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Evidence-Based Practice
奇美醫學中心 林宏榮
What evidence-based medicine is:
“Evidence-based medicine is the
integration of best research evidence with
clinical expertise and patient values”
-
Sackett, et al 2001
What evidence-based medicine is
Patient
Values
Clinical
Expertise
Best
Evidence
Rule 31 –
Review the World Literature Fortnightly*
*"Kill as Few Patients as Possible" - Oscar London
5,000?
per day
Medical Articles per Year
2500000
2000000
1500000
1000000
500000
55 per
day
1,400
per day
0
Trials
MEDLINE
BioMedical
Managing Information
The Airline industry
Boeing 777 manuals
24 binders
10 feet shelf space
Conversion to CD
Reduced search by 60%
The Health Industry
Memorize “the manuals”
Exams, audits, etc to check
Systematic review of bed rest
after medical procedures
10 trials of bed rest after spinal puncture
no change in headache with bed rest
Increase in back pain
Protocols in UK neurology units - 80% still
recommend bed rest after LP
Serpell M, BMJ 1998;316:1709–10
…evidence of harm available for 17 years
preceding...
Allen, Glasziou, Del Mar. Lancet, 1999
Getting Evidence in to Practice
How do you “do” EBP?
What EBP do you do/help with?
What other EBP do you know of?
Compare with you neighbour
Teaching Tip:
Special
background
for activities.
Managing Information
“Push” and “Pull” methods
“Push” - alerts us to new information
“Just in Case” learning
Use ONLY for important, new, valid research
“Pull” – access information when needed
“Just in Time” learning
Use whenever questions arise
EBM Steps: Question; search; appraise; apply
Bimonthly “just in case” journal
Valid, Relevant & (almost) No Effort!
80 journals scanned
Is it valid?
Intervention: RCT
Prognosis: inception cohort
Etc
Is it relevant?
GPs & specialists ask:
Will this change your practice?
www.evidence-basedmedicine.com
“Just in Time” learning:
Doctor’s information needs
Setting: 64 residents at 2 New Haven hospitals
Method: Interviewed after 401 consultations
Questions
Asked 280 questions (2 per 3 patients)
Pursued an answer for 80 questions (29%)
Not pursued because
Lack of time
Forgot the question
Sources of answers
Textbooks (31%), articles (21%), consultants (17%)
Green, Am J Med 2000
Doctor’s information needs
Most of our questions are NEVER
answered
When answered, the information is likely
to be neither the best nor up-to-date
Step #1
Developing an
answerable Clinical
Question
Your Clinical Questions
Write down one recent patient problem
What was the critical question?
Did you answer it? If so, how?
Good questions
Important to your practice
Important to your patients
Specific
Answerable!
Good Questions
Which patients is this question about?
What is the main intervention?
Is there an alternative intervention?
What can I hope to accomplish?
“Hunting” questions - “PICO”:
“P” - patient or problem
“I” - intervention (e.g., diagnostic test,
treatment, cause, prognostic
factor)
“C” - comparison intervention
(if necessary)
“O” - outcome
Examples of good questions
In patients with insulin-dependent
diabetes mellitus
receiving current standard insulin
therapy
will an intensive insulin regime
reduce the risk of developing
microvascular complications
Examples of good questions
Among women in premature labour
expected to deliver before thirty weeks of
gestation
does an intensive corticosteroid regime
compared with the standard regime
reduce the risk of RDS in their babies?
Information “pull”
Steps in EBM process
1. Formulate an answerable question
2. Track down the best evidence
3. Critically appraise the evidence
4. Integrate with clinical expertise and patient
values
An example: “the first sign of
hyperkalaemia is death”
An anxious laboratory technician phoned about
a potassium of 7.3 mmol/l (Ref Range 3.5-5.0)
found on a routine blood test of a 50 year old
woman.
I arranged an urgent repeat of the electrolytes
(to rule out a spurious elevation) and an ECG.
The latter was reassuringly normal, but left me
asking: Does a normal ECG rule out a serious
elevation of potassium?
1. The question
Does a normal ECG rule out a serious
elevation of potassium?
Population - In suspected hyperkalemia
Indicator - does a normal ECG
Comparator Outcome - rule out hyperkalemia?
1. The question
Does a normal ECG rule out a serious
elevation of potassium?
Population – hyperkal*
Indicator – ECG OR EKG
Comparator Outcome – hyperkal*
Underline keywords; think of synonyms
Step #2
Efficiently track down the
best evidence to
answer clinical questions
Useful data sources
MEDLINE
Cochrane Library
Clinical Evidence
searchable
through
Medline
searchable
together
searchable
individually
Using the tools
NLM (who make Medline) index
thousands of medical journals
Each article is given keywords Major MESH terms
Minor MESH terms
The article title and abstract are also
searchable - as Textwords
Using the tools
Search engines will sometimes match
your entry to the nearest MESH term.
