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Study Design and Clinical Trials > Midterm Exam > Flashcards

Midterm Exam Flashcards

1
Q

CADR & CIDER

A

Databases from insurance claims for large scale, big data trend searches

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2
Q

Controls

A

Should be the exact same as the cases and would have been included had they had the disease. All other covariates are the same

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3
Q

Types of Matching in Case Control

A

Frequency Matching
Based on the population distribution in cases
1:k
Must be acknowledged in the statistical test

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4
Q

Epidemiological Studies

A

Cross-Sectional
Cohort
Case Control

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5
Q

Exposure

A

Behavioral, environmental, or clinical factor that could influence the incidence of a disease or mortality

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6
Q

Incidence

A

Measure of the risk of developing some new condition within a specified time period

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7
Q

Prevalence

A

Proportion of the population with a given disease

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8
Q

Case Report

A

Simplest

Physician notes an event and then documents the course of the patient to develop of hypothesis

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9
Q

Case Series

A

Medical study tracks patients prospectively or retrospectively to observe the effects

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10
Q

Observational Studies

A

No causality
Have a large N number
Looks at association
Open to bias

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11
Q

Cross Sectional

A

Non-experimental
Data on exposure and disease taken at the same time
Bias: publication, survival, recall, selection

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12
Q

Statistics for Cross Sectional

A

OR, RR and logistic regression

If b>0 then it means that there is positive connection
if b=0 then there is no connection
if b<0 then there is a negative connection

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13
Q

Retrospective cohort study

A

Medical records of similar individuals except for a key factor is collected and then analyzed to see if there is a difference in the groups. RR and OR can be used
Good for rare diseases

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14
Q

Case Control

A

Disease status is known before the study and then the exposure status is collected retroactively to determine if there is an increased chance of it being in that group.

Use OR

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15
Q

Odds Ratio

A

The OR represents the odds that an outcome will occur given a particular exposure, compared to the odds of the outcome occurring in the absence of that exposure

OR=(ad)/(bc)

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16
Q

Prospective Cohort Study

A 
Non-experimental
A cohort of people is developed with differing exposure levels and then followed overtime
Has the temporal relationship
Incidence can be checked
False correlations can be present
17
Q

Aging Longitudinal Study

A

Starting point is birth
Starts with unaffected
Follow over time

18
Q

Natural History

A

Follow a group of people overtime who have the disease or at risk for a disease
Gives information on how the disease manifests overtime
Time point for the start is normally diagnosis

19
Q

Follow Up Study

A

Longitudinal study where individuals over time are monitored and use survival data

20
Q

Systematic Error

A

error that is not determined by chance but is introduced by an inaccuracy inherent in the system

21
Q

Longitudinal Statistic Methods

A

Mixed Linear Models
Generalized Estimating Equations
Random Coefficients Model

22
Q

Clinical Trial

A

Can be blinded
There is an intervention that is being added and then the effect is measured
Experimental
Most definitive

23
Q

Phases of Clinical Trial

A

Pre-Clinical, Phase I, Phase II, Phase III, Phase IV

24
Q

Phase I

A

MTD is found as well as pharmokinetics
Done in healthy volunteers to determine the safety and the dosing of the drug
Done in small N
Used to find recommended dose

25
Q

Phase II

A

Done to look at safety and efficacy in the target population

Looks at side effects and to determine if a bigger study should be done

26
Q

Phase III

A

Superiority trial against the current standard of care

Done with much larger N

27
Q

Phase IV

A

Post market surveillance to make sure the drug doesnt have additional issues

28
Q

Types of Clinical Trials

A

Historical
Concurrent
Randomized

29
Q

Historical CTs

A

Compared to controls who were not given the intervention but was information from previous studies

30
Q

Concurrent CTs

A

Data from controls are collected at the same time as the intervention group

31
Q

Randomized CTs

A

Assignment to the control and intervention are done at the same time
Randomization spreads baseline characteristics

32
Q

CT classification

A

Screening Trials
Prevention Trials
Therapeutic Trials

33
Q

Population

A

Well defined with inclusion criteria to specify who should be allowed in the study
Exclusion criteria of who is in the study but should be removed because it will bias the results or because they are at higher risk

34
Q

Surrogate Endpoint

A

Measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship.

35
Q

Primary Outcome

A

Outcome of greatest importance

Study Design and Clinical Trials (1 decks)

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