Exam 1 - Research Designs & Methods

Question 1

Validity

Answer 1

The accuracy of results

Extent to which an instrument measures what it is intended to measure

(If it isn’t accurate, it isn’t valid)

Question 2

Internal validity

Answer 2

Degree to which study outcomes can be explained by the differences in the assigned intervention

To strengthen: add a control group

Question 3

External validity

Answer 3

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

(Is it valid outside the study?)

Question 4

Causality

Answer 4

The outcome is the result of the treatment

(Think cause and effect)

Question 5

Analytical studies

Answer 5

Provide casual interpretation of an existing phenomenon

Used to test a hypothesis

(Casual anal)

Question 5

Descriptive studies

Answer 5

Describes a phenomenon

Describes/summarizes info about diseases/events without making any casual inferences

Casual inferences = who, what, when, where, why

Question 6

Prospective studies

Answer 6

Data is collected after the study as individuals are followed

Time and cost intensive

Researchers determine variables

Question 7

Interventional/experimental studies

Answer 7

Researcher controls the treatment

Usually involved randomization

Question 7

Retrospective studies

Answer 7

Researchers go backward in time to determine relationship between cause and outcome that has already occurred

Require minimal resources; researchers have NO control over variables

(Retro = past)

Question 8

Quasi-experimental studies

Answer 8

Experimental designs WITHOUT randomization

Kind of like observational studies

Question 9

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

Answer 9

Randomized controlled trials

Question 10

2 essential elements of RCTs

Answer 10

Randomization of participants to interventional and control groups

Prospective - patients in study group are followed after the intervention to evaluate changes in clinical outcome

(Random and prospective)

Question 10

Do RCTs increase or decrease internal validity

Answer 10

Increase

Question 11

What is the key element of observational designs

Answer 11

Non-randomization of the independent variable

Question 11

Observational designs

Answer 11

Researcher observes the relationship between independent (intervention/exposure) and dependent (outcome/disease) variables in a natural setting

(Observing variables)

Question 12

Types of observational studies

Answer 12

Case report
Cross sectional
Case control
Cohort studies

(4 Cs or Really Sad Cassie Studies)

Question 13

Case report

Answer 13

Study of a single case of a new disease/manifestation

Question 14

Cross-sectional

Answer 14

The exposure and outcome are measured at the same point in time

(The exposure and the outcome cross)

Question 15

Case control

Answer 15

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

(To compare, you have to control the case)

Question 16

Cohort studies

Answer 16

Followed exposed and unexposed groups over a period of time until the development of the outcome of interest (RR)

Question 17

Research methodology

Answer 17

Focuses on data collection and measurement techniques

(Collection and techniques are methods)

Question 18

Primary methods (research methodology)

Answer 18

Collect data specifically for the research question under consideration

Ex. Surveys and observations

Question 19

Pros/cons of primary methods (research methodology)

Answer 19

PROS: researcher can collect data to fit needs of study

CONS: resource intensive (cost and time)

(Takes more time and money to have something personalized)

Question 20

Pros/cons of secondary methods (research methodology)

Answer 20

PROS: easier to conduct and less costly

CONS: may not include certain variables needed for the purposes of the study and may be difficult to interpret

(You save time and money if you don’t order something personalized, but it may not be exactly what you want)

Question 21

Secondary methods (research methodology)

Answer 21

Use of data that was collected for a different purpose

Ex. Medical charts and medical claims

Question 22

Reliability

Answer 22

Consistency and reproducibility of results

Question 23

RCTs are in which phase of the drug development process

Answer 23

Phase III

Question 23

Bias

Answer 23

Systematic errors that can occur during the implementation of a study

Question 23

What can be done to reduce selection bias

Answer 23

Randomization

Question 24

Investigator bias

Answer 24

Errors in the the:

• study design
• implementation
• analysis by the investigator

Question 24

Simple randomization

Answer 24

Use of a random number generator to allocate participants to study groups

(Random number generator sounds like the easiest [simplest] option)

Question 24

Hawthorne effect

Answer 24

Subjects modify their behavior because of the fact they’re being studied or observed

(Hawthorne was a man, and men be changing their behavior like this)

Question 24

Selection bias

Answer 24

Preferential enrollment of specific patients into one treatment group over another

Question 25

Randomization

Answer 25

Assigned patients to a treatment or control group by chance

Question 25

Block randomization

Answer 25

Ensures treatment groups have an equal number of patients by dividing into “blocks”

Question 26

Stratified randomization

Answer 26

Ensures certain baseline characteristics are equal between groups of a study

Question 27

Group/cluster randomization

Answer 27

Subjects in the same cluster would be randomized and receive the same treatment

Question 28

Blinding

Answer 28

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

(Blind to their treatment)

Question 29

Double blind

Answer 29

Two sets of individuals are unaware of what the patients are receiving

(Double = two sets)

Question 30

Single blind

Answer 30

Only one set of individuals is unaware of what the patients are receiving

(Single = one set)

Question 31

Sample size

Answer 31

Number of participants to be enrolled in each treatment group in a study

Question 32

Effect size (sample size)

Answer 32

Statistical elimination of the magnitude of effect due to treatment or the association between 2+ variables that is likely to occur

(How big is the effect)

Question 32

Power (sample size)

Answer 32

Measures the capacity to detect a difference in the study groups if a true difference exists (a larger study group indicates greater power)

(Think power difference)

Question 33

Clinical research protocol

Answer 33

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

(Think of it as the instruction manual)

Question 34

Inclusion criteria

Answer 34

The specific characteristics that the investigator is most interested in studying

(You’re only included if the researcher is interested in you)

Question 35

Exclusion criteria

Answer 35

The factors that would confound or impair the ability to interpret the study results or eliminate patients that should not be receiving the intervention

Question 36

Relative risk

Answer 36

Ratio between the rate of the outcome in the treatment and control groups

Question 36

Placebo

Answer 36

Consists of an inert substance (ex. Lactose powder) that is identical in appearance (shape, form, taste, color) to the active treatment

Question 37

Relative risk difference

Answer 37

How far away the relative risk is from the “no difference mark” of 1

Question 38

Number needed to treat

Answer 38

The number of patients that must receive the treatment in order for one patient to experience a desired outcome

(Number needed for treatment to work in one person. Like 1 in X)

Question 39

Number needed to harm

Answer 39

The number of patients that must receive the treatment in order for one patient to experience an adverse outcome (should be high to be considered a safe medication)_

(Think out of # people, only one was harmed. Ex. You have a 1 in 1 million chance)