Evidence Based Medicine

Introduction
&
Information Resources
Dr. Suman Bhusan
Bhattacharyya
MBBS, ADHA, MBA
&
http://www.cebm.net/
 An Evaluation
What?
Why?
Where?
How?
Pain areas
 Evidence Based Medicine
What?
Widely credited to have been coined by Dr. David
Eddy of Kaiser Permanente
It is believed that its philosophical base dates
back to the sceptics of post-revolutionary France
(Xavier Bichat, Pierre Louis, Franois Magendie)
May have origins in China, B.C.
The conscientious, explicit and judicious use of
current best evidence in making clinical
decisions about the care of individual patients
(Dr. David Sackett, 1996)
 Evidence Based Medicine
- When?
There is evidence that something
works, is good and benefits the
patient, do it
There is evidence that something
does not work, is harmful, does not
benefit the patient, do not do it
There is insufficient evidence, be
conservative, relying on individual
clinician expertise
 Evidence Based Practice
- What?
Any practice that applies up-to-date
information from relevant and valid
research about the usefulness of various
diagnostic tests or the predictive power
of prognostic factors or the beneficence
of a particular treatment method across
healthcare, including education, practice
management and health economics, it is
said to be EBM-enabled.
Evidence Based Enablement,

but
Mere application of evidence
based medicine is in itself
simply not good enough. The
end results need to be
validated. This is done by
performing outcomes analysis,
preferably on a continuous basis
 Evidence Based Practice
Why?
The old way of depending on a combination
of informed guesswork, unsystematic
observation, common sense, the consensus
views of clinical experts, and the so-called
standard and accepted practice, meaning
the treatments and procedures used by
most other clinicians in a local community
was fine, but with the addition of enormous
amounts of information every day, things
are threatening to get out of control.
So, is this way the only way?
 The Pain Areas
27 Kg of guidelines,
3000+ new papers per day,
1000 new Medline articles,
46 randomized clinical trials
The number
of biomedical journals alone doubling since 1970.
Average workload for a clinician of anything
between 100 to 200 consultations a week
resulting in 5000 to 10000 per year.
Add to it the difficulty of relying solely on
experience while using 2 million pieces of
information all stored in ones memory, ever
increasing pressures to provide value-for-money
services, raised patient demands and
expectations, pressures due to a myriad of
obtrusive and mostly confusing regulatory
compliances, and rapidly altering business
demands.
Hmmm
The Pain Areas [Contd.]
Every encounter with a patient
identifies gaps in our knowledge about
the etiology, diagnosis, prognosis, or
therapy of their illness. Recent
research reveals that even as seasoned
clinicians we generate about five
knowledge needs for every in-patient
encounter, and two needs for every
three out-patients encounters.
 The Pain Areas
a plausible answer
To bridge these gaps and fulfill the
needs, we need to practice evidence
based medicine, and to evaluate the best
evidence that evidence based medicine is
supposed to reveal we need to perform
outcomes analysis
Practicing medicine based on best
evidence in the form of clinical protocols
helps as a valid legal cover in malpractice
suits
 Best Evidence

Current best evidence is up-to-date

information from relevant, valid
research about the effects of
different forms of healthcare, the
potential for harm from exposure to
particular agents, the accuracy of
diagnostic tests, and the predictive
power of prognostic factors.
 PICO
well built clinical questions
 Evidence Based Medicine
How? The way of seven
Assess the patient
As a clinical conundrum or question that arises out of the clinical examination

Ask the patient the care provider needs to construct a well-built clinical question from the findings
in step 1

Access the information the appropriate resources needs to be selected and searched for the answer to the
question framed in step 2

Appraise the evidence the information gathered in step 3 needs to be critically appraised using the
various indices for its validity and applicability to the patients problems

Apply the findings the validated evidence needs to be integrated with clinical expertise and patient
preferences and then applied as required

Assess the outcomes the performance of the evidence with the patient needs to be evaluated

Add the knowledge the information so gathered added to the clinicians knowledge base for future
reference to best evidence in similar problems
 Evidence Based Medicine
The Types
Diagnostic
Here the importance of various
observations, value of diagnostic tests,
etc. are evaluated in ruling in or out a
diagnosis
Treatment
Here the value of a treatment method
or the necessity of a particular
medication or procedure is determined
Evidence Based Balance
Sheet
An evidence based balance sheet is
an important tool that supports the
practice of evidence based medicine.

