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College of Medicine and Health Sciences

Department of Public Health


Epidemiology Unit
Module Title: Measurement of Health & Disease
Module Code: SPH- M-2052
Module ECTS: 5
Duration: 14 weeks
Mode: Parallel
For: 2nd year regular BSc Nursing Students
Delivered by: Epidemiology and Biostatistics
Tilahun Degu (MPH in Epidemiology)
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Chapter-1: Introduction to public health

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Outlines
Health and disease:
• concepts, definitions and perspectives
Public health:
• definition, philosophy, history, development,
core functions and services
Public health sciences:
• their scope and use in medicine

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Lesson Objectives
At the end of this lesson, students will be able to:
• Explain the notion of health from scientific(Medical),
layman and WHO perspectives.

• Describe the history, evolution and functions of public


health and its relevance to the practice of Nursing
profession.

• Describe disciplines of Public Health sciences and their


scope.

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How can you define Health in your perspective?

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Health and Disease
 Health concepts:
Health is more difficult to define.

concept of health must include all dimensions of human life.

Health must be positive, not only the absence of disease.

A commonly communicating agenda

closer looks show various and diverse meanings.

Health can be defined based on lay, professional and WHO


point view.
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Lay point of View---definition of Health
• Persons are healthy when they are doing their activities.

• Health is doing activities with no apparent symptoms of


disease.

• Health as ‘the state of being free from illness


or injury’- dictionary definition.

• It lacks basic concepts of disease which are not


interfere with normal daily activities.

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Professional view– definition of Health
• Health is a measure of the state of the physical
bodily Organs.

• Health is the ability of the body as a whole to


function.

• Health is a freedom from medically defined diseases.

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WHO view—Definition of Health
“Health is a state of complete physical, mental, and social
well-being and not merely the absence of disease or
infirmity.” (WHO, 1948-preample of the constitution)

Further expands the ability to lead a “socially and


economically productive life”.

 A condition or quality of the human organism expressing


the adequate functioning of the organism in given
conditions or environment.=multidimensional definition.

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Physical Health ( Dimension-1)
• is concerned with anatomical integrity and
physiological functioning of the body.

• It means the ability to perform routine tasks


without any physical restriction.

• E.g., Physical fitness is needed to walk from place to


place.

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Mental Health(Dimension-2)
• is the ability to learn and think clearly and coherently.

• a state of well-being in which the individual realizes his or


her own abilities,

• State of cope with the normal stresses of life,

• A state of work productively and fruitfully, and

• is able to make a contribution to his or her community

• E.g. a person who is not mentally fit (retarded) could not


learn something new at a pace in which an ordinary normal
person learns.
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Social Health (Dimension-3)
• is the ability to make and maintain acceptable
interaction with other people.

• Those who are well integrated into their communities


tend to live longer and recover faster from disease.

• E.g. to celebrate during festivals; to mourn when a close


family member dies; to create and maintain friendship
and intimacy, etc.

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Emotional Health (Dimension-4)
• is the ability of expressing emotions in the appropriate
way, for example to fear, to be happy, and to be angry.

• The response of the body should be congruent with


that of the stimuli.

• Emotional health is related to mental health and


includes feelings.

• It is maintaining one’s own integrity in the presence of


stressful situation such as tension, depression and
anxiety.
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Spiritual Health(Dimension-5)

• Some people relate health with religion.

• For others it has to do with personal values, beliefs,


principles and ways of achieving mental satisfaction,
in which all are related to their spiritual wellbeing.

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Draw backs of WHO definition of Health
• Its overly idealistic expectation of complete well-
being.

• Its view of health as static, rather than as a dynamic


process that requires constant effort to maintain.

• It does not lend itself to direct measurement.

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Definition of Common Words

• Wellness is the subjective experience of health.

• Health is an objective process associated with


stability and balance.

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Different Perspectives Of Health

• Health is viewed as:


• a right- without any distinction
• a consumption good- individual view
• an investment-prerequisite for development

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Disease concepts
• Until 19th century, disease is considered as an
imbalance between individuals and their
environment (Philosophical).

• Disease was as clinical signs and symptoms arising


from injury originating from specific causal agents
(Emergence of Modern Medicine=20th C).

• Different terms such as illness, sickness and disease


were detected.
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Disease concepts……..
• Illness is the subjective state of the loss of health or
personal side of abnormality.

• Illness is suffering but the expression of suffering may not be


translated as the diagnosis of a disease.

• Sickness transcends both of these concepts by focusing on


social consequences.

• Is a state of social dysfunction; i.e. a role that an


individual assumes when ill.

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Disease concepts….
• Disease is thought to be the objective state of ill health
where a problem is detected by medical science

• Is a medical conception of pathological abnormalities.

• Disease means living with a diagnosis mediated through a


set of interventions by the health system.

• For example:

• There are circumstances in which a person does not feel ill,

• But has been diagnosed with a lesion that may not have
produced clinical symptoms, characterizing the presence of a
potential
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disease. 20
Disease concepts…………
• There should be a way of differentiating between
feeling healthy and not having a disease.

• So, healthiness is conditional, which means One


meaning does not correspond exactly to the other.
• Scientific medical knowledge is not always capable
of dealing:
• adequately with the subjective dimension of
human suffering that comes from living with

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illness. 21
Approaches to Health and Disease
• There are different models that relate Health to Disease.

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Conclusion…. Health and Disease
Health Illness
• Subjective experience
scientifically: • Suffering
• Absence of disease • Primary intuition
• Statistical normalcy • Need
• Biological function Disease
Philosophically: • Objective scientific
concept
• Value
• Disease diagnosis
• Normativeness
• Medical intervention
• Capacity to withstand
• Demand
environmental adversities
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Public Health

Which is better, Individual Health or Public


Health concern???

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Definition
• Public health is:
• what we, as a society,
• do collectively
• to assure the conditions in which people can
be healthy.

• The term public health has two meanings:


• Health status of the public
• Organized social efforts to preserve and
improve the health of a defined population
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Definition…
• Public health is the science and art of:
• preventing disease,
• Prolonging life, and
• promoting health and efficiency through
• the organized community efforts.
• It is concerned with the health of the whole population and
the prevention of disease from which it suffers.
• It is the combination of sciences, skills and beliefs that is
directed to the maintenance and improvement of the
health of all the people through collective social actions.
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Definition…..
• Health Promotion: a guiding concept involving
activities to increase involvement and control of
the individual and the community in their seeking of
own health.

• Prevention: is promoting, preserving, and


restoring health when it is impaired, and to
minimize suffering and distress.
• It can be primary, secondary or Tertiary.
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Philosophy of Public Health

• Philosophy: is how and what people think about


basic and longstanding human concerns such as
knowledge, reasoning, free will, morality, objectivity
and rationality, facts and values, and freedom.

• A central concern is the extent to which individual


autonomy is constrained in the name of the common
good when public health interventions are
implemented.
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Philosophy of Public Health….
• Causation, ethics, science, and society are some of
the signposts along public health’s philosophy.

• A core concern of a philosophy of public health is


the balance between the interests of communities
and populations and those of individuals.

• These emanates from two complementary and


essential public health goals: the prevention of
disease and the promotion of health and well-being.
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History and Development
The history of public health is derived from:
• many historical ideas, trial and error,
• the development of basic sciences, technology,
and Epidemiology.

The history of public health is a story of the search


for effective means of securing health and
preventing disease in the population.

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History and Development ……

Reading Assignment
Looking back helps in looking ahead!!!

Source: Sci-Hub | A History of Public Health. The New


Public Health, 1–42 | 10.1016/B978-0-12-415766-
8.00001-X

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Core functions and services
• Public Health works to :
• research diseases,
• respond to epidemics,
• develop health programs,
• increase access to health services, and
• educate populations on proper health care.

• Core functions that are fundamental to achieving


the goals of public health are called EPHF.
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Core functions and services…..

• Assessment: involves the collection and analysis of


information regarding health problems.

• Policy Development: involves the process of


information sharing, consulting, and citizen
participation to decide on public health measures.

• Assurance: involves active pushes to ensure


communities are healthy and protected.

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Public Health Sciences/ Disciplines
• The core public health disciplines are:
• health policy and management (HSM),
biostatistics, environmental health sciences,
epidemiology, and Health promotion and
Behaviors Etc.

• Public health touches every aspect of our lives and


addresses.

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Public health Sciences….
• Demography: is the study of population, especially
with reference to size and density, fertility, mortality,
growth, age distribution, migration, and the interaction of
all those with social and economic conditions.
• Biostatistics is the application of statistics to biological
problems especially to medical problems.
• Epidemiology is the study of frequency, distribution, and
determinants of diseases and other Health related states
or events in specified populations.

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Public health Sciences….
• Health Economics is concerned with the alternative
uses of resources in the health services sector and with
the efficient utilization of economic resources such as
manpower, material and financial resources.

• Health Service Management is getting people to


work harmoniously together and to make efficient use of
resources in order to achieve objectives.

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Public health Sciences….
• Ecology: is the study of relationship among living
organisms and their environment. It is the science,
which deals with the inter-relationships between the
various organisms living in an area and their relationship
with the physical environment. Human ecology means
the study of human groups as influenced by
environmental factors, including social and behavioral
factors.

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Public health Sciences….
• Nutrition: is the science of food, the nutrients and
other substances therein, their action, interaction and
balance in relation to health and disease.

• Reproductive health: is a state of complete physical,


mental and social being not only absence of disease or
infirmity, in all matters relating to reproductive system
and to its functions and process.

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Public health Sciences….
• Environmental Health is the basic approach to
environmental control is first to identify specific biologic,
chemical, social and physical factors that represent
hazards to health or well-being and to modify the
environment in a manner that protects people from
harmful exposures. The principal components of
environmental health are water sanitation, waste
disposal , etc.

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Public health Sciences….
• Health Education is defined as a combination of learning
experiences designed to facilitate voluntary actions
conducive to health. It is an essential part of health
promotion.

• Research is a conscious action to acquire deeper


knowledge or new facts about scientific or technical subjects.

• It is a systematic investigation towards increasing


knowledge. It aims at the discovery and interpretation of
facts, revision of accepted theories, or laws in the light of
new facts or practical application of such new theories or
laws.
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CHAPTER-2

Epidemiological concepts of disease causation

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Outlines
• Introduction to Epidemiology

• Concepts of disease causation

• Epidemiological models in disease causation

• Factors and establishing of causation

• Time, Place and Person concept in disease causation

• Natural history of diseases (communicable and non-


communicable)

• Levels of prevention

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Learning Outcomes
At the end of this lesson, students will be able:

• Describe the concept of Epidemiology correctly to the


standard.

• Explain concept of disease causation and Epidemiological


models of disease causation (Epidemiological triangle, web of
causation, wheel model).

• Identify factors of disease causation and the concept of PPT

• Describe the natural history of disease and level of


prevention

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Brain Storming

Why does a disease develop in some people and not


in others?

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Introduction to Epidemiology-definition
Epidemiology is the study of the :
• frequency,
• distribution and
• determinants of health-related states or events
• in specified populations and
• the application of this study to control of health problems
and related events.
• The underlined concept of Epidemiology: Health status is
not randomly distributed in human population
• Epidemiology is the basic science of Public Health.
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Introduction to Epidemiology-Key words
• Study: collection, analysis and interpretation of data=action

• Frequency: quantitative science

• Distribution: describes the disease in Person, place and


time=Descriptive Epidemiology

• Determinants: causal factors for the health


condition=Analytical Epidemiology

• Health and Health related events: health outcomes

• Population: studies in aggregates or groups=Popn Medn

• Application: provides data for public Health action (Whole


aim)
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Introduction to Epidemiology-Why basic Science?
Because Epidemiology is:
Built on the knowledge of probability, statistics, and sound
research methods.

A Method of causal reasoning by developing and testing


hypothesis.

A tool for public Health action to promote and protect


public’s health.

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Introduction to Epidemiology: Evolution
• Originally, it was concerned with epidemics of communicable
disease.
• Lately, extended to endemic communicable diseases and
non-communicable infectious diseases.
• recently, concerned to chronic diseases, injuries, birth
defects, maternal and child health, occupational health, and
environmental health.
• Now, even health behaviors, such as care-seeking, safety
practices, violence, and hygienic practices are valid subjects
for epidemiologic investigation.

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Introduction to Epidemiology: Objectives

To identify the etiology/cause of the disease and relevant

risk factors.===ultimately reduce morbidity and mortality.

To determine the extent of disease found in the community.

To study the natural history and prognosis of disease.

To evaluate existing and newly developed preventive and

therapeutic measures and modes of health care delivery.

To provide the foundation for developing public policy.


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Introduction to Epidemiology-Think

Have you got the concept of Epidemiology following


the introduction?

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Concepts of disease causation
Cause of disease : is
• an event,
• condition,
• characteristic or

• a combination of these factors which plays an


important role in producing the disease.

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Concepts of disease causation….
Not all associations between exposure and disease are causal.
A cause of a disease can be defined as a factor
(characteristic, behavior, event, etc.) that influences the
occurrence of disease.
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".
These can be primary causes or risk factors/Secondary
causes (predisposing, enabling, aggravating or
reinforcing
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factors). 52
Disease causation…Primary causes

Necessary for a disease to occur,

absence --the disease will not occur.

etiologic agent” can be used for Infectious causes


of diseases.

