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Study Design
A study design is a specific plan or protocol for
conducting the study, which allows the investigator
to translate the conceptual hypothesis into an
operational one.
1
Epidemiologic study designs
Epidemiological Study designs can be classified in
two ways:
1. According to the power of the investigator to control the
factors to be assigned to the study groups
1. Experimental studies
2. Observational studies
2. According to the intention in carrying out the
epidemiological investigation:
1. Descriptive Studied
2. Analytic Studies
2
3
Study Designs
Analytical
Descriptive
Experimental Observational
- Case Report
Clinical Trials - Cohort Study
- Cross-Sectional
Cross-Sectional
- Ecological
4
Design Selection depends on
Scientific Knowledge
New
Adding
Redoing / Confirming
Hypothesis
Generating
Testing
5
Design Selection depends on
Epidemiologic / Statistical
Disease (rare vs rampant)
Exposure
Sample Size
6
Types of epidemiologic study
designs
Descriptive (person, place, and time)
Purpose is = Hypothesis generating
Analytic (causal)
Purpose = Hypothesis testing
7
Descriptive Study Designs
Purpose and characteristics
mainly concerned with distribution of diseases
useful for managers to allocate resources.
used for hypothesis generation.
less time consuming and less expensive (use routinely
collected information).
8
Descriptive Study Designs
Used to describe disease patterns and generate hypotheses
9
Types of Descriptive study designs
1. Correlational (ecological) studies
Use data from entire population to compare disease
frequencies b/n /or d/t groups during the same period of time,
or in the same population at d/t points in time. (unit of
analysis is population)
Example:
Examination of state data on tobacco sales and mortality from
CHD.
First step in examination of a disease exposure relationship.
10
Correlation studies
Strength
Quick and inexpensive, can be used as first step.
It is useful in giving a fruitful start for more detailed
epidemiological studies.
Limitation
Doesnt link specific persons exposure with specific
outcome
Risk of ecological fallacy
Cant control for potential confounding factors
11
Descriptive study Designs
Case Reports and Case Series
Describes single patient or group of patients experience
Most common form of study published in medical journals.
Presents an unusual disease or unusual presentation of a
disease.
12
Case Report/Series studies
Strengths
May lead to formulation of new hypotheses
Important link between clinical medicine and
epidemiology
Limitation
Cannot be used to test hypotheses
13
Case report/series studies:
Examples
E.g. Case report: A 40-year old pre-menopausal woman
developed pulmonary embolism 5 weeks after beginning to
use an oral contraceptive preparation to treat endometriosis.
14
Descriptive studies
Cross-Sectional (or prevalence) Studies (Survey)
Both Exposure and disease status are simultaneously
assessed in a population at a point in time.
15
Cross-sectional studies
Strengths
Provides information about the frequency and
characteristics of a disease.
Decision making and priority setting
prevalence of disease or other health outcome in special
groups (e.g. occupations)
investigates exposures that are fixed characteristics of
individuals, ( ethnicity, socio-economic status and blood
groups).
16
Cross-sectional studies
Limitation
Cant determine whether exposure preceded or occurred
as a result of the disease (Chicken and egg dilemma!!)
17
Analytic studies: Purpose and
Characteristics
focus on the determinants (causes) of diseases.
18
Types of Analytic studies
Observational - Natural course of events assessed.
Case-control,
Cohort and
Cross-sectional
19
Observational studies
Case-Control
Cases: persons with disease
Controls (Comparison group): persons without the disease
Cohort
Subjects classified on basis of exposure of a factor
Follow-up to determine presence of disease
Prospective vs. retrospective
20
Intervention studies
Experimental Studies - Clinical Trials
Provides most reliable evidence
Gold standard study design
Randomization
Controls for known risk factors
Controls for unknown risk factors
Useful for studying small to moderate effects
Ethical considerations are main constraints.
