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Epidemiology > [2] Class 15: General Methodological Concepts Of Research > Flashcards

[2] Class 15: General Methodological Concepts Of Research Flashcards

1
Q

What does the research evidence pyramid tell us?

A

The increasing strength of evidence based on design of research

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2
Q

What is the most useful and appropriate study design?

A

It depends

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3
Q

Study design uses numbers to represent data

A

Quantitative

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4
Q

Study design uses words to represent data

A

Qualitative

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5
Q

2 forms of quantitative study design

A

Interventional

Observational

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6
Q

Study design forced allocation to study groups

A

Interventional

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7
Q

Study design that does not force allocation to study groups

A

Observational

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8
Q

Study design selection can depend on:

A 
Hypothesis
Force group allocation (randomization?)
Ethics 
Efficiency and practicality
Costs!
Validity of acquired info.-internal
Generalizability=external validity
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9
Q

Helps frame study intent and can direct researcher to more effective study design to answer question

A

“I wonder if..”

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10
Q

A research perspective which states there will be no difference between the groups being compared

A

Null hypothesis

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11
Q

Statistical perspective that one Tx/exposure is better

A

Superiority

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12
Q

Statistical perspective that tries to prove a Tx/exposure is atleast as good as the other

A

Noninferiority

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13
Q

statistical perspective that one Tx/exposure is equivalent

A

Equivalency

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14
Q

Rejecting the null when you shouldn’t have

A

Type I error

False positive

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15
Q

Not rejecting the null when you should have

A

Type II error

false negative

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16
Q

If there is randomization, what type of study design is being looked at ?

A

Interventional

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17
Q

Study design considered “natural”- subject selected elements
Useful for unethical study designs
No researcher forced group allocation

A

Observational

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18
Q

Can observational study designs prove causation?

A

Most of the time=NO

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19
Q

Interventional study steps increasing evidence:

A 
Pre-clinical [phase 0]
Phase 1
2
3
4
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20
Q

Observation study steps increasing evidence:

A 
Case reports/series
Cross-sectional
Ecological
Case-control
Cohort
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21
Q

All individuals making up a common group, from which a sample can be obtained

A

Population

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22
Q

A subset of the full, complete population

“Representatives”

A

Sample

23
Q

Study population or sample picked by:

A

Hypothesis
Population of interest
Most useful group of ppl
Inclusion/exclusion selection criteria [interventional studies]

Case/control or exposed/nonexposed [observational]
Ethics

24
Q

Selection criteria can affect what?

A

generalizability=

External validity

25
Q

Genuine confidence that an intervention may be worthwhile [risk v. Benefit] in order to use it in humans

A

Equipoise

26
Q

4 key principles of bioethics:

A

Nonmaleficence
Autonomy
Beneficence
Justice

27
Q

Self-rule: deciding for oneself w/o outside influence w/ full/complete understanding of risks/benefits

A

Autonomy

28
Q

To benefit, or do good for, the patient [not society]

A

Beneficence

29
Q

Equal and fair Tx regardless of patient characteristics

A

Justice

30
Q

Do no harm. Researchers can’t:
Withhold info.
Provide false info.
Exhibit professional incompetence

A

Nonmaleficence

31
Q

1978 issued by national commission for protection of human subjects of biomedical /behavioral research- summarizes ethical principles and guidelines

A

Belmont report

32
Q

Belmont report 3 guiding principles:

A

-Respect for persons- research should be voluntary

  • Beneficence
  • Justice
33
Q

Agreement to participate, based on being fully and completely informed- by individual of legal age

A

Consent

34
Q

Agreement to participate, based on being fully and completely informed, given by mentally-capable individuals not able to give legal consent (children)

A

Assent

35
Q

Who determines if research is ethical?

A

IRB: Institutional Review Board “ethics committee”

36
Q

Do all human subject studies have to be reviewed by an IRB?

A

YES!

37
Q

How’re IRB regulated?

A

Federal statutes developed by department of health and human services (DHHS)

38
Q

Who enforces laws/regulations on IRB’s?

A

The office of human research protections (OHRP)

39
Q

Mindset when beginning study w/ regard to null

A

Mindset is opposite the null…want to set out to prove something, but null says there’s no difference

40
Q

What do IRB’s look for when reviewing?

A 
4 key principles of bioethics:
Autonomy 
Beneficence
Justice
Nonmaleficence
41
Q

Levels of IRB:

A

Full board
Expedited
Exempt

42
Q

Level of IRB: used for ALL interventional trials w/ > minimal risk to patients…ton of documentation:

A

Full board

43
Q

Level of IRB w/ minimal risk and/or no patient identifiers

A

Expedited

44
Q

Level of IRB, no patient identifiers, low/no risk, deidentified dataset analysis, environmental studies, use of existing data/specimens [deidentified]

A

Exempt

45
Q

What is the main differences btw the levels of IRB’s:

A

of members and time for committee review/approval

Level of detail to documentation needed for review

46
Q

Who decides the level of IRB?

A

Data safety and monitoring board (DSMB)

47
Q

Semi-independent committee not involved w/ the conduct of the study but charged w/ reviewing study data as study progresses, to assess for undue risk/benefit btw groups

A

Data safety and monitoring board (DSMB)

-looking out for people in the study.

48
Q

Types of outcomes from a study

A

Patient-oriented v. Disease oriented

Individual v combined outcomes

49
Q

Outcomes that patients view as important

A

Patient-oriented

50
Q

Can be difficult to discern the outcome if this is used b/c different outcomes can have different rates of occurrence

A

Combined outcomes

51
Q

Scientifically-rigorous and standardized

Objective>subjective

Accurate/reproducible/scientifically inside the study

A

Internal validity

52
Q

What section of the study is most pertinent to internal validity?

A

Method. Most boring but if the procedure is wrong it is not valid

53
Q

Putting many studies together and making global recommendations from them:

A

Meta-analyses

54
Q

Similar to a book report on “37” articles

A

Systematic review

Epidemiology (12 decks)

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