Presented by : Dr.??? [e-mail]

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• Presented by Dr.???clifchen_at_ms1.hinet.net
• http//clifchen.idv.tw

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• Johns Hopkins University, M.P.H.???????
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Initially, EBM grew as a bottom-up approach to
continuing medical education under the name of
Clinical Epidemiology (CE).

• Sackett DL, Haines RB, Tugwell P. Clinical
  epidemiology. Boston, Little, Brown Co, 1985

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A CASE STUDY OF EBM

• ???????

????2002/8/14????
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• NHLBI Stops Trial of Estrogen Plus ProgestinDue
  to Increased Breast Cancer Risk, Lack of Overall
  Benefit

-- NIH NEWS RELEASE. Tuesday, July 9, 2002
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• The National Heart, Lung, and Blood Institute
  (NHLBI) of the National Institutes of Health
  (NIH) has stopped early a major clinical trial of
  the risks and benefits of combined estrogen and
  progestin in healthy menopausal women due to an
  increased risk of invasive breast cancer.

-- NIH NEWS RELEASE. Tuesday, July 9, 2002
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• The report from the WHI investigators on the
  estrogen plus progestin study findings will be
  published in the July 17 issue of The Journal of
  the American Medical Association (JAMA) because
  of the importance of the information, the study
  is being released early on Tuesday, July 9, as an
  expedited article on the JAMA Web site. (Full
  text version available to all at jama.com.)

-- NIH NEWS RELEASE. Tuesday, July 9, 2002
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• The estrogen plus progestin trial of the WHI
  involved 16,608 women ages 50 to 79 years with an
  intact uterus.
• An important objective of the trial was to
  examine the effect of estrogen plus progestin on
  the prevention of heart disease and hip
  fractures, and any associated change in risk for
  breast and colon cancer.
• The study did not address the short-term risks
  and benefits of hormones for the treatment of
  menopausal symptoms.

-- NIH NEWS RELEASE. Tuesday, July 9, 2002
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• Women enrolled in the estrogen plus progestin
  study were randomly assigned to a daily dose of
  estrogen plus progestin or to a placebo.

-- NIH NEWS RELEASE. Tuesday, July 9, 2002
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The WHI results--

• During 1 year, among 10,000 postmenopausal women
  with a uterus who are taking estrogen plus
  progestin,
• 8 more will have invasive breast cancer,
• 7 more will have a heart attack,
• 8 more will have a stroke,
• 18 more will have blood clots,
• including 8 with blood clots in the lungs, than
  will a similar group of 10,000 women not taking
  these hormones.
• This is a relatively small annual increase in
  risk for an individual woman.

-- NIH NEWS RELEASE. Tuesday, July 9, 2002
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Specific study findings for the estrogen plus
progestin group compared to placebo include

• A 41 percent increase in strokes
• A 29 percent increase in heart attacks
• A doubling of rates of venous thromboembolism
  (blood clots)
• A 22 percent increase in total cardiovascular
  disease
• A 26 percent increase in breast cancer

-- NIH NEWS RELEASE. Tuesday, July 9, 2002
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Specific study findings for the estrogen plus
progestin group compared to placebo include

• A 37 percent reduction in cases of colorectal
  cancer
• A one-third reduction in hip fracture rates
• A 24 percent reduction in total fractures
• No difference in total mortality (of all causes)

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  ??,??,?????????????????????

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• ??????--
• NIH?WHI??(Women's Health Initiative
  Study),????????????,?????????????????????,????,???
  ?????????????????????????????????,????????????????
  ?????WHI??,????????????,???????????

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• ????????????????,?????????????,????????????,???WHI
  ???,?????????????,???????,?????????,???????

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COMMITTEE

• GROUP COMPOSITION Treatment of Pressure Ulcers
  Guideline Panel The panel was a
  multidisciplinary, 20-member committee consisting
  of seven physicians (family medicine,
  dermatology, plastic surgery, surgery-nutrition,
  gerontology, and physical medicine and
  rehabilitation), seven nurses (rehabilitation,
  aging, acute care, enterostomal therapy, wound
  care, nutrition, healthcare education, and
  management), one occupational therapist
  (rehabilitation), two biomedical engineers
  (rehabilitation), two basic scientists (wound
  healing), and one consumer representative.