• For example:

“Mycobacterium tuberculosis” is the primary cause


(etiologic agent) of pulmonary tuberculosis.
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Disease causation…Risk factors/2ndry
Are important for a disease to occur but not necessary.
A factor associated with an increased occurrence of a
disease is risk factor for the exposed group
A factor associated with a decreased occurrence of a
disease is a risk factor for the non exposed group.
Risk factors could be related to the agent, the host and
the environment.
The etiology of a disease is the sum total of all the
factors (primary causes and risk factors) which
contribute
2/2/2023 to the occurrence of the disease. 54
Disease causation…Predisposing factors
 Those create a situation or state of susceptibility.
 so that the host tends to react in a specific fashion to a
disease agent or stimulus.
 Examples: age, sex, marital status, family size, educational
level, previous illness experience, presence of concurrent
illness, working environment, and attitudes toward the use
of health services.
These factors may be “necessary” but are rarely “sufficient” to
cause the phenomena.

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Disease causation…Enabling factors
are those that facilitate the manifestation of disease,
disability, ill health, or the use of services or
 those that facilitate recovery from illness, maintenance or
enhancement of health status, or more appropriate use of
health services.
Examples include income, health insurance coverage,
nutrition, climate, housing, personal support systems,
and availability of medical care.
It may be “necessary” but are rarely “sufficient” to cause the
phenomenon.

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Disease causation…precipitating factors
are those associated with the definitive onset of a disease,
illness, accident, behavioral response, or course of action.

Examples include exposure to specific disease agent, amount


or level of an infectious organism, drug, noxious agent,
physical trauma, personal interaction, occupational stimulus,
or new awareness or knowledge.

Usually one factor is more important or more obviously


recognizable than others if several are involved and one may
often be regarded as “necessary.”
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Disease causation…Reinforcing factors
Are those tending to perpetuate or aggravate the presence of
a disease, or health condition.

They may tend to be repetitive, recurrent, or persistent

may or may not necessarily be the same or similar to those


categorized as predisposing, enabling, or precipitating.
Examples: repeated exposure to the same noxious
stimulus such as an infectious agent, work, household, or
interpersonal environment, presence of financial incentive
or disincentive, personal satisfaction or deprivation.

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Epidemiologic variables in Disease causation
• Person (who), place (where) and time (when) are the Three
essential characteristics of disease.

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Disease causation…..

• Identify the primary causes and risk factors for


Malaria?

• When we establish the causation correctly?

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Epidemiological models in disease causation
A model is an abstract representation of the relationship
between logical, analytical, or empirical components of a
disease or phenomena or system.
In Epidemiology, there are different models which illustrate
concept of disease causation.
These are:
Epidemiological triangle/triad model
Rothman Causal pie model
Wheel Model
Web causation model
Dever’s Epidemiological Model
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Epidemiological triangle/triad model
traditional model of causation of infectious disease.
not everyone exposed to disease causing agent
contracted the disease.
Not only the causative agent but also the host and
the environment are cause of the disease.
Disease occurs only when host, agent and
environmental factors are not in balance.

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Rothman Causal pie model
• multifactorial nature of causation for a disease/outcome.

• If all the pieces of pie fall into place, the pie is complete and
the disease will occur.

 Public health action does not depend on the identification of


every component cause rather blocking any single component
of a sufficient cause
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Rothman Causal pie model……
• The completion of a sufficient cause is synonymous
with the biologic occurrence of the outcome.

• A component cause that must be present in every


sufficient cause of a given outcome is a necessary
cause.

• Each component cause has different induction, and


latent period (detectable pre-clinical phase).

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Rothman Causal pie model……Example

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Wheel Model
• Disease is caused due to human-environment interaction.

• It consisted of a hub (the host or human), which has:


• genetic make-up as its core and
• surrounded by the environment.

• The wheel model is schematically divided as biological,


social, and physical.

• The size of the components of the wheel depends on the


specific disease problem under consideration.

• The genetic core would be large and less for hereditary


disease
2/2/2023 and infectious disease respectively. 66
Wheel Model……graphic presentation

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Web of causation Model
• The process that actually generates disease or leads to
injury is much more complex.

• Disease develops from a chain of causation in which each


component is a result of complex interaction of preceding
events.

• This chain of causation, which may be the fraction of the


whole complex, is web of causation.

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Web of causation Model…..Graphic
presentation

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Dever’s Epidemiological Model
There are four factors:
• Human Biology- epidemiological triad and includes genetic
inheritance, complex physiological system, factors related to
maturation and ageing.
• Life style- daily living activities, customs, traditions, health
habits etc.
• Environmental Factors- physical, biological, social and
spiritual components
• Health care system factors- availability, accessibility,
adequacy and use of health care services at all levels.
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Disease Causation Theories
• Before the discovery of microorganisms (Lois pasture in
1822-1895).

• Several theories explaining the cause of disease were put


forward time to time.

• Among which commonly known are:


• Miasma Theory
• Supernatural theory
• Ecological theory
• Germ theory

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• Multifactorial causation theory 71
Self Exercise

• Use the epidemiological triangle model to


describe the role of the immunodeficiency virus in
AIDS???

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Natural History of Disease
• Is the progression of disease process in an individual over
time, in the absence of intervention.

• Most diseases have a characteristic natural history,

• although the time frame and specific manifestations of


disease may vary from individual to individual.

• The usual course of a disease may be halted at any point in


the progression by preventive and therapeutic measures,
host factors, and other influences.

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Natural History of the disease---Stages
• There are four stages in the natural history of a disease.

• These are:

Stage of susceptibility- the presence of factors that


favor its occurrence.
Stage of pre-symptomatic (sub-clinical) disease- the
signs and symptoms of the disease are not present but
pathologic change

Stage of clinical disease- sn and sx developed.


Stage of disability or death/recovery-outcome
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Natural History of the disease---Stages

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Natural History of the disease---Stages

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Self Exercise

How could you think about the natural history of


communicable and non communicable diseases?

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Level of Prevention
• Prevention is a way of interrupting or slowing the
progression of disease through appropriate intervention.

• Epidemiology plays a central role in disease prevention:

• by identifying modifiable causes and risk factors of


disease.

• There are three/four levels of prevention.

• Primordial, primary. Secondary and tertiary

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Level of Prevention…Primordial
• A type of primary prevention

• To avoid the emergence and establishment that are known


to contribute to an increased risk of disease.

• identified because of increasing knowledge about the


epidemiology of cardiovascular diseases.
• avoid the basic underlying cause such as a diet high
in saturated animal fat.
• advocate the side effect of consuming diet saturated
with animal fat.

• Example: Taxation and increasing price of tobacco- cancer


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Level of Prevention…Primary
• individuals may or may not be exposed to the risk factors.
• all interventions before the biologic onset of a disease.
• main aim is:
• to prevent the development of disease and
• to reduce the dose of exposure to the risk factor.
• The effort can be directed to the whole population or high
risk individual.
• Components:
• Health promotion-non-specific intervention
• Prevention of exposure- specific before exposure
2/2/2023 • Prevention of disease- specific after exposure 80
Level of Prevention-Secondary
• Preventive measures after biologic onset.
• But before permanent damage.
• Aimed to:
• stop or slow the progression of disease
• prevent or limit permanent damage.

• reduce the more serious consequence of disease

• prevention of spread of the disease.

• Directed at the period between the onset of disease, and the


normal time of diagnosis.

• Strategically, through early detection and treatment of


disease.
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Level of Prevention-Secondary
• Requirements for secondary prevention:
• safe and accurate method of detecting the disease –
preferably at a preclinical stage and
• effective methods of intervention.
• Examples:
 testing of eyesight and hearing in school age children,
 screening for high blood pressure in middle age,
 testing for hearing loss in factory workers, and
 skin testing and chest radiography for TB.

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Level of Prevention- Tertiary
• Targeted towards people with permanent damage or
disability.

• It is needed in some diseases because primary and


secondary preventions have failed.

• In others primary and secondary prevention are not


effective.
• Objectives:
• Disability limitation-limiting the continuation of
loss of function
2/2/2023 • Rehabilitation activities-rehabilitation medicine
83
Level of Prevention- Tertiary

• Examples:
• Foot care for diabetic patients to prevent injuries

• passive joint movement for polio to prevent deformity

• Plastic surgery for burn patients,

• kidney transplantation.

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NHD Level of Prevention- summary

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Self exercise

• Describe two strategies for each levels of diseases


prevention in relation to the four stages of natural
history of diseases.

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CHAPTER-3

Measurement in Epidemiology

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Outlines
• Measuring disease frequency (incidence, prevalence,
disability measures)

• Comparing disease occurrence (absolute and relative


comparisons, standardization)

• Measuring morbidity frequency (Death rates)

• Epidemiology of diseases of public health significance


in Ethiopia

• Using available information to measure health and


disease (health information system)
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Learning objectives
At the end of this lesson, students will be expected:

• To calculate and interpret measures of morbidity and


mortality.

• To identify different indices used to measure burden of


disease.

• To compare disease/event occurrences in a population.

• To discuss epidemiology of diseases of public health


significance in Ethiopia.

• To discuss on available information to measure health and


disease.
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Epidemiological indices
• Epidemiology is mainly a quantitative science.
• Measures of event frequency are the basic tools of the
epidemiological approach.
• Health status of a community is assessed by the collection,
compilation, analysis and interpretation of data on illness
(morbidity), death (mortality), disability and utilization of
health services.
• To measure such frequencies, epidemiological indices are
important:
• Count
• Ratio
• Proportion
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Epidemiological indices
• Measurement is fundamental in Epidemiology, because:

• Indicates the pattern of health outcome

• To make comparisons

• To monitor the health status of the population


• To plan health services
1. Simple count:
• number of cases in a specified population.

• is the numerator value of cases of disease, health


problems or death.
• Used to determine the quantity of health care resources
required to meet peoples need.
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Epidemiological indices … Ratio
• Quantifies the magnitude of one occurrence or
condition in relation to another. E.g.: Male /Female

• Numerator and Denominator are independent events.

• Compares two quantities.

E.g.: Age dependency ratio


Maternal mortality ratio
Death to case ratio
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Epidemiological indices … Ratio uses
Used both as descriptive and analytical tools
• Descriptive- male to female ratio, control to case ratio
• Analytical- odds ratio, rate ratio, risk ratio
• Example: Assume a kebelle with 2 health posts serving for
10,000 populations residing in the catchment area of the
kebelle.
A. What is the ratio of health posts to population size?
B. What is the ratio of population size to health posts?
Answers: A. 2/10,000=0.0002 Health post per person
B. 10,000/2=5000===1:5000 ratio
2/2/2023 93
Epidemiological indices … Proportion

• is a type of ratio

• which quantifies occurrences in relation to population in


which these occurrences take place.

• The numerator should be included in the denominator

• Expressed in Percentage.

• Used as descriptive measures.

• Describe the amount of disease attributed to specific cause.


94
Epidemiological indices … Rate
• A proportion with a time dimension.
• The ratio of cases of event to the population at risk in a
specified period.

• A proportional ratio that does measure an event in a


population over time.
• It can be crude, specific or adjusted.

2/2/2023 95
Epidemiological indices … Crude Rate
• is a summary measures

• based on the actual number of events (birth, death, illness)

• In the total population over a given time period.

• may obscure the possible difference in risk among subgroups


of the total population.

• Example:

• Crude death rate=all death/total population*n

• Crude birth rate= all live births/ Total population*n

2/2/2023 96
Epidemiological indices … Specific Rates
• are rates of health events in specific subgroups of
the population.

• When calculating specific rates, the denominator


should be the population in that specific group

• Do not add up age specific rates to get crude rate.

• e.g. Infant mortality rate, neonatal mortality rate


and post-neonatal mortality rate.

2/2/2023 97
Epidemiological indices … Adjusted Rates
• is summary/standardized rate that has undergone
statistical transformation.
• to permit fair comparison between groups differing in
some characteristics that may affect risk of disease.
• overcomes the limitations of both crude rates as well as
specific rates.
• Rates can be adjusted by sex, race or age, etc. but
the most common adjustment is by age.
• It can be done in direct and indirect methods.
2/2/2023 98
Measures of Morbidity
• are measures that quantify the occurrence of disease in a
specified population in a specified time.
• The frequency of health related events are measured by risk,
prevalence and incidence rate.
• characterize the number of persons in a population who
become ill or are ill at a given time.
• Methods of measuring frequency of diseases:
• depend upon the nature of the disease and
• the purpose for which it is being counted.
• There are two commonly used measures of disease
occurrence:
2/2/2023 incidence and prevalence. 99
Measures of Morbidity--Incidence
 Quantifies a new occurrence of disease in a population at
risk over a specified period of time interval.
 measures risk of developing a disease.
 Risk is the probability (the likelihood) of a person contracting
a disease per a given time period.
 There are two specific types of incidence measures:
 cumulative incidence /Incidence proportion
 incidence rate or incidence density.

2/2/2023 100
cumulative incidence
• is the probability that individuals in the population
get the disease during the specified period.

• The period of follow up entirely depends on the time


required for the development of the outcome under
investigation.

• It is usually calculated for closed population.

2/2/2023 101
cumulative incidence
• Example 1: A study conducted in a primary school
with 200 children. Imagine that, on the first day of
the new term, 20 children had a cold. Over the week
follow up another 10 children developed the cold.

• What is the incidence of cold in the follow up period?


• CI=10/180*1000=55.56 per 1000 children per week.

2/2/2023 102
Incidence rate/Density
• Measures the rate at which new cases of disease occur in the
population at risk during a defined period.
• Incidence density represents rate at which new cases are
occurring.
• Does not indicate the risk for any individual in a population.
• The population at risk is dynamic.
• Each person in the population contributes the amount of time
that they remained under observation and free from disease
(person-time).

