Module 1-3 Flashcards
a state of complete physical, mental and
social well-being and not merely the
absence of disease or infirmity.
Health
the science and art of preventing disease, prolonging life, and promoting health and efficiency through organized community efforts for the:
a. Sanitation of the environment
b. Control of community infection
c. Education of the individual in personal health
d. Organization of medical and nursing services for the early diagnosis and treatment of disease
e. Development of social machinery which will
ensure to every individual in the community a
standard of living adequate for the maintenance or improvement of health
Public Health
Focus of a public health intervention is to
prevent rather than treat a disease through
surveillance of cases and the promotion of
healthy behaviors
T/F
T
From the early beginnings of human civilization, it was recognized
that __ may spread
vector-borne diseases?
polluted water & lack of proper waste disposal
Rules governing medical practice
1700 BC The Code of Hammurabi
Personal, food and camp hygiene, segregating lepers, overriding
duty of saving of life (Pikuah Nefesh) as religious imperatives.
1500 BC Mosaic Law
Personal hygiene, fitness, nutrition, sanitation, municipal doctors,
occupational health; Hippocrates –clinical and
epidemic observation and environmental health
400 BC Greece
aqueducts, baths, sanitation, municipal planning, and sanitation services, public baths, municipal doctors, military
and occupational health.
500 BC to AD 500 Rome
destruction of Roman society and the rise of Christianity; sickness as punishment for sin, mortification of the flesh, prayer, fasting and
faith as therapy; poor nutrition and hygiene
pandemics; antiscience; care of the sick as religious duty.
500 – 1000 Europe
origins in Asia, spread by armies of Genghis Khan, world pandemic kills 60 million in fourteenth century, 1/3 to 1/2 of the
population of Europe.
1348 – 1350 Black Death
bubonic plague, smallpox, leprosy, diphtheria, typhoid, measles, influenza, tuberculosis, anthrax, trachoma, scabies and others
until eighteenth century
1300 Pandemic
microscope, observes sperm and bacteria.
1673 Antony van Leeuwenhoek
first vaccination against smallpox.
1796 Edward Jenner
growth of science.
1830 Sanitary and social reform
waterborne cholera in London: the Broad Street Pump, Father of epidemiology; founded the science of epidemiology
1854 John Snow
modern nursing and hospital reform – Crimean War
1854 Florence Nightingale
He proves no spontaneous generation of life.
1858 Louis Pasteur
publishes On the Origin of Species.
1859 Charles Darwin
He publishes findings on microbial causes of disease.
1862 Louis Pasteur
He discovered anthrax bacillus.
1876 Robert Koch
He discovered gonococcus organism.
1879 Neisser
He discovered the tuberculosis organism, tubercle bacillus.
1882 Robert Koch
He discovered bacillus of cholera.
1883 Robert Koch
Vaccinates against anthrax
1883 Louis Pasteur
Gas gangrene organism discovered by
1892 Welch and Nuttal
Pertussis vaccine developed
1926
Alexander Fleming discovers penicillin
1928
wide spread economic collapse, unemployment,
poverty, and social distress in industrialized
countries.
1929 – 1936 The Great Depression
World Health Organization was founded on year?
1946
WHO declares eradication of smallpox
achieved
1979
First recognition of cases of acquired immune deficiency syndrome (AIDS).
1981
W.F. Anderson performs first successful gene therapy.
1990
brief document that recognizes primary health care as a means to achieving the objective of health for all people of all nations.
Alma Ata Declaration
In terms of health and safety programs, it’s a joint declaration of nations under the umbrella of the World
Health Organization (WHO) that was adopted and
announced to the world in 1978 during the International Conference on Primary Health Care in Almaty, Kazakhstan.
Alma Ata Declaration
Core Functions of Public Health:
Assessment: of the health of the community
Policy Development: in the public interest
Assurance: of the public’s health
Systematically collect, analyze, and make available information on healthy communities
Assessment
Promote the use of a scientific knowledge
base in policy and decision making
Policy Development
Ensure provision of services to those in need
Assurance
failure of the body defense mechanism to cope with forces tending to disturb body equilibrium
Disease
science of theory of the causes or origins of diseases
Etiology
study of the distribution of disease and the factors that influence the occurrence of disease in groups of people
Epidemiology
is an organized plan of services.
