exam 1 Flashcards

1
Q

what is pharmacoepideminology

A

the study of the use and effect of drugs in large numbers of people

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2
Q

pharmacology vs clinical pharmacology

A

pharmacology study of effects of drugs while clinical pharmacology is the study of effect of drugs in humans

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3
Q

epidemology vs pharmacoepi

A

epidemology is the study of the distribution and determinants of diseases in populations
pharmcoepi is a subset

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4
Q

pure food and drug act 1906

A

in response to excessive adulteration and misbranding of food and drug at that time. Fed gov now allowed to remove drug that was adulterated or misbranded

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5
Q

food, drug and cosmetics act

A

in response to people dying from renal failure. Preclinical toxicity testing required and manufacturers required to gather clinical data about drug

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6
Q

Case report

A
  • report of an event in a single patient
  • useful in generating hypotheses
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7
Q

Case series and when useful

A

collections of patients all of whom have either a single exposure or single outcome
- useful: quantify an ADE and ensure ADE are not happening in population larger than that studied prior to drug marketing

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8
Q

case-control studies

A

compare cases (w/ outcome) to controls (w/o outcome) to look for differences in

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9
Q

cohort studies

A

a study that identifies a cohort of subjects and follows them over time to determine outcome

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10
Q

random control/clinical trial

A

a study where participants are randomly assigned between exposure and control groups

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11
Q

pragmatic clinical trials

A

A study in which the investigator tests the effectiveness of an intervention under ‘real-world’ conditions

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12
Q

different types of bias

A
  • information bias: interviewer and recall bias
  • selecting bias: control doesnt represent the population that produced the cases
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13
Q

what is a confounder

A

a variable related to both the exposure and the outcome
- variable distributed unequally b/w the groups

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14
Q

why dont RCTs translate to the real world

A

problems with clinical trials
- expensive
- small
- often drugs are compared against placebo
- exclude elderly, children, pregnant women, patients w/ comorbidities
- not timely
- unethical

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15
Q

pragmatic clinical trials design and setting

A

designed to improve practice and policy
- take place in settings where everyday care happens, such as community clinics, hospitals and health systems

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16
Q

rct vs pct
- GOALS

A
  • RCT determine causes and effects of therapy
  • PCT: improves practice and inform clinical and policy decisions
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17
Q

rct vs pct
- design

A
  • RCT: test intervention against placebo
  • PCT: test 2 or more real-world treatments using flexible protocols and local customization
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18
Q

rct vs pct
- participants

A
  • RCT: highly defined and carefully selected
  • PCT: more representative b/c less strict criteria
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19
Q

rct vs pct
- measures

A
  • RCT: require data collection outside routine clinical care
  • PCT: brief and designed so data can be easily collected in clinical settings
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20
Q

rct vs pct
- results

A
  • RCT: rarely relevant to everyday practice
  • PCT: useful in everyday practice, especially clinical decision making
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21
Q

Pragmatic research features

A
  • use EHRs
  • randomize treatment alt based on normal health care operations
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22
Q

Comparative effectiveness research

A

A rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients.

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23
Q

drug efficacy vs effectiveness

A

efficacy: investigates drug ability to have intended effect
effectiveness: investigates if drug achieves its desired effect in the real world

24
Q

strengths of HMO database

A
  • large, diverse, defined populations
  • automated claims, EMR data, access to providers
  • varied delivery models and practice patterns
  • ability to contact enrollee for participation
25
Q

weaknesses of HMO database

A
  • absence of population/groups that are uninsured
  • smaller fraction of elderly
  • meds filled outside of plan, nonrx drugs and inpt dispensing not routinely recorded
26
Q

strengths of US gov claims database (medicare/medicaid)

A
  • population size and length of follow up
  • accuracy of pharmacy claims
  • validity of procedure claims
  • over-represention of underserved populations
  • ability to validate outcomes
  • ability to link to external data
27
Q

weakness of US gov claims database (medicare/medicaid)

A
  • non-representativeness
  • unavailable information
  • limitations in rx coverage
  • eligibility
  • data validity/ acess to records
  • out of plan care
28
Q

strengths of hospital databases

A
  • sample size
  • versatile data source
  • data quality
  • efficient
  • data longevity
29
Q

weaknesses of hospital databases

A
  • misclassification
  • lack of generalization
  • ascertainment bias (different length of stays)
30
Q

sensitivity vs specificity
how to calculate

A
  • sensitivity: ability of a test to identify correctly those who HAVE the disease; true positive
    Sensitivity= TP / (TP+FN)
  • specificity: ability of a test to identify correctly those who DO NOT HAVE the disease; true negative
    Specificity= TN / (TN+ FP)
31
Q