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Incidence density…..
• Example: Investigators enrolled 2,100 men in a
study and followed them over 4 years for 6400
person Years observations to determine the rate of
heart disease. At the end of the follow up period, 16
were developed heart disease. What is the ID?
• 16/6400*1000=2.5 cases per 1000 person years
observations.

2/2/2023 104
Attack rate
• a special type of cumulative incidence used in an outbreak
situation.

• The attack rate is usually expressed as a percent.

• Overall attack rate is the total number of new cases divided


by the total population.

• There are two types of attack rate.

• Primary attack rate

• Secondary attack rate

2/2/2023 105
Primary and 2ndry attack rate
• Primary: a type of attack rate calculated for individuals who
have primary disease.

• 2ndry

• is a measure of the frequency of new cases of a


disease among the contacts of known cases.

2/2/2023 106
Primary and 2nd attack rate……
• Example: Consider an outbreak of acute watery diarrhea
(AWD) in which 18 persons in 18 different households
became ill at which the community had 1000 populations.
then the One incubation period later, 17 persons in the same
households develop AWD as these primary cases developed .
If the 18 households included 86 persons,
calculate the primary and secondary attack rate.
• Primary attack rate is 18 / 1,000 x 100% = 1.8%.
• Secondary attack rate= 17/(86-18) x 100 = 17/68x100%
= 25 %

2/2/2023 107
Measures of Morbidity….Prevalence
• is the proportion of persons in a population who have a
particular disease or attribute at a specified point in time or
over a specified period of time.(rate)
• It is the total number of newly occurring plus pre-existing
cases in a given population within a specified period of
time.(Prevalence)
• It can be point, period and life time prevalence.

2/2/2023 108
Point prevalence
• Measures the proportion of a population affected with a
certain condition during a specified point of time.

• This is not a true rate; rather it is a simple proportion.

Example:

2/2/2023 109
Period prevalence
• Measures the proportion of a population affected
with a certain condition during a specified period of
time.

Example:

2/2/2023 110
Life time prevalence
• is the total number of persons known to have had the
disease for at least some part of their lives.
• It is used when it is difficult to know when the disease
considered present.
• It is not used frequently since it combines both point
prevalence and incidence in a single parameter
(cumulative prevalence).
• A special type of period prevalence is the cumulative
lifetime prevalence which provides an estimate of the
occurrence of a condition at any time during an
individual's
2/2/2023 past time. 111
Factors affecting Prevalence

2/2/2023 112
Difference between incidence and Prevalence

2/2/2023 113
Measures of Mortality
• measure the occurrence of deaths in a population.
• Rates whose denominators is the total population.
• Uses either the mid - interval population or the average
population.
• because population size fluctuates over time
due to births, deaths and migrations.

• It can be crude, specific or adjusted death rates.

2/2/2023 114
Crude, specific and adjusted death rates
• Crude rates are highly sensitive to the structure (age/sex) of
the population and are not directly used for comparison
purposes.

• Adjusted rates are often used to permit comparison of


morbidity or mortality rates in populations which differ in
structure.

• Specific rates apply to specific subgroups in the population.


• It may be used for comparison but tedious work is
needed.

2/2/2023 115
Adjusted death rates
• An important use of mortality data is to compare:

• two or more populations, or

• one population in different time periods.

• Adjusted rate is a summary rate that has undergone

• statistical transformation,

• to permit fair comparison

• between groups differing in some characteristics


that may affect risk of disease. It can be done
using direct or indirect method.

• Age is commonly used for adjustment.


2/2/2023 116
Direct Adjustment
• It is a type of adjustment in which:
• the age specific rate is from the study population
• age specific population is from the standard
population.
• It is used when stable stratum-specific rates are
available.
• Source of standard population can be:
• the biggest of the two populations or
• the summation of the two populations or
• other standard population of the country or
2/2/2023 international population. 117
Direct Adjustment…..
 Direct adjustment requires:

Age-specific rates of the sample populations

Age-structure of a standard population

Yields a summary figure of Age Adjusted Rate

Example: Which district experienced the highest mortality rate


based on Table 5.1 data?

2/2/2023 118
Direct Adjustment……

2/2/2023 119
Direct Adjustment……..

2/2/2023 120
Direct Adjustment……..
Finally:
summing expected death rate for each stratum of each
district=total expected death rate for each district.
total expected death rate for district-A =Age ADR for A
total population of the standard population
So, district A= 20,020/1,769,074 = 1,132 per 105
district-B = 21,094/1,769,074 = 1,192 per 105
Age standardized rate ratio=1,132 per 105/1,192 per
105=0.95
Interpretation:
• The age-adjusted death rate appears to be approximately 5%
lower in District A compared to district B or
• The age-adjusted death rate appears to be approximately 5%
higher
2/2/2023
in district B compared to district A. 121
Indirect Adjustment
Used:

when stratum-specific rates are unavailable or

unstable because of small numbers.

To apply age-specific mortality rates of the


reference/standard population.

Answers the question:

what would be the number of deaths (i.e., expected


deaths) in certain population if people in that population
were dying at the same (age-specific rate) as people in
the standard population?
2/2/2023 122
Indirect Adjustment…….
Indirect method of standardization/adjustment requires:

Age structure of the sample study population

Total death in the sample study population

Age-specific death rates for a standard population

Yields a summary figure of standardized mortality


ratio (SMR)

2/2/2023 123
Indirect Adjustment…….
• In the following table, which population potash miners or
general population experience more death rates?

2/2/2023 124
Indirect Adjustment…….

2/2/2023 125
Indirect Adjustment…….
Interpretation:
We estimate that underground potash miners have around 6%
higher risk of mortality than the general population.
Generally:
 If SMR =100 rates are similar to the standard population
or comparison groups.
If SMR <100 Lower deaths occurred than expected (rates
are lower than the standard)
If SMR >100 More deaths occurred than expected (rates
are higher than the standard)

2/2/2023 126
Summary on types of Mortality rate
Rate Advantage Disadvantage

Crude Difficult to interpret


death Not good for comparison
 Actual summary rates
rate purposes
Easy to obtain
Unclear difference in risks
in subgroups
Specific Apply to subgroups  Difficult to obtain
death More appropriate for  are not a summary figure
rate comparisons  Cumbersome to compare
Give more detailed many subgroups of two
information populations or more
Adjuste Comparable summery It is not actual numbers
d rate figure of the population

2/2/2023 127
Measures of disease Burden
Disease burden is measured in disability adjusted life years
(DALYs).

DALY is a measure that takes into account:

• years of life lost due to premature death or

• years of productive life lost to poor health or disability.

DALYs are calculated:

• by summing the Years of Life Lost (YLL)


prematurely and weighted Years Lived with
Disability (YLD).
2/2/2023 128
Years of Potential life lost (PYLL)

• It is an estimate of the average years a person would have


lived if he or she had not died prematurely.

• It is a measure of premature mortality.

• gives more weight to death that occur among younger


people.

• The reference age should correspond roughly to the life


expectancy of the population under study.

• PYLL can be calculated using individual level data or using


age grouped data.
2/2/2023 • 129
Years of Potential life lost (PYLL)
The individual method, each person's PYLL is calculated by
subtracting the person's age at death from the reference age.
If a person is older than the reference age when he or she
dies, that person's PYLL is set to zero (i.e., there are no
"negative" PYLLs).
 In effect, only those who die before the reference age are
included in the calculation.
sums the individual PYLLs for all individuals in that
population.
If a person is older than the reference age when he or she
dies, that person's PYLL is set to zero.
2/2/2023 130
Disability Adjusted Life Year (DALY)
• A measure of overall disease burden.
• Expressed as the number of years lost due to ill health,
disability or early death.
• Becoming increasingly common in the field of public health
and health impact assessment (HIA).
• Extends the concept of potential years of life lost due to
premature death:
• to include equivalent years of healthy‘ life lost due
to poor health or disability.
• Mortality and morbidity are combined into a single,
2/2/2023
common metric. 131
Disability Adjusted Life Year (DALY)….
DALYs assign Health related quality of life to specific diseases
and disabilities.
Health liabilities were expressed using one measure:
The Years of life Lost (YLL) due to dying early.
The Years Lived with Disability (YLD) component
measures the burden of living with a disability.
So, DALYs are calculated by taking the sum of these two
components.

2/2/2023 132
Quality adjusted life years (QALYs)
• A measure of disease burden including both the quality and
the quantity of life lived.

• A measure of the value of health outcomes.

• The QALY is based on the number of years of life that would


be added by the intervention.

• Each year in perfect health is assigned the value of 1.0 down


to a value of 0.0 for being dead.

• The extra life-years are given a value between 0 and 1 due


to non-full health.

• Health
2/2/2023 is a function of length of life and quality of life. 133
Quality adjusted life years (QALYs)….
• The QALY was developed to combine the two functional
components of health into a single index number.

• It assumes that a year of life lived in perfect health is


worth 1 QALY (1 Year of Life × 1 Utility value = 1QALY)
and that a year of life lived in a state of less than this
perfect health is worth less than 1.

• QALYs are expressed in terms of years lived in perfect


health.

2/2/2023 134
Quality adjusted life years (QALYs)….
• Each year in perfect health is assigned the value of 1.0 down
to a value of 0.0 for being dead.

• For example: half a year lived in perfect health is


equivalent to 0.5 QALYs (0.5 years × 1 Utility), the same as 1
year of life lived in a situation with utility 0.5 (e.g. bedridden)
(1 year × 0.5 Utility).

2/2/2023 135
Health Management Information system

 Information: - is data that have been deliberately selected,


processed and organized to be useful to the manager.

 Data:-raw, unprocessed facts and figures.

 Management information system (MIS) - Is a formal


method of availing accurate and timely information for
decision making and enable managers solve problems and
carryout their functions effectively and efficiently.

 HMIS is application of the principles of MIS in health care.

2/2/2023 136
Health Management Information system…
Desirable characteristics of information in health
system:
Timeliness
 Reliable-quality, accuracy of information, consistent
Relevance – appropriate to the situation
Completeness – contains all facts just sufficient
Conciseness (shortness)
Understandable - presented in a suitable form
Cost effective – created and disseminated at a reasonable
cost
2/2/2023 137
Health Management Information system…
 Information provided to a manager through MIS helps for:

 Planning

 Organizing

 Leading

 Controlling and

 Proper use of resources.

 In the past use of information was mostly informal but


nowadays, electronic data processing using computers is
being practiced.
2/2/2023 138
Steps in development of effective HMIS
1. Identify users: for whom?

2. Identify needs: planning, organizing, directing


controlling or decision making

3. Select indicators

4. Select data collection instruments

5. process data into useful information

2/2/2023 139
Steps in development of effective HMIS
• Tasks in HMIS include:

• Analyzing and compiling

• Filing and storing

• Transmission (Reporting) of finding to potential


uses.

2/2/2023 140
Source of information
• When describing and comparing the rates of disease between
populations:
• we need to know the size of the local population to
provide a denominator for estimates of prevalence and
incidence.
• Even though all of them may not found in every country, key
sources of epidemiologic data are:
• Census data
• Vital records
• Data from health institutions
• Special surveys
• Others such as police records

2/2/2023 141
Census
• A nation-wide counting of population.

• Obtained by a direct canvass of each person or household.

• Large and complicated to undertake.

• A population census is taken to:


• Determine the size of the population of a country
• Obtain statistical information on various characteristics.

• Information to be collected:
• Sex, age, marital status, educational characteristics,
economic characteristics, place of birth, language, fertility
mortality , citizenship, living conditions, religion, etc..

2/2/2023 142
Survey
• A technique based on sampling methods to obtain specific
information from samples.

• Are made:
• At a given moment, in a specific territory, sporadically and without
periodicity for the deep study of a problem.

• Perform in a lighter operation than a census.

• Needing less time, less hand and fewer funds.

• Allows collection of more in-depth information

• Infers information valid for the whole population.

2/2/2023 143
Vital events registration
• is an ongoing recording of vital events (birth, death, marriage,
divorce, etc.).

• is a system by which all births, deaths, etc. occurring


nationwide are registered, reported to a control body and
compiled centrally.

• is a continuous process.

2/2/2023 144
CHAPTER-4

Epidemiological Study Designs

2/2/2023 145
Outlines
• Introduction
• Descriptive epidemiological study
• Correlational /ecological studies
• Case report / Case series
• Cross-sectional surveys
• Analytic epidemiological study
• Observational studies
• Case-control study
• Cohort study
• Experimental / intervention studies
2/2/2023 • Randomized and Non-randomized 146
Learning outcomes

At the end of this lesson, students will be able to:

• Identify the two basic types of epidemiological study


designs correctly.

• Apply the different subtypes of epidemiologic studies to


the standard.

• Discuss the strength and limitation of the different


subtypes of epidemiologic study designs.

2/2/2023 147
Introduction
• Epidemiology is primarily concerned with the distribution and
determinants of disease in human populations.

• This concern is achieved through conducting epidemiological


studies which have different design.

• Study design is the arrangement of conditions for the


collection and analysis of data to provide the most accurate
answer to a question in the most economical way.