Health care system
responsible for the maintenance of the Barangay Health Center and provision of servicesand facilities
related to general hygiene
Barangay
for primary health care programs, establishment of clinics and health centers, and provision of services and facilities related to general hygiene
City or Municipality Government
is mandated to assist the municipal and barangay government through hospitals and pollution control systems
Provincial Government
composed of barangay, municipal, and medicare healthcare institutions, which have facilities and capabilities for first emergency care
Primary Level
consists of district healthcare institutions with capabilities and facilities for medical care of cases requiring hospitalization. Municipal hospital with 50-100 bed capacity
Secondary Level
composed of specialized centers, regional healthcare institutions, and provincial. Regional medical center with complete facilities and above100-bed capacity
Tertiary Level
Primary focus on population
PUBLIC HEALTH/MEDICINE
PUBLIC HEALTH
Primary focus on individual
PUBLIC HEALTH/MEDICINE
MEDICINE
Emphasis on Prevention and Health Promotion of the whole community
PUBLIC HEALTH/MEDICINE
PUBLIC HEALTH
Emphasis on Diagnosis and Treatment of the whole patient
PUBLIC HEALTH/MEDICINE
MEDICINE
Paradigm: Intervention aimed at environment, human
behavior and lifestyle, medical care.
PUBLIC HEALTH/MEDICINE
PUBLIC HEALTH
Paradigm: Medical care
PUBLIC HEALTH/MEDICINE
MEDICINE
Organizational Lines of Specialization:
-Analytical (epidemiology)
-Setting and populations (occupational health)
-Substantive health program (nutrition)
-Skills in assessment, policy, development and assurance.
PUBLIC HEALTH/MEDICINE
PUBLIC HEALTH
Organizational Lines of Specialization:
-Organs
-Patient group
-Etiology, pathophysiology
-Technical skills
PUBLIC HEALTH/MEDICINE
MEDICINE
Science that forms the basis for public health action and unites the public health professions. It now refers to the study of the distribution and determinants or conditions in defined population
Epidemiology
Applied to the study of outbreaks of acute infectious diseases and was defined as science of epidemics. It is based on two fundamental assumptions:
○ Diseases do not occur by chance
○ Diseases are not distributed randomly in the
population; thus their distribution indicates
something about how and why that disease process
occurred
Epidemiology
often described as the basic science of public health”
Epidemiology
refers not only to the number of health events
Frequency
refers to the occurrence of health-related events by time, place, and person.
Pattern
the causes and other factors that influence the occurrence of disease and other health-related events.
Determinants
is the study (scientific, systematic, data-driven) of the distribution (frequency, pattern) and determinants (causes, risk factors) of health-related states and events (not just diseases) in specified populations (patient is community, individuals viewed collectively), and the application of (since epidemiology is a discipline within public health) this study to the control of health problems.
Epidemiology
is the ongoing, systematic collection, analysis, interpretation, and dissemination of health data to help guide public health decision making and action.
Public health surveillance
One of the first actions that results from a surveillance
case report or report of a cluster is investigation by the
public health department.
Field investigation
Clusters or outbreaks of disease frequently are
investigated initially with
Descriptive epidemiology
Analytic epidemiology
Descriptive epidemiology
the use of a valid comparison group.
Descriptive epidemiology
Analytic epidemiology
Analytic epidemiology
the process of determining, as systematically and objectively as possible, the relevance, effectiveness, efficiency, and impact of activities with respect to established goals
Evaluation
refers to the ability of a program to produce the intended or expected results in the field; effectiveness differs from efficacy, which is the ability to produce results under ideal conditions.
Efficiency
Effectiveness
Effectiveness
refers to the ability of the program to produce the intended results with a minimum expenditure of time and resources.
Efficiency
Effectiveness
Efficiency
To promote current and future collaboration, the epidemiologists need to maintain relationships with staff of other agencies and institutions.
Linkages
Epidemiologists working in public health regularly provide input, testimony, and recommendations regarding disease control strategies, reportable disease regulations, and
health-care policy.
Policy Development
aims to describe the distributions of diseases and determinants.
Descriptive epidemiology
Analytic epidemiology
Descriptive epidemiology
It provides a way of organizing and analyzing these data to describe the variations in disease frequency among populations by geographical areas and over time (i.e., person, place, and time).
