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Epidemiology Exam II Material > Class #15 General Methodological Concepts of Research > Flashcards

Class #15 General Methodological Concepts of Research Flashcards

1
Q

What kind of studies have the highest research evidence

A

Meta-analyses studies

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2
Q

What kind of studies have the second highest strength of evidence

A

Systematic Reviews

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3
Q

Study design selection is based on

A

Perspective of research question (hypothesis)
Ability/desire to force group allocation (randomization)
Ethics of methodology
efficiency & Practicality (time/resource commitment)
Costs
Validity of acquired information (internal & External)

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4
Q

What is internal validity

A

are the methods and study design valid

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5
Q

What is external validity

A

how do the findings compare to the general public

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6
Q

What is a null hypothesis

A

a research perspective which states there will be no (true) difference between the groups being compared

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7
Q

What is an alternative Hypothesis (H1)

A

A research perspective which states there will be a (true) difference between the groups being compared

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8
Q

Name 3 statistical perspectives that can be taken by the researcher

A

Superiority
Non-inferiority
Equivalency

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9
Q

Type I Error (alpha error)

A

False positive

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10
Q

Type II Error (Beta error)

A

False negative

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11
Q

What are observational studies

A

considered to be “natural”
researchers “observe” subject elements occurring naturally or selected by individual (naturally or freely)
most observational study designs are not able to prove causation

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12
Q

What are most observational study designs not bale to prove

A

Causation

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13
Q

In observational studies there is no what?

A

no researcher-forced group allocation

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14
Q

What are interventional study designs

A

Considered “experimental”
investigator-selects interventions (exposure)
There is researcher-forced group allocation

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15
Q

in interventional studies there is what

A

researcher-forced group allocation

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16
Q

Name 5 types of Interventional Studies in order from least to most evidence `

A

Pre-clinical, phase 1, Phase 2, Phase 3, Phase 4

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17
Q

The 5 types of interventional studies have what in common

A

they each have a researcher-forced group allocation

they are analytical studies

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18
Q

Name 5 types of observational studies from least to most evidence

A

Cases (reports/Series), Ecological, Cross-sectional, Case-Control, Cohort

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19
Q

What are the 3 types of observational studies that are analytical studies

A

Cross-sectional, Case-control, and Cohort

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20
Q

What is a study population

A

The final group of individual selected for a study

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21
Q

What is a population

A

All individuals making up a common group; form which a sample (smaller set) can be obtained, if desired

22
Q

what is a sample

A

A subset or portion of the full, complete population (“representatives”)

23
Q

what is generally used to draw a sample for a study

A

Randomization processes

24
Q

When is using a sample needed

A

When studying the complete population is not feasible

25
Q

what is the most common type of bias

A

Selection bias

26
Q

What are study population selections based on

A

Research hypothesis/question
inclusion & Exclusion selection criteria (interventional studies) & Case and Control group or exposed and non exposed group selection criteria
- Desired vs. Logical vs. plausible selection criteria
- These impact generalizability
-external validity
Ethics

27
Q

Study population selection has an effect on what factor

A

External Validity

28
Q

What is Equipoise

A

genuine confidence that an intervention may be worthwhile (risk vs. benefit) in order to use it in humans

29
Q

what are the 4 principles of bioethics

A

Autonomy, Beneficence, Justice, Nonmaleficence

30
Q

What is meant by Autonomy in bioethics

A

it is one of the 4 key principles

  • self-rule/self-determination, participants must…….
    • have full & complete understanding of the risks and benefits
    • must be able to decide for ones-self, without outside influences
31
Q

What is meant by Beneficence in bioethics

A

One of the 4 basic principles

To benefit, or do good for, the patient (not society)

32
Q

What is meant by justice in bioethics

A

One of the 4 basic principles

equal & Fair treatment regardless of patient characteristics

33
Q

What is meant by nonmaleficence in bioethics

A

Do not harm, researchers must not……

 - withhold information
- provide false information    - Exhibit professional incompetence
34
Q

Belmont Report

A

1978

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

35
Q

what are the 3 guiding principles of the Belmont Report

A

Respect for persons
- research should be voluntary, subjects autonomous
Beneficence
-Research risks are justified by potential benefits
Justice
- Risks and benefits of the research are equally distributed

36
Q

what is consent

A

Agreement to participate, based on being fully and completely informed (given by mentally-capable individuals of legal consenting age)

37
Q

What is the IRB

A

Institutional Review Board
Determines if a study is ethical (proper/safe)
role is to protect human subjects form undue risk

38
Q

When must all human subject studies be reviewed and by who

A

Prior to the study by the Institutional Review Board (IRB)

39
Q

Who regulates the IRB

A

Federal statues (laws and regulations)

40
Q

Who developed the federal statutes that the IRB must follow

A

The Department of Health and Human Services (DHHS)

41
Q

What are the Federal statutes normally called

A

CFR (common federal rules)

42
Q

The CFR apply to what

A

All studies funded by federal government; standards also usually apply to studies reviewed by an IRB

43
Q

What agency enforces that administers and enforces the regulations of the CFR (common Federal Rules)

A

Office of Human Research Protections (OHRP)

44
Q

What are the 3 levels of IRB review

A

Full Board
Expedited
Exempt

45
Q

When is Full board review used

A

used for all interventional trials with more than minimal/no risk to patients

46
Q

when is expedited review used

A

Minimal risk and/ no patient identifiers

47
Q

When is exempt review used

A

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

48
Q

What is the Data Safety and monitoring board (DSMB)

A

Semi-independent committee not involved with the conduct of the study but charged with reviewing study data as study progresses, to assess for undue risk or benefit

49
Q

The Data Safety and monitoring board (DSMB) has _______ determined review periods (interim analyses)

A

Pre-determined

50
Q

If either overly-positive or overly-negative findings are evident then the DSMB can do what

A

Stop the study early

51
Q

What are two methodologies of human studies

A

outcomes and internal validity

52
Q

What is internal validity

A

Assessments (measurements)

  • scientifically-rigorous and standardized
    - objective better than subjective assessments
    - Valid, accurate and reproducible

Epidemiology Exam II Material (5 decks)

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