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Pharmaceutical Informatics > Study Design > Flashcards

Study Design Flashcards

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1
Q

is a specific plan or protocol for conducting study, which allows the investigator to
translate the conceptual hypothesis into an operational one

A

Study Design

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2
Q

a study design where participants are
randomly assigned to either a treatment group or a control group to test the effectiveness of a
new medication.

A

randomized controlled trial

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3
Q

Studies that do not involve any intervention or experiment.

A

Observational

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4
Q

Studies that entail manipulation of the study factor (exposure) and randomization of subjects to treatment (exposure) groups.

A

Experimental

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5
Q

Non-experimental

A

Observational Studies

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6
Q

Observational because there is no individual intervention

A

Observational Studies

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7
Q

Treatment and exposures occur in a “non controlled” environment

A

Observational Studies

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8
Q

Individuals can be observed prospectively, retrospectively or currently

A

Observational Studies

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9
Q

Case Reports

A

Descriptive Studies

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10
Q

Detailed presentation of a single case or handful of cases.

A

Descriptive Studies

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11
Q

Generally report a new or unique finding:
*previous undescribed disease
*unexpected link between diseases
*unexpected new therapeutic effect
*adverse effects/events

A

Descriptive Studies

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12
Q

To observe and analyze
relationships between
variables without manipulation
by the researcher.

A

Observational Study

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13
Q

Typically focuses on
understanding relationships,
associations, or patterns
between variables.

A

Observational Study

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14
Q

Analyzes relationships
between variables using
statistical techniques.

A

Observational study

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15
Q

To describe characteristics,
behaviors, or phenomena
without manipulation or
intervention

A

Descriptive Study

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16
Q

Typically focuses on
describing characteristics,
behaviors, or phenomena
within a specific population or
setting.

A

Descriptive Study

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17
Q

Analyzes relationships
between variables using
statistical techniques.

A

Descriptive Study and Observational Study

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18
Q

Experience of a group of patients with a similar diagnosis

A

Case Series

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19
Q

A case series typically involves a group of patients who have been diagnosed
with the same or similar medical condition.

A

Case Series

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20
Q

Cases may be identified from a single or multiple sources

A

Case Series

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21
Q

Cases for a case series can be identified from various sources, including a
single hospital or clinic, multiple healthcare facilities, or population-based
registries.

A

Case Series

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22
Q

Generally report on new/unique condition

A

Case Series

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23
Q

Case Series is useful for hypothesis generation T/F

A

T

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24
Q

Case Report is Informative for very rare disease with few established risk factors T/F

A

F. Case Series is informative…

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25
Q

Disadvantage of case series is it cannot study cause and effect relationships T/F

A

T

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26
Q

Case series can assess disease frequency T/F

A

F. cannot assess

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27
Q

one cause of unusual findings

A

Case report

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27
Q

2 descriptive studies

A

Case report
Case series

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28
Q

involves the detailed description of a single patient or a small group of patients
who present with an unusual or rare medical condition, complication, or
unexpected response to treatment.

A

case report

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29
Q

multiple cases of findings

A

Case series

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30
Q

*involves the analysis and description of a group of patients who share similar
clinical characteristics, diagnoses, or experiences.

A

Case series

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31
Q

Basic question in analytical study:

A

ARE EXPOSURE AND DISEASE LINKED?

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32
Q

relationship between exposure and disease:

A

E –> D; Exposure leads to disease

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33
Q

Group data

A

Ecological Study

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34
Q

Individual data

A

Cross-sectional study
Case-control study
Cohort study

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35
Q

An investigation of the distribution of health and its determinants between groups
of individuals.

A

Ecological study

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36
Q

Unit of study is the aggregate data not individual level

A

Ecological study

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37
Q
  • It is usually be conducted as the first step study for research
A

Ecological data

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38
Q

The result is difficult to interpret because of confounding and bias

A

Ecological data

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39
Q

Advantage of Ecological data is it is cheap, quick and convenient since is
usually comes from existing data . T/F

A

True

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40
Q

Ecological data is unable to link exposure with diseasein individual (ecological fallacy) T/F

A

T

41
Q

A disadvantage of ecological data is its limit to control effect of other factors. T/F

A

True

42
Q

An observational design that surveys exposures and disease status at a single point of a time (a cross section of the population)

A

Cross Sectional Study

43
Q

Often used to study conditions that are relatively frequent with long duration of
expressions (nonfatal, chronic conditions)

A

Cross-sectional Study

44
Q

It measures prevalence, not incidence of disease

A

Cross-sectional Study

45
Q
  • Not suitable for studying rare or highly fatal diseases or a disease with short
    duration of expression
A

Cross-sectional Study

46
Q

CROSS-SECTIONAL STUDY Gives general description or scope of problem, T/F

A

T

47
Q

Cross-sectional study is useful in health service evaluation and planning. T/F

A

T

48
Q

Cross sectional study is the baseline for retrospective study. T/F

A

F. baseline for prospective study

49
Q

Cross-sectional study advantage is that it is low cost. T/F

A

T

50
Q

A disadvantage of cross-sectional study is that there is no calculation of risk. T/F

