Drug lit midterm (exam 1) - EBM Flashcards
What is Evidence-Based Medicine?
Evidence-based medicine (EBM) is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.
good but eliminates our knowledge tho…
What is EBM?
EBM is the integration of best research evidencewith clinical expertiseand patient values.
so this includes our knowledge and what patients care about
Why EBM?
Relying on primary knowledge
- Overestimate efficacy
- Underestimate risks
can lead to:
Variation in clinical services
- Inappropriate care
- Lack of care
- Increased costs
Which of the following best describes evidence-based medicine?
Medical practices are solely based on personal experience and intuition.
The integration of clinical expertise, patient values, and the best available research evidence in decision-making.
Relying exclusively on traditional or alternative medicine without considering scientific studies.
A rigid adherence to standardized treatment protocols regardless of individual patient needs.
Making medical decisions solely based on the latest trends and popular opinions in the healthcare community.
The integration of clinical expertise, patient values, and the best available research evidence in decision-making.
Sources of Knowledge in Medicine
Reference to tradition - what we have always done
Reference to authority- follow the expert
Trial and error- try until something works
Logical reasoning- coming up with idea based on reason
Scientific method- hypothesis experiment more reputable way to get answers
The Problem…
Practice continues to rely on sources of knowledge other than scientific method
why? we are afraid of doing something new based on evidence
Gap between new researchfindings and incorporationinto practice
Publication to Implementation
this is a forest plot
study of aspirin (which was meant to decrease mortality)
shows lots of evidence in 1 table
randomized control trials in 1 publication - meta analysis
shows how evidence has progressed over time
when apsirin became routine practice but was proven unsafe and then changed 10 years later
Cochrane Library Logo
meta-analysis
studies where smaller studies are combined to see true impact of study
figure slide 11
Rx was still prescribed even tho it was harmful which goes to show that the doctors we not up to date on the literature
Evidence Based Practice
Making a conscientious effort to base clinical decisions on research that is most likely to be free from bias, and using interventions most likely to improve how long or well patients live.
EBM Process
PPCP
EBM Process: (cycle)
assess
ask
acquire
appraise
apply
PPCP: (cycle)
collect
assess
plan
supplement
follow up: monitor and evaluate
Patient Scenario
JL is a 70-year-old woman with type 2 diabetes mellitus (DM) presenting for a prescription refillfor hydrochlorothiazide (HCTZ).
JL tells you that her doctor suggested switching her blood pressure medication from HCTZ to lisinopril to better protect her kidneys from damage related to type 2 DM since she had an abnormal urine test.
JL is reluctant to make this change because her friend had a “bad reaction” to lisinopril.
She would like to know what you think about her doctor’s suggestion.
Assess
Assess patient and/or problem to determine pertinent issues
Background Questions
Covers the more basic scientific concepts
Does not refer to a particular patient situation
Can be answered using tertiary resources
Foreground Question
Covers how these concepts are applied to an individual patient’s circumstance
Must have adequate background knowledge to ask and answer these questions
Think – Pair – Share
How would you assess this situation?
What background questions wouldyou ask about the disease stateor medications in question?
mechanism of action
side effects
storage
stability
contraindication
how does DM2 damage kidneys
lisinopril is an ACE inhibitor
how long for DM2 to cause kidney damage
Developing a Clinical Question
Four parts to the question (PICO)
The __________ or problem being addressed
The __________ or exposure being considered
The __________ intervention or exposure when relevant
The clinical _________________ of interest
The _patient_________ or problem (disease most often) being addressed
The _intervention_________ or exposure being considered
The _comparison _________ intervention or exposure when relevant
The clinical __outcome_______________ of interest
Think – Pair – Share
What is the PICO question for this scenario?
P:
I:
C:
O:
Question:
P: elderly woman with DM2 + HTN
I: lisinopril
C: HCTZ
O: protect kidneys or prevent diabetic nephropathy
Question: is lisinopril better at protecting that kidney than HCTZ in elderly ppl with DM2
Classification of Questions
Therapy or prevention
Etiology or harm
Prognosis
Diagnosis
Economic impact
Hierarchy of evidence
Evidence-Based Guidelines
background info, expert opinion
case report/case series
case control study
cohort study
non-randomzed controlled trials
randomized controlled trials
systematic reviews & meta-analysis
In which order is it recommended that you search resources?
Primary, secondary, then tertiary
Secondary, primary, then tertiary
Tertiary, primary, then secondary
Primary, tertiary, then secondary
Secondary, tertiary, then primary
Tertiary, secondary, then primary
Tertiary, secondary, then primary
Types of Biomedical References
Primary
Original Research:
Meta-Analysis
clinical trials
Observational Studies
Case Reports/Series
Secondary
Indexing/Abstracting Resources:
PubMed
ovid medline
Scopus
Tertiary
Filtered/Summarized:
Lexicomp
DynaMed
Review Articles
Think – Pair – Share
What source(s) can you use to answer your background questions?
lexicomp or dynamed then pubmed then meta-analysis
Acquire
DynaMed
diabetic kidney disease
- ADA recommendations for the management of diabetic kidney disease
– preventative angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)
— for nonpregnant patients with diabetes and hypertension
either an ACE inhibitor or an ARB is recommended for those with modestly elevated urinary albumin-to-creatinine ratio (30-299 mg/g creatinine)
either an ACE inhibitor or an ARB is strongly recommended for those with a urinary albumin-to-creatinine ratio (> 300 mg/g creatinine and/or estimated GFR < 60 mL/minute/1.73 m^2
ACE inhibitors or ARBs are not recommended for the primary prevention of chronic kidney disease in patients with diabetes who have
- normal blood pressure
- normal urinary albumin-to-creatinine ratio
- normal estimated GFR
Identifying search terms from a PICO question
Each component (P – I – C – O) can serve as a search term
Generally start with P (diseasestate) and I
Add C if specific to case at hand
Add O if needed to narrow search
Identify the search terms from the PICO question Below
Is lisinopril better at protecting the kidneys than HCTZ in elderly people with DM2
What term(s) will we start with? - DM2, Lisinopril, HCTZ
What term(s) can help narrow the search? - protecting the kidneys
What term(s) can help us include or eliminate articles? - protecting kidneys, elderly
pub med chart
Appraise
valid
applicable
can we apply it to the patient
Evaluating validity
The “So What?” test
What outcomes were evaluated?