1. Examine the evidence that a

treatment is effective.
2. If so, then determine the
magnitude of its benefits, harms,
and costs.
Evidence Based Balance
Sheet
Display in a compact form the
evidence as quantitative estimates
of the effects of alternative
treatments on all the important
outcomes
The decision-makers can more
easily grasp the consequences of
the different options they face.
Specially useful for informed
shared decision-making between
physicians and patients.
 Developing an Evidence
Based Balance Sheet The 4
Main Steps
1. Identification of the alternative treatments
that are available to the patient
2. Identification of the health outcomes (i.e.,
the outcomes that can be experienced by,
and are important to, the people who will
receive the treatments) that are affected by
the treatments
3. Estimation of the probabilities or
magnitudes of each of the health outcomes,
for each of the alternative treatments
4. Displaying the information in a table
 EBM Balance Sheet An
Example
One-year probabilities of outcomes associated with Alendronate 5 mg vs. no drug, for a 55-
year-old average-risk woman.

Item NoDrug Drug Difference NNT

Hipfracture .00046 .00032 .00014 7143

Wristfracture .00316 .00223 .00093 1078

Spinefracture .00144 .00084 .0003 3322

Long-termbenefits 0 ? ? ?

Inconvenience 1 0 1 1

Gastricdistress 30% 0 30% 3

Long-termHarms 0 ? ? ?

Costofdrug $0 $308 +$308

Expectedcostoftreatment $220 $203 -$17

Netcost $220 $511 +$291

 Problems associated with
Evidence Based Practice
Problems
Resources and commitments in terms of time and money
that needs to be delivered away from actual patient care
Finding and evaluating the evidence is costly in terms of
time
Lack of skills in computer use and locating evidence
Resources needed to acquire and maintain databases
Searching may only result in discovering gaps in medical
knowledge
Poor indexing may lead to frustration of futile literature
searches
The quality and quantity of research mostly unknown
Demands a high degree of statistics knowledge
Viewed as a form of rationing
Solutions/Workarounds
Evaluate against opportunity cost, follow-on and
abandonment option costs. Evidence based practice
wins hands down as a strategic investment
Use EPR
Train personnel. This is not an issue with the
generation next.
Availability in electronic form and increased usage will
bring the prices down
One must seriously doubt our capabilities and question
our insecurities
Use online searches and make all literature available
searchable online
Use refined studies performed real-time using EPR
Use EPR that have the calculations as well as their
interpretations built-in
Evidence based medicine is about improving the
quality of patient care. It is just as likely to show that
effective interventions are underused as to show that
ineffective procedures are over-used
EBM in Clinical Protocols
Clinical protocols need to be made
based on the current best evidence
These protocols must undergo
continuous revalidation in order to
continue to be relevant according to
the current best evidence
Protocols change according to triage
assessments and specialty so they
need to be user and problem-specific
 Evidence-Based
Information Resources

Push, Pull, Prompt

ways to deal with
too much information
 Evolution of EBM Info
PreEBM: Passive diffusion
(publish it and they will come)
Early EBM: Pull diffusion (teach
them to read it and they will
come)
Current EBM: Push diffusion
(read it for them and send it to
them)
Future EBM: Prompt diffusion
(read it for them, connect it to
their individual patients, prompt
 Information in the
Internet Age*
Information in the Internet age may be
constrained by a variant of Malthus
law:
The amount of information is growing
exponentially, but our attention is not.
A wealth of information creates a
poverty of attention.
The low cost of production of poor
quality information results in high
quality information being drowned out.
The cost of finding specific
information rises as the amount of
information
*Coiera increases.
E. Information economics and the internet
J Am Med Inform Assoc 2000;7:215-21.
 The Slippery Slope
100% r = -0.54
Choudhry, Fletcher and.Soumerai,
.. p<0.001
knowledge
Ann . . ....
... .
Intern Med 2005;142:260-73
of current 50% found decreasing
...
-94% of 62 studies ...
....with
best care ...tasks,
competence for at least some
increasing physician age. .... ..
0%

years since
graduation
 The McMaster PLUS
project
only a tiny proportion of all
research is ready for application
only a tiny fraction of the ready
research is relevant to the
practice of a given clinician

only a tiny proportion of the

relevant research for a given
practitioner is interesting in the
sense of being something new,
important, and actionable.
Evidence-Based Journals

Critical Appraisal Filters

~3,500 articles/yr
60,000 articles/yr
meet critical appraisal
from 120 journals
and content criteria
(95% noise reduction)
 McMaster PLUS Project

Clinical Relevancy Filter (MORE)

~25 articles/yr for

clinicians (99.95%
~3,500 articles/yr meet noise reduction)
critical appraisal
and content criteria ~5-50 articles/yr for
(95% noise reduction) authors of evidence-
based clinical topic
reviews
McMaster Online Rating of Evidence: >6000 practicing clinicians
http://bmjupdates.mcmaster.ca
 User End

Users sign up according to discipline

Users control relevance and flow
Users can change disciplines at any time,
and can sign up for as many as they wish
Users can search according to discipline or
not
Users can access PubMed Clinical Queries
(We can monitor individual use, if agreed)
Dear Dr. Haynes,

We want to alert you to NEW articles in the PLUS system.

