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Epidemiology > Exam 2 : Lecture General Methodlogical Concepts Of Research > Flashcards

Exam 2 : Lecture General Methodlogical Concepts Of Research Flashcards

1
Q

What is the most useful and appropriate study design?

A

It depends on question being asked and the desired perspective

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2
Q

Quantitative

A

Numbers

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3
Q

Qualitative

A

Words (highly, likely, not likely)

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4
Q

Quantitative studies can be divided into two groups, what are they?

A

Interventional

Observational

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5
Q

Interventional study design

A

Forced allocation

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6
Q

Observational study design

A

No forced allocation to study group

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7
Q

How is a study design selected?

A

Based on:
Perspective (hypothesis)
Ability/desire of researcher to force group allocation (randomization)
Ethics of methodology
Efficiency & practicality (time/ resource commitment)
Cost
Validity of acquired info (internal validity)
Application of acquired info to non-study patients (external validity; generalizability)

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8
Q

Null hypothesis

A

Research perspective which state there will be NO (true) difference between the groups being compared

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9
Q

Researchers either reject or don’t reject the null hypothesis based on results, T or F

A

True

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10
Q

What hypothesis is the most conservative and commonly utilized?

A

Null

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11
Q

Superiority means

A

Better than the other

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12
Q

Equivalency means

A

Just as good

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13
Q

Noninferiority means

A

Novel treatment “not worse?”

Good for when we cant use a placebo, so we compare to another known drug

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14
Q

Opposite of null hypothesis

A

Alternative hypothesis

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15
Q

Alternative hypothesis

A

Research prospective which states there WILL be a (true) difference between groups

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16
Q

Errors of Accepting or rejecting the null:

A

Type I

Type II

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17
Q

Type I

A

False positive
Don’t reject the null even though its false
Alpha error

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18
Q

Types II

A

False neg
Reject the null even though its true
Beta error

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19
Q

Forced group allocation is what study design?

A

Interventional

Considered experimental

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20
Q

Investigator selects interventions (exposure)

A

Interventional

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21
Q

Researchers observe. NO forced group allocation. What study design is this?

A

Observational

Natural

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22
Q

Most observational study designs are able to prove causation. T or F?

A

False

They are mostly NOT able to prove causation

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23
Q

Interventional phases

A 
Phase 0
Phase 1
Phase 2
Phase 3
Phase 4
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24
Q

Observational phases

A 
Case report/series
Ecological
Cross sectional
Case control
Cohort
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25
Q

Human studies include these sizes

A

Population

Sample

26
Q

All individuals making up a common group; from which a sample can be obtains if desired

A

Population

27
Q

Subset or portion of the full, complete population

A

Sample

28
Q

What are study population selections based on?

A 
Research hypothesis
Population of interest
Group of individuals most useful and applicable to answer the research question
Inclusion and exclusion 
Ethics
29
Q

Does inclusion/ exclusion, case/control, and expose/ nonexposed impact generalizability?

A

Yes

External validity

30
Q

Principles of bioethics MUST be met. T or F

A

True

31
Q

Equipoise

A

Genuine confidence that an intervention may be worthwhile (risk vs benefits) in order to use it in humans

32
Q

4 principles of bioethics?

A

Autonomy
Beneficence
Justice
Nonmaleficence

33
Q

Self-ruling/ self determining, participants must decide for oneself, without outside influence (no coercion, reprisal, financial manipulation)

HAVE TO HAVE FULL & COMPLETE UNDERSTANDING OF RISKS & BENIFITS

A

Autonomy

34
Q

Benefit, or do good for, the patient, not society

A

Beneficence

35
Q

Equal and fair treatment regardless of patient characteristics

A

Justice

36
Q

Do no harm. Researchers must not

  • with hold info
  • Provide false info
  • exhibit professional incompetence
A

Nonmaleficence

37
Q

Guiding principles that researchers have to be aware of

A

Belmont report

38
Q

1978, issued by national commission for protection of human subjects of biomedical and behavioral research

A

Belmont report

39
Q

Belmont report contain 3 principles what are they?

A

Respect for person
Beneficence
Justice

40
Q

Research should be voluntary

A

Respect for person

41
Q

Research risks are justified by potential benifits

A

Beneficence

42
Q

Risks and benefits of research hare equally distributed

A

Justice

43
Q

Legally able to give permission

A

Consent

44
Q

Not legally old enough to agree to a study

A

Assent

45
Q

Who determines if a study is ethical

A

Institutional Review Broad (IRB)

Referred to as the ethics committee

46
Q

Only a few human studies must be review by an IRB prior to study initiation. T or F

A

False. ALL studies have to be reviewed

47
Q

DHHS

A

Department of health and human services develop ethics laws

48
Q

How is IRB regulated?

A

Federal statutes

49
Q

Rules are referred to as _________________

A

Common federal rules

50
Q

OHRP

A

Office of human research protections

-administers and enforces the regulations

51
Q

Levels of IRB review and differences

A

Full
Expedited
Exemp

52
Q

Used for ALL interventions trials with more than minimal risk to patients

A

Full board

53
Q

Minimal risk and or no patient identifiers

A

Expedited

54
Q

No patent identifiers, low/no risk, de identified dataset analysis, environmental studies, use of existing data/specimens (de-identified)

A

Exempt

55
Q

DSMB

A

Data safety and monitoring board

56
Q

Data safety and monitoring board

A

Semi-independent committee not involved with the conduct of the study but charged with reviewing study data as study processes, to asses for undue RISK/Benefit between groups

57
Q

Strength of recommendation

A

A
B
C

58
Q

Strength of rec: A

A

Consistent, good quality patient-oriented evidence

59
Q

Strength of Rec: B

A

Inconsistent or limited quality patient oriented evidence

60
Q

Strength of Rec: C

A

Consensus, disease-oriented evidence, usual practice, expert opionion, or case series for studies of diagnosis

61
Q

order of CHEST guidelines

A 
1A
1B
1C
2A
2B
2C

Epidemiology (9 decks)

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