Human rights review
Data monitoring
21
Case-Control Studies
Properties
the most frequently undertaken analytical studies
the only practical approach for identifying risk factors for
rare diseases
best suited to the study of diseases for which medical
care is sought, such as cancers or hip fracture
Design
At baseline:
Selection of cases and controls based on disease status
Exposure status is unknown
Retrospective design lacks temporality!
22
Case control design
Direction of inquiry
Exposed Start with:
Cases (people with disease)
Not exposed
Not exposed
Controls (people with out
disease)
Exposed
23
Steps in conducting case-control
studies
1. Define cases
- is establishment of strict diagnostic criteria and definition of
the disease or outcome of interest.
2. Population (community)
expensive
avoids selection bias
25
Steps
3. Select controls
consider comparability, practicability and economic impact.
26
Steps
Sources of controls
1. Hospital controls
Advantages:
easily identified & readily available in sufficient number
less costly
more likely than healthy individuals to be aware of antecedent
exposures or events.
this decreases recall bias
they are more likely to be cooperative
27
Hospital controls
Disadvantages:
They are different from healthy individuals in many ways
28
Sources of controls
2. General population controls
If cases are selected from the population, it is good to select
controls from the population too.
Advantages:
Generalization is possible
Disadvantages:
Costly & time consuming
recall bias (may not be concerned about past exposure since
they are healthy)
people might be less motivated to participate
29
Steps
4. Check the exposure status
Information regarding the exposure status can be obtained by
interview or from different records.
5. Analysis
Prepare 2X2 table
calculate Odds Ratio (OR)
Perform statistical tests to check whether there is significant
association.
30
Case-Control Analysis
D+ D- Total
Exposed a b a+b
Non-Exposed c d c+d
Total a+c b+d
Yes No Total
OR = ad/bc= 23*28163
133*304
= 1.6
Interpretation:
Women who were current OC users had 1.6 times higher risk
of developing myocardial infarction when compared to non-
users of OC
33
Case- Control studies
Advantages
Uniquely suited to diseases with long incubation periods
More efficient in terms of time and money
Good for study of rare disease
Can look at multiple exposures for a single disease
Disadvantages
Inefficient for evaluation of rare exposures
Cannot directly compute incidence rates of disease
Temporal relationship between E and D may be hard to
establish
Particularly prone to bias (selection and recall in particular)
34
Cohort studies
Are those designs in which we start with exposure and look for
the outcome to develop.
35
What to look for in cohort studies?
Who is at risk?
Who is exposed?
36
Types of cohort studies
Classification is based on the temporal relationship between
the initiation of the study and the occurrence of the disease.
37
Cohort studies -Prospective
Direction of inquiry
Exposed
No disease
Disease
Non-Exposed
No disease
38
Types of cohort studies
2. Retrospective cohort
Both the exposures and outcomes have already occurred when
the study begins
Not Disease
Not Disease
Not Exposed
Disease
40
Steps in conducting cohort study
Step 1: Define exposure
41
Steps
Step 3: Select controls (non-exposed)
control groups should be comparable to the exposed group
43
Relative Risk (RR)
Relative Risk (RR) or Risk Ratio shows the magnitude of
association between exposure & disease.
44
Relative Risk (RR) . . .
Incidence among exposed (Ie)
RR = ____________________________
Incidence among non-exposed (Io)
a
= (a + b)
c
(c+d)
= risk of disease among exposed
________________________
risk of disease among exposed
45
Example
This table shows data from a cohort study of oral contraceptive
(OC) use and bacteruria among women aged 16-49 years
Bacteruria
57 455 512
Yes
No 77 1831 1908
Total 134 2286 2420
46
Example . . .
RR = Ie = 57/512
Io 77/1908
= 2.8
Interpretation: women who used oral contraceptive had 2.8
times higher risk of developing bacteruria when compared to
non-users.
47
Example . . .
