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DEBRE TABORE UNIVERSITY

COLLEGE OF HEALTH SCIENCE

Module: Measurement of health and


disease For MLT Students
Mekonnen Assefa (MPH in Epidemiology & Biostatistics)
April,2017
Introduction to Epidemiology
Objectives:
Define epidemiology and discuss its
component
Discuss the history of epidemiology
Describe the scope and purpose of
epidemiology
Identify & distinguish between clinical
and community medicine
Discuss the chain of disease
transmission.
Measurment of Health and Disease 2
Epidemiology: Definition:
Epidemiology is the study of the
frequency,
distribution and
determinants
of diseases and other health related
states or events in specified
populations, and the application of this
study to the promotion of health, and
to the prevention and control of
health problems.
Measurment of Health and Disease 3
Components of Definition

Frequency: epidemiology to be mainly a


quantitative science and Epidemiology is concerned
with the frequency of diseases and other health
related conditions.
Population: the focus of epidemiology is
mainly on the population rather than individuals

Health related conditions: are conditions


which directly or indirectly affect or influence
health such as injuries, vital events, health related
behaviors, social factors, economic factors etc.

Measurment of Health and Disease 4


Components of Definition
Distribution.
Person- Who :
Young Vs Old, Female Vs Male, Rich Vs Poor,
etc.
Place .Where:
Lowland Vs Highland, Urban Vs Rural
Time - When:
Seasonal Variations, Long term variations
Descriptive epidemiology is
concerned with it. 5
Measurment of Health and Disease
Components of Definition

Determinants:
How: mechanism- Mode of transmission
Why: cause-
Genetic Vs environmental, Social and
cultural conditions
Analytical Epidemiology deals with it

Measurment of Health and Disease 6


Purpose of Epidemiological
Information:

Community need assessment- setting


priority
Individual decisions- preventing/avoiding
risky behaviors
Understanding clinical presentations
Identify cause of diseases
Completing the clinical picture of disease
Identifying new syndromes

Measurment of Health and Disease 7


Purpose of Epidemiology

Determining effectiveness of therapeutic and


preventive measures
e.g. Mammograms, clinical trials
Monitoring the health of a community, region, or
nation
e.g. Surveillance, accident reports
Studying trends over time to make predictions for
the future
e.g. Smoking and lung cancer
Estimating health services needs

Measurment of Health and Disease 8


Epidemiology: Scope

Originally,
Epidemics of communicable diseases
and epidemic investigations.
Later,
Endemic communicable diseases
and non-communicable diseases.

Measurment of Health and Disease 9


Scope.
At present
Infectious and non Cancer
infectious diseases Occupational health
Injuries and accidents
Environmental health
Nutritional
deficiencies Health behaviors
Mental disorders Violence, etc.
Maternal and child All disease
health conditions and
Congenital anomalies other health related
READ:- History of events.
epidemiology
Measurment of Health and Disease 10
Epidemiology: Basic Assumptions

Non random Occurrence of diseases

Human diseases have causal and


preventive factors that can be:
identified through systematic
investigations of populations or group
of individuals in different places or at
different times.

Measurment of Health and Disease 11


Epidemiological concepts of disease
causation

A cause of a disease can be defined as a


factor (characteristic, behavior, event,
etc.) that influences the occurrence of
disease.
Not all associations between exposure and
disease are causal
If disease does not develop without the factor
being present, then we term the causative
factor "necessary
If the disease always results from the factor,
then we term the causative factor
"sufficient".
Measurment of Health and Disease 12
Factors involved in disease
causation
Host factors (intrinsic factors):
influence exposure, susceptibility or
response to the agents
Age, Sex
Immunity and immunologic response
Genetic factors e.g. sickle cell anemia
Physiological status e.g. pregnancy,
puberty, stress, etc.
Human behavior e.g. personal hygiene,
dietary habit, occupation, utilization of
health services, sexual activity, etc.
Concurrent or pre-existing disease: e.g.
HIV, diabetes, etc.
Measurment of Health and Disease 13
Factors involved in disease
causation
Extrinsic (environmental) factors
Physical environment (heat, cold,
chemicals)
Biologic environment (infectious
agents of disease, vectors, plants and
animals)
Social environment (economic,
political, culture)

Measurment of Health and Disease 14


Factors involved in disease
causation
Agent: a specific factor in whose absence a
disease wouldnt develop; also called necessary
cause E.g:- M.tb for tuberculosis
Agents:
Living organisms (infectious agents)
Chemical agents (e.g. poison, allergens)
Psychological factors and stress
Nutritive elements
Physical agents (e.g. radiation)
Risk factors
Factors that increase occurrence of adverse
health outcome
E.g:- smoking cigarette
Measurment of Health and Disease 15
Factors involved in disease
causation

The environmental factors are closely


related to each other and to host factors

If the existing balance of forces is


precarious, disease develops

Different epidemiologic models have


been developed to depict the ways in
which these interactions influence the
occurrence of disease
Measurment of Health and Disease 16
Concept of cause

Measurment of Health and Disease 17


Conceptual Models of
Causation
Objectives:
Describe concept of causation
Explain criteria for establishing causation
Indentifying the Process of establishing
causation
Differentiate the various epidemiological
diseases causation model.

