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Epidemiology > General Concepts of Research > Flashcards

General Concepts of Research Flashcards

1
Q

types of quantitative study designs

A

interventional and observation

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2
Q

interventional study design

A

considered “experimental”

forced allocation to study groups

investigator selects interventions (exposure)

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3
Q

observational study design

A

considered “natural”

no forced allocation to study groups

researchers “observe” subject-elements occurring naturally or selected by individual (naturally or freely)

useful for unethical study designs using forced interventions

no designed to prove causation

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4
Q

Interventional and Observation study design strength of evidence

A

Interventional Observational

  • Phase 0 -Case Reports/Series
  • Phase 1 -Ecological (not important)
  • Phase 2 -Cross-Sectional
  • Phase 3 -Case-Control
  • Phase 4 -Cohort

*Increasing strength downward

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5
Q

Research Evidence Pyramid

A 
Systematic Reviews/Meta-Analyses
Interventional (Explanatory)/Pragmatic (Exploratory)
Cohort
Case-Control
Ecological (not important)
Case Series
Case Reports
Animal Research
In vitro (test-tube) research
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6
Q

Research question

A

Purpose statement; formed as a question

Helps frame study intent and can direct researcher to selecting and developing an effective study design and methods to answer question

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7
Q

Study design and methods selection is based on what?

A
  • perspective of research question
  • ability/desire of researcher to force group allocation and intervention (randomization)
  • ethics of methodology selected
  • efficiency and practicality
  • costs
  • Internal validity (validity of acquired information)
  • external validity
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8
Q

population

A

all individuals making up a common group; from which a sample can be obtained

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9
Q

sample

A

a subset or portion of the full and complete population

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10
Q

interventional study population is based on what?

A

research hypothesis

population of interest

inclusion and exclusion criteria (impacts external validity)

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11
Q

observational study population is based on what?

A

research hypothesis

population of interest

Case and Control group OR Exposed and Non-Exposed group selection criteria (impacts external validity)

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12
Q

Null hypothesis (Ho)

A

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

Odds ratio is 1 between groups

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13
Q

type I error

A

false positive

rejecting a true null hypothesis

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14
Q

type II error

A

accepting (fail to reject) a false null hypothesis

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15
Q

statistical-perspectives used in deciding to reject or not reject null hypothesis

A
  • superiority: is the drug better than placebo? OR better than another drug?
  • noninferiority: drug is not worse than the placebo
  • equivalency: both drug and the placebo are the same
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16
Q

prospective study

A

Don’t know outcome yet

groups are followed into future to assess for outcomes of interest and then groups are compared

used by all interventional studies and some observational studies

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17
Q

retrospective study

A

outcome known at start of study

outcomes of interest have already occurred; researchers have goal of assessing past history of some activity (exposure/treatment)

18
Q

ambidirectional

A

uses retrospective design to assess past differences in occurrences of events (exposure or outcome), but also adds future data collected on additional outcomes prospectively from start of study

19
Q

probability samples

A

every element in population has a known (non-zero) probability of being included in sample

most common

20
Q

simple random sampling

A

type of probability sampling

assign random numbers, then take randomly-selected numbers to get desired sample size

OR

assign random numbers, then sequentially-list numbers and take desired sample size from top (or bottom) of listed numbers

21
Q

stratified simple random sampling

A

type of probability sampling

stratify sampling frame by desired characteristic (e.g. gender), then use simple random sampling to select desired sample size

22
Q

multi-stage random sampling

A

type of probability sampling

uses simple random sampling at multiple-stages towards patient selection

e.g. –> counties –> zip codes –> households –> individual

23
Q

non-probability sampling scheme

A

not a known probability

can produce selection bias

24
Q

quasi-systematic or convenience samples

A

not really completely random or fully probabilistic

decide on what fraction of population is to be sampled and how they will be sampled

e.g. all last name M-Z; all persons attending clinic every M/W/F for 6 months

25
Q

primary outcome

A

most important, key outcomes

main question used for developing study

26
Q

secondary/tertiary outcomes

A

less important outcomes but still valuable

used for possible future hypothesis generation

27
Q

single outcome

combined outcome

A

one type of outcome

single outcomes combined under one outcome

28
Q

internal validity

A

validity of methods inside study; answering question that’s asked

used standardized assessments that are accurate and reproducible

clinically applicable

29
Q

equipoise

A

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

e.g some don’t agree with use of placebo if a treatment is available, even though placebo can provide some benefit

30
Q

4 principles of bioethics

A

AUTONOMY: self-rule/self-determination; participants must decide for them-selves without outside influences (no coercion or financial manipulation); have full and complete understanding of risks vs benefits (consider language or education level)

BENEFICENCE: benefit to individual patient (not society); risks are justified by potential benefits

JUSTICE: equal and fair treatment regardless of patients characteristics (equipose); risks and benefits are equally distributed

NONMALEFICENCE: do no harm; researchers cannot withhold information, provide false information, or exhibit professional incompetence

31
Q

belmont report

A

issued by National Convention for Protection of Human Subjects of Biomedical and Behavioral Research

contains 3 principles: respect for persons (autonomy), beneficence, and justice

32
Q

consent

A

agreement to participate, based on being fully and completely informed as adults and mentally-capable individuals

33
Q

assent

A

agreement to participate, based on being fully and completely informed and mentally-capable individuals that are not able to give legal consent (minors)

34
Q

Institutional Review Board (IRB)

A

“ethics committee”

role is to protect human subjects from undue risk

all human subjects studies must be reviewed by an IRB prior to study initiation

35
Q

DHHS

A

Department of Health and Human Services

developed federal statutes that regulate IRB –> known as Common Federal Rule (CFR)

36
Q

OHRP

A

Office of Human Research Protections: agency that administers and enforces regulations by DHHS

37
Q

full board IRB eview

A

used for al intervention studies with more than minimal risk to patients

consists of entire board

38
Q

expedited IRB review

A

minimal-moderate risk (with/without patient identifiers)

consists of entire board

39
Q

exempt IRB review

A

low/no risk; no patient identifiers (anonymous); environmental studies; use of existing de-identified existing date/specimens

does not consist of entire board

40
Q

DSMB

A

Data Safety and Monitoring Board

reviews study data as study progresses to assess for risk/benefits and abiding of guidelines by IRB

can stop study early if one group receives more benefit or harm than the other group

Epidemiology (9 decks)

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