2/2/2023 148
Types of Epidemiologic study designs

I. Based on objective/focus/research question

1. Descriptive studies

• Describe: who, when, where & how many

2. Analytic studies

• Analyse: How and why

2/2/2023 149
Types…

II. Based on the role of the investigator

1. Observational studies

• The investigator observes nature

• No intervention

2. Intervention/Experimental studies

• Investigator intervenes

• He has a control over the situation

2/2/2023 150
Types…
III. Based on timing
1. One-time (one-spot) studies

• Conducted at a point in time

• An individual is observed at once

E.g: Cross sectional studies

2. Longitudinal (Follow-up) studies

• Conducted in a period of time

• Individuals are followed over a period of time

• E.g.: Cohort studies


2/2/2023 151
Types…
IV. Based on direction of follow-up/data collection
1. Prospective

• Conducted forward in time

2. Retrospective

• Conducted backward in time

2/2/2023 152
Types…
V. Based on type of data they generate
1. Qualitative studies

• Generate contextual data

• Also called exploratory studies

2. Quantitative studies

• Generate numerical data

• Also called explanatory studies

2/2/2023 153
Types…

VI. Based on study setting


1. Community-based studies

• Conducted in communities

2. Institution-based studies

• Conducted in institution settings

3. Laboratory-based studies

• Conducted in major laboratories

2/2/2023 154
Study Design Sequence

Hypothesis formation

Descriptive
Case reports Case series
epidemiology

Analytic Animal Lab


epidemiology study study
Clinical
trials Hypothesis testing

Cohort Case- Cross-


control sectional
2/2/2023 155
Descriptive Studies Develop
hypothesis
Increasing Knowledge of

Case-control Studies Investigate it’s


Disease/Exposure

relationship to
outcomes

Cohort Studies
Define it’s meaning
with exposures

Test link
Clinical trials
experimentally
2/2/2023 156
Descriptive Study designs

Cases

Person Time
1200 25
1000
20
800
600 15

400 10
200
0 5

0-4 '5-14 '15- '45- '64+ 0


44 64 1 2 3 4 5 6 7 8 9 10
Age Group

Who? Where? When?

2/2/2023 157
Characteristics of Persons

“Who is getting the disease?”

 Age, sex, religion, socio-economic status, race

Young Vs old, males Vs females, rich vs poor, more


educated vs less educated, black Vs white, etc.

2/2/2023 158
Characteristics of Place

 “Where are the rates of disease highest/ lowest?”

• Urban vs rural, some regions more affected than others?

• National vs international?

• High altitude or low altitude?

• Polluted areas or unpolluted areas?

• Mountainous vs valley

• Adequate rainfall or little rainfall areas?

 Differences in frequency of diseases are related to place.

2/2/2023 159
Characteristics of Time

“When does the disease occur commonly/ rarely?”

Was there a sudden increase over a shorter period of


time?

 Is the problem greater during rainy or dry season?

 “Is the frequency of the disease now different from the


corresponding frequency in the past?”

Is the problem gradually increasing/ decreasing?

2/2/2023 160
Uses of Descriptive Studies

Describe the pattern of disease occurrence

Describe the problem in terms of person, place and time

Generate numbers of events (frequency)

Help to calculate ratio, proportion and rates

Program planning / resource allocation

Generate hypothesis to be studied by analytic methods

2/2/2023 161
Categories of descriptive epidemiological studies

1. Population as study subject

o Correlational /ecological studies

2. Individual as study subjects

o Case report / Case series

o Cross-sectional (survey)- it may also have analytical


part.

2/2/2023 162
Ecological study
An ecological study is an epidemiological study in which
the unit of analysis is a population rather than an individual.

• An ecological study is appropriate for initial investigation of


causal hypothesis.

• Uses data from entire population to compare disease


frequencies

• Does not provide individual data, rather presents average


exposure level in the community.

• Cause could not be ascertained.


2/2/2023 163
Ecological analyses are only of value when the groups or
communities being compared are relatively heterogeneous in
their mean levels of exposure to outcome variable.

 For this reason, they have been used most extensively for
between-country rather than within-–country comparisons.

 Within–country comparisons:

ex: The People's Republic of China

-- because there are wide variations in disease rates from


one region to another, accompanying substantial differences
in culture, behavior and lifestyle.
2/2/2023 164
What type of ecological study was conducted?
18000
percapita fat consumption
and breast cancer death 16000

Number of ITN distributed


18000 14000
16000
12000
14000
10000
12000
10000 8000

8000 6000
6000
4000
4000
2000
2000
0 0
2006 2008 2010 2012 2014 0 200 400 600 800

per capita fat consumption


Reported malaria morbidity
average breast cancer death

2/2/2023 165
Strength
• Can be done quickly and inexpensively, often using
available data.

• May be best design to study health effects of


environmental exposures, e.g
• Do heat waves increase death rate?
• Does soft drinks increase heart disease?
• Do economic recessions increase suicide rate?

• Such questions only sensibly addressed at population


(or community) level
2/2/2023 166
Limitations
• Ecological fallacy

• Confounding is a particular problem in ecological studies of


diet and diseases associated with industrialization.

• Between-country comparisons may be restricted by the


absence of comparable data, usually on dietary intake .

• Within-country comparisons may yet be restricted by the


limited size of the population in each region and the
consequent instability in rates, as well as by homogeneity of
exposures within the country as a whole.
2/2/2023 167
Types of Descriptive …Cont’d
• Case report or case series

• Detailed report of a single patient (case report) or a


group of patients (case series) with a given disease.

• Used for:
• Document unusual medical occurrences

• Gives the first clues in the identification of new disease


and adverse effects of exposures

• An important link between clinical medicine and


epidemiology
2/2/2023 168
Possible Reasons For a Case Report
• Very rare disease

• Association of diseases

• Rare presentations of more common diseases

• Outcome of a novel treatment

• Reporting a particular outcome of a case management

• Mistakes, complications and lessons learned

• A new disease entity

2/2/2023 169
Case Series
• Experience of a group of patients with a similar diagnosis

• Assesses prevalent disease

• Cases may be identified from a single or multiple sources

• Generally report on new/unique condition

• May be only realistic design for rare disorders

2/2/2023 170
2/2/2023 171
Case Report One case of unusual
findings

Case Series Multiple cases of


findings

Descriptive
Population-based
Epidemiology Study
cases with denominator

2/2/2023 172
Case reports / case series

Advantages

• Simple, quick, inexpensive

• Formulate hypothesis

 Disadvantages

• Can’t be used to test hypotheses

• Based on the experience of one or few people (small


sample size)

• Lacks comparison group

2/2/2023 173
Cross-sectional Study
• Data collected at a single point in time

• Describes associations

• Prevalence is simple obtained.


A “Snapshot”
Cross-sectional studies are useful to generate a hypothesis
rather than to test it

For factors that remain unaltered overtime (e.g. sex, race,


blood group) can produce a valid association.

2/2/2023 174
Timing of study

2/2/2023 175
Cross-sectional study design…………….
Comparison groups are formed after data collection.

Groups are compared either by exposure or disease status.

Cross-sectional studies are also called prevalence studies.

Cross-sectional studies are characterized by concurrent


classification of groups.

Odds ratio is the measure of association.

2/2/2023 176
Design

Study begins Defined population

Collect data on exposure and


disease status

Exposed Exposed Not Not


Have Have no exposed exposed
disease disease Have Have no
disease disease

2/2/2023 177
Cross-sectional…
Types of cross-sectional studies

1. Single cross-sectional studies: determine single


proportion/mean in a single population at a single point in
time

2. Comparative cross-sectional studies: determine two


proportions/means in two populations at a single point in
time

3. Time-series cross-sectional studies: determine a single


proportion/mean in a single population at multiple points in
time
2/2/2023 178
Cross-sectional…
Advantages of cross-sectional studies

• Less expensive

• Less time consuming

• Provides more information

• Describes well

• Generates hypothesis

2/2/2023 179
Cross-sectional…
Limitations of cross-sectional studies

• Antecedent-consequence uncertainty

“Chicken or egg dilemma”

• Data dredging leading to inappropriate comparison

• More vulnerable to bias—survivor bias

• Impractical for rare diseases and rare exposure – because


we need to take very large sample size

• Miss diseases still in latent period

• Recall of previous exposure may be difficult


2/2/2023 180
Case-control studies
• Subjects are selected with respect to the presence (cases) or
absence (controls) of disease, and then inquiries are made
about past exposure.

• We compare diseased (cases) and non-diseased (controls) to


find out the level of exposure.

• Exposure status is traced backward in time.

2/2/2023 181
2/2/2023 182 182
Case-control…
Steps in conducting case-control studies

I. Define who is a case

• Establish strict diagnostic criteria

• All who fulfil the criteria will be “case population

• Those who don’t fulfil will be “control population”

II. Select a sample of cases from case population

• This sample must be representative of the case


population

2/2/2023 183
Case-control…

Sources of cases

1. Hospitals (Health institution)

• Cost-less

• Bias-more

2. Population (Community)

• Cost-more

• Bias-less

2/2/2023 184
Case-control…
III. Select controls from a control population

• Should be representative of control population

• Should be similar to cases except outcome

• Should be selected by the same method as cases

Sources of controls

1. Hospital (Health institution) controls

• Readily available

• Low recall bias

• More cooperative
2/2/2023 185
Case-control…
However, hospital controls are
• Less representative
• More confounding

2. Population (community) controls


• More representative
• Less confounding
• Costly and time consuming
• More recall bias
• Less cooperative
2/2/2023 186
Case-control…
IV. Measure the level of exposure in cases & controls

• Review or interview for exposure status

• Use same method for case and controls

V. Compare the exposure between cases & controls

• Prepare 2X2 table

• Calculate OR

• Perform statistical tests

2/2/2023 187
Case-control…
Types of case-control studies

I. Based on case identification

1. Retrospective case-control
• Uses prevalent cases
• Increased sample size
• Difficult to establish temporal sequence
• Useful for rare outcomes

2/2/2023 188
Common bias in case-control studies

oInformation bias

- recall bias

- non-response bias

oSelection bias

- using different criteria to select cases and controls

- the probability of selecting a real case and control

2/2/2023 189
Case-control…

Advantages of case-control studies

Optimal for evaluation of rare diseases

Examines multiple factors of a single disease

Quick and inexpensive

Relatively simple to carry out

Guarantee the number of people with disease

2/2/2023 190
Case-control…
Limitations of case-control studies
o Inefficient for evaluation of rare exposure

o Can’t directly compute risk

o Difficult to establish temporal sequence(retrospective case


control)

o Determining exposure will often rely on memory

2/2/2023 191
Cohort studies

 A cohort study is an observational research design which


begins when a cohort of free of disease (outcome of interest)

classified according to a given exposure and then followed


(traced) over time.

 The investigator compares whether the sub-sequent


development of a new cases of disease (other outcome of
interest) differs between the exposed and non-exposed
cohorts.

2/2/2023 192
Design of cohort studies
If we want to know weather exposure to drinking coffee during
pregnancy will result in abnormal birth
Diseased
Exposed Give abnormal
Drink more baby
than five cup of
Coffee per day Not diseased
People
without Give normal baby
Population
at risk the Diseased
outcome Not Exposed Give abnormal
Pregnant baby
Not drink
mothers any coffee
Not diseased
Give normal baby
Time
Direction of enquiry
2/2/2023 193
Basic futures of cohort studies

“Disease free” or “without outcome” population at entry

Selected by exposure status rather than outcome status

Follow up is needed to determine the incidence of the

outcome

Compares incidence rates among exposed against non-

exposed groups

2/2/2023 194
Cohort…
 Two types of cohort studies

1. Prospective (classical) cohort study

• Outcome hasn’t occurred at the beginning of the study

• It is the commonest and more reliable

2. Retrospective (Historical) cohort study

• Both exposure and disease has occurred before the


beginning of the study

• Faster and more economical

• Data usually incomplete and in accurate


2/2/2023 195
Cohort…
Steps in conducting cohort studies

1. Define exposure

2. Select exposed group

3. Select non-exposed group

4. Follow and collect data on outcome

5. Compare outcome b/n exposed & non-exposed

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Follow up period of cohort studies
o The follow-up is the most critical and demanding part of a
cohort study

o Lost to follow-up should be kept to an absolute minimum (<


10-15%)

o Changes in the level of exposure to key risk factors, after the


initial survey and during the follow-up period, are a potentially

important source of random bias.

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Ascertainment of outcome of interest
• The aim of good case ascertainment is to ensure that the
process of finding cases, whether deaths, illness episodes, or
people with a characteristic, is as complete as possible.

• Must have a firm outcome criteria and standard diagnostic


procedure which are equally applied for exposed and non-
exposed individuals.

• Any outcome measurement should be done equally both to


the exposed and non-exposed groups.

2/2/2023 198
Cohort studies…..

• The primary objective of the analysis of cohort study data is


to compare disease occurrence in the exposed and
unexposed groups

• It is a direct measurement of a risk to develop the outcome


of interest

• Calculation and comparison of rates of the incidence of the


outcome for exposed and non-exposed subjects using
relative risk (RR) as measure of association.

2/2/2023 199
Strength of cohort studies:

 Particularly efficient when exposure is rare

 Can examine multiple effects of a single exposure

 Minimize bias in outcome measurement if prospective

 Allows direct measurement of incidence (risk)

 Can elucidate temporal relationship between exposure and


outcome of interest (if prospective )

2/2/2023 200
Limitation of cohort studies:
 Costly and time consuming if disease is rare and/or long
latency period (if prospective)

 Validity of the results can be seriously affected by loss to


follow up (if prospective)

 If retrospective, requires availability of adequate records

 Exposure status may change during the course of study

2/2/2023 201
Experimental studies
• Individuals are allocated in to treatment and control groups
by the investigator

• ” Investigators must formulate a hypothesis before launching


an experimental study

- Ho: New drug “A” can not threat vivax malaria

- Ha : New drug “A” can threat vivax malaria

• If properly done, experimental studies can produce high


quality data

• It 2/2/2023
is the gold standard study design 202
Design of experimental study

2/2/2023 203
Study groups in interventional studies
The comparison groups in intervention study are known as
the intervention group and the control group

The intervention group receives therapeutic or preventive


intervention such as health education, diet and physical
exercise etc…

The control group shall be offered the best known


alternative or placebo activity with no known effect on the
outcome variable

2/2/2023 204
Example: Does salted drinking water affect blood pressure (BP)
in mice?