Measurment of Health and Disease 18


Conceptual Models of Causation

Depict multi factorial causation,


confounding, interdependence of effects,
direct and indirect effects, levels of
causation, and systems or webs of
causation
Models the epidemiologic triangle, web
of causation, wheel model, sufficient-
component cause model

Measurment of Health and Disease 19


Epidemiologic Triangle

The epidemiologic triangle or triad is


the traditional model of infectious
disease causation.
It has three components: Agent, Host,
and Environment

Measurment of Health and Disease 20


Epidemiologic Triangle

Was widely used for many years and still


referred frequently in epidemiological
literature
Each component must be analyzed and
understood for prediction of patterns of a
disease
This model highlights the agent of
disease as a separate component

Measurment of Health and Disease 21


EPIDEMIOLOGIC TRIANGLE AND TRIAD
(BALANCE BEAM)

Measurment of Health and Disease 22


Sufficient-component cause pie
model
Causal pie is one of the models that take
into account multiple factors which are
important in causation of disease.
In the causal pie model, the factors are
represented by pieces of the pie called
component causes
In disorders with multi-factorial causation
often no specific causes are known,
Many factors appear to be important, and
mechanisms of causation are not
apparent.
Measurment of Health and Disease 23
Rothman's Causal Pies: Conceptual
Scheme for Disease Causation

Measurment of Health and Disease 24


The Web of Causation

Effects never depend on single isolated


causes, but rather develop as the result
of chains of causation in which each link
is the result of a complex genealogy of
antecedents

Measurment of Health and Disease 25


E.g. The web of causation underlying
coronary heart disease

Measurment of Health and Disease 26


The Wheel Model
Consists of a hub (the host or human), which
has genetic make-up as its core,
surrounded by the environment, schematically
divided into the three sectors - biological,
social, and physical
The relative size of the different components
of the wheel depend upon the specific disease
problem under consideration
Hereditary disease - genetic core is
relatively large
Measles - state of immunity of the host &
biological sector of the environment is large
Measurment of Health and Disease 27
Wheel Model

Measurment of Health and Disease 28


GROUP DISCUSSION
Use the two models (Agent-Host-Environment
and Causal Pies) to describe the following :
a. Use the Agent-Host-Environment model to
describe the role of the human immunodeficiency
virus (HIV) in AIDS.
Agent:
Host:
Environment:
b. Some of the risk factors for heart disease are
smoking, hypertension, obesity, diabetes, high
cholesterol, inactivity and stress. Are these risk
factors necessary causes, sufficient causes, or
component causes?
Measurment of Health and Disease 29
Establishing causation
Causal inference should not be made
until certain requirements have been
satisfied, which relate to two major
questions:
Is there actually an association?
If there is an association, is it likely to be
causal?

Measurment of Health and Disease 30


Process of establishing causation

Develop Hypothesis
Testing Hypothesis , assess presence of
association
Use criteria to establish association,
Bradford hills criteria
1. Developing a hypothesis
From descriptive studies: Suggest
possible determinants
2. Testing the hypothesis
Using analytic studies
Assess presence of association
Measurment of Health and Disease 31
Does association imply
causation?
An observed association could be
Non-causal
Artifactual
Sampling error
Confounding
Bias
Reverse causality-bias, the effect may
result the cause, take Vitamin A and
Diarrhoeal disease association.
Coincidence
Other causes
Causal
Measurment of Health and Disease 32
Does association imply causation.

Measurment of Health and Disease 33


3. Use criteria for establishing
causation
How to separate causal from non-
causal associations in epidemiology?
Setting criteria
Offered by Bradford Hill
Guides, not rules

Measurment of Health and Disease 34


Guidelines
Strength,
Temporality,
Biologic gradient,
Consistency,
Plausibility,
Specificity,
Coherence,
Experimental evidence

Measurment of Health and Disease 35


Criteria for establishing causation...
1. Strength of the Association is when
the relative risk or the odds ratio is
high.
High dose vs low dose epinephrine and
24 hour survival - odds ratio, 8.6
Pancreatic duct dilatation as a sign of
high risk for pancreatic cancer odds
ratio, 32.5
2. Temporal relationship is when the
exposure occurs before the outcome.
HIV and AIDS
exposure disease
Measurment of Health and Disease 36
3. Dose-response: The risk of disease
increases with increasing exposure
intensity.
is the change in outcome (response)
caused by differing levels of exposure
(dose).
Number of cigarettes and lung cancer
Benzene and lymphoma
Alcohol and impaired driving

Measurment of Health and Disease 37


E.g. Death due to ischemic heart disease
among male doctors above the age of 45 years
followed in cohort

Measurment of Health and Disease 38


4. Consistency of Relationship
Refers to repeated observation of association
in different populations under different
circumstances
The same association should be demonstrated
by other studies both with different methods,
settings and different investigators.
Serves to rule out the role of a factor that
varies across studies
That is why we compare our findings with
other studies.
If a relationship is causal, the findings should
be consistent with other data.
Measurment of Health and Disease 39
5. Biologic plausibility
is when a reasonable biologic explanation
exists that links the exposure to the
outcome.
Knowledge about physiology, biology and
pathology should support the cause-effect
relationship
If a finding doesnt go with what is known,
then it is losing biological plausibility
Alternative explanations are taken into
account when determining the relationship
between exposure and outcome
Coffee drinking and pancreatic cancer (smoking)
Smoking and lung cancer (pollution)
Measurment of Health and Disease 40
6. Reversibility
Removal of a possible cause results in a
reduced disease risk
E.g. Cessation of cigarette smocking is
associated with reduction in risk of Lung
cancer relative to those who continue.
If the cause leads to rapid irreversible
changes (as in HIV infection), then
reversibility cannot be a condition for
causality.

Measurment of Health and Disease 41


Cessation of exposure
Upon elimination or reduction of
exposure to the factor, the risk of
disease declines.
HOWEVER, in certain cases, the
damage may be irreversible.
Emphysema is not reversed with the
cessation of smoking, but its
progression is reduced.