Descriptive epidemiology
Analytic epidemiology
Descriptive epidemiology
3 epidemiologic variables:
Time
Place
Person
The occurrence of disease changes over time. Some of these changes occur regularly, while others are unpredictable.
* Displaying the patterns of disease occurrence by time is critical for monitoring disease occurrence in the community and for assessing whether the public health interventions made a difference.
Time
Place
Person
Time
Graphing the annual cases or rate of a disease over a period of years shows long- term or secular trends in the occurrence of the disease
Day of week and time of day
Secular (long-term) trends
Epidemic period
Seasonality
Secular (long-term) trends
For some conditions, displaying data by day of the week or time of day may be informative. Analysis at these shorter time
periods is particularly appropriate for conditions related to occupational or environmental exposures that tend to occur at regularly scheduled intervals.
Day of week and time of day
Secular (long-term) trends
Epidemic period
Seasonality
Day of week and time of day
To show the time course of a disease outbreak or epidemic, epidemiologists use a graph called an epidemic curve.
Day of week and time of day
Secular (long-term) trends
Epidemic period
Seasonality
Epidemic period
disease occurrence can be graphed by week or month over the course of a year or more to show its seasonal pattern, if any
Day of week and time of day
Secular (long-term) trends
Epidemic period
Seasonality
Seasonality
Describing the occurrence of disease by place provides insight into the geographic extent of the problem and its geographic
variation. Characterization by place refers not only to place of residence but to any geographic location relevant to disease
occurrence.
Time
Place
Person
Place
“Person” attributes include age, sex, ethnicity/race, and socioeconomic status.
Time
Place
Person
Person
Person Attribute:
Age
Sex
Ethnic and Racial Groups
Socioeconomic Status
most important “person” attribute. When analyzing data by age, epidemiologists try to use age groups that are narrow enough to detect any age- related patterns that may be present in the data.
Age
Sex
Ethnic and Racial Groups
Socioeconomic Status
Age
Males have higher rates of illness and death than do
females for many diseases.
* For some diseases, this sex-related difference is
because of genetic, hormonal, anatomic, or other
inherent differences between the sexes.
* These inherent differences affect susceptibility or
physiologic responses
Age
Sex
Ethnic and Racial Groups
Socioeconomic Status
Sex
Sometimes epidemiologists are interested in analyzing
person data by biologic, cultural or social groupings such
as race, nationality, religion, or social groups such as
tribes and other geographically or socially isolated
groups.
* Differences in racial, ethnic, or other group variables
may reflect differences in susceptibility or exposure, or
differences in other factors that influence the risk of
disease, such as socioeconomic status and access to
health care.
Age
Sex
Ethnic and Racial Groups
Socioeconomic Status
Ethnic and Racial Groups
Socioeconomic status is difficult to quantify. It is made up of many variables such as occupation, family income, educational achievement, or census track, living conditions, and social standing.
Age
Sex
Ethnic and Racial Groups
Socioeconomic Status
Socioeconomic Status
The key feature of analytic epidemiology is a
_______?
comparison group
concerned with the search for causes and effects, or the why and the how. Epidemiologic studies fall into two categories:
____ and _____.
experimental
observational
is similar in concept to the experimental study
* In a _____ the epidemiologist records whether each study participant is exposed or not, and then tracks the participants to see if they develop the disease of interest.
COHORT STUDY
An alternative type of cohort study is a ______. In this type of study both the exposure and the outcomes have already occurred.
retrospective cohort study
A sample of persons from a population is enrolled and their exposures and health outcomes are measured simultaneously.
* tends to assess the presence (prevalence) of the health outcome at that point of time without regard to duration.
CROSS-SECTIONAL STUDY
in order for a disease process to occur, there must be a
unique combination of events, a harmful agent that comes in contact with a susceptible host in the proper environment.
Epidemiologic Triangle
s consistent with the infectious disease process, but it can also
be applied to chronic noninfectious diseases
Triangle Model
refers to a disease that occurs infrequently and irregularly.
Endemic
Sporadic
Epidemic
Hyperendemic
Sporadic
refers to the constant presence and/or usual prevalence of a disease or infectious agent in a population within a geographic area.
