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
primary outcome
most important, key outcomes main question used for developing study
26
secondary/tertiary outcomes
less important outcomes but still valuable used for possible future hypothesis generation
27
single outcome combined outcome
one type of outcome single outcomes combined under one outcome
28
internal validity
validity of methods inside study; answering question that's asked used standardized assessments that are accurate and reproducible clinically applicable
29
equipoise
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
4 principles of bioethics
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
belmont report
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
consent
agreement to participate, based on being fully and completely informed as adults and mentally-capable individuals
33
assent
agreement to participate, based on being fully and completely informed and mentally-capable individuals that are not able to give legal consent (minors)
34
Institutional Review Board (IRB)
"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
DHHS
Department of Health and Human Services developed federal statutes that regulate IRB --> known as Common Federal Rule (CFR)
36
OHRP
Office of Human Research Protections: agency that administers and enforces regulations by DHHS
37
full board IRB eview
used for al intervention studies with more than minimal risk to patients consists of entire board
38
expedited IRB review
minimal-moderate risk (with/without patient identifiers) consists of entire board
39
exempt IRB review
low/no risk; no patient identifiers (anonymous); environmental studies; use of existing de-identified existing date/specimens does not consist of entire board
40
DSMB
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