Measurment of Health and Disease 42


7. Specificity of Association:
Specific exposure is associated with
only one disease.
Single exposure Single
disease
Plasmodium Sp. Malaria

This is/was used by tobacco companies


to argue that smoking is not causal in
lung cancer.
Smoking is associated with many
diseases. Measurment of Health and Disease 43
8. coherence
implies that a cause-and-effect
interpretation for an association does
not conflict with what is known of the
natural history and biology of the
disease.
9. Experimental Evidence: Evidence
from human experiments, however, is
seldom available for epidemiologic research
questions,
Uncertainty in extrapolations from animals
to humans often dominates the uncertainty
of quantitative risk assessments

Measurment of Health and Disease 44


DISCRIPTIVE EPIDEMIOLOGY

In descriptive epidemiology, we organize


and summarize data according to time,
place, and person.
These three characteristics are
sometimes called the epidemiologic
variables.
Not intended to confirm
causes/determinants.

Measurment of Health and Disease 45


DISCRIPTIVE
EPIDEMIOLOGY
To describe the occurrence of a disease
fully, the following questions must be
answered.
Who is affected?
Where? and
When do the cases occur?
How many?

Measurment of Health and Disease 46


PERSON

PERSON: indices of person include:


basic demographic factors: as age, sex,
race, marital status, or occupational
status
life-style variables: the consumption of
various foods or medication use
This answers the question of who is/ is
not most affected?.

Measurment of Health and Disease 47


Place characteristics

A health event is described by place to


gain insight into the geographical
extent of the problem.
For place, we may use place of
residence, birthplace, place of
employment, school district, hospital
unit, etc., depending on which may be
related to the occurrence of the health
event.

Measurment of Health and Disease 48


Spot maps

Plot location of each case of a disease,


usually by residence or workplace
Traditionally used to investigate outbreaks
of disease
Density of spots can be related to density
of population or workplaces, obscuring
source of problem

Measurment of Health and Disease 49


Distribution of cholera cases in the
Golden Square area of London, August-
September 1854

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Time

With regard to time, descriptive


studies may examine seasonal
patterns in disease onset or
compare the frequency recent time
with that of previous years.

Measurment of Health and Disease 51


There are three kinds of changes in
disease occurrence over time

a. Secular trend: slow and gradual


changes over long period of time.
b. Periodic or cyclic changes: recurrent
alternations in the frequency of diseases.
c. Sporadic: refers to the occurrence of
individual cases or outbreaks of disease at
irregular and unpredictable interval.

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Natural History and Spectrum of
Disease
The progress of a disease process in an
individual over time, in the absence of
intervention.
Without medical intervention, the process
ends with recovery, disability, or
death.
With a particular individual, the usual
course of a disease may be halted at
any point in the progression by
preventive and therapeutic measures,
host factors, Measurment
and ofother influences.
Health and Disease 53
Natural history of disease

Figure . Natural History of Disease

Measurment of Health and Disease 54


Natural history of disease
Three terms are used to describe an
infectious disease according to the various
outcomes that occur after exposure to its
causative agent
Infectivity: refers to the proportion of
exposed persons who become infected.
Pathogenicity: refers to the proportion of
infected persons who develop clinical
disease.
Virulence: refers to the proportion of
persons with clinical disease who become
severely ill or die
Measurment of Health and Disease 55
Natural history of disease

INFECTI DISEASE DISEASE


EXPOSURE
ON OUTCOME

Infectiousness Pathogenesis Virulence


(Infection rate) (Clinical to sub- (Case-fatality rate,
clinical ratio) Hospitalization rate)

4/27/2017 CDC 56
Natural history of disease
The natural history and spectrum of disease
presents challenges to the clinician and to the
public health worker.
Because of the clinical spectrum, cases of illness
diagnosed by clinicians in the community often
represent only the tip of the iceberg.

For the public health worker, the challenge is that


persons with in apparent or undiagnosed
infections may nonetheless be able to transmit
them to others. Such persons are called
carriers
Measurment of Health and Disease 57
Figure 1: pyramid and Iceberg of diseases
Measurment of Health and Disease 58
Chain of Infection

Measurment of Health and Disease 59


Chain of Infection
Components of infectious process
Agent
Reservoir
Portal(s) of exit from
the reservoir
Mode(s) of transmission
Portal(s) of entry in to the
new host
Presence of susceptible
host.

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Agent
An organism that causes the infections
or infectious process
Classification:
a. Metazoa- multi cellular organisms
b. Protozoa- Unicellular organisms e.g.
amoebae
c. Bacteria-T. pallidum, M.tuberclosis
d. Fungus-e.g. C. alibicans
e. Virus-e.g. Chicken pox, Polio etc

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The reservoir:
is an organism or habitat in which an
infectious agent normally lives,
transforms, develops and/or
multiplies.
Usual reservoirs:
- human beings
- vertebrate animals,
- invertebrates (arthropods, molluscs) and
-environmental sources (plants, soil,
water, etc)
Measurment of Health and Disease 62
Reservoir
Usually the human host is the only
reservoir for: measles, diphtheria,
pertussis, poliomyelitis, syphilis and
gonorrhea.
As a general rule, the greater the
number of different reservoirs for a given
disease, the greater the difficulty in
controlling that disease. (e.g. malaria)

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Carrier:
An infected person without manifestations of
disease, but capable of transmitting the infection
to others.
There are four types of carriers:
a. Incubatory carrier: measles, chicken pox,
mumps etc
b. Convalescent carrier: diphtheria, hepatitis
c. Asymptomatic carrier: polio, amoebiasis
d. Chronic carrier: typhoid fever
Importance: number, recognition,
chronicity, mobility

Measurment of Health and Disease 64


Portal(s) of Exit
All body secretions and discharges:
mucus, saliva, tears, breast milk;
vaginal, cervical and urethral discharges;
semen, pus, exudates from wounds.
Other routes: exhalation, talking and
coughing, through excretions,
blood and tissues (placenta).

