利用電話訪問之方式收集台大學生之運動行?、社會階層及社會心理因素等資料。結果：受試者共397人，其中62.7%表示平日有運動習慣，但真正符合美國運動醫學會認定之規律運動的標準則僅24.2%；其中男生有規律運動者佔31.6%，女生僅16.0%；低年級規律運動的比率?31.6%，高年級僅17.6%；父母教育程度高其規律運動比率高，在女生尤其明顯。可以預測全體受訪者規律運動之因素包括：性別、年經、自覺健康狀況；預測男性規律運動之因素則?年經及可利用金錢充格程度；預測女性規律運動僅母親教育程度。結論：台大學生規律運動比率偏低，社會階層與社會心理因素確實會影響規律運動行?，應好好思考如何增加學生規律運動行?。
  Objectives: This study investigated the exercise behaviors and correlates among undergraduate students at National Taiwan University. Methods: A cross-sectional telephone interview was used to collect information about students exercise behaviors, socioeconomic status (SES) and psychosocial factors. Results: Among 397 students being interviewed, 62.7% of them had self- reported durable exercise. However, according to the ACSM’s (American College of Sports Medicine) definition, only 24.2% of the students were qualified as having regular exercise, including 31.6% male students and l6.0% female students. Junior students were likely to have regular exercise than senior students (3l.6% vs. l7.6%). Students with parents who had higher education were prone to regularly exercise, and this was more obvious in female students. Gender, grade, and perceived health status were predictors of regular exercise behaviors for all subjects. Grade and level of disposable income were predictors of regular exercise behaviors in male students. Mother's education level was the only predictor of regular exercise behaviors in female students. Conclusion: Regular exercise is generally not appreciated by university students. SES and psychosocial factors are associated with the practice of regular exercise in these students. It is worthwhile to make efforts to improve regular exercise behaviors among students.
• 325 - 334
• 10.6288/TJPH2005-24-04-06

• Link 原著 Original Article
• 1985-1987台北地區孕婦使用中草藥之盛行率及其相關因素Prevalence and Related Factors of Chinese Herbal Medicine Use in Pregnant Women of Taipei, 1985-1987
• 莊昭華、賴榮年、王榮德、張蓓貞、陳保中
  Chao-Hua Chuang, Jung-Nien Lai, Jung-Der Wang, Pei-Jen Chang, Pau-Chung Chen
• 中草藥 ； 孕婦 ； 盛行率 ； 相關因素
  Chinese herbal medicine ; pregnant women ; prevalence ; related factors
• 目標：孕婦使用草藥越趨流行，本研究的目的?探討台北地區孕婦使用中草藥之盛行率及其相關因素。方法：於1985-87年間到台北市立婦幼醫院進行產檢之懷孕26週或以上之孕婦，經由訪員使用結構式問卷進行訪談，以獲得詳細資料。利用複邏輯迴歸分析不同時期孕婦使用中草藥、西藥及鐵劑或維它命之相關因素。結果：69%的孕婦曾於孕前用過中草藥，42.3%於孕中使用過中草藥。家庭收入較低、未生產過、孕前有婦科病史、或孕前月經不現則之孕婦較易於孕前使用中草藥；較低教育、非專業性職業、曾有過流產或死產、或有B形肝炎之孕婦較易於孕中使用中草藥。結論：此1980年代的研究顯示台北地區孕婦普遍存在使用中草藥之情形，未來需繼續釐清草藥對胎兒之潛在健康影響，及孕期照護人員須詢問及注意孕婦使用中草藥之習慣。
  Objectives: The use of herbal medicines during pregnancy is becoming fashionable. The purpose of this study is to explore the prevalence and related factors of pregnant women using Chinese herbal medicines in Taipei. Methods: During 1985-87, a total of 10,756 pregnant women with 26 or more weeks of gestation who came to the Taipei Municipal Maternal and Child Hospital for prenatal care, were interviewed by trained interviewers using structured questionnaires to obtain detailed information. Multiple logistic regressions were used to estimate odds ratios of the dichotomous outcomes such as Chinese herbal medicines, medicines and supplements during different time periods. Results: The use of at least one herbal medicine was 6.9% before pregnancy and 42.3% during pregnancy. Before pregnancy, women used significantly more Chinese herbal medicines associated with lower family incomes, primipara, gynecological diseases, and irregular cycles of menstruation. During pregnancy, pregnant women with characteristics of lower education, a non-professional job, previous spontaneous or induced abortion or stillbirth, and women carried HBsAg virus tended to use Chinese herbal medicines. Conclusions: This mid-1980s survey showed that Chinese herbal medicines were frequently used before and during pregnancy in Taipei women, especially among those with low socio-economic levels. It deserves future studies to clarify their potential health effects on fetuses and enquire about such habits during prenatal care.
