FCM 32 13 December 2018

EVIDENCE-BASED MEDICINE 3.1 Natakneng 2020

Dr. Ricardo Guanzon, MD Mariano Marcos State University

Outline: Patient: Mr. A

A. Introduction Mr. A is a 60 year old presenting with 1 hour of retrosternal chest pain.
B. Definition of Evidence Based Medicine ECG shows lateral ST-elevation consistent with acute MI.
C. Evidence-based health care practice
D. Importance of EBM QUESTION: In patients with acute MI, does treatment with aspirin
E. Evolution of EBM
F. Decision making in EBM reduce mortality?
G. Five-Step Approach to Practicing EBM
H. Benefits of Adopting EBM What is the best evidence?
I. Misconceptions in EBM
J. Evidence-based Public Health
K. Conclusion Evidence: 1988
Reduction of mortality in acute myocardial infarction with
streptokinase and aspirin therapy. Results:
INTRODUCTION Patients with acute MI treated with Aspirin vs. placebo had a
BLOOD-LETTING significant 23% relative risk reduction in five-week
3000years ago cardiovascular mortality, with an absolute risk reduction of
Egyptians, Greeks then Romans, Arabs 11.8% to 9.4%
and so on The combination of SK and Aspirin resulted in a 42% relative
The cure for (hot, moist diseases) risk reduction in cardiovascular mortality after five weeks
several medical conditions. compared with the placebo
Galen was able to propagate his ideas
through the force of personality and the Application: 1997
power of the pen How many patients receive ASA following acute myocardial
infarction?
Pierre Louis (1787-1872) Aspirin was not given to 55%!!!
Inventor of the “numeric method” and the 78% of patients who did receive aspirin received it more
“method of observation” than 30 minutes after arrival to the emergency department
French physician who wanted to analyze the But as late as 2000, even in the US, aspirin was being prescribed
efficacy of bloodletting in the treatment of for at most one third of patients with coronary artery disease (for
acute pneumonia whom there were no contraindications to its use)
Examined the clinical course and outcomes Relatively simple, and cheap practices shows that we have a
of 77 patients problem in getting providers to apply knowledge gained through
Overall Results (n=77) research
The paradigm for the translation of new information from research
bench to bedside has been conceptualized as a “translational
highway”.

William Osler (1849 -1919)
First “attending physician” at Johns Hopkins
Author of hugely influential textbook, 'The
Principles and Practice of Medicine' believed
that most drugs in his day were useless, but
still advocated blood-letting in some cases
Conclusion: Effect of bloodletting procedure
was actually much less helpful than has been commonly believed
EVIDENCE-BASED MEDICINE
“Evidence-based medicine is the integration of best research
evidence with clinical expertise and patient values”
- David Sackett
“Explicit, judicious, and conscientious use of current best
evidence from medical care research to make decisions about the
medical care of individuals”

Bloodletting today
Today phlebotomy therapy is primarily used in Western
medicine for a few conditions such as hemochromatosis,
polycythemia vera, and porphyria cutanea tarda.
Why did it persist?
It resulted from the dynamic interaction of social, economic,
and intellectual pressures, a process that continues to EVIDENCE-BASED HEALTH-CARE PRACTICE
determine medical practice The integration of:
individual clinical expertise
But….. best available external clinical evidence from systematic
research

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INDIVIDUAL CLINICAL EXPERTISE

Skills
Judgement
which individual health care workers acquire through
clinical experience and clinical practice

BEST AVAILABLE CLINICAL EVIDENCE

Clinically relevant research derived from:
basic medical sciences and
patient-centred clinical research into the safety and efficacy
of therapeutic interventions
Systematic Reviews

IMPORTANCE OF EBM
New types of evidence are being generated which can create
changes in the way patients are treated
How much is actually being applied to patient care?
Although evidence is needed on a daily basis, usually
physicians don’t get it
lack of time
out-of-date textbooks
the disorganization of the up-to-date journals

IMPORTANCE OF EBM FOR PRACTICING CLINICIANS

EVOLUTION OF EBM
Pre EBM: 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”)
Evidence increasing so rapidly we need better skills to keep
up-to-date more efficiently than previous generations of
clinicians

Why do we need to use evidence efficiently?