Measurment of Health and Disease 65


Modes of Transmission
1. Direct transmission
a. Direct contact: (Biting in rabies,
Passage through birth canal)
b. Direct projection: saliva droplets by
expiratory activities, coughing, sneezing,
spitting, talking and singing.
has to be with in one meter proximity.
c. Trans-placental: maternal to fetus
with passage through the placenta

Measurment of Health and Disease 66


Modes of Transmission
2. Indirect transmission
a. Airborne: e.g. pulmonary tuberculosis
Droplet nuclei
Dust re-suspended droplets
b. Vehicle borne: a vehicle: is non living
substance or object by which an infectious agent
can be transported into a host through a suitable
portal of entry
E.g. food, milk, water, soil, blood, fomites etc
c. Vector borne
Mechanical
Biologic

Measurment of Health and Disease 67


Portal of Entry
Determines whether or not the agent
will succeed in establishing an
infection.

E.g. Cl. tetani requires an injury to enter


and cause infection. If ingested it is
harmless.

Measurment of Health and Disease 68


Susceptible Human Host
Defn:- A person lacking sufficient
resistance to a particular pathogenic agent
to prevent disease if exposed .
The concept of host susceptibility or
resistance can be seen at two level,
individuals and that of the population
Host resistance at the population level is
called herd immunity
Immunity: - is the state of defense
carried out by specific immunological
reaction in theMeasurment
bodyof Health and Disease 69
Human Host: Types of
Immunity
1. Inherited
Natural resistance of a species or race
2. Acquired
A. Natural
(I) Active: Infection by an agent
stimulates the host to produce
antibodies
(ii) Passive: Antibodies produced by the
mother cross the placenta into the blood
stream of the fetus i.e. Maternal
antibodies
Measurment of Health and Disease 70
Types of Immunity..
B. Artificial
(1) Active: Host is stimulated to produce
antibodies by the injection of an
attenuated pathogen (antigen)
i) Killed vaccine
ii) Modified live vaccine
(2) Passive: Host receives antibodies
produced elsewhere.

Measurment of Health and Disease 71


Time Course of Infectious Diseases

o Prepatent period: is the time interval between


infection (or biological onset), and the point at
which the infection can first be detected, as
measured by the time of first shedding of the
agent by the host.
*window period for HIV/AIDS
o Incubation period: between the biological and
clinical onset.
o Communicable period
o Latent period- The time interval between
recovery and the occurrence of a relapse

Measurment of Health and Disease 72


Time Course.

Figure : Time Course of a Disease in Relation to Its Clinical Expression and


Communicability
Measurment of Health and Disease 73
PRINCIPLES OF COMMUNICABLE
DISEASES CONTROL
1. Attacking the source (reservoir) of
infection
A. Treatment of cases and carriers through
mass treatment as in typhoid fever,
shistosomiasis
B. Isolation: separation of infected person for a
period of communicability
C. quarantine: limitation of movement of a
person or animal who has been exposed to
infectious disease for a maximum incubation
period for the disease
D. mass vaccination and killing/ burning (rabies,
anthrax).
E. Active surveillance of contacts
Measurment of Health and Disease 74
PRINCIPLES
2. Interrupting the chain of
transmission:
Environmental control,
Personal hygiene,
Vector control,
Disinfection and sterilization
3. Reducing host susceptibility.
Immunization ,
Better and improved nutrition,
Health education, Chemo prophylaxis,
Person protection (mosquito nets, clothing
repellents, shoes, etc.)
Measurment of Health and Disease 75
Levels of Disease Prevention
1. Primary prevention: before
occurrence of disease
Health promotion: includes general non
specific intervention that enhance health
and the body ability to resist disease.
Prevention of exposure: includes the
provision of safe and adequate water,
proper excreta disposal, vector control
Prevention of disease: this occurs during
the latency period b/n exposure and
biological onset involves activities such as
active and passive immunization
Measurment of Health and Disease 76
Levels of prevention
2. Secondary prevention:-
prevention after biological onset but
before permanent damage to stop or slow
the progression of disease so as to prevent
or limit permanent damage
screening and case detection and treatment
3. Tertiary prevention: disease has
already
occurred and left residual damage to limit
the impact of that damage.
Rehabilitation: retaining of remaining
functions for maximal effectiveness.
Limitation of disability

Measurment of Health and Disease 77


Levels of Disease Prevention

Measurment of Health and Disease 78


Screening and diagnostic
tests
is the presumptive identification of
unrecognized disease or defect by
means of rapidly applied tests,
examinations or other procedures in
apparently healthy individuals.
Screening is a public health
intervention intended to improve
the health of a precisely defined target
population
Screening tests sort out apparently
well persons who probably have a
disease from those who probably do
not
Measurment of Health and Disease 79
Screening.
A screening test is not intended to be
diagnostic and is an initial examination
only; positive responders require a
second, diagnostic examination.
Aim of screening program
To reverse, halt, or slow the progression of
disease
To alter the natural course of disease for
a better outcome for individuals affected
Protect society from contagious disease
Rational allocation of resources
Measurment of Health and Disease 80
Screening...
Diseases Appropriate for Screening:
Serious
Treatment given before symptoms should
be more beneficial in terms of reducing
morbidity or mortality than that given
after disease
High prevalence of preclinical disease

Measurment of Health and Disease 81


Criteria for establishing screening
program
Important health problem
Accepted treatment for patients with
recognized disease
Facilities for diagnosis and treatment
Recognized latent or early
symptomatic stage
Suitable test with high validity
Test acceptable to the population
Measurment of Health and Disease 82
Criteria
Adequately understood natural
history
Balanced cost of case-finding
with medical care as a whole.
Case finding should be a
continuous process and not a
once and for all project

Measurment of Health and Disease 83


Evaluation of Screening
Tests
For a successful screening the test
should ideally be:
Inexpensive
Easy to administer
Impose minimal discomfort on the
patients.
Valid
Reliable
Measurment of Health and Disease 84
Validity of a Screening Test

Is the ability to differentiate accurately


between those who have the disease
and those who do not.
A. Sensitivity - is the ability of a test to
identify correctly those who have the
disease
B. Specificity - is the ability of a test to
identify correctly those who do not have
the disease

Measurment of Health and Disease 85


How do we judge the
validity of a
screening test?