Experiment:

1. Provide a mouse with water containing 1% NaCl and


plain water
2. Wait 14 days.
3. Measure BP.
4. Compare BP in mice fed salt water to BP in mice fed
plain water.
5. Ideally, the experimental group is compared to
concurrent controls (rather than to historical controls).
2/2/2023 205
20
Experimental…
 Experimental studies can be:

1. Therapeutic trials
• Conducted on patients
• To determine the effect of treatment on disease

2. Preventive trials/prophylactic trial


• Conducted on healthy people
• To determine the effect of prevention on risk(drug for
prevention, health education, healthy diet )

3. Safety trial
- Conducted on healthy or patients
- To determine the safety issue of the treatment or preventive drug
2/2/2023 206
Experimental…
Three different ways of classifying intervention studies

I. Based on population studies

Clinical trial: on patients in clinical settings

Field trial: used in testing medicine for preventive purpose


and the subjects are healthy people. Eg; vaccine trial

Community trial: the unite of study is the community not an


individual(Fluoridation of water to prevent dental caries)

2/2/2023 207
Experimental…
II. Based on design

• Uncontrolled trial: no control (self-control)

• Non-randomized controlled: allocation not random

• Randomized control: Allocation random

III. Based on objective

• Phase I: to determine toxic effect

• Phase II: to determine therapeutic effect

• Phase III: to determine applicability


2/2/2023 208
Steps of interventional studies

1. Selection of study population

2. Allocation of treatment regimen

3. Maintenance and assessment of compliance

4. Ascertainment of outcomes

5. Analysis & conclusion of experimental studies

2/2/2023 209
Experimental…
Challenges in intervention studies

• Ethical issues

• Harmful treatment shouldn’t be given

• Useful treatment shouldn’t be denied

• Feasibility issues

• Getting adequate subjects

• Achieving satisfactory compliance

• Cost issues

• Experimental studies are expensive


2/2/2023 210
Experimental…
• The quality of “Gold standard” in experimental studies can be
achieved through

• Randomization

• Blinding

• Placebo

2/2/2023 211
Experimental…
1. Randomization: allocation of study subjects in to treatment & control
groups.

• Advantage: Avoids bias & confounding, Increases confidence on results

2. Levels of blinding

• Non-blinded/open: All (the observer, study subjects and data analyst)


know which intervention a patient is receiving

• Single blinded: The observer is aware but the study subjects is not aware
of treatment assignment.

• Double blinded: Neither the observer nor the study subjects is aware of
treatment assignment

• Triple blinded: The observer, study subjects and data analyst are not
aware of treatment assignment. Advantage: Avoids observation bias 212
2/2/2023
Experimental…
Placebo: an inert material indistinguishable from active
treatment

Placebo effect: tendency to report favourable response


regardless of physiological efficacy

• Placebo is used as blinding procedure

2/2/2023 213
Summary of designs

Have you understood the different study designs so


far explained?

2/2/2023 214
CHAPTER-5

Epidemiological Measures of Association

2/2/2023 215
Outlines
• common measures of association

• Common measures of public health impact

• Calculate and interpret relative measures

• Calculate and interpret absolute measures

2/2/2023 216
Learning objectives
• At the end of this session students will be able:

• List common measures of association

• List common measures of public health impact

• Calculate and interpret relative measures output

• Calculate and interpret absolute measures output.

2/2/2023 217
Measure of Association
• Application of epidemiology is:
• To estimate how much disease is caused by a certain
modifiable risk factors.
• The study of association and causation in exposure
and outcome of interest.
• To assess the impact of a risk factor or interventions
in the population.
• An association is an relation between two variables when a
change in one variable parallels or coincides with a change
in another ones.

2/2/2023 218
Measure of Association…….
• Measure of association:

• Is a single summarizing number that reflects the


strength of a relationship,

• indicates the usefulness of predicting the dependent


variable from the independent variable,

• Often shows the direction of the relationship between


two variables.

• Involve comparison of incidence in two or more groups

2/2/2023 219
Measure of Association…………..
•The probability of association happening can be expressed as
a risk or as an odds.

• Risk:

•Is the number of people experiencing an event as a


proportion of the number of people in the population.

•Probability of an individual developing a disease or change


in health status over a fixed time interval

•Odds:

•are a ratio of the probability that an event occurs to the


probability that the event does not occur.
2/2/2023 220
Measure of Association……
RISK = the chances of something happening
the chances of all things happening

ODDS = the chances of something happening


the chances of it not happening

Thus a risk is a proportion but an odds is a ratio.

An odds is a special type of ratio, one in which the numerator


and denominator sum to one.

2/2/2023 221
Measure of Association….
• Epidemiological data are often presented in Two by Two
table(Contingency table).

Risk of disease among exposed=a/ a+b, or risk of exposed


among disease=a/a+c
Odds of disease among exposed=a/b or Odds of exposure
among disease=a/c
2/2/2023 222
Types of Measure of Association/impact
• Risk can be: absolute or relative risk, so there are relative
and absolute measure of association.

• Relative risk: the probability of an event occurring in


exposed people compared with the probability of the event in
unexposed people.

• Absolute risk- is the incidence of disease in a population


due to a specific exposure with out comparing unexposed
one.

2/2/2023 223
Relative measures of Association
• Relative measures:
• estimate the size of an association between exposure and
disease
• Indicate how much more likely people in an exposed
group are to develop the disease than those in an
unexposed group.
• There are three relative measures that can be used to
calculate association between disease and exposure:
• risk ratio
• rate ratio
• odds ratio.
2/2/2023 224
Risk ratio/Relative risk/Rate ratio
• Estimates the magnitude of the association between
exposure and disease.
• Indicates the likelihood of developing the disease in the
exposed group relative to those who are not exposed.
• A direct measurement of a risk to develop the outcome of
interest.
• Usually used in cohort and experimental studies.
• The risk ratio is the ratio between the cumulative incidence in
the exposed group and the cumulative incidence in the
unexposed group.

2/2/2023 225
Risk ratio/Relative risk/Rate ratio

2/2/2023 226
Risk ratio/Relative risk/Rate ratio
• Used as a measure of etiological strength.

• A value of 1.0 will be obtained if the incidence of disease in


the exposed and unexposed groups is similar.

• Interpreted as:

• Strong=>=3

• Moderate=1.5-2.9

• Weak=1.2-1.4

• Rate ratio is similarly calculated except incidence rate is used


instead of cumulative incidence.
2/2/2023 227
Risk ratio/Relative risk/Rate ratio
Example: Assume that among the 100 people at risk, 50 are
men and 50 are women. If 15 men and 5 women develop
influenza, then the relative risk of developing influenza in men,
as compared with women, is:

Risk in men = 15/50

Risk in women = 5/50

RR= Risk in men = 15/50 = 3.0

Risk in women 5/50

(Note that from the way the question was put, the two risks are
cumulative incidence rates.)
2/2/2023 228
Risk ratio/Relative risk/Rate ratio

2/2/2023 229
Odds ratio
• In case-control and cross-sectional studies:

• It is usually not possible to calculate the rate of


development of disease given the presence or absence of
exposure.

• The RR can be estimated by calculating the ratio of the


odds of exposure among the cases to that among the
controls.

• Thus, it is an indirect measure of a risk in a disease of rare


occurrence.

2/2/2023 230
Odds ratio…..
 A valid estimate of the relative risk in Case control
studies, when:

 The outcome is rare event

 Study subjects selected as cases are incident cases

 The cases and controls are representative of population


and comparable.

2/2/2023 231
Odds ratio………

2/2/2023 232
Odds Ratio…..
 Guide to the Strength of an Epidemiologic Association

Rate/ratio Strength of Association

1.0 ………….. None

>1.0 – < 1.4 …Weak

1.5 – 2.9 ………..Moderate

3.0 – 9.9……… Strong

> 10.0 ……… Very strong/infinite

2/2/2023 233
Odds ratio…
Example: A principal investigator wants to assess the effect of
chat chewing on academic performance among Gondar
university students. He takes a sample of 400 students and
collect data. Finally he has found a total of 130 chat chewer
and 100 non chewers with good academic performance and 87
non chewers with bad academic performance.

1. What type of study was conducted

2. Create two-by-two table

3. What is appropriate measure of association

4. Calculate and interpret the result


2/2/2023 234
Absolute measure of Association
• Absolute measures are used to indicate exactly:

• what impact a particular disease or condition will have


on a population,

• in terms of the numbers or percentage of that


population affected by their being exposed.

• how many more people are affected in the exposed


group than in the unexposed group.

• Absolute measure is arguably a more useful measure in public


health terms.

2/2/2023 235
Attributable risk (AR)/Risk Difference
 can give information on:

 how much greater the frequency of a disease is in the


exposed group than in the unexposed group,

 assuming the association between the exposure and


disease is causal.

 It is the risk of disease in the exposed group that is


attributable to the risk factor, after taking into account the
underlying level of disease in the population (from other
causes).

2/2/2023 236
Attributable risk (AR)/Risk Difference..
• AR is calculated as:

• the difference of cumulative incidences (risk difference)


or incidence density (rate difference).

2/2/2023 237
Attributable risk (AR)/Risk Difference..

 For example in the study of OC use and bacteriuria:

 AR=27/482 – 77/1908 = 0.01566 = 1566/105

 Thus, the excess occurrence of bacteriuria among OC


users attributable to their OC use is 1566 per 100,000.

 If there is no association between disease and exposure,


AR=0.

 If AR is greater than 0, this indicates the number of cases


of the disease among the exposed that can be
attributable to the exposure itself.
2/2/2023 238
Attributable risk (AR)/Risk Difference..

2/2/2023 239
Attributable Risk Percent (AR %)
• Estimate the proportion of the disease among the exposed
that is attributable to the exposure.

• Estimates the proportion of the disease in the exposed


group that could be prevented by eliminating the exposure
under study.

2/2/2023 240
Attributable Risk Percent (AR %)
Example: In the cohort study of OC use and bacteriuria:
AR%= 1566/105* 100=27.96%
27/482

Interpretation: If OC use causes bacteriuria, about 28%


of bacteriuria among women who use OC can be
attributable to their OC use and could therefore be
eliminated if they did not use OC.

 Formula is used for case control and cross sectional


studies.
2/2/2023 241
Population Attributable Rate or Risk (PAR)
• Estimates the proportion of disease occurring in the total
population attributable to the exposure.

• The excess rate of disease in the total population that is


attributable to the exposure or risk factors.

• It helps to determine which exposures have the most


relevance to the health of a community.

• It is the risk in total population minus risk in the non


exposed groups.

• PAR = Iet - Io, or PAR=(AR)(Pe)


2/2/2023 242
Population Attributable Rate or Risk (PAR)
• If we do not know the risk of disease in the population,
Population attributable risk = proportion of population in
exposed × Attributable risk.

• The population attributable risk will therefore always be less


than the attributable risk in the exposed group, since p
should always be less than 1.

2/2/2023 243
Population Attributable Risk fraction or
percent (PAR %)
• is the proportion of disease observed in the whole population

that is attributable to exposure to the risk factor.

• It estimates the proportion of disease that might be

prevented if the risk factor were removed.

• is the incidence in the whole population minus incidence

in the non-exposed population divided by incidence in the

whole population and multiplied by 100.

2/2/2023 244
Population Attributable Risk fraction or
percent (PAR %)
• If the proportion of exposed in the control group can be used as an
estimate of Pe, the PAR% can be calculated by the equivalent
formula.

PAR% = AR% x (proportion of exposed cases)

For example, in the case-control study of OC use and MI, the


prevalence of OC use in the population can be estimated as the
prevalence of OC use in the controls.

2/2/2023 245
Population Attributable Risk fraction or
percent (PAR %)

2/2/2023 246
Summary
Hypertension

Yes Yes No Total

120 280
Smoking
No 30 570

Total

2/2/2023 247
Summary…..
• Based on the previous slide’s table, calculate and interpret the
following measure of association:
1.Odds ratio
2.Relative risk (RR)
3.Attributable risk (AR)
4.Attributable risk percent (AR%)
5.Population attributable risk (PAR)
6.Population attributable risk percent (PAR%)

2/2/2023 248
CHAPTER-6
Evaluation of Evidence and Judgment of
causality

2/2/2023 249
Outlines
• Other explanation for observed association

• Factors affecting generalizability

• Judgment of causality

2/2/2023 250
Learning Objectives
 At the end of this session, 2nd year Nursing students will be
to:

 Describe chance, bias and confounding

 Judge whether an association of an exposure and a


disease is causal.

 To identify other explanation for observed association.

 Identify factors affecting generalizability of the study


findings.

2/2/2023 251
Introduction
 The interpretation of study findings is subject to debate:

 due to the possible errors in measurement which


might influence the results.

 While the results of an epidemiological study may reflect the


true effect of an exposure(s) on the development of the
outcome under investigation:

• it should always be considered that the findings may in


fact be due to an alternative explanation

2/2/2023 252
Introduction….
• Observational studies are particularly susceptible to the effects
of :

• chance, bias and confounding,

• need to be considered at both the design and analysis


stage of an epidemiological study so that their effects
can be minimized.

