UNIT 7
EPIDEMIOLOGICAL METHODS
Naila Rani
MSN, BSN, RN
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Objectives
Explain Epidemiological Research Designs
Define Descriptive & Analytic Research Design
Explain Cross Sectional Research Design and its Pros/Cons.
Explain Cohort Research Design and its Pros/Cons
Explain Case-Control Research Design and Pros/Cons
Calculate Odd ratio & Relative Risk with examples
Describe the Intervention / Experimental study
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EPIDEMIOLOGICAL RESEARCH
DESIGNS
Epidemiological studies aim at investigating the distribution
and causes of the diseases in population.
Epidemiological studies are conducted to investigate causes
of different diseases in either
prospective approaches (cause to effect)
or
Retrospective approaches (effect to cause).
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Types of epidemiological studies
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Types of Observational Studies
The investigator simply observes , describe, measures and
analyses but does not actively intervene.
Observational studies can be of two types :
1) Descriptive studies
2) Analytical studies
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1.Descriptive study
Descriptive studies describes the occurrence of disease in a
population in terms of time, Place and Person.
This is often first step in epidemiological investigation and help
in formulating a hypothesis.
Population based descriptive studies:
Descriptive studies provide the information about the health
status of a community.
Descriptive studies are usually based on death statistics and
may examine patterns of death, by age, sex or ethnicity
during specific time period in various countries
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Conti…….
Descriptive studies can be further divided to:
Case reports
Case series
Case reports: are defined here as singular reports on one
individual patient.
Case series are collections of information on more than one
patient.
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THE BASIC TRIAD OF DESCRIPTIVE
EPIDEMIOLOGY
The three essential characteristics in descriptive epidemiology:
TIME (When does it occur)
Seasonal variation, epidemic, endemic
PLACE (Where does it occur)
Place of resident (rural/urban), environmental factor
PERSON (Who are affected):
“Person” refers to socio-demographic characteristics of cases and
includes variables such as age, ethnicity, sex/gender, occupation,
and socioeconomic status.
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ANALYTICAL EPIDEMIOLOGICAL
STUDIES
Analytical epidemiology attempts to analyze the causes of
diseases by testing hypothesis which have been formulated
based on the results of descriptive studies. Analytical
epidemiological tries to ascertain whether a particular
exposure or risk factor can cause a disease or not.
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Types of Analytical Studies
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1.Cross-Sectional Study
Cross sectional studies
They are conducted at one point in time and try to concurrently
evaluate exposure (risk factor) and outcome (disease) in a population.
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ADVANTAGE OF CROSS-SECTIONAL STUDIES
1. Provide information about distribution of disease in a population.
2. Helpful in describing burden of disease in a community and its
distribution therefore, they are help in planning purposes.
3. Generally easy to carry out and economical to conduct
4. They provide association between disease and various variable
5. It is a rapid method for collecting health information data and
assess health care needs.
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DISADVANTAGE OF A CROSS
SECTIONAL STUDY
Time sequence is not available
Provide no information about natural history of disease or its
etiology
Cannot measure the occurrence of new cases of a disease over a
period of time(incidence).
Cross-sectional studies only measure the existing cases of a
disease at a point in time and thus miss earlier cases of the
disease who have either died or whose symptoms have
disappeared .This is referred to as Neyman Bias.
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2. CASE CONTROL STUDY
Aim of Study: The aim of a Case control study is used to
investigate the causes of disease, particularly rare conditions.
Two groups of individuals are compared , one who have been
diagnosed as having the disease ( cases) with those who are free
from the disease( control).
The Participants are divided into two groups.
Groups are made on the basis of presence or absence of disease
Eg., Investigation of history of smoking in patients diagnosed
with lung cancer.
Case(with disease)
Control(without disease)
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DESIGN OF A CASE CONTROL STUDY
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Conti…..
A case control study is also referred to as a retrospective or flash
back study, because the investigator is looking backwards from
the disease to its possible cause Risk factor/ protective factor
If prevalence of exposure is higher in cases it may be termed a
risk factor for disease
If it is lower in the cases it may be called protective factors.
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METHODOLOGY OF CASE CONTROL
STUDY
1) Stating the hypothesis : Clearly state the hypothesis
2) Define cases: It is important to establish the correct definition for
a case based on histopathological criteria or a clinical pattern
3) Selection of cases: preferable to identify newly diagnosed or
incident cases
4) Selection of controls: It is most difficult part of case control
study .The purpose of selecting a control is to give a reliable
estimate of exposure to risk factors among the population at risk of
becoming case
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Conti………
5) Matching of control: It is a way of increasing the efficiency
of the study .Control can be matched to the cases either
individually or collectively.
