What is

evidence-based medicine?
By
Dr Saba
 ‫‪Definition‬‬
‫ک ازنگری‪ ،‬ن قد ‪ ،‬و‬‫• ‪ Evidence-based medicine‬عبارتاز پ روسه س یستماتی ب‬
‫استفاده از ریسرچ هایک لینیکیب ه منظور ارایه خدماتص حی مناسبب ه مریضان‬
‫میباشد‪.‬‬
‫• ارگان های ارایه دهنده خدمات صحی بصورت روز افزون برای تنظیم منابع خود‬
‫از شواهد علمی(‪ )evidence‬و قوت این شواهد (‪ ) strength‬که از نتیجه ریسرچ‬
‫های کلینیکی بدست میاید با در نظر داشت ‪ cost effectiveness‬شان استفاده‬
‫مینمایند‪.‬‬
‫• این ارگان ها متخصصین مراقبت های صحی مختلف و سیستم صحی ملی‬
‫(‪ ) national health system‬را تشویق میکنند تا به تداوی های اعتماد کنند و‬
‫آنرا در حیات کلینیکی روز مره خود استفاده کنند که موثریت شان هم از نظر‬
‫تحقیقات کلینیکی و هم از نظر ‪ cost effective‬ثابت شده باشد و از سرمایه گذاری‬
‫باالی تداوی هاییکه این معیارات را نداشته باشند اجتناب کنند‪.‬‬
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:‫ قرار ذیل است‬EBM ‫اهداف‬
 Production of evidence through research and scientific
review.
 Production and dissemination of evidence-based
clinical guidelines .
 Implementation of evidence-based, cost-effective
practice through education and management of change
.
 Evaluation of compliance with agreed practice guidance
through clinical audit and outcomes-focused incentives.
 The history of EBM
• EBM first established in the 1940s
• In 1972 that Professor Archie Cochrane, director of the Medical Research Council
Epidemiology Research Unit in Cardiff, expressed what later came to be known
as evidence-based medicine (EBM) in his book Effectiveness and Efficiency:
Random Reflections on Health Services.
• These concepts were developed into a practical methodology by groups working
at Duke University in North Carolina (David Eddy) and McMaster University in
Toronto (Gordon Guyatt and David Sackett) in the late 1980s and early 1990s.
• In 1992, the UK government funded the establishment of the Cochrane Centre in
Oxford under Iain Chalmers, with the objective to facilitate the preparation of
systematic reviews of randomised controlled trials of healthcare.
• The following year it expanded into an international collaboration of centres, of
which there are now thirteen, whose role is to co-ordinate the activities of
11,500 researchers.
• The establishment of the Cochrane Collaboration should be considered as one
of the critical factors in spreading the concept of EBM worldwide.
 The impact of EBM
• The basic principle of EBM – that we should treat where there is
evidence of benefit and not treat where there is evidence of no
benefit (or harm) – is of relevance at all levels of the NHS.
• Strategically : The NHS should use the principles of EBM coupled
with health economic analysis directly commissioned the health
technology assessment that inform the guidance as to which
treatment should be available within NHS.
• Tactically :Primary care organizations and hospital trusts formulate
and implement formularies, care pathways and guidelines based on
HTAs and other assessments issued by EBM-focused organizations.
• Individually: An understanding of the evidence base allows the
clinician to tailor treatment to the circumstances and risk–benefit
profile of the individual patient.
 The logic behind EBM
• To make EBM more acceptable to clinicians and to encourage
its use, it is best to turn a specified problem into answerable
questions by examining:
 The person or population in question
 The intervention given
 The comparison (if appropriate)
 The outcomes considered.
Next, it is necessary to refine the problem into explicit questions
and then check to see whether the evidence exists.
But where can we find the information to help us make better
decisions?
 Common sources include:
 Personal experience – for example, a bad drug reaction
 Reasoning and intuition
 Colleagues
 Published evidence.
• It is only by educating healthcare professionals and
making them aware of the strength of published
evidence in contrast to more traditional – and less
rigorous – sources of information, that the use of
ineffective, costly or potentially hazardous interventions
can be reduced.
 Accessing information
• There are many sources of information to inform clinical
practice.
• The following website – Netting the Evidence –
• www.shef.ac.uk/scharr/ir/netting Probably the most valuable
single access point is The Cochrane Library.
• This is accessible free of charge from any UK-based computer
at : www.thecochranelibrary.com
• The Cochrane Library contains high-quality, independent
evidence to inform healthcare decision-making.
• It includes the databases , all of which can be searched
simultaneously from a single user interface.
 Analyzing information
• In using the evidence it is necessary to:
 Search for and locate it
 Appraise it
 Interpret it in context
 Implement it
 Store and retrieve it
 Ensure it is updated
 Communicate it.
 Levels of evidence
• Evidence is presented in many forms, and it is
important to understand the basis on which it is
stated.
• The value of evidence can be ranked according to its
potential for bias.
• Although classification of this type provides a useful
focus when reading clinical trial data, it is important
to recognize that accurate grading requires a clear
understanding of what predisposes a study to bias.
 SIGN classification for grading evidence
• 1++ High-quality meta-analyses, systematic reviews of RCTs, or RCTs with
very low risk of bias
• 1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a lo
risk of bias
• 1– Meta-analyses, systematic reviews, or RCTs with a high risk of bias
• 2++ High-quality systematic reviews of case-control or cohort studies High-
quality case-control or cohort studies with a very low risk of confounding
or bias and a high probability that the relationship is causal
• 2+ Well-conducted case-control or cohort studies with a low risk of
confounding or bias and a moderate probability that the relationship is
causal
• 2– Case-control or cohort studies with a high risk of confounding or bias
and a significant risk that the relationship is not causal
• 3 Non-analytic studies; for example, case reports, case series
• 4 Expert opinion
 Critical appraisal
• For any clinician, the real key to assessing the usefulness of
a clinical study and interpreting the results to an area of
work is through the process of critical appraisal.
• This is a method of assessing and interpreting the
evidence by systematically considering its validity, results
and relevance to the area of work considered.
• The Cochrane Collaboration, which coordinates an
international network of researchers involved in systematic
review, has evolved a generic approach to appraising a
clinical trial, allowing the reader to make an objective
assessment of study quality and potential for bias.
 Systematic review and
meta-analysis
• Sometimes an RCT may fail to give a clear result, or results from multiple
studies may yield different estimates of treatment effect.
• However, by identifying all published information in a given clinical area
(systematic review) and pooling the results in a statistically valid fashion
(metaanalysis) it is possible to arrive at a more precise estimate of
treatment effect.
• This approach is very attractive, as it allows all evidence in the field of
interest to be taken into account.
• However, the danger exists that a poorly executed systematic review and
metaanalysis may give deceptive results.
• It is therefore important to critically appraise the paper in just the same
way as one would an RCT.
• The following are critical issues to be aware of.
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There should be a focused clinical question agreed prior to
examination of the literature.
Search strategies should include multiple sources, to reduce
the risk of publication bias, and should not be subject to
artificial limitations (for example, English language only).
 Each individual study needs to be quality appraised, to limit
the chance of biased results being entered into the analysis.
If patient populations, interventions, comparisons or
outcomes vary significantly, it may be inappropriate to pool
study results.
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 Equally, even if studies appear similar, if there
is significant heterogeneity in the results, this
may also raise the question of whether it is
reasonable to carry out a statistic aggregation.