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Managing Tissue Loads-----While in Bed

• Positioning Techniques
• Avoid positioning patients on a pressure ulcer.
  (Strength of Evidence C.)
• Use positioning devices to raise a pressure ulcer
  off the support surface. If the patient is no
  longer at risk for developing pressure ulcers,
  these devices may reduce the need for
  pressure-reducing overlays, mattresses, and beds.
  Avoid using donut-type devices. (Strength of
  Evidence C.)
• Establish a written repositioning schedule.
  (Strength of Evidence C.)
• Assess all patients with existing pressure ulcers
  to determine their risk for developing additional
  pressure ulcers. For those individuals who remain
  at risk, institute the following measures
  recommended in Pressure Ulcers in Adults
  Prediction and Prevention. Clinical Practice
  Guideline, No. 3

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Misunderstanding of EBM
only 10-20 of interventions are supported
by good evidence
No of patients
Type of evidence
58(53) 32(29) 19(18)

1. Evidence from RCT
2. Convincing non-experimental evidence
3. Interventions without substantial evidence

Earle CC. Weeks JC. Evidence-based medicine a
cup half full or half empty? editorial
comment. American Journal of Medicine.
106(2)263-4, 1999 Feb.
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???? KM

• Knowledge Power ??????
• K (People Experience)Share
• ?? (???)?????
• Arthur Andersen Consulting?

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???? (core competence)

• ????????, ?????????????.

Gary Hamel and C.K.Prahalad
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Evidence-Based Medicine

• McMaster University in Hamilton, Ontario in the
  early 1990s
• EBM is the conscientious and judicious use of
  current best evidence from clinical care research
  in the management of individual patients.
• The ability to track down, critically appraise,
  and incorporate this rapidly growing body of
  evidence into ones clinical practice

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Emergence of EBM

• Background
• Medical Community
• information explosion
• highly specialization
• continuous medical education (CME)
• quality assurance(QA)
• General Public Patients
• medical errors
• quality of care
• Insurance Company Government
• overwhelming expansion of cost
• managed care quality

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EBM / EBP is not new, but

• Standards of evidence are new
• Randomized Controlled Trials (RCT)
• Tools are new
• Meta-analysis, decision analysis
• New decision making framework
• Informed consumers

---cited from ?????? Alan Talbot (???)
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(????,???????)
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History of EBM Development

• 1972 Archie Cochran emphasized RCTs
  (Randomized Controlled Trials)
• 1960s Dave L. Sackett doubt the golden basis of
  pathophysiology
• 1980 McMaster University start a class of
  clinical epidemiology biostatistics
• 1992 NHS (UK) set up Cochrane collaboration
• 1997 USA set up 12-EBPC (Evidence Based
  Practice Center)

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Cochrane Collaboration Logo
(meta-analysis of seven trials)
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Effect of manual therapy on pain.
(Reprinted from Aker P.D., et al.(1996).
Conservative management of mechanical neck pain
Systematic review and Meta-analysis. BMJ, 313
1291-6, with permission.)
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CQI ????????

• Lower length of stay
• Lower total charges

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EBM 5 Steps vs. FOCUS

• Asking an answerable question
• Tracking down the best evidence
• Critical appraisal
• Integrating the appraisal with clinical expertise
  patients preference
• Auditing performance in step 1-4

• Find problem
• Organize team
• Clarify boundaries
• Understand problem
• Select opportunity

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Five Steps in EBM Practice

• Ask a clinical question you can answer
• - patient/diagnosis intervention/outcome
• Search for the evidence
• - PubMed/Health gate/AHCPR/Yahoo-H
• Critical appraise the evidence - RCT
• Apply the evidence to your practice
• - guideline/pathway/DRG
• Measure the outcome of patient care
• - MM/quality of life

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Asking Answerable Questions

• What types of Participants?
• What types of Interventions?
• What types of Comparison?
• What types of Outcomes?

These components can be adapted to different
types of clinical questions (etiology, causation,
therapy, prognosis) e.g. Interventions / Exposure
---cited from ?????? Alan Talbot (???)
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Well-formulated Diagnosis Question

• Is diagnostic ultrasound imaging as accurate as
  MRI in detecting partial thickness rotator cuff
  tear in middle age?

Participants
Comparison
Outcome
Intervention
---cited from ?????? Alan Talbot (???)
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Well-formulated Diagnosis Question

• Is diagnostic ultrasound imaging as accurate as
  MRI in detecting partial thickness rotator cuff
  tear in middle age?