A

T

51
Q

A disadvantage of cross-sectional study is that temporal sequence is unclear. T/F

A

T

52
Q

A disadvantage of cross-sectional study is that it is good for rare disease. T/F

A

false. It is NOT good

53
Q

A disadvantage of cross-sectional study is that selective recall can lead to bias. T/F

A

T

54
Q

An “observational” design comparing exposures in diseases cases vs healthy
controls from same population

A

Case Control Study

55
Q

Exposure data collected retrospectively

A

Case control study

56
Q

Most feasible design where disease outcomes are rare

A

Case Control Study

57
Q

The ODDS ratio

A

Odds ratio = ad/bc

58
Q

An advantage of case control study is that it is Cheap, easy and quick studies. T/F

A

True

59
Q

An advantage of case control study is that it Require comparatively few subjects. T/F

A

T

60
Q

In case control studies, its advantage is that Multiple exposures can be examined.

A

T

61
Q

In case control studies, rare diseases and diseases with long latency can be studied

A

True

62
Q

A disadvantage in case control studies is that the Case and control selection are
troublesome. T/F

A

T

63
Q

A disadvantage in case control studies is that it is subject to bias. T/F

A

T

64
Q

In case control study, a disadvantage is that direct estimation of incidence is not
possible

A

T

65
Q

In case control studies, if the incidence of exposure is low, it is difficult to show the difference between cases and controls, a disadvantage.

A

F. incidence of exposure is high

66
Q

An “observational” design comparing individuals with a known risk factor or
exposure with others without the risk factor or exposure.

A

Cohort Study

67
Q

Looking for a difference in the risk (incidence) of a disease over time.

A

Cohort Study

68
Q

One of the best observational design

A

Cohort study

69
Q

Data usually collected prospectively (some retrospective)

A

Cohort study

70
Q

Cohort study advantage is that it can establish population-based incidence. T/F

A

T

71
Q

In cohort study, there is an inaccurate relative risk (risk ratio) estimation. T/F

A

F. Accurate relative risk

72
Q

In Cohort study an advantage is that it can be used where randomization is
not possible. T/F

A

T

73
Q

In Cohort study, Selection and information biases are increased. T/F

A

F. Decreased

74
Q

In Cohort study, multiple outcomes can be studied. T/F

A

T

75
Q

A disadvantage of Cohort study is that it is lengthy and expensive. T/F

A

T

76
Q

Cohort studies may require large samples. T/F

A

T

77
Q

Cohort studies are not suitable for rare diseases. T/F

A

T

78
Q

Cohort studies are not suitable for diseases with long-latency. T/F

A

T.

79
Q

In cohort studies, unexpected environmental changes may influence the association. T/F

A

T

80
Q

In Cohort studies, a disadvantage is nonresponse, migration and
loss-to-follow-up biases. T/F

A

T.

81
Q

In this study, treatment and exposures occur in a “controlled” environment.

A

Experimental study.

82
Q

In this study, there are Planned research designs.

A

Experimental study.

83
Q

The most well known experimental designs

A

Clinical trials

84
Q

In this study, Investigator can “control” the exposure to laboratory experiments except living populations are the subjects.

A

Experimental study.

85
Q

This study generally involves random assignment to groups

A

Experimental study.

86
Q

It is the ultimate step in testing casual hypothesis

A

Experimental study

87
Q

The “gold standard” of research designs

A

Experimental study.

88
Q

Provides most convincing evidence of relationship between exposure and effect

A

Experimental study.

89
Q

An advantage of experimental study is its ability to randomize subjects. T/F

A

T.

90
Q

An advantage of experimental study is the temporal sequence of cause and
effect. T/F

A

T.

91
Q

An advantage of experimental study is it can control extraneous variables. T/F

A

T.

92
Q

An advantage of experimental study is it is the best evidence of casuality. T/F

A

T.

93
Q

One disadvantage of experimental study is that it is expensive.

A

T.

94
Q

One disadvantage of experimental study is that it may be unethical to assign persons
to certain treatment or comparison
groups.

A

T.

95
Q

A design with the subject randomly assigned to “treatment” and “comparison”
groups.

A

Randomized Clinical Trial

96
Q

Provides most convincing evidence between exposure and effect

A

RCT

97
Q

It is possible to use RCT’s to test effects of exposures that are expected to be
harmful for ethical reasons. T/F

A

F. It is NOT possible.

98
Q

What are other types of Experimental study

A

Field trials
Community Trials
Animal studies

99
Q

statistical analysis of a collection of studies

A

Meta analysis

100
Q

Focus on contrasting and comparing results from different studies in anticipation of identifying consistent patterns and sources of
disagreements among these results.

A

Meta-analysis methods.

Pharmaceutical Informatics (3 decks)

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