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AN EBM APPROACH TO EDUCATION IDENTIFYING THE BEST STUDY

Evidence cart on ward rounds - 1995
Looked up 2-3 questions per patient
Took 15-90 seconds to find
Change about 1/3 decision

Prof Archibald Cochrane, CBE (1909 - 1988)

The Cochrane Collaboration is named in honor of Archie
Cochrane, a British researcher.
In 1979 he wrote, "It is surely a great
criticism of our profession that we
have not organized a critical summary,
by specialty or subspecialty, adapted
periodically, of all relevant randomized
controlled trials”

WHY THE SUDDEN INTEREST IN EBM?

Increasing realization among clinicians that years of experience
unaccompanied by updating of knowledge can result in decline of
clinical performance
The need for valid information about diagnosis, therapy,
prognosis, and prevention in this era of consumer activism
The common man has access to the very same medical literature
as the clinicians through numerous sources
Limited time available to the clinician for acquiring information is a
major impediment for updating the knowledge from traditional
sources

ASSUMPTIONS OF EVIDENCE-BASED PRACTICES

Not all evidence is equivalent
There is a hierarchy of study design
External evidence can inform but can never replace individual
clinical expertise (Sackett et al., 1996)
Starting from the best external evidence and work from there.
Values always influence decisions

DECISION MAKING IN EBM

Decision-making is the cognitive process resulting in the selection
of a course of action among several alternative possibilities

THE EVIDENCE PYRAMID

IN CLINICAL PRACTICE

OUTCOME – the only thing that matters

What EBM additionally provides is
Opportunity for change
Opportunity for better treatment

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How evidence affects clinicians? EBM METHOD

Everything that’s old is outdated?

Think 100 times before refuting an old time tested method of
treatment
Classic example is vaginal hysterectomy for benign
diseases
“Give me 2 retractors, 2 scissors , 2 clamps, one tissue Answerable Questions
holding forceps and one needle holder, I will do a
vaginal hysterectomy in any setup”
- Surgeon

Laparoscopic Hysterectomy Setup

New developments ( unnecessary) in minimally
invasive surgery
Studies sponsored by pharma companies
Use of meshes in different clinical conditions
Mesh Erosion in bladder or bowel, infection or rejection
of mesh, vaginal pain or painful intercourse, groin
infection/abscess, extrusion , obstruction , voiding
dysfunction and erosion. Ask Clinical Questions

Changes in clinical practice Changes in clinical practice

shouldn’t be like this should be like this

STEP 1
Clinical Scenario :
12 years old only male child
admitted to ICU
history of accidental ingestion of OP compound 4 hours back
On admission the patient was comatose but
hemodynamically stable
THE FIVE-STEP APPROACH TO PRACTICING EBM
Step 1 - Framing a Proper, Pertinent, Focused and Answerable
The anaesthesiologist used his past experience, knowledge,
Question
skill & expertise and treated the patient with an infusion of
Step 2 - Searching the Literature
atropine
Step 3 - Critical Appraisal of the Literature
Inspite of that patient developed respiratory paralysis in the
Step 4 - Integrating the Evidence with Clinical Expertise and Patient
next 2 hours
Values
The clinician used his expertise puts him on mechanical
Step 5 - Evaluating the process
ventilation
The anaesthesiologist used his past experience, knowledge,
skill & expertise and treated the patient with an infusion of
atropine