In general the strength of association can be considered:
High - if the RR is 3.0 or more
Moderate if the RR is from 1.5 to 2.9
Weak if the RR is from 1.2 to 1.4
48
Cohort Study
Advantages
Can measure incidence and thus risk
No recall bias
Exposure precedes disease
Can study several diseases
Can be very efficient for rare exposures
49
Cohort Studies
Disadvantages
Large number of subjects/participants
Inefficient for rare diseases
Long follow-up period
Subjects may change health behaviors during course of
study
Possible changes over time in ascertainment of disease
Very costly
50
Advantages and limitations of cohort and case control study
Case Control Cohort
Advantages: valuable when exposure is rare
optimal for evaluation of rare disease can examine multiple effects
can examine multiple factors of a single exposure
for a single disease temporal relationship is known
Quick & inexpensive allows direct measurement of risk
relatively simple to carry out minimize bias in ascertainment of
guarantee the number of exposure
persons with a disease
52
Blinding
Triple blind: the patient, the observer and the analyst do not
know
52
Experimental design . . .
Experiment design flow sheet
Disease
Healthy Received
Intervention No diseased
Individuals
Diseased
Not Received
Intervention No diseased
54
Experimental design . . .
Produces high quality data if done properly.
55
Experimental design . . .
Intervention studies can generally be considered either
therapeutic or preventive.
56
Experimental design . . .
A preventive (or primary prevention) trial involves the
evaluation of whether an agent or procedure reduces the risk of
developing disease among those free from that condition at
enrollment.
57
Experimental design . . .
A. Uncontrolled trial - no control group. control will be past
experience (history).
58
Steps in conducting experimental
studies
Step 1. Identify new drug/intervention/prevention
B. Control group
group that will receive no treatment, a placebo, or standard
form of therapy
60
Steps in experimental studies
Step 9. Collect data
Collect all relevant information including the outcome
61
Experimental design . . .
Advantages of randomization:
It eliminates selection bias
On average the study groups will be comparable (confounders
will be equally distributed controls confounding effect )
62
Problems Related to Intervention
Studies
1. Ethical considerations prevent evaluation of many
treatments or procedures using an intervention design
strategy.
2. Cost
63
Experimental design . . .
Ideally
All subjects adhere to treatment regimens;
do not seek additional treatment;
do not drop out, die, move or have to be withdrawn from
study;
attend follow-up sessions and provide outcome data
64
Experimental design . . .
The quality of "gold standard" in experimental studies can
be achieved through :
Randomization
Use of placebo
Double Blinding
65
Measures of Association
Exposure Outcome
66
Measures of Association . . .
Statistical tests like Chi-square show mainly the presence or
absence of association.
67
Two-by-Two (Contingency) Table
Yes No Total
Yes a b a +b
No c d c+d
69
How strong is the association?
Relative Risk (RR) - indicates the likelihood of developing
the disease in the exposed group relative to those who are not
exposed.
70
Example: this table shows data from case control study of oral
contraceptive (OC) use & myocardial infarction in pre
menopausal female nurses .
Current OC use
Yes No Total
OR = ad/bc= 23*2816
133*304
= 1.6
Interpretation:
Women who were current OC users had 1.6 times higher risk
of developing myocardial infarction when compared to non-
users of OC
72
Attributable Risk (AR) / Risk
Difference(RD)
AR is a measure of association that provides information
about the absolute effect of the exposure or the excess risk of
disease in those exposed compared with those who are not
exposed.
73
AR . . .
Quantify the excess risk in the exposed that can be attributable
to the exposure by removing the risk of disease that could have
occurred anyway due to other causes.
74
Example
Refer OC use and Bacteruria example and calculate AR
57 455 512
Yes
No 77 1831 1908
Total 134 2286 2420
75
Refer OC use and Bacteruria
example and calculate AR
AR = Risk among exposed (Ie) Risk among non exposed (Io)
= 57/512 - 77/1908
= 0.1113281-0.040356
= 0.0709721 = 709721per 10,000,000 OC users
Interpretation: The excess occurrence of bacteruria among OC
users attributable to their OC use is 709721 per 10,000,000 OC
users.
