EPIDEMIOLOGICAL STUDIES II (Case Control, Experimental) Flashcards

(48 cards)

1
Q

‘Trohoc’ Study: Opposite of cohort
Retrospective: go back to the past to check the exposure and why you have the outcome now at the present
Classify the outcome and will serve as the case
Analytic Observational
Direction of inquiry: past
Longitudinal: measuring variables at two different time point

A

Case-Control Studies

Outcome: start of the study
Exposure: some time in the past
Best design for diseases that are rare; rare outcomes and multiple exposure
Rare exposure, multiple outcomes: Cohort Study
Rare exposure and outcome: Case Series
Objective: to show that the probability of E is greater than in those with D+ than D-

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2
Q

Study groups are defined on the basis of presence or absence of the disease.
Outcome or disease is measured first
Study begins by selecting subjects based on the diseases, cases or outcome
Go back to the past to check for the exposure variables (exposed and non-exposed)

A

Case-Control Studies

The exposure status of the participants are then determined and compared between the study groups.

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3
Q
ODD MAN OUT:
Advantages of Case-Control Studies
1. Quick and inexpensive
2. Suited to disease with long latency
3. Optimal for rare disease
4. Can examine multiple etiologic factors for a single disease
5. Vulnerable to bias
A
  1. Vulnerable to bias
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4
Q
ODD MAN OUT:
Disadvantages of Case-Control Studies
1.  Very cost-efficient
2. Inefficient for rare exposure
3. Cannot generate incidence of disease
4. Difficult to establish temporal sequence
5. Prone to bias
A
  1. Very cost-efficient
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5
Q
Steps in Case-Control Study: 
Diagnostic criteria for the disease
Eligibility criteria
Hospitals
Population
A

Step 1: Define and select cases
Establish objective criteria
Select cases

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6
Q

Step 1: Define and select cases (Establish objective criteria)
tests are performed; PE, questionnaire
What outcome you would like to measure first

A

Diagnostic criteria for the disease

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7
Q

Step 1: Define and select cases (Establish objective criteria)
May be problematic if diagnostic procedure is expensive
Consider the price of the tests

A

Eligibility criteria

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8
Q

Step 1: Define and select cases (Select cases-sources)

secondary or case-defined base; available list of the disease

A

Hospitals

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9
Q

Step 1: Define and select cases (Select cases-sources)

primary study base

A

Population

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10
Q

Types of Cases:
____ : old + new cases
____: new cases; better type for case-control

A
Prevalent cases
Incidence cases
(Uniform diagnosis 
Accurate recall of exposure
Temporal sequence)
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11
Q

Methods of selection of cases:

A

Total enumeration

Random sampling: larger population

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12
Q

Steps in Case-Control Study:
Most important and difficult aspect of the case-control design
Should represent the source population the cases arose from
Should not be influenced by the knowledge of the exposure status

A

Step 2: Definition and selection of controls

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13
Q
Step 2 (Definition and selection of controls):
Comparable to the source of population cases
Similar to the cases except for the disease of interest
Difference should be the absence of the disease of interest 
Control should not have the disease of interest
A

Define control group
Matching -to achieve comparability
1-1 matching: 1 case: 1 control
Category matching: females: females

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14
Q
Step 2 (Definition and selection of controls):
Get controls from the same source population as the case
A

Select control

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15
Q

Sources of Case and Control:
select controls from patients that are admitted for other reasons in the same hospital as the cases
Better recall of exposure, less time and money, cooperative
Patients may have come from different source population than the cases or other diseases may be associated with the exposure

A

Hospital

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16
Q

Sources of Case and Control:
neighborhood controls; select control from the same neighborhood as the cases
Source population is very clear
More time and money needed
Healthy control; no better recall of exposure

A

General population

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17
Q

Sources of Case and Control:
selecting the family or friends of the cases as the control group
Source population is very clear
Healthy but are motivated to participate in the study
Twin studies: best when want to remove potential effects of genetics

A

Special Groups

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18
Q

Methods of Case Control Sampling:

A
Random sampling 
Paired sampling (matched)
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19
Q

Steps in Case-Control Study:
Operational definition of exposure variable
Sources: subjects or medical records
Methods of data collection: same for the 2 groups (cases and controls)
Reference point should be identified: basis on which as individual should be considered exposed: to know who will be considered to be exposed and non-exposed

A

Step 3: Ascertainment of exposure

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20
Q

Steps in Case-Control Study:
No measure of disease frequency because research decides how many cases to recruit
Measures of association: Odds ratio (OR): estimate of risk

A

Step 4: Analysis

21
Q
likelihood of the event occurring vs it is not occurring; used in Case-control  
# with characteristics / # without characteristics 
Minus # of with characteristics to the total population
22
Q
risk (cohort); exposure risk 
# with characteristics / total unit
23
Q

What Step?
“Living with a sputum positive adult Ptb case for one year is associated with development of Ptb in children 7 years old and below”