• 335 - 347
• 10.6288/TJPH2005-24-04-07

• Link 原著 Original Article
• 肺結核病患未完成治療原因探討Factors Affecting the Failed Treatment for Tuberculosis Patients
• 胡曉雲、 蔡文正、 龔佩珍
  Hsiao-Yun Hu, Wen-Chen Tsai, Pei-Tseng Kung
• 肺結核 ； 未完治率 ； 完治率 ； 結核病
  Pulmonary tuberculosis ; Failure rate ; Cure rate ; Tuberculosis
• 目標：結核病是全球重要的健康問題之一，未完成治療不但是影響國內結核病防治的重大因素，同時也增加防疫與治療上的困難，因此本研究希望藉由全國性之調查，了解造成肺結核患者未完成治療之因素。方法：本研究對象?疾病管制局2001年1~12月所登錄全國之肺結核病急，針對完治及未完治病患，利用分層隨機比例抽樣，以電話訪問方式進行問卷調查。並利用羅吉斯迴歸分析探討影響肺結核患者是否完成肺結核治療之相關因素。結果：在治療的過程中以服藥後有副作用(30.7%)及感覺很不舒服(25.8%)?困擾及造成肺結核病患未完治之主要問題。曾因?罹患肺結核而更換工作或離職者其未完治機率較低（勝算比0.46)；病患治療過程中曾中斷服藥者其未完治機率顯著較高（勝算比4.37）。另外，治療期間有更換過醫院、中等教育程度、家庭收入低、未規則服藥。治療過程對生活相當有影響者亦有較高的機率未完成治療。然病患越瞭解服用藥物後的副作用越有未完成治療的傾向，當病患瞭解肺結核傳染途徑及治療時間時則其未完治機率較低。結論：由本研究結果可知藥物副作用、服藥遵從性、對肺結核疾病的認知及是否有固定就醫場所都是影響肺結核病患是否完治的重要關鍵因素。因此，需加強病患對疾病與療程的認知，同時醫療院所實施個案管理是降低肺結核病患未完治率的首要任務。
  Objectives: Incomplete treatment is an important factor, which contributes to the difficulty in the prevention and treatment of tuberculosis (TB). This study investigated the factors associated with treatment failure in TB patients. Methods: The data were derived from the Center for Disease Control (CDC) nationwide dataset of pulmonary TB patients registered in 2001. TB patients were selected by proportional random sampling. Structured questionnaires were used to interview TB patients by phone, and logistic regression analysis was used to examine the factors that affected treatment outcome. Results: TB patients reported that side effects (30.7%) and general discomfort (25.8%) were the main problems encountered after taking medication. Treatment failure rates were lower in patients who changed jobs during treatment (OR 0.46) and higher in patients who interrupted treatment (OR 4.37). Other factors contributing to treatment failure included changing hospitals during treatment, having a mid-level education, having lower household income, taking medication irregularly, and the negative effect TB has on quality of life. In addition, patients who knew about the drugs' side effects had higher treatment failure rates; furthermore, patients who had knowledge about the transmission route of TB and the time needed for successful treatment had lower rates of treatment failure. Conclusion: Side effects of medication, compliance, the awareness of TB, and regular place of care were the key factors for successful TB treatment. Based on the results, we conclude that patients need to be made aware of TB and the appropriate treatment courses. The implementation of a case management program may increase the rate of successful treatment.
