CPP 463

EVIDENCE BASED MEDICINE

WHAT IS EVIDENCE-BASED MEDICINE?

The term EBM first appeared in the published literature in 1991; 5 years later,
the most-cited EBM landmark article described EBM as the conscientious,
explicit and judicious use of the current best evidence in making decisions
about the care of individual patients. Another characterisation, appearing a few
years later, described EBM as a systematic approach to clinical problem-
solving that allows integration of the best available research evidence with
clinical expertise and patient values. A final characterisation highlights three
key principles underlying optimal clinical practice: systematic summaries of
the best evidence, a schema for deciding what constitutes the best evidence
and the prominent consideration of individual patient values and preferences.

Anaesthesia and evidence-based medicine (EBM) are considered as two of the

15 most important medical milestones. The birth of anaesthesia on
16th October 1846 and the subsequent publication of this discovery as a case
study 33 days later in the high-impact Boston Medical and Surgical Journal (the
current New England Journal of Medicine) resulted in its widespread use that
dramatically changed surgical practice. Likewise, EBM, born at McMaster
University in the early 90s, has had a considerable impact on the modern day
health-care practice.

Evidence-based medicine
1. Evidence-based medicine (EBM) is the scientific method used to
organize and apply current data to improve
healthcare decisions.

2. Evidence-based medicine (EBM) may be defined as the health

decision-making process that relies on the conscious and
judicious use of the best available scientific data, information
(evidence) .
3. The best approach to EBM is the systematic approach to
medicine in which physicians, pharmacists and other health care
professionals use the best available scientific data, information/

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 evidence from clinical observations and research to make
decisions n the care process of individual patients.
4. Evidence-based medicine is a perpetual wheel of improvement.
It is not a one-time linear process.

Figure 1. Components of EBM

5. Evidence-based medicine systems are intended to objectively evaluate

the quality of clinical research by critically assessing techniques
reported by researchers in their publications and other presentations.
These are trial design considerations that emphasises high-quality
studies which have clearly defined eligibility criteria and have minimal
missing data.

6. EBM is only as good as the quality of its three components

namely expertise, research, and patient values. EBM can
therefore be summarized to mean ” The process of systematically
finding, appraising, and using contemporaneous research findings as the
basis for clinical decisions”
Evidence-Based Practice Tutorial: Steps in the Evidence-Based
Practice Process
 Asking Clinical Questions.
 Acquiring the Evidence.
 Appraising the Evidence.
 Applying the Results.
 Assessing the Outcome.

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 4 pillars of evidence-based practice
Evidence-based practice: is based on critical clinical reasoning to
integrate information from the following four sources which are clinical
expertise, research evidence, the patient's values and
circumstances, and the practice context. Thus, the best available
science is combined with the healthcare professional's clinical
experience, expertise and the patient's values to arrive at the best
medical decision for the patient

Occupational Therapy Australia

https://otaus.com.au › publicassets › ebppositionstatement
Clinical case study:
Clinical Scenario:
The patient is a 65 year old male with a long history of type 2 diabetes and
obesity. Otherwise his medical history is unremarkable. He does not smoke. He
had knee surgery 10 years ago, but has had no other major medical problems.
Over the years he has tried numerous diets and exercise programs to reduce
his weight, but has not been very successful. His granddaughter just started
high school, and he wants to see her graduate and go on to college. He
understands that his diabetes puts him at risk for heart disease and is
frustrated that he cannot lose the necessary weight. His neighbor told him
about a colleague at work who had his stomach stapled and as a result not
only lost over 100 lbs., but also "cured" his diabetes. He wants to know if this
procedure really works.
https://guides.hshsl.umaryland.edu/c.php?g=109874&p=743637

Evidence-based medicine and practice

For example, a doctor could be prescribing antibiotics due to pressure

from patients, even thought they might not be clinically necessary.
Using evidence is generally the best way to make decisions about
healthcare and health policy, but there are limitations.

https://www.ncbi.nlm.nih.gov/books/NBK470182/

Evidence-Based Medicine
Steven Tenny; Matthew Varacallo Last Update: September 10, 2024.

Definition/Introduction
Evidence-based medicine (EBM) is the scientific method used to organize and
apply current data to improve healthcare decisions. The best
available scientific evidence in procedures, treatment, cost
implication and risk/safety are combined with the healthcare
professional's expertise (knowledge), clinical experience and the
patient's values to arrive at the best treatment option/ decision for
the patient.
There are 5 main steps for applying EBM.

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  Defining a clinically relevant question
 Searching for the best evidence
 Critically appraising the evidence
 Applying the evidence
 Evaluating the performance of EBM
 Table 1: showing the 5 steps of EBM


Evidence-Based Medicine in Pharmacy Practice

It is very important that Pharmacists should be well versed in

EBM, so they are able to effectively give appropriate response/s
and answers to clinical questions with accuracy. EBM
also allows the pharmacist to better scrutinize physician orders
so as to identify a more suitable medication or a less expensive
alternative that will give optimal outcomes and ensure patients
safety.

