Kaitlin Montagano, PharmD

Evidence-Based Pharmacotherapy

Evidence-Based Medicine (EBM)1-3

Evaluation
“Conscientious, explicit, and of
Evidence
judicious use of current best
Clinical Patient
evidence in making Expertise Factors
decisions about the care of
individual patients.”2
EBM
Challenges & Criticisms
of EBM1
❖ “Cookbook approach” ❖ Resource constraints
❖ Time limitations ❖ Improved clinical outcomes?

Top-Down EBM Bottom-Up EBM

•Guidance for groups of patients •Decisions for individual patients

•Not point-of-care •Point-of-care
•Time & resource intensive •Used when time & resource constraints exist
•Classic EBM framework •Abbreviated EBM framework
•Question --> Answer •Answers already exist --> apply to patient

EBM Framework1,3
•Develop a question regarding the clinical situation
Ask

•Gather evidence
Search

•Evaluate evidence
Appraise

•Use evidence to help make the clinical decision

Apply

•Evaluate the effectiveness of the process & note opportunities for future improvement
Assess

Developing a Question1
o Background: general questions about a therapeutic area that apply to group(s) of patients
▪ (Who, what, where, when, why, or how) + (a verb) + (a disease, symptom, test, or therapy)
• Why is metformin considered first-line treatment for T2DM?
Kaitlin Montagano, PharmD

o Which approach (top down or bottom up) would be more likely to be used to
answer this? Top down
o Foreground: questions that apply background information to guide decisions regarding individual
patients → PICO
▪ P: patient
▪ I: intervention
▪ C: comparative intervention
▪ O: outcome
• Lily Aldrin, a 28-year old kindergarten teacher, comes into your pharmacy and complains
that she ends up catching a cold every year from her students. Her friend, Robin, a news
reporter, told her about a story she recently reported on about zinc being used to
prevent colds. Lily isn’t sure what to do because her friend, Ted, told her that he always
takes echinacea in the winter and he never gets sick. She’s hoping you can tell her what
to take to prevent her from catching a cold this year.
o P: 28-year old female kindergarten teacher
o I: zinc
o C: echinacea
o O: common cold prevention
• How could this be abbreviated in a bottom-up approach? Exp: “is zinc effective at
preventing the common cold?” – just including intervention and outcome
• A full PICO search strategy should be used in the bottom-up approach when questions
are obscure or more specific results are desired

Gathering Evidence1,3
o Seek out the highest-ranking evidence that can answer your question
o Sources of evidence
▪ Cochrane Database of ▪ Database of Abstracts of
Systematic Reviews Reviews of Effects
▪ Cochrane Central Register of ▪ MEDLINE
Controlled Trials ▪ EMBASE

o Sources of evidence helpful for bottom-up approach

▪ Systematic reviews & meta-analyses
▪ Clinical Evidence (www.clinicalevidence.com) → high quality syntheses of evidence from
systematic reviews & RCTs pertaining to benefits and risks of interventions
▪ UpToDate (www.uptodate.com) → comprehensive disease state & treatment information
compiled by expert authors; strength of supporting evidence is variable
▪ Physician’s Information and Education Resource (DynaMed)
(http://pier.acponline.org/index.html) → evidence synthesis containing information on over 300
disease states; strength of evidence is identified
▪ Clinical Practice Guidelines
• National Guideline Clearinghouse (www.guidelines.gov)
o No longer funded – where do we go for guidelines now?
▪ Clinical trials
o Full-text primary literature is preferred; avoid relying on abstracts to support therapy recommendations
– Why? Can’t properly assess the quality of the study, so can’t fully trust the results presented
▪ No-cost sources of free full text articles
Kaitlin Montagano, PharmD

• BioMed Central (www.biomedcentral.com)

• Free Medical Journals (www.freemedicaljournals.com/#fmj)
• PubMed Central (www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Pmc)

Appraising the Evidence1

o Validity: degree to which the results of
the study are true
Systematic review

Randomized controlled trial

Nonrandomized, prospective clinical trial

Cohort

Case-control

Case series

Expert opinion

o Impact: magnitude of the study’s

effects
▪ Ensure positive effects are not
overestimated & negative
effects are not underestimated
o Applicability: usefulness of evidence for
answering the clinical question
▪ Degree of similarity between
the study population and
patient/population of interest

Apply the Evidence to the Clinical Decision1

Strength of Evidence Clinical Judgment

•Validity •Incorporate evidence + patient Recommendation
•Impact specific factors & preferences
•Applicability

References
1. Harvey E. Evidence-Based Pharmacotherapy. Pharmacotherapy Self-Assessment Program, 5th ed.
2. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996; 312:71-2.
3. Moores KG. Evidence-Based Clinical Practice Guidelines. In: Malone PM, Kier KL, Stanovich, eds. Drug Information: A Guide for Pharmacists. 3rd ed. The
McGraw-Hill Companies, Inc.; 2006: 289-338.