P
I
C
O
Participants
Comparison
Outcome
Intervention
---cited from ?????? Alan Talbot (???)
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2.?????? (Tracking down the best evidence)

• Best practice

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Best Evidence

• Scientific evidence derived from research.
• Research increases the understanding of health,
  ill-health and the process of healthcare.
• Research enables an assessment of the
  interventions to promote health.
• A well-done cohort study will be more reliable
  than a poorly performed RCT.

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The Methodology for Problem Solving
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??????(EBMR)?????

• Cochrane Collaboration ?ACP?????????????,?????????
  ??????????????,?????????????
• Cochrane????????(Topic Reviews)
• ACP???????50?????????, ?????????????,?????????????
  ???????????
• ??????,??????????????? ???????,?????????????

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3.?????? (Critical Appraisal )

• Do the Right Things Right

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Some books are to be tasted, others to be
swallowed, and some few to be chewed and
digested.

• - -Sir Francis Bacon, 1597

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The Evidence Pyramid
???? ??? ??????
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Type and Strength of Evidence

• (I) Strong evidence from at least one systematic
  review of well designed RCTs
• (II) Strong evidence from at least one properly
  designed RCT of appropriate size
• (III) Evidence from well designed trials without
  randomization single group pre-,post-, cohort,
  time series of matched case-controlled studies
• (IV) Evidence from well designed non-experimental
  studies for more than one center or research
  group
• (V) Opinions of respected authorities, based on
  clinical evidence, descriptive studies or reports
  of expert committees
• (VI) Someone once told me

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EBM toolbox
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Basic Terminology
When the outcome is undesirable, a RR or OR of
lt1.0 represents a beneficial treatment, with zero
representing 100 effectiveness. An ARR lt 0
represents a benefit, and 100 effectiveness
would be equivalent to the risk observed in the
control group. If a is small relative to b and c
is small relative to d, the OR and the RR are
approximately the same.
---cited from ?????? Alan Talbot (???)
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Basic Calculations
---cited from ?????? Alan Talbot (???)
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The WHI results--

• During 1 year, among 10,000 postmenopausal women
  with a uterus who are taking estrogen plus
  progestin,
• 8 more will have invasive breast cancer,
• 7 more will have a heart attack,
• 8 more will have a stroke,
• 18 more will have blood clots,
• including 8 with blood clots in the lungs, than
  will a similar group of 10,000 women not taking
  these hormones.
• This is a relatively small annual increase in
  risk for an individual woman.

-- NIH NEWS RELEASE. Tuesday, July 9, 2002
54
Specific study findings for the estrogen plus
progestin group compared to placebo include

• A 41 percent increase in strokes
• A 29 percent increase in heart attacks
• A doubling of rates of venous thromboembolism
  (blood clots)
• A 22 percent increase in total cardiovascular
  disease
• A 26 percent increase in breast cancer

-- NIH NEWS RELEASE. Tuesday, July 9, 2002
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NNT NNH (Ttreat, Hharm)

• The number of patients needed to treat to prevent
  one additional bad outcome
• A dimension of follow-up time
• NNT2 NNT1 x (time1 / time2)
• Are estimates 95 confidence intervals
• Need to apply to your specific patient
• LHH (1/NNT) x ft (1/NNH) x fh

---cited from ?????? Alan Talbot (???)
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4.??????? (Integrating the Appraisal with
Clinical Expertise Patients Preference)

• Just do it !!!
• Information must be translated into action.

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Primum non nocere

• Hippocrates
• ?????????
• Do No Harm

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????????

• We have spent years as an organization talking
  the talk, and its not quite as easy to walk the
  walk.
• Its more difficult to implement systems
  thinking than to talk about it.
• Terrence Weeks
  Director of System Planning

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Beds, Mattresses and Cushions for Pressure Sore
Prevention and Treatment
Cullum N, Deeks J,
Sheldon TA, Song F, Fletcher AW, 2001

• Some high specification foam mattresses were more
  effective than standard hospital foam
  mattresses in moderate-high risk patients.
• Limited evidence suggests that low air loss beds
  reduce the incidence of pressure sores in
  intensive care.

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Animal Bite of Face

• Copious irrigation, excision
• Wound repair still attempted
• Antibiotics
• Rabid dogs1012. Incubation period 28
  weeks.Vaccination within the incubation

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Antibiotic Prophylaxis for Mammalian Bites

Medeiros I, Saconato H, 2001

• There is no evidence that the use of prophylactic
  antibiotics is effective for cat or dog bites.
• There is evidence that the use of antibiotic
  prophylactic after bites of the hand reduces
  infection but confirmatory research is required.

