Evidence-based Medicine and Therapeutic Guidelines & Clinical Reasons

Definition

Evidence-based Medicine (EBM) is an approach to medical practice that uses the results
of patient care research and other available objective evidence as a component of clinical decision
making. Similarly, evidence-based pharmacotherapy, as defined by Etminan et. al, is an approach
to decision making whereby clinicians appraise scientific evidence and its strength to support their
therapeutic decisions.

The National Library of Medicine (NLM) introduced the term evidence-based medicine
(EBM) as a medical subject heading to PubMed in 1997. It is defined as: “An approach of practicing
medicine with the goal to improve and evaluate patient care. It requires the judicious integration of
best research evidence with the patient’s values to make decisions about medical care. This
method is to help physicians make proper diagnosis, devise best testing plan, choose best
treatment and methods of disease prevention, as well as develop guidelines for large groups of
patients with the same disease.”

EBM de-emphasizes (but not limited) intuition, unsystematic clinical experience and
physiologic reasoning as sufficient grounds for clinical decision-making and emphasizes the
systematic evaluation of evidence from clinical research.

Process

EBM is a process of life long, problem based learning. The process involves:

i. Converting medical information into competent, searchable, focused questions

ii. Efficiently tracking down the best evidence with which to answer the question.
iii. Critically appraising the evidence for validity and clinical usefulness.
iv. Applying the results in clinical practice
v. Evaluating the performance of the validity and clinical usefulness.

Is EBM a new concept?

Even though the group led by Gordon Guyatt in 1992 consolidated the concept of
Evidence-based Medicine, mention about the practice of evidential research-Kaozeng –can be
found in ancient Chinese medicine during the reign of Emperor Qianlong.

Factors facilitating the practice of EBM

1. The type of literature being made available to the medical fraternity has undergone substantive
qualitative change.

2. The unstructured review articles based on personal opinions of experts in the fields have been
replaced by peer-reviewed reports of research studies designed and executed with scientific rigor

3. Systematic reviews of multiple research studies and the publication of a number of evidence-
based journals provide validated information to the reader.

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Information dissemination systems have come a long way from the days of storing information in
large mainframe computers at few privileged academic of users all across the glove through the
World Wide Web.

How does one practice EBM?

A clinician who wants to practice EBM must be able to understand the patients’
circumstances or predicaments (including issues such as social supports and financial resources)
to identify knowledge gaps and frame questions to fill those gaps, to conduct an efficient literature
search, to critically appraise the research evidence and to apply that evidence to patient’s care.
This whole process has been divided into five simple steps, which if followed systematically can
bring out a very successful outcome and a desired benefit to the patient care.

The Five-Step Approach to Practicing EBM

Step 1- Framing a Proper, Pertinent, Focused, and Answerable Question

The first and foremost step in the practice of EBM is to convert the need for information
into a patient focused, pertinent, relevant and answerable question. This need for information may
be related to find out the cause (etiology) of a disease process, or to encounter the difficulty faced
in diagnosing a syndrome or to optimize the treatment of a disease or to answer a query put forth
by a patient’s or a patients relative to know the course (prognosis) of a clinical condition.

Clinical Scenario: A 12 years old only male child of a schoolteacher was admitted to RICU with a
history of accidental ingestion of O. P compound 4 hours back. On admission the patient was
comatose but hemodynamically stable. The anesthesiologist used his past experience, knowledge,
skill & expertise and treated the patient with an infusion of atropine, but inspite of that patient
developed respiratory paralysis in the next 2 hours. Again the clinician used his expertise,
anticipated the respiratory paralysis & puts him on mechanical ventilation. Now, the consultant
understands the gap in his knowledge & he identifies the same. The consultant wanted to
administer Inj Pralidoxime. But he was not sure of the dosage and the mode of administration (a
single bolus dose or an infusion)

PICO Model- 4 Criteria

‘P’ –Patient Problem
‘I’ –Intervention strategy
‘C’ –Comparison
‘O’ –Outcome

Additional criteria to be considered while framing the question: In addition to the four PICO criteria,
there are two additional considerations in formulating the question.

Type of Question: How would I categories this question? Is it related to etiology, diagnosis, therapy
or prognosis? In this example the question is about the therapy of OP poisoning

Type of Study: The other consideration is the type of study that will answer a therapy question.
Various study designs provide specific answers. The accompanying table provides the guideline
for choosing the type of study design for each category of questions.