• The existence of statistical significant association does not in


itself constitute a proof of causation.

• The observed association could be real or false ( artifactual).

2/2/2023 253
Judging Observed Association
, Could it be due to selection or measurement bias?

No
.
Could it be due to confounding?

No

Could it be a result of chance?

Probably NOT

Could it be Causal?

• Apply the criteria and make judgment of causality


2/2/2023 254
Judging Observed Association……
• Explanation for the observed association other than
cause and effect relationships:

• The association may be the result of chance

• The association may be the result of bias

• The association may be the result of a confounding

• The cause can be both a cause and effect and effect (


reciprocal causation).

• E.g. Vitamin A deficiency can cause diarrhea or diarrhea can


cause Vitamin A deficiency
2/2/2023 255
Judging Observed Association……
 To Show a Valid Statistical Association:

 We need to assess:

 Role of chance: how likely is it that what we


found is a true finding.

• Bias: whether systematic error has been built into


the study design

• Confounding: whether an extraneous factor is


related to both the disease and the exposure

2/2/2023 256
The role of chance
 we can draw inferences about the experience of an entire
pop. based on evaluation of only a sample.

 One of the major problems in drawing such inference is


that the play of chance may always affect the results
observed simply because of random variation from
sample to sample.

 One of the major determinants of the degree to which


chance affects the findings in any particular study is
sample size.

2/2/2023 257
Role of chance……
 The larger the sample on which the estimate is based, the
less variability and the more reliable the inference.
.
 It is important to quantify the degree to which chance
variability may account for the results observed in any
individual study.

 This is done by performing an appropriate test of statistical


significance.

 A measure that is often reported from all tests of statistical


significance is the P value.

2/2/2023 258
Role of chance……
• The p-value is the probability of the occurrence of a value for
the test statistic as extreme as or more extreme than the
actual observed value, under the assumption that the null
hypothesis is true.

• By more extreme we mean a value in a direction farther from


the center of the sampling distribution (under the null
hypothesis) than what was observed.

• If p-value is less than or equal to 0.05 , meaning that there is


no more than a 5-percent probability that the observed effect
is 2/2/2023
due solely to chance. 259
Role of chance….
• Evaluation of the role of chance involves two components:
1. Hypothesis testing, or performing a test of statistical
significance

• The role of chance is assessed by calculating the P-value:


 if this is low, it is unlikely that the observed results would
have been caused by chance alone, and
if it is high, it is more likely that they are due to chance.
P-value =0.05 means that there is a 5% probability
that the results were due to random chance.
P-value =0 .10 means that there is a 10% probability
the results were due to random chance.
2/2/2023 260
Role of chance….
2. The estimation of the confidence interval:
• This indicates the range within which the true estimate of
effect is likely to lie.

• reflecting the precision of the point estimate of effect.

Example: the relative risk and the 95% confidence intervals.

2/2/2023 261
2/2/2023 262
Role of chance….
• Confidence interval (CI) is far more informative measure than
P-value to evaluate the role of chance.

Provide information that p-value gives.

– If null value is included in a 95% CI, by definition the


corresponding P-value is > 0.05.

Indicate the amount of variability (effect of sample size) by the


width of the CI

– This information can not be obtained from p-value

2/2/2023 263
Role of chance…..
Wide CI

indicate greater variability

suggest inadequacy of the sample size

Particularly important in interpreting non-significant results


Narrow CI  suggest that truly there is no association
Wide CI  suggest inadequacy of sample size to have
adequate statistical power
2/2/2023 264
Bias
 Bias- is any systematic error that results in an incorrect
estimate of the association between exposure and disease.

• Is any systematic error in the design, conduct, or analysis


of a study that results in a distorted estimate of
measurement

 The two main types of bias include:

1. Selection Bias

2. Information Bias

2/2/2023 265
 Selection Bias

• Selection bias refers to any error that arises in the process of


identifying the study populations

Examples

• Invitational (who gets invited into the study?)

• Acceptance (who accepted the invitation?)

• Loss to follow-up

• Volunteer/Compliance bias

• Non-response bias

 Selection bias is a particular problem in case control and


2/2/2023 266
retrospective cohort studies.
Types of Selection Bias
a. Berksonian bias

spurious association between diseases or between a


characteristic and a disease because of the different
probabilities of admission to a hospital for those with the
disease, without the disease and with the characteristic of
interest.

• Case-control studies carried out exclusively in hospital


settings are subject to selection bias attributable to the fact
that risks of hospitalization can combine in patients who
have more than one condition.
2/2/2023 267
b. Self selection/ Volunteer bias/ Compliance bias

People who accept to participate in a study, or people who


refuse to participate are often quite different from the general
population.

c. Non-response bias

• This is due to difference in the characteristics between the


responders and non-responders to the study.

• It reduces the effective sample size, resulting in loss of


precision of the survey estimates.

2/2/2023 268
d. Loss to follow up

• It is major source of bias in cohort studies

• Is also a problem in intervention studies before outcome of


interest occurs.

• If the proportion is 30 to 40 %, this would certainly raise


serious doubts of validity of the study results.

• The more difficult issue is probability of loss may be related to


the exposure, outcome, or to both.

2/2/2023 269
e. Healthy worker bias
• Bias in occupational health studies which tend to
underestimate the risk associated with an occupation due to
the fact that employed people tend to be healthier than the
general population

• When the patients admitted to an institution do not represent


the cases originated in the community.

2/2/2023 270
f. Diagnostic bias
• Occurs when a disease is more likely to be diagnosed in
some one with exposure to a suspected risk factor.

• For example women who take oral contraceptives (OCs) may


be screened more often for breast cancer than women
who do not take OCs b/c of the suspected link b/n OCs and
breast cancer.

• This would result in breast cancer being diagnosed more


readily in those who are exposed to Ocs.

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Ways of minimizing selection bias
 Population-based studies are preferable.

 Avoid the inclusions of volunteered study subjects.

 keep losses to follow-up to an absolute minimum.

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Information Bias/ Observation bias
 Refers to bias which arises during the data collection process.

 It occurs because of mistakes in categorizing study subjects


with respect to their exposure or disease status.

 Errors in measurement might be introduced by the observer


(observer bias), by the study participants (re-call bias), or by
the measurement tools such as weighing scales or
questionnaires.

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Types of Information bias
a. Investigator bias/ Interviewer bias-an interviewer’s
knowledge may influence the structure of questions and
the manner of presentation, which may influence
responses.

b. Response bias/ Recall bias-those with a particular


outcome or exposure may remember events more clearly or
amplify their recollections. This source of bias is more
problematic in retrospective cohort or case-control
studies.
2/2/2023 274
c. Observer Bias – observers may have preconceived
expectations of what they should find in an examination

d. Loss to follow-up – those that are lost to follow-up or


who withdraw from the study may be different from those
who are followed for the entire study.

e. Social desirability bias- occurs because subjects are


systematically more likely to provide a socially acceptable
response.

2/2/2023 275
f. Hawthorne effect –people act differently if they
know they are being watched.

g. Surveillance bias – the group with the known exposure


or outcome may be followed more closely or longer
than the comparison group.

2/2/2023 276
Controls for Bias
• Be purposeful in the study design to minimize the chance for bias
• Example: use more than one control group

• Define, a priori, who is a case or what constitutes exposure so


that there is no overlap
• Define categories within groups clearly (age groups, aggregates of
person years)

• Set up strict guidelines for data collection


• Train observers or interviewers to obtain data in the same fashion
• It is preferable to use more than one observer or interviewer,
but not so many that they cannot be trained in an identical manner

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Ways of minimizing information bias
1) Institute a masking process if appropriate

Three types of masking process

• Single masked /blinding/ study – subjects are


unaware of whether they are in the experimental or
control group

• Double masked study – the subject and the observer


are unaware of the subject’s group allocation

• Triple masked study – the subject, observer and data


analyst are unaware of the subject’s group allocation
2/2/2023 278
2) Same standard procedures, instruments, questionnaires,
interviewing techniques should be used for data collection
in both comparison groups.

3) Classification of study subjects according to their outcome


& exposure status should be based on the most objective
& accurate methods available.

4) When exposure status is determined by interview, it should


be assessed in several d/t ways for both groups, so as to
assist all study subjects to make a thorough attempt at
recall
2/2/2023 279
The Role of Confounding
• Confounding is distortion of the estimated effect of an
exposure on an outcome, caused by the presence of an
extraneous factor (3rd factor) associated both with the
exposure and the outcome.

• The extraneous factor creates wrong association.

• Confounding variable, confounder is a variable that


can cause or prevent the outcome of interest.

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CONFOUNDING

E D

Confounding IS
present

CF

Confounding
NOT E ?CF D
present

2/2/2023 281
• In order for a variable to be considered as a confounder, it
should fulfill these three criteria :

1. The variable must be independently associated with the


outcome (i.e. be a risk factor).

2. The variable must be associated with the exposure under


study in the source population.

3. It should not lie on the causal pathway between exposure


and disease.

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Effect of Confounding
• Confounding factors, if not controlled for, cause bias in the
estimate of the impact of the exposure being studied.

• The effects of confounding can result in:

An observed difference between study populations when no


real difference exists.

No observed difference between study populations when a


true association does exist.

An underestimate of an effect.

An overestimate of an effect.
2/2/2023 283
Control for Confounding Variables
 In the design:

– Randomization

– Restriction

– Matching

 During analysis:

– Standardization

– Stratification

– Multivariate analysis

2/2/2023 284
1. Randomization

• It ensures that all potential confounding factors are evenly


distributed among the comparison groups.

• This is especially important in intervention studies.

2. Restriction

• Individuals who fall with in a specific category or categories


of the confounder will be included in the study.

• E.g. If smoking is a potential confounding factor, either


smokers only or non smokers only will be included in the
study.
2/2/2023 285
3. Matching

• Randomization and restriction are done during the design


stage

• Matching can be done during the design and analysis


stage

• In matching the particular subjects are in such a way that


the potential confounders are distributed in an identical
manner among each of the study groups.

• Matching is primarily used in case control studies

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4. Stratified analysis

• This used during the analysis stage.

• It involves the evaluation of the association with in


homogenous categories or strata of the confounding
variable.

5. Multivariate analysis

• This used during the analysis stage.

• It can control many confounding factors simultaneously.

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Judgment of Causality
• One of the major purposes of epidemiological studies is
discovering the causes of disease

• Judge whether an association of an exposure and an outcome


is a causal relationship.

• An association is a statistical relationship between two or


more events, characteristics, or other variables.

• An additional level of evidence is required to support


causation.

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• One cannot conclude to a cause-and-effect relationship from
the results of a single observational study showing an
association between an exposure and a disease.

• Properly conducted experimental trials do provide more direct


proof of cause and effect, yet are usually not possible
because of ethical considerations.

• In the absence of an experimental trial, establishing


causation is a difficult process, involving the considerations of
a number of criteria.

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 The Bradford Hill criteria are the ones most frequently
employed in trying to establish causation.

 None provides in itself a perfect means of providing


causation, and each has its limitations.

 However, when they are considered together, the weight of


the evidence may allow a tentative conclusion to be reached.

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Bradford Hill criteria
1. Strength of the association

• Refers to RR: the larger the RR, the greater the likelihood that
the factor is causally related to the outcome

2. Dose-response relationship

• risk of disease increases with increasing exposure with the


causal agent

3. Consistency of the relationship

• This criterion requires that an association uncovered in one


study persist on testing under other circumstances, with other
study
2/2/2023 population, and with different study methods. 291
Bradford hill criteria….
4. Temporal relationship

• Exposure to the suspected factor must antedate the onset of


disease.

5. Specificity of the association

• the association is more likely causal if a single exposure is


linked to a single disease

2/2/2023 292
6. Biological plausibility (coherence with existing
information)

• Additional support for the causal nature of an association


exists if a causal interpretation is plausible in terms of
current knowledge about the factor & disease.

7. Prevention

• If the exposure is a cause of the disease, then


eliminating the exposure (or modifying host response to
the exposure, for example through immunization ) should
be followed by a decrease in the incidence rate of the
disease
2/2/2023 293
Validity of Epidemiological Studies
Validity= (does a measurement/a test give correct results?):
is the finding a reflection of the truth?

Precision= is the finding due to sampling variation

Accuracy = Validity + Precision

= Validity + Precision

2/2/2023 294
Validity of Epidemiological Studies
Two types of validity

A. Internal validity - is the degree to which the results of


the study are correct for the particular group of people
studied.

b. External validity (generalizability) - is the extent to


which the results of study apply to people not in it.

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Factors affecting generalizability
• Basic factors that determine the generalizability of the study
findings are:

• Sample size

• Sampling procedures

• Participation/ response rate

2/2/2023 296
Summary

Let we discuss important points seen so far.

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CHAPTER-7

Screening

2/2/2023 298
Outlines
• Definition of screening

• Types of screening

• Criteria for screening

• Factors affecting validity and reliability of screening tests

• Biases in Screening

2/2/2023 299
Learning outcomes
At the end of this lesson, students will be able:
• To define screening

• List and identify the different types of screening

• Use screening criteria to establish a screening program

• Describe criteria for establishing and evaluating screening


programs.

• Identify factors that affect validity and reliability of screening


tests.

2/2/2023 300
Screening---definition and introduction
• Test-is any device, machine or process designed to detect a
sign, a substance, or a tissue change.