6) Determination of start and duration of Exposure: This can
be estimated by questioning ,going through documentary records
and taking biological samples
7) Minimize biases: A bias is defined as any systematic error in
the determination of the association between the exposure and
disease.
8) Take care of confounding factors
9) Analysis A case control study can be analyzed by calculating
the odds ratio which measures the association of the exposure and
the disease.
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ANALYSIS OF CASE CONTROL
STUDY
A case control study can be analyzed by calculating the odd
ratio which measures the association of the exposure and the
disease Odds ratio;
The odds ratio is the ratio of the odds ( chances ) of exposure
among the cases to the odds in favor of exposure among the
controls
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CASE CONTROL ADVANTAGES
1. It is cheap &inexpensive
2. It is relatively quick to carry out
3. Good for studying rare diseases
4. Does not require many subjects
5. The study does not expose subjects to any risk
6. Prolonged follow up of subjects is not required
7. Identify more than one risk factor in the same data set
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DISADVANTAGES OF CASE
CONTROL
1. It is difficult to validate the information
2. Relies on the ability to recall past events or history of exposure
which may not be accurate
3. Incidence rate in exposed and unexposed cannot be calculated
4. Selecting of control is difficult undertaking
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3. COHORT STUDY
In a cohort study, subjects with an exposure to a causal factor are
identified and the incidence of a disease over time is compared
with that of controls (persons who do not have the exposure).
It is also called prospective, incidence or follow up studies.
It establish a time relationship between presumed antecedents
(exposure) and presumed effects (disease).
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COMPARISON AMONG STUDIES
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METHODOLOGY
1.Selection Of Cohort: it is important to make sure at the
start of the study the cohort is free from disease.
2.Collection Of Relevant Baseline Data: baseline data is
collected to asses exposure status of study group. Those
suffering from disease any disease are excluded.
3.Follow-up: regular follow-up is mandatory, efforts should
made to prevent dropouts. A 10% lost is generally acceptable
4.Analysis: measure of association in cohort
The advantage of a cohort is that we can directly count the
number of new cases developing disease in both the exposed
and non-exposed group.
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Conti…..
It can help in determining the relative risk or risk ratio which is
simply the ratio of the incidence rate in the exposed group and
the incidence rate in the unexposed group.
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COHORT ADVANTAGES
1.Incidence can be calculated
2.Suitable for rare exposure
3.Multiple outcomes of a single exposure
4.Temporal relationship can be proved
5.Direct measurement of incidence in exposed and non-exposed
groups
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DISADVANTAGES OF COHORT
1. Long time of follow-up
2. Expensive and time consuming
3. Requires adequate records
4. Not suitable for rare diseases
5. Large number of subjects
6. Loss of follow-up
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EXPERIMENTAL STUDY DESIGNS
Experimental studies are also called intervention studies.
In this the researcher attempts to change the progress of a disease
through treatment / intervention.
The effect of this intervention/treatment are measured by
comparing the outcome in the experimental group with that in a
control group
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TYPES OF EXPERIMENTAL STUDIES
1. Randomized control trial-Clinical trial
2. Non randomized control trial/quasi experiment
3. Field trials
4. Community trials
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1.RANDOMIZED CONTROLLED TRIAL
In RCT, subject are randomly allocated in groups called study
and control by the process of randomization.
Randomization:
“It is a process in which study participants have equal chance
to be allocated in treatment or control Group.”
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Randomized controlled trial
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METHODOLOGY
1.Formulating hypothesis
2.Choose appropriate study population from reference population
3.Randomization
4.Manipulation/intervention
5.Follow up
6.Assessment
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ADVANTAGE & DISADVANTAGE
Advantage :
1. Control of the investigator
2. Finding can be generalize
3. Less chance of error
Disadvantage:
1. Can lead to ethical problems
2. It is much costly
3. Follow up may be difficult
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(A)FIELD TRIALS
These trials use healthy individual in the community who are
disease free but presumed to be at risk.
Data collection takes place in field.
Field trials are very expensive and require a large number of
subjects
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(B)COMMUNITY TRIAL
In this form of experiment the treatment groups are communities.
It is actually an extension of a field trial.
A limitation of such studies is that random allocation of
communities is not practicable
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