Morbidity definition and how its described

A

Rate of disease in a population
- cumulative incidence proportion
- incidence rate
- prevalence
- attack rate

32
Q

Incidence vs prevalence
how to calculate

A
  • Incidence: number of NEW CASES of a disease during specific period of time in population at risk for developing disease
    ( # new cases in the population/ # of people at risk of developing disease during that time. ) x 100
  • prevalence: number of affected people in the population / number of people in the population x100
33
Q

what is attack rate
how to calculate

A

aka outbreaks
- (# of people exposed to virus/bacteria/etc. that then end up getting sick)/ total # of people exposed

34
Q

mortality rate

A

number of deaths from a cause in a certain population over a specific period of time

35
Q

standardization and two types

A

set of techniques used to remove the effects if differences when comparing populations
- direct: rate of disease/death in STUDY POPULATION assuming dame age distribution
- indirect: compares the rate of death/disease observed to expected rate from STANDARD POPULATION

36
Q

risk ratios vs odds ratio
how to calculate

A
  • risk: risk of disease in exposed individuals to the risk of unexposed individuals
    RR= a/(a+b) / c/(c+d)
  • odds: ration of the probability of occurrence of an event to that of non-occurrence
    OR= (AxD) / (BxC)
37
Q

characteristics of risk ratio

A
  • chance of outcome/ all possible outcomes
  • looks at the total number of people in the population
  • prospective, cohort studies
38
Q

characteristics of odds ratio

A
  • the probability of occurrence of an event/probability of the event not occurring
  • looks at those that experience vs did not experience event
  • retrospective case control studies
  • multiple logistic regression
39
Q

Attributable risk

A
  • amount of disease incidence or risk that can be attributed to a specific exposure
    AR= risk exposed- risk unexposed
    ex = cigarette smoke and lung cancer
40
Q

Population Attributable risk ex

A
  • PAR= 12% in a study assessing the relation between smoking and low birth weight
  • making all people in the population stop smoking would eliminate 12% of all cases of low birth weight in the population
41
Q

confidence intervals

A
  • smaller ranger, more reliable
  • if range includes 0 there is no significant change
42
Q

what is the quadruple aim of health care

A
  • improving population health
  • reducing cost of care
  • enhancing the patient experience
  • improving provider satisification
43
Q

humanistic outcomes

A

consequences of disease or treatment on patient QOL

44
Q

clinical outcomes

A

medical events that occur as a result of disease or treatment

45
Q

economic outcomes

A

direct, indirect, intangible costs compared w/ the consequences of medical treatment alternatives
** multiple perspectives

46
Q

ex of direct medical cost

A

medications, supplies, lab test, hospitalization, healthcare professional time

47
Q

ex of direct non-medical cost

A

transportation, food, family care, home aids

48
Q

ex of indirect cost

A

low wages (morbidity)
income forgone b/c of death

49
Q

intangible cost

A

pain, suffering, inconvenience, grief

50
Q

opportunity cost

A

lost opportunity, revenue forgone

51
Q

full vs partial economic eval

A
  • full: encompasses 2 basic characteristics; compare 2 or more treatment alternatives, both the cost and consequence are examined
  • partial: only 1 characteristic ^
52
Q

What is Cost-effective analysis (CEA)

A

compares alternatives with therapeutic effects measured in natural units ; may differ in clinical outcome but has same unit of benefit

53
Q

Cost effective treatment alternatives

A

Less expensive w/ equal effectiveness
More expensive w/ added benefit worth the additional cost
Less expensive and less effective where the added benefit is not worth the cost

54
Q

what is cost minimization analysis (CMA)

A

finds the least expensive cost alternative; used when benefits are the same

55
Q

what is cost of illness (COI)

A

estimates the cost of a disease on a defined population; can compare prevention vs treatment options
- identifies direct and indirect cost
- provides estimation of financial burden of a disease

56
Q

what is cost benefit analysis (CBA)

A

compare cost and benefit of treatment alternatives; program w/ different objectives ; unit is money