USERS OF EBM
Evidence-Based Practice takes a more multidisciplinary approach, it
includes nurses, clinicians, nurse practitioners, physician's assistants,
physical & occupational therapists, etc., and includes many facets of
health such as etiology, prevention, diagnosis, treatment and more

STEPS IN EBM begins with

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 a. Defining or obtaining the clinical question/s:
An issue that the healthcare provider wishes or intends to addresses with or in
the patient
b. Search for information
Seek formulated, relevant scientific evidence that is related to the
clinical question. Scientific evidence includes study outcomes
and opinions
c. Appraisal
Note that, not all data have the same level of strength and
acceptance. Therefore, in evidence-based medicine, the levels of
evidence or data are scored in accordance with their relative
strength/s of acceptability and usability. Stronger evidence should
be given more weight when making clinical decisions. For example,
recommendations from an expert are not as robust as the results
of a well-conducted study. This is less than those of a set of well-
conducted studies.

The evidence is commonly stratified into 6 different levels:

1. Level IA META ANALYSIS; evidence is obtained from a meta-analysis of
multiple well-conducted and well-designed randomized trials.
Randomized trials provide some of the strongest clinical evidence, and if
these are repeated and the results are combined in a meta-analysis,
then the overall results are assumed to be even stronger.
2. Level IB evidence is obtained from a single well-conducted and well-
designed randomized controlled trial. When well-designed and well-

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 conducted, the randomized controlled study is a gold standard for clinical
medicine.
3. Level IIA evidence is from at least one well-designed, executed, non-
randomized controlled study. When randomization does not occur, there
may be more bias introduced into the study.
4. Level IIB evidence is from at least one well-designed case-control
or cohort study. A randomized controlled study cannot effectively or
ethically study all clinical questions.
5. Level III evidence is from at least one non-experimental study. Typically,
it would include case series, not well-designed case-control or cohort
studies.
6. Level IV includes expert opinions from respected authorities on the
subject based on their clinical experience.

 All clinical studies or scientific evidence can be classified into any one of
the above categories.
 Clinical studies have specific inclusion and exclusion criteria and the
specific population studied.
 Patients that are being treated by the health care professional may have
some substantial differences from the population in the study.
 The health care professionals use their clinical judgment to determine
how the variations between the patient and the study population are
important or not and how they affect applying the study results to the
specific patient to achieve best outcome.
 Health care professionals must then use their professional knowledge,
and clinical experience to adapt evidence as it applies to the specific
patient.
 Application of evidence
Finally, health care professionals especially clinicians using evidence-
based medicine must put all of the information in the context of the
patient's values or preferences.
 The patient's values or preferences may conflict with some of the
possible options. Even strong evidence supporting a specific treatment
may not be compatible with the patient's preferences, and thus, the
clinician may and should not recommend the treatment to the patient.
 Also, the treatment might not apply to the specific patient. As
an example, a patient may have a particular form of cancer. Level IA
evidence may suggest life expectancy can double from 8 to 16 months
with chemotherapy. Chemotherapy has significant side effects. The
patient may find those side effects not acceptable and elect not to
pursue chemotherapy secondary to the specific patient's preferences
and values.
 The outcome must be evaluated once the clinical question is formulated,
relevant scientific information is evaluated, and clinical judgment is used
to apply the relevant scientific evidence to the specific patient and their
values.
 Re- appraisal; The final step is a re-evaluation of the patient and
clinical outcome after the application of the applied information. Did the
intervention help? Were the outcomes as expected? What new
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 information is obtained? How can this information be applied to future
situations and patients? Evidenced-based medicine starts with the
clinical question and returns to the clinical question at the end to see
how the process works.
 Without continuous re-evaluation, the medical provider will be unsure if
their impact is positive or negative. Evidence-based medicine is a
perpetual wheel of improvement rather than a one-time linear process.

Finally, clinicians using evidence-based medicine must put all of the

information in the context of the patient's values or preferences. The patient's
values or preferences may conflict with some of the possible options. Even
strong evidence supporting a specific treatment may not be compatible with
the patient's preferences, and thus, the clinician may not recommend the
treatment to the patient. Also, the treatment might not apply to the specific
patient.
The outcome must be evaluated once the clinical question is formulated,
relevant scientific information is evaluated, and clinical judgment is used to
apply the relevant scientific evidence to the specific patient and their values.
The final step is a re-evaluation of the patient and clinical outcome after the
application of the applied information. Did the intervention help? Were the
outcomes as expected? What new information is obtained? How can this
information be applied to future situations and patients? Evidenced-based
medicine starts with the clinical question and returns to the clinical question at
the end to see how the process works. Without continuous re-evaluation, the
medical provider will be unsure if their impact is positive or negative.
Evidence-based medicine is a perpetual wheel of improvement. It is
not a one-time linear process.