In a population of 10,000,000 OC users, 709721 would be
expected to develop bacteruria, 1566 of those who developed
bacteruria being related to OC use & the remainder, 4036, to
other factors
76
Attributable Risk Percent (AR %)
AR% = Ie-Io
Ie
77
Refer OC use and Bacteruria example
and calculate AR%
AR % = 27/482 - 77/1908
27/482 X 100
= 27.96%
78
Population Attributable Risk
(PAR)
79
For the following data calculate
PAR
Given : AR = 89 per 100,000 per year
Prevalence rate of cigarette smoking = 20 %
80
Population Attributable Risk
Percent (PAR %)
PAR % = PAR X 100
Incidence rate in total population
Calculate PAR %
81
PAR% . . .
Interpretation: 72% of deaths from lung cancer occurring in
the general population could be prevented by eliminating
cigarette smoking.
82
Where we have been?
Measuring disease occurrence,
83
Where we are heading?
to discuss the various threats we face to getting the right
answer, in other words, the threats to validity.
84
OTHER
POPULATIONS
Disease
+ -
+
Exposure
-
REFERENCE/
TARGET/
Two types of
SOURCE
inferences POPULATION
aka
STUDY BASE STUDY SAMPLE
85
20 to 65 year
>65 years old olds, in Europe
in Ethiopia.
Disease
+ -
+
Exposure
-
20 to 65 year
olds, in Ethiopia, Region 3, 20
outside of to 65 years old
Region 3
SAMPLE of Region 3,
20 to 65 yrs old 86
Attempts in study design to
Most enhance the second inference
important are often in conflict with goal
inference is of making a sound first
the first one inference
Disease
Without an + -
accurate first +
inference, Exposure
-
there is little
point
REFERENCE/
considering TARGET/
the second SOURCE
inference POPULATION
aka
STUDY BASE STUDY SAMPLE
87
Goal of any study
The goal of any study is make an accurate (true) inference, i.e.:
measure of disease occurrence in a descriptive study
measure of association between exposure and disease in an
analytic study
88
Errors
Ways of getting the wrong answer/or missing the truth:
systematic error; also called bias
any systematic process in the conduct of a study that causes
a distortion from the truth in a predictable direction
captured in the validity of the inference
89
Validity and Precision:
Each Shot at Target Represents a Study Sample of a Given Sample
Size
90
Validity and Precision
91
Validity and Precision Random
error
Random (chance)
error
(chance)
No Systematic
Systematic error
error (bias)
Poor Validity Good Validity
Good Precision Poor Precision
92
Performing an Actual Study:
You Only Have One Shot
Only judgment
can tell you
about
Field of systematic error
statistics can (validity)
tell you the
random error
(precision) with
formulae for
confidence
intervals Judgment
requires
substantive and
methodological
knowledge
93
Validity of epidemiological studies
Validity = The degree of closeness b/n a measured value and
the true value of what is being measured.
94
OTHER ? EXTERNAL
POPULATIONS
VALIDITY
(generalizability)
Disease
+ -
+
Exposure ?
-
INTERNAL
REFERENC VALIDITY
E/
Two Types of TARGET/
Inferences SOURCE
POPULATIO
Correspond to Two N STUDY SAMPLE
Types of Validity 95
Possible outcomes in studying the
relationship between disease and
exposure
1. No association between exposure and disease, AR=0, RR=1
96
Alternative explanations for the
observed association other than
cause and effect relationships.
A) The association may be the result of chance
97
Alternative explanations. . .
D) An apparent cause can be an effect, rather than a cause
(reverse causation)
98
The role of chance
It is important to quantify the degree to which chance
variability may account for the results observed in any
individual study.
99
The role of chance . . .
The key question in the statistical analysis is whether an
observed association in a sample is large enough to be
evidence of a true association in the population from which the
sample was drawn.
100
The role of chance . . .
Confidence interval gives a plausible range of values that
should contain the true association in the population.
101
The role of chance . . .
P- value
is the probability that an effect at least as extreme as that
observed in a particular study could have occurred by chance
alone, given that there is truly no relationship between the
exposure and disease
102
The role of bias
Bias is any systematic error in the design, conduct, or analysis
of a study that results in a distorted estimate of what the study
is attempting to measure.