Sometimes they don’t
Experiment!
Filters
A filter is a sequence of Medline search
instructions intended to locate specific
types of study design
Filters exist for
clinical trials
studies of prognosis
studies of adverse effects
and many others….
Filters
Some search engines provide
prepackaged filters
PubMed for example
Most don’t
PubMed via
Google
Diagnosis
button
“OR” synonyms
* Means
any letters
Diagnosis
button
Sensitivity of
62% or 55%
Limit to
EBM Reviews
Most
Recent Update
Step #3
Appraising the
evidence for
validity
The “best” evidence depends on the type
of question
1. What are the phenomena/problems?
Observation (e.g., qualitative research)
2. What is frequency of the problem? (FREQUENCY)
Random (or consecutive) sample
3. Does this person have the problem? (DIAGNOSIS)
Random (or consecutive) sample with Gold Standard
4. Who will get the problem? (PROGNOSIS)
Follow-up of inception cohort
5. How can we alleviate the problem?
(INTERVENTION/THERAPY)
Randomised controlled trial
Treating hyperkalemia
She refused to go to hospital
Resonium A, but it is around $100 (RPBS
but not PBS) which she could not afford.
My search had mentioned albuterol as a
treatment.
Step #4
Applying the results
in clinical practice
“Just in Time” learning
The EBM Alternative Approach
Shift focus to current patient problems
(“just in time” education)
Relevant to YOUR practice
Memorable
Up to date
Learn to obtain best current answers
Dave Sackett
Advanced threshing
Read the abstract
Read the author list
Read references cited in several other
papers
Consider levels of evidence
(as far as you can from abstracts)
Step #5 Explain Evidence
Internal validity
Is the study credible?
Was it done welll?
Was it done right?
Do you believe the authors?
Is the study good enough to consider
making decisions based on its results?
Levels of evidence
Randomised controlled trials
Cohort studies
Case-control studies
Routine data hunting
Case series
Case reports
Allow for serendipity
Type and Strength of Evidence
Absolute truth or divine revelation
I
Systematic review of well designed RCTs
II Well designed RCT of appropriate size
III Nonrandomized trials: single group pre-post, cohort,
case control
IV Non-experimental studies from more than one site or
research group
V Opinions of respected authorities, not based on above
VI Someone once told me
Quality of evidence
Use Sackett’s guidelines for the various
different types of study
Gain experience
Quality assessment is quite subjective, no
matter how experienced you are
Allow for serendipity
Assessing an RCT
A r e th e r e s u l t s o f th i s s i n g l e p r e v e n t i v e o r th e r a p e u t i c
tr i a l v a li d ?
W a s th e a s s ig n m e n t o f p a ti e n t s t o tr e a t m e n t
r a n d o m i s e d , a n d w a s th e r a n d o m is a t i o n lis t
con c e aled ?
W e r e a ll p a ti e n t s w h o e n t e r e d th e tria l
a c c o u n t e d f o r a t it s c o n c lu s i o n ?
W e r e th e p a t i e n t s a n a ly s e d in th e g r o u p s t o
w h ic h th e y w e r e r a n d o m i s e d ?
W e r e p a ti e n t s a n d clin ic i a n s k e p t b lin d a s t o
w h ic h tr e a t m e n t w a s r e c e i v e d ?
A s id e fr o m th e e xp e r i m e n t a l tr e a t m e n t w e r e
th e t w o g r o u p s tr e a t e d e q u a lly ?
W e r e th e t w o g r o u p s si m il a r a t th e st a rt o f th e
tria l ?
External validity
Given that the study is credible, and in
some sense that it is good enough..
Is it of any use?
Can I apply the results at all?
Is it likely that my patients are like those
in the study?
Does it apply to me?
Well, does it apply to
My continent?
My setting?
My patients?
Women?
Children or elderly people?
Poor people?
The four B’s
Burden of illness (the patient's, towns, etc
risk of the event)
Barriers to treatment (including
economics, geography, etc)
Behaviours needed (yours and your
patient's) to adopt the treatment
Balance between expending efforts this
way or in some other way.
Step #6 Performance
evaluation
Validity
Sackett proposes that internal validity
should be left to experts (people like 柯)
External validity should be left to users
(people like 林)
Is it wrong…
What do you think?
Evidence based practice
Is it possible to do this?
Isn’t this just the latest fashion?
Isn’t it too difficult?
What about clinical freedom?
Aren’t we becoming overpaid clerks?
Why does it matter?
Is it possible?
Yes
Real clinicians are doing it now
It addresses a genuine clinical need
Clinicians need information
If asked
We need it twice a week
We get it from textbooks and journals
The Slippery Slope
knowledge
of current
best care
. ..