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Inspite of that patient developed respiratory paralysis in the The outcome of this research study is very much relevant and
next 2 hours beneficial in solving the clinical dilemma
The clinician used his expertise puts him on mechanical
ventilation STEP 4 - Integrating the Evidence with Clinical Expertise and
Now, the consultant understands the gap in his knowledge & Patient Values
he identifies the same. The best documented critically appraised research evidence is
The consultant wanted to administer Inj Pralidoxime. already with the clinician
But he was not sure of the dosage and the mode of Take into consideration the patient values for example:
administration (a single bolus dose or an infusion) The patient is a precious, lone male child of the parents.
The economical/financial status of the parents does not permit
P Patient Problem: How would I describe a group expensive therapies
of patients similar to mine? No contraindications for the drug to be administrated
Low dose regime requiring 1/16 of the high dose has better effect
In this clinical situation it is a male pediatric patient (12
years) who has developed organophosphorous STEP 5 – Evaluating the process
poisoning following its ingestion. Was he able to formulate a focused question?
Was he able to devise a precise search strategy for locating the
I Intervention strategy: Which main intervention, evidence?
prognostic factor or exposure am I considering? Did he use the most appropriate resource?
Were more pertinent resources like practice guidelines available
Here the intervention is the therapy with Pralidoxime in to him?
optimum dosage. Did the ‘evidence’ work in his patient?
The clinician should document the outcomes of the application of
C Comparison: What is the main alternative to the evidence and based on his experiences
compare with the intervention? Those of his colleagues should be able develop management
protocols
In his patient the clinical dilemma pertains to the
dosage and mode of administration of Pralidoxime (low BENEFITS OF ADOPTING EBM
dose infusion vs. single large bolus dose Minimize the errors in patient care
O Outcome: What can I hope to accomplish? Reduces the cost of treatment to the patient
Optimizes the quality of patient care
Recovery from OP poisoning and decrease in morbidity Skills learnt in practicing EBM are the very same ones needed for
& mortality being a lifelong, self-directed learner
Habit of accessing literature on a daily basis is the best guarantor
of ensuring advancement of knowledge and keeping abreast of
STEP 2 - Literature Search scientific progress
‘Traditional’ print resources like textbooks or journals
‘Browse’ online electronic databases EBM MISCONCEPTIONS
FALLACY FACT
STEP 3 - Critical Appraisal of the Literature EBM is useless when there is EBM means appropriately using
1) Screening for internal validity and relevance no good evidence the best available evidence to
2) Determining the intent of the article 3.Evaluating the validity care for patients
based on its intent
3) Evaluating the validity based on its intent EBM is algorithms that ignore Clinical judgment must be used
clinical judgment/expertise in deciding how to apply the
The article that was tracked down is Prospective randomized evidence
placebo controlled clinical trial of Pralidoxime in two similar groups
of patients. (Control group-low dose and study group-high dose) EBM is just numbers EBM is not numbers in a
Block randomization was used and statistics vacuum – the evidence must be
The investigators were not blinded individualized to each patient
The intent of the article is to evaluate two treatment regimes of
PAM in the management of OP poisoning
The next thing to determine is the strength of the outcome. How WHO BENEFITS?
large was the treatment effect? Practitioners - current knowledge to assist with decision making
Low dose group fared better than high dose group Researchers - reduced duplication identify research gaps
PAM is a very expensive imported drug requiring considerable Community - recipients of evidence-based interventions
amount of foreign exchange and there are difficulties in procuring Funders - identify research gaps/priorities
it Policy maker - current knowledge to assist with policy formulation
It is imperative for the clinician to find a cost- effective
and yet effective treatment. EVIDENCE-BASED PUBLIC HEALTH
Patient’s father, being a primary school teacher, cannot afford the “The development, implementation, and evaluation of effective
exuberant cost of the drug. programs and policies in public health through application of
principles of scientific reasoning, including systematic uses of

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data and information systems, and appropriate use of behavioral

science theory and program planning models”

CLINICAL VS. PUBLIC HEALTH INTERVENTIONS

CLINICAL PUBLIC HEALTH
• Individuals • Populations and
• Single interventions communities
• Outcomes only (generally) • Combinations of strategies
• Often limited consumer • Processes as well as
input outcomes
• Quantitative approaches to • Involve community
research and evaluation members in design and
evaluation
• Qualitative and quantitative
• Health promotion theories
and beliefs

Challenges – The Research Practice Gap CONCLUSION

Medicine is not an exact science, but a science of probability
The challenge to physicians is to provide up to-date medical care
The ultimate goal for clinicians should be to help patients live
long, functional, satisfying, and pain and symptom free life
By adopting the principles of Evidence Based Medicine, it will be
possible to maximize the benefits of scientific research for patient
care
Medical educators and medical colleges have the singular
responsibility of indoctrinating the principles of EBM as a
concept, a philosophy, a religion necessary for being efficient,
compassionate, caring, and responsible clinician among the
future physicians during their formative years of training

Challenges – The Research Policy Gap

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