Evidence Based Medicine 實證醫學或循證醫學. Se-Yuan Liu Surgery Ping-tung Christian Hospital

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1 Evidence Based Medicine 實證醫學或循證醫學 Se-Yuan Liu Surgery Ping-tung Christian Hospital

2 實證醫學或循證醫學 究竟是甚麼東東? 為什麼我該了解這個東西? 該怎麼做? 很困難嗎?

3 What is EBM or EBN? Evidence-based medicine (EBM) is the integration of best research evidence with clinical expertise and patient values Evidence-based nursing (EBN) nurses as important, active decisionmakers

4 Best Research Evidence Clinically relevant research, often from the basic sciences of medicine Especially from patient centered clinical research Power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens

5 Clinical Expertise The ability to use our clinical skills and past experience To rapidly identify each patient s unique health state and diagnosis, their individual risks and benefits of potential interventions, and their personal values and expectations

6 Patient Values The unique preferences, concerns and expectations each patient has Must be integrated into clinical decisions if they are to serve the patient Clinicians & patients form a diagnostic and therapeutic alliance, optimizes clinical outcomes and quality of life

7 法國小鎮

8 Why the Sudden Interest in EBM? These ideas have been around for a long time post-revolutionary Paris a much earlier origin in ancient Chinese medicine Consolidated and named EBM in 1992 by a group led by Gordon Guyatt at McMaster University in Canada

9 4 Realizations Daily need for valid information about Dx, prognosis, therapy and prevention The inadequacy of traditional sources for this information The disparity between diagnostic skills, judgment, knowledge, and performance Inadequate time for study and reading

10 5 Developments Strategies to track & appraise evidence Systematic reviews and concise summaries (Cochrane Collaboration) Creation of evidence-based journals of secondary publication Creation of information systems Strategies for life-long learning

11 How Do We Actually Practice EBM? Asking an answerable question Tracking down the best evidence Critically appraising that evidence for its validity, impact, and applicability Integrating appraisal, clinical expertise and patient s values, circumstances Evaluating & seeking ways to improve

12 Ask An Answerable Question: The PICO format P: Patient or population, a 50-year old lady recently diagnosed with breast cancer, or a 2-year old boy with bronchopneumonia I & C: Intervention & Compare, type of surgery, chemo or not, choice of antibiotics O: Outcome, survival or quality of life, recurrence rate, effect of treatment

13 Different Modes of Practice The appraising mode, all steps For the conditions we encounter every day Very sure about what we are doing The searching mode, skip step 3 For the conditions we encounter less often The replicating mode, doubtful Authoritative or merely authoritarian?

14 4S: Studies, Syntheses, Synopses, Systems

15 Can Clinicians Actually Practice EBM? Do full-time clinicians really recognize working in these modes? Can they actually get at the evidence quickly enough to consider it on a busy clinical service? Can clinicians actually provide evidence-based care to their patients?

16 What Are The Limitations of EBM? Limitations that are universal to science (whether basic or applied) and medicine The shortage of coherent, consistent scientific evidence Difficulties in applying any evidence to the care of individual patients Barriers to any practice of high quality medicine

17 What Are The Limitations of EBM? Limitations that are unique to the practice of EBM The need to develop new skills in searching and critical appraisal Busy clinicians have limited time to master and apply these new skills Evidence that EBM works has been late and slow to come

18 Pseudo-limitations Denigrates clinical expertise Limited to clinical research Ignores patients values & preferences Promotes a cookbook medicine Cost-cutting tool An ivory tower concept Leads to therapeutic nihilism

19 巴黎聖心堂

20 Bill Clinton Awaits Heart Surgery NEW YORK (CNN) -- Former President Bill Clinton said he feels "a little scared, but not much" as he waits to undergo heart bypass surgery scheduled for early next week September 4, 2004 Next Week

21 Doctors Confirm Lee Teng-hui Still Healthy Lee has undergone two catheterization heart surgeries, in 2001 & 2003 The Taipei VGH did surgery on Lee with the assistance from Dr. Kazuaki Mitsudo, who also performed Lee's first operation. Taipei Times

22 問題來了! 兩位前任總統分別接受了不同的治療 到底是開心手術好, 還是心導管好呢? 記住! 你不只是閱讀新聞, 看熱鬧而已, 明天這就可能是病患或家屬對你提出的疑問 你是根據甚麼來回答這個問題呢?