Measurment of Health and Disease 86


The contingency table
Condition According to Gold Standard

Present Absent Total

Positive a = True b = False a+ b


positives positives
Test
Result
Negative c = False d = True
negatives negatives
c+ d
Total
a+c b+d
Grand Total
a+b+c+d

Measurment of Health and Disease 87


Validity.

SENSITIVITY= TP *100
TP+FN

SPECIFICITY = TN *100
TN+FP

Measurment of Health and Disease 88


Predictive Value of a Screening
Test
is the ability of a test to predict the
presence or absence of disease from
test results.
1. Predictive Value of a Positive Test
(PVPT) or Positive Predictive Value
(PPV)
shows the probability that the person
tested positive by this specific test truly
has the disease.
PVPT = TP *100
TP + FP
Measurment of Health and Disease 89
Predictive Value
2. Predictive Value of a Negative
Test (PVNT) or Negative
Predictive Value
Shows the degree of confidence the
disease can be ruled out by using
this specific test.
PVNT = TN X 100
TN+FN

Measurment of Health and Disease 90


Reliability (Precision)
One that gives consistent results
when the test is performed more
than once on the same individual
under the same conditions.
Two major factors affect
consistency of results:
a) variation inherent in the method
b) observer variation (observer error).

Measurment of Health and Disease 91


Reliability
1. The variability of a method-
the stability of the reagents used
fluctuation in the substance being measured (e.g.
in relation to meals, diurnal variation).
2. Observer variation
inter-observer variation
intra-observer variation
These variations can usually be reduced
by:
1. careful standardization of procedures
2. intensive training period for all observers
3. periodic checks/supervision at work
Measurment of Health and Disease 92
Evaluation of screening
program
Involves consideration of:
1) Feasibility :
acceptability, cost-effectiveness,
treatment, and yield (Y).
Y= TP/(TP+TN+FP+FN)
2) Effectiveness: reduction of
morbidity, mortality and disability

Measurment of Health and Disease 93


Exercise
Case: To evaluate a new laboratory for
accuracy in conducting urine drug tests, 1,209
urine samples were obtained from individuals
who volunteered for a drug-avoidance program
and were analyzed by the new lab.
416 samples contained evidence of cocaine use,
and of these, the new lab reported that 150
were positive for cocaine use.
793 samples did not contain evidence of
cocaine use, and of these, the new lab
reported that 8 were positive for cocaine use.

1. Construct 2x2 table?


2. Calculate: the PPV, NPV, sensitivity,
specificity ?
Measurment of Health and Disease 94
Introduction to
Epidemiological Study
Designs

Measurment of Health and Disease 95


Session Objectives
Describe well all types of epidemiological study
designs
Explain the uses of the various study designs.
Express well the characteristics of descriptive
study designs and how hypothesis is
generated.
Determine when to proceed with an analytic
study for further test of the hypothesis
Describe the characteristics and design of
observational and experimental design
Describe the concepts, merits, demerits and
application of various epidemiological study
designs

Measurment of Health and Disease 96


Broad categories of epidemiologic designs
I. Observational
investigator simply observes
without having the power of assigning or
allocating the factors to the study
participants
can be descriptive or analytic
II. Interventional
investigator assigns factors
are special type of analytic designs and termed
as evaluative Measurment of Health and Disease 97
Specific types of epidemiologic
designs
Observational
Descriptive
case-report, case-series, cross-sectional,
ecological
Analytic
Case-control, cohort
Interventional
Experimental
Clinical trials, field trials, community
trials
Measurment of Health and Disease 98
Epidemiological studies
Population Ecologic

Descriptive Case report, case-series


Individuals Descriptive Cross-sectional
Observational
Comparative Cross-sectional

Analytical Case-control
Ep. Designs
Prospective
Cohort
Clinical trials Retrospective
Intervention Community trials
Field trials
Measurment of Health and Disease 99
Descriptive study designs
Purpose and characteristics
mainly concerned with the distribution of
diseases
useful for health managers to allocate
resources.
hypothesis generation.
less time consuming and less expensive
(use routinely collected information).
most common study designs used by
epidemiologists.
Measurment of Health and Disease 100
Descriptive study designs:
types
Correlational (ecological) studies
Observational studies conducted at a
population level rather than an individual
level.
Examine characteristics of entire
populations(unit of analysis is
population)
Example: 1. Examination of state data on
tobacco sales and mortality from CHD.
2. Fluoride content of water and dental
caries
Prevalence of people with dental caries in
villages Vs Fluoride content of water in
villages Measurment of Health and Disease 101
Correlational studies.
Strength
Quick and inexpensive, can be used as
first step in investigating a possible
exposure-disease relation ship.
It is useful in giving a fruitful start for
more detailed epidemiological studies.
Limitation
Doesn't link specific persons exposure
with specific outcome
Risk of ecological fallacy
Can't control for potential confounding
factors
Measurment of Health and Disease 102
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 or Useful for the
recognition of new diseases
Useful for constructing of the natural history
of a disease,
Useful to formulate a hypothesis and to
detect an epidemic

