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Epidemiology Exam 2 > Methodology & Study Design > Flashcards

Methodology & Study Design Flashcards

1
Q

2 categories of general study design

A

qualitative

quanitative

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2
Q

2 categories of numerical studies

A

quantitative studies

interventional or observational

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3
Q

random or forced allocation to study groups

A

interventional study

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4
Q

no random or forced allocation to study groups

A

observational study

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5
Q

types of experimental studies

A

pre-clinical/animal studies

phase 0 - 4

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6
Q

in general observational studies cannot ______ ?

A

prove causality

interventional can

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7
Q

types of observational studies in order of increasing evidence

A 
case report/series
ecological
cross-sectional
case-control
cohort
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8
Q

what is the most useful and appropriate study design?

A

it depends

the best study design is the one that best answers the primary question of the research hypothesis

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9
Q

what criteria are considered when choosing study design? (7)

A 
perspective of hypothesis
ability to randomize
ethics
practicality/efficiency
cost
validity of data
applicability (generalizability)
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10
Q

population vs. study population

A

study population = sample size

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11
Q

3 perspectives taken by the null hypothesis

A

superiority
noninferiority
equalness

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12
Q

types of sampling schemes

A

probability samples

non-probability sampling

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13
Q

types of probability sampling (6)

A 
simple random sampling
systematic rs
stratified simple rs
stratified disproportionate rs
multistage rs
cluster multistage rs
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14
Q

type of non-probability sampling

A

quasi systematic or convenience sampling

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15
Q

random number generator use

A

simple random sampling

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16
Q

sampling by choosing every 5th number given by a random number generator

A

systematic random sampling

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17
Q

sampling that stratifies by desired characteristics then uses a random number generator

A

stratified simple random sampling

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18
Q

use of stratified simple random sampling on a population that does not have the desired proportional percentages

A

stratified disproportionate random sampling

weighted sampling

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19
Q

simple random sampling at multiple stages

A

multi-stage random sampling

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20
Q

simple random sampling at multiple stages within a cluster of the desired element

A

cluster multi-stage random sampling

21
Q

some known or unknown order to the sampling which can introduce bias

A

quasi systematic sampling also called convenience sampling

22
Q

what does external validity represent?

A

the ability to generalize the findings to the population

23
Q

define equipoise

A

genuine confidence that an intervention may be worthwhile in order to use it in humans

confidence that the benefits outweigh the risks

24
Q

what is the difference between consent and assent?

A

consent you can give yourself

assent is given by a legal guardian

in both ways you must be mentally capable of knowing what you are being enrolled in

25
Q

what must be met in order for a study to begin? what subject does this represent?

A

principles of bioethics

ethics

26
Q

principles of bioethics

A

autonomy
beneficence
justice
Nonmaleficence

27
Q

define autonomy principle of bioethics

A

participants must be able to decide for themselves and must be able to understand the risks and benefits

w/o influence, coercion, financial manipulation, etc.

28
Q

define beneficence principle of bioethics

A

the intervention must be to improve the individual not society

29
Q

define justice principle of bioethics

A

equal and fair treatment regardless of patient characteristics

ex. gender, age, race, etc.

30
Q

define Nonmaleficence principle of bioethics

A

do no harm

31
Q

3 things the researcher must not do…..according to the Nonmaleficence principle of bioethics

A

withhold info from patient

provide false info to patient

exhibit professional incompetence

32
Q

issuing of the Belmont report

A

1978

issued by the national commission for protection of human subjects of biomedical and behavioral research

33
Q

the Belmont report

A

3 guiding principles of research methods

  1. respect for persons
  2. beneficence
  3. justice
34
Q

Belmont - respect for persons

A

research is voluntary and subjects can be anonymous

35
Q

beneficence - Belmont report

A

the potential benefits outweigh the risks

36
Q

justice - Belmont report

A

risks and benefits are equally distributed

37
Q

who determines if a study is ethical?

A

IRB

also called ethics committee

38
Q

what does IRB stand for?

A

institutional review board

39
Q

what is IRB’s goal?

A

to protect the subject

40
Q

what are levels of IRB review?

A
  1. exempt
  2. expedited
  3. full board
41
Q

key concepts of exempt level

A

use of existing data
no personal identifiers
virtually no risk

42
Q

key concepts of expedited level

A

very low risk
no invasive interventions
no personal identifiers

43
Q

key concepts of full board level

A

used for all interventional studies
higher than minimal risk
entire board reviews methods

44
Q

who enforces the rulings of the IRB?

A

OHRP

45
Q

what does OHRP stand for?

A

office of human research protections

46
Q

who monitors that study during it’s conductance?

A

DSMB

47
Q

what does DSMB stand for?

A

data safety and monitoring board

48
Q

role of DSMB

A

not involved in study conduct
just review data as it comes it to make sure it complies with ethical principles
harm of the study can be positive or negative

49
Q

what are the two types of harm that DSMB can use to shut down a study?

A

positive —- the benefits are so good that it is unethical to not allow the placebo group to have access to it

negative —- the consequences are so great that it is unethical to continue putting the subjects at risk

Epidemiology Exam 2 (6 decks)

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