• Screening- is the process of using tests on a large


scale/small scale to identify the presence of disease/ specific
exposure in apparently healthy people.

• Screening test-the search for unrecognized disease or defect


by means of rapidly applied tests, examinations or other
procedures in apparently healthy individuals.

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….Definition and introduction….
• Screening is a procedure in order to:
• separate those with a relatively high probability of
having a given disease from those with a relatively low
probability of having the disease.
• perform early detection of disease, precursors to
disease, or susceptibility to disease in individuals who do
not have signs and symptoms of a disease.

• Screening test is done:


• In individuals with no such symptoms or signs
• On apparently healthy persons
• For early detection of a disease condition
2/2/2023 302
….Definition and Introduction…..
• Diagnostic tests are used to confirm the presence or absence of
illness, provide prognostic information, and predict a response
to treatment.

• Therefore:
• Identify and confirm a disease condition in individuals
• Diagnostic test is performed in persons with symptoms
or a signs of an illness
• Tests performed in patients
• case finding within a population that is probably disease.

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…..Definition and Introduction…..
• Screening tests are after sub-clinical disease changes have
occurred, but before symptoms are manifest.

• Diagnostic tests are after symptoms manifested.

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……Definition and Introduction…….

2/2/2023 305
Aim of screening tests
• To lower morbidity and mortality of the disease in a
population.
• To provide access to the medical care system.
• To protect society from contagious disease
• For rational allocation of resources
• Research study on natural history of disease
• Selection of healthy individuals usually for employment.
• To alter the natural course of disease
• To reverse, halt, or slow the progression of a disease
• To2/2/2023
improve quality of life 306
Types of Screening program
1) Selective Vs mass screening
Selective screening (Targeted screening):
 screening of people with selective exposure.
 It is targeted screening of groups with specific exposures.
 is often used in environmental and occupational health.
Mass screening:
 screening of people without reference to specific exposure.
 It involves screening of a whole population

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Types of Screening program…..
2) Single Vs Multiple
Single: involves a single screening test for occasion.
Multiple/Multiphasic:
• Involves a variety of screening tests on the same occasion.
• Can be classified as multiple-parallel Vs series
• 1. Parallel testing: applying two screening tests and a
positive result on either test is sufficient to be labeled as
positive E.g. Breast ca screening
• 2. Series testing: applying two screening tests and both
must be positive in order to prompt action. Example: HIV
2/2/2023 308
testing
Types of Screening program…..

3) Case-finding or opportunistic screening:


is restricted to patients who consult a health practitioner
for some other purpose

Example: TB patients will be screened for HIV.

NB: Series tests are further go if the initial screening test is


positive, otherwise the result will be notified with the initial test,
which improves the overall positive predictive value and
specificity of the test in opposite to parallel tests.

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Criteria for establishing a screening program
• Importance of public health problem-- severe, common

• Costs- justifiable

• Nature of the screening test- cheap, valid, acceptable,


reliable and easy to apply

• The natural history of the disease

• Impact of treatment of the disease

• Adequate availability of facilities

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WHO Criteria for establishing a screening program
• Is it a health problem?

• Is there treatment?

• Are there facilities in place?

• Is it detectable pre-clinically?

• Is there a suitable screening test?

• Is the screening test acceptable to people?

• Is the natural history of disease understood?

• Are the costs acceptable?

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Characteristics of a screening tests
• Screening tests can be questions, clinical examinations,
laboratory tests, x-ray, genetic tests, etc….

• Characteristics of good screening tests:

• Simple

• Easy to administer

• Inexpensive

• Rapid

• Safe and acceptable

• Valid (Accurate) and reliable (Precision)


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Accuracy measures of a screening test
• Accuracy is the ability of the test to correctly classify
individuals according to their disease status.
• The validity of a screening test is measured by its ability to
do:
• what it is supposed to do, or
• correctly categorize persons who have pre-clinical
disease as test-positive

• those without preclinical disease as test-negative.

• Reliability is the consistency of results when repeated


examinations are performed on the same persons under the
same
2/2/2023 condition. 313
Validity
• Validity has two components: sensitivity and specificity.

• The following are key measures to be calculated:

• Sensitivity

• Specificity

• Predictive Value

• Yield

• In order to simplify the calculation of these validity measures


of a screening test the next slide contingency (two by two)
table is important.
2/2/2023 314
Validity….

2/2/2023 315
Sensitivity
• Is the ability of a test to identify correctly those who have the
disease.
• the proportion of cases with a positive screening test among
all individuals with pre-clinical disease
• the proportion of people with a disease who have a positive
test result
• A sensitive test is preferable:
• penalty for failing to detect a disease
• the probability of disease is relatively low
• to discover possible cases.
2/2/2023 316
Sensitivity…..
• A test with high sensitivity will have few false negatives.

• Want a highly sensitive test in order to identify as many cases


as possible.

• There’s a trade off with specificity.

2/2/2023 317
Specificity
• The proportion of individuals with a negative screening test
result among all individuals with no pre-clinical disease.

• The proportion of people without a disease who have a


negative test.

• Is the ability of a test to identify correctly those without the


disease.

2/2/2023 318
Predictive value
• It is the ability of the test results to predict the presence or
absence of disease

• Measures whether or not an individual actually has the


disease, given the results of a screening test.

• The predictive value of a test is depend on (determined by):

• Specificity

• Sensitivity

• Prevalence of preclinical disease= a+c/a+b+c+d

2/2/2023 319
Predictive Value…..
• The higher the prevalence, a positive test is predictive of the
diseases.

• The more sensitive a test, the greater the predictive value


negative.

• The more specific the test, the greater the predictive value
positive.

• For rare disease, the major determinant of the predictive value


positive is the prevalence of the disease.

• No matter how specific the test, if at low risk of having the


disease,
2/2/2023
results that are positive will mostly be false positives.
320
Predictive value of positive test
• Is the proportion of individuals with the condition among
those who have positive results.

• Is the proportion of screening test positives who are truly


positive.

• It is the probability of disease in a person with a positive


(abnormal) test result.

2/2/2023 321
Predictive Value of a negative test
• is the proportion of those who don’t have the condition
among those have negative screening results.

• is the proportion of screening test negatives who are truly


negative

• is the probability of not having the disease when the test


result is negative (normal).

2/2/2023 322
Yield
• The number of cases of disease detected by the screening
test in relation to the total number of person screened

• The following are several factors that affect the yield of the
screening program: -
• Sensitivity of the test
• Prevalence of unrecognized disease
• Multi-phase screening
• Frequency of screening
• Participation in screening and follow up
2/2/2023 323
Reliability/Precision
• The consistency of results when repeat examinations are
performed on the same persons under the same condition.

• The ability of a test to give consistent results when it is


performed more than once on the same individual under the
similar conditions

• Does the test give the same measurement each time?

• Affected by variation in the method, observer and the


characteristic to be measured.

2/2/2023 324
Types of reliability
• Biological variation- inherent in the actual manifestation
being measured such as BP.
• Variation due to the test method or measurement
Which relates to the reliability of the instrument itself, such
as standard mercury sphygmomanometer for BP
• Intra observer variability - differences in repeated
measurements by the same screener
• Inter observer variation- inconsistencies attributable to
differences in the way different screeners apply or interpret
test results.
2/2/2023 325
Reliability….
• Reliability variations can usually be reduced by:

• Careful standardization of procedures

• An intensive training period for all observers (or


interviewers)

• Periodic checks on their work

• The use of two or more observers making independent


observations.

2/2/2023 326
Biases in Screening program evaluation
 Lead-time bias: the interval between the time a condition is
detected through screening & the time it would normally have
been detected by the reporting of symptoms & signs.

 Length bias: the duration of the preclinical stage is a


function of the rate of Ds progression & the patients
awareness of symptoms.

 Patient-self-selection bias: Participants in early detection


programs may differ from those not participating in terms of
characteristics that may be related to survival.
2/2/2023 327
Summary
Golden standard test
positive negative total
Screening test +ve 1555 988 2543
-ve 514 1394 1908
Total 2069 2382 4451
1. What is the sensitivity of the test?1555/2069=0.75
2. What is the specificity of the test?1394/2382=0.58
3. What is the percent false positive? =0.25
4. What is the percent false negative? =0.42
5. What is the PPV of the test? 1555/2543=.61
6. What is the NPV of the test? 1394/1908=0.73
7. What is the Yield of the test? 1555/4451=0.35
8. What ii the prevalence of disease 2069/4451=0.46 328
CHAPTER-8

Public Health Surveillance

2/2/2023 329
Outlines
• Definition of Surveillance

• Attributes and Principles of public health surveillance

• Integrated disease surveillance and response

• Timely warning and intervention

2/2/2023 330
Surveillance
• Surveillance is the continued watchfulness:

• over the distribution and trends of incidence of a disease

• through the systematic collection, consolidation, and


evaluation of morbidity and mortality reports and other
relevant data.

• Public health surveillance is the ongoing systematic collection,


analysis, interpretation and dissemination of health data to
help and guide public health decision making and action.

2/2/2023 331
Surveillance……
• Surveillance relies on simple systems to collect a limited
amount of information about each case.
• Currently existing surveillance systems target injuries, chronic
diseases, genetic and birth defects, occupational and
potentially environmentally related diseases, and health
behaviors.
• Surveillance is used to detect outbreaks of new or old
diseases.
• Recently, a crucial component of national and global defenses
against catastrophic epidemics, globally, regionally and locally.

2/2/2023 332
Application of Public Health Surveillance
• Learn more about the natural history, and epidemiology of a
disease.

• To learn ongoing pattern of disease occurrence and the


potential for disease in a population.

• provide us with a baseline data for prevention and control

• Monitoring trend of health events and conditions

• Identifying and targeting high risk groups

• Monitoring of geographic pattern of health events

• Stimulates
2/2/2023 diagnosis and link to clinical services
333
Application of Public Health Surveillance….

• Stimulate research and links to hypothesis testing

• Evaluation of interventions, programs and policies

• Planning and projections (prediction and forecasting)

• Guides education and policy

• Archive of disease activities

2/2/2023 334
Criteria to select and prioritize diseases for
surveillance system
• Public health importance of the problems:
• incidence, prevalence
• severity, sequela, disabilities
• mortality caused by the problem
• socioeconomic impact
• Communicability
• potential for an outbreak occurrences
• public perception and concern, and international
requirements

2/2/2023 335
Criteria to select and prioritize diseases for
surveillance system
• Ability to prevent, control, or treat the health problem
• preventability and
• control and treatment measures

• Capacity of health system to implement control measures for


the health problem
• speed of response
• Economics
• availability of resources, and
• what surveillance of this event requires

2/2/2023 336
Criteria to select and prioritize diseases for
surveillance system
• Can easily be identified using simple case definitions

• If the diseases have a high potential for causing epidemics

• If the diseases have been targeted for eradication or


elimination

• If the diseases have significant public health importance

• If the diseases can be effectively controlled and prevented

2/2/2023 337
Attributes of Public Health Surveillance
• Simple
• Flexible
• Acceptable
• Sensitive-able to detect the problem
• Good predictive value positive-good yield
• Representative
• Timely
• Cost effective
• Continuous/ dynamic
• Purposeful/orientation to action

2/2/2023 338
Types of Public Health Surveillance
• Based on case detection mechanism, there are three main
types of surveillance.
• Active surveillance
• Passive surveillance and
• Sentinel surveillance

• All of which may co-exist in a single geographical area or


health system.

2/2/2023 339
Active Surveillance
• It is based on active case detection mechanism
• It is more accurate and better representative as community
based data
• It is not routine activities because it is expensive and time
consuming
Example: Outbreak investigation and control
• It is appropriate when:
Periodic evaluation of ongoing program
 programs with limited time of operation
 The occurrence of unusual health situations
2/2/2023 340
Passive Surveillance
• It is a form of data collection:

• Healthcare providers send reports to a health


department on the basis of a known set of rules and
regulations.

• It is based on passive case detection, routine recording and


reporting of activities.

• It may not be complete because not all events will be


reported.
• usually unreliable, inaccurate, non-representative and
untimely.
2/2/2023 341
Sentinel surveillance
• Pre-arranged sample of reporting sources agree to report all
cases of one or more conditions.
• Usually the sample sources are selected to be those most likely
to see cases.
• Particularly in developing countries, provides a practical
alternative to population-based surveillance.
• Identify institutions that serve the population subgroups of
interest, and will obtain data regarding the condition of
interest.

2/2/2023 342
Sentinel Surveillance….
 Main Purposes:
 To detect changes
 To direct and focus control efforts
 To develop intervention strategies
 To promote further investigations
 Provide the basis for evaluating preventive strategies.
 NB: Enhanced surveillance: the collection of additional data
about cases reported under routine surveillance.
Intensified surveillance:: The upgrading from a passive to
an active surveillance system for a specified reason and for a
limited period (usually because of an outbreak)
2/2/2023 343
Activities in Surveillance
• Data collection and recording

• Reporting and notification

• Compilation, data analysis and interpretation

• Dissemination of the findings for appropriate action

• Disease prevention and control

• Health planning and resource allocation

• Research and teaching

2/2/2023 344
Activities in Surveillance…..

2/2/2023 345
Case definition
• is a set of standard criteria for deciding whether an individual
should be classified as having the health condition of interest
or if the case can be considered for reporting and
investigation.

• Standard case definition: If the use of case definition is


agreed by everyone in the country or across boundaries or
continents.

• Three are types.

2/2/2023 346
Types of case definition

• Confirmed (definite) case: is a case with laboratory


confirmation.