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• People with chronic illnesses dont bounce back
  from an acute episode to a healthy, independent
  baseline.They force physicians to look beyond
  fixing the medical problem.
• 
  Susan J. Denman,
  M.D.
  Senior
  Vice President
  
  for Medical Affairs
  
  Philadelphia Geriatric Center

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Pressure Relieving Interventions for Preventing
and Treating Diabetic Foot Ulcers Spencer S,
2001

• There is very limited evidence of the
  effectiveness of therapeutic shoes.
• There is very limited evidence of the
  effectiveness of total contact casts in the
  treatment of diabetic foot ulcers.

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Compression for Preventing Recurrence of Venous
Ulcers (Cochrane Review)

Nelson EA,
Bell-Syer SEM, Cullum NA, 2001

• Recurrence rates may be lower in high compression
  hosiery than in medium compression hosiery.
• Not wearing compression was associated with
  recurrence in both studies identified in this
  review.
• Compliance rates were significantly higher with
  medium compression than with high compression
  hosiery.

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• A very big component of lifestyle and
  environment and socioeconomic issues affects the
  chronically ill to the extent that they can or
  cannot follow a medical regimen.
  Deborah Paone, M.D.
  
  Vice
  President
  
  National Chronic Care
  
  Consortium

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Compression for Venous Leg Ulcers Cullum N,
Nelson EA, Fletcher AW, Sheldon TA, 2001

• Compression increases ulcer healing rates
  compared with no compression.
• Multi-layered systems are more effective than
  single-layered systems.
• High compression is more effective than low
  compression.

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Purpose of guidelines

• To make evidence based standards explicit and
  accessible
• To make decision making easier and more objective
• Assessing professional performance
• To educate patients and professionals about
  current best practice
• To improve the cost effectiveness of health
  services
• To serve as a tool for external control

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5.??????? (Auditing performance in step 1-4)
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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.
• Therefore, alternative evidence-based approaches
  are required.

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Application of EBOE. From Fabian J Trauma,
Volume 47(2).August 1999.225-232
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???????????????

• Evidence for the effectiveness of CME. A review
  of 50 randomized controlled trials.
• JAMA. 268(9)1111-7, 1992 Sep 2

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???????????????

• To assess the impact of diverse continuing
  medical education (CME) interventions on
  physician performance and health care outcomes.
• DATA SOURCES-- MEDLINE, Social Science Index
• STUDY SELECTION--randomized controlled trials
• DATA SYNTHESIS--777 CME studies, of which 50 met
  all criteria.
• CONCLUSION--Broadly defined CME interventions
  using practice-enabling or reinforcing strategies
  consistently improve physician performance and,
  in some instances, health care outcomes.

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The Bottom Line

• EBM is just one component of decision making
• EBM is labor intensive and time consuming
• Easy medical information access is crucial
• EBM is one tool of quality improvement

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EBM

• EBM is a supplement to, not a substitute for,
  professional skills and experience.

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Whats Next?

• Methodology controversies
• Unpublished data in meta-analyses
• Publication bias
• Standards, Guidelines, Options
• Need for flexibility
• How to apply to individual patient
• Economic analyses
• Valid cost effectiveness guidelines

---cited from ?????? Alan Talbot (???)
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• ????
• ??????,
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• ???????
• ????????,
• ?????
• ???????
• ??? (Dorothy D. Billington)

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Web-based Server

• ?????????????,??Internet??????????????
• ?????????????,???????,???????

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???????? (clinical practice guideline)

• ??????????????,???????????????
• ???????? (clinical practice guideline),????????,??
  ????????????????,?????????

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4?????(grading system for recommendations)

•   Group A??Level I???????
•   Group B??Level II???????
•   Group C??Level III???????
•   Group D??Level III????????
• ???

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????(guideline)

• ??????????(To make evidence based standards
  explicit and accessible)
• ?????????(To make decision making easier and more
  objective)
• ???????????????????(To educate patients and
  professionals about current best practice)
• ?????????(To improve the cost effectiveness of
  health services)
• ???????(To serve as a tool for external control)

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??????(EBM consult)

• ????????20?????????????
• ????????????????????,???????????ICD???,???????,???
  ????,???????? ??????(EBM consult),?????????????
  ?????

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• ?????? ?????clifchen_at_ms1.hinet.net
• http//clifchen.idv.tw