103
The role of bias
Selection bias affects the representativeness of the study subjects,
either as a result of sample selection, or as a result of non-response
or loss to follow-up.
Non-response bias
Loss to follow up
104
Ways of minimizing selection bias
Population based studies are preferred
105
minimizing selection bias
In longitudinal studies (cohorts/RCTs):
Screen for occult disease/precursors at baseline
Avoid losses to follow-up
Consider approaches to tracking down the lost
106
Information (Observation) bias
Results from systematic differences in the way data on
exposure or outcome are obtained from the various study
groups
107
Ways of minimizing information
bias
1. Blinding
109
Criteria to be a confounder
1. The variable (confounder) must be associated with the
exposure and, independent of that exposure, be a risk factor
for the disease.
110
How to control confounding
Randomization
Matching
Restriction
Stratified analysis
Multivariate analysis
111
Epidemiological Surveillance
112
Surveillance
the continuous (ongoing) scrutiny of the factors that
determine the occurrence and distribution of diseases and
other health related events through a systematic collection of
data. (WHO)
114
Surveillance and survey
Surveillance Survey
Quality control may be the More in-depth data could be
major problem collected
May not provide More accurate assessment of
representative data true incidence and
prevalence
Can identify those which
dont warrant medical care
115
Surveillance: purposes and uses
Prediction and early detection of outbreaks, diseases,
injuries, hazards, etc.
116
Purposes and Uses of Surveillance
Monitoring trends and estimate magnitude of health problem
Epidemic (outbreak) detection and prediction
Monitor progress towards a control objective
Monitor programme performance
Estimate future disease impact
Evaluating an intervention
Understand characteristics of health events
Distribution and spread
Natural history
Facilitate planning
117
Surveillance activities and
resulting public health action
Surveillance Activities Public Health Actions
Data collection and Priority Setting
recording
Planning, implementing and
Data compilation, analysis evaluating disease
and interpretation - Investigation
- Control
Reporting and notification - Prevention
Dissemination of
information
118
Selection Criteria of disease for
surveillance
The importance of a health event to be included in surveillance
system, it should be assessed by:
119
Selection Criteria of disease for
surveillance
2. Feasibility of control measures
4. Resource availability
120
Elements of Surveillance System
1. Case definition of diseases included in the surveillance.
6. Incentives to participation
121
1. Case Definition
A case definition is a set of criteria used to decide a person has
a particular disease.
It includes:
- Criteria: Signs and symptoms with or without a laboratory test
- Restriction by time, place and person can be done depending
on the nature of the disease
Classification of case definition
1. Confirmed: a case definition by appropriate laboratory test
2. Probable: a case with typical clinical features of the disease
without laboratory confirmation
3. Possible/ Suspect: a case with few of the typical clinical
features.
122
Advantages of case definition
Facilitates early detection and prompt management of cases
123
2. Population under surveillance
target population can:
- < 5 year children,
- women of child bearing age,
- people livining refugee etc
(prepare detail demographic data)
124
3. Time period of data collection
It is useful to identify problems and solve timely
There are three periods of reporting:
1. Immediate reporting:
A. For diseases that include presence of a suspect consider as
epidemic.
E.g. Cholera,
B. a suspected epidemic when threshold is crossed
2. On weekly basis: for epidemic prone diseases.
E.g. Malaria, meningitis
3. On monthly basis: for routine surveillance
E.g. Tuberculosis, Leprosy, AIDS cases
125
4. Sources of data, who would
report, etc.
Mortality registration
Morbidity registration
Epidemic reporting
Reports of laboratory utilization (Including lab test results)
Reports of individual case investigations
Reports of epidemic field investigations
Special surveys
Information on animal reservoir and vector distribution
Report of biologics and drug utilization
Knowledge of the population and environment
126
1) Passive case detection: detection in
course of normal operation of health services-via
self-reporting of patients to health institutions.
