Block 1 Flashcards

1
Q

What is evidence?

A

Refers to findings from clinical research

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2
Q

What are some advantages of evidence-based medicine?

A
  • 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
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3
Q

What are some limitations of evidence-based medicine?

A
  • 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
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4
Q

What are the levels of evidence starting from the bottom?

A

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

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5
Q

What is the orange book for?

A

Therapeutic equivalence

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6
Q

What is the red book for?

A

Prescription and OTC product availability and price

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7
Q

Harriet Lane Handbook covers what?

A

Pediatric information

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8
Q

What is a key characteristic of case reports, case studies, and case series?

A

**lack a control or comparison group

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9
Q

What is a case study?

A

Record of a SINGLE patient

*Case report is just a singular report of one individual

**Case series = subjects share common characteristics

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10
Q

What is a negative from case reports, studies, and series?

A

Series of AE can lead to false-positive reporting and prone to reporting bias

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11
Q

Adverse Drug Event
Adverse Drug Reaction
Medication Error
Medication Misadventure

Which one is broad? Specific?

A

Broad = ADE + Misadventure

Specific = ADR + Error

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12
Q

What is pharmacovigilance?

A

Process of detecting and preventing AE of Rx

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13
Q

What is passive surveillance?

A

Spontaneous reports of ADEs, Case series, and annual reports

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14
Q

What is active surveillance?

A

Registries and pharmacoepidemiologic studies

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15
Q

What is dechallenge and rechallenge?

A

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

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16
Q

What are the ranges of the naranjo ADR scale?

A

9+ is definite

5-8 is probable

1-4 is possible

0 is doubtful

17
Q

What is internal and external validity?

A

Internal = quality of design which translates to quality of results

External = ability to apply results to practice which is meaningful for practitioners

18
Q

What is an inclusion and exclusion criteria?

A

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.

19
Q

Of the epidemiologic studies, which ones are analytical/explanatory studies?

A

Observational and Experimental studies

20
Q

What are the observational studies?

A

Cohort and Case Control

21
Q

What are the experimental studies?

A

Quasi and RCTs

22
Q

Of the epidemiologic studies, which ones are descriptive studies?

A

Case studies and case series

23
Q

What are some main ideas that fall under descriptive epidemiology?

A

Incidence and prevalence

Drug utilization

Does NOT use control groups and only generates hypotheses

24
Q

What is causal inference?

A

Difference of outcomes between Tx and control group due to intervention

25
Q

What is a case-control study?

A

Subjects are selected on the basis of their status

26
Q

What is a cohort study?

A

Subjects are selected with respect to the presence and absence of a characteristic

27
Q

What is confounding?

A

Factors that relate to both exposure and the outcome