以實證為基礎促進病人安全 when ebm meets ps …. 萬芳醫院 --...

以實證為基礎促進病人安全

When EBM meets PS….萬芳醫院 --建構病人安全文化員工教育訓練課程

2004/2/19實證醫學中心陳杰峰主任

http://www.wanfang.gov.tw/[email protected]

http://www.wanfang.gov.tw/ebm

問題•什麼是以實證為基礎促進病人安全？•實證醫學對促進病人安全有何助益？

Primum non nocere

• Hippocrates•以不傷害為首要原則• First, do no harm!!

後 SARS 時代公共衛生工具之重視

Preventive medicine and Epidemiology•評鑑制度及醫學教育轉變

Best practice and updated knowledge•重視病人安全

Patient safety

病人安全（ Patient Safety ）• 對於健康照護過程中引起的不良結果或傷害所應採取的避免、預防與改善措施。

•這些不良的結果或傷害，包含錯誤、偏差與意外。 Cooper JB, Gaba DM, Liang B, Woods D, Blum LN. National Patient Saf

ety Foundation agenda for research and development in patient safety. MedGenMed. 2000; 2(4). Available at; www.medscapc.com/MedGenMed/PatientSafety

http://www.tjcha.org.tw/safe/safe.asp

過失（ Negligence ）•照護水準低於所處醫界中一般醫師所預期的標準之下。 Brennan TA, Leape LL, Laird NM, et.al. Incidence of adverse

events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991; 324(6):370-376.


醫療過失（ Malpractice ）•一般而言，醫療錯失【 mispractice 】後指誠實的誤判（ misjudgment ），而由疏忽所造成的錯誤，通常則稱之為醫療過失 (處置不當 )【 malpractice 】。 Kapp MB. Medical error versus malpractice. DePaul J Law. 19

97; 1:751-772.


IOM Report 1999

•美國智囊機構 Institute of Medicine 在1999 年出版的報告書 ” To Err is Human ”中指出，依據數個大型的流行病學研究結果，估計美國每年死於醫療疏失的人數約在 44,000 人至 98,000 人左右

相對於同年國民主要死因分析中，排名第八遠高於每年因交通意外事故死亡的人數，也高於死於乳癌的人數。


系統性錯誤（ System errors ）

•發生於系統中之技術設計或組織議題或決策錯誤所造成的遲發性後果。 Battles JB, Kaplan HS, Van der Schaaf TW, Shea CE. The attr

ibutes of medical event-reporting systems: experience with a prototype medical event-reporting system for transfusion medicine. Arch Pathol Lab Med. 1998; 122(3):231-238.


人為錯誤（ Human Error ）•人為錯誤是指以下兩種狀況：

1. 未能依照原先的規劃完成計畫中的行為 (即 “執行的錯誤” )

2. 使用了不正確的計畫去達到目的 (即 "計畫的錯誤 ")

Reason J. Human Error. Cambridge, UK; Cambridge University Press, 1990.


JCAHO 2003 美國的醫療機構評鑑單位 JCAHO(Joint Commission on Accreditation of Healthcare Organization)更在2003 年初提出六大目標，作為所有醫療機構應該致力促進病人安全的方向。

• 病患辨識之準確性• 醫療服務者間之有效溝通• 提高高危險藥物之用藥安全• 消除手術病患手術位置及術式錯誤的發生• 增進輸液幫浦之使用安全• 改善臨床警示系統之效益


常考題 !

醫療糾紛• 國內根據衛生署醫事鑑定小組的統計分析，1987年至 2001年每年接受醫事鑑定的委託件數從 147件增加至 406件，其中依告訴原因分析：近四分之一（ 24%）乃因為醫療不良其次為手術相關（15%）誤診延醫（ 11%）用藥不當（ 9%）

• 案件中將近八成（78%）發生於醫院，雖然據統計只有20%最後被判定為有疏失或可能有疏失，但是，若依據Anne C. O’Neil 等人的研究，醫療不良事件中僅有1~2%的病患會進入出法律途徑。


