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EPIDEMIOLOGY > 5. Overview of Study Designs and Experimental Study Designs > Flashcards

5. Overview of Study Designs and Experimental Study Designs Flashcards

1
Q

What are the 6 differences in how study designs differ?

A
  1. Number of observations made
  2. Directionality of exposure
  3. Data collection methods
  4. Timing of data collection
  5. Unit of observation
  6. Availability of subjects
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2
Q

What is an experimental design study approach?

A

Manipulation of the study factor - if the exposure of interest was controlled by the investigator

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3
Q

What are the 2 types of design study?

A

Experimental and Observational

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4
Q

What is an observational design study approach?

A

Randomization of study subjects - if there was use of random processes to determine exposure of study subjects

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5
Q

What does controlled assignment mean related to in study designs?

A

Experimental studies/manipulated

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6
Q

What does uncontrolled assignment mean related to study design?

A

Observational studies

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7
Q

Is a cohort study prospective or retrospective?

A

Prospective

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8
Q

Is a case control study prospective or retrospective?

A

Retrospective

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9
Q

Associations between exposure and disease status

A

slide 10

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10
Q

What does the specific interpretation of results from a 2x2 study depend upon?

A

the design of the study

How cases status and exposure status were ascertained

Whether cases are incident or prevalent

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11
Q

What are true experimental studies?

A

They are most convincing for conferring evidence of associations between risk factors and outcomes

for manipulation of study factors and randomization of subjects

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12
Q

What is an example of a true experimental study?

A

randomized clinical trials

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13
Q

What are the two main types of experimental studies?

A
  1. Randomized clinical trials

2. Quasi-experimental studies

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14
Q

What do randomized clinical trials mostly focus on?

A

individuals

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15
Q

What do Quasi-experimental studies mostly focus on?

A

on the group or community

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16
Q

What gives the strongest evidence for causality?

A

Study Designs

specifically with internal validity = experimental studies

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17
Q

What is the strength of the evidence usually referred to as?

A

internal validity

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18
Q

Will clinical trials generally be representative of a population?

A

not generally

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19
Q

What does randomization create?

A

It creates comparable groups by equally distributing known and unknown factors (e.g., confounders) that could otherwise bias results

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20
Q

What is performed after informed consent?

A

randomization

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21
Q

What are the 3 types of randomization?

A
  1. Simple
  2. Restricted
  3. Stratified
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22
Q

What does randomization increase?

A

increases internal validity

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23
Q

What is internal validity?

A

The ability to make causal inferences from the study results

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24
Q

What is external validity?

A

The ability to generalize the results to a greater population

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25
Q

What does RCT stand for?

A

Random Clinical Trial

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26
Q

How do large RCT’s relate to internal or external validity?

A

large RCT’s generally have good internal validity but poor external validity

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27
Q

What gets to the tension between epi as an science and an applied field of research?

A

internal vs. external validity

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28
Q

In an external validity RCT when would you compare the study population? and why?

A

in the latter stages because there is not enough information in the early stages to assess differences in participants vs. non-participants

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29
Q

What is the definition of a Randomized Clinical Trial (RCT)?

A

A research activity that involves the administration of a test regiment to humans to evaluate its efficacy and safety

30
Q

What is the variation of usage in RTCs?

A

there is a wide variation of usage

31
Q

what was the first use of the term RCT?

A

the first use of the term was for studies in humans without any control treatment

32
Q

What does the usage of RCT’s now denote?

A

a rigorously designed and executed experiment involving random allocation of test and control treatment

33
Q

What are the 5 characteristics of clinical trials?

A
  1. carefully designed and rigidly enforced protocol
  2. tightly controlled in terms of eligibility, delivery of the intervention, and monitoring of outcomes
  3. duration ranges from days to years
  4. participation is generally restricted to a highly selected group of individuals
  5. Once subjects agree to participate, they are randomly assigned to one of the study groups
34
Q

What is randomized assignments in design studies?

A

a method of choice for assigning subject to the treatment or control conditions of a clinical trial

35
Q

What how might non-randomization confuse assignments in design studies?

A

non-randomization assignments may cause mixing of the effects of the intervention with difference (like demographics) among the participants of the trial

36
Q

What is a crossover designs?

A

any change of treatment for a patient in a clinical trial involving a switch of study treatment

37
Q

What happens in planned crossover designs?

A

in planned crossovers a protocol is developed in advance, and the patient may serve as his or her own control

38
Q

why do unplanned crossover designs exist?