Health workers detect
diseases when people
come to health facilities
127
2) Active case detection: active search for
cases by special surveys or other non routine health
services.
(people undertaking surveillance facilitate data
collection)
Health workers going out
searching for health
problems in the community
128
Surveillance: types
Active Surveillance
Passive Surveillance
Sentinel Surveillance
129
Active Surveillance
A method of data collection usually on a specific disease,
for relatively limited period of time and with involvement of
persons who conduct the surveillance activity.
130
Active Surveillance
Health Dept.
131
Active Surveillance: data
collection techniques
Sending out a letter
132
Active Surveillance
Advantages:
the collected data is complete and accurate
information collected is timely.
Disadvantages:
it requires good organization,
it is expensive
requires skilled human power
it is for short period of time (not a continuous process)
it is directed towards specific disease conditions
133
Conditions in which active
surveillance is appropriate
Periodic evaluation of an ongoing program
Programs with limited time of operation such as eradication
program.
135
Passive Surveillance
Health Dept.
136
Passive surveillance
Advantages:
covers a wide range of problems
it is relatively cheap
137
Passive surveillance
Disadvantages:
The information generated is to a large extent unreliable,
incomplete and inaccurate.
Most of the time, you may not get the kind of information you
desire
139
Sentinel Surveillance
Advantages:
relatively inexpensive
provides a practical alternative to population-based
surveillance
can make productive use of data collected for other purposes
Disadvantages:
the selected population may not be representative of the whole
population
use of secondary data may lead to data of lesser quality and
timeliness
140
Attributes of Surveillance
1. Sensitivity: to what extent the system identify all of the
events in the target population?
Timely notification
143
Limitations of the existing
surveillance system in Ethiopia
Deficiencies in data collection
diagnostic accuracy, completeness and representativeness
Deficiencies in reporting/ notification
multiplicity of case reporting forms, compliance, timeliness
Deficiencies in data analysis
central than local level, results in national indicators of
health status rather than local indicators
Deficiencies in dissemination
aggregate information, no feedback system
lack of follow-up for action
144
Integrated Disease Surveillance
and Response (IDSR)
An approach adapted to strengthen national disease
surveillance systems by coordinating and streamlining
all surveillance activities and ensuring timely
provision of surveillance data to all disease prevention
and control programmes in order to initiate timely
response (intervention).
145
List of Priority diseases and
conditions in Ethiopia
(A) Epidemic Prone Diseases
_ Cholera
_ Diarrhea with blood (Shigella)
_ Meningitis
_ Measles
_ Plague
_ Viral Haemorrhagic fevers
_ Yellow fever
_ Relapsing fever
_ Endemic Typhus
_ Malaria
146
List of Priority diseases
(B) Diseases Targeted for Elimination/Eradication
Acute flaccid paralysis (AFP/Polio)
Neonatal Tetanus
Leprosy
Dracunculiasis (Guinea worm)
Measles
147
Epidemic Investigation
and
Management
148
Objectives
At the end of this chapter the student is
expected to:
Define epidemic
Identify types of epidemic
Describe the different steps in the investigain
of epidemic
Discuss the management of epidemic
149
Levels of Disease Occurrence
Diseases occur in a community at different
levels at a particular point in time.
Some diseases are usually present at a
predictable level.
This is called the expected level
Endemic
Hyperendemic
Sporadic
150
Levels of Disease Occurrence.
Some diseases can occur in excess of what is
expected.
Epidemic
Outbreak
Cluster
Pandemic
151
Expected Vs Excess Cases
Types of Epidemics
Common Source Epidemic
Point source
Continuous common sourse
Mixed Epidemics
153
1. Common source epidemics
Occur as a result of the exposure of a group of persons
or population to a common source for the etiologic
agent.
Ex. Contaminated water supply
Food in a caf
Point source
Continuous common source
Intermittent common source
.
2. Propagated or progressive epidemics
serial transfer of infection
3. Mixed Epidemics
The epidemic begins with a single, common source
of an infectious agent with subsequent propagative
spread.
