Lecture 7: General Methodologies Of Study Design Flashcards

(40 cards)

1
Q

Two types of quantitative studies

A

Interventional and observational

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2
Q

What occurs in an interventional study?

A

Researchers forces people into groups— typically by a type of randomization

Leads to increasing evidence and hopefully causation

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3
Q

What’s the basis of observational studies?

A

“Natural” study— people are NOT forced into groups.

Useful for when group allocation is unethical.

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4
Q

What is a weakness of observational studies?

A

Most are not able to prove causation

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5
Q

How do you decide which type of study to use?

A

It all depends on the RESEARCH QUESTION that you are trying to answer.

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6
Q

How are subjects chosen for certain studies?

A
Depends on:
Research question
Population of interest
Inclusion/exclusion criteria
Case/control OR exposed/unexposed groups
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7
Q

How does selection criteria impact a study?

A

Selection criteria is inclusion/exclusion criteria. It affects generalizability and external validity

EX: mental health exchangeability

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8
Q

Types of Null hypotheses

A

Superiority
Non-inferiority
Equivalency

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9
Q

Superiority question/null hypothesis

A

Question: is my drug SUPERIOR to placebo/another drug?

Null hypothesis: drug is NOT superior to placebo/another drug

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10
Q

Non-inferiority question/null hypothesis

A

Question: is my drug NOT WORSE than another drug?

Null hypothesis: drug IS worse than other drug

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11
Q

Equivalency question/null hypothesis

A

Question: is my drug equal to other drug?

Null Hypothesis: drug is NOT equal to other drug

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12
Q

What are the different types of sampling/randomization?

A
Simple random
Systematic random
Stratified simple random
Stratified disproportionate random
Multi-stage random
Cluster multi-stage random
Quasi-systematic
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13
Q

Simple random

A

Assigned numbers then randomly pick numbers

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14
Q

Systematic random

A

Assign random numbers and then randomly sort the numbers, then systematically choose desired sample

Ex: top 10, bottom 10, every 3rd, etc.

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15
Q

Stratified simple random

A

Framed by desired characteristic, then use simple random to select desired sample size

Ex: stratified by gender

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16
Q

Stratified disproportionate random

A

Disproportionately uses stratified simple random sampling when baseline pop is not as desired proportional percentages to the referent population

“Weighted” to return to baseline
Useful for over-sampling

Ex: adding/removing based on race to mimic USA population

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17
Q

Multi-stage random

A

Simple at many stages in succession

EX: random region —> random city —> random hospital —> random incident

18
Q

Cluster multi-stage random

A

ALL elements are clustered together are selected for inclusion

EX: ALL hospitals in Overland Park, ALL households in community

19
Q

Quasi-systematic

A

A NON-PROBABILITY sampling scheme

First come first served; mostly based on convenience— not really completely random

Weakness: opportunity for BIAS (selection bias)

20
Q

What is a research question?

A

“I wonder if…” statement
Helps frame your study and direct researchers to selecting and developing an effective stud design to answer the question.

21
Q

What is study design based on?

A

Hypothesis
Ability/desire of researcher to force groups (randomization)
Ethics of methodoligy
Efficacy/practicality
Costs
Validity of acquired info (internal validity)
Applicability of acquired information (external validity

22
Q

Population

A

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

23
Q

Sample

A

“Study population”

A subset or portion of the full, complete population

24
Q

internal validity

A

methods inside study

assessments
accurate and reproduciblt

25
equipoise
genuine confidence that an intervention may be worthwhile (risk vs. benefit) in order to use it in humans
26
what are the 4 principles of bioethics?
autonomy, beneficence, justice, nonmaleficence
27
autonomy
must decide for oneself to participate and have full and complete understanding of risk/benefits
28
beneficence
to benefit, or do good for the patient (NOT society)
29
justice
equal and fair treatment regardless of patient characteristics
30
nonmaleficence
do no harm; researchers must not.... | withhold information, provide false information, or exhibit professional incompetence
31
consent
agreement to participate based on being fully informed and of legal consenting age --adults age 18+
32
assent
agreement to participate, based on being fully informed and given by mentally-capable individuals NOT able to give consent --children and adolescents
33
IRB
institutional review board--> ethics committee GOAL: to protect human subjects must be done prior to start of study risk/benefit AND 4 ethical principles MUST be met.
34
who develops IRB laws
the department of health and human services (DHHS)
35
who enforces IRB laws
office of human research protections (OHRP)
36
what are the different levels of IRB review
full board expedited exempt
37
full board review
used for ALL interventional trials with more than minimal risk to patients LOTS of review is necessary. used when: pills given, needles used, CTs needed, etc.
38
expedited
minimal risk and no patient identifiers | used for: surveys --> ensures no traumatic questions or extreme measures are taken
39
exempt
no patient identifiers, low/no risk, uses existing data/specimens (de-identified) example: crunching numbers from CDC
40
who decides what level of review to use?
data safety and monitoring board (DSMB) | can stop study early if too much harm/too much benefit is occurring during study.