Measurment of Health and Disease 103


Case report
It is the study of health profile of a single
individual using a careful and detailed
report by one or more clinicians.
It is common form that is published in
articles
Report is usually documented if there is
unusual medical occurrence, thus it may
be first clue for identification of a new
disease
It is made using: Simple history,
Physical examination and
Lab. / radiologic investigation.
Measurment of Health and Disease 104
Case series
Individual case report can be expanded
to a case series which describes
characteristics of a number series, of
patients (usually 5-12) with a similar
disease.
Similar to case report, it is usually
made on cases having new and/ or
unusual disease (giving interest to
clinicians)
It is often used to detect the
emergence of new disease or an
epidemics.
Measurment of Health and Disease 105
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

Measurment of Health and Disease 106


Case report/series studies:
Examples
E.g. case report: A 40-year old
premenopausal woman developed
pulmonary embolism 5 weeks after
beginning to use an oral contraceptive
preparation to treat endometriosis.
E.g. case series: Five young, previously
healthy homosexual men were diagnosed
as having pneumocystis carinii
pneumonia at 3 Los Angeles hospitals
during a 6 month period in 1980 to 1981.

Measurment of Health and Disease 107


Cross-Sectional (prevalence)
Studies
Exposure and disease status are
simultaneously assessed in a population
Information about the status of an
individual with respect to the presence or
absence of exposure and disease is
assessed at the same point in time.
Cross-sectional surveys could provide
information about the frequency of a
disease by furnishing a snapshot at a
specified time.

Measurment of Health and Disease 108


Cross-Sectional studies.
May be useful first step in longitudinal
studies.
Data are obtained only once
Measures of association is made using
odds ratio.
Strength
Provides information about the
frequency and characteristics of a
disease.
decision making and priority setting
Measurment of Health and Disease 109
Cross-Sectional studies.
prevalence of disease or other health
outcome in special groups (e.g.
occupations)
investigates exposures that are fixed
characteristics of individuals, ( ethnicity
and blood groups).
Limitation
Cant determine whether exposure
preceded or occurred as a result of
the disease (chicken and egg
dilemma!!)

Measurment of Health and Disease 110


Analytic epidemiological studies

Objectives /aim
To test hypothesis about causal
relationship
To search for cause and effect. Why???
How???
To compare treatment regimens /
prevention programs
To assess diagnostic tests
To quantify the association between
exposure and outcome
Measure of association

Measurment of Health and Disease 111


Analytic Studies
Explicit comparison of exposure and
disease
Appropriate comparison/control group
Hypothesis testing
Two types
Observational - natural course of
events
Intervention - investigator allocates
exposure and follows subjects

Measurment of Health and Disease 112


Case-Control Studies
Properties
suitable for identifying risk factors for
rare diseases
Design
Selection of cases (disease) and
controls (no disease) based on
disease status
Exposure status is unknown
lacks temporality
Measurment of Health and Disease 113
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: Select cases
sources:
1. Hospitals (health institutions)
2. Population (community)
Measurment of Health and Disease 114
Steps
3: Select controls
consider comparability, practicability and
economic impact.
controls should be similar with the cases
except the disease or other outcome of
interest.
Sources of controls
1. Hospital controls
2. General population controls
Advantages:
Generalization is possible
If cases are selected from the population,
it is good to select controls from the
population too.
Measurment of Health and Disease 115
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.

Measurment of Health and Disease 116


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 directlyMeasurment
compute incidence rates of
of Health and Disease 117
Cohort studies
Types of cohort studies
Classification is based on the temporal
relationship between the initiation of the
study and the occurrence of the disease.
1. Prospective cohort study
the outcome has not yet occurred at the
beginning.
is the commonest type.
unless specified cohort study refers to the
prospective type of cohort
more reliable than the retrospective

Measurment of Health and Disease 118


Fig. prospective cohort studies
Measurment of Health and Disease 119
Types of cohort studies
2. Retrospective (Historical) cohort
study
the investigation is initiated at a point in
time after both the exposure and disease
have already occurred.
less costly and less time consuming
often uses data collected for other
purposes, hence information obtained
might be incomplete and non comparable
for all subjects
Measurment of Health and Disease 120
Retrospective or Prospective

Measurment of Health and Disease 121


Steps in conducting cohort study
1: Define exposure
2: Select exposed group
3: Select controls (non-exposed)
control groups should be comparable to the exposed
group
4: Identify sources of data for exposure and outcome
Possible sources of exposure data:
pre-existing records
conducting interview
Possible sources of outcome data:
routine surveillance
death certificate
periodic health examination
hospital records etc.

Measurment of Health and Disease 122


Steps
5: collect data
6: Analyze data
prepare 2X2 table
calculate Relative Risk (RR)
perform statistical tests to check whether
there is statistical significant association

Measurment of Health and Disease 123


Cohort (Cont)

Advantages
Can measure incidence and thus
relative risk
No recall bias
Exposure precedes disease
Can study several diseases
Can be very efficient for rare
exposure
Measurment of Health and Disease 124
Cohort
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
Measurment of Health and Disease 125
Advantages and limitations of cohort and case control
studies
Case control Cohort
Advantages: valuable when exposure is rare
optimal for evaluation of rare can examine multiple effects
Disease of a single exposure
can examine multiple factors temporal relationship is known
for a single disease allows direct measurement of
Quick & inexpensive risk
relatively simple to carry out minimize bias in ascertainment of
guarantee the number of persons exposure
with a disease
Limitations: inefficient in evaluation of
inefficient in evaluation of rare rare diseases
exposure expensive
can not directly compute risk time consuming
difficult to establish temporal loss to follow up create problem
relationship
determining exposure will
often rely on memory Measurment of Health and Disease 126
Experimental/Intervention
studies
Individuals are allocated into
experiment or control group by the
investigator.
can produce high quality data.
Experimental study is the gold
standard study design compared
to other designs.

