cross sectinal and methods
TRANSCRIPT
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Observational Research
Methods
Ivan J Perry
Department of Epidemiology &
Public Health
University College Cork
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Scenario
It is suggested that occupational exposure to
volatile anaesthetic agents causes depression.
You wish to test this hypothesis.
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At the end of this lecture you should be able to:
List and distinguish between the four major types of
observational analytical study designs, including the
strengths and limitations of each design
Understand the difference between prevalence and incidence
Given a research question you should be able to select the
appropriate study design
Learning objectives
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Observational
Descriptive Analytical
Experimental
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Type of
Study
Alternative
Name
Unit of
Study
Ecological
Cross-sectional
Case-control
Cohort
Correlational
Prevalence
Case-reference
Follow-up
Populations
Individuals
Individuals
Individuals
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Ecological studies often provide the first tentative evidence ofan association between a causal factor and disease
The units of analysis are populations or groups of people
rather than individuals
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Advantages
Suitable exposure and outcome data may not be
available as the data is usually pre-existing
Data can be used from populations with widely differing
characteristics
Ecological studies are simple to conduct, often using
pre-existing data collected for other purposes
Disadvantages
Usually not possible to adjust for potential confounders
Links between exposure and disease seen at the aggregate
(population) level may be spurious and not seen at the
individual level (ecological fallacy)
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Objectives
To examine health problem or disease
frequency
To examine association between the exposure
and health problem or disease frequency
Unit of analysis is individual
Exposure and disease status of individual is
assessed at the same time
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Cross-sectional Studies measure prevalencePrevalence is the number of cases in a
defined population at a specified point in
time, expressed as a proportion of the totalpopulation at risk for the condition. The
prevalence rate for a disease is calculated as
follows:P = No. of people with disease at specified time
No. of people in population at risk at specified time
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0
10
20
30
40
50
60
%
50-54 55-59 60-64 65-69
Male Female
Cork and Kerry Diabetes & Heart Disease Study, 1998
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AdvantagesA cross sectional study is short term,
easy and economical to conduct
A cross sectional study generally starts
with a reference population and is
generalisable
Causal inference can be made from cross
sectional data, provided it is known that the
exposure preceded the effect or disease
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DisadvantagesIt is not possible to determine in some
cases whether the exposure preceded the
condition or disease
The problem of selective survival may
be an issue
Not suitable for investigation of rare diseases
Generally requires large number of subjects
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Type of
Study
Alternative
Name
Unit of
Study
Ecological
Cross-sectional
Case-control
Cohort
Correlational
Prevalence
Case-reference
Follow-up
Populations
Individuals
Individuals
Individuals
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Doll and Hills Data
Lung cancer patients Controls Total
Smokers 647 622 1269
Non-smokers 2 27 29
Total 649 649 1298
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AdvantagesWell suited to the study of rare disease
Relatively quick and inexpensive to conduct
Requires comparatively few subjects
Existing records can be used in
some case-control studiesNo loss to follow-up.
Allows study of multiple potential
causes of disease
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Disadvantages
Relies on record or recall for
information on past exposure
(potential for recall bias)
Unsuitable for the study
of rare exposure
Selection of an
appropriate control
group may be difficult
May not be able to
establish sequence of
events
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Incidence rate
Cumulative Incidence
Relative Risk
Incidence rate (IR)is the number of new cases arising in a
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No. people who get disease (given time period)Sum of time each person remained under
observation and at risk of becoming a case
Usually expresses as number of cases per 1000 or per,
100,000 person years of follow-up.
Incidence rate (IR)is the number of new cases arising in a
given period in a specified population. Incidence can be
measured as follows:
Cumulative Incidence measures the denominator only at the
beginning of the study. Cumulative incidence can be measured as
follows:
IR =
CI= No. people who get disease (given time period)No. disease free people in population at risk at
the beginning of the period
Usually expresses as % risk during a defined period of
follow-up, e.g. over 1 year or 5 years
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Ratio Measure
Incidence of disease in exposedIncidence of disease in non-exposed
Note: in case-control studies relativerisk is derived indirectly from the
odds ratio.
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Smoking category No. stroke cases Person-yearsobservation (>8)
Strokeincidence rate
(per 100,000person-years)
Never smokes 70 395,594 17.7
Ex-smoker 65 232,712 27.9
Smoker 139 280,141 49.6
Total 274 908,447 30.2
Cigarette smoking and incidence rate of
stroke in a cohort of 118,539 women
Colditz et al., 1988
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Advantages
Suitable for the study of rare exposureCan assess multiple outcomes (effects)
of single exposure
Can demonstrate temporal relationship
between exposure and diseaseAllows direct measurement of incidence
of disease in the exposed and non-exposed
population
Changes in exposure over time can be
studied
Recall and selection bias are unlikely
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DisadvantagesNot suitable for the study of a rare disease,
unless a large sample size is obtained
If prospective, can be expensive and
time consuming
If retrospective, requires the availabilityof existing record
Validity of the result can be affected
by loss of follow up