Block 1 Flashcards
What is evidence?
Refers to findings from clinical research
What are some advantages of evidence-based medicine?
- attempts to find interventions that work, not that it should or seem to work
- helps you find new info as it is published
- faster communication
- helps one to see flaws in others
What are some limitations of evidence-based medicine?
- focuses only if intervention works not how it works
- requires knowledge to practice effectively
- perceive it as a threat to their clinical autonomy
- many questions dont have sufficient evidence to inform clinical decision making
What are the levels of evidence starting from the bottom?
Background info / expert opinion
Case-controlled studies / case series + reports*
Cohort studies*
RCTs*
Critically-appraised individual articles**
Critically-appraised topics**
Systematic reviews**
- = unfiltered
** = filtered
All but background info/expert opinion are searched via TRIP databases
What is the orange book for?
Therapeutic equivalence
What is the red book for?
Prescription and OTC product availability and price
Harriet Lane Handbook covers what?
Pediatric information
What is a key characteristic of case reports, case studies, and case series?
**lack a control or comparison group
What is a case study?
Record of a SINGLE patient
*Case report is just a singular report of one individual
**Case series = subjects share common characteristics
What is a negative from case reports, studies, and series?
Series of AE can lead to false-positive reporting and prone to reporting bias
Adverse Drug Event
Adverse Drug Reaction
Medication Error
Medication Misadventure
Which one is broad? Specific?
Broad = ADE + Misadventure
Specific = ADR + Error
What is pharmacovigilance?
Process of detecting and preventing AE of Rx
What is passive surveillance?
Spontaneous reports of ADEs, Case series, and annual reports
What is active surveillance?
Registries and pharmacoepidemiologic studies
What is dechallenge and rechallenge?
Dechallenge = suspected Rx is d/c then you monitor pt symptoms to determine whether the ADR is reduced
Rechallenge = suspected Rx is d/c then you wait for symptoms to reduce then administer the same Rx to elicit same effect
Dechallenge is essential in clinical practice unlike rechallenge. Rechallenge might be necessary in certain situations like for ABx or chemos
What are the ranges of the naranjo ADR scale?
9+ is definite
5-8 is probable
1-4 is possible
0 is doubtful
What is internal and external validity?
Internal = quality of design which translates to quality of results
External = ability to apply results to practice which is meaningful for practitioners
What is an inclusion and exclusion criteria?
Inclusion = what they need to have to be enrolled in trial
Exclusion = what prevents someone from enrollment. If they have it later in the trial, they will be kicked out.
Of the epidemiologic studies, which ones are analytical/explanatory studies?
Observational and Experimental studies
What are the observational studies?
Cohort and Case Control
What are the experimental studies?
Quasi and RCTs
Of the epidemiologic studies, which ones are descriptive studies?
Case studies and case series
What are some main ideas that fall under descriptive epidemiology?
Incidence and prevalence
Drug utilization
Does NOT use control groups and only generates hypotheses
What is causal inference?
Difference of outcomes between Tx and control group due to intervention
What is a case-control study?
Subjects are selected on the basis of their status
What is a cohort study?
Subjects are selected with respect to the presence and absence of a characteristic
What is confounding?
Factors that relate to both exposure and the outcome