Measurment of Health and Disease 127


Experimental Studies

The investigator through randomization allocates


subjects to different categories of exposure.
Randomization: An allocation procedure that
assigns subjects into (one of the) exposure groups
being compared so that each subject has the same
probability of being in one group as in any other.
Measurment of Health and Disease 128
Classification of Intervention Studies
A. Classification based on the population
studied
1. Clinical trial: usually performed in the clinical
setting and the subjects are patients
2. Field trial: used in testing medicine for
preventive purpose. Subjects are healthy
peoples
E.g. vaccine trial
3. Community trial: unity study is group of
people/community
E.g fluoridation of water to prevent dental caries

Measurment of Health and Disease 129


Classification of Intervention
Studies
B. Classification based on design
1. Uncontrolled trial
No control group. Control will be past
experience
2. Non randomized controlled: There is a
control group allocation to either group is
not randomized
3. Randomized controlled: there is
control group
there is random allocation of subjects to
either group Measurment of Health and Disease 130
Problems related to experimental
studies
Ethical issues:
harmful should not be used in this
study.
beneficial treatment should not be
withheld from any affected individuals.
Feasibility / practical issues
subject recruitment
difficult to achieve satisfactory
compliance.
Cost
Measurment of Health and Disease 131
Measures of Disease and Death
Frequency
Counts, Proportions, ratios, rates
Measures of disease frequency -
measures disease risk or burden in a
population
Prevalence ( point, period, lifetime)
burden
Incidence( CI)
risk
Measurment of Health and Disease 132
Measures of Frequency.
Ratio
occurrence of one event in relation to the
other
Ratio=A/B ; A:B
Used to compare two quantities
ratio of female to male births
Age dependency ratio,
maternal mortality ratio
the ratio of people with tuberculosis to those
without tuberculosis.

Measurment of Health and Disease 133


Measures of Frequency.
Proportion:
is a type of ratio which quantifies
occurrences in relation to the
population in which these occurrences
take place. ( i.e. denominator
includes the numerator).
P=A/A+B
e.g. proportion of TBC cases among
inhabitants of a certain locality.
Measurment of Health and Disease 134
Measures of Frequency.
Rates
Special form of proportion that includes
a specification of time
Most commonly used in epidemiology
because it most clearly expresses
probability or risk of disease or
other events in a defined population
over a specified period of time.
Rate=A/A+B + time element

Measurment of Health and Disease 135


Measures of Morbidity
1. Incidence
Measure of new cases of disease (or
other events of interest) that develop in at
risk population during a specified period of
time.
Measure of the probability that unaffected
persons will develop the disease.

IR= (no of people who developed a certain condition during a


specified period of time) / (population at risk for the condition)

Measurment of Health and Disease 136


Incidence.
Population at risk: those individuals
who are not having the disease
currently but capable of developing it.

E.g. There were 70 cases of breast


cancer developed over the five years
follow up of 3,000 women.

Calculate the IR of breast


cancer???

Measurment of Health and Disease 137


Measures of Morbidity
2. prevalence
Proportion of individuals in a population
with disease at a specific point of time
Provides an idea of how severe a problem
may be
Useful for planning health services
(facilities, staff)

P=number of existing cases of disease at a given pt/pd in time


Total population at risk

Measurment of Health and Disease 138


Types of prevalence
1. Period prevalence rate: measures the
proportion of a population that is
affected with a certain condition during a
specified period of time
PPR= no of people with a condition during a specified
period of time / total population
2. Point prevalence: number of cases that
exist at a given point in time
Point prevalence rate is directly
proportional to both the incidence rate
and the average duration of disease
Point prevalence rate ~ IR*D
Measurment of Health and Disease 139
Types of prevalence.
3. Lifetime prevalence: proportion of the
population that has a history of a given
disorder at some point in time
Factors determining prevalence
Severity of illness
Duration of illness
The number of new cases

Measurment of Health and Disease 140


Measure of Mortality
Mortality rate and ratio measure the
occurrence of death in a population
using different ways.
Rate whose denominator are the total
population are commonly calculated
using either the mid interval or the
average population.
This is due to population size
fluctuation over time due to birth,
death and migration

Measurment of Health and Disease 141


Measure of Mortality..
Three types of rates:
Crude rates
Specific rates
Adjusted rates

Measurment of Health and Disease 142


Crude rates
are summary rates based on the actual
number of events (births, deaths,
diseases) in the total population over
a given time period.
most widely used in description of
populations are the crude birth rate
(CBR) and the crude death rate (CDR).
# Of deaths in a year
CDR = ---------------------------------X 1000
Average (mid-year) population.

Measurment of Health and Disease 143


Crude rates ..
Advantages:
Actual summary rates
Calculable from minimum information
Widely used despite limitations
Disadvantages:
Difficult to interpret due to variation in
composition (e.g.: age)
Obscure significant differences in risk
between subgroups.