Finally, the results need to be presented in a

meaningful fashion that enables clinical
decisions to be taken
 Practical examples of EBM
• EBM is not a purely academic or financial exercise, however –
its implementation has major clinical implications.
• 1. Single studies: Management of fever in children (evidence
level 1+) Fever is common in the under-fives and, although
usually benign, may occasionally cause convulsions.
• This risk, combined with the desire to alleviate symptoms in
infants, has led to widespread use of paracetamol or ibuprofen
as antipyretics.
• Current NICE guidelines state that either approach is effective.
• However, many parents will also use a combination of both
agents, in the belief that this will enhance speed of resolution.
Is this belief based in reality?
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• A UK primary care-based study randomised 156
children aged between six months and six years to
receive either paracetamol alone, ibuprofen alone or a
combination, as treatment for pyrexia (37.8–41.0 °C)
in the presence of otitis media managed at home.
• Treatment was given for the first 24 hours to all
patients and for the subsequent 24 hours if symptoms
demanded.
• Randomization was by automated system and blinding
was maintained using a double-dummy approach.
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• The primary outcome was a comparison of the mean time
without fever in the first four hours.
• Children taking paracetamol alone had significantly less
time free of fever than those on combination therapy (116.2
versus 171.1 minutes; p<0.001).
• There was no significant difference between those taking
ibuprofen alone and those on combination therapy (156.0
versus 171.1 minutes; p=0.2).
• Secondary outcomes included 24- and 48- hour
assessments, as well as mean temperature, time to first
temperature relief and a range of patient-related outcomes.
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• These all showed the same qualitative trend, with
combination therapy being significantly better than
paracetamol alone, but generally showing non-significant
benefits versus ibuprofen alone.
• Ibuprofen alone was also significantly better than
paracetamol alone for both the primary outcome and
most secondary outcomes.
• This study gives practical information for primary care –
suggesting that combination therapy offers advantages
over paracetamol alone, although probably not over
ibuprofen.