Many food borne pathogens result in mixed
epidemics
Epidemic Curve
168
Steps in epidemic investigation
1. Prepare for field work
2. Verify the existence of an epidemic
3. Verify the diagnosis
4. Describe the epidemic with person, place and time
5. Formulate and test hypothesis
6. Search for additional cases
7. Analyze the data
8. Make a decision on the hypothesis tested
9. Intervention and follow up
10. Report of the investigation
169
1. Prepare for fieldwork
Preparations can be categorized into three:
A. Investigation related: scientific knowledge,
supplies, and equipment to carry out the
investigation. Discuss the situation with
knowledgeable people, review applicable
literature, and collect sample questionnaire.
B. Administration related: arrange transportation
and organize personnel
C. Consultation: clarify your team role in the field
170
2. Verify the existence of an epidemic
Compare the number of cases with the past
levels to identify whether the present
occurrence is in excess of its usual frequency.
Reasons for Unreal excess report:
Changes in local reporting procedures
Changes in case definition,
Improvement in diagnostics,
Increased awareness.
Changes in size of the population.
171
3. Confirm the diagnosis.
Carry out clinical and laboratory studies.
Classify depending on symptoms, laboratory
results, or both.
Establish criteria for labeling persons as cases.
Use a case definition i.e. a standard set of criteria
to differentiate between cases and non cases.
172
Cases can be one of the following:
Confirmed / definite: A case with laboratory
verification.
Probable: A case with typical clinical features
but without laboratory confirmation.
Possible: A case with fewer of typical clinical
features.
173
4. Describe the data in terms of
time, place and person.
Age, sex, educational status, occupation.
Use the following tools when characterizing
the epidemic:
Epidemic curve
Spot map
Attack rates
174
5. Formulate and test hypothesis
This step involves the assessment of the data
collected to date and the generation of
hypotheses that may explain the outbreak.
The goal is to explain the specific exposure
(s) that caused the outbreak.
The hypothesis should address source of
agent, mode of transmission and exposure
that caused the disease.
175
6. Search for additional cases.
Locate unrecognized or unreported cases:
Passively by inquiring if physicians or
hospitals have seen similar cases,
Actively by doing intensive investigation in
the community on asymptomatic persons or
contact of the cases.
176
7. Analyze the data.
Assemble all the results.
Interpret findings.
177
8. Make a decision on the
hypothesis tested.
The findings must be consistent with the
hypothesis.
178
9. Intervention and follow-up
Intervention must start as soon as possible
depending on the specific circumstances.
Aim control measures at the weak link or links
in the chain of infection.
One might aim control measures at the specific
agent, source, or reservoir.
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10. Report of the investigation.
At the end prepare a comprehensive report and
submit to the appropriate agency.
The report should discuss in detail:
Factors leading to the epidemic.
Evaluation of measures used for the control
of the epidemic.
Recommendations for the prevention of
similar episodes in the future.
Managing Outbreak/epidemics 180
Management of epidemics
Requires an urgent use of appropriate
measures against the spread of the disease.
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1. Measures Directed Against the
Reservoir
Domestic animals as reservoir:
Immunization
Testing of herds
Destruction of infected animals
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Measures Against Reservoir. . .
Humans as reservoir
Removal of the focus of infection- e.g.
cholecystectomy for Typhoid fever.
Isolation of infected persons.
Treatment to make them noninfectious- e.g.,
tuberculosis.
Disinfection of contaminated objects.
Quarantine-
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Measures that interrupt the
transmission of organisms
Action to prevent transmission of disease by
ingestion:
Purification of water
Pasteurization of milk
Inspection procedures designed to ensure
safe food supply.
Improve housing conditions.
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Measures that reduce host
susceptibility
Active immunization, when either the
altered organism or its product is given to a
person to induce production of antibodies.
Passive immunization, provision of ready
made antibodies.
Chemoprophylaxis: use of antibiotics for
known contacts of cases- for example, in
meningitis.
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