Measurment of Health and Disease 144


Specific rates
Apply to specific subgroups in the population, such
as :
Age-specific rates
Gender-specific rates
Race-specific rates
Cause-specific rates
Place-specific rates
Examples: Infant Mortality Rate (IMR), Neonatal
Mortality Rate (NMR), Maternal Mortality Ratio
(MMR), Sex specific mortality rate
# Of deaths from a specified cause in a year
CSDR=--------------------------------------------x 1000
Average population in the same period

Measurment of Health and Disease 145


Specific rates
Advantages:
The rates apply to homogenous subgroups
The rates are detailed and useful for
epidemiological and public health
purposes.
Disadvantages:
It is cumbersome to compare many
subgroups of two or more populations

Measurment of Health and Disease 146


Commonly used mortality measures
Crude Death rate (CDR) = Total no. of deaths reported during a given
time interval X 1000
Estimated mid interval population
Age- specific mortality rate = No. of deaths in a specific age group
during a given time X1000
Estimated mid interval population of sp. age group
Sex- specific mortality rate = No. of deaths in a specific sex during a
given time X 1000
Estimated mid interval population of same sex
Cause- specific mortality rate = No. of deaths from a specific cause
during a given time X 100,000
Estimated mid interval population
Measurment of Health and Disease 147
mortality measures.
Proportionate mortality ratio = No. of deaths from a sp. cause
during a given time x 100
Total no. of deaths from all other causes in the same time
Case Fatality Rate (CFR) = No. of deaths from a sp. disease during
a given time x 100
No. of cases of that disease during the same time
Perinatal Mortality Rate = No. of fetal deaths of 28 wks or more
gestation Plus no. of infant deaths under 7 days x1000 .
no. of live births during the same period.
Measurment of Health and Disease 148
mortality measures.
Neonatal Mortality Rate = No. of deaths under 28 days of age reported during a given time x
1000
No. of live births reported during the same time
Infant mortality rate (IMR) = No. of deaths under 1 yr of age during a given time X 1000
No. of live births reported during the same time interval
Child mortality rate (CMR) = No. of deaths of 1-4 yrs of age during a given time X 1000
Average (mid-interval) population of same age at same time
Under- five mortality rate = No. of deaths of 0-4 yrs of age during a given time X 1000
Average (mid-interval) population of the same age at same time
Maternal Mortality Ratio = No. of pregnancy associated deaths of mothers in a given
time x 100000
No. of live births in the same time

Measurment of Health and Disease 149


Measures of Association
Epidemiological data are often presented in the
forms of two by two (contingency) table

2x2 table contain 4 cells a , b , c , d

The strength of association assessed by calculating


relative risk(RR), odd ratio or other measure of
association
Measurment of Health and Disease 150
Measures of Association

Measurment of Health and Disease 151


Measures of Association

Measurment of Health and Disease 152


Measures of Association
TESTS
1. Showing mainly the presence or absence of
association. E.g. Chi-square.

2. Showing the strength of


association: Relative Risk (RR),Odds Ratio (OR) or other
measures of association.

Measurment of Health and Disease 153


A. Relative Risk (RR) or
Risk Ratio

shows the magnitude of association


between exposure & disease
Indicates the likelihood of
developing the disease in exposed
group relative to those who are not
exposed

Measurment of Health and Disease 154


Relative risk

Example: Cohort study of oral contraceptive (OC)


use and bacteruria among women aged 16- 49
years (table:2)
Measurment of Health and Disease 155
Bacteruria
Oral
contraceptive Yes No Total
(OC) Yes 27 455 482
Use
No 77 1831 1908

Total 104 2286 2390

Table:2 Calculate RR ???? 1.4


Interpretation: Women who used oral contraceptive had 1.4 times
higher risk of developing bacteruria than non users
Measurment of Health and Disease 156
Odds Ratio (OR)
RR can be estimated by calculating the ratio of the odds
of exposure among the cases to that among the
controls i.e. the OR.
Difficult to calculate RR

OR = a/c ad
b/d bc

Measurment of Health and Disease 157


Odds Ratio (OR)
Example: Table 3: this table shows from case control study of
oral contraceptive (OC) use and myocardial infarction in
pre menopausal female nurse. Calculate OR????
Interpretation????
Myocardial infarction
Oral
contraceptiv Yes No Total
e (OC) Yes 23 304 327
Use
No 133 2816 2949
Total 156 3120
Measurment of Health and Disease
3276 158
Attributable risk(AR)
AR or RD is a measure of association that
provides information about the absolute effect
of the exposure or the excess risk of
diseases in those exposed compared with
those non exposed

AR= incidence among exposed- incidence


among non exposed (Ie-Io)

Example: In the study of OC use and


bacteruria (table: 2), the attributable risk

Measurment of Health and Disease 159


Interpretation: the excess occurrence of bacteriuria
among OC users attributable to their OC use is 1566
per 100,000.

Measurment of Health and Disease 160


Attributable risk percent(AR%)
Estimate the proportion of the disease
among the exposed that is attributable to
the exposure, or the proportion of the
disease in the exposed group that could
be prevented by eliminating the
exposure

AR%= (Ie- Io)x100


Ie
Interpretation: if OC use cause bacteriuria,
for AR% of 28 % about 28% of bacteriuria
among women who use OC can attributed to
their OC use and can be eliminated if the they
did not use oral contraceptive.
Measurment of Health and Disease 161
POSSIBLE OUTCOMES IN STUDYING THE
RELATIONSHIP BETWEEN DISEASE AND EXPOSURE

1. No association between exposure and


disease
AR=0, RR=1
2. Positive association between exposure
and disease (more exposure, more
disease)
AR>0, RR>1
3. Negative association between exposure
and disease (more exposure, less disease)
AR<0 (negative), RR <1(fraction)
Measurment of Health and Disease 162
Measurment of Health and Disease 163
QUESTION

Measurment of Health and Disease 164


MI
SMOKING YES NO
YES 157 110 267
NO 209 313 522
366 423 789

SOLUTION
OR=ad/bc=157*313/209*110=2.14
RR=157/267-209/522=0.18
AR= Ie-Io(157/267-209/522)=0.187=187 per 1000 population
AR%= AR/Ie=0.187/(157/267)=31.8%

Date 05/10/2004
Measurment of Health and Disease 165

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