These articles that have received very high relevancy and newsworthiness scores:

1. Brazg
R, et al. Effect of adding sitagliptin, a dipeptidyl peptidase-4 inhibitor, to metformin
on 24-h glycaemic control and beta-cell function in patients with type 2 diabetes. Diabetes
Obes Metab. 2007;9:186-93.

Ratedby:IM/General(patientsreferredfrom
Relevance:5of7 Newsworthiness:5of7
PrimaryCare)

We hope that you will find these articles of value in your clinical practice.

Best wishes from the PLUS Team

CONCLUSIONS: In this 24-week study, once-
daily sitagliptin monotherapy improved glycemic
control in the fasting and postprandial states {vs
placebo}, improved measures of beta-cell
function, and was well tolerated in patients with
type 2 diabetes.
 Medscape Best Evidence
Alerts

Free at
https://profreg.medscape.com/px/newslet
ter.do
The evolution of information resources
for evidence-based decisions Examples
Systems Computerized
decision support

Evidence-based
Summaries
textbooks

Evidence-based
Synopses journal abstracts

Systematic reviews
Syntheses

Original journal
Studies articles
 Premier evidence
resources
Systems: EMR with decision
support
Summaries: Clinical Evidence,
PIER, UpToDate, Dynamed
Synopses: ACP Journal Club,
EBM
Syntheses: via BMJUpdates+
Studies: via BMJUpdates+,
PubMed Clinical Queries
58 year old obese male with
type 2 diabetes mellitus
A1c 9% (elevated) on glyburide
and rosiglitazone, with
metformin intolerance
continuing
Can the to
newgain weight
incretin
very reluctant
therapies (eg,toexenatide,
take insulin
pramlintide or sitagliptin)
help?
 For type 2 diabetes, what are
Systems
the effects
Summaries
Synopses
- good and bad -
Syntheses of incretin therapy?
Studies

Systems: no Computerized Decision

Support
Summaries: in UTD, PIER, Dynamed,
not CE
Synopses: sitagliptin in ACP JC
Syntheses: one for pramlintide in
BMJUpdates+
Studies: exenatide, pramlintide,
sitagliptin in UTD, PIER, CE,
Section updated June 2007

Comments on exenatide, pramlintide,

sitagliptin, with drug monographs for
each

Many questions remain unanswered

regarding clinical use and long-term
outcomes with these drugs.
Januvia is approved for use by people with type 2 diabetes
US$5 adequately
that can't be controlled per pill with diet and exercise.
 Includes exenatide, pramlintide, and
sitagliptin, with drug monographs for each

Consider metformin as a first-line agent

because it causes less hypoglycemia and
weight gain, along with possible improvements
in cardiovascular risk.

Consider other oral agents, such as

sulfonylureas, thiazolidinediones, and DPP-IV
inhibitors {sitagliptin}, as reasonable first-line
agents, although some are costly and the long-
term benefits of these drugs have not been
well studied.
CONCLUSIONS: Incretin therapy offers an alternative
option to currently available hypoglycemic agents for
nonpregnant adults with type 2 diabetes, with modest
efficacy and a favorable weight-change profile.
Careful postmarketing surveillance for adverse
effects, especially among the DPP4 inhibitors, and
continued evaluation in longer-term studies and in
clinical practice are required to determine the role of
this new class among current pharmacotherapies for
type 2 diabetes.
 Survey of traditional
textbooks of medicine
Harrisons Textbook nothing
Books@Ovid nothing
Kelleys Textbook - nothing
 My conclusions about
exenatide, pramlintide,
sitagliptin
Interesting new options for diabetes
Not well studied (eg, no comparisons
with current best medications)
Exenatide and pramlintide would likely
be out for this patient (injections)
Sitagliptin is a possibility, but not until
better known options tried (acarbose,
Avandamet, repaglinide)
 Finding evidence when
youre not sure where to
look
TRIP
SUMSEARCH
CLINICAL QUERIES
(Pick One)
 To keep up with
evidence
Systems

Summaries

Pull
Synopses

Syntheses

Studies

Push

Promptsome labs
and EMRs with a
credible evidence-
based pedigree (Zynx)
Thank You!