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Step 2 - Searching the Literature

The second step in the process is to locate the ‘best’ evidence to answer the question. The clinician
has two basic choices for finding the evidence. The clinician has two basic choices for finding the
evidence through;

a. ‘traditional’ print resources like textbooks or journals

Manually searching through voluminous literature is an unenviable task requiring immense

periods of time, a commodity that is in limited supply given the potentially life threatening situation
that the patient is in.

b. ‘browse’ online electronic databases

Number of online information resources that the clinician may tap to find the evidence.
These include: textbooks, journals, patient profiles, practice guidelines issued by specialty boards,
EBM reviews, and databases of indexed publications. ‘Medline’ published by the National Library
of Medicine USA is the most popular and most exhaustive database. ‘Pubmed’ service hosted by
the same agency has several additional features and is probably the most versatile search engine
for exploring Medline. This search offers a number of ‘browsers (Clinical Queries, MesH etc) for
searching the information.

Step 3 - Critical Appraisal of the Literature

To know whether this is the best available evidence or not is the next step. It is essential that
clinicians must master the skills of critical appraisal of the literature, if they are to apply evidence-
based medicine to the daily clinical problems they encounter.

3 Stages of Clinical Appraisal of the literature

a) Screening for initial validity and relevance

b) Determining the intent of the article
c) Evaluating the validity based on its intent

Validity of the literature pertains to determining the closeness to the ‘Truth’. Different kinds of errors
can creep in during the conduct of a study. There are many ways/methods of eliminating these

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errors in the study like: Blinding, Randomization, using placebo-controlled groups, minimizing loss
to follow-up of patients, and treating the data by appropriate statistical analysis.

Step 4 –Integrating the Evidence with Clinical Expertise and Patient Values

EBM, by definition, is the optimal integration of best research evidence with clinical expertise, and
patient’s biology and values. The best documented critically appraised research evidence is already
with the clinician. The physician has already exercised his expertise arising from prior knowledge
and past experience in treating his patient by starting an infusion of Atropine, and putting the patient
on mechanical ventilation. He now has to take into consideration the patient values.

For example: The patient is a precious, lone male child of the parents. The economical/financial
status of the parents does not permit expensive therapies. He also has to consider the patient’s
biology. Fortunately, though there are no contraindications for the drug to be administrated. He has
found the evidence that low dose regime requiring 1/16 of the high dose has better effect.

Step 5 – Evaluating the Process

Once the therapy is administered the clinician needs to evaluate the previous four steps. The final
step is to reassess the strategy and take it onwards from there. The clinician should document the
outcomes of the application of the evidence and based on his experiences and those of his
colleagues should be able to develop management protocols. Beyond this he must also collaborate
with professional bodies in developing practice guidelines. This last step completes the feedback
loop of EBM.

Advantages of Using an EBM Approach

 Guides prescribing decisions to get predictable improvements in patient outcomes.

 Helps sort through the marketing, opinions, and theory to get an accurate assessment of
the benefits and risks of various treatments.
 Can help identify and target opportunities to improve drug therapy
 Assists with decisions about use of limited resources
 Provides incentive to conduct useful research

Limitations of EBM

 Studies may not answer the question you are trying to answer
-Evidence may be lacking or of low quality
-Surrogate endpoints
 The body of evidence continues to change
 It can take a lot of resources to conduct clinical trials or create original high quality evidence
reviews
 It does not make clinical decisions or value judgements about cost versus benefit
-But it can assist you in doing so

Alternatives to EBM

Since EBM asks us to incorporate valid scientific literature in to our practice without
significant data and tells us that such approach improves patient outcomes and the practice of
EBM consumes time and may detract from other educational initiatives, it is wise to reflect some
alternatives to the practice of EBM. A recent review by Isaacs D, (1999) of alternatives to EBM
demonstrates the pitfalls of the practice of EBM without incorporation of valid scientific evidence.
In the absence of scientific literature to guide clinical decision-making personality characteristics
such as seniority (eminence based medicine) drive clinical decision-making. Indeed, traditional

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medicine uses the lack of scientific evidence of efficacy as a defense against alternative forms of
medicine.

Conclusion

The needed skills for practicing EBM may appear daunting, but once acquired, they can help
healthcare professionals to better use available resources and time by knowing how to focus a
search and be more critical in what reading and information to integrate into their knowledge base.
Several sites have demonstrated that EBM can be incorporated into practice successfully.
Furthermore, an evidence-based pharmaceutical care plan facilitates dialogue with patients about
the rationale for management decisions. Finally, using EBM principles enables practicing
healthcare professionals to update their knowledge continuously. 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. To do so requires us to balance compassion
with competence. 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, and a religion necessary for being efficient, compassionate, caring, and responsible
clinician among the future physicians during their formative years of training.

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