學習地圖

Decision analysis Practice guidelines

EBM應用於病人安全

實證醫學國內外發展情況實證醫學的理念文獻檢索及網路概念應用實證醫學與流行病學的應用PBL-EBM整合教學實證護理、藥學文章評讀實證醫學臨床診療指引實證醫學在醫院管理的應用實證醫學在醫學資訊的應用萬芳醫院推動實證醫學的模式

實證醫學專書

以流行病學及統計學的方法，從龐大的醫學資料中過濾出值得信賴的部份，嚴格評讀、綜合分析、將所能獲得的最佳文獻、證據 (Evidence) ，與醫護人員的經驗 (Experience) ，及病人期望 (Expectation) 的結合，以應用於臨床工作中。

實施實證醫學五大步驟 1. 整理出一個可以回答的問題 (Asking an answerable question) 2.尋找文獻證據 (Tracking down the best evidence) 3.嚴格評讀文獻 (Critical appraisal ) 4.應用於病人身上 (Integrating the appraisal with clinical expertise & patients’ preference) 。 5.對過程進行稽核 (Auditing performance in step 1-4)

考題：什麼是實證醫學５步驟？

以病患為中心之系統A patient-centered system

• Give me access to my own medical record• Serve a range of socioeconomic backgrounds

• Support care in many different settings• Help me view, use and understand health data with or without intermediation

• Facilitate education and research, for me and my health care provider

以醫業為中心之系統A provider-centered system• Give me condition or procedure-specific decision support

• Give me interfaces to biomedical literature and research data

• Let me pull clinical data easily into research databases

• Provide automated alerts (warnings,correlations with research data, clinical trials)

• Track outcomes of care I provide

EBM 的趨勢

Growing attention to avoidable costs

Increased recognition of gap between evidence and practice (IOM)

Pending shift of clinical decisions to consumers – are they ready?

Guidelines: The Backbone of EBM

“Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” (IOM, ’92)

Derived from…10,000 RCT’s annually

4000 guidelines since 19892500 periodicals in NLS

EBM – 健康照護契約關係的共同語言

Patient

Physician

Provider

Payer

Opinion –based Medicine

Physician Centered EBM

Patient Centered EBM

Emphasize clinical evidence

Focus on patient understanding

Integrate physician experience with patient values

Relies on memory

Emphasizes experience

Popularized since 1992

Emphasize published clinical science

Practitioner experience is important

Acknowledge patient values

Evolution of Evidence-Based Medicine

EBGs: Characteristics for Optimal Use

Easy to Understand Available at decision-making time

Strong evidence support Useful Actionable

Barriers to EBG Adherence between physicians and patients (Cabana)

• Lack of awareness• Lack of familiarity• Lack of agreement• Lack of self-efficacy• Lack of outcome expectancy• Inertia of previous practice

• External barriers

Serious Medication Error

Rates Before and After CPOE

0

2

4

6

8

10

12

Serious Medication Errors

Eve

nts

/100

0 P

atie

nt-

day

s

Phase I

Phase II

Delta = -55%p < .01

Bates et. al. Effect of Computerized Physician Order Entry and a Team Intervention on Prevention of Serious Medication Errors, JAMA 1998.

Shojania K, Duncan B, McDonald K, Wachter RM, eds.

Evidence Report/Technology Assessment No. 43; AHRQ publication 01-E058.

Rockville, Md: Agency for Healthcare Research and Quality; 2001.

Leape LL, Berwick DM, Bates DW. What practices will most improve safety? Evidence-based medicine meets patient safety. JAMA. 2002 Jul 24-31;288(4):501-7.

Making Health Care Safer: A Critical Analysis of

Patient Safety Practices.

( 共 672 頁， public domain ，可列印 )

IOM report

• the IOM report also recommended that the Agency for Healthcare Research and Quality (AHRQ) determine which safety practices are effective and disseminate a list of "best practices" to all clinicians.


AHRQ

• AHRQ requested the National Quality Forum to use a consensus process of experts to define a list of best practices.

• To inform this process, it also commissioned the Evidence-Based Practice Center (EPC), University of California, San Francisco-Stanford University, to evaluate the evidence supporting a long list of proposed safety practices.