Endemic
Sporadic
Epidemic
Hyperendemic
Endemic
refers to persistent, high levels of disease occurrence.
Endemic
Sporadic
Epidemic
Hyperendemic
Hyperendemic
refers to an increase, often sudden, in the number of cases of a disease above what is normally expected in that population in that area.
Endemic
Sporadic
Epidemic
Hyperendemic
Epidemic
carries the same definition of epidemic, but is often used for a more limited geographic area.
Cluster
Outbreak
Pandemic
Outbreak
refers to an aggregation of cases grouped in place and time that are suspected to be greater than the number expected, even though the expected number may not be known
Cluster
Outbreak
Pandemic
Cluster
refers to an epidemic that has spread over several countries or continents, usually affecting a large number of people
Cluster
Outbreak
Pandemic
Pandemic
outbreak is one in which a group of persons are all exposed to an infectious agent or a toxin from the same source
Common-source
Propagated
Mixed
common-source
If the group is exposed over a relatively brief period
point-source outbreak
intermittent common-source outbreak
continuous common-source outbreak - case
point-source outbreak
patients may have been exposed over a period of days, weeks, or longer
point-source outbreak
intermittent common-source outbreak
continuous common-source outbreak - case
continuous common-source outbreak - case
has a pattern reflecting the intermittent nature of the
exposure
point-source outbreak
intermittent common-source outbreak
continuous common-source outbreak - case
intermittent common-source outbreak
results from transmission from one person to another. Transmission is by direct person-to-person contact
Common-source
Propagated
Mixed
Propagated Outbreak
have features of both common-source epidemics and propagated epidemics. Pattern of a common-source outbreak followed by secondary person-to-person spread
Common-source
Propagated
Mixed
Mixed Epidemics
_____compare one part of the distribution to another part of the distribution, or to the entire distribution.
Frequency Measures
Proportions
Prevalence
Incidence
Counts
Ratio
Rate
Frequency Measures
refer to the number of cases of a disease or other health event under study
Frequency Measures
Proportions
Prevalence
Incidence
Counts
Ratio
Rate
Counts
is the relative magnitude of two quantities
Frequency Measures
Proportions
Prevalence
Incidence
Counts
Ratio
Rate
Ratio
examine all persons with the health event of interest (A, nominator) and all persons in the total population (A + B,
denominator).
Frequency Measures
Proportions
Prevalence
Incidence
Counts
Ratio
Rate
Proportions
is a measure of the frequency with which an event occurs in a defined population over a specified period of time.
Frequency Measures
Proportions
Prevalence
Incidence
Counts
Ratio
Rate
Rate
refers to the rate of occurrence of new cases of a disease or disorder in a given period in a specific population.
Frequency Measures
Proportions
Prevalence
Incidence
Counts
Ratio
Rate
Incidence
refers to frequency of existing cases in a defined population at a given point in time
Frequency Measures
Proportions
Prevalence
Incidence
Counts
Ratio
Rate
Prevalence
has been defined as any departure, subjective or objective, from a state of physiological or psychological well-being. In practice, it encompasses disease, injury, and disability.
Morbidity
is a measure of the frequency of occurrence of death in a
defined population during a specified interval.
mortality rate
crude mortality rate
infant mortality rate
age-specific mortality rate
cause-specific mortality rate
mortality rate
is the mortality rate from all causes of death for a population
mortality rate
crude mortality rate
infant mortality rate
age-specific mortality rate
cause-specific mortality rate
crude mortality rate
is the mortality rate from a specified cause for a population.
mortality rate
crude mortality rate
infant mortality rate
age-specific mortality rate
cause-specific mortality rate
cause-specific mortality rate
is a mortality rate limited to a particular age group
mortality rate
crude mortality rate
infant mortality rate
age-specific mortality rate
cause-specific mortality rate
age-specific mortality rate
is perhaps the most commonly used measure for comparing
health status among nations
mortality rate
crude mortality rate
infant mortality rate
age-specific mortality rate
cause-specific mortality rate
infant mortality rate
widely used measure of health status because it reflects the health of the mother and infant during pregnancy and the year thereafter
mortality rate
crude mortality rate
infant mortality rate
age-specific mortality rate
cause-specific mortality rate
infant mortality rate
covers birth up to but not including 28 days
neonatal period
postneonatal period
neonatal period
defined as the period from 28 days of age up to but not
including 1 year of age
neonatal period
postneonatal period
postneonatal period
is really a ratio used to measure mortality associated with
pregnancy
mortality rates
race-specific mortality rate
sex-specific mortality rate
maternal mortality rate
death-to-case ratio
maternal mortality rate
is a mortality rate among either males or females
mortality rates
race-specific mortality rate
sex-specific mortality rate
maternal mortality rate
death-to-case ratio
sex-specific mortality rate
is a mortality rate related to a specified racial group
mortality rates
race-specific mortality rate
sex-specific mortality rate
maternal mortality rate
death-to-case ratio
race-specific mortality rate
can be further stratified by combinations of cause, age, sex, and/or race.
