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Biostats > Exam 1 (First Two Handouts) > Flashcards

Exam 1 (First Two Handouts) Flashcards

1
Q

The degree of confidence a researcher has that the changes observed in the dependent variable (clinical outcome) are because of the independent variable (treatment)

A

Internal Validity

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2
Q

The extent to which the results of a study can be generalized to other settings

A

External Validity

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3
Q

The outcome is a result of the treatment

A

Causality

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4
Q

Cause occurs before the outcome

A

Temporality

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5
Q

Plausibility of causation increases with the strength of the relationship

A

Strength

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6
Q

A linear relationship like a dose-response is observed

A

Biological Gradient

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7
Q

One-to-one relationship between cause and effect

A

Specificity

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8
Q

There should be a reasonable biological explanation/mechanism for the effect

A

Plausibility

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9
Q

The relationship should be explained by existing knowledge

A

Coherence

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10
Q

The effect is similar to those accepted phenomena as observed in preclinical trials

A

Analogy

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11
Q

It is the strongest evidence when the cause is controlled by the researcher and the effect is observed in randomly assigned subjects as in RCTs

A

Experiment

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12
Q

To describe a phenomenon

A

Descriptive

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13
Q

Provide casual interpretation of an existing phenomenon

A

Analytical

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14
Q

What are the five important elements (5 W’s) pertaining to a new disease or event:

A

-Who
-What
-Why
-When
-Where
-So What (later added as a 6th element)

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15
Q

Analytical studies typically involve this word (hint)

A

Causal

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16
Q

Prospective Studies

A

-data are collected after the study as individuals are followed
-researchers get to determine the variables and collect relevant data
-they are resource (time and cost) intensive

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17
Q

Retrospective Studies

A

-researchers go backward in time to determine the relationship between cause and outcome that has already occurred
-analyze existing data so they relatively require minimal resources
-researchers have no control over the variables needed and how they are defined and collected

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18
Q

What three things play an important role in choosing an appropriate research design?

A

-objective of research
-topic of research
-practical considerations

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19
Q

Experimental designs to test their research hypotheses are common in what type of research?

A

Basic

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20
Q

We see both experimental and observational designs in what type of research?

A

Clinical Research

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21
Q

What is the most commonly used experimental design?

A

RCTs

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22
Q

What are the commonly used observational designs are..

A

-cohort
-case-control
-cross-sectional
-case series
-case reports

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23
Q

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

A

Randomized Controlled Trials

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24
Q

What are the TWO essential elements of RCTS?

A

-randomization
-prospective

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25
Q

However the elements of RCTs that increase the internal validity of study results also contribute towards restricting…

A

their external validity (generalizability)

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26
Q

The key element in observational studies is..

A

non-randomization of the independent variable of interest

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27
Q

Primary data technique examples

A

-interviews
-surveys

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28
Q

Secondary data technique examples

A

-medical charts
-medical claims

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29
Q

Involve a study of a single case of a new disease or manifestation

A

Case Report

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30
Q

Exposure and outcome are measured at the same point in time

A

Cross-sectional

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31
Q

Involve comparison of exposure status among individuals with the disease or outcome of interest (cases) and those without the disease or outcome (controls)

A

Case-control

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32
Q

Cases and controls are both identified from the same..

A

source population

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33
Q

Follow exposed and unexposed over a period until the development of outcome

A

Cohort

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34
Q

Cohort studies determine the incidence of the outcome among exposed and unexposed groups and therefore provide a measure of..

A

relative risk

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35
Q

There is no randomization involved in Cohort studies which makes it vulnerable to..

A

selection bias

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36
Q

Cohort studies can be divided into two types:

A

retrospective and prospective

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37
Q

Involve numerical or countable information to study research phenomenon

A

Quantitative Data

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38
Q

Involve words or textual information

A

Qualitative Data

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39
Q

The consistency and reproducibility of results

A

Reliability

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40
Q

Consistent when the same measurement instrument is used by multiple investigators

A

Reproducibility

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41
Q

Measures what is it intended

A

Validity

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42
Q

Participant is aware that he/she is being observed

A

Obtrusive Observation

43
Q

Participant is unaware of the observer who may be either hidden or under disguise

A

Unobtrusive Observation

44
Q

Strongest type of primary study design and most common type of trial

A

RCTs

45
Q

RCTs are required by the FDA as part of a…

A

New Drug Application (NDA)

46
Q

Phase 3 studies are also referred to as..

A

“pivotal trials”

47
Q

The degree to which the findings represent the truth

A

Validity

48
Q

How can you strengthen internal validity?

A

include a control group

49
Q

What is the most effective way to reduce selection bias?

A

Randomization

50
Q

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

A

Hawthorne Effect

51
Q

The external events that occur during the course of the study

A

History Bias

52
Q

Normal changes in study participants over time

A

Maturation Bias

53
Q

Refers to differential dropout of patients from the treatment or control groups

A

Attrition Bias

54
Q

The mean refers to cases where initial measurements of a variable are extremely different from the population mean, but then subsequent measurements are closer to the average

A

Regression (or reversion)

55
Q

Systematic differences between groups in how outcomes are determined

A

Detection Bias

56
Q

Random Number Generator

A

Simple Randomization

57
Q

To ensure that treatment groups have an equal number of patients

A

Block Randomization

58
Q

Ensuring certain baseline characteristics are equal between the groups of a study

A

Stratified Randomization

59
Q

A specific group of subjects are selected for randomization such as those enrolled in a clinic or hospital