EPC

• Given a 6-month time frame, the EPC enlisted numerous experts nationwide to conduct the analyses.

• The resulting report by Shojania and colleagues.


Evidence-based assessment

• conducted by the EPC• a formal method of literature analysis that uses standardized techniques and places heavy emphasis on data from randomized controlled trials.

•可量化衡量的，不見得是最重要的。


Classification of evidence --US Agency for Health Care Policy and Research

Classification (AHCPR, 1992)

Evidence level

Description

Ia: evidence from meta-analysis of randomised controlled trials

Ib: evidence from at least one randomised controlled trial

IIa: evidence from at least one controlled study without randomisation

IIb: evidence from at least one other type of quasi-experimental study

III: evidence from non-experimental descriptive studies, such as comparative studies, correlation studies and case-control studies

IV: evidence from expert committee reports or opinions and/or clinical experience of respected authorities

考題２：什麼是實證醫學中 Level I 的證據？

Grading of recommendations Eccles M et al.(1998) North of England Evidence Based Guideline Development Project:guideline for angiotensin converting enzyme inhibitors in primary care management of adults with symptomatic heart failure.British Medica

l Journal 316:1369.

A directly based on category I evidence, or assigned this grading by the developers, for explicit and documented reasons

B directly based on category II evidence, or assigned this grading by the developers, for explicit and documented reasons

C directly based on category III evidence, or assigned this grading by the developers, for explicit and documented reasons

D directly based on category IV evidence, or assigned this grading by the developers, for explicit and documented reasons

EBM

• Advocates of evidence-based medicine (EBM) argue that medical decisions should be based, as much as possible, on a firm foundation of high grade scientific evidence, rather than on experience or opinion.


EBM

• The motivation for EBM stems from the observation that many widely used practices lack supporting evidence and are therefore of questionable value.

• In the past, many experience-based and opinion-based practices have proved to be ineffective or even harmful.


Do Something is Better than

Do Nothing?“依據我的經驗 :肝硬化合併門脈高壓的患者 , 接受分流手術治療 (Portal-Systemic Shunting) 者

比未接受手術治療者 , 發生食道靜脈出血的機率要來得少腹水比較容易控制因此也活得比較久 …”

---- 摘自‘實證醫學教學法’摘自‘實證醫學教學法’ ,, 張張家勳家勳 MD, MSc, MD, MSc,

Clinical outcomes depend on:

• Severity of illness • Co-morbidity • Other prognostic factors (known and unknown)

• Drug compliance, health awareness, social support…

• Treatment

---- 摘自‘實證醫學教學法’摘自‘實證醫學教學法’ ,, 張張家勳家勳 MD, MSc, MD, MSc,

What practices will most improve safety? Evidence-based medicine meets

patient safety

Leape LL, Berwick DM, Bates DW. JAMA. 2002 Jul 24-31;288(4):501-7.

CONTROVERSIES

Evidence Report 43

• many found that a number of the improvements in safety practice they have been working so hard to implement are not even mentioned in the report


Evidence Report 43

• Of the 11 practices, Shojania et al recommend most highly as "clear opportunities for safety improvement" because they met the formal criteria for strength of evidence regarding impact and effectiveness, only 3 have been usually characterized as safety issues at all.


3 safety issues

• anticoagulation for prevention of deep venous thrombosis

• antibiotic prophylaxis to prevent surgical infections

• use of pressure-relieving materials to prevent pressure ulcers


The Harvard Medical Practice Study, 1991

• high rate of iatrogenic injury (3.7%) among hospitalized patients

• about one third of adverse events were currently unpreventable.

• The evidence report, on the other hand, is heavily weighted toward the "other third" of AEs


Conclusion

• We urge serious consideration of the top-level practices certified by the evidence report

• the list in the evidence report is neither a complete nor necessarily an appropriate inventory of practices for priority action to improve patient safety.


Conclusion

• Evidence from randomized trials is important information, but it is neither sufficient nor necessary for acceptance of a practice

• There will never be complete evidence for everything that must be done in medicine.


how many cochrane reviews are needed…..

• How many cochrane reviews are needed to cover existing evidence on the effects of healthcare interventions?10000 reviews are needed.Now, 1600 reviews2010-2015, 10000 reviews will be ready.