• Probable (presumed) case: a case with typical clinical


features of the disease without laboratory confirmation.

• Suspected (possible) case: a case presented with fewer of


the typical clinical features of the disease without laboratory
confirmation.

2/2/2023 347
Sources of data for surveillance
• Census data
• Mortality reports (birth and death certificates, autopsy reports)
• Morbidity reports (notifiable disease reports)
• Hospital data
• Absenteeism records (school, workplace, compensation claims)
• Epidemic reports
• Laboratory test utilization and result reports
• Drug utilization records
• Adverse drug reaction reports
• Special surveys (e.g., research data, serologic surveys)
• Police records
• Information on animal reservoirs and vectors
• Environmental data (hazard surveillance, water and food testing)
• Special surveillance systems (e.g., for injury and occupational
illness)

2/2/2023 348
Integrated Disease Surveillance and
Response (IDSR)
• is an approach adapted to strengthen national disease
surveillance systems.
• It is done by coordinating and streamlining all surveillance
activities
• Ensuring timely provision of surveillance data to all disease
prevention and control programs in order to initiate timely
response (intervention).
• Improving communicable disease surveillance and response
through linking community, health facility, woreda and
national levels in the country which promotes rational use of
resources.
2/2/2023 349
IDSR…….
• Focuses at the woreda level.

• Coordinates and streamline all surveillance activities

• Facilitate collaboration between surveillance focal points and


response committees at each level

• Taking appropriate and timely public health responses and


actively seek opportunities for combining resources.

• The overall objective of the IDSR is to improve the ability of


health workers to detect and respond efficiently.

• Effective and timely decision-making based on good


2/2/2023
evidence. 350
IDSR…..
 In order to achieve its objectives seeks to:
• Strengthen the capacity of districts.
• Integrate multiple surveillance systems
• Improve the use of information for decision making
• Improve the flow of surveillance information between and
within levels of the health system
• Improve laboratory capacity in identification of pathogens
and monitoring of drug sensitivity
• Increase the involvement of health workers.
• Emphasize community participation

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Public Health Emergency Management (PHEM)
 is the process of anticipating, preventing, preparing for,
detecting, responding to, controlling and recovering from
consequences of public health threats in order that health and
economic impacts are minimized.
 Has four phases:
 Mitigation- pre-event planning and actions.
 Preparedness-actions taken before an emergency
 Response- activities to address immediate and short-term
effects of a disaster.
 Recovery-restore essential functions and normal operation
2/2/2023 352
Limitations of Public Health Surveillance
• Underreporting
• Lack of knowledge of the reporting requirements
• Negative attitude toward reporting of cases
• Misconceptions
• Lack of representativeness
• Lack of timeliness and inconsistency of case-definitions
Timely warning and intervention is the main principle of
PHEM.

2/2/2023 353
Summary

Let we conclude the pertinent points seen so far in Public


Health surveillance.

2/2/2023 354
Chapter-9

Outbreak investigation and management


methods

2/2/2023 355
Outlines
• Patterns of occurrence of diseases

• Disease outbreaks

• Steps of investigation of an outbreak

• Management and control of an outbreak or epidemic

2/2/2023 356
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.
• The examples of expected level are endemic and hyper
endemic.
• But sometimes they occur in excess of what is expected.
• Outbreak
• Epidemic, and
• Pandemic 357
Definition of terms on level of disease occurrence

1. Endemic: Presence of a disease at more or less stable


level.

• Malaria is endemic in the lowland areas of Ethiopia.

2. Hyper endemic: Persistently high level of disease


occurrence.

3. Sporadic: Occasional or irregular occurrence of a


disease. When diseases occur sporadically they may
occur as epidemic.
358
Definition of terms …
4. Epidemic: The occurrence of disease or other health related
condition in excess of the usual frequency in a given area or
among a specific group of people over a particular period of
time.
5. Outbreak: Epidemics of shorter duration covering a more
limited area.
6. Pandemic: An epidemic involving several countries or
continents affecting a large number of people.
• For example the worldwide occurrence of HIV/AIDS is a
pandemic
359
Epidemics
 Three points to be kept in mind

1. Epidemic refers to
 Acute and chronic infection
 Non infectious diseases
 Other health related conditions

2. No minimum number

3. Knowledge of the usual frequency

360
Types of epidemics
• Epidemics (outbreaks) can be classified according to
• the method of spread or propagation,
• nature and length of exposure to the infectious agent,
and duration.

1. Common Source Epidemics:

 Disease occurs as a result of


 exposure of a group of susceptible persons to a
common source of a pathogen,
 often at the same time or within a brief time period.361
Types of epidemics….
 When the exposure is simultaneous, the resulting cases
develop within one incubation period of the disease and
this is called a point source epidemic. E.g. Food borne
epidemic

362
Fig. the epidemic curve for point source epidemic

Epidemic
Number of
cases

Usual rate

Time
Characteristics:
•Sharp rise and fall
•Unimodal peak
•Short duration 363
Types of epidemics….

• If the exposure to a common source continues over time it


will result in a continuous common source epidemic.

• E.g. A waterborne outbreak that spreads through a


contaminated community water supply

• The epidemic curve may have a wide peak because of the


range of exposures and the range of incubation periods.

364
Pattern of a continuous common source epidemic

Epidemic
Number
of cases
Flat top

Usual rate

Time

365
Types of epidemics….
2. Propagated/ Progressive Epidemics:-

• The infectious agent is transferred from one host to another.

• It can occur through direct person to person transmission or it can


involve more complex cycles in which the agent must pass through a
vector as in malaria.

• Propagated spread usually results in an epidemic curve with a relatively


gentle upslope and somewhat steeper tail.

• An outbreak of malaria is a good example of propagated epidemic.

• When it is difficult to differentiate the two types of epidemics by the


epidemic curve, spot map (studying the geographic distribution) can help
366
Pattern of a propagated type epidemic
Number Epidemic
of cases

Usual
rate
Time
Characteristics:
•Slow increase
•Several peaks
•Sharp fall
367
Types of epidemics….

3. Mixed Epidemics:-

 The epidemic begins with a single, common source of an


infectious agent with subsequent propagated spread.

 Many food borne pathogens result in mixed epidemics.

368
Investigation of an Epidemic
• Investigating disease outbreaks is a form of active
surveillance.

• The purpose is :
• to determine the specific cause or causes of the
outbreak at the earliest time and
• to take appropriate measure directed at controlling the
epidemic and preventing future occurrence.

369
Questions should be answered when investigating
an epidemic.
1. What is the etiological agent responsible for the epidemic?
2. What is/are the predominant modes of transmission?
3. What specific source/s of disease can be identified?
E.g. human carriers, breeding sites for vectors, etc.
4. What specific practices or environmental deficiencies have
contributed to the outbreak?
E.g. improper food handling, human made breeding sites for
mosquitoes.
5. What is the chain of events that led to the outbreak?
E.g. accumulation of susceptible hosts in an area. 370
Basic Principles of Outbreak Investigation
• Conduct multiple activities simultaneously; run a dynamic process.

• Maintain communication with officials, stakeholder and the public.

• Apply epidemiological and statistical principles regarding study


design and analysis appropriately.

• Record all steps taken in the investigation and all information


gathered.

• Careful and critical review of the literature should be undertaken.

Investigators must maintain open but critical mind to uncovered new


pathogens/transmission means
371
Steps in epidemic investigation
1. Prepare for fieldwork.

 Before leaving for the field you should be well prepared to


under take the investigation.

 Preparations can include:


a. Investigation-
– appropriate scientific knowledge,
– supplies, and equipment to carry out the investigation
b. administration, and
c. consultation.
372
Steps in epidemic investigation….
2. Verify (confirm) the existence of an epidemic.

 This initial determination is often made on the basis of available


data.

 Compare the number of cases with the past levels to identify


whether the present occurrence is in excess of its usual
frequency.

 Instead of comparing absolute numbers it is advisable to


compare rates like incidence rate

373
Steps in epidemic investigation….
3. Verify (confirm the diagnosis).

 Always consider whether initial reports are correct.

 Carry out clinical and laboratory investigations on the reported cases.


For example the already collected blood film slides can be seen by
laboratory experts to check whether the initial report was correct.

 It is important to investigate the index case (the first case that comes to
the attention of health authorities) and other early cases.

 The sooner the index case and other early cases are investigated, the
greater the opportunity to arrest the outbreak at earliest stage possible.

374
Steps in epidemic investigation….
4. Identify and count cases.

 Remember excess may be due to


• Changes in local reporting producers
• Changes in case definition
• Improvement of diagnostic

• A standard case definition is required to differentiate cases and non cases


• Confirmed / definite – a case with clinical features and laboratory
investigation
• Probable – a case with typical clinical features without laboratory
confirmation
• Possible a case with fewer of typical clinical features

375
Steps in epidemic investigation….
5. Describe the epidemic with respect to person, place and time.

• Each case must be defined according to standard epidemiologic


parameters:

• the date of onset of the illness,

• the place where the person lives or became ill,

• and the socio-demographic characteristics (age, sex, education


level, occupation).

• The tools to be used when characterizing the epidemic are

• Epidemic curve,

• spot map and attack rates. 376


Steps in epidemic investigation….
• Epidemic curve is an important tool for the investigation
of disease outbreaks.

• In epidemic curve the distribution of cases is plotted over


time, usually in the form of histogram, with the date of
onset of cases on the horizontal axis, and the number of
cases corresponding to each date of onset on the vertical
axis.

377
Steps in epidemic investigation….
• Spot map is a map of locality where the outbreak has occurred,
on which the location of cases is plotted.
• The spot map is often helpful in detecting the source of an
outbreak.
• Mapping disease can be done at kebele, woreda, regional, and
national level.
• One limitation of spot map is that it does not take into account
underlying geographic differences in population density.
• Thus the spot map needs to be supplemented by calculation of
place specific attack rates.
378
Steps in epidemic investigation….
6. Formulate hypothesis
• The hypothesis should addressed
• Source of the agent
• Mode of transmission
• Exposure that cause the disease
• All factors that can contribute to the occurrence of the epidemic
should be assessed.
• The epidemic investigating team should try to answer questions
like:
• Why did this epidemic occur?
• Are there many susceptible individuals?
• Is the temperature favorable for the transmission of the
diseases?
• Are there breeding sites for the breeding of vectors? Etc
379
Steps in epidemic investigation….
7. Search for additional cases
• Using active and passive case detection
• Investigation of inapparent asymptomatic person

• 8. Analyze the data


• interpret findings

9. Make a decision on the hypothesis tested

10. Intervention and follow up


• Intervention must be as soon as possible
• Control
• Mode of transmission
• Destroying contaminated food
• Sterilizing
380
Steps in epidemic investigation….
11. Reporting

• Comprehensive report to concerned agencies


• Factor leading to epidemics
• Evaluation of measures
• Recommendation for prevention of similar episodes

381
Epidemic/Outbreak management
• Management of epidemics requires an urgent and
intelligent use of appropriate measures against the spread
of the disease.

• Action to be taken is dependent on


• the type of the disease
• the source of the outbreak.

• However, the actions can be generally categorized as


presented below to facilitate easy understanding of the
strategies
382
Epidemic management….
1. Measure directed against the reservoir

 Domestic animals as reservoir:


• Immunization. Example – giving anti-rabies vaccine
for dogs
• Destruction of infected animals e.g anthrax

 Wild animals as reservoir:


• post-exposure prophylaxis for human beings-
Example: rabies

383
Epidemic management….
 Humans as reservoir-

A . Isolation of infected persons.

 This is separation of infected persons from non-infected for the


period of communicability.

B. Treatment to make them noninfectious- e.g., tuberculosis.

C. Quarantine- is the limitation of freedom of movement of apparently


healthy persons or animals who have been exposed to a case of
infectious disease.

• Usually imposed for the duration of the usual maximal incubation


384
period of the disease.
Epidemic management….
• The three internationally quarantinable diseases by
international agreement:
• Cholera,
• Plague, and
• yellow fever

• Now quarantine is replaced in some countries by active


surveillance of the individuals;

• Maintaining close supervision over possible contacts of ill


persons to detect infection or illness promptly; their freedom
of movement is not restricted. 385
Epidemic management….
2. Measures that interrupt the transmission of organisms

 Action to prevent transmission of disease by ingestion:


i. Purification of water
ii. Pasteurization of milk
iii. Inspection procedures to ensure safe food supply.

iv. Improve housing conditions.

 Actions to reduce transmission of respiratory infections


• include ventilation of rooms

 In the case of diseases that involve an intermediate host for transmission,


• for example schistosomiasis, clearing irrigation farms from snails is an
appropriate measure.
386
Epidemic management….
3. Measures that reduce host susceptibility

 Immunization
• Active immunization – antigen
• Passive immunization- antibody eg TAT

 Chemoprophylaxis: for example, use of chloroquine to


persons traveling to malaria endemic areas.

 After the epidemic is controlled, strict follow up


mechanisms should be designed so as to prevent similar
epidemics in the future.
387
Challenges of investigating outbreaks
• Urgency to find the source and prevent additional cases.
• Substantial pressure from the public/decision makers to
conclude investigation quickly.
• Inadequate statistical power of the investigation due to limited
number of cases.
• Early media reports concerning the outbreak may bias responses
of persons subsequently identified and interviewed for the
investigation.
• Useful clinical and environmental samples may be very difficult
or impossible to obtain if investigation is not started promptly.
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Summary

2/2/2023 389
Thank You!!!

2/2/2023 390

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