A

Cluster (Group) Randomization

60
Q

Those involved in the trial are unaware of what treatment the patients are receiving

A

Blinding (masking)

61
Q

-Least object type of design
-All individuals in the study are aware of what treatment the patients are receiving
-Restricted to early pharmacokinetic studies or phase 1 trials

A

Open Label

62
Q

Only one set of individuals is unaware

A

Single Blind

63
Q

Two sets of individuals are unaware

A

Double Blind

64
Q

All individuals involved in the study are unaware of what the patients were receiving (including investigators)

A

Triple Blind

65
Q

More than one placebo is used

A

Double Dummy

66
Q

Measures the capacity to detect a difference in the study groups if a true difference exists

A

Power

67
Q

Standardized document that provides instructions to the investigators on all aspects of carrying out the study

A

Clinical Research Protocol

68
Q

Specific characteristics that the investigator is most interested in studying

A

Inclusion Criteria

69
Q

Factors that would confound or impair the ability not interpret the study results or eliminate patients that should not be receiving the intervention or an active control

A

Exclusion Criteria

70
Q

Each subject is only randomized to either to a treatment group or a control group

A

Parallel Study Design

71
Q

Receives all of the interventions based on a specified sequence of events

A

Crossover

72
Q

Each subject receives all of the interventions based on a specified sequence of events

A

Crossover

73
Q

What is the most common type of RCT and what is its purpose?

A

-Superiority trial
-Which aims to determine whether or not one treatment is better than another

74
Q

Aims to determine whether or not two interventions are equivalent or nearly equivalent based on a set of acceptance criteria

A

Noninferiority Trial

75
Q

Systematic study to gain knowledge or understanding necessary to determine the means by which a recognized and specific need may be met

A

Applied Research

76
Q

Refers to the collection of information based on human experience. All aspects of science should be observed and measured to be considered as scientific evidence

A

Empiricism

77
Q

Means that there is no subjectivity or bias in any aspect of research including definition, measurement, design, and analysis

A

Objectivity

78
Q

Provides an understanding or explanation of a natural phenomenon. In pharmaceutical research, theories are often based on pathophysiology of a disease and pharmacology of a medication to investigate medication effects

A

Theory

79
Q

Provide the moral societal standards for responsible research conduct

A

Ethics

80
Q

What is the framework often used to develop a good clinical question?

A

PICOTS

81
Q

What does PICOT stand for

A

P- Population to be studied
I- Intervention to be applied
C- Comparator to be used
O- Outcomes to be evaluated
T- Timeline to evaluate the outcomes and healthcare
S- Setting of interest

82
Q

Specifies an expected relationship between intervention and outcome, or two or more variables.

A

Hypothesis

83
Q

involve testing a drug in humans with the intent of establishing the initial toxicity profile of the substance (“tolerability”)

A

Phase 1 Trials

84
Q

Are designed to provide preliminary evidence of efficacy and safety

A

Phase 2 Trials

85
Q

-Generate efficacy and safety data to allow evaluation of the overall risk­ to­ benefit relationship of the drug
-Are usually set up as a Randomized Controlled Trial (RCT) often involving blinding and placebo controls.

A

Phase 3 Trials

86
Q

Studies may be required by FDA to generate longer­term safety/toxicity data.

A

Phase 4 Trials or Post-Marketing

87
Q

Is intended to allow patients to obtain investigational medications outside of clinical trials or current expanded access programs

A

Right-To-Try Act

88
Q

-Individuals should be treated as autonomous agents
-Persons with diminished autonomy are entitled to protection
-The informed consent process ensures the respect to person

A

Respect for Persons

89
Q

-Maximizing possible benefits.
-Minimizing possible harm.
-Never knowingly cause (permanent) injury

A

Beneficence

90
Q

-Sense of fairness in distributing the burdens and benefits of research.
-Researchers are obligated to ensure that no group inappropriately bears the burdens of research for others’ benefit.

A

Justice

91
Q

What are the three basic principles of the Belmont Report?

A

-Respect for persons
-Beneficence
-Justice

92
Q

National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, which was set up by the National Research Act, published Ethical Principles and Guidelines for the Protection of Human Subjects of Research known as the

A

Belmont Report

93
Q

There are three types of IRB review:

A

-Exemption
*Surveys/interviews, use of existing data, or specimens without identifiers

-Expedited review by the chair or designee
*minimal risk protocols that do not meet one of the exemptions

-Full review by the whole board
*all protocols involving greater than minimal risk

94
Q

Charged with protecting the rights and welfare of human subjects of research and ensuring that research is conducted in accordance with accepted ethical standards.

A

Institutional Review Board

95
Q

Used to estimate the effect of an exposure on a disease outcome (measures of effect such as causal RRs and causal rate ratios, respectively).

A

Risk ratios (RRs) and rate ratios

96
Q

The most basic form of medical evidence that often provides the first suspicion that an issue exists

A

Case Report

97
Q

Case reports only serve to provide a description of a situation and is not…

A

intended to lead to a conclusion or answer a hypothesis

98
Q

The removal of most medications from the market due to adverse reactions are due to…

A

case report evidence

99
Q

Report adverse drug reactions to…

A

MedWatch

100
Q

Why are adverse drug reactions in special populations not frequently identified?

A

these patients are often excluded from research

101
Q

Due to case reports describing novel occurrences, it has a high _______

A

sensitivity; however it has a chance of reporting false results and therefore a lower level of specificity

102
Q

How are sensitivity and specificity related?

A

Inversely

103
Q

Case Series

A

Descriptive

Biostats (19 decks)

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