23 Arguments for Grafting Surgery is the best intervention for severe coronary artery disease David P Taggart, Professor of Cardiovascular Surgery, University of Oxford BMJ 2005;330:785-6

24 Surgery is The Best? Most studies of percutaneous coronary intervention have been done on patients with single or double vessel disease and have limited follow up, being increasingly used to treat multivessel ischaemic heart disease Studies of coronary artery bypass grafting have established its safety & long term effectiveness Patients must be given all the evidence to enable an informed choice about treatment

25 The Coronary Artery Bypass Graft Surgery Trialists Collaboration (1994) 1 Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration From National Heart, Lung, and Blood Institute, Bethesda, Maryland 1324 patients: CABG surgery; 1325 medical management between 1972 and 1984 Lancet Aug 27;344(8922):563-70

26 The Coronary Artery Bypass Graft Surgery Trialists Collaboration (1994) 2 The CABG group had significantly lower mortality than the medical treatment group at 5 yrs (10.2 vs 15.8%; OR 0.61 [95% CI ], p = ), 7 yrs (15.8 vs 21.7%; 0.68 [ ], p < 0.001), and 10 yrs (26.4 vs 30.5%; 0.83 [ ]; p = 0.03) The risk reduction was greater in patients with left main artery disease than in those with disease in three vessels or one or two vessels (OR at 5 years 0.32, 0.58, and 0.77) The absolute benefits of CABG surgery were most pronounced in patients in the highest risk categories

27 Long-Term Survival CABG vs PCI (2004) 1 Propensity Analysis of Long-Term Survival After Surgical or Percutaneous Revascularization in Patients With Multivessel Coronary Artery Disease and High-Risk Features Cardiovascular Medicine and Cardiothoracic Surgery, Cleveland Clinic Foundation, Cleveland, Ohio Circulation. 2004;109:

28 Long-Term Survival CABG vs PCI (2004) 2 Most randomized clinical trials have suggested that long-term survival rates after percutaneous coronary intervention (PCI) or surgical multivessel coronary revascularization (CABG) are equivalent Some post hoc analyses in high-risk groups and adjustment for severity of coronary disease have suggested higher mortality after PCI

29 Long-Term Survival CABG vs PCI (2004) consecutive patients for revascularization in the late 1990s. PCI in 872; 5161 CABG Half the patients had significant left ventricular dysfunction or diabetes PCI was associated with an increased risk of death (propensity-adjusted hazard ratio, 2.3; 95% CI, 1.9 to 2.9; P<0.0001) In multivessel coronary artery disease & many high-risk factors, CABG with better survival than PCI after adjustment for risk profile

30 Cochrane Reviews 1 Percutaneous transluminal coronary angioplasty with stents versus coronary artery bypass grafting for people with stable angina or acute coronary syndromes (Cochrane Review) The Cochrane Database of Systematic Reviews 2004, Issue 4

31 Cochrane Reviews 2 To examine evidence from randomised controlled trials (RCTs) on benefit of stents or CABG in reducing cardiac events in people with stable angina or acute coronary syndrome (ACS) Nine studies (3519 patients) Four RCTs included patients with multiple vessel disease, five focused on single vessel disease

32 Cochrane Reviews 3 No statistical differences were observed between CABG and stenting for meta-analysis of mortality or AMI, but there was heterogeneity Composite cardiac event and revascularisation rates were lower for CABG than for stents Restenosis at 6 months (single vessel trials) favoured CABG

33 Cochrane Reviews 4 CABG is associated with reduced rates of major adverse cardiac events, mostly driven by reduced repeat revascularisation Limited by follow-up, unrepresentative samples and rapid development of both surgical techniques and stenting Need further study at different groupings and risk factors

34

35 Evidence Based Medicine QUESTION: Does screening for breast cancer by regular self examination or clinical examination (or both) reduce the incidence of breast cancer and death? Conclusions:The available evidence on breast self examination is limited. Based on 2 studies, regular breast examination does not reduce breast cancer mortality but increases the number of women who have biopsies with benign results.

36 Evidence Based Medicine QUESTION: In women with an increased risk of breast cancer, does tamoxifen reduce the risk of breast cancer and what are the associated harms? Conclusion: In women with an increased risk of breast cancer, tamoxifen reduced the risk of breast cancer but increased the risks of thromboembolic events and all cause mortality. From the International Breast Cancer Intervention Study, first result (IBIS-I)

37 Some Useful Resources PubMed British Medical Journal (BMJ) The Cochrane Library Evidence Based Medicine or EBM Online

38 Evidence-Based Nursing It s free and a lot of fun!

39 Topics in EBN Journal 1 Review: adequately randomised trials showed that mammography screening did not significantly reduce breast cancer, cancer, or all cause mortality but increased breast surgeries Review: inhaled insulin provides better glycaemic control than oral hypoglycaemic agents but not better than subcutaneous insulin

40 Topics in EBN Journal 2 Calcium reduced loss of bone mineral density but did not prevent fractures in healthy postmenopausal women Postoperative ibuprofen increased bleeding complications in hospital and did not improve pain or physical function at 6 12 months after total hip replacement

41 Topics in EBN Journal 3 Review: exercise improves glycaemic control and reduces plasma triglycerides and visceral adipose tissue in type 2 diabetes Review: regular exercise improves quality of life and physical fitness in women with breast cancer

42

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