What was the magnitude of the benefit?
The number needed to treat (NNT) / Number needed to harm (NNH)
Relative risk reduction vs. absolute risk reduction
How will this change my practice?
Applicability (generalizability)
Are the study participants similar to your patients?
- Demographics
- Level of risk
What is the patient’s perspective and preference?
- Values
- Cultural norms
- Costs
Types of Evidence
Disease-Oriented Evidence (DOE) - does the drug reduce BP or cholesterol, did the drug change a marker for disease
Patient-Oriented Evidence (POE) - what patients care about
Patient-Oriented Evidence that Matters (POEMs)
Evaluates the effectiveness of interventions that clinicians and patients care about
DOE - Statins down cholesterol
Statins down CV mortality/morbidity
POEM - statins down overal mortality
Disease Oriented Evidence (DOE) vs. Patient Oriented Evidence (POE)
DOE
Vitamin E is a powerful antioxidant
HRT (down) LDL and (up) HDL
Erythropoietin increases Hgb in patients with cancer
POE
Vitamin E _does not prevent____________ CV disease or cancer
HRT _raises risk of______ stroke and breast cancer
Erythropoietin __increases mortality___________ in cancer patients
How do you determine if a study is POEM?
1- Does the primary outcome of the study address an outcome patients care about?
2- Is the intervention feasible?
3- Will the information require you to change practice?
If yes to all 3 = POEM
abstract A vs abstract B
A - talks about how the epithelial cells work which patients do not care about
B - patients care about not having stroke
Which abstract best represents Patient oriented evidence that matters?
Abstract A
Abstract B
Neither
Unsure
B is better because it focuses on what the patient cares about
appraise
can it be applied to the patient?
How do we respond to JL?
the doctor is right, I don’t know your values but if they are abnormal then lisinopril will help you
Influence of PhRMA
Levels of interactions
- Clinicians
- Researchers
- Professional organizations
- Journals
- Continuing education (CE)
- Direct-to-consumer advertising
How bad is PhRMA’s influence?
JNC V (1993) recommendations vs. actual practice
Survey of 35,000 retail pharmacies (62% of US) for 1992 and 1995:
PhRMA Influence
Most studies have shown that physicians do not believe that interactions with sales representatives impact prescribing
Receipt of a higher number of gifts associated with the belief that there was no impact on prescribing
Drug samples lead to higher brand-name prescriptions
Sponsored lectures/symposia lead to prescribing without sufficient evidence
Opioid Crisis
Purdue Pharma
- Funded > 20,000 educational programs
- Provided financial support for the American Pain Society
- Salesforce provided doctors with merchandise
they are addicted to drugs now :(
Curbing industry influence
Code on Interactions with Healthcare -
- Professionals (HCP)
- Developed by PhRMA
- Implemented in 2002, updated in 2009
- Limits on interactions with HCP
Centers for Medicare & Medicaid Services (CMS) Open Payments Database
- System to track physicians that receive payment from a pharmaceutical company
Did it work?
Comparison of prescribing in US academic medical centers with restrictions on sales representatives vs. those without
Hospitals in 5 states evaluated (CA, IL, MA, PA, NY)
Drugs in 8 classes were evaluated
Analyzed > 1.6 million prescriptions written by > 2000 physicians
Stricter policies led to modest by significant changes in prescribing
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FDA Requirements
- Accurate, truthful, and not misleading
- Reflect balance betweenharms and benefits
- Make claims only supported by appropriate evidence
- Be consistent with FDA-approved labeling
PhRMA Requirements
- Educate patients about treatment options
- Increase awareness about diseases
- Motivate patients to consult their doctors
- Increase the likelihood that patients will receive appropriate care
- Encourage compliance with prescription drug treatment regimens
Assessment Question
What do you notice in this advertisement?
in the fine print: 1/2 of the patients lived 12 months compared to 9 months
procort
the transfusion increased survival by 1 day
Assessment Question
A sales representative tells you that Fosamax reduces the risk of hip fractures by 51%
Is this true?
- yes
Information Gathering
Balancing your information
PUSH
- Receiving information from various sources on various topics
- Extracting what we think we need for our practice
PULL
- Seeking informationto answer a specificquestion
EBM Search Engines
Scour primary resources more completely than you could do on your own
Utilize available data to answer questions
Identify a variety of clinical information
- Clinical practice guidelines
- Patient education
- Systematic reviews
EBM Tools
MCPHS Library
A-Z Databases
- Change “All Subjects” to “Evidence-Based Practice”
Partial list
- DynaMed
- Cochrane Library
- TRIP Database
- EBM Reviews
- Pharmacist’s Letter
Adopting a Lifelong Process
EBM is a life long learning process
- Founded on problem-based learning
- Converting information needs into focused questions
- Utilizing web-based resources to generate evidence
- Critical appraisal of the facts
- Apply your conclusions to your patients
