Exam 1 Flashcards
(93 cards)
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
2
Q
External validity
A
Refers to the extent to which the results of a study can be generalized to other settings/larger population
3
Q
Causality
A
The outcome is the result of the treatment
4
Q
What are the 9 criteria for casual relationships
A
Temporality
Strength
Biological gradient
Consistency
Specificity
Plausibility
Coherence
Analogy
Experiment
(ACCEPTS Some Bitches)
5
Q
What is meant by temporality
A
Cause occurs before the outcome
6
Q
What is meant by strength
A
Plausibility of causation increases with the strength of the relationship
7
Q
What is meant by biological gradient
A
Linear relationship like a dose response is observed
8
Q
What is meant by consistency
A
Casual relationship exists in different settings
9
Q
What is meant by specificity
A
One to one relationship between cause and effect
10
Q
What is meant by plausibility
A
Reasonable biological explanation
11
Q
What is meant by coherence
A
Explained by existing knowledge
12
Q
What are descriptive studies
A
Describe/summarize info without making any casual inferences
12
Q
What is meant by experiment
A
Evidence that cause is controlled by the researcher
12
Q
What is meant by analogy
A
Effect is similar to accepted phenomena
13
Q
What is the purpose of a study
A
- to describe a phenomena
- provide casual interpretation of existing phenomenon
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)
15
Q
What are analytical studies
A
- aimed at understanding casual mechanism
- can involve both experimental and observational designs
16
Q
What is common in basic research
A
Experimental designs
17
Q
What is seen in clinical research
A
Both experimental and observational designs
18
Q
What is most commonly used in experimental design
A
Randomized controlled trials (RCT)
19
Q
What are the two essential elements of randomized controlled trials
A
Randomization and prospective
19
Q
What is the gold standard in evaluating safety and efficacy of an intervention
A
Randomized controlled trials (RCT)
20
Q
What is the independent variable
A
Exposure of interest, like medication or intervention
20
Q
What types of data can be utilized in observational studies
A
- primary data (interviews, surveys)
- secondary data (medical charts)
20
What is a limitation of RCTs
Restricted external validity; may not be generalizable to real world settings
21
What is the key element of observational studies
Non-randomization of independent variable
22
What can case reports lead to
Generation of a hypothesis
22
What does a case report involve
A study of a single case of a new disease of manifestation
22
When are cross sectional studies inappropriate to be used
To study causality
22
How is a cross sectional study conducted
Exposure and outcome are measured at the same point in time
23
Where are case and controls identified from in case-control studies
From the same source population
24
When are cross sectional studies inappropriate to be used
To study causality
25
What is the design of choice to study a rare outcome and when there is a long latency period
Case control studies
26
How are cohort studies conducted
Follow exposed and unexposed over a period until development of outcome
27
How are the groups defined in cohort studies
Exposure status (exposed vs unexposed)
28
What does a cohort study provide a measure of
Relative risk
29
What is a retrospective (historic) cohort study
Uses previously collected data
29
What is a prospective cohort study
Groups followed in the future
29
What is a limitation of cohort studies
No randomization, so vulnerable to selection bias
30
What is quantitative data
Numerical or countable information
31
What is qualitative data
Words or textual information
32
What are primary methods
- collects data specifically for the research question
- surveys and observations
33
What are secondary methods
- data that was collected for a different purpose
- medical charts and medical claims
34
What guides the choice of data collection method
- research question
- population of interest
- availability and feasibility of method
- cost
35
What are the strengths of secondary methods
- easier to conduct
- less costly
36
What are the weaknesses of secondary methods
- may not include needed variables
- difficult to interpret (may lack info)
37
What are the strengths of primary methods
Data collected fits need of study and can be tailored
38
What are the weaknesses of primary methods
Resource intensive (cost, time)
38
What is reliability
Consistency and reproducibility of a given result
39
What is validity
- extent to which it measures what is intended
- degree to which findings represent the truth
40
What are the strengths of open ended questions
Provides flexibility to patient
41
What are the weaknesses of open ended question
- unsuitable for statistical analysis
- challenging
- time consuming
42
What are the strengths of close ended questions
- provides specific set of responses
- easy to code and use in statistical analysis
43
What is an unobtrusive observation
Participant is unaware of the observer
43
What are the weaknesses of close ended questions
Limits option choices
44
What is an obtrusive observation
Participant is aware that he/she is being observed
45
What is the:
- strongest type of primary study
- most common type of trial used to determine efficacy
- required by the FDA
?
Randomized controlled trials (RCTs)
46
What are RCTs referred to as
Phase III studies or pivotal trials
47
What does bias refer to
Systematic errors
48
What threatens the internal validity of a study the most
Biases
49
What is the purpose of including a control group
Strengthening internal validity
50
How do you get selection bias
Preferential enrollment
51
When is selection bias the most problematic
Retrospective trials or in observational designs
52
What is the most effective way to reduce selection bias
Randomization
53
What is the Hawthorne effect
Subjects modify their behavior because of the fact that they are being studied or observed
54
What is the placebo effect
Leads to favorable response because patients believe it should work
55
What is the best way to minimize the Hawthorne and placebo effect
Control group and blind participants
56
What is history bias
External events (death of family, loss of job) that occur during the course of the study that can alter the outcome
57
What is maturation bias
Normal changes in study participants over time
58
What is maturation bias
Normal changes in study participants over time
59
What is attrition bias
- differential dropout of patients in treatment and control groups
- controlled by enrolling more patients
60
What is testing bias and how is it minimized
- 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
What is regression to the mean and how is it minimized
- 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
(IRAT Q): a scientific study designed to test a medical intervention in humans is known as
A clinical trial
62
(IRAT Q): Case reports are effective in
Generating a hypothesis
63
(IRAT Q): Cohort studies mirror the clinical trial design in the following way
They start with groups exposed and unexposed
64
(IRAT Q): Which research deals with the areas of inquiry like pharmacology, med chem, pharmaceutics
Applied
64
(IRAT Q): Which of the following is NOT an objective of case reports
- disease identification
- adverse reaction reporting
- quality assurance
- medication efficacy testing
Medication efficacy testing
65
(IRAT Q): _____ refers to the collection of information based on human experience
Empiricism
66
(IRAT Q): Which is considered to be the gold standard in evaluating the safety and efficacy of an intervention
Randomized clinical trials
67
(IRAT Q): Equitable selection is based on which ethical principle
Justice, because the risks of research should be shared equally
68
(IRAT Q): Which of the following other observational study designs observe study participants at only one point in time
Cross-sectional study design
69
(IRAT Q): Which of the following are true regarding consent for the publication of a case report
If a patient has passed away, next of kin should be contacted for consent
70
(IRAT Q): ______ reflects the extent to which the clinical outcome of interest (dependent variable) in a study is caused by the treatment (independent variable)
Internal validity
71
(IRAT Q): The ____ of an event is calculated as a ratio between two incidence proportions or two incidence rates
Relative risk
72
(IRAT Q): Which of the following is included in evidence based medicine
Research evidence
Clinical expertise
Patient values
All of these are correct
73
(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
After phase I trials
74
(IRAT Q): A study’s ____ measures the capacity to detect a difference in the study groups if a true difference exists
Power
74
(IRAT Q): Which study design is universally superior to other study designs
None
75
(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
Random sampling
76
In what phase of clinical trials does the evaluation of safety data take place
Phase I
Phase II
Phase III
77
(IRAT Q): If a figure or table is included in a case report, which of the following is correct
A table or figure should be able to stand on its own
78
(IRAT Q): A major difference between a case series and case report is
Sample size