mortality rates
race-specific mortality rate
sex-specific mortality rate
maternal mortality rate
death-to-case ratio
mortality rates
is the number of deaths attributed to a particular disease during a specified time period divided by the number of new cases of that disease identified during the same time period.
mortality rates
race-specific mortality rate
sex-specific mortality rate
maternal mortality rate
death-to-case ratio
death-to-case ratio
is the proportion of persons with a particular condition (cases)
who die from that condition
case-fatality rate
maternal mortality rate
death-to-case ratio
Proportionate mortality
case-fatality rate
describes the proportion of deaths in a specified population over a period of time attributable to different causes.
case-fatality rate
maternal mortality rate
death-to-case ratio
Proportionate mortality
Proportionate mortality
study of uses and drug effects in a defined population
Pharmacoepidemiology
“the study of the use and effects/side-effects of drugs in large numbers of people with the purpose of supporting the rational and cost-effective use of drugs in the population thereby improving health outcomes”
Pharmacoepidemiology
Examines real world = experience; Mainly relies on observational research
Pharmacoepidemiology
Pharmacoepidemiology involves disciplines such as:
epidemiology, clinical pharmacology and biostatistics
Father of modern medicine. Coined the term ‘endemic’ and promoted clean hands for wound management.
40 BC Hippocrates
Father of modern epidemiology; work in tracing the source of a cholera outbreak in Soho, England.
1854 John Snow
British Surgeon. Discovered antiseptic (carbolic acid) as an antiseptic by applying Louis Pasteur’s advances in microbiology.
1865 Joseph Lister
Introduced mathematical methods in epidemiology
Early 20th Century Ronald Rose & his team
Molecular epidemiology focusing on the relationship between biomarker and disease evolved.
Later 20th Century Ronald Rose & his team
US govt passed pure Food and Drug act in response to excessive adulteration and misbranding of food and drugs
1906
people died from renal failure due as a result of the elixir sulfanilamide dissolved in diethylene glycol
1937
Drug and Cosmetics Act was passed
1938
Thalidomide tragedy
1950-1960s
UK established a committee on safety of medicines
1968
WHO established a bureau to collect and analyze information and similar national drug monitoring organizations
1968
Kefauver-Harris Amendments
1962
related field of drug utilization was developed along with the study of ADRs
– considered to be the beginning of field of pharmacoepidemiology
1960
obtain more data on risk and benefits of drugs in population and to discuss, develop & disseminate information
ISPE (International Society for Pharmacoepidemiology)
Activities related to ISPE:
- Pharmacovigilance
- Drug utilization research and outcome
research - therapeutic risk management
is an area unique to pharmacoepidemiology and it is a type of
continual monitoring of unwanted effects and other safety-related aspects of drugs.
