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Biostats > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

Internal validity

A
  • the degree of confidence a researcher has that the changes observed in the dependent variable are because of the independent variable
  • degree to which study outcomes can be explained by differences in assigned intervention
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2
Q

External validity

A

Refers to the extent to which the results of a study can be generalized to other settings/larger population

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3
Q

Causality

A

The outcome is the result of the treatment

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4
Q

What are the 9 criteria for casual relationships

A

Temporality
Strength
Biological gradient
Consistency
Specificity
Plausibility
Coherence
Analogy
Experiment

(ACCEPTS Some Bitches)

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5
Q

What is meant by temporality

A

Cause occurs before the outcome

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6
Q

What is meant by strength

A

Plausibility of causation increases with the strength of the relationship

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7
Q

What is meant by biological gradient

A

Linear relationship like a dose response is observed

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8
Q

What is meant by consistency

A

Casual relationship exists in different settings

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9
Q

What is meant by specificity

A

One to one relationship between cause and effect

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10
Q

What is meant by plausibility

A

Reasonable biological explanation

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11
Q

What is meant by coherence

A

Explained by existing knowledge

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12
Q

What are descriptive studies

A

Describe/summarize info without making any casual inferences

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12
Q

What is meant by experiment

A

Evidence that cause is controlled by the researcher

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12
Q

What is meant by analogy

A

Effect is similar to accepted phenomena

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13
Q

What is the purpose of a study

A
  • to describe a phenomena
  • provide casual interpretation of existing phenomenon
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14
Q

What are the 5 Ws of descriptive studies

A

Who (demographic)
What (case definition)
Why (clues about casual mechanism)
When (time period)
Where (place of occurrence)
So What (significance)

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15
Q

What are analytical studies

A
  • aimed at understanding casual mechanism
  • can involve both experimental and observational designs
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16
Q

What is common in basic research

A

Experimental designs

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17
Q

What is seen in clinical research

A

Both experimental and observational designs

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18
Q

What is most commonly used in experimental design

A

Randomized controlled trials (RCT)

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19
Q

What are the two essential elements of randomized controlled trials

A

Randomization and prospective

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19
Q

What is the gold standard in evaluating safety and efficacy of an intervention

A

Randomized controlled trials (RCT)

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20
Q

What is the independent variable

A

Exposure of interest, like medication or intervention

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20
Q

What types of data can be utilized in observational studies

A
  • primary data (interviews, surveys)
  • secondary data (medical charts)
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20
Q

What is a limitation of RCTs

A

Restricted external validity; may not be generalizable to real world settings

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21
Q

What is the key element of observational studies

A

Non-randomization of independent variable

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22
Q

What can case reports lead to

A

Generation of a hypothesis

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22
Q

What does a case report involve

A

A study of a single case of a new disease of manifestation

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22
Q

When are cross sectional studies inappropriate to be used

A

To study causality

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22
Q

How is a cross sectional study conducted

A

Exposure and outcome are measured at the same point in time

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23
Q

Where are case and controls identified from in case-control studies

A

From the same source population

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24
Q

When are cross sectional studies inappropriate to be used

A

To study causality

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25
Q

What is the design of choice to study a rare outcome and when there is a long latency period

A

Case control studies

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26
Q

How are cohort studies conducted

A

Follow exposed and unexposed over a period until development of outcome

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27
Q

How are the groups defined in cohort studies

A

Exposure status (exposed vs unexposed)

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28
Q

What does a cohort study provide a measure of

A

Relative risk

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29
Q

What is a retrospective (historic) cohort study

A

Uses previously collected data

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29
Q

What is a prospective cohort study

A

Groups followed in the future

29
Q

What is a limitation of cohort studies

A

No randomization, so vulnerable to selection bias

30
Q

What is quantitative data

A

Numerical or countable information

31
Q

What is qualitative data

A

Words or textual information

32
Q

What are primary methods

A
  • collects data specifically for the research question
  • surveys and observations
33
Q

What are secondary methods

A
  • data that was collected for a different purpose
  • medical charts and medical claims
34
Q

What guides the choice of data collection method

A
  • research question
  • population of interest
  • availability and feasibility of method
  • cost
35
Q

What are the strengths of secondary methods

A
  • easier to conduct
  • less costly
36
Q

What are the weaknesses of secondary methods

A
  • may not include needed variables
  • difficult to interpret (may lack info)
37
Q

What are the strengths of primary methods

A

Data collected fits need of study and can be tailored

38
Q

What are the weaknesses of primary methods

A

Resource intensive (cost, time)

38
Q

What is reliability

A

Consistency and reproducibility of a given result

39
Q

What is validity

A
  • extent to which it measures what is intended
  • degree to which findings represent the truth
40
Q

What are the strengths of open ended questions

A

Provides flexibility to patient

41
Q

What are the weaknesses of open ended question

A
  • unsuitable for statistical analysis
  • challenging
  • time consuming
42
Q

What are the strengths of close ended questions

A
  • provides specific set of responses
  • easy to code and use in statistical analysis
43
Q

What is an unobtrusive observation

A

Participant is unaware of the observer

43
Q

What are the weaknesses of close ended questions

A

Limits option choices

44
Q

What is an obtrusive observation

A

Participant is aware that he/she is being observed

45
Q

What is the:
- strongest type of primary study
- most common type of trial used to determine efficacy
- required by the FDA
?