How many Cochrane reviews are needed to cover existing evidence on the effects of healthcare interventions?How many Cochrane reviews are needed to cover existing evidence on the effects of healthcare interventions? Susan Mallett and Mike Clarke Evid Based Med 2003 8: 100-101. Susan Mallett and Mike Clarke Evid Based Med 2003 8: 100-101.

學習地圖

process auditing

clin ica l application

critica l appra isa l

evidence find ing

question form ation

學習地圖

研究

Decision analysis Practice guidelines

臨床服務教學

EBM 應用

決策樹 (Decision tree) 的特色

• The power of decision analysis is not in the numbers at the decision node

• It is the ability to change the utilities and probabilities

• Watching how this affects the decision node

• Thus it should be seen as a dynamic tool

應用於病人身上

(Integrating the Appraisal with Clinical

Expertise & Patients’ Preference)

Information must be translated into action.

CAGES – a Computer Assisted

Guideline Enhancement System

Chiehfeng Chen, Yu-Chuan Li, Te-Hui Hao, Chang-I Chen, San-Yuan Chen, Chung-Jung Fu, Chia-Cheng

Chao, Hung-Yu Yang, Paul Chan

Result

• Time spending per caseBefore CAGES 116 secAfter CAGES

Complete :159.4 sec (30.9 sec for the CAGES)

Abort : 149.5 sec

CAGES

• – provide consistency in care!

• – reduces chance of error during implementation

臨床指引 (guideline)•形成明確易使用的標準 (To make evidence based standard

s explicit and accessible)•較容易作客觀的決定 (To make decision making easier an

d more objective)•可教育病人或醫護人員目前的最佳治療方式 (To educ

ate patients and professionals about current best practice)•增進醫療的成本效應 (To improve the cost effectiveness

of health services) •當作管控的工具 (To serve as a tool for external contro

l)

1 / ARR 傷害需要病例數 NNHNumber Needed to Harm

[a/(a+b)] – [c/(c+d)]ARRAbsolute Risk Reduction

1 – RRRelative Risk Reduction

[a/(a+b)] / [c/(c+d)]RRRelative Risk 相對危險度(a/b) / (c/d)OROdds Ratio 勝算比

dcNegative

baPositive

NegativePositive

Adverse OutcomeExposure to the Treatment

Confusion Matrix常考題 !

1.整理出一個可以回答的問題

(Asking An Answerable Question)

提出問題 , 才有可能解決問題

2.尋找文獻證據

(Tracking down the best evidence)

In the long run, we're all dead. John Maynard Keynes, 1883 - 1946

http://www.brainyquote.com/quotes/quotes/j/johnmaynar110030.html

Unfiltered DATABASES

• MEDLINE• CINAHL• PsycINFO• ERIC (Education Resources Information Center)

Searching

• Key Words :• 搜尋策略 top down

RCT

Case-Control

Case Reports

Opinions

萬芳醫院有哪些 EBM 期刊？常考題 !

3.嚴格評讀文獻

(Critical Appraisal )

Are We Doing the Right Things Right ?

4.應用於病人身上

(Integrating the Appraisal with Clinical

Expertise & Patients’ Preference)

Information must be translated into action.

5.對過程進行稽核

(Auditing performance in step 1-4)

evidence-based outcome evaluation (EBOE)

• the evidence-based outcome evaluation (EBOE) should be the engine driving the guideline process.

• This could be performed by statistical means with meta-analyses.

• That approach requires RCTs. Unfortunately, there are not many RCTs in most surgical fields, including trauma.

延伸學習• Oxford Centre for EBM

http://www.cebm.net

• Canada Centre for health evidencehttp://www.cche.net/che/home.asp

操作

http://www.nhitb.gov.tw/

Oxford Centre for EBMhttp://www.cebm.net

http://www.nhitb.gov.tw/

陳杰峰醫師[email protected]

實證醫學中心 http://www.wanfang.gov.tw/ebm

敬請指教 !

以實證為基礎 促進病人安全 when ebm meets ps …. 萬芳醫院 --...

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