• 348 - 359
• 10.6288/TJPH2005-24-04-08

• Link 實務 Public Health Practice
• 研究受試者保護：台灣之現況與政策改革建議Human Research protections-current Status in Taiwan and Policy Proposals
• 石曜堂、施淑芳、陳迺聖、陳振興
  Yaw-Tang Shih, Shu-Fang Shih, Nan-Shen Chen, Cheng-Shing Chen
• 研究受試者保護 ； 研究倫理 ； 倫理審查委員會
  Human Research Protections ; Research Ethics ; Institutional Review Boards
• 目標：本研究主要目標為分析國內研究受試者保護之現況。方法：本研究分析國內有關研究受試者保護相關之法令或法現。此外，本研究於民國89年2月至90年1月間針對12家醫學中心及教學醫院之院長進行深度訪談，收集66家國內醫學及公共衛生相關領域期刊雜誌之投稿須知並針對其期刊主編進行問卷調查。同時，本研究亦針對全國11家醫學中心及教學醫院之醫師進行問卷調查，以了解台灣生物醫學界對受試者保護之態度與看法。結果：根據本研究結果發現，在整體國家層面而言，國內目前有關研究受試者保護之政策仍侷限於新藥、新技術及新的醫療器材。在機構層面，除臨床試驗依法律規定必須送審倫理委員會外，研究者並未被要求將研究計畫送倫理委員會審查。在個人層面，醫師與期刊雜誌主編對於受試者保護相關之規定也並不熟悉。然而雖然大多數醫師認為將研究計畫送審倫理審查委員會將會影響研究發展，但大多數的期刊主編對於那些未受醫療法現範之介入性研究計畫、觀察性研究以及調查研究送審倫理審查委員會都持正面的態度。結論：嚴謹的研究其研究行為的道德面必須受到同樣的重視。唯有透過政府、學術界及其他專業團體的共同努力，始能改革台灣受試者保護的現況以確保參與研究者之利益。根據本研究之結果與參考國外之經驗與作法，本研究建議短期內國內可採納目前國際上現有的受試者保護規定、國內的專業期刊雜誌將有關研究受試者保護之規定納入其投稿須知中，以及加強因參與研究受到傷害之財務保護機制之安全網。至於中期目標則是於國內建立一個中立之機構以負責領導及協調國內受試者保護系統之建立，並且將研究受試者保護政策納入醫院及大學評鑑中。長期目標則是加強所有參與或涉及有關人方面研究的醫學院及其他相關領域之研究所、機構及經費支持者必須提供研究受試者保護方面相關之課程訓練。
  Objectives: This study analyzes the current status of Human Research Protections (HRP) in Taiwan. Methods: The laws and regulations covering HRP in Taiwan are first reviewed. Besides, between the February 2000 and the end of January 2001, we interviewed the CEOs of 12 medical centers, collected and studied the instructions to authors sections of 66 Taiwanese peer-reviewed journals, surveyed the chief editors of the same journals, and conducted a survey of physicians in 11 medical centers and medical teaching hospitals to understand the attitudes of Taiwan's biomedical community toward HRP. Results: At the national level, all regulations or guidelines on HRP were limited to studies for new drugs, medical techniques and medical devices. At the institutional level, except for clinical trials, which are required to obtain IRB reviews, few researchers were asked to submit proposals to Institutional Review Boards (IRBs). At the individual level, physicians and chief-editors were generally unfamiliar with HRP issues. Physicians generally considered IRB reviews as hindrances to research, while chief-editors held more positive attitudes toward HRP in intervention studies not regulated by Taiwan's Medical Care Act, observational studies and surveys. Conclusions: As a matter of principle, ethical research practices should go hand in hand with sound research design. Only through collaboration between the government, the academic community, and other professionals can HRP reform be improved and the protection of human beings be ensured. Based on our analysis and experiences from other countries, in the short-term we recommend an existing set of HRP guidelines be adapted to suit our needs, that professional organizations and journals add HRP stipulations to their ITAs, and that we strengthen our financial liability safety net to better cover research injury. In the middle-term, we recommend that a single, independent national office be established to lead and coordinate the HRP system and that HRP be made one of the dimensions of annual hospital and university accreditation. In the long-term, we recommend that medical schools, graduate schools for all disciplines, all institutions and sponsors involved in human research be required to offer research ethics courses to their staff and students.
• 360 - 373
• 10.6288/TJPH2005-24-04-09