A

Randomized controlled trials (RCTs)

46
Q

What are RCTs referred to as

A

Phase III studies or pivotal trials

47
Q

What does bias refer to

A

Systematic errors

48
Q

What threatens the internal validity of a study the most

A

Biases

49
Q

What is the purpose of including a control group

A

Strengthening internal validity

50
Q

How do you get selection bias

A

Preferential enrollment

51
Q

When is selection bias the most problematic

A

Retrospective trials or in observational designs

52
Q

What is the most effective way to reduce selection bias

A

Randomization

53
Q

What is the Hawthorne effect

A

Subjects modify their behavior because of the fact that they are being studied or observed

54
Q

What is the placebo effect

A

Leads to favorable response because patients believe it should work

55
Q

What is the best way to minimize the Hawthorne and placebo effect

A

Control group and blind participants

56
Q

What is history bias

A

External events (death of family, loss of job) that occur during the course of the study that can alter the outcome

57
Q

What is maturation bias

A

Normal changes in study participants over time

58
Q

What is maturation bias

A

Normal changes in study participants over time

59
Q

What is attrition bias

A
  • differential dropout of patients in treatment and control groups
  • controlled by enrolling more patients
60
Q

What is testing bias and how is it minimized

A
  • improvements that can occur by repeated testing
  • participant may alter behaviors because of monitoring
  • minimized by having consistent assessment methods by unbiased investigators or use control group that is similarly influenced
61
Q

What is regression to the mean and how is it minimized

A
  • initial measurements of a variable are extremely different from population mean, but subsequent measurements are closer to the average
  • avoid extreme groups and use control drugs
62
Q

(IRAT Q): a scientific study designed to test a medical intervention in humans is known as

A

A clinical trial

62
Q

(IRAT Q): Case reports are effective in

A

Generating a hypothesis

63
Q

(IRAT Q): Cohort studies mirror the clinical trial design in the following way

A

They start with groups exposed and unexposed

64
Q

(IRAT Q): Which research deals with the areas of inquiry like pharmacology, med chem, pharmaceutics

A

Applied

64
Q

(IRAT Q): Which of the following is NOT an objective of case reports

  • disease identification
  • adverse reaction reporting
  • quality assurance
  • medication efficacy testing
A

Medication efficacy testing

65
Q

(IRAT Q): _____ refers to the collection of information based on human experience

A

Empiricism

66
Q

(IRAT Q): Which is considered to be the gold standard in evaluating the safety and efficacy of an intervention

A

Randomized clinical trials

67
Q

(IRAT Q): Equitable selection is based on which ethical principle

A

Justice, because the risks of research should be shared equally

68
Q

(IRAT Q): Which of the following other observational study designs observe study participants at only one point in time

A

Cross-sectional study design

69
Q

(IRAT Q): Which of the following are true regarding consent for the publication of a case report

A

If a patient has passed away, next of kin should be contacted for consent

70
Q

(IRAT Q): ______ reflects the extent to which the clinical outcome of interest (dependent variable) in a study is caused by the treatment (independent variable)

A

Internal validity

71
Q

(IRAT Q): The ____ of an event is calculated as a ratio between two incidence proportions or two incidence rates

A

Relative risk

72
Q

(IRAT Q): Which of the following is included in evidence based medicine

Research evidence
Clinical expertise
Patient values

A

All of these are correct

73
Q

(IRAT Q): At what point of the drug development process does a patient request a developmental drug as part of the “right to try” act

A

After phase I trials

74
Q

(IRAT Q): A study’s ____ measures the capacity to detect a difference in the study groups if a true difference exists

A

Power

74
Q

(IRAT Q): Which study design is universally superior to other study designs

A

None

75
Q

(IRAT Q): Which of the following sampling strategies has the best possibility to result in a representative sample of participants from a source population

  • Convenience sampling
  • Purposive sampling
  • Random sampling
  • Both convenience and random sampling
A

Random sampling

76
Q

In what phase of clinical trials does the evaluation of safety data take place

A

Phase I
Phase II
Phase III

77
Q

(IRAT Q): If a figure or table is included in a case report, which of the following is correct

A

A table or figure should be able to stand on its own

78
Q

(IRAT Q): A major difference between a case series and case report is

A

Sample size

Biostats (19 decks)

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