EXAMPLES
I. “For example, a specific patient may be a 70-year-old female with a
history of hyperlipidemia and a new diagnosis of hypertension, looking
at hypertension treatment options. The clinician may find a good
randomized controlled trial looking at medications to control
hypertension, but the study's inclusion criteria were a population of
18 to 65-year-olds. Should the clinician ignore the results as the
specific patient does not meet the study demographics? Should the
clinician ignore the age difference between the specific patient and
the study population? This is where the clinical judgment helps bridge
the gap between the relevant scientific evidence and the specific
patient being treated”.
II. As an example, a patient may have a particular form of cancer. Level
IA evidence may suggest life expectancy can double from 8 to 16
months with chemotherapy. Chemotherapy has significant side
effects. The patient may find those side effects not acceptable and
elect not to pursue chemotherapy secondary to the specific patient's
preferences and values.

CHALLENGES

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  Evidence-based medicine brings together 3 different entities:
 The patient's condition and preferences
 The best available, relevant, scientific information to provide improved
medical care.
 The healthcare professional's knowledge and clinical judgment

Criticisms of EBM
1. Publication Bias
Evidence-based medicine is based on published results. Classes I and II are
given prominence.
Many studies have shown that positive results are more likely to be published
than negative results. This leads to skewing towards only the positive while
hiding the negatives.
Additionally, studies funded by companies are more likely to get published to
promote the use of the studied medication or device, which often leads to
skewing of the available evidence. Authors are usually required to declare
interests that are involved in the study.
2. Randomized, Controlled Trial Bias
Though the best and most acceptable, some situations may not be
amenable to RCT. Such conditions include very rare cases with very
low prevalence (progeria; 1 in 4 to 8m), too risky to carryout
situations like common sense assumptions (parachutes) and having
too many questions with little resources

3. Lag Time
Significant changes in the medical landscape can occur between the trial's
design and initiation and the results' publication.
4. Values
Clinicians can easliy be swept away in trying to implement the "best evidence"
or "best practices" before understanding how these either fit or contradict the
patient's values.

Some References
1.
Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS.
Evidence based medicine: what it is and what it isn't. 1996. Clin Orthop
Relat Res. 2007 Feb;455:3-5. [PubMed]
2.
Sackett DL, Straus SE. Finding and applying evidence during clinical
rounds: the "evidence cart". JAMA. 1998 Oct 21;280(15):1336-
8. [PubMed]
3.

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 Sackett DL. Evidence-based medicine. Spine (Phila Pa 1976). 1998 May
15;23(10):1085-6. [PubMed]
4.
Steves R, Hootman JM. Evidence-Based Medicine: What Is It and How
Does It Apply to Athletic Training? J Athl Train. 2004 Mar;39(1):83-
87. [PMC free article] [PubMed]
5.
Fernandez A, Sturmberg J, Lukersmith S, Madden R, Torkfar G, Colagiuri
R, Salvador-Carulla L. Evidence-based medicine: is it a bridge too
far? Health Res Policy Syst. 2015 Nov 06;13:66. [PMC free article]
[PubMed]
6.
Horwitz RI, Charlson ME, Singer BH. Medicine based evidence and
personalized care of patients. Eur J Clin Invest. 2018
Jul;48(7):e12945. [PubMed]
7.
Wivel AE, Lapane K, Kleoudis C, Singer BH, Horwitz RI. Medicine Based
Evidence for Individualized Decision Making: Case Study of Systemic
Lupus Erythematosus. Am J Med. 2017 Nov;130(11):1290-
1297.e6. [PubMed]
8.
Jefferson T, Doshi P, Boutron I, Golder S, Heneghan C, Hodkinson A, Jones
M, Lefebvre C, Stewart LA. When to include clinical study reports and
regulatory documents in systematic reviews. BMJ Evid Based Med. 2018
Dec;23(6):210-217. [PubMed]
9.
Horwitz RI, Singer BH. Why evidence-based medicine failed in patient
care and medicine-based evidence will succeed. J Clin Epidemiol. 2017
Apr;84:14-17. [PubMed]
10.
Thakur H, Cohen JR. Depression screening in youth: Multi-informant
algorithms for the child welfare setting. Psychol Assess. 2019
Aug;31(8):1028-1039. [PubMed]
11.
García-Carrasco M, Mendoza-Pinto C, Rojas-Villarraga A, Molano-González
N, Vallejo-Ruiz V, Munguía-Realpozo P, Colombo AL, Cervera R.
Prevalence of cervical HPV infection in women with systemic lupus
erythematosus: A systematic review and meta-analysis. Autoimmun
Rev. 2019 Feb;18(2):184-191. [PubMed]
12.
Koretz RL. Assessing the Evidence in Evidence-Based Medicine. Nutr Clin
Pract. 2019 Feb;34(1):60-72. [PubMed]
Disclosure: Steven Tenny declares no relevant financial relationships
with ineligible companies.

Disclosure: Matthew Varacallo declares no relevant financial

relationships with ineligible companies.
Copyright © 2024, StatPearls Publishing LLC.

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This book is distributed under the terms of the Creative Commons Attribution-
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Bookshelf ID: NBK470182PMID: 29262040

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