Pharmacovigilance
Randomized clinical trials
Experimental/Non-experimental
Experimental
Field trials
Experimental/Non-experimental
Experimental
Community intervention trials
Experimental/Non-experimental
Experimental
Prospective cohort
Experimental/Non-experimental
Non-experimental
Retrospective cohort
Experimental/Non-experimental
Non-experimental
Case control
Experimental/Non-experimental
Non-experimental
Case series
Experimental/Non-experimental
Non-experimental
Case report
Experimental/Non-experimental
Non-experimental
Cross sectional
Experimental/Non-experimental
Non-experimental
Ecological
Experimental/Non-experimental
Non-experimental
Hybrid Studies
Experimental/Non-experimental
Non-experimental
Randomized
Interventional/Clinical Trial
Observational
Interventional/Clinical Trial
Protocol-mandated visit & treatment schedule
Interventional/Clinical Trial
Observational
Interventional/Clinical Trial
Treatment by protocol
Interventional/Clinical Trial
Observational
Interventional/Clinical Trial
Restrictive entry
Interventional/Clinical Trial
Observational
Interventional/Clinical Trial
Rigidly specified
Interventional/Clinical Trial
Observational
Interventional/Clinical Trial
Prospective
Interventional/Clinical Trial
Observational
Interventional/Clinical Trial
One primary objective
Interventional/Clinical Trial
Observational
Interventional/Clinical Trial
Non-randomized
Interventional/Clinical Trial
Observational
Observational
Routine care, no mandated visit & treatment schedule
Interventional/Clinical Trial
Observational
Observational
Broad entry criteria
Interventional/Clinical Trial
Observational
Observational
Naturalistic
Interventional/Clinical Trial
Observational
Observational
Prospective and / or retrospective
Interventional/Clinical Trial
Observational
Observational
Could state several objectives
Interventional/Clinical Trial
Observational
Observational
Little / no monitoring
Interventional/Clinical Trial
Observational
Observational
Study patients with specific disease
Community intervention trials
Randomized clinical trials
Field trials
Randomized clinical trials
study subjects to prevent disease
Community intervention trials
Randomized clinical trials
Field trials
Field trials
Study communities to prevent disease
Community intervention trials
Randomized clinical trials
Field trials
Community intervention trials
Observe group of patients treated with the same drug
Case control
Retrospective cohort
Prospective cohort
Prospective cohort
Extract data from an existing repository to look at outcomes of exposed group
Case control
Retrospective cohort
Prospective cohort
Retrospective cohort
determine association between a drug and a rare event
Case control
Retrospective cohort
Prospective cohort
Case control
Reveal common experience of a number of patients following drug exposure
Cross-sectional
Ecological
Case report
Case series
Case series
reveal the experience of a single patient following drug exposure
Cross-sectional
Ecological
Case report
Case series
Case report
Determine the prevalence of drug use in a patient population at a given time
Cross-sectional
Ecological
Case report
Case series
Cross-sectional
Determine the association between drug use of a population or group and an event
Cross-sectional
Ecological
Case report
Case series
Ecological
study of the effects of drugs
Pharmacology
study of the effects of drugs in humans
Clinical Pharmacology
therapy should be individualized which requires the determination of a risk/benefit balance
Central principle of clinical pharmacology
is the study of the distribution and determinants of diseases
in populations
Epidemiology
Reasons to perform Pharmacoepidemiology Studies:
- Regulatory
- Marketing
- Legal
- Clinical
– Hypothesis testing
– Hypothesis generating
SOURCES OF PHARMACOEPIDEMIOLOGY DATA:
Spontaneous AE reporting
Global Drug surveillance
Case-control surveillance
Prescription event monitoring
Automated databases
Others
all unsolicited reports of suspected AEs
– confirmed by formal epidemiological studies
Spontaneous reporting
large complex databases
data mining
signal
data mining
previously unrecognized hazard
– known hazard more frequent or more serious
data mining
signal
signal
uses case-control methodology to systematically evaluate and detect effects of medications and other exposures on the risk
of serious illnesses
* non prescription drugs and dietary supplements
Case Control Surveillance
defined from prescriptions and followed-up for a defined period as to identify all adverse events occurring in the early post-treatment period
Prescription Event Monitoring
potential data sources
– Claim databases – Medical record databases – e.g. Medicaid, United Health Group
Automated Databases
provide insight into disease and treatment patterns of physicians e.g National Disease and Therapeutic Index
Drug utilization studies
useful in performing analysis of secular trends
Disease Incidence data
collection of cases w/out controls useful for performing case-control study
RegistryData
• artificial and raise logistical problems
• intended to address specific questions about drug efficacy and few for drug safety
Randomized Control Trial as post marketing surveillance
- practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market
- important part of pharmacovigilance
POST MARKETING SURVEILLANCE (PMS)
Applications of Pharmacoepidemiology:
- Estimation of risk of drug use
- Use in patient counseling
- Formulation of public health policy decision
- Formulation of therapeutic guidelines and discovery of new indications
- Facilitate thepharmaco-economic evaluation