. . ........
...
r = -0.54
p<0.001
...
...
....
..
....
years since
graduation
Clinicians really need information
If shadowed
We need it up to 60 times a week (twice
per three patients) and it could affect up
eight decisions a day
We only get 30% of it
and that comes from passers-by
my textbooks are out of date
my journals are too disorganised
Our patients need it too
Patients die when doctors make it up as
they go along.
Proven for
Tuberculosis treatment
Testicular cancer treatment
Abdominal aortic aneurysms
Myocardial infarction
Why we get it wrong
Our information is out of date
Our textbooks are very out of date
Nobody can read enough journals to keep
up.
We are taught to remember in medical
school, not to think.
What can we do?
Accept that there is a problem
Take steps to fix it
Review of practice (Audit)
Review of clinical decisions (EBM)
Review of outcomes (Quality assurance)
Why are people afraid?
Appraisal is challenging
It’s easy to perceive it as a threat
In practice it often is
We are not used to thinking reflectively
about what we do. It’s not part of the
medical ethos.
Is EBP just a fad?
Nope
Is EBP going to turn us into
mindless automatons?
Not unless you are one already
Guidlines are what they say - GUIDES
Good practice includes careful and
reflective application of guidelines, and
other pieces of knowledge to the
individual patient
Medicine is an art and a science
What about clinical freedom
Freedom to do harm is not available
Freedom to do good is
Patients are unique
We must individualise care
We must care, as well as diagnose and cure
We must be responsible or else lose our
freedom
The Barriers to EBP
1. Attitude of question & inquiry
2. Know-how in finding, appraising, and
applying evidence
3. Information Resources on tap
4. Lack of Time
EBP in Teams
Question focused journal clubs
Structure:
Appraise & apply “homework” article
New questions? Discuss & assign
Plan and monitor changes
Are there barriers to the change?
Can we measure the change?
EBP for Teams: example
Initial “EBP lunch” questions on annual check
TRIGGER: Is blood monitoring better than urine
monitoring in NIDDM? – No; give patients option
Session 1: formulate questions
Should all diabetics be on aspirin? – Most; audit
Are aerobic or resistance exercises helpful for
diabetic control? – Both improve control; audit;
purchased 12 pedometers
(Subsequent sessions)
Who needs to see the podiatrist? – High risk
What is the best test for neuropathy? - Monofilament
How can we improve compliance?
When should oral medications be started?
Using evidence for prioritising
Q: Which diabetics need podiatry?
PLAN
Current wait time is 3 Months
About half workload is diabetics
Cohort study shows 2% ulcers/yr with 5 risk factors
Current ulcer
Past ulcer
Neuropathy
Deformity
Poor pulses
Abbot. Diab ed 2002: 377-84
Summary
Is there an information deluge?
Yes – 5,000 articles per day
Does CME help?
Maybe a little
Can EBM (patient-centred learning) help?
Yes, it uses the more effective methods of CME
What are the barriers?
Evidence resources, skills, inquiring attitude
What is evidence-based
practice?
Clinical Skills
Keeping
up to date
Clinical question
THE
PATIENT
Audit
Find the Evidence
Apply to Practice
Critical Appraisal
Current Format Emphasizes
Small group learning
On-the-fly reviews
Rapid analysis of medical literature/evidence
Single clinical question per month
Module approach
Treatment
Diagnosis
Harm
Assigned Resident Preparation
Choose a “real patient” scenario in
which a clinical question has arisen
Literature search performed
3 articles chosen
not distributed beforehand
Lead the discussion of an article
worksheet completed ahead of time
EBM - Journal Club
30 minute social time
Good food and beer help with attendance!
1.5 hours EBM exercise
Mini-Lesson
10-minute “mini-lesson”
Prepared & presented by faculty sponsor
Topic examples:
Hierarchy of evidence
NNT/NNH
RR/OR
2X2 tables
Case control, cohort studies
EBM – Journal Club
Clinical Scenario is presented
Clinical question is constructed (PICO)
PICO
EBM – Journal Club
Handout of Medline search provided –
brief discussion
Search Sample
EBM – Journal Club
Divide into 3 small groups
Led by EM resident
Everyone provided EBM worksheet
Each group discusses one of the articles
EBM – Journal Club
Given 5 minutes to review the article
“on the fly” philosophy teaches residents to
efficiently read/scan the medical literature
Seek out tables, figures
leader takes group through the worksheet
EBM – Journal Club
Entire group reconvenes
Spokesperson from each group
summarizes worksheet
Closing the Loop
Integrating the evidence with clinical
experience and patient preferences, values
Translating the evidence
Can I apply the results to my patient in my locale?
Will the evidence change my practice behavior?
How do we handle “imperfect” evidence?