A

unplanned crossovers exist for various reasons, such as a patient’s request to change treatment

39
Q

History of clinical trials

A

slides 28-29

40
Q

What is a prophylactic trial?

A

it evaluates the effectiveness of a substance that is used to prevent disease, it can also involve a prevention program

41
Q

What is a therapeutic trial?

A

involves a study of curative drugs or a new surgical procedure to improve a patients health

42
Q

What is the main difference between prophylactic and therapeutic trials?

A

outcomes

43
Q

What are clinical trial outcomes referred to as?

A

clinical outcomes or end points

44
Q

What could clinical outcomes include?

A

rates of disease, death, or recovery

45
Q

How is an outcome of interest measured?

A

measured both in the intervention and control arms of a trial to evaluate efficacy

these must be measured in a comparable manner!

46
Q

What is the purpose of blinding (or masking) in clinical trials?

A

to maintain the integrity of a study and reduce the potential for bias

47
Q

What are the 2 popular approaches to blinding (or masking) in clinical trials?

A
  1. Single blind design - where the subject is unaware of group assignment
  2. Double blind design - where neither the subject nor experimenter is aware of group assignment
48
Q

What must happen before a vaccine, drug, or treatment can be licensed for general use?

A

It must go through several stages of development

49
Q

Why are there phases to clinical trials?

A

to protect the public from a potentially deleterious vaccine

to satisfy the urgent needs for new vaccines

50
Q

What are the 2 primary stages in the development of a vaccination program?

A
  1. pre-licensing evaluation of a vaccine

2. post-licensing evaluation

51
Q

What phases does pre-licensing evaluation of a vaccine cover?

A
  1. phase I - safety of adult volunteers
  2. phase II - immunogenicity and reactogenicity in the target population
  3. phase III - protective efficacy
52
Q

What does post-licensing evlaution cover?

A

safety and efficacy of vaccine

disease surveillance

serologic surveillance

measurement of vaccine coverage

53
Q

What are phase IV trials?

A

involve post-marketing research to gather more information about risks and benefits of a drug

54
Q

Can there be more than 3 phases in a clinical trial?

A

yes - there can be 4

55
Q

What are the ethical aspects that must happen in human experimentation?

A

the benefits must outweigh the risks

56
Q

What are some ethical issues in human experimentation?

A

informed consent

withholding treatment known to be effective

protect the interest of the individual patient

monitoring for side effects

deciding when to withdraw a patient

57
Q

What is the CONSORT statement?

A

this is a protocol that guides the reporting of randomized trials by providing a 22-item checklist and a flowchart

58
Q

What are some of the strengths of clinical trials?

A

provide the greatest control over the amount of exposure, the timing and frequency of exposure, and the period of observation

ability to randomize reduces likelihood that groups will differ significantly

59
Q

What are some of the limitations of clinical trials?

A

artificial setting

limited scope of potential impact

adherence to protocol is difficult to enforce

ethical dilemmas

60
Q

What do community trials determine?

A

the potential benefit of new policies and programs

61
Q

What is the definition of an intervention program?

A

any program or other planned effort designed to produce changes in a target population

62
Q

What does community refer to in community trials?

A

community refers to a defined unit - like a county, state, or school district

63
Q

Should a variety of measures be used in community trials?

If so, what are some examples?

A

yes

examples are disease rates, knowledge, attitudes, and practices

64
Q

What is the process for community trials?

A

start by determining eligible communities and their willingness to participate

collect baseline measures of the problem to be addressed in the intervention and control communities

65
Q

Are community trials randomized and followed over time?

A

yes

66
Q

Are outcomes of interest measured in community trials?

A

yes

67
Q

What are some of the advantages of community trials?

A

they represent the only way to estimate directly the impact of change in behavior or modifiable exposure in the incidence of disease

68
Q

What are some of the disadvantages of community trials?

A

they are inferior to clinical trials with respect to ability to control entrance into the study, delivery of the intervention, and monitoring of outcomes

fewer study units are capable of being randomized, which affects comparability

they are affected by population dynamics, secular trends, and nonintervention influences

69
Q

How are quasi-experiment/community trials ranked in strength?

A

ranked immediately below controlled experiments in rigor

70
Q

In quasi-experimental/community trials might there be contamination across the conditions of the study?

A

yes

71
Q

Under the algorithm for determining study type - what type of study is it when an investigator does assign exposures?

A

an experimental study

EPIDEMIOLOGY (8 decks)

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