A

State the hypothesis in clear and specific terms

24
Q

What Step?
Exposure: living with sputum positive adult Ptb case for 1 year
Outcome: development in Ptb in children 7 years old and below

A

Define study variables operationally

25
What Step? | ≤ 7 year old children residing in barangay X
Define study population
26
What Step? Case: ≤ 7 year old children who has Ptb based on WHO criteria of the disease Control: same source of population; neighborhood not living with sputum positive adult Ptb case for a year or other sources like special group
Define and select a case and control
27
What Step? method should be same as case and control History of exposure to the factor Reference point: exposure should have occurred at least 12 months before the diagnosis of Ptb Method: Face-to-face interview
Data collection
28
"there is an association and exposure is a risk factor"
Analysis
29
Odds ratio 1: no association >1: association, risk factor <1: association, protective factor
Interpretation
30
Analytical, prospective, and experimental type of study Study comparing the effects and value of intervention against the control in human being Investigator manipulates the exposure assigned to the participants in the study Investigators intervenes in one group and withholds intervention in another group
Experimental Studies
31
have the exposure at the start of the study and outcome sometime in the future
Prospective
32
there is manipulation and assignment of exposure variable Similar with cohort but is observational; no assigning and manipulation; prospective observational study Compare effects and value
Experimental
33
Characteristics of Experimental Studies: Independent and dependent variables Exposure and outcome Treatment and effect
Involves a test hypothesis
34
Characteristics of Experimental Studies: Individuals are enrolled on the basis of their exposure status Entire group is followed up and monitored
Prospective
35
Characteristics of Experimental Studies: Investigators allot exposure by applying randomized allocation scheme Purpose: create groups that differ only randomly at the time of allocation with regard to subsequent occurrence of the study outcome
Random allocation of study subjects
36
Characteristics of Experimental Studies: Intervention group: receives the treatment Control group: withhold from the treatment
Comparison group
37
Classification of Experimental Studies according to Type of subjects/ unit of analysis: Patients as subjects
Randomized clinical trials (RCT)
38
Classification of Experimental Studies according to Type of subjects/ unit of analysis: Interventions assigned to individual community members Subjects are not defined by presence or absence of the disease but by the initial occurrence of the disease (Community settings)
Field trials
39
Classification of Experimental Studies according to Type of subjects/ unit of analysis: Interventions assigned to whole communities Group level intervention
Community intervention trials
40
Classification of Experimental Studies according to Purpose: Agent is administered to determine its effects on controlling or treating the diseases Conducted among patients with a particular disease to determine the ability of an agent to procedure or diminish symptoms, prevented occurrence or decrease risk of death from the disease Study population: persons with disease
Therapeutic (secondary prevention)
41
Classification of Experimental Studies according to Purpose: Agent is administered or procedure is performed to determine its effect on preventing the disease Evaluation of whether an agent or procedure reduces the risk of developing the disease among those free from the disease at enrollment Study population: person without disease
Preventive (primary prevention)
42
Classification of Experimental Studies according to Treatment modality: Most widely used design in clinical research Compare outcomes observed in two or more groups of subjects or patients who received different interventions Effects on the dependent variable for one subjects or group of subjects are compared with the effect for another subject or another group of subjects
Between subjects design (parallel group design)
43
Classification of Experimental Studies according to Treatment modality: All subjects experience all treatments in succession but order vary; groups experiences all the treatment only difference is the order of treatment Repeated measurement of the outcomes in each subject Needs less participants for they will be counted twice Wash out period: allows the body to remove the first intervention taken, to minimize residual effect
Within subjects design (cross-over design) Effects on the dependent variable for an experimental condition and for the controlled condition are compared within one person Applicable for outcomes that are reversible Time consuming and expensive but gives credible data (both will receive both treatment)
44
Classification of Experimental Studies according to Treatment modality: Used to test two or more hypothesis simultaneously Subjects are first randomized to treatments A & B to address one hypothesis Within each treatment group there is further randomization to treatments evaluate a second question
Same group of subjects (factorial design)
45
Classification of Experimental Studies according to Phase of development of a treatment (RCTs): determine the pharmacologic and metabolic effects of the drug in human study. Subjects are human volunteers First used in experimental animals before human
Phase I
46
Classification of Experimental Studies according to Phase of development of a treatment (RCTs): new treatment is tried for the first time in the type of patients for whom the treatment is intended Dosing studies for optimal dose
Phase II
47
Classification of Experimental Studies according to Phase of development of a treatment (RCTs): treatment is brought to real-life situation with outcomes considered to be Clinically relevant in patients diagnosed with the indication for the treatment
Phase III
48
Classification of Experimental Studies according to Phase of development of a treatment (RCTs): post marketing (surveillance) trial Side effects cause over time by the treatment is still being studied Look for the other side effects that were not seen in other trials Also study how well a treatment works over a long period of time
Phase IV